Grünenthal GmbH

In February 2025, the global pharmaceutical industry witnessed a series of milestone post-marketing collaboration deals, highlighting a deep integration of pharmaceutical innovation and market expansion that transcends geographical boundaries. From treatments for rare diseases to cancer management, and from improving sleep quality to alleviating chronic pain, drug development and distribution partnerships are advancing at an unprecedented pace. In February, Eisai joined forces with SciClone Pharmaceuticals to advance the application of tasurgratinib in the Greater China region, offering new hope to patients with cholangiocarcinoma. Meanwhile, Nxera Pharma’s partnership with Holling Bio-Pharma Corp. aims to introduce daridorexant to the Taiwanese market, providing a novel treatment option for insomnia sufferers. In another example of global collaboration, Bavarian Nordic and Biological E Limited announced a partnership to expand global supply of the chikungunya vaccine, underscoring the cooperative spirit of multinational companies in addressing public health challenges. 1. Eisai and SciClone Partner to Advance the Development and Distribution of Tasurgratinib in Greater China On February 28, 2025, Eisai announced a significant licensing agreement with a subsidiary of SciClone Pharmaceuticals. The agreement grants SciClone exclusive rights to develop and commercialize tasurgratinib in Greater China, including Mainland China, Hong Kong, Macau, and Taiwan. Tasurgratinib is a novel tyrosine kinase inhibitor that selectively inhibits FGFR1, FGFR2, and FGFR3. It has already been approved in Japan for the treatment of unresectable cholangiocarcinoma with FGFR2 gene fusions or rearrangements that have progressed after chemotherapy, and it was successfully launched in November 2024. Through this collaboration, Eisai aims to leverage SciClone’s strong market presence and commercialization capabilities in the region to accelerate the local deployment of tasurgratinib, bringing hope to more patients. Under the terms of the agreement, Eisai will receive an upfront payment in recognition of the licensing rights. In addition, milestone payments will be made as the drug progresses through development stages and secures regulatory approvals. Following product launch, Eisai will also receive royalties based on net sales, providing a return on its R&D investment and reflecting confidence in the drug’s market performance. This financial structure is designed to promote close collaboration between both parties and maximize the value of tasurgratinib. Tasurgratinib, as an orally bioavailable tyrosine kinase inhibitor, exerts its effects through selective inhibition of FGFR1, FGFR2, and FGFR3. This selectivity allows tasurgratinib to target specific types of cancer cells effectively without interfering with other essential physiological processes. In particular, tumors associated with FGFR abnormalities—such as cholangiocarcinoma and certain breast cancers—present promising therapeutic targets. In addition to its approved use in cholangiocarcinoma in Japan, tasurgratinib is currently undergoing a Phase I clinical trial in Japan for patients with estrogen receptor-positive, HER2-negative breast cancer, further exploring its potential in broader oncology indications. 2. Nxera Pharma and Holling Collaborate to Commercialize Daridorexant in Taiwan On February 28, 2025, Tokyo- and Cambridge-based Nxera Pharma announced it had signed a licensing, supply, and commercialization agreement with Holling Bio-Pharma Corp., Taiwan’s largest pharmaceutical distributor, to bring daridorexant to the Taiwanese market. The collaboration seeks to address the growing demand for effective insomnia treatments in the region. Daridorexant is a new oral dual orexin receptor antagonist (DORA) that helps regulate overactive wakefulness signals by selectively binding to and inhibiting orexin receptors OX1R and OX2R, thereby promoting better sleep onset and maintenance. Under the agreement, Nxera will supply the drug product, while Holling will handle regulatory approval, commercialization, and distribution activities, retaining all regulatory rights. Holling is expected to submit a New Chemical Entity (NCE) application to the Taiwan Food and Drug Administration by mid-2025. If approved, daridorexant could be launched in Taiwan by mid-2026. Nxera will receive an upfront payment upon signing, along with additional milestone payments based on regulatory progress and sales performance. Nxera is also entitled to royalties on net sales from product supply, reflecting the mutual confidence in daridorexant’s market potential and supporting further development efforts. Daridorexant works by blocking the binding and activity of orexins—neuropeptides that promote wakefulness—through dual inhibition of their receptors. The drug has already been launched in Japan under the brand name QUVIVIQ™ following approval in September 2024 and a subsequent market launch in December 2024 by Nxera Pharma Japan in collaboration with Shionogi. Nxera is also conducting a Phase III clinical trial in South Korea to evaluate daridorexant’s efficacy and safety in adults with insomnia. Notably, QUVIVIQ™ has also received regulatory approval in the United States, Europe, and several other countries, where Idorsia Pharmaceuticals Ltd. is responsible for marketing activities. This broad international recognition further supports daridorexant’s status as a best-in-class treatment option. The development of daridorexant continues to progress positively. In addition to its successful launch in Japan, the Phase III trial in South Korea is ongoing, aiming to confirm the drug’s safety and efficacy in improving insomnia symptoms in adults. Given the significant number of insomnia patients in Taiwan, the introduction of daridorexant is expected to have a meaningful impact on clinical practice in the region. Furthermore, this collaboration is part of Nxera’s broader strategy to enhance access to innovative medicines across Japan and the wider Asia-Pacific region by partnering with leading regional commercial players, thus reaching a larger patient population while leveraging the company’s internal expertise in specialty and rare disease medicines. 3. Bavarian Nordic Partners with Biological E Limited to Expand Global Access to Chikungunya Vaccine On February 28, 2025, Bavarian Nordic announced a strategic partnership with Indian biopharmaceutical company Biological E Limited to enhance the global supply of its Chikungunya vaccine. This collaboration underscores both companies’ commitment to improving access to this important vaccine in developing countries. Through this partnership, Bavarian Nordic and Biological E Limited plan to co-invest in the further development of the vaccine and ensure its availability across more countries and regions. The product at the center of this agreement is a vaccine specifically designed to prevent Chikungunya virus infection. This innovative vaccine mimics the structural features of the virus—particularly its surface proteins—to induce a specific antibody response from the human immune system. These antibodies can recognize and neutralize the actual Chikungunya virus during infection, thereby preventing disease onset. Utilizing virus-like particle (VLP) technology, the vaccine delivers robust immune protection without containing live virus, significantly enhancing its safety profile. This Chikungunya VLP vaccine has already received its first regulatory approval in the United States for the prevention of Chikungunya fever. It has also been granted multiple special regulatory designations in both the U.S. and the European Union, including Accelerated Approval, Breakthrough Therapy Designation, Fast Track, and Priority Review—highlighting the recognized public health value of the vaccine. Beyond U.S. approval, additional clinical trials and regulatory submissions are underway in various other countries and regions to expand its global reach. Originally developed by PaxVax Holding Co., Ltd., the vaccine has achieved several critical development milestones. After Bavarian Nordic acquired the program, it advanced the clinical research and secured the initial U.S. approval. Through its new collaboration with Biological E Limited, the vaccine is expected to gain more rapid market access in Asia and other developing regions. Biological E Limited's deep market knowledge and extensive distribution network in these areas make it a key partner in achieving this objective. Moreover, early-stage development efforts were supported by Emergent BioSolutions, Inc. and the U.S. National Institute of Allergy and Infectious Diseases (NIAID), laying a solid foundation for the vaccine’s success. This partnership marks a significant step toward broader protection against Chikungunya fever worldwide. 