A new regulatory agreement could give Indonesia greater access to newer drugs and Chinese companies greater market share in Southeast Asia’s largest market.
Hutchmed Ltd.’s savolitinib became the first selective MET inhibitor approved in China to treat patients with non-small-cell lung cancer with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy.
China’s drug regulator granted a first CAR T therapy approval to Fosun Kite Biotechnology Co. Ltd.’s FKC-876. Marketed as Yescarta (axicabtagene ciloleucel) in the U.S. and EU, the approval by the National Medical Production Administration for the CD19-directed CAR T therapy came 3.5 years after the FDA nod.
Remegen Ltd.’s HER2-targeted disitamab vedotin became the first domestic antibody-drug conjugate (ADC) to win marketing approval in China, just three months after the company scored its first NDA approval in China for its lupus drug Tai’ai (telitacicept).
Suzhou Zelgen Biopharmaceuticals Co. Ltd. won approval from China’s NMPA for Zepsun (donafenib tosylate) to treat patients with unresectable hepatocellular carcinoma who have not received systemic treatment.
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