Chong Kun Dang Pharmaceutical Corp.

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? 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With the introduction of a subcutaneous formulation, ENTYVIO has expanded patient convenience and global accessibility. Continued growth is supported by rising IBD prevalence and ongoing geographic expansion. LAS VEGAS, April 15, 2025 /PRNewswire/ -- DelveInsight's " ENTYVIO Market Size, Forecast, and Market Insight Report" highlights the details around ENTYVIO, a gut-selective biologic developed by Takeda Pharmaceutical. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of ENTYVIO. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Takeda Pharmaceutical's ENTYVIO (vedolizumab) Overview Vedolizumab is a biologic medication approved for both intravenous (IV) and subcutaneous (SC) use, with regulatory approvals varying by region. The SC formulation is authorized for use in the United States, European Union, and over 50 other countries, while the IV formulation has received approval in more than 70 countries, including the US and the EU. Collectively, vedolizumab IV and SC have accumulated over one million patient-years of global exposure. Vedolizumab is a humanized monoclonal antibody that selectively targets the alpha4beta7 integrin, blocking its interaction with mucosal addressin cell adhesion molecule 1 (MAdCAM-1) — a protein primarily found on blood vessels and lymph nodes in the gastrointestinal tract. This integrin is present on certain white blood cells involved in the inflammatory processes of ulcerative colitis and Crohn's disease. By disrupting the binding between alpha4beta7 integrin and MAdCAM-1, vedolizumab may reduce the migration of these immune cells into the gut, thereby decreasing inflammation. ENTYVIO Dosage For adults with ulcerative colitis, the advised dosage of ENTYVIO is 300 mg given through intravenous infusion at weeks 0, 2, and 6, followed by maintenance infusions every 8 weeks. Treatment should be discontinued if no clinical improvement is observed by week 14. Learn more about ENTYVIO projected market size for Crohn's disease and ulcerative colitis @ ENTYVIO Market Potential Crohn's disease is a progressive type of inflammatory bowel disease (IBD) that results in chronic inflammation throughout the gastrointestinal tract, most commonly affecting the terminal ileum and colon. This inflammation can lead to complications such as strictures, fistulas, and ulcers. In 2024, there were 1.1 million diagnosed prevalent cases of Crohn's disease in the United States. Current treatment approaches primarily include biologics such as adalimumab (HUMIRA and its biosimilars), ustekinumab (STELARA), infliximab (REMICADE and biosimilars), along with systemic corticosteroids, immunosuppressants, 5-aminosalicylic acid (5-ASA), and other therapies. Among these, adalimumab held the largest market share in the 7MM in 2024, generating around USD 4 billion in revenue for Crohn's disease treatment. In 2024, the market size of Crohn's disease was highest in the US among the 7MM, accounting for approximately USD 8 billion, which is further expected to increase at a CAGR of 4.5%. The Crohn's disease market is projected to expand due to the introduction of novel therapies with improved efficacy and more convenient routes of administration, broader use of biologics in pediatric populations, growing commercial opportunities in biologic-treated patients, advancements in biomarker development for early diagnosis, and the overall rising prevalence of the disease. Discover more about the Crohn's disease market in detail @ Crohn's Disease Market Report Ulcerative colitis is one of the primary types of chronic inflammatory bowel disease (IBD) affecting the gastrointestinal tract. It is an idiopathic and long-standing inflammation of the colonic mucosa, typically presenting with symptoms like diarrhea, abdominal discomfort, and rectal bleeding. In 2023, there were an estimated 3.1 million diagnosed prevalent cases of ulcerative colitis across the 7MM, with numbers expected to rise over the forecast period. According to current US treatment guidelines, mild-to-moderate cases are initially managed with aminosalicylates or by using corticosteroids for induction followed by maintenance therapy with aminosalicylates. For patients with moderate-to-severe disease, maintenance treatment may involve immunosuppressants like azathioprine or 6-mercaptopurine after corticosteroid induction. Alternatively, biologics—particularly anti-TNF agents such as infliximab or adalimumab—can be used alone or alongside immunosuppressants to achieve and sustain remission and mucosal healing. The treatment landscape across the 7MM is categorized into commonly used drug classes, including conventional therapies, anti-TNF