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Kelun-Biotech’s RET Inhibitor A400 Advances to Phase II Trial with FDA Approval
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Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422), a Chinese pharmaceutical company, has announced that its innovative drug development subsidiary, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd (HKG: 6990), has received approval from the US Food and Drug Administration (FDA) to proceed with a Phase II clinical study for its RET inhibitor A400/EP0031…
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Zhejiang Huahai Pharmaceutical Wins IND Approval for Antibody-Drug Conjugate from China’s NMPA
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Zhejiang Huahai Pharmaceutical Co., Ltd (SHA: 600521), a China-based pharmaceutical company, has announced that it has received Investigational New Drug (IND) approval from the National Medical Products Administration (NMPA) for its innovative injectable drug candidate, HB0052. The drug is initially intended for evaluation in patients with general advanced solid tumors.…
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iRegene’s Pioneering Cell Therapy NouvNeu001 Administered in Wuhan for Parkinson’s Disease
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Wuhan-based cell therapy developer iRegene has reached a clinical milestone with the administration of its novel treatment, NouvNeu001, to a patient at Zhongnan Hospital of Wuhan University. The patient’s postoperative condition has been reported as good. In August 2023, NouvNeu001 received approval to be evaluated in a multi-center, open Phase…
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Chengdu Kanghong Pharmaceutical Gets US FDA Nod for Clinical Trial of KH658 for Wet AMD
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a leading pharmaceutical company based in China, has announced that it has received approval from the US Food and Drug Administration (FDA) to commence clinical trials for its KH658 eye injection. The drug is designed for the treatment of neovascular (wet) age-related…
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Yantai Dongcheng Pharmaceutical Receives NMPA Approval for Advanced Solid Tumor Therapy
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Yantai Dongcheng Pharmaceutical Group Co., Ltd (SHE: 002675), a leading pharmaceutical company based in China, has announced that it has been granted clinical trial approval by the National Medical Products Administration (NMPA) for its innovative drug, 177Lu-LNC1008. This targeted radioactive in vivo therapeutic drug is designed to treat general advanced…
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AbelZeta Pharma’s CAR-T Therapy C-CAR031 Receives Implicit Approval for Clinical Study in China
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Sino-US biotechnology company AbelZeta Pharma Inc., operating in Rockville, Maryland, and Shanghai, China, has received implicit approval for its autologous armored GPC3-targeted chimeric antigen receptor (CAR) T cell therapy, C-CAR031, developed by its subsidiary, Shanghai Cellular Biopharmaceutical Group Ltd. The therapy is intended for the treatment of GPC3+ advanced or…
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Wuhan Bio-Raid Biotechnology Secures NMPA Approval for First-in-Class CD99-Targeted CAR-T Therapy
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Wuhan Bio-Raid Biotechnology Co., Ltd, a leading developer of chimeric antigen receptor (CAR)-T cell therapies in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its proprietary BRD-03. This autologous CD99-targeted CAR-T therapy is classified as a Category 1 biologic therapeutic…
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Shanghai Henlius Biotech Achieves First Patient Dosing in Phase I Trial for Fibrosis Treatment HLX6018
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Shanghai Henlius Biotech Inc. (HKG: 2696), a biopharmaceutical company based in China, has announced the completion of the first patient dosing in a Phase I clinical study for HLX6018, a GARP/TGF-β1 compound monoclonal antibody (mAb). The drug is under development for the treatment of fibrosis-related diseases and has been tested…
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Huadong Medicine’s HDM1005 Receives US FDA Clinical Trial Approval for Weight Management
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China-based Huadong Medicine Co., Ltd (SHE: 000963) has announced that it has received clinical trial approval from the US Food and Drug Administration (FDA) for its investigational drug HDM1005. This long-acting agonist targets the GLP-1 receptor and GIP receptor and is under development for weight management in overweight or obese…
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Jiangsu Hengrui Pharmaceuticals Gets NMPA Go-Ahead for Camrelizumab Combination Therapy Study in Pancreatic Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a multi-center, randomized, controlled Phase II/III clinical study. The study will assess the efficacy and safety of its programmed death-1 (PD-1)…