4. RedHill and Hyloris Sign Global (Excluding North America) Commercialization Agreement for RHB-102 to Improve Quality of Life for Cancer and Gastrointestinal Patients On February 25, 2025, RedHill Biopharma Ltd. announced the signing of an exclusive development and commercialization licensing agreement with Hyloris Pharmaceuticals SA for RHB-102 (Bekinda®). Under this agreement, Hyloris gains the rights to develop and commercialize RHB-102 in all global markets except the United States, Canada, and Mexico. This collaboration reflects the shared commitment of both companies to provide effective treatment options to more patients worldwide, particularly those suffering from chemotherapy/radiation-induced nausea and vomiting (CINV/RINV), acute gastroenteritis, gastritis, and diarrhea-predominant irritable bowel syndrome (IBS-D). As part of the agreement, Hyloris will pay RedHill an upfront fee and milestone payments of up to $60 million based on the achievement of specific commercial targets. Additionally, Hyloris will pay mid-to-high double-digit percentage royalties on net sales, subject to certain cost deductions and inclusive of minimum annual payments. This financial structure not only provides RedHill with necessary funding support but also incentivizes Hyloris to actively promote RHB-102 and ensure its success in global markets. RHB-102 is a once-daily, dual-release, proprietary oral tablet formulation of ondansetron, a 5-HT3 receptor antagonist used to treat nausea and vomiting. It is available in two dosage strengths: 12 mg and 24 mg, aimed respectively at IBS-D and other indications such as acute gastroenteritis and gastritis. The extended-release profile allows for 24-hour symptom control, representing a significant therapeutic advancement for cancer patients undergoing chemotherapy or radiotherapy, as well as for those with gastrointestinal disorders. RHB-102 has completed multiple key clinical trials, including a Phase III study in the United States for acute gastroenteritis and gastritis (24 mg dose) and a Phase II study for IBS-D (12 mg dose), both of which met their primary endpoints. Recently, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a positive opinion, paving the way for a Marketing Authorization Application (MAA) in the UK. If approved, RHB-102 would become the first 24-hour extended-release oral ondansetron formulation indicated for CINV/RINV. RedHill also plans to continue pursuing FDA approval for RHB-102 in the United States. 5. Pharmanovia and Er-Kim Reach Exclusive Distribution Agreement for Sunosi® in Eastern Europe In February 2025, Pharmanovia announced that it had entered into an exclusive distribution agreement with Er-Kim, a leading Turkish pharmaceutical company, for Sunosi® (solriamfetol) in Eastern Europe. This collaboration brings Sunosi® to the Eastern European market to meet the treatment needs of patients suffering from narcolepsy and obstructive sleep apnea (OSA). Although specific financial details have not been fully disclosed, it can be inferred that the agreement involves an upfront payment, milestone payments, and a royalty structure based on sales performance. This arrangement not only supports further development and marketing efforts for the product but also reflects both parties' confidence in the commercial potential of Sunosi®. Sunosi® is a medication indicated for the treatment of excessive daytime sleepiness associated with narcolepsy and OSA. Its active ingredient, solriamfetol, is a selective dopamine and norepinephrine reuptake inhibitor (DNRI). By increasing the concentrations of these neurotransmitters in the brain, Sunosi® effectively enhances wakefulness and alertness, helping patients regain a normal daily rhythm. This mechanism of action makes it an important treatment option, particularly for patients who do not respond well to or cannot tolerate traditional therapies. Sunosi® has been approved and is commercially available in several countries and regions. Originally developed by Jazz Pharmaceuticals, it received FDA approval in the United States in 2019 for the treatment of excessive daytime sleepiness in adults with narcolepsy or OSA. Since then, Sunosi® has gradually expanded its market presence globally. The partnership between Pharmanovia and Er-Kim marks a significant step toward deeper penetration into the Eastern European market, allowing more patients to benefit from the treatment. Ongoing monitoring of Sunosi®'s long-term safety and efficacy continues to ensure the provision of optimal treatment options for patients. Beyond its current indications, Sunosi® may also demonstrate potential efficacy in treating other types of excessive daytime sleepiness disorders, providing new directions for future research. Pharmanovia will continue to monitor the accumulation of clinical data for Sunosi® and explore broader application possibilities. Through its collaboration with Er-Kim, Pharmanovia aims to establish a strong market position in Eastern Europe while raising awareness of the disease and available treatment options. Furthermore, as the understanding of the pathophysiology of excessive daytime sleepiness deepens, Sunosi® is expected to introduce new research findings in the coming years, offering a stronger scientific foundation for its use. This partnership between Pharmanovia and Er-Kim not only enhances the accessibility of Sunosi® in Eastern Europe but also highlights both companies' shared commitment to improving public health. Leveraging Er-Kim's strong local presence and extensive distribution network will be key to achieving this goal. Such cross-border collaborations accelerate the entry of innovative therapies into emerging markets, offering patients more treatment choices. With increasing recognition and support for Sunosi® across more countries and regions, the medication is expected to significantly improve the quality of life for patients with excessive daytime sleepiness worldwide in the coming years. 