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Henlius’ Serplulimab Phase III Study Approved in Spain for LS-SCLC
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China-based Shanghai Henlius Biotech (HKG: 2696) has announced that its global, multi-center Phase III clinical study (NCT05353257) for HaiSiZhuang (serplulimab) in limited stage small-cell lung cancer (LS-SCLC) has been approved in Spain, a member country of the European Union (EU). The study will assess the PD-1 inhibitor combined with chemotherapy…
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Hengrui Pharmaceuticals Receives Clinical Trial Approvals for Three New Drugs
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China-based Jiangsu Hengrui Pharmaceuticals (SHA: 600276) has announced receiving clinical trial approvals for three in-house developed drug candidates: HRS-1780, HRS-1358, and SHR-7367. These approvals mark significant milestones in the company’s pipeline development, positioning Hengrui to advance innovative treatments for chronic kidney disease and advanced malignant tumors. HRS-1780 ProfileHRS-1780 is an…
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Haisco’s HSK31858 Gains Ethical Approval for Phase II Study in NCFBE
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China-based Haisco Pharmaceutical Group Co., Ltd (SHE: 002653) has announced that its drug candidate HSK31858 obtained ethical approval at the First Affiliated Hospital of Guangzhou Medical University. The in-house developed Category 1 drug will be assessed for its efficacy and safety in a multi-center, randomized, double-blind, placebo-controlled Phase II study…
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Ascletis Pharma’s PD-L1 Inhibitor ASC61 Gains NMPA IND Approval
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced the approval of the Investigational New Drug (IND) application by China National Medical Products Administration (NMPA) for its in-house developed oral programmed-death ligand 1 (PD-L1) small molecule inhibitor ASC61. This approval will accelerate the global development of the drug, which is currently…
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Kelun Pharma’s SKB264 Advances to Phase II Study for NSCLC
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China-based Sichuan Kelun Pharmaceutical Co., Ltd (SHE: 002422) has announced that its antibody drug conjugate (ADC) SKB264, targeting trophoblast cell-surface antigen 2 (TROP2), has obtained approval from the National Medical Products Administration (NMPA) to enter a Phase II clinical study in advanced or metastatic non-small cell lung cancer (NSCLC). The…
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Kanghong Pharma Gains NMPA Approval for Innovative Eye Injection KH631
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China-based Chengdu Kanghong Pharmaceutical Group Co., Ltd (SHE: 002773) has announced receiving clinical trial approvals from the National Medical Products Administration (NMPA) for its Category 1 innovative eye injection KH631 and a generic version of Acadia Pharmaceuticals Inc’s pimavanserin. The approvals are for the treatment of neovascular (wet) age-related macular…
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Kelun-Biotech’s SKB264 Receives FDA Approval for Phase II Study
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China-based Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd has announced receiving approval from the US FDA to conduct a Phase II clinical study for its drug candidate SKB264, an antibody drug conjugate (ADC) targeting trophoblast cell-surface antigen 2 (TROP2), in combination with the PD-1 inhibitor pembrolizumab. The initial development target is selected…
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LaNova Medicines Gets NMPA Approval for LM-305 Clinical Study
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Shanghai-based cancer therapy developer LaNova Medicines Ltd has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a clinical study for its antibody drug conjugate (ADC) LM-305, targeting GPRC5D. This marks a significant milestone for LaNova as it advances its innovative ADC into clinical…
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Innovent Biologics Initiates Phase III Trial for Mazdutide in Obesity
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China-based Innovent Biologics, Inc. (HKG: 1801) has announced the first patient dosing in the randomized, double-blind, placebo-controlled Phase III GLORY-1 study for its mazdutide (IBI362), a glucagon-like peptide-1 (GLP-1) and glucagon receptor dual agonist. The drug is being evaluated for the treatment of overweight or obese Chinese patients, marking a…
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Guangdong Zhongsheng Starts Phase III Trial for COVID-19 Drug RAY1216
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the enrollment of the first subject in a randomized, double-blind, placebo-controlled Phase III study for its drug candidate RAY1216, which is being evaluated as a treatment for mild SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild…
