Jilin, China-based Huisheng Biopharmaceutical Co. Ltd. gained China NMPA approval for Huiyoujing (proline janagliflozin tablets), its independently developed sodium glucose transporter 2 (SGLT2) inhibitor for type 2 diabetes. The regulatory clearance, announced on Jan. 23, makes janagliflozin the second China-made SGLT2 inhibitor after Jiangsu Hengrui Medicine Co. Ltd.’s henagliflozin (SHR-3824), which was launched domestically in May 2022. Read More
Biontech SE and Duality Biologics Co. Ltd. have progressed BNT-323/DB-1303 to pivotal phase III trials, beginning in China in patients with hormone receptor-positive and HER2-low metastatic breast cancer. Read More
Windtree Therapeutics Inc. is out-licensing China rights for phase III-ready heart failure candidate istaroxime to Lee’s Pharmaceutical Ltd. for $138 million, plus royalties. Lee’s, of Hong Kong, plans to begin a phase III study for istaroxime in acute heart failure in greater China, while Windtree, of Warrington, Pa., will conduct a global trial in cardiogenic shock, a form of sudden heart failure. Windtree reported positive phase II data in April 2022 that tested istaroxime in cardiogenic shock, which happens when the heart cannot pump enough blood and oxygen to vital organs. Read More
A tire company is the latest to test out the waters of the biopharmaceutical industry with Tirebank Co. Ltd. and 13 affiliated individuals becoming the largest shareholders in flailing Korean antibody biotech Pharmabcine Inc. with a 13.31% stake. Read More
The U.S. FDA has granted Mesoblast Ltd.’s allogeneic cell therapy Revascor (rexlemestrocel-L) rare pediatric disease designation following submission of results from a clinical trial in children with hypoplastic left heart syndrome, a potentially life-threatening congenital heart condition. Read More
The U.S. FDA issued a complete response letter to Shin Nippon Biomedical Laboratories Ltd.’s U.S. subsidiary, Satsuma Pharmaceuticals Inc., for its NDA for dihydroergotamine nasal powder (STS-101) for acute treatment of migraine, with or without aura, in adults. Shin Nippon acquired Satsuma for $220 million in April 2023 and gained rights to STS-101. Read More
Taiwan’s Bora Pharmaceuticals Co. Ltd. is acquiring Upsher-Smith Laboratories Inc. from Sawai Group Holdings Co. Ltd. and Sumitomo Corp. of Americas for $210 million to boost its commercial presence in the U.S. Read More
As gene therapies gain unprecedented traction into 2024, preclinical-stage South Korean biotech Genecraft Inc. said it raised ₩10 billion (US$7.48 million) in a series A financing to further R&D for its therapy against lung cancer. Read More
Researchers at ETH Zurich have identified a proteomic signature that could recognize long COVID six months after acute infection. Biologically, the signature indicated that the complement system remained active in patients with long COVID six months after infection. Translationally, it could lead to a diagnostic test for long COVID, and suggests that targeting the complement system could be a therapeutic approach to prevent or treat the disorder. Read More
Biopharma stocks saw a resurgence in 2023, with the BioWorld Stock Index finishing the year with a gain of 33.59%, in contrast to the 32.75% decline in 2022. An analysis of 516 stocks from the index showed that 193 companies (37%) concluded the year on a positive note, while shares of 322 companies (62%) experienced a downturn. Anebulo Pharmaceuticals Inc. (NASDAQ:ANEB), a biopharma focused on substance use disorders, saw its stock end 2023 at the same price as its 2022 closing. Meanwhile, the BioWorld Biopharmaceutical Index ended November up 4.37%. Read More
Clinical updates from Asia, including trial initiations, enrollment status and data readouts and publications: Adagene, Chipscreen Newway, Golden Biotechnology, Hope Medicines, Junshi. Read More
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Sun Pharmaceutical, Substipharm, Taro Pharmaceuticals, Zuellig. Read More
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Amplia, Carsgen, Drug Farm, Eiger, Innocare, Remegen, Takeda. Read More
