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Shenzhen Chipscreen Biosciences’ Tivozanib Secures NMPA Approval for ES-SCLC Phase III Trial
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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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Tasly Pharmaceuticals Gets FDA Approval for Acute Ischemic Stroke Cell Therapy Clinical Study
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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 Gets New Zealand Approval for Asthma Bispecific Antibody Trial
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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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Youcare Pharmaceutical Group Gets NMPA Approval for YKYY015 Phase I Study
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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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Akeso Biopharma Initiates Phase III Clinical Trial for PD-1/VEGF Bispecific Antibody Combination
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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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AIM Vaccine Secures NMPA Approval for mRNA Vaccine Targeting RSV
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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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Sunshine Guojian Pharmaceutical Secures NMPA Approval for Clinical Trials of SSGJ-626 in Lupus Indications
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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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Sun-Novo Pharmaceuticals Gets Green Light for CAR-T Therapy Clinical Trial in Lupus Treatment
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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…
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CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Myasthenia Gravis Clinical Trial
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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 its SYS6020. This investigational treatment is a BCMA-targeted chimeric antigen receptor (CAR)-T cell therapy intended for myasthenia gravis (MG). Notably,…
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Humanwell Healthcare Receives NMPA Approval for Chemically Synthesized Semaglutide Clinical Trial
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Humanwell Healthcare (Group) Co., Ltd (SHA: 600079), a leading healthcare company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 2.2 chemically synthesized semaglutide injection, intended for the treatment of type 2 diabetes. Semaglutide, a glucagon-like peptide-1…
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RiboX Therapeutics’ Circular RNA Therapy RXRG001 Gets FDA Green Light for Dry Mouth Clinical Trial
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RiboX Therapeutics, a Shanghai-based developer of circular RNA (circRNA) therapies, has announced that it has received approval from the US Food and Drug Administration (FDA) to initiate the Phase I/IIa clinical study SPRINX-1 for its candidate RXRG001. This study will evaluate the efficacy and safety of RXRG001 in patients suffering…
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Shanghai MicroPort Initiates Pre-Marketing Clinical Study for Embolic Microspheres in Liver Cancer Treatment
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Shanghai MicroPort Endovascular MedTech Co., Ltd (SHA: 688016), a Chinese medical technology company, has announced the commencement of a pre-marketing clinical study for its polyvinyl alcohol embolic microspheres. The company has completed the first pre-marketing clinical implantation in transcatheter arterial chemoembolization (TACE) surgery for left lobe lesions in patients with…
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Asieris Pharmaceuticals Gets FDA Green Light for USP1 Inhibitor APL-2302 in Advanced Solid Tumors
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Asieris Pharmaceuticals (SHA: 688176), a China-based specialist in urogenital cancer treatments, has announced that it has received clinical clearance from the U.S. Food and Drug Administration (FDA) for its in-house developed ubiquitin specific peptidase 1 (USP1) inhibitor, APL-2302, for the treatment of advanced solid tumors. Preclinical studies have indicated that…
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Henlius Biotech Commences Global Phase III Trial for Serplulimab in First-Line Metastatic Colorectal Cancer
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Shanghai Henlius Biotech Inc., (HKG: 2696), a leading biopharmaceutical company based in China, has announced the dosing of the first patient in a global, multi-center Phase III study for its anti-programmed death-1 (PD-1) inhibitor, HanSiZhuang (serplulimab, HLX10). The study combines serplulimab with bevacizumab and chemotherapy for the first-line treatment of…
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ImmuneOnco Biopharmaceuticals Initiates Phase Ib Study for Dual-Target Therapy in Systemic Lupus Erythematosus
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ImmuneOnco Biopharmaceuticals (Shanghai) Co., Ltd (HKG: 1541), a Chinese biopharmaceutical company, has announced the first patient in (FPI) for a Phase Ib clinical study of its dual-target macromolecular drug amulirafusp alfa (IMM0306) in the treatment of moderate to severe systemic lupus erythematosus (SLE). This marks a significant advancement in the…
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Gan & Lee Pharmaceuticals Initiates Phase I Clinical Trial for Biosimilar Secukinumab
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Gan & Lee Pharmaceuticals (SHA: 603087), a Chinese pharmaceutical company, has announced the commencement of a Phase I clinical study for GLR1023, a biosimilar candidate to Novartis’ Cosentyx (secukinumab). The company has recently dosed the first patient in the trial, which is focused on evaluating the safety and efficacy of…
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Kanghong Pharmaceutical’s NASH Drug KH629 Approved for Clinical Trials in China
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Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773), a Chinese pharmaceutical company, has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its Category 1 chemical drug KH629, which is intended for the treatment of adult non-alcoholic steatohepatitis (NASH). This development follows the…
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Huadong Medicine Gets Green Light for HPK1 PROTAC Drug HDM2006 in Advanced Solid Tumors
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Huadong Medicine Co., Ltd (SHE: 000963), a Chinese pharmaceutical company, has announced that it has received approval from China’s National Medical Products Administration (NMPA) to conduct a study for its Category 1 chemical drug HDM2006, which targets advanced solid tumors. This development marks a significant step for Huadong as it…
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Jiangsu Hengrui Pharmaceuticals Initiates Phase III Clinical Trial for SHR-A1904 in Gastric Cancer
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Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has filed for a Phase III clinical study of its Claudin18.2-targeted antibody drug conjugate (ADC) SHR-A1904 on Clinicaltrials.gov. The study aims to enroll 524 patients with second-line recurrent or metastatic gastric cancer and is anticipated to…
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Westgene Biopharma’s Pioneering mRNA Vaccine for EBV-Related Tumors Clears IND Hurdle in China
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Westgene Biopharma has received approval from the Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) in China for its new drug research application (IND) for “WGc-043 Injection.” The approval, dated August 6, 2024, grants Westgene Biopharma the green light to initiate Phase I clinical trials. “WGc-043…
