Asia, led by China, is no longer just following global pharma trends. It is helping to shape them, and for investors, innovators and policymakers, the question is no longer whether to engage with Asia, but how to engage wisely in this new, more complex world.
Hutchmed (China) Ltd. has moved closer to establishing China’s first domestically developed FGFR-targeted therapy for intrahepatic cholangiocarcinoma, after the National Medical Products Administration (NMPA) accepted its NDA for fanregratinib (HMPL-453) and granted the drug priority review.
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.
U.S. policy, China’s strategic rise, blockbuster deals and AI dominated South Korea’s biotechnology industry this year, with U.S. tariffs and the Biosecure Act’s hitch onto 2026 legislation serving as major topics of speculation.
Abbisko Therapeutics Co. Ltd. and its partner Merck KGaA got an early Christmas present from China’s National Medical Products Administration (NMPA) with the approval of pimicotinib (ABSK-021), the first domestically developed systemic therapy for tenosynovial giant cell tumor (TGCT).
“If at first you don’t succeed, try, try again” seems to be the motto of U.S. lawmakers – at least when it comes to the bipartisan Biosecure Act. After missing a ride last year in the must-pass annual defense spending bill, a version of the bill that seeks to protect the genetic data of Americans while securing U.S. pharmaceutical supply chains made it into the 2026 National Defense Authorization Act, which is now just a Senate vote away from becoming law.
China unveiled its first Commercial Health Insurance Innovative Drug List (CIIDL), reimbursing 19 high-value innovative drugs, including all five domestically developed CAR T therapies as well as treatments for rare diseases and Alzheimer's disease.
China’s National Medical Products Administration gave the nod to Innovent Biologics Inc.’s picankibart (IBI-112), branded as Pecondle, for treating moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
The priority BLA from Otsuka Pharmaceutical Co. Ltd., of Tokyo, and its U.S. subsidiary, Otsuka Pharmaceutical Development & Commercialization Inc., for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN) has received accelerated approved by the U.S. FDA.
The U.S. FDA said postmarketing reports of neutralizing antibodies to ADAMTS13, including one reported patient death, have prompted an investigation into Takeda Pharmaceutical Ltd.’s Adzynma (apadamtase alfa), a recombinant protein product approved in 2023 for use in adults and pediatric patients with congenital thrombotic thrombocytopenic purpura.
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