agents, anti-adhesion molecule therapies, JAK inhibitors, and others, reflecting some variations in prescribing practices. Looking ahead, the anticipated introduction of novel therapies, increased focus on early detection, enhanced use in secondary care, improved implementation strategies, and growing disease awareness are likely to contribute to more effective management of ulcerative colitis. As a result, the ulcerative colitis market will grow from USD 8.4 billion in 2023 at a significant CAGR by 2034. However, the high costs of new treatments and the financial burden of disease complications may pose challenges to widespread adoption. For a comprehensive view of the ulcerative colitis market, check out the Ulcerative Colitis Market Assessment Emerging Competitors of ENTYVIO Despite the presence of biosimilars, innovation in Crohn's disease and ulcerative colitis treatment remains strong, with several emerging therapies exploring new inflammatory pathways to improve efficacy and long-term outcomes. RHB-104, a combination macrolide antibiotic, is in Phase III trials targeting potential mycobacterial involvement. VELSIPITY, an S1P receptor modulator, works by limiting lymphocyte migration and reducing inflammation. TREMFYA, which inhibits IL-23, is under evaluation for its immune-modulating effects, while ABBV-154, a TNF inhibitor conjugated with a steroid, aims to enhance TNF suppression. Additional pipeline therapies include Merck's TL1A inhibitor Tulisokibart (PRA023/MK-7240) in Phase III and Pfizer's JAK3 inhibitor LITFULO in Phase II. Teva and Sanofi are also developing Duvakitug, a monoclonal antibody targeting TNFSF15. These investigational drugs represent significant progress for patients unresponsive to current treatments. A range of other promising candidates are in development, each targeting unique pathways. Landos Biopharma's Omilancor (BT-11) is in Phase II and acts via LANCL2, while AVB-114 from Avobis Bio/Alimentiv is also in Phase II. Abivax S.A.'s Obefazimod (ABX464) is being studied for its ability to upregulate miR-124. Roche's RVT-3101 (RG6631), an anti-TL1A antibody, is in Phase II trials, and Mesoblast's RYONCIL (Remestemcel-L), a mesenchymal stem cell therapy, is progressing in Phase III, offering regenerative potential. Other noteworthy agents in Phase II include Zasocitinib (TAK-279) from Takeda, a TYK2 inhibitor; AZD7798 from AstraZeneca, targeting CCR9; Sanofi's Balinatunfib (SAR441566), which blocks TNFR1 signaling; AGMB-129 from Agomab Therapeutics, targeting ALK5/TGFβR1; MBF-118 by Medibiofarma, a PPARγ partial agonist; and MORF-057 by Eli Lilly and Morphic Therapeutic, an α4β7 integrin inhibitor. Together, these developments illustrate a robust and diversified IBD pipeline. To know more about the number of competing drugs in development, visit @ ENTYVIO Market Positioning Compared to Other Drugs Key Milestones of ENTYVIO In April 2024, Takeda announced that the FDA has approved the subcutaneous (SC) formulation of ENTYVIO (vedolizumab) for maintenance treatment in adults with moderately to severely active Crohn's disease who have previously received induction therapy with the intravenous (IV) form of ENTYVIO. In September 2023, Takeda announced that the FDA has approved the SC formulation of ENTYVIO to be used as maintenance therapy in adults with moderately to severely active ulcerative colitis following induction treatment with the IV version of ENTYVIO. In September 2023, Takeda announced that the FDA has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active Crohn's disease, following induction therapy with the intravenous version of ENTYVIO. In April 2023, Takeda announced that the FDA has accepted for review its resubmitted Biologics License Application (BLA) for the investigational subcutaneous formulation of ENTYVIO as a maintenance treatment for adults with moderately to severely active ulcerative colitis following induction therapy with the intravenous version of ENTYVIO. In March 2023, Takeda announced that Japan's Ministry of Health, Labour, and Welfare has approved ENTYVIO Pens and prefilled syringes (108 mg for subcutaneous injection) for use as maintenance therapy in patients with moderate to severe ulcerative colitis. In May 2020, Takeda announced that the European Commission has approved the subcutaneous formulation of ENTYVIO, a gut-targeted biologic, for maintenance treatment in adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2019, Takeda announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved for an expanded indication of ENTYVIO, allowing its use in treating adult patients with moderately to severely active Crohn's disease. In May 2019, Takeda announced that the FDA has accepted for review the BLA for a SC formulation of vedolizumab, intended for maintenance