Hightide Therapeutics Inc.’s berberine ursodeoxycholate (HTD-1801) met the primary endpoint showing superior improvements in key cardiometabolic markers in patients with type 2 diabetes compared to Astrazeneca plc’s SGLT2 inhibitor, Farxiga (dapagliflozin), in a head-to-head phase III trial. Read More
Bao Pharmaceuticals Co. Ltd., a developer of subcutaneous biologic drugs, priced its IPO at HK$26.38 on Dec. 2, aiming to raise about HK$1 billion (US$128 million). Bao expects net proceeds of HK$921.5 million after expenses, which will fund its “two-anti” strategy – developing both antibody and antibiotic drugs worldwide, mainly in China, the U.S. and Europe. Read More
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. Read More
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. Read More
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. Read More
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. Read More
2025 has been the most challenging year in the efforts to fight HIV since at least the advent of antiretroviral therapy. In a report on “Overcoming disruption, transforming the AIDS response,” released last week ahead of World AIDS Day on Dec. 1, the Joint United Nations Program on HIV/AIDS (UNAIDS) described “a global system in shock” by sharply reduced funding from the U.S. and other wealthy nations. Scientifically, for now, progress is ongoing. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Ascentage, Biomx, Celltrion, Enlivex, Junshi, Kelun-Biotech, Renalys. Read More
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. Read More
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. Read More