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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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Bloomage Biotech CEO Investigated Over Discounted Share Sales
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The chairwoman of Chinese medical aesthetics player Bloomage Biotech Corp., Ltd (SHA: 688363), Ms. Zhao Yan, is facing an investigation from stock exchange authorities following whistleblower accusations that she pressured employees into selling their shares in the company at a discount. The China Securities Regulatory Commission (CSRC) and Shandong Securities…
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NMPA Proposes ‘Drug Online Sales Blacklist’ for Public Feedback
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The National Medical Products Administration (NMPA) has released a draft proposal for a “Drug Online Sales Blacklist,” soliciting public feedback. The draft clearly prohibits the online sale of certain high-risk and controlled substances to ensure patient safety and regulatory compliance. Prohibited DrugsThe draft proposal prohibits the online sale of 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…
