Sweeping “radical” changes in both the U.S. FDA and China’s drug development landscape are keeping the global life science industry on its toes in assessing what’s temporary and what’s not, speakers said at the Bioplus Interphex (BIX) Korea 2025 conference in Seoul, South Korea, on Oct. 15.

Dianthus Therapeutics Inc. has joined the recent trend of companies licensing therapies in development from China. The company will pay as much as $1 billion to Nanjing Leads Biolabs Co. Ltd. for DNTH-212, a bifunctional BDCA2 and BAFF/APRIL inhibitor to treat autoimmune disorders. The payment comprises $30 million up front and some near-term milestones, plus an $8 million milestone for getting a phase I study underway. Leads Biolabs is in line to bring in another $962 million in milestones and royalties.

In a deal that could top $2 billion, China-based Innocare Pharma Ltd. licensed the exclusive worldwide development and commercialization rights to the BTK inhibitor orelabrutinib to Zenas Biopharma Inc. for multiple sclerosis and other indications aside from oncology.

Taho Pharmaceuticals Ltd. announced an NDA submission to the U.S. FDA for TAH-3311, developed as the world’s first oral dissolving film formulation of apixaban, marking a regulatory milestone for the Taipei-based biotech.

Kyorin Pharmaceutical Co. Ltd. is licensing Hinge Bio Inc.’s multispecific antibody-based therapy HB-2198 in Japan for multiple autoimmune indications, starting with systemic lupus erythematosus.

The threat of tariffs on imports of branded drugs is about to be realized after U.S. President Donald Trump announced a 100% import duty will apply beginning Oct. 1. However, the flurry of recent announcements by pharma companies of investments in U.S. manufacturing plants may have paid off, with the president saying in his announcement on Truth Social that the 100% rate will be enforced “unless a company is building their manufacturing plant in America.”

Rakuten Medical Inc. is advancing a pipeline of solid tumor therapeutics built on its Alluminox platform worldwide, having gained conditional early approval of ASP-1929, an Alluminox-derived photoimmunotherapy, in Japan in 2020.

Mabwell Bioscience Co. Ltd. and Aditum Bio Management Co. LLC announced, in after-market hours Sept. 17, an agreement to forge a new company called Kalexo Bio Inc. and load the biotech with a preclinical dyslipidemia asset via a potential $1 billion global license deal.

The U.S. FDA approved Merck & Co. Inc.’s Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection on Sept. 19, making it the first and only subcutaneously (SC)-administered immune checkpoint inhibitor that can be administered in about a minute.

Celltrion Inc. announced plans to acquire from Eli Lilly and Co. a Branchburg, N.J.-based biologics cGMP facility for $330 million up front, with plans to invest up to a total of ₩1.4 trillion (US$1 billion) in plant acquisition and expansion.