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Gilead Extends Collaboration with Nurix Therapeutics for Targeted Protein Degradation by Two Years
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Gilead Sciences (NASDAQ: GILD) has announced a two-year extension of its 2019 collaboration with Nurix Therapeutics (NASDAQ: NRIX) focused on the discovery, development, and commercialization of targeted protein degradation therapies. As part of the agreement, Nurix will receive a USD 15 million extension fee for identifying novel agents that induce…
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RemeGen Plans RMB 2.55 Billion Private Placement to Fund Innovative Drug Development
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China-based RemeGen (HKG: 9995) has announced plans to raise RMB 2.55 billion (approximately USD 280.5 million) through a private placement. The funds will be directed towards supporting clinical studies and the development of innovative therapies, including candidates RC18, RC48, RC28, RC88, RC148, and RC198. With a robust product portfolio featuring…
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AstraZeneca and Daiichi Sankyo File for FDA Approval of Datopotamab Deruxtecan in Breast Cancer
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AstraZeneca (AZ; NASDAQ: AZN), headquartered in the UK, and its Japanese partner Daiichi Sankyo (TYO: 4568) have submitted a filing to the U.S. Food and Drug Administration (FDA) for their antibody-drug conjugate (ADC) datopotamab deruxtecan, aimed at treating unresectable or metastatic HR-positive, HER2-negative breast cancer in adults who have previously…
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Sichuan Biokin Secures NMPA Approval for Phase II Study of BL-M07D1 in Advanced Solid Tumors
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Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506), based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its antibody-drug conjugate (ADC) BL-M07D1 in patients with advanced solid tumors. The trial will evaluate BL-M07D1 in combination…
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Jiangsu Hengrui’s Fluzoparib Receives Breakthrough Therapy Designation for HER2-Negative Breast Cancer
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Jiangsu Hengrui Medicine Co., Ltd. (SHA: 600276), a China-based pharmaceutical company, has announced that its indication approval filing for fluzoparib—a poly (ADP-ribose) polymerase (PARP) inhibitor—has been awarded breakthrough therapy designation (BTD) by China’s Center for Drug Evaluation (CDE). The designation applies to fluzoparib, both as a monotherapy and in combination…
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Jiuyuan Gene’s Semaglutide Biosimilar Market Filing Accepted for Review in China
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Hangzhou Jiuyuan Gene Engineering Co., Ltd., based in China, has announced that its market approval filing for a biosimilar version of semaglutide, originally developed by Denmark’s Novo Nordisk, has been accepted for review in China. This biosimilar is aimed at controlling blood glucose levels in patients with type 2 diabetes…
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RemeGen Secures Fast-Track FDA Designation for Telitacicept in Sjögren’s Syndrome Treatment
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China-based pharmaceutical company RemeGen (HKG: 9995) has announced that it has received fast-track designation (FTD) from the U.S. Food and Drug Administration (FDA) for its telitacicept in the treatment of Sjögren’s syndrome (SS). This follows the drug’s clearance for a global, multi-center Phase III study in the U.S. for the…
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Hepalink Secures TFDA Approval for Enoxaparin Sodium Injection, Expanding Thrombosis Treatment Options in Thailand
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Shenzhen Hepalink Pharmaceutical Group Co., Ltd (SHE: 002399), based in China, has announced that it has received marketing approval from the Thailand Food and Drug Administration (TFDA) for its enoxaparin sodium for injection. The approved specifications include 0.2ml (20mg) and 0.4ml (40mg), indicated for the prevention of venous thromboembolic diseases,…
