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Junshi Biosciences’ Ongericimab Wins NMPA Nod for Hypercholesterolemia Treatment
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Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for…
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WuXi AppTec Addresses Media Speculation on Potential Sale of WuXi ATU
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WuXi AppTec Co., Ltd (SHA: 603259, HKG: 2359, OTCMKTS: WUXAY), a leading China-based Contract Development and Manufacturing Organization (CDMO), has issued a statement addressing media speculations about the potential sale of its cell and gene therapy segment, WuXi Advanced Therapies (WuXi ATU). The company clarified that no decision has been…
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Juventas Cell Therapy’s CAR-T Therapy Clears for SLE-ITP Study in China
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The China Center for Drug Evaluation (CDE) has given the green light for a study on inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Juventas Cell Therapy Ltd, a Chinese firm. This therapy is now approved for research in refractory systemic lupus erythematosus-associated immune thrombocytopenia…
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Sanofi Commences Negotiations with CD&R for Potential Sale of Opella Stake
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Sanofi (EPA: SAN; NASDAQ: SNY) has initiated negotiations with private equity firm CD&R for the potential sale of a 50% controlling stake in Opella, its consumer healthcare business, marking a significant milestone in the French pharmaceutical giant’s strategic realignment. While no decision has been finalized, Sanofi will provide further updates…
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JD Healthcare and Genrix Bio Join Forces to Revolutionize Patient Care and Pharmacy Services
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JD Healthcare, a subsidiary of China’s e-commerce juggernaut JD.com (NASDAQ: JD), has formed a strategic partnership with Chongqing Genrix Biopharmaceutical Co., Ltd. This alliance combines Genrix Biopharmaceutical’s prowess in drug research and development with JD Healthcare’s extensive resource and ecological advantages in medical treatment, medication, health management, and insurance. Together,…
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Immupeutics Medicine Secures NMPA Approval for Personalized Liver Cancer Immunotherapy IPM001
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Immupeutics Medicine, a pioneer in tumor immunotherapy based in Beijing, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its proprietary therapy, IPM001. This marks a significant step forward in the field of cancer treatment in China. IPM001 is a groundbreaking multi-antigen targeted…
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Eli Lilly & Co. Partners with Insitro to Leverage AI in Metabolic Disease Drug Development
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Eli Lilly & Co. (NYSE: LLY), a stalwart of the US pharmaceutical industry, has inked three strategic agreements with California-based Insitro, a company at the forefront of machine-learning driven drug development. This collaboration aims to forge ahead with new therapies for metabolic diseases, with a particular focus on metabolic dysfunction-associated…
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Pfizer’s Hympavzi Secures FDA Nod, Offering Novel Once-Weekly Treatment for Hemophilia B
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Pfizer Inc. (NYSE: PFE) has scored a significant win with the US Food and Drug Administration’s (FDA) approval of its drug Hympavzi (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 and older with hemophilia A, characterized by a congenital deficiency of factor VIII (FVIII), or hemophilia B,…
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Hetero and Gilead Sciences Partner to Expand Access to HIV Treatment in Low-Income Countries
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Indian pharmaceutical company Hetero has announced a new partnership with US healthcare giant Gilead Sciences (NASDAQ: GILD), securing a non-exclusive, royalty-free voluntary licensing agreement to manufacture and distribute lenacapavir in 120 primarily low- and lower-middle income countries (LMICs). This marks a significant step in expanding access to this groundbreaking HIV-1…
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Huadong Medicine Secures NMPA Approval for Semaglutide Biosimilar, Aims to Capture Weight Loss Market
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Nanjing-based Huadong Medicine Co., Ltd (SHE: 000963) has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its biosimilar version of Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide, which is marketed under the names Ozempic and Wegovy. Huadong Medicine’s biosimilar will be evaluated for weight management…
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Coherent Biopharma’s CBP-1008 Earns FDA Fast Track for Platinum-Resistant Ovarian Cancer
