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Roche (SWX: ROG), the Swiss pharmaceutical giant, has announced the receipt of another marketing approval from the National Medical Products Administration (NMPA) for its ophthalmology bispecific antibody (BsAb) Vabysmo (faricimab). The new indication is for macular edema secondary to central retinal vein occlusion (CRVO) or hemi-retinal vein occlusion (HRVO). Vabysmo,…
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Intas Pharmaceuticals Ltd, an Indian pharmaceutical company and partner of China’s Shanghai Henlius Biotech Inc. (HKG: 2696), has announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its ustekinumab-srlf. This biosimilar version of Johnson & Johnson’s (J&J, NYSE: JNJ) auto-immune disease drug Stelara…
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RemeGen Ltd (HKG: 9995), a biopharmaceutical company based in China, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has accepted another indication approval filing for its drug candidate disitamab vedotin (RC48). The antibody-drug conjugate (ADC) has been granted priority review status. This…
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AstraZeneca (NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568)’s co-developed antibody drug conjugate (ADC), Enhertu (trastuzumab deruxtecan), has received conditional approval from China’s National Medical Products Administration (NMPA) for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors exhibit activating HER2 (ERBB2)…
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On October 14, 2024, Bristol-Myers Squibb (BMS, NYSE: BMY) announced that the National Medical Products Administration (NMPA) of China has approved a new indication for its dual immune combination therapy, Opdivo (nivolumab) and Yervoy (ipilimumab), for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or deficient…
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Sichuan Biokin Pharmaceutical Co., Ltd, a Chinese pharmaceutical company listed on the Shanghai Stock Exchange as (SHA: 688506), has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its antibody-drug conjugate (ADC), BL-M11D1. This therapy targets CD33…
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BrightGene Bio-Medical Technology Co., Ltd (SHA: 688166), a Chinese biopharmaceutical company, has announced positive results from the Phase II clinical study (CTR20233198) for its investigational drug BGM0504. This dual agonist targets GLP-1 (glucagon-like peptide 1) and GIP (glucose-dependent insulin stimulating polypeptide) receptors and is being studied for the treatment of…
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Dizal Pharmaceutical Co., Ltd (SHA: 688192), a biopharmaceutical company based in China, has announced that it has received Breakthrough Therapy Designation (BTD) from China’s National Medical Products Administration (NMPA) for its next-generation epidermal growth factor receptor (EGFR) inhibitor, sunvozertinib. This designation is in relation to the drug’s potential use as…
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Reforgene Medicine, a pioneer in gene editing therapy based in Guangzhou, has secured Investigational New Drug (IND) approval from China’s National Medical Products Administration (NMPA) for its flagship candidate, RM-101. This AAV-based gene editing drug is aimed at treating Usher syndrome, a genetic condition that leads to significant vision impairment…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd, a leading pharmaceutical company based in China and listed as (SHA: 600276), has received approval from the National Medical Products Administration (NMPA) for its Category 1 drug, RGL-193. This marks a significant step forward as the drug advances into clinical studies focused on Parkinson’s disease…
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The Center for Drug Evaluation (CDE) has indicated that Novartis (NYSE: NVS), the Swiss pharmaceutical giant, has had its second market filing for brolucizumab accepted for review. The filing is anticipated to be for the treatment of visual impairment resulting from macular edema associated with diabetes (DME). Brolucizumab, recognized as…
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Pfizer Inc. (NYSE: PFE) has announced positive topline results regarding overall survival (OS) in the Phase III TALAPRO-2 study for Talzenna (talazoparib), an oral poly ADP-ribose polymerase (PARP) inhibitor, when combined with Xtandi (enzalutamide), an androgen receptor pathway inhibitor (ARPI). This combination is used for the treatment of patients with…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has initiated a Phase III clinical study for its Category 1 drug JMT101. This study combines JMT101 with osimertinib (Tagrisso) and compares it against osimertinib alone in the first-line treatment of locally advanced or metastatic epidermal growth…
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KangaBio, a biopharmaceutical company based in Shanghai, has announced that its investigational new drug (IND) application for KGX101 has received clinical trial approval from the China National Medical Products Administration (NMPA). This Class 1 new drug, an IL-12 Fc fusion protein injection, is expected to be used for the treatment…
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JNJ-78278343, a KLK2-CD3 bispecific antibody, is currently in Phase I clinical trials globally. According to data released by Johnson & Johnson (J&J, NYSE: JNJ), this drug targets kallikrein-related peptidase 2 (KLK2), an antigen highly expressed in prostate cancer, and binds to CD3 on T cells to activate them, inducing an…
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Merck KGaA (MRK, NYSE: MRK) , a leading science and technology company based in Germany, has announced the availability of its ovulation-stimulating treatment Pergoveris in the Guangdong–Hong Kong–Macao Greater Bay Area. The treatment, which combines recombinant human follicle stimulating hormone (r-hFSH) and recombinant human luteinizing hormone (r-hLH), has been approved…
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Junshi Biosciences (HKG: 1877; SHA: 688180), a leading biopharmaceutical company in China, has announced that it has received marketing approval from the National Medical Products Administration (NMPA) for its PCSK9 monoclonal antibody, ongericimab (JS002). This therapy is now approved for use in combination with statins or statins plus ezetimibe for…
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The China Center for Drug Evaluation (CDE) has given the green light for a study on inaticabtagene autoleucel (CNCT 19), a chimeric antigen receptor (CAR)-T cell therapy developed by Juventas Cell Therapy Ltd, a Chinese firm. This therapy is now approved for research in refractory systemic lupus erythematosus-associated immune thrombocytopenia…
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Immupeutics Medicine, a pioneer in tumor immunotherapy based in Beijing, has announced that it has received clinical approval from the National Medical Products Administration (NMPA) for its proprietary therapy, IPM001. This marks a significant step forward in the field of cancer treatment in China. IPM001 is a groundbreaking multi-antigen targeted…
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Pfizer Inc. (NYSE: PFE) has scored a significant win with the US Food and Drug Administration’s (FDA) approval of its drug Hympavzi (marstacimab-hncq) for routine prophylaxis in adults and pediatric patients aged 12 and older with hemophilia A, characterized by a congenital deficiency of factor VIII (FVIII), or hemophilia B,…