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Yiming and Hexaell’s HepaCure Biocolumn Receives IND Approval for HBV-Induced Liver Failure
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China-based Yiming (Beijing) Cell Biotechnology Co., Ltd (also known as Ubrigene) and its partner Shanghai Hexaell Biotech Co., Ltd have received Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for their in-house developed HepaCure Biocolumn. This bioartificial liver product is designed to treat chronic acute liver…
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Yiming and Vitalgen’s Gene Therapy VGR-R01 Receives CDE Approval for Bietti Crystalline Dystrophy
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China-based Yiming (Beijing) Cell Biotechnology Co., Ltd (also known as Ubrigene) and its partner Shanghai Vitalgen Biomed Co., Ltd have received tacit clinical trial approval from the Center for Drug Evaluation (CDE) for their in-house developed gene therapy drug VGR-R01. This marks the second gene therapy from the company to…
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LianBio’s TP-03 Begins Phase III Trial for Demodectic Blepharitis in China
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Shanghai-based biopharmaceutical company LianBio (OTCMKTS: LIANY) has announced the first patient dosing in a Phase III LIBRA study for its TP-03, targeting demodectic blepharitis in Chinese patients. This marks a significant step forward in addressing a prevalent eye disease in the region. Understanding Demodectic BlepharitisDemodectic blepharitis is a common eye…
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Ascletis Files IND Application for COVID-19 Oral Inhibitor ASC11 with FDA
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China-based Ascletis Pharma Inc. (HKG: 1672) has announced that the Investigational New Drug (IND) application for ASC11, an oral inhibitor drug candidate targeting 3-chymotrypsin like protease (3CLpro) for COVID-19, has been filed with the US FDA following a pre-IND consultation. This marks a significant step forward in the development of…
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RemeGen’s Telitacicept Shows Positive Results in Phase II Myasthenia Gravis Study
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China-based RemeGen Co., Ltd (HKG: 9995, SHA: 688331) has released data from a Phase II clinical study for its novel fusion protein telitacicept in Chinese patients with myasthenia gravis (MG), showing positive results. The study demonstrated significant improvements in patient conditions and good safety profiles. Study Design and ResultsThe multicenter,…
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Immunochina Pharmaceuticals Raises Funds for Gene Therapy Development
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Beijing-based gene therapy specialist Immunochina Pharmaceuticals has reportedly raised “hundreds of millions” of renminbi in a Series D+ financing round, following a Series D financing round at the same scale in November 2021. The round was led by ZGC Science City and Beijing Innovation Industry Investment. The proceeds will be…
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BGI Genomics Receives NMPA Approval for Chromosome Aneuploidy Detection Kit
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China-based genomics firm BGI Genomics Co., Ltd (SHE: 300676), the Shenzhen-listed subsidiary of BGI Group, has announced receiving marketing approval from the National Medical Products Administration (NMPA) for its chromosome aneuploidy detection kit (combined probe anchoring polymerization sequencing method). This marks a significant milestone in the company’s efforts to advance…
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Antengene’s ATG-017 Gets FDA Approval for Phase I Clinical Study
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Antengene Corporation has announced receiving approval from the US Food and Drug Administration (FDA) to initiate a Phase I clinical study for its ATG-017, an extracellular regulated protein kinase 1/2 (ERK1/2) inhibitor. The Shanghai-based biotech company will commence the joint part of the Phase I ETASER study, assessing the safety,…
