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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to initiate a clinical study for its pipeline candidate SYS6023. The study will initially focus on patients with general advanced solid tumors.…
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Immorna (Hangzhou) Biotechnology, a biotech company specializing in mRNA-based vaccines and located in Hangzhou, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its self-replicating RNA cancer therapy, JCXH-211-IV (intravenous injection). JCXH-211-IV is a potential first-in-class…
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Hinova Pharmaceuticals Inc. (SHA: 688302), a biotech company based in Chengdu, has announced that it has received approval from the U.S. Food and Drug Administration (FDA) to conduct a Phase I/II clinical study for its drug candidate HP537 in the treatment of hematologic malignancies. The Category 1 chemical had previously…
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Amoytop Biotech Co. Ltd (SHA: 688278), based in Xiamen, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 biologic, peginterferon α-2b, which is indicated for the treatment of primary thrombocytosis. As the first domestically developed long-acting peginterferon α-2b for…
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Doma Biopharmaceutical (Suzhou) Co., Ltd, a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the U.S. Food and Drug Administration (FDA) for its bispecific antibody drug conjugate (ADC), DM001. The molecule is set to be evaluated for safety, tolerability, and preliminary anti-tumor activity…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug HRS-9813, which is intended for the treatment of idiopathic pulmonary fibrosis (IPF). Preclinical efficacy data from…
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced that it has received approval from the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan to conduct a global, multi-center Phase III study. The study will evaluate the anti-programmed death-1 (PD-1) inhibitor HanSiZhuang (serplulimab, HLX10) in…
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its prostate specific membrane antigen (PSMA)-targeted radioactive in vivo therapeutic drug, 177LuLNC1011. The molecule is intended for evaluation…
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SCG Cell Therapy Pte. Ltd, a Singapore-headquartered biotechnology company with a presence in Shanghai, has announced that it has received clearance from the US Food and Drug Administration (FDA) to proceed with a Phase I/II clinical study for its investigational therapy, SCG142. This therapy is a human papillomavirus (HPV) specific…
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Huadong Medicine Co., Ltd (SHE: 000963), a pharmaceutical company based in China, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its antibody drug conjugate (ADC), HDM2005. This molecule targets recombinant receptor tyrosine kinase-like orphan receptor 1 (ROR1) and is intended…
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IASO Biotherapeutics, a biopharmaceutical company based in China, has announced that it has received tacit clinical trial approval from the National Medical Products Administration (NMPA) for its investigational therapy, RD118. RD118 is a fully human GPRC5D-targeted chimeric antigen receptor T-cell (CAR-T) therapy for the treatment of relapsed/refractory multiple myeloma (r/r…
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HighTide Therapeutics Inc., (HKG: 2511), a biopharmaceutical company based in China, has announced the completion of patient enrollment for two Phase III clinical studies of its drug candidate HTD1801 (berberine ursodeoxycholate, BUDCA) for the treatment of type 2 diabetes (T2DM). The studies include the multi-center, randomized, double-blind, placebo-controlled SYMPHONY-1, which…
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for SYS6020, a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy. This marks a significant milestone for the company as SYS6020 is…
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Staidson (Beijing) Pharmaceutical Co., Ltd (SHE: 300204), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its TNFR2-targeted monoclonal antibody (mAb), SBT-1901, for the treatment of locally advanced or metastatic solid tumors. Preclinical studies have demonstrated…
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Asieris Pharmaceuticals (SHA: 688176), a Chinese specialist in urogenital cancer, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its drug candidate APL-1202 for the treatment of free-living amoebae (FLA) infections. APL-1202, an oral MetAP2 inhibitor, is currently in a Phase III…
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for IMC-002, a bispecific antibody (BsAb) targeting CD47 and CD20 for the treatment of systemic lupus erythematosus (SLE). IMC-002 is designed to enhance antibody dependent cell phagocytosis…
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its bispecific antibody drug conjugate (ADC), BL-M17D1, which is designed for the treatment of advanced solid tumors.…
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StarryGene, a biotech company specializing in gene therapy and based in Hefei, China, has announced that the first patient has been dosed in a Phase I clinical study for its gene therapy XMVA09 injection, which is designed to treat wet age-related macular degeneration (wAMD). XMVA09 is positioned as the world’s…
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Zhangzhou Pien Tze Huang Pharmaceutical Co., Ltd. (SHA: 600436), a renowned traditional Chinese medicine (TCM) company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its PZH2113. This is an in-house developed Category 1 chemical drug intended for the treatment…
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Tonghua Dongbao Pharmaceuticals (SHA: 600867), based in China, has announced that the National Medical Products Administration (NMPA) has approved the Phase Ib clinical study for its drug candidate THDBH120, a glucagon-like peptide-1/gastrin inhibitor (GLP-1/GIP) dual-targeted receptor agonist. The drug is intended for the treatment of overweight or obese adults. THDBH120…