China’s National Medical Products Administration approved Innovent Biologics Inc.’s NDA for Tabosun (ipilimumab N01, IBI-310) in combination with sintilimab as neoadjuvant treatment for stage IIB-III resectable microsatellite instability-high or mismatch repair deficient colon cancer.

Speed and innovation from Asia Pacific’s (APAC) biotechnology sector had big pharma scouring the region for the next oncology heir to Keytruda (pembrolizumab), Merck & Co. Inc.’s reigning blockbuster cancer drug.

Shanghai Henlius Biotech Inc. and Organon & Co. announced Nov. 17 that the U.S. FDA cleared Poherdy (pertuzumab-dpzb) as the first and only interchangeable biosimilar to Perjeta (pertuzumab, Genentech Inc./Roche Holding AG).

The Korea Biotechnology Industry Organization on Oct. 30 welcomed the bilateral trade deal between the U.S. and South Korea announced during U.S. President Donald Trump’s state visit alongside the Asia-Pacific Economic Cooperation forum in Gyeongju, South Korea.

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.

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.

South Korea’s pharmaceutical manufacturing reached an all-time high of ₩32.86 trillion (US$23 billion) in 2024, representing a 7.3% increase from 2023 and the highest on record since the country began count in 1998.

The U.S. FDA on July 15 cleared Biocon Biologics Ltd.’s Kirsty (insulin aspart-xjhz) as the first and only interchangeable biosimilar product referencing Novo Nordisk A/S’ Novolog (insulin aspart), a rapid-acting diabetes medication.