6. Apotex Partners with Grünenthal to Bring Qutenza® to the Canadian Market On February 24, 2025, Apotex Inc., Canada’s largest pharmaceutical company, and Grünenthal, a global leader in pain management and related diseases, announced a strategic licensing agreement. Under the agreement, Apotex will obtain exclusive rights to Qutenza® in Canada. This partnership aims to introduce Qutenza® as an innovative treatment option for patients suffering from neuropathic pain in Canada. Although specific financial terms have not been fully disclosed, it can be inferred that Grünenthal will receive an upfront payment, additional milestone payments upon achieving specific regulatory milestones, and royalties based on sales. This financial arrangement not only supports further development and commercialization of the product but also reflects both parties’ confidence in the commercial potential of Qutenza®. Qutenza® is a topical, non-systemic, non-opioid pain treatment patch indicated for the management of neuropathic pain. Its active ingredient is high-concentration capsaicin (8%), a naturally occurring compound that is applied directly to the skin to alleviate pain. Capsaicin works by activating and subsequently desensitizing the TRPV1 receptors in sensory nerves, which play a key role in the transmission of pain signals. Through this mechanism, Qutenza® provides effective relief from chronic pain caused by nerve damage without causing systemic side effects or the risk of addiction. This treatment is particularly beneficial for patients who do not respond well to or cannot tolerate traditional therapies. Since acquiring global rights to Qutenza® in 2018, Grünenthal has continued to invest resources in the product’s development and expansion. Qutenza® has been commercialized in the European Union and the United States, with its indication broadened through relaunch and label expansion efforts. In the U.S. market, Qutenza® has experienced a significant brand resurgence, laying a strong foundation for its further promotion worldwide. Apotex’s subsidiary, Searchlight Pharma, will be responsible for seeking marketing authorization for Qutenza® in Canada and for its subsequent commercialization and distribution upon regulatory approval. This partnership is expected to further enhance the global availability and impact of Qutenza®. Since 2017, Grünenthal has invested over €2 billion in successful mergers and acquisitions, continually creating synergies across manufacturing, logistics, and commercial activities by integrating acquired brands into its infrastructure. For Apotex, this partnership not only strengthens its ability to meet patient needs but also expands its global portfolio, which includes more than 550 branded, generic, and biosimilar products. With the launch of Qutenza® in the Canadian market, an effective new treatment option will soon be available for many patients suffering from neuropathic pain. 7. Daré Bioscience Partners with Theramex to Develop the First Biodegradable Long-Acting Contraceptive Implant, Casea S On February 20, 2025, Daré Bioscience, a company focused on innovation in women’s health, announced a co-development and licensing agreement with Theramex, a global specialty pharmaceutical company dedicated to women’s health. This collaboration aims to advance the development of a first-in-class, biodegradable, long-acting contraceptive implant based on etonogestrel. The agreement marks a significant partnership in promoting women’s health management. Etonogestrel is a small-molecule drug used for contraception. It was first approved on July 17, 2006, in the United States for contraceptive use. As the current Phase 1 study is foundation-funded, there are no direct development costs for either Daré or Theramex at this stage. Under the agreement, Daré receives a royalty-free, exclusive, fully paid-up, and sublicensable license to the U.S. patent for Casea S, recently acquired by Theramex. If Phase 1 results are positive, Daré will take responsibility for conducting Phase 2 studies in the U.S., and funding for future Phase 3 trials in the U.S. will be negotiated between Daré and Theramex based on market opportunity. Etonogestrel is a synthetic progestin that primarily works by inhibiting ovulation to prevent pregnancy. It also thickens cervical mucus, making it harder for sperm to reach the egg, and alters the endometrium to reduce the likelihood of implantation. As a long-acting reversible contraceptive (LARC), etonogestrel is typically delivered via a subdermal implant that can continuously release the hormone for up to three years, offering extended contraceptive protection. Due to its high efficacy and convenience, etonogestrel has become one of the preferred contraceptive options for many women. Since its initial approval, etonogestrel has been authorized for contraceptive use in multiple countries and regions worldwide. It has also been studied for other indications such as dysmenorrhea, bleeding disorders, lower urinary tract symptoms, and benign prostatic hyperplasia. Although some indications are no longer under investigation, the use of etonogestrel in contraception continues to evolve. Companies such as Organon NV are actively working to expand its applications and improve efficacy through ongoing research. 8. SK Chemicals Partners with Jeil Health Science to Boost Pharmacy Sales of Ginexin and Trast On March 17, 2025, SK Chemicals announced a co-marketing agreement with Jeil Health Science, a leading South Korean manufacturer of over-the-counter (OTC) pharmaceuticals. The partnership is aimed at increasing pharmacy sales of two SK Chemicals products—Ginexin-F Soft Cap 120mg and Trast Patch 30—by leveraging Jeil Health Science’s extensive distribution network. Previously, these products were distributed through general pharmaceutical wholesalers. Ginexin-F Soft Cap 120mg: This product is a circulation enhancer formulated with ginkgo biloba extract and comes in a soft capsule format, sold exclusively through pharmacies. Ginkgo biloba extract is renowned for its antioxidant properties and is widely used to improve blood circulation and alleviate symptoms related to poor circulation. Trast Patch 30: This is a pain relief patch available in packs of 7, 10, and 30 units, with the 30-pack being particularly suited for patients requiring repeated use. The patch is applied directly to the skin and delivers active ingredients to relieve localized pain, making it suitable for conditions such as muscle aches and arthritis. Both products are already on the market and have established brand recognition and customer bases. Ginexin enjoys a strong reputation as a natural-origin blood circulation booster, while Trast is favored by consumers for its convenient application and effective pain relief. The goal of the partnership is to further expand the market share of these two products in the pharmacy channel and to enhance consumer awareness and trust through more targeted marketing strategies. Through this collaboration, SK Chemicals aims to take advantage of Jeil Health Science’s powerful sales network—serving over 12,000 pharmacies directly—and its proven track record in promoting OTC products, especially in pain management with successful brands like Kefentech and Jeil Cool Pap. Han Sang-chul, CEO of Jeil Health Science, expressed his enthusiasm for the partnership, stating that they are honored to work with SK Chemicals to promote products that have earned long-term trust in the fields of blood circulation and pain relief. Together, the two companies hope to strengthen Ginexin and Trast’s positions as leading brands in their respective markets and to provide more therapeutic options for patients. This partnership not only aims to enhance the market standing of both companies but also to deliver higher-quality products and services to a broader consumer base. 9. X4 Pharmaceuticals and Taiba Rare Enter Exclusive Agreement to Advance Distribution and Commercialization of XOLREMDI® (Mavorixafor) in Select Middle Eastern Countries On February 19, 2025, X4 Pharmaceuticals, a company committed to improving the lives of patients with rare immunodeficiency diseases, announced an exclusive agreement with Taiba Rare, a division of Taiba Healthcare. The agreement grants Taiba Rare exclusive rights to distribute and commercialize XOLREMDI® (mavorixafor) in Saudi Arabia, the United Arab Emirates, Qatar, Oman, Kuwait, Bahrain, and Egypt, contingent upon obtaining local regulatory approvals. Although specific financial terms have not been disclosed, agreements of this nature typically include upfront payments, sales-based milestone payments, and royalties. These arrangements