-
Hunan Warrant Pharmaceutical’s ZG-002 Receives NMPA Approval for Clinical Trials in Plaque Psoriasis
•
Hunan Warrant Pharmaceutical Co., Ltd, a pharmaceutical company based in China and listed on the Shanghai Stock Exchange’s Science and Technology Innovation Board (SHA: 688799), has received clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 drug candidate, ZG-002. This new molecule is intended for…
-
Everest Medicines Launches Trial for Personalized mRNA Cancer Vaccine EVM16 in Solid Tumors
•
Everest Medicines, a biopharmaceutical company based in China and listed on the Hong Kong Stock Exchange (HKG: 1952), has announced the commencement of an investigator-initiated trial (ITT) for its cutting-edge personalized mRNA cancer vaccine, EVM16. The trial, spearheaded by Beijing Cancer Hospital and Fudan University Shanghai Cancer Center, is a…
-
Sichuan Biokin Launches Phase III Trial for Bispecific ADC BL-B01D1 in Lung Cancer
•
Sichuan Biokin Pharmaceutical Co., Ltd. (SHA: 688506) has commenced the first patient dosing in a Phase III clinical trial for its proprietary bispecific antibody drug conjugate (ADC), BL-B01D1. This innovative therapy is being evaluated for the treatment of recurrent small-cell lung cancer (SCLC) in patients who have previously not responded…
-
Staidson Launches Phase Ia Trial for STSP-0902 Injection in Oligoasthenozoospermia
•
Staidson (Beijing) Pharmaceutical Co., Ltd. (SHE: 300204) has announced that it has received approval from China’s National Medical Products Administration (NMPA) to initiate a Phase Ia clinical trial for its STSP-0902 injection, targeting oligoasthenozoospermia. The randomized, double-blinded, placebo-controlled study aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of STSP-0902…
-
Jiangsu Hengrui Secures NMPA Approval for Clinical Trials of SHR-2106 in Primary Sjögren’s Syndrome
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd. (SHA: 600276) has announced that it has received clinical trial approval from China’s National Medical Products Administration (NMPA) for its investigational drug SHR-2106, targeting active primary Sjögren’s syndrome (pSS). Primary Sjögren’s syndrome is a chronic autoimmune disorder predominantly affecting middle-aged and elderly women, characterized by…
-
Vimgreen Pharma Launches Phase II Trial for A2AR Antagonist VG081821AC in Parkinson’s Disease
•
Zhejiang-based Vimgreen Pharma has announced the launch of a Phase II clinical trial for its innovative A2AR antagonist VG081821AC, targeting early to mid-stage Parkinson’s disease (PD). The company has successfully completed patient dosing for the study. This 12-week, multi-center, randomized, double-blinded trial aims to evaluate the safety and efficacy of…
-
Ascentage Pharma Secures NMPA Approval for Phase III Trial of Lisaftoclax in MDS
•
Ascentage Pharma (HKG: 6855), based in China, has received approval from the National Medical Products Administration (NMPA) to initiate a multi-center, randomized, double-blind Phase III study evaluating the efficacy of its novel drug, lisaftoclax (APG-2575), in combination with azacitidine (AZA) for the first-line treatment of newly diagnosed patients with higher-risk…
-
Hengrui Pharmaceuticals Launches Phase II Trial for SHR7280 to Treat Uterine Fibroids
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading Chinese pharmaceutical company, has received approval from the National Medical Products Administration (NMPA) to initiate a Phase II clinical trial for its investigational drug SHR7280, aimed at treating heavy menstrual bleeding associated with uterine fibroids. SHR7280 is an oral small molecule…
-
GSK Initiates Phase III Study for RSV Vaccine in China Following U.S. Approval
•
GSK (NYSE: GSK), the UK-based pharmaceutical giant, has registered a Phase III bridging study for its recombinant RSV vaccine in China on ClinicalTrials.gov. The vaccine, which received marketing approval in the U.S. in May 2023, will undergo a study that aims to complete its primary endpoint follow-up by March 2025.…
-
IASO Biotherapeutics’ CAR-T Therapy Fucaso Gets FDA Green Light for Lupus Treatment
•
IASO Biotherapeutics, a Chinese biotech firm, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) to commence trials of its BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Fucaso (equecabtagene autoleucel), for the treatment of non-renal systemic lupus erythematosus (SLE) and systemic lupus nephritis…