treatment in adults with moderately to severely active ulcerative colitis. In November 2018, Takeda announced the launch of ENTYVIO in Japan for the treatment of patients with moderately to severely active ulcerative colitis. In June 2014, Takeda announced that ENTYVIO is now commercially available in the United States for treating adults with moderately to severely active ulcerative colitis or Crohn's disease. In May 2014, Takeda announced that the European Commission (EC) has granted Marketing authorization for ENTYVIO. It is the first and only biologic approved at the same time for treating adults with moderately to severely active ulcerative colitis and Crohn's disease who have not responded adequately to, lost response to, or were intolerant of conventional therapies or TNF-alpha inhibitors. In May 2014, Takeda announced that the FDA had granted simultaneous approval of ENTYVIO for the treatment of adults with moderately to severely active ulcerative colitis and Crohn's disease. Discover how ENTYVIO is shaping the Crohn's disease and ulcerative colitis treatment landscape @ ENTYVIO Infusion ENTYVIO Market Dynamics ENTYVIO has established itself as a leading biologic therapy in the treatment of moderate to severe ulcerative colitis and Crohn's disease. As a gut-selective integrin antagonist, ENTYVIO offers a differentiated mechanism of action compared to anti-TNF therapies, which contributes to its positioning as a safer long-term option, particularly for patients at risk of systemic immunosuppression. Its favorable safety profile and efficacy in inducing and maintaining remission have led to its widespread adoption, particularly among patients who have failed previous therapies. The biologics market for inflammatory bowel disease is highly competitive, with key players including HUMIRA, REMICADE, STELARA, and newer entrants like SKYRIZI and RINVOQ. ENTYVIO has managed to capture significant market share by appealing to both gastroenterologists and patients seeking gut-targeted treatment. Its intravenous formulation, though initially a barrier, has been partially offset by the 2019 launch of the subcutaneous version in global markets, enhancing patient convenience and adherence. However, uptake in the US for the SC version has been slower due to regulatory timelines and physician inertia. Biosimilar competition is also a factor shaping ENTYVIO's future market dynamics. While biosimilars of anti-TNFs are gaining traction, ENTYVIO currently remains insulated due to patent protections, with biosimilar entry expected post-2026. This provides Takeda a limited window to maximize revenue, expand its patient base, and reinforce brand loyalty. Strategic moves such as expanding indications, enhancing real-world evidence, and increasing global access will be crucial to maintaining its competitive edge. Moreover, the shift in payer dynamics and healthcare cost containment efforts are increasingly influencing biologic prescribing behavior. Takeda must continue to demonstrate value through outcome-based contracts and cost-effectiveness data. As newer agents with novel mechanisms enter the market, maintaining differentiation and proving long-term value will be central to ENTYVIO's sustained success. Dive deeper to get more insight into ENTYVIO's strengths & weaknesses relative to competitors @ ENTYVIO Market Drug Report Table of Contents Related Reports Crohn's Disease Market Crohn's Disease Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Crohn's disease companies including Novo Nordisk, Eli Lilly and Company, MedImmune, Boehringer Ingelheim, Raziel Therapeutics, Altimmune, Saniona, YSOPIA Bioscience, Innovent Biologics, Glaceum, Shionogi, Aardvark Therapeutics, NuSirt Biopharma, Novartis, CSPC Baike (Shandong) Biopharmaceutical, Jiangsu HengRui Medicine, Carmot Therapeutics, Pfizer, Sciwind Biosciences, Empros Pharma, among others. Crohn's Disease Pipeline Crohn's Disease Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Crohn's disease companies, including Janssen, RedHill Biopharma, Amgen, Pfizer, Prometheus Biosciences, AgomAb Therapeutics, Hoffmann-La Roche, Gilead Sciences, Eli Lilly and Company, Celgene, AstraZeneca, Mesoblast, Alfasigma, Tiziana Life Sciences, Abivax, Arena Pharmaceuticals, Cytocom, HAV Vaccines Ltd, Enzo Biochem Inc., Stero Biotechs, Reistone Biopharma Company Limited, Qu Biologics, Pfizer, Mitsubishi Tanabe Pharma Corporation, Takeda Pharmaceuticals, Soligenix, Immunic, Pfizer, Atlantic Healthcare, 4D Pharma, Landos Biopharma, Janssen, Roche, Eisai, Bristol-Myers Squibb, Iltoo Pharma, Suzhou Connect Biopharmaceuticals, Theravance Biopharma, TaiwanJ Pharmaceuticals, Celularity, Cerecor, GlaxoSmithKline, KangStem Biotech, Immunic, Alpha Cancer Technologies, Koutif Therapeutics, Tract Therapeutics, Trio