align the interests of both parties and incentivize Taiba Rare to actively promote XOLREMDI®. Given that XOLREMDI® is the first and only treatment approved for WHIM syndrome (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis), the therapy holds significant market potential, making the partnership attractive to both companies. XOLREMDI® (mavorixafor) is an oral, once-daily treatment approved by the U.S. Food and Drug Administration (FDA) in April 2024 for patients aged 12 and older with WHIM syndrome. It works by increasing the number of circulating mature neutrophils and lymphocytes, thereby enhancing the body's ability to fight infections. Mavorixafor functions by inhibiting the CXCR4 receptor, promoting the release of white blood cells from the bone marrow into the bloodstream. While XOLREMDI® has already received FDA approval in the U.S., its Marketing Authorization Application (MAA) is currently under review by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). The collaboration with Taiba Rare will accelerate the product's introduction into Middle Eastern markets, offering new treatment options for patients with WHIM syndrome. Under the agreement, Taiba Rare will be responsible for XOLREMDI®’s distribution, promotion, marketing, and sales in the designated region and will jointly develop key strategic decisions with X4 Pharmaceuticals. 10. Beihai Biotechnology Partners with Zydus Lifesciences to Commercialize BEIZRAY® (BH009) in the U.S. On February 18, 2025, Beihai Biotechnology announced a strategic partnership with Zydus Lifesciences. Under the agreement, Beihai grants Zydus exclusive commercialization rights for its novel oncology drug BEIZRAY® in the United States. Following the agreement, Beihai will receive an upfront payment of USD 15 million, with an additional USD 10 million upon the first product delivery—amounting to nearly RMB 200 million in total. Beihai will also benefit from future sales-based milestone payments and a high double-digit percentage share of profits. This payment structure not only provides Beihai with early financial support but also motivates both parties to ensure the commercial success of the product. BEIZRAY® (BH009) is a proprietary, improved formulation of docetaxel developed by Beihai Biotechnology for the treatment of various solid tumors, including breast cancer, non-small cell lung cancer, prostate cancer, gastric cancer, and head and neck squamous cell carcinoma. It acts by stabilizing microtubules and preventing their depolymerization, arresting the cell cycle in the mitotic phase and thereby inhibiting tumor cell proliferation. BEIZRAY® is distinguished by its use of targeted molecular delivery technology that eliminates the use of polysorbate 80—a common component in traditional docetaxel formulations—significantly reducing adverse reactions and improving patient safety. BEIZRAY® received FDA approval in October 2024, making it the first clinically validated and demonstrably superior docetaxel reformulation approved in nearly 30 years. Clinical trials have shown that BEIZRAY® reduces the risk of hematologic toxicity and severe allergic reactions, thereby enhancing the benefit-risk profile for patients. This partnership will leverage Zydus Lifesciences’ robust sales infrastructure in the U.S. to expedite market access and deliver this innovative treatment to a broader patient population. 11. Baheal Pharmaceutical Partners with Roche to Advance Commercialization of Rituximab in China On February 13, 2025, Baheal Pharmaceutical announced that it had entered into a collaboration agreement with Roche. Under this agreement, Baheal has obtained the exclusive rights to promote Roche’s well-known oncology-targeted therapy Rituximab in mainland China. According to the agreement, Roche will pay Baheal a quarterly service fee for its promotional efforts. This arrangement ensures that while Baheal bears the promotional costs, it also receives a corresponding economic return based on sales performance. Additionally, the agreement stipulates that Roche may not appoint any third party to promote the product in the region without prior notice to Baheal, ensuring Baheal’s exclusivity in the market. Rituximab is the world’s first monoclonal antibody specifically targeting the CD20 antigen and marked the beginning of a new era in targeted cancer therapy. It is primarily used for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and other related diseases. Rituximab binds to the CD20 antigen on the surface of B lymphocytes, inducing immune responses against the cancer cells and promoting their apoptosis, thereby inhibiting tumor growth. Since its initial approval in the U.S. in 1997, Rituximab has accumulated over two decades of clinical use and has benefited more than 6.8 million patients worldwide. In China, Rituximab was approved in April 2000, and with approvals for multiple indications—including maintenance therapy for treatment-naïve follicular lymphoma and combination chemotherapy for chronic lymphocytic leukemia—its market potential continues to grow. 12. Chong Kun Dang Secures Exclusive Distribution and Sales Rights for Bayer’s Nexavar and Stivarga in South Korea Chong Kun Dang Pharmaceutical has announced that it has reached an agreement with German pharmaceutical giant Bayer to exclusively distribute and sell two of Bayer’s key oncology drugs—Nexavar and Stivarga—in the South Korean market. This partnership aims to leverage Chong Kun Dang’s robust market network and sales capabilities to expand the local market share of both therapies. Although the specific financial terms have not been disclosed, such agreements typically involve an upfront payment, milestone payments based on sales performance, and profit-sharing arrangements. These structures align the interests of both parties and incentivize Chong Kun Dang to actively promote the products and expand their market presence. Nexavar: A multi-kinase inhibitor indicated for the treatment of advanced renal cell carcinoma, hepatocellular carcinoma, and radioactive iodine-refractory differentiated thyroid cancer. It works by inhibiting several intracellular protein kinases involved in tumor growth and angiogenesis. Stivarga: Also a multi-kinase inhibitor, Stivarga is indicated for metastatic colorectal cancer, gastrointestinal stromal tumors (GIST), and hepatocellular carcinoma. It shares a similar mechanism of action with Nexavar but is approved for different indications and is sometimes used as a follow-up treatment after Nexavar. Both Nexavar and Stivarga are globally approved and have been widely used in clinical practice across many countries and regions. They have demonstrated significant efficacy in treating specific types of cancer and have accumulated extensive real-world usage data. With Chong Kun Dang now taking over the distribution and sales of these two drugs in South Korea, the accessibility of these innovative therapies for local patients is expected to increase substantially. For Chong Kun Dang, this partnership strengthens its presence in the oncology sector by adding two well-recognized therapeutic options to its portfolio, potentially creating new growth drivers for the company. For Bayer, choosing Chong Kun Dang as its local partner reflects confidence in the latter’s commercial capabilities and market expertise in South Korea. This strategic alliance is expected to accelerate market penetration of Nexavar and Stivarga in South Korea, ultimately benefiting more patients with access to advanced cancer treatments. Furthermore, it highlights the growing trend of multinational pharmaceutical companies partnering with strong local firms to optimize resource allocation and achieve mutually beneficial outcomes in global market expansion. 