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Coherent Biopharma Ltd, a specialist in bispecific-ligand drug conjugates (Bi-XDCs) with operations in Suzhou, China, has been granted fast-track status by the US Food and Drug Administration (FDA) for its investigational drug CBP-1008. This drug is indicated for the treatment of platinum-resistant ovarian clear cell carcinoma (OCCC), a particularly aggressive…
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Doma Biopharmaceutical Receives Green Light for Clinical Trial of Novel ADC DM001 Targeting Solid Tumors
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a biotech firm with a presence in China and the United States, has received approval from China’s National Medical Products Administration to commence a clinical study for its innovative Category 1 drug DM001. This bispecific antibody drug conjugate (ADC) is designed to target advanced or…
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Harbour BioMed’s Innovative Antibody Porustobart Shows Promise in Early Clinical Trials for Melanoma
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Harbour BioMed (HKG: 2142), a biopharmaceutical company with operations in the United States, the Netherlands, and Suzhou, China, has announced the publication of the Phase I clinical study results for its CTLA-4 antibody porustobart (HBM4003) in combination with Junshi Biosciences’ PD-1 inhibitor toripalimab. This combination is aimed at treating advanced…
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Eli Lilly Expands Collaboration with KeyBioscience to Develop Obesity Treatments Using DACRA Platform
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Eli Lilly and Company (NYSE: LLY) has announced an extension of its collaboration with KeyBioscience AG, a subsidiary of Danish biotech Nordic Bioscience, to advance the development of Dual Amylin Calcitonin Receptor Agonists (DACRA). This new class of potential treatments targets obesity and related disorders, marking a significant step in…
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XtalPi’s AI Platform XtalFold Secures Licensing Deal with Janssen Biotech, Enhancing Biologics Discovery
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XtalPi (QuantumPharm, HKG: 2228) a leading AI-driven drug discovery firm based in Shenzhen and known as QuantumPharm Inc. (HKG: 2228), has announced a significant licensing agreement with Janssen Biotech, Inc., a subsidiary of Johnson & Johnson (J&J, NYSE: JNJ), for its proprietary AI platform, Ailux Biologics’ XtalFold. This platform, recognized…
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Roche’s Genentech Scores FDA Approval for Itovebi in Advanced Breast Cancer Treatment, Advancing Personalized Oncology
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Roche (SWX: ROG)’s Genentech, a leader in pharmaceutical innovation, has received approval from the US Food and Drug Administration (FDA) for Itovebi (inavolisib), a potent PI3Kα inhibitor. This marks a significant advancement in the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth-factor receptor 2 (HER2)-negative,…
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Johnson & Johnson’s Darzalex Combo Therapy Gets EMA Nod for Multiple Myeloma, Aims to Set New Standard
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Johnson & Johnson (NYSE: JNJ) has taken a significant step in expanding its oncology portfolio with a market filing to the European Medicines Agency (EMA) for its drug Darzalex (daratumumab). The application seeks an indication extension for the subcutaneous (SC) formulation of daratumumab, in combination with bortezomib, lenalidomide, and dexamethasone…
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Jiangsu Hengrui’s SHR2554 Gets Priority Review for Lymphoma Treatment, Strengthening Global EZH2 Inhibitor Market
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) is on the brink of a breakthrough in cancer treatment, with its drug SHR2554 receiving priority review status from China’s Center for Drug Evaluation (CDE). This enhancer of zeste homolog 2 (EZH2) inhibitor is set to revolutionize the treatment of patients with recurrent…
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Jiangsu Hengrui Secures FDA Nod for Generic Abraxane, Strengthening Oncology Portfolio
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has achieved a first in the US market with the FDA’s approval of its Abbreviated New Drug Application (ANDA) for a generic version of Abraxis BioScience’s Abraxane (paclitaxel, albumin-bound). This marks a significant milestone for the Chinese pharmaceutical firm, which now leads in…
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Roche’s VENTANA CLDN18 Assay Receives EU Approval, Enhances Targeted Therapy Options for Gastric Cancer
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Roche (SWX: ROG; OTCMKTS: RHHBY) has secured CE Mark approval in the European Union for its VENTANA CLDN18 (43-14A) RxDx Assay, marking a pivotal advancement in the treatment landscape for gastric cancer. This immunohistochemistry (IHC) companion diagnostic (CDx) test is the first to determine CLDN18 protein expression in tumors of…
