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Sichuan Kelun-Biotech Launches Sacituzumab Tirumotecan for Triple Negative Breast Cancer in China
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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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Joincare Pharmaceutical’s JKN2403 Gains NMPA Approval for COPD Clinical Trials
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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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Sino Biopharmaceutical Ltd. Files for Benmelstobart and Anlotinib Combination Therapy in ASPS Treatment
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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 Receives NMPA Clearance for Innovative Cell-Based Influenza Vaccine
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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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AIM Vaccine Co., Ltd Receives NMPA Approval for Second-Gen Tetanus Vaccine Clinical Trial
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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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MSD’s Clesrovimab for Infant RSV Protection: FDA Accepts BLA for Review
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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…
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MediLink Therapeutics’ YL201 Receives FDA Orphan Drug Designation for Small-Cell Lung Cancer
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Suzhou-based biotech company MediLink Therapeutics (Suzhou) Co., Ltd has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its antibody drug conjugate (ADC) YL201 for the treatment of small-cell lung cancer (SCLC). This designation highlights the potential impact of YL201 in addressing a…
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Everest Medicines’ Nefecon Receives First Prescription for IgAN Treatment in Adults
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China-based Everest Medicines (HKG: 1952) has announced that its targeted-release budesonide, Nefecon, has been prescribed for the first time to treat primary immunoglobulin A nephropathy (IgAN) in adults who are at risk of disease progression. This development signifies a significant step forward in the management of IgAN, a condition that…
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FDA Approves Xcovery Holdings’ Ensartinib for Untreated ALK-Positive NSCLC Patients
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On December 18, 2024, the Food and Drug Administration (FDA) granted approval for Betta Pharmaceutical (SHE: 300558) and its controlling subsidiary Xcovery Holdings, Inc.’s ensartinib (Ensacove), a treatment for adult patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously received…
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Janssen-Cilag Submits for IMBRUVICA Indication Extension in Untreated Mantle Cell Lymphoma
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Janssen-Cilag International NV has announced the submission seeking approval for an indication extension of IMBRUVICA (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP). The extended indication is for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell…
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Chengdu Kanghua Biological Receives NMPA Approval for Recombinant Norovirus Vaccine
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Chengdu Kanghua Biological Products Co., Ltd, (SHE: 300841), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its recombinant hexavalent norovirus vaccine (Pichia pastoris). The vaccine is designed to prevent acute gastroenteritis caused by genotype…
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Huadong Medicine’s HDM1005 Receives FDA Clearance for Heart Failure and Obesity Clinical Trial
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clearance from the US Food and Drug Administration (FDA) for its Category 1 chemical drug, HDM1005. The drug will now proceed to clinical trials involving patients with heart failure with preserved ejection fraction (HFpEF) and obesity. HDM1005:…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Approval for SHR-1501 Combo in Bladder Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276), a leading China-based pharmaceutical company, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for the combination of SHR-1501 with adebrelimab (SHR-1316) for the treatment of non-muscle invasive bladder cancer. Adebrelimab: A PD-L1 Monoclonal Antibody with…
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Sino Biopharmaceutical’s Benmelstobart Meets Primary Endpoint in Phase III NSCLC Study
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Sino Biopharmaceutical Ltd (HKG: 1177), a leading China-based biopharmaceutical company, has announced positive results from the Phase III study (TQB2450-Ⅲ-05) for its anti-programmed death-ligand 1 (PD-L1) monoclonal antibody (mAb) benmelstobart (TQB2450). The study evaluated benmelstobart, with or without multi-target kinase inhibitor anlotinib, as a consolidation therapy for locally advanced/unresectable (stage…
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UCB’s Minzasolmin Fails to Meet Endpoints in ORCHESTRA Study for Early Parkinson’s
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Belgium-based biopharmaceutical company UCB (EBR: UCB) has announced the disappointing results of the ORCHESTRA proof-of-concept (POC) study for minzasolmin, an alpha-synuclein misfolding inhibitor co-developed with Swiss pharmaceutical giant Novartis (NYSE: NVS). The study was designed to assess the efficacy of minzasolmin in treating early Parkinson’s disease, but it failed to…
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Everest Medicines’ Velsipity (Etrasimod) Receives First Prescription in Foshan under GBA Policy
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Everest Medicines (HKG: 1952), a leading biopharmaceutical company based in China, has announced that its Velsipity (etrasimod) has been prescribed for the first time at Foshan Fosun Chancheng Hospital. This prescription was made possible under the “Hong Kong-Macau Drug and Device Access” policy, which is part of the Greater Bay…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Amulirafusp Alfa in NMOSD
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ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKG: 1541), a China-based biopharmaceutical company, has announced the commencement of a Phase Ib study for its innovative dual-target macromolecular drug, amulirafusp alfa (IMM0306), in patients with neuromyelitis optica spectrum disorders (NMOSD). This marks a significant step as the first patient has been dosed in the…
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Eli Lilly’s Kisunla Receives NMPA Approval for Early Alzheimer’s Disease Treatment
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Eli Lilly and Company (NYSE: LLY), a leading pharmaceutical corporation in the US, has announced that it has received marketing approval from China’s National Medical Products Administration (NMPA) for its drug donanemab-azbt, marketed under the name Kisunla. The drug is administered as a 350 mg/20 mL injection every four weeks…
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BioNova Pharmaceuticals’ BN104 Receives Breakthrough Therapy Designation in China
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The China’s Center for Drug Evaluation (CDE) website has indicated that BioNova Pharmaceuticals (Shanghai) Ltd.’s novel small molecule, BN104, is on track to obtain Breakthrough Therapy Designation (BTD). This development marks a significant milestone for the treatment of relapsed/refractory acute leukemia patients carrying KMT2A rearrangement and/or NPM1 mutation in China.…
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Evopoint Biosciences Submits Pre-NDA for Funobactam, Imipenem, and Cilastatin to NMPA
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Suzhou-based Evopoint Biosciences Co., Ltd. has announced the submission of a Pre-NDA (New Drug Application) for its Category 1 product, a combination of funobactam, imipenem, and cilastatin, to the National Medical Products Administration (NMPA). This product, once approved, is poised to become the world’s first β-lactam/β-lactamase inhibitor (BL/BLI) with a…
