Regulatory snapshots for biopharma and med tech in Asia-Pacific, including global submissions and approvals, and other regulatory decisions and designations: Haisco, Innovent, Iovance, Lupeng, Lupin, Nxera, Quoin, Reach Surgical, Santhera, Shionogi, Wockhardt.
Biopharma and med-tech happenings in Asia-Pacific, including deals and partnerships, and other news in brief: Agios, Astrazeneca, Biond, Circio, Daiichi Sankyo, Everest Medicines, Genassist, Leica, Luminopia, Mabworks, Oscotec, Rohto, Telix, United Imaging Healthcare.
Clinical updates for biopharma and med tech in Asia-Pacific, including data readouts and publications: Akeso, Cstone, Dizal, Genesis Medtech, Immutep, Innocare, Innovent, Juncell, Kelun-Biotech, Otsuka, Summit.
D&D Pharmatech Inc. announced May 27 positive top-line tissue biopsy results of zabopegdutide (DD-01) from a 48-week phase II study of metabolic dysfunction-associated steatohepatitis (MASH), pushing company shares up 30% on the day.
On the heels of the multibillion-dollar licensing deal between Bristol Myers Squibb Co. and Jiangsu Hengrui Pharmaceuticals Co. Ltd., Chairman John Moolenaar (R-MI), of the House Select Committee on the Chinese Communist Party, sent a letter to Treasury Secretary Scott Bessent urging him to add biotechnology as a prohibited technology under the Comprehensive Outbound Investment National Security (COINS) Act of 2025.
China’s National Medical Products Administration has issued final implementation measures for drug trial data protection that mark a significant step toward aligning China’s pharmaceutical intellectual property framework with global standards.
Chinese biotech Longbio Pharma Co. Ltd. announced its IPO on the Hong Kong Stock Exchange to raise HK$1.362 billion (US$174 million) to progress its lead candidate, LP-003, a next-generation anti-IgE antibody.
Hanmi Pharmaceutical Co. Ltd. secured a $1.26 billion deal with Eli Lilly and Co. to out-license ex-Korea rights to sonefpeglutide (HM-15912), a Lapscovery-based glucagon-like peptide-2 analog in development for multiple indications, including an ongoing phase II study of short bowel syndrome. It was one of two billion-dollar Asian company deals signed by Lilly on June 1, with the second transaction involving Haisco Pharmaceutical Group Co. Ltd., of Beijing.