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FDA Clears sBLA for Eisai and Biogen’s Leqembi Maintenance Dosing
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Partners Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have announced that the US Food and Drug Administration (FDA) has cleared their supplemental Biologics License Application (sBLA) for once every four weeks Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing. The drug is approved in the US for the treatment…
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Guangzhou Innogen’s Efsubaglutide Alfa Approved by NMPA for Type 2 Diabetes
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China-based Guangzhou Innogen Pharmaceutical Group Co., Ltd, a biopharma focused on metabolic diseases, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its efsubaglutide alfa to treat type 2 diabetes (T2D). This approval marks a significant milestone in the development and commercialization of efsubaglutide alfa, positioning…
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MSD and Eisai’s Keytruda/Lenvima Combo Shows Promise in Gastroesophageal Cancer Study
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Partners Merck, Sharp & Dohme (MSD, NYSE: MRK) and Eisai (TYO: 4523) have announced the latest results from the Phase III LEAP-015 study, which evaluated the combination of MSD’s anti-PD-1 therapy Keytruda (pembrolizumab) with Eisai’s kinase inhibitor Lenvima (lenvatinib) plus chemotherapy. The study focused on the first-line treatment of patients…
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Novo Nordisk’s Amycretin Shows Promising Weight Loss Results in Phase Ib/IIa Study
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Denmark – based pharmaceutical giant Novo Nordisk A / S (NYSE: NVO) has announced topline results from a Phase Ib / IIa study of its investigational drug amycretin, a unimolecular GLP – 1 and amylin receptor agonist. The study was designed to evaluate the safety, tolerability, pharmacokinetics, and proof –…
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Boehringer Ingelheim’s Nerandomilast Granted Priority Review for IPF in China
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German pharmaceutical giant Boehringer Ingelheim has announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted priority review status to its investigational drug nerandomilast. The drug is being developed for the treatment of idiopathic pulmonary fibrosis (IPF), a rare and debilitating lung disease…
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Shenzhen Kangtai Halts COVID-19 Vaccine Development Amid Market Shifts
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Shenzhen based biopharmaceutical company Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601) has announced the termination of its research and development efforts for the COVID – 19 inactivated vaccine (Vero cells). The decision was driven by the evolving nature of the novel coronavirus and the changing market environment for COVID…
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China Medical System Partners with MabGeek for Innovative Drug MG-K10
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China Medical System Holdings (CMS; HKG: 0867) has announced a new license agreement with MabGeek Biotechnology Co., Ltd., a fellow Chinese biotech firm, for the latter’s Category 1 drug MG-K10. This marks CMS’s second major licensing deal in less than a month. Financial details of the agreement were not disclosed.…
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BioCity Biopharma Launches Phase III Study for Kidney Disease Drug SC0062
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BioCity Biopharma, a leading biopharmaceutical company, has announced the initiation of a Phase III clinical study for its kidney disease drug SC0062 at the Guangdong Provincial People’s Hospital, the leading institution for the study. The study, named SUCCESS-01, aims to evaluate the efficacy and safety of SC0062 capsules in patients…
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Hengrui’s Long-Acting Insulin Analogue Accepted for Review by China’s NMPA
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that its market filing for a long-acting insulin analogue, a Category 1 biologic product, has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant milestone for Hengrui as it seeks to bring China’s first…
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Shenzhen Beike Initiates First Chinese Stem Cell Study for Systemic Lupus Erythematosus
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China-based stem cell specialist Shenzhen Beike Biotechnology Co., Ltd has announced the initiation of a Phase I/II clinical study for human umbilical cord mesenchymal stem cells in patients with moderate to severe systemic lupus erythematosus (SLE). This marks the first regulatory study for stem cell therapy targeting SLE in China,…
