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US-based Pfizer (NYSE: PFE) has announced receiving an indication extension approval from the US Food and Drug Administration (U.S. FDA) for Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation. Braftovi’s Existing…
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US pharmaceutical giant Eli Lilly & Co. (NYSE: LLY) has revealed that the US Food and Drug Administration (FDA) has granted another indication approval for its drug Zepbound (tirzepatide), marking it as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. Zepbound can…
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Denmark-based Novo Nordisk A/S (NYSE: NVO) has announced that the US Food and Drug Administration (FDA) has granted marketing approval for its Alhemo (concizumab-mtci) injection. The drug is indicated as a once-daily prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years…
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China-based CStone Pharmaceuticals (HKG: 2616) has announced the clinical filing for its CS2009, a PD-1/VEGF/CTLA-4 trispecific antibody, in Australia. This first-in-human study is registered and published on Clinicaltrials.gov with the NCT number: NCT06741644. Innovative Design and Mechanism of CS2009CS2009 boasts an innovative molecular design that simultaneously targets PD-1, VEGFA, and…
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China-based Yifan Pharmaceutical Co., Ltd (SHE: 002019) has announced that its subsidiary, Evive Biotech Ltd, has received marketing approval from the Brazil National Health Surveillance Agency (ANVISA) for Ryzneuta (efbemalenograstim alfa, F-627). This approval follows previous marketing nods in China, the United States, and the European Union. Ryzneuta (F-627): A…
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Changchun BCHT Biotechnology Co., Ltd (SHA: 688276), a China-based biotechnology company, has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its mRNA vaccine, LVRNA101. The vaccine is designed to prevent genital herpes caused by herpes simplex virus type 2 (HSV-2) infection. HSV-2 and the Need…
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Shenzhen Chipscreen Biosciences Co., Ltd (SHA: 688321), a China-based biopharmaceutical company, has announced receiving the go-ahead from the National Medical Products Administration (NMPA) to conduct a clinical study for its drug candidate CS231295 in advanced solid tumors. CS231295: A Promising Multi-Target InhibitorCS231295 is a multi-target protein kinase inhibitor that has…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with clinical testing of its Category 1 biologic product, SHR-1681. Novel Biologic Product SHR-1681The product, SHR-1681, is designed to specifically bind to antigens present on the surface…
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced clinical clearance from the National Medical Products Administration (NMPA) for its SYH9017, a biosimilar version of Denmark-based Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy). The clearance allows SYH9017 to proceed to clinical trials focused on weight management for…
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China-based CSPC Pharmaceutical Group Co., Ltd. (HKG: 1093) has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its antibody drug conjugates (ADCs), SYS6005 and SYS6043. Pre-Clinical Success and Potential ApplicationsBoth SYS6005 and SYS6043, classified as Category 1 biologic products with undisclosed…
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CanSino Biologics (SHA: 688185, HKG: 6185) has announced the initiation of a Phase I/II study for its CS-2036, a recombinant polio vaccine, in Indonesia with financial support from the Bill & Melinda Gates Foundation. This development is accompanied by the first subject enrollment in the Phase I trial. Additionally, the…
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its taletrectinib, a second-generation ROS1 tyrosine kinase inhibitor. The drug is now approved for use in treating adult patients with ROS1 positive locally advanced or metastatic non-small cell lung cancer (NSCLC)…
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Shanghai, China, December 21, 2024 — YolTech Therapeutics today announced that its proprietary in vivo gene-editing drug, YOLT-201, has successfully completed the dose-escalation phase in Phase I clinical trials for the treatment of transthyretin amyloidosis (ATTR) and is set to enter the dose-expansion phase. YOLT-201: A Novel Gene-Editing Therapy for…
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Swiss pharmaceutical giant Roche (SWX: ROG) has published results from the Phase IIb PADOVA study for its investigational monoclonal antibody, prasinezumab, in patients with early-stage Parkinson’s disease (PD). The study aimed to assess the drug’s impact on the primary endpoint of time to confirmed motor progression, with a hazard ratio…
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced the commercial launch of its sacituzumab tirumotecan (SKB264/MK-2870) in China, marking a significant milestone in the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have been previously treated with at least two…
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China-based Jo2006incare Pharmaceutical Group Industry Co., Ltd (SHA: 600380) is set to advance its Category 1 chemical drug, JKN2403, into clinical trials for the treatment of moderate to severe chronic obstructive pulmonary disease (COPD), following approval from the National Medical Products Administration (NMPA). JKN2403: A Novel COPD Treatment with Promising…
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China-based Sino Biopharmaceutical Ltd (HKG: 1177) is poised to make another indication approval filing with the National Medical Products Administration (NMPA) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450) in combination with the multi-target kinase inhibitor anlotinib. The targeted indication for this combination therapy is advanced alveolar…
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AIM Vaccine Co., Ltd (HKG: 6660), a China-based biopharmaceutical company, has announced that it has received clearance from the National Medical Products Administration (NMPA) to conduct a clinical study for its suspension cultured quadrivalent MDCK cell influenza vaccine. This marks a significant step forward in the development of a novel…
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its second-generation high-valent adsorbed tetanus vaccine. This development is a significant step forward in the company’s efforts to combat a disease that is both serious and…
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Merck, Sharp & Dohme (MSD; NYSE: MRK) has announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), the company’s investigational prophylactic long-acting monoclonal antibody. This antibody is designed to protect infants from respiratory syncytial virus (RSV) disease during their first…