Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific, including: Ascentage, Ascletis, Astellas, Astrazeneca, Biovaxys Technology, Direct Biologics, Gtreebnt, Humanigen, Kyowa Kirin, Levena, Mabpharm, Moderna, Oblato, Organicell Regenerative Medicine, Rarestone, Regeneron, Sanofi, Sinovac, Sorrento, Swedish Orphan Biovitrum, Yisheng.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications, including: Acticor, Antengene, Bonus Biogroup, Frontier, Kyowa Kirin, Nrx, Ose Immunotherapeutics, Qilu, Redhill, Samsung Bioepis, Sesen, Sorrento, Takeda.
Jiangsu Hengrui Medicine Co. Ltd. reported positive interim data from its phase III trial for SHR-3680, an androgen receptor antagonist, demonstrating that it reduced the risk of disease progression or death in metastatic hormone-sensitive prostate cancer patients with high-volume disease burden.
Innovent Biologics Inc. and Ascentage Pharma Group Corp. Ltd. inked a three-component collaboration that comes with joint commercialization of an NDA-stage Bcr-Abl inhibitor and co-development of combination therapies, as well as Innovent taking a stake in Ascentage. The collaboration involves a deal worth up to $145 million and a $50 million investment.
China’s Center for Drug Evaluation has released the guideline on developing oncology drugs with a clinical value-oriented approach, part of its ongoing efforts to encourage the development of truly innovative oncology drugs in China.
The lack of data surrounding the efficacy of Chinese COVID-19 vaccines against the Delta variant has had many questioning them, especially after a recent study showed that one of those vaccines, Sinovac Biotech Ltd.’s Coronavac, was less effective than Pfizer Inc. and Biontech SE’s Comirnaty in Chile.
Harbour Biomed Therapeutics Ltd. said its anti-FcRn monoclonal antibody, batoclimab, generated top-line phase II data in generalized myasthenia gravis, and the company expects to move into a phase III study by the end of this year, with final data reported in April 2022.
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