-
Ascletis Files IND Application for COVID-19 Oral Inhibitor ASC11 with FDA
•
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…
-
RemeGen’s Telitacicept Shows Positive Results in Phase II Myasthenia Gravis Study
•
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,…
-
Immunochina Pharmaceuticals Raises Funds for Gene Therapy Development
•
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…
-
BGI Genomics Receives NMPA Approval for Chromosome Aneuploidy Detection Kit
•
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…
-
NMPA Suspends GSK’s Avodart Amid Inspection Findings
•
The National Medical Products Administration (NMPA) has decided to suspend the import, sales, and use of GlaxoSmithKline’s (GSK, NYSE: GSK) Avodart (dutasteride) in China. The drug had previously won a spot during the fifth round of volume-based procurement (VBP). However, recent overseas non-on-site inspections revealed that not all batches of…
-
Antengene’s ATG-017 Gets FDA Approval for Phase I Clinical Study
•
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,…
-
China Grand’s STC3141 Reaches Primary Endpoint in ARDS Phase Ib Study
•
China-based Grand Pharmaceutical Group Limited (HKG: 0512) has announced that the Phase Ib clinical study (NCT05000671) for its drug candidate STC3141 in acute respiratory distress syndrome (ARDS) has reached its primary endpoint. This marks a significant step forward in the development of the drug for this critical condition. Phase Ib…
-
Allogene Overland Biopharm Completes State-of-the-Art AlloCAR T Facility in Shanghai
•
Allogene Overland Biopharm, a joint venture between Overland Pharmaceuticals and Allogene Therapeutics, Inc. (NASDAQ: ALLO), has announced the completion of its state-of-the-art AlloCAR T manufacturing facility in Shanghai, China. This marks a significant milestone in the company’s efforts to expand its cell therapy production capabilities. State-of-the-Art GMP FacilityThe new 68,000…