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CanSino Biologics Receives NMPA Approval for Haemophilus influenzae type B (Hib) Conjugate Vaccine Clinical Trial
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China-based biopharmaceutical company CanSino Biologics (HKG: 6185) has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its freeze-dried Haemophilus influenzae type B (Hib) conjugate vaccine. Haemophilus influenzae, a Gram-negative bacterium, is a leading cause of acute lower respiratory tract infections in children.…
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Hengrui Pharmaceuticals Gets Green Light from NMPA for Two Anti-Cancer Drugs
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for two of its drug candidates, SHR-3276 and HRS2398. SHR-3276 is slated for study in patients with general advanced solid…
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Sichuan Biokin Gets NMPA Green Light for BL-B01D1 ADC in NSCLC Clinical Trial
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Sichuan Biokin Pharmaceutical Co., Ltd (SHA: 688506), a leading biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative antibody-drug conjugate (ADC), BL-B01D1. The approval allows for the combination of BL-B01D1 with a PD-1 inhibitor, with…
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ImmuneOnco Receives NMPA Approval for Phase III Clinical Trial of CD47 Inhibitor TIMDARPACEPT
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541) has announced that it has received approval from the National Medical Products Administration (NMPA) to proceed with a Phase III clinical study for its investigational drug timdarpacept (IMM01). This drug is the first SIRPαFc fusion protein targeting CD47 to be designed in China.…
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Shanghai Henlius Biotech Advances TIGIT-Targeting HLX53 to Phase II Clinical Trial for Hepatocellular Carcinoma
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Shanghai Henlius Biotech Inc., (HKG: 2696), a biopharmaceutical company based in China, has received approval from the National Medical Products Administration (NMPA) to commence a Phase II clinical study. The study will evaluate the tolerability, safety, and efficacy of HLX53, an Fc fusion protein targeting T cell immunoglobulin and ITIM…
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Innovent Biologics’ IBI133 Receives Tacit Approval for Clinical Trial from China’s CDE
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The Center for Drug Evaluation (CDE) in China has granted tacit clinical trial approval to Innovent Biologics, Inc. (HKG: 1801) for its antibody drug conjugate (ADC) IBI133. The molecule is slated for assessment as a treatment for irresectable locally advanced or metastatic solid tumors. Previously, in December 2023, IBI133 had…
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Kangtai Biological Receives NMPA Approval for 20-Valent Pneumococcal Vaccine Clinical Trial
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Shenzhen Kangtai Biological Products Co., Ltd (SHE: 300601), a leading biopharmaceutical company in China, has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its 20-valent pneumococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent infectious diseases caused by…
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Sirnaomics Receives FDA Feedback on STP705 Development Plan for isSCC Treatment
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Sirnaomics Ltd (HKG: 2257), a leading biopharmaceutical company focused on the discovery and development of RNAi therapeutics, has announced receiving a written response from the U.S. Food and Drug Administration (FDA) regarding the required Class C meeting for STP705, a treatment for in situ squamous cell carcinoma (isSCC). The Class…
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Sanofi Advances Phase I/II Trial of Trifunctional NK Cell Engager in Blood Cancers
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Sanofi (NASDAQ: SNY), a French multinational pharmaceutical company, has administered the first dose to a patient in the second part of a Phase I/II clinical trial for the trifunctional NK cell engager SAR443579, targeting blood cancers. The announcement was made by fellow French biotechnology company Innate Pharma (NASDAQ: IPHA) this…
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Keymed Biosciences Achieves First Dosing in Global Phase III Trial for Claudin 18.2 Targeting ADC
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Keymed Biosciences Inc., (HKG: 2162), a biopharmaceutical company based in China, has announced the completion of the first dosing in a global multi-center Phase III study for its Claudin 18.2 (CLDN18.2)-targeted antibody-drug conjugate (ADC) CMG901 (AZD0901). The ADC is being evaluated as a treatment for advanced solid tumors in the…