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United Laboratories’ Biosimilar Semaglutide Accepted for Review by China’s NMPA
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Hong Kong-listed United Laboratories International Holdings Ltd (HKG: 3933) has announced that its market filing for a biosimilar version of Novo Nordisk’s (NYSE: NVO) weight loss drug semaglutide (Ozempic/Wegovy) has been accepted for review by China’s National Medical Products Administration (NMPA). This marks a significant step towards introducing a more…
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Beijing Aosaikang’s ASKB589 Shows Promise in Phase I/II Study for Gastric Cancer
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China’s Beijing Aosaikang Pharmaceutical Co., Ltd (SHE: 002755) has unveiled the latest results from a Phase I/II study of its Category 1 biologic product candidate ASKB589, which is being evaluated as a first-line treatment for advanced gastric/esophagogastric junction (G/GEJ) adenocarcinoma. The study assessed the efficacy and safety of ASKB589 in…
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Biogen’s Higher-Dose Spinraza Regimen Under Review by FDA and EMA
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US-based biopharmaceutical company Biogen (NASDAQ: BIIB) has submitted supplemental New Drug Applications (sNDAs) to the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for a higher-dose regimen of its spinal muscular atrophy (SMA) treatment, Spinraza (nusinersen). The applications are currently under review by both regulatory bodies,…
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YolTech Initiates Study for YOLT-204 in Transfusion-Dependent Beta-Thalassemia
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Shanghai-based YolTech Therapeutics, a biotech startup specializing in lipid nanoparticle delivery and gene editing, has announced the initiation of a dosage escalation study to preliminarily assess the safety and efficacy of a single-dose regimen with YOLT-204 in transfusion-dependent beta-thalassemia (TDT). This marks a significant step forward in the development of…
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Haichang Bio’s siRNA Drug HC016 Cleared for US Clinical Trials
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China-based Zhejiang Haichang Biotech Co., Ltd has announced that its siRNA drug, HC016 complex lipid, has been cleared by the US Food and Drug Administration (FDA) for clinical trials. This marks a significant milestone in the development of innovative treatments for solid tumors, leveraging Haichang Bio’s proprietary QTsome technology platform.…
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Abbott Labs Posts Q4 Growth, Projects Strong 2025 Outlook
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US-based Abbott Laboratories (NYSE: ABT) has released its Q4 2024 financial results, reporting an 8.8% increase in organic sales to USD 10.974 billion. Excluding COVID-19 testing-related sales, the company achieved a 10.1% growth rate. For the full year, Abbott generated USD 42.0 billion in revenues, up 7.1% on an organic…
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Haisco’s HSK44459 Approved for Clinical Trials in Behcet’s Disease
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its investigational product HSK44459 in Behcet’s disease. This rare disease is listed in China’s second catalogue of rare diseases, highlighting the significant unmet medical need it represents. Behcet’s…
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Belief BioMed’s BBM-D101 Receives FDA Approval for DMD Clinical Trial
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China-based gene therapy specialist Belief BioMed Inc. (BBM) has announced receiving clinical trial approval from the US Food and Drug Administration (FDA) for its BBM-D101. An open, single-dose clinical study is scheduled to commence, assessing the safety and efficacy of the gene therapy in boys aged 4 to 9 with…
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United Laboratories’ UBT251 Approved for Phase II Trials in Chronic Kidney Disease
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Hong Kong-based United Laboratories International Holdings Ltd (HKG: 3933) has announced receiving approval from the National Medical Products Administration (NMPA) to conduct Phase II clinical trials for its Category 1 drug UBT251 in chronic kidney disease (CKD). This marks a significant step forward in the development of innovative therapies for…
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Sanofi’s Sarclisa Approved in EU for Newly Diagnosed Multiple Myeloma
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France-based Sanofi (EPA: SAN, NASDAQ: SNY) has announced receiving marketing approval in the European Union (EU) for its CD38 monoclonal antibody (mAb) Sarclisa (isatuximab) in combination with the standard-of-care regimen of bortezomib, lenalidomide, and dexamethasone (VRd). The approval is for the treatment of adult patients with newly diagnosed multiple myeloma…
