Toripalimab

CHICAGO, IL, USA I June 27, 2024 I Meitheal Pharmaceuticals, Inc. (“Meitheal”), a fully integrated biopharmaceutical company based in Chicago and focused on the development and commercialization of generic injectables, fertility, biologic, and branded products, today announced it has gained exclusive commercial rights in the U.S. to YUSIMRY ® (adalimumab-aqvh), a biosimilar of Humira ® (adalimumab), through an exclusive license and supply agreement with its parent company, Hong Kong King-Friend Industry Co., Ltd. (“HKF”). “The licensing of YUSIMRY ® is a pivotal moment for Meitheal, solidifying our foothold in the biosimilars market and providing us with a high-value asset with the potential for robust growth in the coming years,” said Tom Shea, Chief Executive Officer of Meitheal Pharmaceuticals. “With our expertise across research, manufacturing, and commercialization, Meitheal is well-positioned to enhance patient access to high-quality biosimilars like YUSIMRY ® while continuing to advance its clinical and commercial development.” HKF has acquired worldwide rights to YUSIMRY ® through an asset purchase agreement with Coherus BioSciences, Inc. Under the agreement, HKF gains substantially all assets related to YUSIMRY ® , including any results of development and regulatory activities, in exchange for an upfront cash payment of $40,000,000. The closings of both the asset purchase agreement and Meitheal’s exclusive licensing agreement with HKF are effective immediately, subject to standard conditions and approvals. “Adalimumab is a critical medication for many Americans living with autoimmune conditions, and we look forward to continuing to deliver YUSIMRY ® , a more affordable option to Humira ® , to patients at a fair and sustainable price,” said Brian McCarthy, Meitheal Senior Vice President of Specialty. “With adalimumab biosimilars recently gaining traction, YUSIMRY ® is positioned to meet the ongoing demand for accessible treatment options due to key macro forces and the strategic investments being made in its production and commercialization.” In recent years, Meitheal and its parent company HKF have made multiple investments to expand the Company’s biologics portfolio and capabilities. This new, exclusive licensing agreement for YUSIMRY ® adds a fifth biosimilar and the first on-market biosimilar to Meitheal’s portfolio. Meitheal’s parent company and related entities have invested over $300 million in capital and R&D in recent years to support sustainable product supply, including investing $30 million in a monoclonal antibody drug substance facility. “We are pleased to have acquired the rights to this critical option for patients and are confident that Meitheal is best positioned to deliver fairly priced YUSIMRY ® to U.S. patients in need,” said Eric Tang, President of HKF. “We remain focused on strategic investments in the important biosimilars market and we look forward to a continued partnership with Meitheal to support accessible healthcare solutions.” YUSIMRY ® is currently approved by the U.S. Food and Drug Administration (“FDA”) in nine different indications as a biosimilar of Humira ® , including in both prefilled syringe (PFS) and autoinjector presentations. As a top-selling pharmaceutical for multiple inflammatory diseases, demand for adalimumab products remains high. Meitheal will continue the development of both pediatric presentations and a high concentration (100mg/mL) formulation of YUSIMRY ® . Meitheal will work closely with Coherus to ensure a seamless transition of existing YUSIMRY ® operations, including the existing and comprehensive support hub for patients and healthcare providers. ABOUT YUSIMRY ® YUSIMRY ® (adalimumab-aqvh), a biosimilar of Humira ® (adalimumab), is a tumor necrosis factor (“TNF”) blocker indicated to reduce the signs and symptoms of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, and ankylosing sponddylitis, and to treat Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. INDICATIONS Limitations of Use: The effectiveness of YUSIMRY has not been established in patients who have lost response to or were intolerant to TNF blockers. *Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of YUSIMRY has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information. Please see Full Prescribing Information , including Boxed Warning and Medication guide ABOUT MEITHEAL PHARMACEUTICALS Founded in 2017 and based in Chicago, Meitheal Pharmaceuticals is focused on the development and commercialization of generic injectable medications and, as of 2022, has expanded its focus to include fertility, biologic, and branded products. Meitheal currently markets over 55 US Food and Drug Administration (FDA)-approved products across numerous therapeutic areas including anti-infectives, oncolytics, intensive care, and fertility. As of the end of May 2024, Meitheal, directly or through its partners, has over 20 products in the research and development phase, 14 products planned for launch in 2024, and an additional 19 products under review by the FDA. Meitheal’s mission is to provide easy access to fairly priced products through robust manufacturing, consistent supply, and rapid response to our customers’ needs. Ranked among the top 100 Crain’s Best Places to Work in Chicago, Meitheal emulates the traditional Irish guiding principle we are named for — Meitheal (Mee·hall): working together toward a common goal, for the greater good. Learn more about who we are and what we do at www.meithealpharma.com . ABOUT HONG KONG KING-FRIEND INDUSTRIAL COMPANY (HKF) Hong Kong King-Friend Industrial Company is a wholly owned subsidiary of NKF, founded in 2010. ABOUT NANJING KING-FRIEND BIOPHARMACEUTICAL COMPANY (NKF) Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF) is a China-based company principally engaged in the research and development, production and sales of Active Pharmaceutical Ingredients (API) and Finished Dosage Form (FDF). Established in 1986 as one of world leading manufacturers of heparin related APIs, NKF has grown into a fully integrated API and FDF manufacturer in multiple therapeutic areas including critical care and oncology. With three U.S. FDA approved manufacturing sites in China and more than 500 employees, including more than 100 dedicated research and development experts, NKF strives to meet patient needs globally with market presence in the U.S., China, EU and across the world. The Company is publicly listed on Shanghai Stock Exchange with a market capitalization over U.S. $3.0 billion. ABOUT COHERUS BIOSCIENCES Coherus is a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer. Coherus is developing an innovative immuno-oncology pipeline that is expected to be synergistic with its proven commercial capabilities in oncology. Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor immunologic response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in two ongoing clinical studies: a Phase 1/2 study in advanced solid tumors and a Phase 2 study in hepatocellular carcinoma. CHS-114 is a highly selective, competitively positioned, cytolytic anti-CCR8 antibody currently in a Phase 1 study in patients with advanced solid tumors. CHS-1000 is a preclinical candidate targeting immune-suppressive mechanisms via the novel pathway ILT4. Coherus markets LOQTORZI ® (toripalimab-tpzi), a novel next-generation PD-1 inhibitor and UDENYCA ® (pegfilgrastim-cbqv), a biosimilar of Neulasta ® (pegfilgrastim). SOURCE: Meitheal Pharmaceuticals