-
CSPC Pharmaceutical’s SYS6020 Receives NMPA Approval for Clinical Trials in Systemic Lupus Erythematosus
•
CSPC Pharmaceutical Group Ltd (HKG: 1093), a leading pharmaceutical company in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its innovative therapy, SYS6020. This therapy is a BCMA-targeted chimeric antigen receptor (CAR)-T cell treatment designed for systemic lupus erythematosus (SLE),…
-
Lee’s Pharma Subsidiary Receives Green Light for Phase III Dry Eye Study and Completes Myopia Trial
•
Lee’s Pharmaceutical Holdings Ltd (HKG: 0950), a prominent Chinese pharmaceutical company, through its subsidiary Zhaoke Ophthalmology Ltd (HKG: 6622), has announced significant advancements in its ophthalmic pipeline. The company’s cyclosporine A gel, intended for the treatment of dry eye, has received clearance to proceed to a Phase III clinical study…
-
Jiangsu Hengrui Pharmaceuticals Gains NMPA Approval for Five Drug Candidates, Including IL-17A mAb for Psoriasis
•
Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a prominent pharmaceutical company in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for a total of five drug candidates. This development marks a significant step in the company’s pipeline advancement. Vunakizumab, an…
-
WestGene Biopharma’s EB Virus-Targeting mRNA Vaccine WGc-043 Clears for Clinical Trials in China
•
WestGene Biopharma Co., Ltd., a biotechnology company based in Chengdu, has received approval from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to proceed with clinical trials for its candidate drug, WGc-043. This marks a significant milestone as WGc-043 is the world’s first mRNA therapeutic…
-
Insilico Medicine’s ISM6331 Earns FDA Orphan Drug Designation for Mesothelioma Treatment
•
Insilico Medicine, a China-based biotechnology company at the forefront of generative artificial intelligence (AI), has announced that it has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA) for its pipeline candidate ISM6331. This potential best-in-class candidate drug is designed to treat mesothelioma, a rare and…
-
Haisco Pharmaceutical’s PDE4B Inhibitor HSK44459 Gets NMPA Green Light for Interstitial Lung Disease Clinical Trial
•
Haisco Pharmaceutical Group Co., Ltd (SHE: 002653), a Chinese pharmaceutical company, has announced that it has obtained clinical trial approval from the National Medical Products Administration (NMPA) for its Category 1 chemical drug HSK44459. This phosphodiesterase 4B (PDE4B) inhibitor is now set to be evaluated for its efficacy in treating…
-
Akeso Biopharma Initiates Phase III Clinical Trial for Cadonilimab in Hepatocellular Carcinoma
•
Akeso Biopharma (HKG: 9926), a biopharmaceutical company based in China, has announced the first patient dosing in a Phase III clinical study for its drug candidate, cadonilimab, in combination with lenvatinib and transcatheter arterial chemoembolization (TACE) for the treatment of unresectable, non-metastatic hepatocellular carcinoma (HCC). The study’s data for this…
-
Hotgen Biotech’s SGC001 Receives NMPA Approval for Clinical Trials in Myocardial Infarction
•
Hotgen Biotech Co., Ltd (SHA: 688068), a biopharmaceutical company based in China, has announced that it has received clinical trial approval from the National Medical Products Administration (NMPA) for its monoclonal antibody (mAb), SGC001. This emergency use mAb is intended for the treatment of anterior ST segment elevation myocardial infarction…
-
Suzhou Zelgen Biopharmaceuticals’ ZG005 Receives NMPA Approval for Clinical Trials in Solid Tumors
•
Suzhou Zelgen Biopharmaceuticals Co., Ltd (SHA: 688266), a biopharmaceutical company based in China, has announced that it has received separate clinical trial approvals from the National Medical Products Administration (NMPA) for its pipeline drug candidate ZG005. The approvals will pave the way for trials to evaluate the efficacy and safety…
-
Gan & Lee Pharmaceuticals Gets FDA Green Light for Phase I Clinical Trial of Insulin Aspart Biosimilar
•
Gan & Lee Pharmaceuticals (SHA: 603087), a leading pharmaceutical company based in China, has received approval from the U.S. Food and Drug Administration (FDA) to commence a Phase I clinical study for its insulin aspart 30 injection, a biosimilar version of Novo Nordisk (NYSE: NVO)’s pre-mixed NovoMix 30 used in…
