Pertuzumab biosimilar (Hisun Pharma)

Revenue Exceed RMB30.9 Billion with R&D Expenditure RMB3.9 Billion Continuing to Consolidate its Dominant Position In The fields of Breast Cancer and Lung Cancer SHANGHAI, Oct. 29, 2024 /PRNewswire/ -- On October 29, Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), announced its operating performance for the first three quarters of 2024. From January to September 2024, Fosun Pharma achieved revenue of RMB30.91 billion, an increase of about 5.74% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.84 billion, up by 24.58% YoY. In 2024, Fosun Pharma will further focus on innovative drugs and high-value devices, and continue to promote lean operations, cost reduction, efficiency improvement, and asset rationalization to optimize assets and financial structure, actively promote supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2024, the net cash flow from operating activities of Fosun Pharma was RMB2.99 billion, a year-on-year increase of 21.33%; the management expense ratio decreased by 0.15 percentage points YoY; excluding the impact of newly acquired companies, management expenses decreased by approximately RMB300 million on the same basis. Focusing on advantageous therapeutic areas with innovative R&D pipelines continue to advance In terms of innovative R&D, Fosun Pharma continues to focus on advantageous pipelines to achieve efficient results and continuous implementation of innovative products. In the first three quarters of 2024, Fosun Pharma's R&D expenditure totaled RMB3.92 billion. In particular, R&D expenses were RMB2.65 billion. In addition to independent R&D, the Group fully implemented an open R&D model, and incubated and invested in R&D projects by initiating/managing industrial funds and other diversified ways, so as to ensure the sustainability of innovation and R&D. Fosun Pharma's innovative drug business mainly covers the core therapeutic areas of solid tumors, hematological tumors and immuno-inflammatory diseases, with emphasis on the enhancement of the core technology platforms of antibody/ADCs, cellular therapy and small molecules, to create an open and global innovative R&D system, continuously enhance pipeline value, and promote the development and commercialization of its products. In the field of tumor immunotherapy, on September 13, 2024, Fosun Pharma announced it will acquire the 50% stake in Fosun Kite and will wholly own Fosun Kite (now renamed as "Fosun Kairos"). In the future, Fosun Kairos will serve as the core platform of Fosun Pharma's cell therapy, continue to focus on the field of tumor immunotherapy, as well as to promote the development and commercialization of existing licensed products, Axi-Cel (i.e. Fosun Kite's marketed product "Yi Kai Da") and Brexu-Cel (i.e. Fosun Kite's pipeline project FKC889), in Chinese mainland, Hong Kong SAR and Macau SAR with Kite Pharma. In the third quarter of 2024, Fosun Pharma's multiple independently developed innovative products and pipeline clinical trial results were announced in industry conferences and journals, further consolidating its dominant position in the fields of hematological tumors, breast cancer, lung cancer and other tumors. Particularly, the interim analysis results of the Phase III study of Foritinib Succinate (SAF-189s), an innovative drug independently developed to treat ALK-positiveb advanced non-small cell lung cancer (NSCLC), were released during the 2024 World Conference on Lung Cancer ("WCLC"). The above-mentioned studies have found that the overall efficacy of Foritinib Succinate is good. Compared with crizotinib treatment, it can significantly improve PFS and reduce the risk of CNS progression. Its safety is controllable, and no new safety signals appeared after treatment. Faritinib Succinate is expected to break through the current clinical difficulties faced in the treatment of ALK-positive NSCLC and bring new treatment options to NSCLC patients. The multicenter real-world study of Fosun Pharma's self-developed serplulimab-based immunochemotherapy for extensive-stage small cell lung cancer was released at the 2024 WCLC. The ASTRUM-005R study provides additional empirical evidence to support the therapeutic value of serplulimab plus chemotherapy and complements the pivotal data from the ASTRUM-005 clinical trial. Additionally, during the reporting period, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency (EMA) issued a positive opinion recommending approval for Fosun Pharma's self-developed serplulimab injection in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The CHMP's opinion will be submitted to the European Commission (EC) as a reference for marketing authorization approval. Results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with Han Qu You (trastuzumab) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The results showed that add HLX22 to HLX02 (trastuzumab) and chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety. In