Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Aldeyra, Appili, Arch, Ascentage, Beigene, Beyondspring, Canbridge, Gan & Lee, Gannex, Junshi, Kiadis, Mateon, Reven, SK, Vaxart, Zai.
An Australian study led by University of Melbourne scientists has identified a previously unknown role for the hepatokine, sparc-related modular calcium-binding protein 1 (SMOC1), in suppressing hepatic glucose production.
HONG KONG – Xuanzhu (Shijiazhuang) Biopharmaceutical Co. Ltd., Beijing-based Sihuan Pharmaceutical Holdings Group Ltd.’s innovative drug R&D platform, has secured ¥800 million (US$117.2 million) in series A funding from the State Development and Investment Corp. (SDIC). CMG-SDIC Capital Co. Ltd. (CMG-SDIC) invested the entire ¥800 million, giving SDIC an 18.6% equity interest in the platform, a company spokesperson told BioWorld.
PERTH, Australia – Australia’s biopharma sector fared better than the country at large at the end of the financial year that ended June 30, as the country saw GDP fall 7% in the final quarter, the largest drop since 1959. Australia’s trading relationship with China helped the country sidestep the global financial recession of 2008, but the recent divide between the U.S. and China is also putting a wedge between Australia and China relations.
LONDON – Results from two non-randomized phase I/II trials of the Russian COVID-19 vaccine Sputnik V that recently received conditional regulatory approval show both a frozen and a freeze-dried formulation of the two-shot vaccine had a good safety profile and induced antibody responses in all 76 participants within 21 days.
A nearly $2 billion global development and commercialization deal with Abbvie Inc. and a $418 million private placement have bolstered I-Mab Biopharma Co. Ltd.’s position globally. I-Mab framed the deal as being the largest out-licensing and global partnership transaction ever executed by a China-based biotech. Abbvie and I-Mab plan to develop and commercialize the anti-CD47 monoclonal antibody lemzoparlimab for treating multiple cancers globally, with the exception of China. Lemzoparlimab, also called TJC-4, is Shanghai-based I-Mab’s discovery and its lead cancer therapy. The company will get an up-front $180 million by licensing the highly differentiated antibody to Abbvie, along with a $20 million milestone payment based on phase I results.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Arch Biopartners, Cytodyn, Dompé, Inmune, Innovent, Mesoblast, Nippon Shinyaku.
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