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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study combining its CDK 4/6 inhibitor, Dalpiciclib (SHR6390), with HRS-1358 for the treatment of breast cancer. This marks a significant step in expanding…
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Anhui Anke Biotechnology (Group) Co., Ltd (SHE: 300009), a biopharmaceutical company based in China, has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its drug candidate AFN0328. The drug is intended for the treatment of malignant tumors associated with HPV16/18 infection, including cervical…
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Consun Pharmaceutical Group Ltd (HKG: 1681), a leading Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to commence clinical studies for SK-08. This Category 1 chemical drug, co-developed with Contract Research Organization (CRO) WuXi AppTec (HKG: 2359), is intended to target…
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Grand Pharmaceutical Group Limited (HKG: 0512), a China-based pharmaceutical company, has announced that it has received approval to conduct a Phase II clinical study for its drug candidate STC3141 in the treatment of sepsis in China. Design and Scope of the Phase II StudyThe Phase II study is a multi-center,…
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BeiGene (NASDAQ: BGNE; HKG: 6160; SHA: 688235) has announced that the National Medical Products Administration (NMPA) in China has approved its clinical filing for the Category 1 pipeline candidate BG-C9074. The antibody drug conjugate (ADC) is set to be initially assessed for the treatment of general advanced solid tumors, marking…
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Celling Biotechnology Co., Ltd, a Guangzhou-based biopharmaceutical company, has announced that its pipeline candidate CEL001 has received tacit clinical trial approval in China. The drug candidate is an antibody fusion protein targeting PD-1, TIGIT, and IL-15, and is intended for the treatment of advanced solid tumors, with a particular focus…
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Betta Pharmaceuticals (SHE: 300558) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its EYP-1901 intravitreal implant, intended for the treatment of wet age-related macular degeneration (wAMD). The drug candidate is a combination of vorolanib, a multi-target tyrosine kinase VEGFR/PDGFR inhibitor, and…
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Shenzhen Tyercan Bio-pharm Co., Ltd, a biopharmaceutical company based in China, has announced that it has received tacit Investigational New Drug (IND) approval from the US Food and Drug Administration (FDA) for its anti-tumor drug TYE1001. The drug is intended for the treatment of advanced solid tumors and lymphomas. TYE1001…
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Mabwell (Shanghai) Bioscience Co., Ltd (SHA: 688062) has announced that China’s National Medical Products Administration (NMPA) has granted approval for a Phase II clinical study of its antibody drug conjugate (ADC) 9MW2821, which targets Nectin-4, in patients with triple negative breast cancer (TNBC). The study will evaluate the efficacy and…
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Shanghai Ruijin Hospital’s Hainan subsidiary has initiated a real-world study for Orserdu (elacestrant), a next-generation selective estrogen receptor degrader (SERD) originally developed by Eisai (TYO: 4523). The drug was transferred to Radius Health for global development back in 2006. In a strategic move in July 2020, the Menarini Group, based…
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shanghai Regenelead Therapies Co., Ltd., has conducted the first surgical dosing in a clinical study for its dual adeno-associated virus (AAV) gene therapy, RGL-193, aimed at treating Parkinson’s disease (PD). The procedure…
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Shanghai Escugen, a biopharmaceutical company based in China, has announced the dosing of the first patient in a Phase III clinical study for its candidate drug ESG401. The study is assessing the efficacy of ESG401 in patients with hormone receptor positive and human epidermal growth factor receptor 2 negative (HR+/HER2-)…
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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 initiate a clinical study for its antibody-drug conjugate (ADC), BL-M14D1, intended for the treatment of advanced solid tumors. BL-M14D1 leverages the same…
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Beijing Sun-Novo Pharmaceutical Research Co., Ltd (SHA: 688621), a biopharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a clinical study for its investigational drug candidate STC008. This study will focus on the treatment of tumor cachexia…
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Shanghai Vitalgen BioPharma Co., Ltd, a biopharmaceutical company based in China, has initiated a Phase I/II clinical study for its gene therapy candidate VGN-R09b at Huashan Hospital, targeting primary Parkinson’s disease (PD). VGN-R09b received clearance to proceed with clinical trials in China for primary PD and aromatic L-amino acid decarboxylase…
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Suzhou Sanegene Bio Inc., a leading RNAi specialist with research and development centers in both the US and China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its investigational drug SGB-3908. This antihypertensive siRNA drug has been co-developed with Innovent Biologics,…
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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 National Medical Products Administration (NMPA) for its investigational STSP-0902 eye drops, which are intended for the treatment of neurotrophic keratitis (NK). Neurotrophic keratitis, also referred to as…
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Shandong Buchang Pharmaceuticals Co., Ltd (SHA: 603858), a pharmaceutical company based in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 biologic product BC008-1A. This product is intended for the treatment of glioblastoma and advanced…
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Jiangsu-based HOB Biotech Group Corp., Ltd (SHA: 688656) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its MM09 sublingual spray. The product is intended to target indications such as mild to moderate asthma and allergic rhinitis/nasal conjunctivitis, with a focus on…
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Shanghai Fosun Pharmaceutical Group Co., Ltd (SHA: 600196; HKG: 2196), a prominent pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its co-developed FH-2001 in combination with HanSiZhuang (serplulimab, HLX10) for the treatment of advanced…