September 2024, Fosun Pharma announced the Biologics License Application ("BLA") for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark: 达希斐®) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was approved by the National Medical Products Administration ("NMPA"), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Chinese mainland. Additionally, the results of a Phase III multicenter, double-blind, placebo-controlled study conducted in China for the treatment of moderate to severe glabellar lines were published in the Journal of Plastic, Reconstructive & Aesthetic Surgery (JPRAS). The study demonstrates that the product provides durable efficacy and high safety in Chinese patients with moderate to severe glabellar lines. Actively implementing share repurchases and increasing holdings with continuous efforts on enhancing ESG Fosun Pharma, a company listed on both the A-share and H-share markets, and its controlling shareholder Fosun High Tech have actively engaged in share repurchases and increased holdings this year, demonstrating confidence in the Company's future development and further boosting market confidence. In the first three quarters of 2024, Fosun Pharma spent approximately RMB127 million and approximately HKD66.9 million to repurchase around 5.68 million A shares and 5.47 million H shares respectively. As of now, the H Share Repurchase Plan is still valid. In addition, the controlling shareholder Fosun High Tech, has spent a total of approximately RMB101 million to increase its holdings of around 4.30 million A shares of Fosun Pharma, under the latest Shareholding Increase Plan. Founded in 1994 and with three decades of development, Fosun Pharma has grown into a global innovation-driven pharmaceutical and healthcare industry group. The Company always regards innovation as its primary social responsibility, consistently focusing on unmet clinical needs, prioritizing innovative R&D, advancing the launch of innovative products, promoting drug accessibility and affordability, and driving high-quality corporate growth. Fosun Pharma maintained an A grade rating in MSCI ESG Ratings for three consecutive years and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS"). With its sustained excellence in innovation and global operational capabilities, Fosun Pharma has been recognized by multiple authoritative institutions in innovative R&D, ESG and other areas. The Company ranked in the top four of China's 2023 Top 100 Pharmaceutical Industry, was included in the "China Best Managed Companies" List (BMC) for the second consecutive year and was listed in Forbes 2024 China ESG 50. In addition, the Company has actively introduced its independently developed artemisinin-based innovative products to Africa, providing a Chinese solution to the global fight against malaria. This initiative highlights the inclusive, diverse, and open nature of ESG and earned Fosun Pharma recognition as an "Inspirational ESG Case", serving as a model for corporate ESG practices. *** About Fosun Pharma Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196.SH, 02196.HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business. Fosun Pharma is patient-centered and unmet clinical needs-oriented. Through diversified and multi-level cooperation models such as independent research and development, cooperative development, license-in, and industrial investment, the company continues to enrich its innovative product pipeline and focus on differentiated product R&D with high-tech barriers, to continuously enhance the value of its pipeline. Fosun Pharma's innovative products focus on core therapeutic areas such as solid tumors, hematologic tumors and immunity inflammation. It also strengthens core technology platforms such as antibodies/ADC, cell therapy, and small molecules. Guided by the 4IN strategy (Innovation, Internationalization, Intelligentization, and Integration), Fosun Pharma adheres to the business philosophy of "Innovation for Good Health", continues to promote innovative transformation, actively deploys internationalization, strengthens business focus by product lines, promotes integrated operations and efficiency improvement, and is dedicated to being the global leading integrator of pharmaceutical and healthcare innovation. For more information, please visit the official website: SOURCE Fosun Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Collaboration adds multiple modular swappable antigen recognition regions to lead program, HSB-3215, a bispecific antibody targeting novel epitopes on HER2/HER3 receptors Capitalizes on “Knob” biologics (Picobodies TM ) for tumor targeting, extends partnership to include validated target, HER3 IND filing for HSB-3215 planned in 2024 BRIDGEWATER, NJ, USA I July 20, 2023 I Hillstream BioPharma, Inc. (“Hillstream”, the “Company”) today announced the expansion of its collaboration with Minotaur Therapeutics, Inc. (“Minotaur”) and