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CDE’s BL-B01D1 on Track for Breakthrough Therapy Designations for EGFR Wild-Type and Mutant NSCLC
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The Center for Drug Evaluation (CDE) has indicated on its website that two indications for its in-house developed bispecific antibody drug conjugate (ADC), BL-B01D1, are on track to receive breakthrough therapy designations (BTDs). The first indication is for patients with locally advanced or metastatic EGFR wild-type non-small cell lung cancer…
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Acotec Scientific’s Heart Valve Balloon Dilatation Catheter RunFlow Wins NMPA Approval
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Acotec Scientific Holdings Ltd (HKG: 6669), a leading medical device company based in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its product RunFlow, a heart valve balloon dilation catheter. Designed for autologous valve dilation of the aorta during artificial aortic…
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AimingMed Technologies Partners with RekeyMed to Advance Biotech and Organoid Innovations
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Hangzhou AimingMed Technologies Co., Ltd., a leading organoid specialist based in China, has entered into a strategic partnership with RekeyMed Technology Co., Ltd, a company focused on regenerative medicine biomaterials. The collaboration aims to leverage the complementary strengths of both entities to foster the integration and innovative application of modern…
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Shanghai Fudan-Zhangjiang Enrolls First Patient in U.S. Phase II Study for Port Wine Stain Treatment
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Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd (HKG: 1349; SHA: 688505), a leading biopharmaceutical company based in China, has announced the enrollment of the first patient in a Phase II clinical study for its hemoporfin photo-dynamic therapy (PDT) in the United States. The study is focused on treating port wine stain (PWS),…
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Antengene’s Xpovio Receives NDA Approval in Thailand for Multiple Myeloma Treatment
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Antengene Corp., Ltd (HKG: 6996), a biopharmaceutical company based in China, has announced that it has received New Drug Application (NDA) approval in Thailand for its drug Xpovio (selinexor). This approval allows the use of Xpovio in combination with bortezomib and dexamethasone to treat adult patients with relapsed or refractory…
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Wuhan YZY Biopharma Presents M701 Interim Results at 2024 ESMO Congress for NSCLC-Related Pleural Effusion
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Wuhan YZY Biopharma Co., Ltd (HKG: 2496), a biopharmaceutical company based in China, has announced the presentation of interim analysis results from a Phase Ib clinical study for its investigational drug M701 at the 2024 European Society of Medical Oncology (ESMO) Congress. M701 is a recombinant anti-EpCAM and CD3 human…
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Allist Pharmaceuticals’ EGFR Inhibitor AST2303 Approved for Clinical Trial in NSCLC by NMPA
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Allist Pharmaceuticals Inc. (SHA: 688578), a Shanghai-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its AST2303, an oral small molecule epidermal growth factor (EGFR) inhibitor, for adult patients with advanced non-small cell lung cancer (NSCLC) that carries the…
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Haisco Pharmaceutical’s HSK21542 for Itching in Dialysis Patients Receives NMPA Review
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Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a prominent Chinese pharmaceutical company, has announced that its marketing application for HSK21542, a Category 1 drug, has been accepted for review by the National Medical Products Administration (NMPA). The drug is intended for the treatment of moderate to severe itching associated with…
