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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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Cyramza Prescribed in China for Advanced Gastric Cancer
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Cyramza (ramucirumab) was first prescribed on November 6, 2022, at the Zhongshan Hospital in Shanghai and Beijing Cancer Hospital, marking a new treatment option for second-line advanced gastric cancer patients in China. This milestone follows the drug’s market approval in March 2022 for treating second-line advanced metastatic gastric cancer in…
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Merck’s Keytruda Receives 10th Indication Approval in China for TNBC
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US-based Merck Sharp & Dohme’s (MSD, NYSE: MRK) programmed death-1 (PD-1) inhibitor Keytruda (pembrolizumab) has obtained its 10th indication approval from China’s National Medical Products Administration (NMPA). The drug can now be used to treat early high-risk triple negative breast cancer (TNBC) with tumors expressing PD-L1 (CPS ≥ 20) in…
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Qilu Pharma’s QL1706 Shows Promise in Phase II Cervical Cancer Study
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China-based Qilu Pharmaceutical has published the latest results from a Phase II clinical study for QL1706, a dual-targeted antibody against programmed death 1 (PD-1) and cytotoxic T lymphocyte-associated antigen-4 (CTLA-4). The findings were presented at the Chinese Society of Clinical Oncology (CSCO) annual meeting. Study Design and ResultsPrevious clinical studies…
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Ascletis Pharma Presents Phase I Study Results for ASC43F at AASLD
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China-based Ascletis Pharma Inc. (HKG: 1672) made a poster presentation detailing the abstract of a Phase I study for ASC43F in a single dose to treat non-alcoholic steatohepatitis (NASH) at The Liver Meeting 2022 of the American Association for the Study of Liver Diseases (AASLD). The presentation highlighted the drug’s…
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Ji Xing Pharmaceuticals’ Omecamtiv Mecarbil Accepted for Review by CDE
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Shanghai-based Ji Xing Pharmaceuticals, backed by RTW Investments, announced that a market filing for its investigational omecamtiv mecarbil has been accepted for review by the Center for Drug Evaluation (CDE). The small molecule is a potential first-in-class cardiac myosin activator being developed as a treatment for heart failure with reduced…
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Innovent Biologics’ Tafolecimab Shows Strong LDL-C Reduction in Phase III Study
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China-based Innovent Biologics, Inc. (HKG: 1801) announced the results of the Phase III CREDIT-1 study for tafolecimab (IBI306), a recombinant fully human anti-PCSK-9 monoclonal antibody (mAb), in Chinese patients with non-familial hypercholesterolemia (non-FH). The findings were presented at the American Heart Association (AHA) Scientific Sessions 2022 as an e-poster (VP173).…
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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,…
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Betta Pharmaceuticals’ BPI-452080 Accepted for Review by NMPA
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China’s Betta Pharmaceuticals (SHE: 300558) has announced that a clinical trial filing for its Category 1 drug candidate BPI-452080 has been accepted for review by the National Medical Products Administration (NMPA). This marks a significant step forward in the development of the drug, which is designed to treat advanced solid…
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Qilu Regor’s RGT-264 Phosphate Tablets Approved for Phase I Study
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China-based biotech Qilu Regor Therapeutics Inc has announced receiving approval from the National Medical Products Administration (NMPA) to conduct a Phase I study. The study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of its RGT-264 phosphate tablets in patients with advanced solid tumors. RGT-264 ProfileRGT-264 is a…
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Reforgene Medicine RM-001 Thalassemia Gene Editing
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China-based Guangzhou Reforgene Medicine Co., Ltd’s in-house developed β-thalassemia gene editing drug RM-001 (HBG gene modified autologous CD34+ hematopoietic stem cell injection) has obtained tacit clinical trial approval from the National Medical Products Administration (NMPA). This marks a significant milestone for the first thalassemia gene editing novel drug program in…
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Walvax Biotech Launches Phase IIIb Trial for mRNA COVID-19 Vaccine
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China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the initiation of a Phase IIIb clinical study with ethics approval. The study is designed to assess the immunogenicity and safety of its “novel coronavirus variant mRNA vaccine” (S protein chimera) in individuals aged 18 and above who have completed three…
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Guangdong Zhongsheng Initiates Phase III Study for RAY1216 in COVID-19
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China-based Guangdong Zhongsheng Pharmaceutical Co., Ltd (SHE: 002317) has announced the initiation of a randomized, double-blind, placebo-controlled Phase III study with ethics approval for its RAY1216 in mild and common SARS-CoV-2 infection. The study is expected to enroll 1,070 patients with mild and common COVID-19 infection, using placebo as the…
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Ascentage Pharma Announces Clinical Advances for Olverembatinib at ASH
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Suzhou-based Ascentage Pharma (HKG: 6855) announced the latest clinical development of its olverembatinib (HQP1351), a third-generation BCR-ABL-targeted tyrosine kinase inhibitor (TKI), Bcl-2 inhibitor lisaftoclax (APG-2575), and MDM2-p53 inhibitor alrizomadlin (APG115) at the 64th American Society of Hematology (ASH) annual meeting this year. Olverembatinib in CML and Ph+ALLOlverembatinib can overcome drug…
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Abbisko Enrolls First Patient in Phase II Study for ABSK091 in Urothelial Carcinoma
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China-based Abbisko Therapeutics Co., Ltd (HKG: 2256) has announced the enrollment of the first patient in a Phase II clinical study for its investigational pan-FGFR inhibitor ABSK091, in combination with BeiGene Ltd’s anti-PD-1 antibody tislelizumab, for the treatment of urothelial carcinoma (UC). This marks the first clinical combination trial of…
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Blue Shield Pharma’s LD013 CAR-T Therapy Approved for Clinical Trials
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China-based Blue Shield Biotech’s in-house developed LD013, an autologous chimeric antigen receptor (CAR)-T cell therapy, has obtained clinical trial approval from the National Medical Products Administration (NMPA). The intended indication is recurrent refractory ovarian cancer, a condition that poses significant challenges in treatment and management. Mesothelin as a TargetMesothelin (MSLN)…
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Akeso Biopharma Completes Enrollment for AK112 Phase III Study
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China-based Akeso Biopharma (HKG: 9926) has announced the completion of enrollment for its Phase III study of AK112, a bispecific antibody (BsAb) targeting programmed death-1 (PD-1) and vascular endothelial growth factor (VEGF). The study aims to assess the drug in combination with chemotherapy for locally advanced or metastatic non-squamous non-small…
