Sciwind Biosciences Co. Ltd. started dosing in a phase III clinical trial in China of its ecnoglutide (XW-003) candidate in adults with type 2 diabetes, targeting patients who have not responded adequately to either metformin or changes in lifestyle.
Certa Therapeutics Pty Ltd. is progressing antifibrotic agent FT-011 to phase III trials following positive results in a phase II trial that showed clinically meaningful improvements for more than 60% of patients with scleroderma in 12 weeks. FT-011 targets a previously undrugged G protein-coupled receptor, and these early efficacy outcomes in scleroderma suggest potential for FT-011 to treat other indications in Certa’s pipeline, including diabetic retinopathy and other forms of chronic kidney disease.
The ruling Communist Party of China increasingly views intellectual property (IP) through a national security lens, and generally accepted concepts of IP as a private right and respect for the rule of law don’t always apply as China prioritizes its pursuit of global technology dominance.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Abbisko, Alpha, Arcturus, Ascletis, Eisai, Greenlight, Help, Huidagene, Junshi, Mesoblast, Pfizer, Pharmala, Zai Lab.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Carsgen, Cidara, Healion, Qurient, Roche, TB Alliance, Tonix, Wuxi XDC, Ymmunobio.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Biophytis, Daiichi Sankyo, Ocumension, Oricell, Qurient, Sciwind.
Alpha Biopharma Ltd. submitted an NDA in China for zorifertinib, a next-generation EGFR tyrosine kinase inhibitor (EGFR-TKI) to treat advanced EGFR-mutated non-small-cell lung cancer with central nervous system metastases. Zorifertinib is the first EGFR-TKI to be tested in a clinical study for this patient population, according to the company.
The U.S. FDA granted breakthrough therapy designation to Abbisko Therapeutics Co. Ltd.’s pimicotinib for patients with tenosynovial giant cell tumors who are not able to have surgery.
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