South Korean researchers led by Lee In-suk of Yonsei University have reported the most complete oral microbiome catalog to date, with more than 72,000 genomes. Detailed in Cell Host & Microbe on Nov. 12, 2025, the database is expected to serve as a universal platform for academia and enable “precision microbiome medicine” for the industry, Lee told BioWorld.
Boehringer Ingelheim GmbH has licensed an unnamed small-molecule preclinical candidate from Kyowa Kirin Co. Ltd. in the autoimmune disease space in a deal worth up to €640 million (US$739 million).
Celltrion Inc. announced Oct. 29 the signing of an $87.75 million joint drug R&D agreement with AI and spatial transcriptome-based biotech Portrai Inc.
For 75 years, the standard tools for autoimmune disease have consisted of steroids, cytotoxics and broad biologics that tamp down the entire immune system. They can help, but they are rarely curative. “They’re blunt instruments,” Regcell Inc. CEO Mike McCullar told BioWorld. “They can’t distinguish good immune cells and bad immune cells,” which is why many carry black-box warnings and must be taken for years, sometimes for life.
Genfleet Therapeutics (Shanghai) Inc. debuted on the Hong Kong Stock Exchange on its second attempt at an IPO, raising HK$1.819 billion (US$234 million). Genfleet’s shares (HKEX:2595) rose to HK$44.00 at the opening bell on Sept. 19 and closed at HK$42.10, about 106% higher than the listing price.
While U.S. policymakers are scaling back funding on mRNA vaccine research, Australia is accelerating investment in the technology. At the center of this effort is Moderna Inc., which is establishing an mRNA research and manufacturing footprint in the country and banking on decades of local expertise to bring new therapies to the clinic and serve as a regional hub for Asia Pacific.
South Korea’s Ministry of Food and Drug Safety announced Sept. 12 plans to significantly raise drug application fees for biosimilars but slash their review times starting next year.
Bio-Thera Solutions Inc. announced Aug. 26 that the European Commission cleared Usymro (BAT-2206) as a biosimilar to Janssen Pharmaceuticals Inc.’s Stelara (ustekinumab). The EMA issued marketing authorization for Usymro on Aug. 14, following the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion on June 19.
Beijing Luzhu Biotechnology Co. Ltd.’s shingles vaccine LZ-901 outperformed GSK plc’s Shingrix (HZ/su) vaccine in a head-to-head phase III trial. A recombinant herpes zoster vaccine candidate independently developed by Luzhu, LZ-901 is the company’s core product.
Quantumpharm Inc., known as Xtalpi Inc., announced receiving $51 million up front from a potential $5.99 billion deal with Dovetree LLC on Aug. 6. The collaboration, first inked through a letter of intent between the two parties on June 23, will combine Shenzhen, China-based Xtalpi’s AI-based and robotics-driven discovery platform with Dovetree’s “biological insights.” The goal will be to select and validate potential first-in-class candidates for Dovetree across five areas of oncology, immunology and inflammatory diseases, neurological disorders and metabolic dysregulation.