Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Ascletis, Beigene, Direct Biologics, Iaso, Kiniksa, Kyowa Kirin, Moderna, Ocugen, RDIF, Takeda, Vicore.
Biopharmas in Asia-Pacific raising money in public or private financings, including: Ambrx, Cygenica, Heartseed, Hifibio, Novocodex, Regencell Bioscience.
The Guangzhou Sino-Israel Bio-industry Investment Fund (GIBF) has raised more than half of its proposed ¥2 billion (US$313 million) round. “The second fund, GIBF2, will focus on Israeli and European biotechnology companies, which are developing innovative drugs and are in phase II to III clinical trials,” Avner Lushi, the CEO and co-founder of the GIBF, told BioWorld. The Chinese RMB fund is managed by The Guangzhou Elim Biotech Industry Venture Capital Management Company, which is controlled by a group of prominent Israeli professionals.
Micurx Pharmaceuticals Inc. has won marketing approval from China's NMPA for its lead antibacterial, contezolid, for treating adults with complicated skin and soft tissue infection (cSSTI), marking the first NDA for the Shanghai drugmaker. Set to be marketed as Youxitai in China, Micurx discovered the new-generation oral oxazolidinone antibiotic, developing it over 12 years. It’s designed to treat multidrug-resistant gram-positive bacteria such as methicillin-resistant Staphylococcus aureus and vancomycin-resistant Enterococci.
Sinovac Biotech Ltd.'s inactivated COVID-19 vaccine, Coronavac, has been approved by Chinese regulators for emergency use in children aged between 3 and 17, the company’s CEO Yin Weidong told Chinese state media on June 4. Sinovac briefly unveiled phase I/II data in the age group back in April. Chinese state media, China Central Television, said it confirmed the news with an expert from China’s State Council, though an official announcement has yet to be made. Sinovac did not immediately respond to BioWorld’s query to confirm the news.
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