Myrio Therapeutics Pty Ltd. has been able to accomplish something no other company has yet been able to crack: to develop binders where both the affinity and the specificity can be increased.
Vigencell Inc. plans to seek conditional approval in South Korea for VT-EBV-N, an antigen-specific killer T-cell therapy for natural killer T-cell lymphoma, after gaining positive top-line data from a phase II study Nov. 25.
China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Biogen, Innovent, Otsuka, Sun Pharmaceuticals, Teva.
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Ascentage, Biomx, Celltrion, Enlivex, Junshi, Kelun-Biotech, Renalys.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Agnes, Biocortex, CD Biopharma, Geneditbio, RK Pharma, Toolgen, Vasomune, Zydus Lifesciences.
Success in Japan may further bolster Protara Therapeutics Inc. in its push with TARA-002 in pediatric patients with macrocystic and mixed cystic lymphatic malformations (LMs), for which the New York-based firm disclosed interim results from an ongoing phase II trial.
RSS
