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.
The increased availability of capital, greater access to talent, strong local governmental support and more focused attention on IP issues have increased the complexity of deals taking place between biotech and big pharma companies in China, according to Michelle Chan, chief business officer of Insilico Medicine Inc.
Astellas Pharma Inc.’s zolbetuximab, a monoclonal antibody targeting Claudin 18.2, met the primary endpoint for progression-free survival as well as secondary endpoints for overall survival in the phase III Glow trial in CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma.
The Australian government will deliver $50 million to a new biomedical and med-tech incubator (BMTI) program for health discoveries spanning early-stage drug development through to cutting edge medical devices and evidence-based digital health technologies.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Abbisko, Biontech, Everest Medicines, Glenmark, Kuria, Likang, Pfizer, Skye.
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