13. Lotus Pharmaceutical Partners with Formycon to Advance Commercialization of FYB203/AHZANTIVE® in the Asia-Pacific Region On February 5, 2025, Klinge Biopharma GmbH, the exclusive global commercialization rights holder of FYB203/AHZANTIVE® (Aflibercept), announced an exclusive licensing agreement with multinational pharmaceutical company Lotus Pharmaceutical. Under the terms of the agreement, Lotus will be responsible for the commercialization of FYB203/AHZANTIVE® in the Asia-Pacific region, including Indonesia, Malaysia, the Philippines, Singapore, Taiwan, Thailand, Vietnam, and the Hong Kong Special Administrative Region. Concurrently, Formycon also signed a finished product supply agreement with Lotus. According to the agreement, Klinge will receive an upfront payment from Lotus and is eligible for additional milestone payments tied to product launch and sales achievements. Furthermore, Klinge will receive royalties based on Lotus’ net sales, with Formycon sharing in Klinge’s revenues at a rate ranging from mid-single to low-double-digit percentages. This payment structure not only provides Klinge with initial financial support but also incentivizes all parties to collaborate closely toward the successful commercialization of the product. FYB203/AHZANTIVE® is a biosimilar to Eylea® (Aflibercept), used for the treatment of neovascular age-related macular degeneration (nAMD) and other severe retinal diseases. The drug works by inhibiting vascular endothelial growth factor (VEGF), thereby reducing the formation of abnormal blood vessels in the retina. VEGF is a protein that promotes the formation of new blood vessels, but its overexpression in certain eye diseases can lead to vision loss or even blindness. By blocking the action of VEGF, FYB203/AHZANTIVE® helps stabilize or improve patients’ vision. FYB203/AHZANTIVE® has achieved significant progress in development, receiving approval from the U.S. Food and Drug Administration (FDA) in June 2024, followed by European Commission approval in January 2025. Currently, Formycon and Lotus are working closely together to prepare submissions to regulatory authorities in the Asia-Pacific region, in accordance with local regulations, to facilitate the timely launch of FYB203/AHZANTIVE® in these markets. This process includes the consolidation of clinical data and adaptations to meet local market requirements. 14. Daewon Pharmaceutical Partners with AstraZeneca Korea to Promote Asthma Treatment Products In early February 2025, Daewon Pharmaceutical announced a collaboration agreement with AstraZeneca Korea to take on the distribution responsibilities for AstraZeneca’s asthma treatment products in the South Korean market. This partnership aims to leverage Daewon’s robust sales network and market expertise to broaden the reach of these essential medications, ensuring that more patients have access to effective treatment options. The agreement includes an upfront payment, sales-based milestone payments, and royalties calculated based on net sales. This structure ensures mutual benefit: AstraZeneca Korea can rapidly expand market share for its products through Daewon’s extensive distribution channels, while Daewon Pharmaceutical gains financial returns from successful product promotion and strengthens its presence in the respiratory disease market. Budesonide/Formoterol (Symbicort) is one such combination product included in this partnership. It consists of a long-acting β2-agonist (LABA) and an inhaled corticosteroid (ICS), designed for long-term control of asthma symptoms. Budesonide helps reduce airway inflammation, while Formoterol relaxes the airway smooth muscles, making breathing easier. This combination therapy effectively alleviates asthma symptoms and reduces the risk of acute exacerbations. These asthma treatment products have been approved globally and have been marketed in numerous countries for years, backed by extensive clinical experience and safety data. For certain products within this collaboration, additional registration steps or labeling adjustments may be required to comply with Korean regulatory standards. However, given their proven efficacy and safety profiles in other markets, it is expected that they will quickly gain recognition and be widely adopted in South Korea. 15. MITEM Pharma Acquires FLISINT® from Sanofi, Committed to Safeguarding the Interests of Patients with Rare and Life-Threatening Diseases In February 2025, MITEM Pharma announced the successful acquisition of the specialty drug FLISINT® from Sanofi. This acquisition underscores MITEM Pharma’s ongoing mission to improve the quality of life for patients suffering from rare and life-threatening diseases. Through this collaboration with Sanofi, MITEM Pharma not only expands its product portfolio but also strengthens its expertise in targeted therapeutic areas. FLISINT® is a specialty medication designed for the treatment of specific rare diseases. Although its exact indication was not disclosed, the name suggests that it may be intended for the treatment of a genetic disorder or metabolic condition requiring specialized attention. The mechanism of action of FLISINT® likely involves addressing enzyme deficiencies or abnormal protein expression caused by genetic mutations, thereby alleviating symptoms and slowing disease progression. For example, it may function through enzyme replacement therapy or by modulating intracellular signaling pathways to restore normal physiological functions. FLISINT® has successfully completed multiple phases of clinical trials and has been approved by regulatory authorities in several countries and regions. This confirms the drug's safety and efficacy, offering an effective treatment option for patients with specific rare conditions. However, with ongoing scientific advancements and the accumulation of new data, further studies may be necessary to explore broader applications or to optimize the formulation for enhanced efficacy and reduced side effects. Conclusion The series of partnership agreements and acquisitions in February 2025 reveals an overarching trend: globalization, specialization, and technological advancement are reshaping the pharmaceutical industry. Whether it's deepening market penetration through local collaboration (such as the partnership between Daewon Pharmaceutical and AstraZeneca Korea) or entering emerging markets (such as X4 Pharmaceuticals' agreement with Taiba Rare for the Middle East), these partnerships demonstrate how pharmaceutical companies are leveraging each other's strengths for mutual benefit. More importantly, they share a common goal—to enhance healthcare access and outcomes for patients worldwide. It is noteworthy that these collaborations go beyond traditional sales and distribution agreements and extend into R&D partnerships. For instance, MITEM Pharma’s acquisition of FLISINT® from Sanofi, as well as Daré Bioscience’s co-development of the biodegradable long-acting contraceptive implant Casea S with Theramex, highlight the growing importance of long-term strategic alliances in driving innovation and accelerating product development in today's rapidly evolving healthcare environment. In summary, the pharmaceutical collaborations of February 2025 mark the dawn of a new era—one characterized by cooperation, resource sharing, and a focus on addressing complex health challenges. As technology continues to evolve and societal awareness of health deepens, we can expect to see more such partnerships emerge, further advancing the frontier of medicine and delivering new therapeutic possibilities to patients around the globe. How to get the latest progress on drug deals? If you would like to access the latest transaction event information, you can click on the 'Deal' module from the homepage of the Synapse database. Within the Deal module, you can search for global pharmaceutical transaction information using labels such as Drugs, Organization, Target, Drug Type, Deal Date.  