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BeiGene’s Tislelizumab Secures EC Approval for Three NSCLC Indications
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the European Committee (EC) has granted approval for its programmed death-1 (PD-1) inhibitor, tislelizumab, for three distinct non-small cell lung cancer (NSCLC) indications. The approvals allow for the use of tislelizumab in the following scenarios: The approvals were supported by…
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Shanghai Henlius Biotech Achieves First Patient Dosing in Phase I Trial for Fibrosis Treatment HLX6018
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced the completion of the first patient dosing in a Phase I clinical study for HLX6018, a GARP/TGF-β1 compound monoclonal antibody (mAb). The drug is under development for the treatment of fibrosis-related diseases and has been tested…
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China’s Insulin Volume-Based Procurement Tender Results Renewed with 17% Higher Contracted Value
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The renewal of winning bids from the insulin volume-based procurement (VBP) tender, initially held in March 2022, has been finalized and is open for public feedback from April 24 to 26. A total of 49 insulin products from 13 manufacturers have been awarded renewed tender spots, with a total contracted…
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China Medical System Holdings’ Desidustat NDA Accepted for Review by China’s NMPA
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China Medical System Holdings (CMS; HKG: 0867) has announced that the National Medical Products Administration (NMPA) has accepted for review the New Drug Application (NDA) for its desidustat. The oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) is under development to treat anemia in adult chronic kidney disease (CKD) patients who…
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Akeso Biopharma Submits sNDA for Cadonilimab in Cervical Cancer to China’s CDE
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China-based Akeso Biopharma (HKG: 9926) has announced the submission of a supplementary New Drug Application (sNDA) for its innovative bispecific antibody, cadonilimab (AK104), which targets both programmed death-1 (PD-1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). The sNDA filing seeks to expand the use of cadonilimab in combination with chemotherapy and…
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Huadong Medicine’s HDM1005 Receives US FDA Clinical Trial Approval for Weight Management
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug HDM1005. This long-acting agonist targets the GLP-1 receptor and GIP receptor and is under development for weight management in overweight or obese…
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Sandoz’s Partner Samsung Bioepis Scores EC Approval for Stelara Biosimilar Pyzchiva
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Switzerland-headquartered Sandoz (SWX: SDZ) has announced that the European Commission (EC) has granted approval for Pyzchiva, a biosimilar version of Johnson & Johnson’s (J&J; NYSE: JNJ) IL-12/23 blocker Stelara (ustekinumab), developed in partnership with South Korea’s Samsung Bioepis. Both biologics are indicated for the treatment of plaque psoriasis, psoriatic arthritis,…
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Jiangsu Hengrui Medicine Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
