China’s Pegbio Co. Ltd. is planning a Hong Kong IPO to advance PB-119, its main glucagon-like peptide 1 receptor agonist for diabetes nearing domestic approval, as it hopes to transition to an operating profit.
Wuxi Apptec quit its membership in the Biotechnology Innovation Organization (BIO) after U.S. Congressman Rep. Mike Gallagher (R-Wis.) sent a March 5 letter to Attorney General Merrick Garland, asking the Department of Justice to investigate BIO because its lobbying efforts on behalf of Wuxi suggested it was operating as an unregistered agent of a foreign company while advancing the interests of the People’s Republic of China and the Chinese Communist Party.
Hyundai Bioscience Corp. is set to become the largest shareholder of ADM Korea Inc., a Seoul, South Korea-based contract research organization (CRO) firm, by purchasing 5.02 million shares for ₩20.4 billion (US$15.5 million) – a 23% stake.
In February, deals formed by biopharma firms reached $7.76 billion, down from January, which marked the sixth-highest month in BioWorld’s records going back to 2016. Meanwhile, biopharma M&As amounted to $18.22 billion for the month, positioning it among the top 10 highest-value months in the past four years.
Asieris Pharmaceuticals Co. Ltd plans to submit a China NDA in the second quarter following positive phase III data for its cold light photodynamic drug-device combination product, Cevira, which is used as nonsurgical therapy for treating high-grade cervical dysplasia.
Samsung Life Science Fund, created jointly by Samsung Biologics Co. Ltd., Samsung Biopeis Co. Ltd. and Samsung C&T Corp., said it invested in Waltham, Mass.-based antibody-drug conjugate (ADC) developer Brickbio Inc. on March 18, as its fifth biotech investment.
China’s National Medical Products Administration (NMPA) approved Kechow Pharma Inc.’s MEK inhibitor, tunlametinib, for treatment of patients with NRAS-mutated advanced melanoma who were previously treated with PD-1/PD-L1 inhibitors. The Center for Drug Evaluation granted tunlametinib a priority review. The approval marks the first targeted therapy for this patient population and the first product that originated from Kechow, a privately held firm founded in 2014 to develop small-molecule therapeutics against cancer.
Regulatory snapshots, including drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations in Asia-Pacific: Astellas, Celltrion, Delta-Fly, Immvira, Mesoblast, Innocare, Transthera.
Biopharma happenings in Asia-Pacific, such as deals and partnerships, grants, preclinical data and other news in brief: Aderans, Elixirgen, ERS Genonics, Ono Pharmaceutical, Ricoh, Stemson, Sibylla.