China & China — National Medical Products Administration

China: The approval of ORPATHYS (savolitinib) in China addresses a significant unmet medical need for gastric cancer patients in the country, where gastric cancer is a leading cause of cancer death.

China — National Medical Products Administration: The China — National Medical Products Administration granted conditional approval for ORPATHYS (savolitinib) for the treatment of gastric cancer, enabling its commercialization in China.

China: China is the target market for Lerociclib, with an estimated 400 million individuals suffering from dyslipidemia and a significant unmet medical need for lipid-lowering treatments.

China — National Medical Products Administration: The China — National Medical Products Administration (NMPA) accepted the Biologics License Application (BLA) for Lerociclib, which is a crucial regulatory step for the drug's potential approval and availability in China.

China: China is the country where the pivotal Phase II clinical trial for fanregratinib was conducted across 53 sites and where the New Drug Application was accepted for review by the China — National Medical Products Administration.

China — National Medical Products Administration: The China — National Medical Products Administration accepted the New Drug Application for fanregratinib and granted it priority review, indicating a potential expedited path to market approval in China.

China: The licensing agreement covers the Greater China region, including the Chinese mainland, China — Hong Kong Special Administrative Region, Macao Special Administrative Region, and Taiwan, indicating the geographical scope of the drug's commercialization.

China — National Medical Products Administration: The China — National Medical Products Administration accepted the new drug application for roconkibart in December 2025, indicating progress in the regulatory approval process for the drug.

China: China is a key market for hepatitis B treatment, with 87 million people chronically infected. The China — National Medical Products Administration of China has granted Breakthrough Therapy Designation for BRII-179 and elebsiran.

China — National Medical Products Administration: The China — National Medical Products Administration's Center for Drug Evaluation granted BRII-179 and elebsiran Breakthrough Therapy Designation, and Brii Biosciences has reached preliminary alignment with them regarding a potential registrational study for ENRICH.