Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Abcellera, Beigene, Betta, Cytodyn, Eisai, Eli Lilly, Exithera, Gtreebnt, Johnson & Johnson, Junshi, Kintor, Lee's, Moderna, Nicox, Oblato, Ocumension, RDIF, Shanghai Junshi, Sorrento, Turnsole, Wellmarker.
The latest global regulatory news, changes and updates affecting biopharma in Asia, including: Biontech, EMA, Health Canada, Minister of Health, Moderna, NIH, Pfizer, PhRMA, WHO.
HONG KONG – Lianbio Co. Ltd. has inked a deal for the development and commercialization of Reviral Ltd.’s sisunatovir, picking up rights to the respiratory syncytial virus (RSV) candidate in mainland China, Hong Kong, Macau and Singapore in exchange for an up-front cash payment of $14 million and development and commercial milestone payments of up to $105 million.
China’s National Medical Products Administration granted conditional approval two Chinese-developed COVID-19 vaccines in less than 24 hours on Feb. 25. One of the vaccines approved was developed by Tianjin-based Cansino Biologics Inc., and the other by China National Pharmaceutical Group (Sinopharm) through its Wuhan Institute of Biological Products subsidiary.
Liver disease specialist Ascletis Pharma Inc. said its nonalcoholic steatohepatitis (NASH)-focused subsidiary, Gannex Pharma Co. Ltd., will start global development of its oral THR-β agonist, ASC-41, after it obtained an IND approval from the FDA based on positive phase I data generated in China.
PERTH, Australia – Sydney-based Kazia Therapeutics Ltd. has out-licensed its ovarian cancer drug, Cantrixil (TRX-E-002-1), to Sweden’s Oasmia Pharmaceutical AB in a deal worth up to $46 million.
Oasmia will pay $4 million up front, and development milestones worth up to $42 million and double-digit sales royalties.
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