Junshi Biosciences Co. Ltd. and Rxilient Biotech Pte Ltd. are forming a joint venture (JV) to develop and commercialize Junshi’s PD-1 inhibitor, toripalimab, in nine Southeast Asian nations.
Data presented at the American Academy of Dermatology annual meeting – March 17-21, including: Acelyrin, Concert, Connect, Inmagene, Nimbus, Sun, Takeda.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astrazeneca, Aurion, Boan, FSD, Henlius, Jiangsu Recbio, Luye, Mesoblast, Olix, Prestige.
China’s NMPA granted conditional approval for a COVID-19 oral pill to treat adult patients with mild to moderate cases of the virus to a unit of Guangdong Zhongsheng Pharmaceutical Co. Ltd.
Biohaven Ltd. has acquired global rights, excluding China, from Highlightll Pharmaceutical Co. Ltd. to develop and commercialize a dual inhibitor of tyrosine kinase 2 (TYK2) and JAK1, BHV-8000 (TLL-041), for the treatment of brain disorders in a deal worth up to $970 million.
Japan’s PMDA has approved Aurion Biotech Inc.’s cell therapy, Vyznova, for the treatment of bullous keratopathy of the cornea, making it the first-ever approval of a cell therapy to treat corneal endothelial disease.
CSPC Pharmaceutical Group Ltd.’s COVID-19 mRNA vaccine, SYS-6006, has been included for emergency use by the NMPA, the company said on March 22, marking the first domestically developed COVID-19 mRNA vaccine approved for use in China.
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