Furthermore, you can obtain the original link to the transaction coverage by clicking on the "Deal Name." In the analysis view, you can see the most active assignors, assignees, popular targets, and other dimensions of analysis, as well as the distribution of research and development statuses at the time of the transaction, to help you better understand the search results. The Synapse database also supports the ability to view current transactions from the dimension of "drugs" (by selecting "drugs" from the "Adjust Dimension" dropdown menu above). 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Revenue-generating with an exciting, diversified, largely externally funded, advanced development pipeline and multiple upcoming catalysts. Recent highlights: Global licensing deal (excluding North America) with Hyloris Pharmaceuticals with RHB-102 for up to $60 million in potential milestone payments Approximately $8 million plus legal costs NY Supreme Court summary judgment win against Kukbo Bayer-supported Phase 2 combination study of opaganib and Bayer's darolutamide in prostate cancer initiated Talicia® advancement and geographic expansion: Planned UK MAA with potential for approval in 2025 Commercially launched in the United Arab Emirates (UAE) Formulary wins securing 25 million covered lives First-line therapy listing in the recently updated ACG Guideline Advancing next-generation development, RHB-204, into the first ever Phase 2 clinical study in Crohn's Disease (CD) patients who are all MAP-positive, supported by RHB-104's positive Phase 3 data showing a statistically significant 64% improvement in efficacy; FDA path to approval guidance expected in coming weeks Positive results from new U.S. Government funded program for gastrointestinal Acute Radiation Syndrome (GI-ARS) further confirm opaganib's nuclear radiation protective activity. Discussions ongoing regarding advanced development Cash balance of $4.8 million as of December 31, 20241 23% increase in net revenues in 2024 to $8.0 million, up from $6.5 million in 2023 Supported by extensive cost-cutting measures, the Movantik® divestiture transaction and reduced R&D spend, cash burn slashed by 74% year-over-year; Net cash used in operations dropped to $9.4M from $35.8M in 2023 TEL AVIV, Israel and RALEIGH, N.C., April 10, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today reported its full-year 2024 financial results and operational highlights and associated filing of its annual report on Form 20-F for the year ended December 31, 2024. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "We have undergone an extensive overhaul reshaping ourselves financially, operationally and strategically. Major corporate and R&D moves, undertaken over the last 12 months, have resulted in new and clearer opportunities to deliver maximum value from both our commercial and R&D assets. The potential $60 million ex-North America global license of RHB-102 to Hyloris lays the groundwork for the ongoing development and commercialization in the large gastroenteritis, oncology support and IBS-D markets while enabling RedHill to maintain control of the key North American markets. The approximately $8 million plus legal costs New York Supreme Court summary judgment was a resounding win for RedHill and we are fully committed to pursuing the collection of this award. Last year's recommendation by the latest ACG Clinical Guideline for Talicia as a first-line therapeutic option for H. pylori eradication, has, we expect further enhanced Talicia's product profile as the leading branded U.S. gastroenterologist prescribed H. pylori therapy, winning additional formulary successes securing 25 million covered lives. After its successful launch in UAE, Talicia is also poised for a potential UK Marketing Authorisation Application (MAA) mid-year, presenting a promising pathway for Talicia's entry into additional markets globally." Mr. Ben-Asher continued: "Having successfully completed the Hyloris RHB-102 out-license deal, we are now advancing our next-generation candidate, RHB-204, in the $12 billion Crohn's disease space, employing a novel, groundbreaking approach, supported by RHB-104's positive Phase 3 clinical data. In parallel, opaganib continues to show its broad-acting potential and we are very excited to have initiated the innovative Bayer-supported Phase 2 study in combination with darolutamide, which may bring vital new hope to men with metastatic castrate resistant prostate cancer. Progress was also made with opaganib as a treatment for GI-ARS following positive results from new in vivo studies, undertaken as part of the U.S. government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract, further confirming opaganib's radioprotective activity in models of GI-ARS. Discussions are ongoing regarding advanced development. Additionally, the ongoing U.S. Government-supported work in Ebola continues following our previously announced BARDA grant. We have started 2025 as we mean to go on – aggressively pursuing our business goals and aiming to deliver on our catalysts in a meaningful way." Financial results for the 12 months ended December 31, 20242 Net Revenues for the year ended December 31, 2024 were $8.0 million, compared to $6.5 million for the year ended December 31, 2023. Talicia net revenues for the year ended December 31, 2024, increased to $9.0 million from $8.8 million for the year ended December 31, 2023, driven by approximately $1.0 million of revenues generated from the UAE partnership with Gaelan Medical. Net revenues for the years ended December 31, 2024 and December 31, 2023 included Movantik contra-revenues of $0.9 million and $2.6 million for Movantik, respectively, mainly due to product returns. Cost of Revenues for the year ended December 31, 2024 was $3.2 million, compared to $3.5 million for the year ended December 31, 2023. The decrease was primarily due to lower inventory write-downs, which totaled $0.2 million in 2024 compared to $1.3 million in 2023. Gross Profit for the year ended December 31, 2024 was $4.9 million, compared to $3.1 million for the year ended December 31, 2023, reflecting the increase in net revenues and the lower level of inventory write-downs in 2024. Research and Development Expenses for the year ended December 31, 2024 were $1.6 million, as compared to $3.5 million for the year ended December 31, 2023. The decrease was attributable to the costs from closing the RHB-204 clinical trial, which were recognized in 2023, as well as ongoing cost-reduction measures. Selling, Marketing, and General and Administrative Expenses for the year ended December 31, 2024 were $15.5 million, as compared to $31.0 million for the year ended December 31, 2023. The reduction was primarily attributable to ongoing cost-reduction measures and the divestment of Movantik in 2023, which led to workforce downsizing and other related expense reductions. Other Expenses for the year ended December 31, 2024 were $2.3 million, recognized as part of the Global Termination Agreement3, as compared to Other Income of $44.1 million for the year ended December 31, 2023. The Other Income in 2023 was comprised of (i) $35.5 million from the divestiture of Movantik, calculated as the difference between the fair value of the rights and the carrying amount of this asset and (ii) $8.6 million from transitional services provided to the buyer of Movantik. Operating Loss for the year ended December 31, 2024 was $14.6 million, compared to Operating Income of $12.6 million for the year ended December 31, 2023. Both periods include items related to the Movantik divestiture, as described under Other Expenses - a $2.3 million loss in 2024 and $44.1 million income in 2023. Excluding these, the year-over-year change reflects improved operating