medicines, ChemoCentryx, Algernon Pharmaceuticals, Neuclone, JHL Biotech, Innovative Pharmacological Research (IPHAR) Co Ltd, Innovation Pharmaceuticals, Exeliom Biosciences SAS, AbbVie, Finch Therapeutics, Akeso Biopharma, Draconis Pharma, MakScientific, Engitix, Origo Biopharma, Navidea Biopharmaceuticals, Orchard Therapeutics, Xbrane, Thetis Pharmaceuticals, Temisis Therapeutics, Synedgen, Synlogic, Morphic Therapeutic, Metacrine, Curacle, Commence Bio Inc, Cloud Pharmaceuticals, Chong Kun Dang Pharmaceutical Corp, Avobis Bio LLC, Avexegen Therapeutics, Assembly Biosciences, Aibios Co Ltd, Aclaris Therapeutics, Athos Therapeutics, Denali Therapeutics, Educell doo, among others. Ulcerative Colitis Market Ulcerative Colitis Market Insights, Epidemiology, and Market Forecast – 2034 report delivers an in-depth understanding of the market trends, market drivers, market barriers, and key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. Ulcerative Colitis Pipeline Ulcerative Colitis Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Ulcerative Colitis companies, including Eli Lilly and Company, Lipid Therapeutics, Hoffmann-La Roche, Arena Pharmaceuticals, InDex Pharmaceuticals, EA Pharma, Theravance Biopharma, Boehringer Ingelheim, Janssen Research & Development, Lycera, LG Chem, Iltoo Pharma, Immunic, Hutchison Medipharma, Tianjin Hemay Pharmaceutical, Celgene, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . 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Augustine Therapeutics has reeled in €77.7 million (about $85 million) to take on Charcot-Marie-Tooth disease, neurodegenerative conditions and cardiometabolic disorders. Two of Europe’s leading biotech investment firms — Novo Holdings and Jeito Capital — co-led the Series A. Eli Lilly also chipped in, as did Barcelona-based Asabys Partners and Paris-based AdBio, multiple other investment firms and the CMT Research Foundation. Augustine, which is based in Leuven, Belgium, is working on pills that inhibit the cytosolic histone deacetylase 6 enzyme, or HDAC6. The startup is based on Ludo Van Den Bosch’s work at the VIB-KU Leuven Center for Brain and Disease Research. He chairs the company’s scientific advisory board. In an interview, CEO Gerhard Koenig said the funding will take Augustine’s first HDAC6 inhibitor, AGT-100216, into Phase 1 this year. The Series A will also help Augustine get Phase 2 proof-of-concept data of the drug in patients with CMT. CMT impacts about 3 million people worldwide, according to the biotech. The peripheral nervous system disorder can debilitate a person’s legs, arms and fingers with progressive muscle weakness. Beyond CMT, Augustine is studying additional HDAC6 inhibitors in cardiometabolic conditions and undisclosed central nervous system disorders. The cardiometabolic program will get through Phase 1 with support from Series A, and the CNS approach will get to the IND stage, Koenig said. “You look at our investors” and “you can speculate what they might be interested” in, Koenig said. Novo Holdings, the controlling shareholder of Novo Nordisk, and Eli Lilly are redefining cardiometabolic medicine as a result of their competing GLP-1s: semaglutide and tirzepatide, both of which are approved to treat diabetes and obesity. Other companies are also exploring inhibition of HDAC6, which is involved in various disease areas and aging-related cellular processes. Novartis bought its way into the field with an $80 million upfront purchase of a Phase 1 asset from Handing Chong Kun Dang Pharmaceutical in late 2023. The Swiss pharma giant has been quiet about the candidate’s development since then, though the licensing agreement “remains active,” a Novartis spokesperson told Endpoints News via email. The spokesperson declined to disclose further details. Tenaya Therapeutics has a small molecule that’s in the clinic ; the HDAC6 inhibitor is being examined in heart failure with preserved ejection fraction. That’s also an area Augustine is considering, according to Koenig. Tenaya said in January that it’s focused on its investigational gene therapies, and there’s been little chatter about the HDAC6 inhibitor named TN-301. Augustine’s HDAC6 inhibition involves a non-hydroxamate and non-hydrazine producing approach. “We have the right chemical matter to really now go after especially chronic indications where you need a certain safety profile to really make that happen,” Koenig said. As for Augustine’s path, Koenig said, “it’s all about science and data right now, and then the rest will follow.” The company employs almost 20 people. Johnson & Johnson bought his last startup, Arkuda Therapeutics, in January for its pipeline of “lysosomal function enhancers.” Financial terms of the deal were not disclosed. Lilly had also invested in that company.