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Shenzhen Chipscreen Biosciences Co., Ltd. (SHA: 688321) has announced that the National Medical Products Administration (NMPA) has approved its New Drug Application (NDA) for Tivozanib in combination with PD-(L)1 monoclonal antibodies and chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Tivozanib, a novel multi-target inhibitor developed…
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079) has received approval from the National Medical Products Administration (NMPA) for the registration of its compound sodium lactate Ringer’s injection. The product, classified as a Class 3 chemical drug, has been granted marketing approval and is considered to have passed consistency evaluation. The…
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The US Food and Drug Administration (FDA) has removed the suspension on clinical studies for three chimeric antigen receptor (CAR)-T therapies developed by CARsgen Therapeutics Holdings Ltd (HKG: 2171), according to the company’s statement to the Hong Kong Stock Exchange. The therapies include CT053 (zevorcabtagene autoleucel), a BCMA-targeted CAR-T therapy…
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China-based AIM Vaccine Co., Ltd (HKG: 6660) has announced the submission of a market filing for its in-house developed 13-valent pneumococcal conjugate vaccine to the National Medical Products Administration (NMPA). Streptococcus pneumoniae disease is a high-priority target for vaccine prevention efforts. The 13-valent pneumococcal conjugate vaccine is designed for infants…
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Eisai Co., Ltd (TYO: 4523) and Biogen Inc. (NASDAQ: BIIB) have jointly announced the completion of a rolling submission of a Biologics License Application (BLA) for their co-developed Alzheimer’s disease drug Leqembi (lecanemab) to the U.S. Food and Drug Administration (FDA). The submission seeks approval for Leqembi as a subcutaneous…
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China-based Tasly Pharmaceuticals (SHA: 600535) has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its investigational therapy, NR-20201. This allogeneic adipose-derived mesenchymal stem cell therapy is in development for the treatment of acute ischemic stroke. Preclinical study results…
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521) has announced receiving clinical trial approval in New Zealand for its HB0056, a bispecific antibody (BsAb) targeting thymic stromal lymphopoietin (TSLP) and interleukin-11 (IL-11), clearing the way for the drug to enter Phase I clinical studies for asthma treatment. HB0056 is the world’s…
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China-based Youcare Pharmaceutical Group (SHA: 688658) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase I clinical study for its investigational drug YKYY015, targeting primary hypercholesterolemia or mixed hyperlipidemia characterized by elevated LDL-C levels. YKYY015, an siRNA drug, is distinctive for…
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China-based Innovent Biologics Inc., (HKG: 1801) has announced product sales exceeding RMB 2.3 billion (USD 323 million) for the third quarter of 2024, marking a 40% year-on-year (YOY) increase. The company’s competitive edge in China is attributed to its product indication expansion, extensive coverage on the National Reimbursement Drug List,…
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China-based CStone Pharmaceuticals (HKG: 2616) has received marketing approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for sugemalimab, in combination with platinum-based chemotherapy, as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This…
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Allergan Aesthetics, a subsidiary of AbbVie (NYSE: ABBV), has announced the official market launch of its Juvéderm VOLUX dermal filler product in China. Juvéderm VOLUX is a hyaluronic acid-based product specifically designed for contouring the lower jaw area. It is used for injection onto the facial periosteum to enhance the…
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Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990) has announced that the National Medical Products Administration (NMPA) in China has accepted for review another indication approval filing for its sacituzumab tirumotecan (SKB264/MK-2870). The new indication is for the treatment of locally advanced or metastatic EGFR mutant non-small cell lung cancer (NSCLC)…
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China-based Akeso Biopharma (HKG: 9926) has announced the enrollment of the first patient in a randomized, controlled, multicenter Phase III clinical study (AK117-302), assessing the combination of the innovative PD-1/VEGF bispecific antibody ivonescimab and its next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive…
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Shanghai Henlius Biotech Inc. (HKG: 2696) and its US partner Organon (NYSE: OGN) have jointly announced that the Biologic License Application (BLA) for HLX14, an investigational biosimilar of Amgen’s (NASDAQ: AMGN) Prolia/Xgeva (denosumab), has been accepted for review by the US Food and Drug Administration (FDA). Denosumab, a recombinant anti-RANKL…
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AIM Vaccine Co., Ltd (HKG: 6660), based in China, has received clinical trial approval from the National Medical Products Administration (NMPA) for its mRNA vaccine targeting respiratory syncytial virus (RSV). RSV is a leading cause of mortality in infants under one year old and significantly contributes to respiratory infections and…
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Swiss pharmaceutical giant Novartis (NYSE: NVS) announced that its drug Scemblix (asciminib) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP). This accelerated approval is supported by the…
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China-based Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675) has announced that it has received fast-track designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy, 177Lu-LNC1004, in patients with metastatic iodine-131 refractory differentiated thyroid cancer who have previously undergone treatment with at least one tyrosine kinase…
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China-based Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd (SHA: 688336) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody, SSGJ-626. This BDCA2-targeted mAb will now enter trials for systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE), indications that have…
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China-based biotech Zai Lab Ltd (NASDAQ: ZLAB; HKG: 9688) has announced encouraging topline results from its Phase III multi-center trial evaluating the safety and efficacy of KarXT (xanomeline and trospium chloride) within China. In line with prior global studies, this registrational bridging trial successfully met its primary endpoint, showing a…
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd. (SHA: 688621) has secured approval from China’s National Medical Products Administration (NMPA) to initiate clinical trials for ZM001, a CD19-targeted chimeric antigen receptor (CAR)-T therapy, in the treatment of systemic lupus erythematosus (SLE). The therapy, co-developed with Beijing-based gene therapy specialist Immunochina Pharmaceuticals, is…