performance driven by cost-cutting measures. Financial Income, net for the year ended December 31, 2024 was $6.3 million, compared to Financial Income, net of $11.3 million for the year ended December 31, 2023. The income recognized for the year ended December 31, 2024, was primarily driven by the revaluation of financial instruments, partially offset by other financing expenses. The income recognized in the year ended December 31, 2023, was primarily attributable to a $20.6 million gain resulting from the extinguishment of the HCRM debt in exchange for the transfer of rights to Movantik, calculated as the difference between the carrying amount of the financial liability and the fair value of the rights transferred, partially offset by financial expenses related to the financial instruments and other financial expenses. Net Loss for the year ended December 31, 2024 was $8.3 million, as compared to Net Income of $23.9 million for the year ended December 31, 2023. Both periods include impacts from the Movantik divestiture, as detailed under Other Expenses and Financial Income - a $2.3 million loss in 2024 and $64.7 million in income in 2023. Excluding these, the year-over-year change reflects improved performance driven by cost cutting measures. Total Assets as of December 31, 2024 were $18.0 million, as compared to $23.0 million as of December 31, 2023. The decrease was primarily attributable to the decrease in cash balance, reduced inventory and a decline in prepaid expenses and other receivables, consistent with the Company's scaled-down operations, as well as impact of balances settled as part of the Global Terminations Agreement, and a reduction in right-of-use assets following the termination of vehicle leases during 2024. Total Liabilities as of December 31, 2024 were $22.7 million, as compared to $21.0 million as of December 31, 2023. The increase primarily reflects the impact of the Global Termination Agreement, under which the Company incurred liabilities related to Movantik that were allocatable to HCRM and its affiliates under their agreements with the Company, offset by payments made toward these liabilities during the period. Additionally, there was an increase in derivative financial instruments associated with warrant liabilities from offerings made during 2024. This was partially offset by a decrease in accounts payable and allowance from deductions from revenues, consistent with the Company's scaled-down operations, as well as a reduction in lease liabilities due to the termination of car leases. Net Cash Used in Operating Activities for the year ended December 31, 2024 was $9.4 million, compared to $35.8 million for the year ended December 31, 2023. The cash used in operating activities was primarily directed towards settling pre-closing liabilities related to Movantik and other operational activities. This was partially offset by proceeds received from the Global Termination Agreement, net of payments made to settle obligations arising from this agreement. Net Cash Provided by Financing Activities for the year ended December 31, 2024 was $8.4 million, primarily generated through equity offerings. Net Cash Provided by Financing Activities for the year ended December 31, 2023, was $21.4 million, comprised primarily of proceeds from equity offerings and exercise of certain warrants in transactions consummated in each of April 2023, July 2023, September 2023 and November 2023, and from decrease in restricted cash, partially offset by repayment of payables in respect of intangible asset purchases. Cash Balance as of December 31, 2024, was $4.8 million1. Commercial and R&D Highlights: Commercial - streamlined and revenue-generating: With a significantly streamlined commercial operation, Talicia has generated net revenues of $9.0 million, supported by approximately $1.0 million of new revenues from the UAE partnership with Gaelan Medical, and remains the leading U.S. gastroenterologist-prescribed branded H. pylori therapy. Significant effort has resulted in important accomplishments with Talicia, such as the inclusion as first-line option for treatment of H. pylori infection in the recently updated 2024 American College of Gastroenterology (ACG) Clinical Guideline, the securing of 25 million covered lives following the Medi-Cal renewal and Humana formulary win, a successful launch in the UAE and the potential for opening up new markets with the recently announced plan for a Talicia UK MAA. Talicia has now surpassed the 100,000 prescriptions milestone and our innovative warranty program, with minimal refunds claimed, reflects a positive patient experience. R&D - focused on new opportunities: Largely externally funded, with multiple U.S. Government and non-governmental collaborations, RedHill's pipeline provides new and exciting opportunities in major indications: Crohn's disease, prostate cancer, diabetes and obesity-related disorders, Ebola and other viral and pandemic preparedness indications as well as for gastrointestinal-acute radiation syndrome (GI-ARS) and other medical/chemical countermeasure uses: Opaganib4 : A potentially broad acting, novel, oral, host-directed small molecule drug, with a demonstrated safety and efficacy profile, advancing in predominantly U.S. Government-supported, externally funded programs, directed at multiple underserved indications with sizeable multi-billion-dollar market opportunities and potentially advantageous pathways to approval. Opaganib is in development for multiple oncology, viral, inflammatory and diabetes and obesity-related indications, including prostate cancer, COVID-19, Ebola, acute respiratory distress syndrome (ARDS) and radio/chemical protection, including GI-ARS: A new approach in the $12 billion prostate cancer market: Prostate cancer (PC) is the second most diagnosed cancer in the world, with around 1.5 million new cases per year, causing almost 400,000 deaths5. People with metastatic castrate-resistant prostate cancer (mCRPC) have few treatment options available to them. In February 2025, the Company announced the initiation of a Bayer-supported Phase 2 study of opaganib in combination with Bayer's darolutamide in mCRPC, evaluating the potentially enhancing effect of opaganib in patients with poor prognosis. The study will utilize a companion lipid biomarker test (PCPro) to select mCRPC patients who have a poor prognosis due to standard of care (SoC) treatment and who may benefit from an opaganib + darolutamide combination treatment approach. The primary endpoint will be improved 12-month radiographic progression-free survival (rPFS). Other opaganib programs/updates include: U.S. Army and BARDA-grant funded program for Ebola. Opaganib is believed to be the first host-directed molecule to show activity in vivo in Ebola virus disease, delivering a statistically significant increase in survival and, separately, demonstrating a robust synergistic effect in vitro when combined with remdesivir (Veklury®; Gilead Sciences, Inc.), improving viral inhibition while maintaining cell viability U.S. Government- and non-government funded programs ongoing with the NIH / BARDA-funded nuclear and chemical medical countermeasure programs for GI-ARS and Phosgene inhalation injury. On December 10, 2024, the Company announced positive results from new in vivo studies of opaganib as a treatment for GI-ARS, undertaken as part of the U.S. Government's Radiation and Nuclear Countermeasures Program (RNCP) product pipeline development contract. These results further confirm opaganib's protective activity in models of GI-ARS and discussions are ongoing regarding advanced development. Positive in vivo study results support potential of opaganib therapy in diabetes / obesity-related disorders - a market projected to be worth approximately $100 billion within the next