its license agreement with OmniAb, Inc. (“OmniAb”) to advance the development of next generation targeted Knob biologics (Picobodies TM ) against HER3 and a new undisclosed oncology target. Hillstream will collaborate with Minotaur using OmniAb’s “OmniTaur™” technology to discover targeted biotherapeutic Picobodies complementing Hillstream’s most advanced program, HSB-3215, a HER2/HER3 bispecific antibody (BsAb). As a diverse group of molecules, BsAbs recognize distinct epitopes on two different antigens, in the case of HSB-3215, HER2 and HER3. These validated targets, belong to the ERBB receptor tyrosine kinase family and are exploited by cancer cells to promote oncogenesis. HER2 is an extensively validated target, and emerging evidence suggests that HER3 plays a key role as well. While HER3 has little to no tyrosine kinase activity on its own, its activation promotes tumors through dimerization or locking into place with HER2, which is believed to intensify its cancer-causing potential. Hillstream’s lead program, HSB-3215, is designed as a BsAb targeting the extracellular domains of HER2 and HER3. HSB-3215 binds to both overlapping and different epitopes on HER2 in contrast to approved therapies, with ligand-blocking and potential complementary fit to HER3, affecting novel conformational epitopes thought to be important in intracellular downstream signaling in tumor cells. HSB-3215 and HER3 associated novel Picobodies offer the potential to target previously undruggable epitopes of these clinically validated targets, distinguishing them from earlier generations of antibodies. Picobodies, which are a characteristic of antibodies in bovine animals, are derived from ultra-long complementary determining region 3 (CDR3) domains which potentially enable access to epitopes that had previously been hidden or highly inaccessible in traditional antibody development. With a much smaller size compared to traditional antibodies, combined with structural diversity, Picobodies can bind to conformational, linear or discontinuous epitopes in “undruggable” targets. Picobodies are derived from bovines, which unlike other species, express ultralong CDR-H3 regions forming an independently folding mini-domain, that protrudes far out from the surface of the antibody and is diverse in both its sequence and disulfide patterns. These atypical antigen binding sites of bovines potentially provide the ability to interact with different antigenic determinants capable of eliciting an immune response, particularly recessed or concave surfaces, compared to traditional antibodies. This conceivable “multi-specific” capacity of Picobodies TM could more efficiently target multiple cell surface portions compared to known or existing biologics. Hillstream aims to develop both HSB-3215 and other antibodies using this framework to interchange antigen-recognition sites designed to fit distinct portions of the HER2/HER3 heterodimer complex potentially effecting both ligand-dependent and independent signaling pathways into tumor cells. The Company intends to develop its lead program, HSB-3215 and file an IND application with the US FDA late next year. Dr. Vaughn Smider, Founder and Chief Executive Officer of Minotaur, stated “We are excited to continue Minotaur’s collaboration with Hillstream to progress novel next-generation targeted cancer biologics.” Randy Milby, Chief Executive Officer of Hillstream, stated, “We are extremely pleased with the progress made to date. The Knob biologics program continues to be a great addition to our portfolio as we rapidly progress our lead asset HSB-3215 towards an IND. Hillstream is now poised to develop a novel technology for creating multiple proteins to enhance targeted cancer immunotherapy.” About Hillstream BioPharma, Inc. Hillstream BioPharma, Inc. is a biotechnology company developing a focused portfolio of therapeutic candidates targeting drug resistant and devastating cancers. The Company’s emerging immuno-oncology pipeline is led by HSB-3215, a novel anti-HER2 monoclonal antibody targeting unique epitopes with a novel mechanism of action. The erbB/HER family of cell surface proteins include well-known and validated drug targets including HER2 and HER3 found in multiple solid tumors, including breast, lung, GYN, endocrinological and CNS. Hillstream has a license agreement with OmniAb, Inc. to access the company’s antibody discovery technology platform. For more information about Hillstream, please visit: www.hillstreambio.com . About Minotaur Therapeutics Minotaur Therapeutics is a private biotechnology company developing unique biotherapeutics for oncology and immunology. Minotaur uses the novel ultralong CDR3 scaffold of bovine antibodies which allows unique targeting properties. Minotaur has licensing and partnership arrangements with The Applied Biomedical Science Institute on this emerging therapeutic class and its underlying technologies. SOURCE: Hillstream BioPharma