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Novo Nordisk’s Semaglutide Meets Primary Endpoints in ESSENCE Phase III Study for MASH
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Denmark-based pharmaceutical company Novo Nordisk (NYSE: NVO; CPH: Novo-B) has announced that part 1 of the Phase III ESSENCE study, a pivotal 240-week, double-blinded trial involving 1,200 adults with metabolic dysfunction-associated steatohepatitis (MASH) and moderate to advanced liver fibrosis, has successfully reached its primary endpoints. The trial evaluated the efficacy…
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Jiuzhitang Co., Ltd Announces Clinical Clearance for Volagidemab in Type 1 Diabetes
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China-based traditional Chinese medicine (TCM) giant Jiuzhitang Co., Ltd (SHE: 000989) has announced that volagidemab (REMD-477), a Category 1 drug developed by Beijing CoSci-REMD Bio Med-Tech Co, Ltd (CoSci-REMD Bio), a subsidiary of U.S. biotech REMD Biotherapeutics Inc., has received clearance for clinical study in type 1 diabetes in China.…
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Shenzhen Chipscreen Biosciences Receives NMPA Approval for Chiauranib Clinical Study
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China-based biopharmaceutical company Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321) has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its category 1 innovative drug, chiauranib. The study will evaluate chiauranib in combination with a programmed-death (PD)-(ligand) 1 monoclonal antibody and chemotherapy as a…
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Innovent Biologics Halts Subscription Agreement with Lostrancos Ventures
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the decision not to proceed with a subscription agreement between its wholly owned subsidiary, Fortvita, and Lostrancos Ventures Ltd. The agreement would have seen Lostrancos acquire a 20% stake in Fortvita for USD 20.5 million. Despite this setback, Innovent Biologics reaffirmed its…
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China’s CDE Releases 88th Batch of Reference Preparations for Generic Drug Evaluation
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The Center for Drug Evaluation (CDE) in China has announced its 88th batch of reference preparations for the purpose of generic quality and consistency evaluation (GQCE). This selection is a critical step in ensuring the quality and efficacy of generic drugs within the Chinese market. Expansion and Refinement of Reference…
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AstraZeneca’s China President Leon Wang Confirmed to Assist in Investigation Amid Fraud Allegations
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On October 29, 2024, just hours after celebrating a business school anniversary on social media, AstraZeneca’s (AZ, NASDAQ: AZN) Global Executive Vice President and China President, Leon Wang, was confirmed to be cooperating with an investigation. The announcement came less than 48 hours later via AstraZeneca China’s official website. On…
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Novartis’ Trispecific Antibody PIT565 Secures NMPA Approval for Clinical Trial
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Swiss pharmaceutical giant Novartis (NYSE: NVS) has received acceptance for its clinical trial application for the investigational drug PIT565 from the China National Medical Products Administration (NMPA). PIT565 is a potential “first-in-class” trispecific antibody targeting CD3, CD19, and CD2, which Novartis is developing to treat B-cell malignancies. Preclinical research results…
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Shenzhen Chipscreen Biosciences’ Tivozanib Secures NMPA Approval for ES-SCLC Phase III Trial
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Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) has announced that the National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Tivozanib in combination with PD-(L)1 monoclonal antibodies and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Tivozanib, a novel multi-target inhibitor developed…
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