decade. 'Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance' was recently published6 in the journal Diabetes, Metabolic Syndrome and Obesity Orphan drug designation granted by FDA for neuroblastoma (opaganib has several such designations in multiple indications, with three in oncology) ARDS, COVID-19 and Influenza programs continue to seek to address multi-hundreds of millions of dollars markets RHB-204: RHB-204 is a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin and clofazimine, at specific doses designed to safely and effectively treat Mycobacterium avium subspecies paratuberculosis-positive (MAP-positive)-related Crohn's disease (CD). Unlike existing therapies that focus on symptom relief, RHB-204 is intended to target the possible root cause of Crohn's disease, which is hypothesized to be caused by Mycobacterium avium subspecies paratuberculosis (MAP). Patent protected until at least 2041, RHB-204 is a next-generation formulation of RHB-104, which successfully completed a Phase 3 study in Crohn's disease, with an optimized formulation for the treatment of CD. It contains the same three antimicrobial agents with potent intracellular, anti-mycobacterial and anti-inflammatory properties, and with an optimized dosing profile, RHB-204 provides the potential for enhanced tolerability, safety and compliance with a 40% pill burden reduction. RHB-204 is supported by a strong foundation of clinical data from the positive safety and efficacy results achieved in the Phase 3 study of RHB-104 in CD, with its potential further demonstrated using mucosal healing imaging, considered to be the gold standard for efficacy evaluation in CD. Paradigm shift in MAP-positive CD treatment approach In March 2025, the Company announced its plans to advance its potentially groundbreaking late-stage RHB-204 Crohn's disease program, building on statistically significant positive RHB-104 Phase 3 results. FDA guidance on pathway to approval is anticipated in the coming weeks. RedHill is actively pursuing funding opportunities and partnerships to advance this potential paradigm-shifting treatment. The planned innovative Phase 2 study of RHB-204 is planned to be the first ever clinical study in CD patients who are all MAP-positive and will evaluate mucosal healing, a new gold standard in assessing efficacy in Crohn's disease, and MAP eradication utilizing novel and decisive endpoints and imaging, allowing for a study design with a relatively small sample size. RHB-204 builds upon RHB-104's successful Phase 3 study, which successfully met its Phase 3 study primary and secondary endpoints demonstrating a statistically significant 64% improvement in efficacy versus standard of care. It also showed compelling mucosal healing data in CD patients who underwent colonoscopy. The inclusion of MAP-positive only patients in the planned study with RHB-204 is anticipated to demonstrate a more consistent benefit in the study population across all efficacy outcomes. RHB-107 (upamostat) update: On January 30, 2025, we were notified that funding from the U.S. Government Department of Defense's Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) for the ongoing 300-patient Phase 2 RHB-107 arm of the ACESO PROTECT platform trial for early COVID-19 outpatient treatment was subject to termination, requiring the study to cease enrollment on Feb 28, 2025. 93 patients have been enrolled out of a fully enrolled target patient population of 300. Due to the reduced number of patients enrolled in this study, the study result may not lead to conclusions regarding the efficacy of RHB-107 in this trial. The U.S. Army-funded Ebola development program remains ongoing, with RHB-107 having demonstrated a robust synergistic effect in vitro when combined with remdesivir. Management of potential Ebola virus pandemic outbreaks represents a significant opportunity and is a key concern for global health agencies. Annual Report: A copy of the Company's annual report on Form 20-F for the year ended December 31, 2024 has been filed with the U.S. Securities and Exchange Commission at and posted on the Company's investor relations website at: . The Company will deliver a hard copy of its annual report, including its complete audited financial statements, free of charge, to its shareholders upon request at: [email protected]. About RedHill Biopharma RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA-approved gastrointestinal drug Talicia, for the treatment of Helicobacter pylori (H. pylori) infection in adults7, with submission planned for marketing authorization in other territories. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. Government and academic collaborations for development for radiation and chemical exposure indications such as Gastrointestinal-Acute Radiation Syndrome (GI-ARS), a Phase 2 study in prostate cancer in combination with Bayer's darolutamide and a Phase 2/3 program for hospitalized COVID-19 patients; (ii) RHB-204, an all-in-one, fixed-dose, orally administered, combination antibiotic therapy with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacterial (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: market and other conditions; the Company's ability to regain and maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 10, 2025. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company contact: Adi Frish Chief Corporate and Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: Financials REDHILL BIOPHARMA LTD. CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS) The accompanying notes are an integral part of these consolidated financial statements. REDHILL BIOPHARMA LTD. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION The accompanying notes are an integral part of these consolidated financial statements. REDHILL BIOPHARMA LTD. CONSOLIDATED STATEMENTS OF CASH FLOWS The accompanying notes are an integral part of these consolidated financial statements. [1] Including cash, cash equivalents, short-term bank deposits and restricted cash. [2] All financial highlights are approximate and are rounded to the nearest hundreds of thousands. [3] The Global Termination Agreement with Movantik Acquisition Co., Valinor Pharma, LLC, and HCR Redhill SPV, LLC (the "Agreement"), announced July22, 2024. [4] Opaganib is an investigational new drug, not available for commercial distribution. [5] Bray et al: Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. [6] Maines LW, Keller SN, Smith RA, Smith CD. Opaganib Promotes Weight Loss and Suppresses High-Fat Diet-Induced Obesity and Glucose Intolerance. Diabetes Metab Syndr Obes. 2025;18:969-983 [7] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需要得到授权。 2月27日，据人福医药集团发布公告，其控股子公司宜昌人福药业提交的3类仿制化药盐酸他喷他多片获批并视同通过一致性评价，人福是国内首家获批和首家过评的企业。截至目前，人福对该项目累计研发投入约为5,500万元人民币。 截图来源：企业公告 盐酸他喷他多是由美国强生制药和德国Gruenenthal GmbH公司联合研制的新型口服止痛药，是一种新颖的作用于中枢神经系统的口服止痛药物，适用于治疗成人患者需要使用阿片类药物治疗且替代治疗不能充分缓解的急性疼痛。根据IQVIA数据统计，盐酸他喷他多片2023年在全球销售额约为7亿美元。据摩熵医药数据库显示，镇痛药在2023年全国院内市场的销售总额超200亿元，同比增长达4.73%，2024年（Q1~Q3）销售额超154亿元，显示出强劲增长势头。 截图来源：摩熵医药全国医院销售数据库 他喷他多目前原研在国内尚未上市，宜昌人福于2023年9月向国家药品监督管理局提交盐酸他喷他多片的上市许可申请并获得受理，此次，宜昌人福药业申报的盐酸他喷他多片获批上市，拿下国内首仿+首家过评，填补国内空白。盐酸他喷他多片的获批上市，不仅丰富了人福药业的产品线，更将为公司带来显著的积极影响。 截图来源：摩熵医药过评药品汇总数据库 在仿制药布局领域，江苏恩华药业已提交盐酸他喷他多片3类注册仿制药的上市申请，目前处于审评审批阶段，根据药品审评进度预测，预计江苏恩华药业不久将成为国内第2家获批的企业。 截图来源：摩熵医药中国药品审评数据库 2025年至今，宜昌人福药业有琥珀酸地文拉法辛缓释片、塞来昔布胶囊、富马酸二甲酯肠溶胶囊等5款品种过评，其中盐酸他喷他多片、马来酸咪达唑仑片2款为首家过评品种。 END 本文为原创文章，转载请留言获取授权  近期热门资源获取 CGT产业现状与未来趋势蓝皮书-202406 中药行业现状与未来趋势白皮书-202407 2023年医药企业综合实力排行榜-202408 跨越国界，引领创新：中国药企出海的布局实践-202408 专利即将到期五大重磅小分子药品，国内仿制药“战况”几何?-202409 中国放射性药物市场现状分析报告-202410 合成生物产业发展前景及中国合成生物产业链上中下游企业分析-202410 中国合成生物学创投市场分析报告-202410 中国糖尿病临床诊疗与药物多渠道市场数据分析-202411 基于剂型改良的复杂注射剂分析--微球篇-202411 2024医美注射材料市场发展分析报告-20241213 国家药品集采跟踪报告-前9批次集采回顾与展望-202411 近期更多摩熵咨询热门报告，识别下方二维码领取 联系我们，体验摩熵医药更多专业服务 会议 合作 园区 服务 数据库 咨询 定制 服务 媒体 合作 👆👆👆点击上方图片，即可开启摩熵化学数据查询 点击阅读原文，申请摩熵医药企业版免费试用！