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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…
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Eli Lilly & Co. Boosts Suzhou Plant with $211M to Meet Diabetes and Obesity Drug Demand
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Eli Lilly & Co.(NYSE: LLY)’s China subsidiary is poised to invest a substantial RMB 1.5 billion (USD 211.95 million) to expand its manufacturing capabilities in Suzhou, a strategic move aimed at augmenting the production of drugs for type 2 diabetes and obesity. This capital expenditure is set to not only…
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Sunvozertinib’s Companion Diagnostic Gets NMPA Nod, Fortifying Targeted Therapy Arsenal for NSCLC in China
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Dizal Pharmaceutical Co., Ltd (SHA: 688192) and Burning Rock Ltd (NASDAQ: BNR, FRA: 6BU0) have announced a significant regulatory milestone in China’s precision medicine space. Their jointly developed companion diagnostic (CDx) for epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), designed to pair with the targeted therapy sunvozertinib,…
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Sino Medical Sciences Secures NMPA Nod for Balloon Guided Catheter to Aid Vascular Procedures
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China-based Sino Medical Sciences Technology Inc. (SHA: 688108) has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its balloon guided catheter. The device is designed to assist in the insertion of intravascular catheters and guide them into the target vessel within the peripheral…
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Nona Biosciences Partners with OverT Bio to Develop Next-Generation Cell Therapies for Solid Tumors
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Nona Biosciences, a wholly-owned subsidiary of HBM Holdings Ltd (HKG: 2142), has entered into a partnership with US biotechnology company OverT Bio, Inc. to develop next-generation cell therapies targeting solid tumors. The collaboration will leverage Nona’s heavy-chain antibody (HCAb) Harbour Mice platform, with no financial specifics disclosed. Nona Bio’s HCAb…
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Bill & Melinda Gates Foundation Invests $17 Million in CanSino Biologics’ Recombinant Polio Vaccine
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The Bill & Melinda Gates Foundation has committed USD 17 million to support the development of CS-2036, a recombinant polio vaccine, by China-based CanSino Biologics (SHA: 688185, HKG: 6185). The investment will fund various development efforts, including clinical trials, process development, scaling-up, and the development of a candidate combined vaccine…
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InnoCare Pharma’s ICP-488 Shows Promising Results in Phase II Psoriasis Study
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China-based InnoCare Pharma (HKG: 9969; SHA: 688428) has announced positive results from a Phase II clinical study for its TYK2 (tyrosine kinase 2) JH2 allosteric inhibitor, ICP-488, in patients with moderate to severe plaque psoriasis. The study demonstrated the drug’s potential in treating psoriasis and other autoimmune diseases by inhibiting…
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Ascletis Pharma Faces US Import Ban for NASH Drugs ASC41 and ASC43F in Trade Secrets Dispute
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China’s Ascletis Pharma Inc. (HKG: 1672) is navigating legal proceedings involving its oral thyroid hormone receptor-beta (THRβ) agonist ASC41 and a compound preparation ASC43F, both under development for the treatment of non-alcoholic steatohepatitis (NASH). US-based Viking Therapeutics (NASDAQ: VKTX) filed a lawsuit in the United States against Ascletis in December…
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Beijing Aosaikang Pharmaceuticals Boosts Stake in US Subsidiary AskGene with RMB 220 Million Investment
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Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has announced a capital injection of RMB 220 million (USD 31 million) into its US-based subsidiary, AskGene Limited, established in 2012. This investment increases the Chinese firm’s shareholding in AskGene from 59.07% to 62.86%, solidifying its position as the controlling shareholder. Concurrently, TF…
