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Insilico Medicine Launches Clinical Study for First-in-Class PHD Inhibitor ISM5411 in IBD
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Insilico Medicine, a China-based biotech leveraging generative artificial intelligence (AI), has announced the initiation of a clinical study for its potential first-in-class PHD inhibitor, ISM5411, targeting inflammatory bowel disease (IBD). ISM5411 is an intestinal-restricted small-molecule inhibitor developed using Insilico’s Pharma.AI platform, featuring a novel molecular framework and a unique binding…
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Simcere Secures NMPA Approval for Edaravone Sublingual Tablets Targeting Post-Stroke Cognitive Impairment
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Jiangsu Simcere Pharmaceutical Co., Ltd (HKG: 2096) has received clinical trial approval from the National Medical Products Administration (NMPA) for its edaravone, borneol sublingual tablets, targeting post-stroke cognitive impairment (PSCI) in patients suffering from acute ischemic stroke (AIS). The edaravone, borneol sublingual tablet is a solid oral formulation designed for…
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Jiangsu Hengrui Receives NMPA Approval for Esophageal Cancer and Breast Cancer Clinical Trials
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276) has received approval from the National Medical Products Administration (NMPA) to conduct a Phase II study for adebrelimab (SHR-1316) in combination with neoadjuvant chemotherapy for locally advanced surgically resectable esophageal squamous cell carcinoma (ESCC) in the perioperative setting. Additionally, the Chinese pharmaceutical company…
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Beijing Konruns Pharmaceutical Launches Phase III Study for KC1036 in Advanced Esophageal Cancer
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Beijing Konruns Pharmaceutical Co., Ltd (SHA: 603590), based in Beijing, has received approval from China’s Center for Drug Evaluation (CDE) to commence a Phase III clinical study for its investigational drug candidate, KC1036. This randomized, controlled, open-label, multi-center Phase III trial aims to evaluate the efficacy and safety of KC1036…
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Henlius Biotech Gets FDA Clearance for Clinical Study of PD-L1 Targeting ADC HLX43
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Shanghai Henlius Biotech Inc. (HKG: 2696), a Chinese biopharmaceutical company, has received approval from the US Food and Drug Administration (FDA) to conduct a clinical study for its antibody drug conjugate (ADC) HLX43, which is co-developed with Suzhou-based Medilink Therapeutics. The molecule is set to be evaluated in patients with…
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CSPC Pharmaceutical Gets NMPA Green Light for SYH2038 Solid Tumor Study
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CSPC Pharmaceutical Group Ltd (HKG: 1093), a Chinese pharmaceutical company, has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a clinical study for its Category 1 chemical drug, SYH2038, in advanced solid tumors. SYH2038 is a highly selective SOS1 inhibitor, with no similar…
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Abbisko Therapeutics Launches Phase II Trial for Pimocitinib in Advanced Pancreatic Cancer
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Abbisko Therapeutics Co., Ltd (HKG: 2256), a Shanghai-based biotechnology company, has announced the initiation of a Phase II clinical study for its Category 1 innovative drug ABSK021 (pimicotinib) in advanced pancreatic cancer in China, with the first patient now dosed. The multi-center, open-label Phase II study (ABSK021-202) is being conducted…
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Yantai Dongcheng Pharmaceutical Gets Green Light for Prostate Cancer Diagnostic Drug Trial
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a Chinese pharmaceutical company, has announced that it has received ethical approval from Beijing Hospital to conduct a Phase III clinical study. The study will assess the diagnostic efficacy of a radionuclide candidate, intended for use with positron emission tomography (PET) imaging,…
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Kintor Pharmaceutical’s KX-826 Shows Promising Results in Phase III AGA Clinical Trial
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Kintor Pharmaceutical Ltd (HKG: 9939), a China-based pharmaceutical company, has released topline data from a Phase III clinical study for its pipeline candidate KX-826, a potential first-in-class androgen receptor (AR) antagonist for the treatment of androgenetic alopecia (AGA). The multi-center, open-label, long-term safety Phase III clinical trial conducted in China…
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Jiangsu Hengrui Pharmaceuticals Receives NMPA Approval for Phase Ib/II Study of Dalpiciclib and HRS-8080
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China-based Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it received approval from the National Medical Products Administration (NMPA) to initiate a Phase Ib/II clinical study. This trial will evaluate the combination of dalpiciclib (SHR6390) and HRS-8080 in patients with ER+/HER2- irresectable or metastatic breast cancer. HRS-8080: A…