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FDA Approves Phase Ib Study for Jiangsu Yahong’s APL1401 in Ulcerative Colitis
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced that it has received approval from the US FDA to conduct a Phase Ib clinical study for its drug candidate APL1401. The trial will evaluate APL1401 as a treatment for moderate to severe active ulcerative colitis…
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CanSino Biologics’ Inhalable COVID-19 Vaccine Authorized in Morocco
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China-based CanSino Biologics (SHA: 688185, HKG: 6185) has announced that it has received emergency use authorization (EUA) for its inhalable recombinant novel coronavirus vaccine (adenovirus type 5 vector) in Morocco. This marks a significant milestone in the global deployment of innovative COVID-19 vaccines. Convidecia ProfileConvidecia, the recombinant novel coronavirus vaccine…
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Sinocelltech’s SCTV01E Vaccine Receives NMPA Approval for Phase II Study
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China-based Sinocelltech Group Ltd (SHA: 688520) has announced that it has received approval from the National Medical Products Administration (NMPA) to conduct a bridging Phase II clinical study assessing the safety and immunogenicity of its SCTV01E vaccine. The quadrivalent (Alpha + Beta + Delta + Omicron variants) S trimer protein…
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LianBio Initiates Phase I Study of SHP2 Inhibitor BBP-398 in China
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Sino-US biotech LianBio has announced the first patient dosing in a Phase I clinical study for its SHP2 inhibitor BBP-398 in Chinese patients with advanced solid tumors. This marks a significant step forward in the development of BBP-398, which targets the SHP2 protein-tyrosine phosphatase. SHP2 links growth factor, cytokine, and…
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Ascentage Pharma Gains CDE Approval for Phase I Study of APG-5918
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Suzhou-based Ascentage Pharma (HKG: 6855) has announced that it has received approval from the Center for Drug Evaluation (CDE) to conduct a multi-center, open-label, dose escalation and expansion Phase I study. The study will assess the safety, pharmacokinetics, and efficacy of its embryonic ectoderm development (EED) inhibitor APG-5918. The drug…
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Liaoning Chengda’s ACYW135 Meningococcal Vaccine Receives NMPA Clearance
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China’s Liaoning Chengda Biotechnology Co., Ltd (SHA: 688739) has announced that it has received clinical clearance from the National Medical Products Administration (NMPA) for its ACYW135 meningococcal polysaccharide conjugate vaccine. The vaccine is designed to prevent epidemic cerebrospinal meningitis caused by Neisseria meningitidis of groups A, C, Y, and W135.…
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Zhaoke Ophthalmology Enrolls First Patients for ZKY001 in Phase II Trials
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China-based Lee’s Pharmaceutical Holdings Ltd (HKG: 0950) spin-off Zhaoke Ophthalmology Ltd (HKG: 6622) has announced the enrollment of the first patients for its ZKY001 in a Phase II clinical study in transepithelial photorefractive keratectomy (TPRK). The study will enroll 120 patients across 10 centers. Additionally, a separate Phase II clinical…
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MicuRx Pharmaceuticals Doses First Patient in China for MRX-8 Trial
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Shanghai-based antibacterial drug developer MicuRx Pharmaceuticals (SHA: 688373) has announced the first patient dosing in a Phase I clinical study in China for its MRX-8, a new drug against gram-negative drug-resistant bacteria. This marks a significant milestone in the development of MRX-8, which aims to address the growing challenge of…
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Zhifei Bio Initiates Global Study for Omicron-Delta COVID-19 Vaccine in Uzbekistan
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China-based Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd has announced the initiation of a global clinical study for its Omicron-Delta variant recombinant COVID-19 protein vaccine in Uzbekistan. This marks a significant step in the development of the second-generation vaccine, which targets the Omicron and Delta variants. Previous Clinical StudiesPreviously, Zhifei Bio chose…
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Jiangsu Yahong Initiates Phase III Study for Hexvix in Bladder Cancer Detection
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China-based urogenital cancer specialist Jiangsu Yahong Meditech Co., Ltd (Asieris, SHA: 688176) has announced the enrollment of the first subject in a prospective, subject-controlled, multi-center Phase III clinical study. The study aims to assess the additional detection rate and safety of Hexvix, a bladder cancer diagnosis and postoperative detection product,…