SHANGHAI, June 25, 2024 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the National Medical Products Administration (NMPA) has approved the supplemental new drug application (sNDA) for toripalimab (product code: JS001) in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC). According to the GLOBOCAN 2020 statistics, breast cancer became the most common cancer in the world, with 2.31 million new cases and 0.67 million deaths. In China, there were 0.36 million new cases and 0.07 million deaths due to breast cancer, accounting for 15.5% and 11.2% of global cases. Amongst these, TNBC accounts for about 10% to 15% of all breast cancer cases, making TNBC a more aggressive type of cancer with a higher risk of recurrence and poor prognosis. Advanced TNBC is not responsive to targeted or endocrine therapies and lacks specific treatment methods. Chemotherapy remains the standard treatment for advanced TNBC in China, but both mono-chemotherapy and combined chemotherapy have poor efficacy, with a median survival time of about 9 to 12 months and a 5-year survival rate of less than 30%. The supplemental NDA approval is based on the TORCHLIGHT study (NCT04085276), a randomized, double-blind, placebo-controlled, multi-center Phase III clinical study jointly conducted in 56 centers across the country. Professor Zefei JIANG, Vice President and Secretary General of the Chinese Society of Clinical Oncology (CSCO) and from the Department of Oncology of the Chinese People’s Liberation Army General Hospital, served as the principal investigator. In February 2023, the Independent Data Monitoring Committee (IDMC) determined in an interim analysis that the primary endpoint of the TORCHLIGHT study had met the pre-defined efficacy boundary. TORCHLIGHT is the first registered domestic Phase III study to achieve positive results in the field of advanced TNBC immunotherapy. In January 2024, Nature Medicine (Impact Factor: 58.7) published the interim results of the TORCHLIGHT study. The findings showed that, compared with paclitaxel alone, toripalimab in combination with paclitaxel in patients with an initial diagnosis of stage IV or recurrent metastatic TNBC can significantly prolong the progression-free survival (PFS) of PD-L1-positive patients. The overall survival (OS) also showed a positive trend, achieving a breakthrough in immunotherapy for advanced TNBC in China. The median PFS in the toripalimab group was 8.4 months, and the risk of disease progression or death was reduced by 35% (P=0.0102). The median OS in the toripalimab group was extended by 13.3 months (32.8 months vs 19.5 months), and the risk of death was reduced by 38% (P=0.0148). The safety pro toripalimab remained consistent with the established safety profile, with no new safety signals identified. “Immunotherapy has become the most important treatment for TNBC,” said Principal investigator Professor Zefei JIANG from the Department of Oncology of the Chinese People’s Liberation Army General Hospital. “The TORCHLIGHT study introduces immune checkpoint inhibitors in addition to traditional chemotherapy, which not only significantly prolongs the mPFS for patients with advanced TNBC, but also demonstrates notable benefits to overall survival, increasing the total survival time for TNBC patients to more than 30 months. As the very first approved immunotherapy for TNBC in China, toripalimab will set a new standard for the first-line treatment of TNBC.” “For a long time, effective treatments for advanced TNBC have been lacking,” said Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences. “The approval of this new indication is another milestone success, and it offers new hope to Chinese patients with advanced TNBC. As of now, toripalimab has 10 approved indications in China. Moving forward, we will remain dedicated to patient care, collaborate with Chinese experts and scholars, and address the long-standing unmet clinical needs of many more patients.” About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are ten approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy; recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy; locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC; in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC); in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC); in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC; in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC); in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC); in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC). The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In April 2024, the Drug Office at the Department of Health in the Government of the Hong Kong Special Administration Region (DO) accepted the NDA for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. In the United States, the US FDA has approved the Biologics License Application for toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy in October 2023. The FDA has granted toripalimab 2 Breakthrough Therapy designations for the treatment of NPC, 1 Fast Track designation for the treatment of mucosal melanoma, and 5 Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC). In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the MHRA for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced/recurrent or metastatic ESCC, in December 2022 and February 2023. In Australia, the new chemical entity (NCE) application was accepted by the Australia Therapeutic Goods Administration (TGA) in November 2023. The TGA has also granted toripalimab an Orphan Drug designation for the treatment of NPC. In Singapore, the NDA application was accepted by the Singapore Health Sciences Authority (HSA) in January 2024. The HSA has also granted priority review designation for the NDA. About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Four of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in China and the US. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 3,000 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: Junshi Biosciences Contact Information IR Team: Junshi Biosciences info@junshipharma.com + 86 021-6105 8800 PR Team: Junshi Biosciences Zhi Li zhi_li@junshipharma.com + 86 021-6105 8800