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Pyrotech Biotechnology’s PTT-936 Gets US FDA Clinical Trial Approval
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Pyrotech (Beijing) Biotechnology Co., Ltd, a China-based biotech firm, has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its in-house developed innate immune agonist, PTT-936. The specific targeted indication for this trial remains undisclosed. Mechanism of Action and Preclinical Success PTT-936…
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MicuRx Pharmaceuticals Secures NMPA Approval for MRX-4 and Contezolid Combination Therapy
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Sino-US firm MicuRx Pharmaceuticals Inc. has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative anti-microbial agent MRX-4, in combination with contezolid (MRX-I). This novel treatment targets infections caused by drug-resistant Gram-positive bacteria, marking a significant advancement in antibiotic therapy. Overview…
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SCG Cell Therapy’s SCG101 Receives Tacit Approval for Cholangiocarcinoma Clinical Trial in China
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China’s Center for Drug Evaluation (CDE) website has indicated that SCG Cell Therapy Pte. Ltd’s SCG101 autologous T cell therapy has obtained tacit clinical trial approval in China. This marks a world-first clinical indication for the treatment of cholangiocarcinoma. SCG101’s Expanding Clinical IndicationsSCG101, a TCR-T cell therapy, targets specific hepatitis…
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Hunan Warrant Pharmaceutical’s ZG-001 Approved for Clinical Trial by NMPA
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Hunan Warrant Pharmaceutical Co., Ltd (SHA: 688799), a China-based pharmaceutical company, has announced receiving clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug, ZG-001, intended to treat adults with major depressive disorder with acute suicidal ideation or behavior (MDSI). ZG-001’s Mechanism and Pre-Clinical Efficacy…
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VivaVision Biotech Inc. Receives FDA Approval for VVN461 Phase II Clinical Trial
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China’s VivaVision Biotech Inc. has announced that it has received approval from the US Food and Drug Administration (FDA) to conduct a Phase II clinical trial for its in-house developed drug candidate, VVN461. The trial will assess the efficacy of VVN461 as a treatment for inflammation following cataract surgery. VVN461’s…
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CSPC Pharmaceutical Group Receives NMPA Approval for Phase II Clinical Study of ALMB-0168
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China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced that it has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical study for its pipeline drug candidate, ALMB-0168. The drug is set to be assessed as a treatment for acute ischemic stroke. ALMB-0168: A…
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Fosun Pharmaceutical Secures Clinical Trial Approvals for VT-101 in China and the US
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Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA: 600196) has announced receiving clinical trial approvals for its VT-101 from both the National Medical Products Administration (NMPA) in China and the US Food and Drug Administration (FDA). VT-101 is a next-generation recombinant oncolytic adenovirus product that features a triple-targeted tumor regulation mechanism,…
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Hansoh Pharmaceutical’s HS-10511 Tablets for Hypertrophic Cardiomyopathy Cleared for Clinical Trials
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Hansoh Pharmaceutical (HKG: 3692) has announced that its affiliated company’s self-developed Class 1 new drug, HS-10511 tablets, have received approval for clinical trials from the National Drug Administration. The drug is intended for the treatment of hypertrophic cardiomyopathy, a condition that requires significant medical innovation. Clinical Trial Approval and IndicationThe…
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Clinical Research on rAAV Gene Drug ZS805 for Fabry Disease Launched by Zhishan Weixin
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Zhishan Weixin Biotechnology Co., Ltd, a China-based biotech company, has announced the launch of the first clinical research project in China focused on a recombinant adeno-associated virus (rAAV) genetic therapy for the treatment of Fabry disease. The study will evaluate the adeno-associated virus vector ZS805 as a potential treatment across…
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Jiangsu Hengrui Pharmaceuticals’ Subsidiary Shengdi Pharmaceuticals Receives NMPA Approval for HRS-9057
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Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading pharmaceutical company in China, has announced that its subsidiary, Shengdi Pharmaceuticals, has received clinical trial approval from the National Medical Product Administration (NMPA) for HRS-9057 tablets. This Class 1 innovative drug will be assessed in clinical trials as a potential treatment for autosomal…
