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HUTCHMED (China) ( (HK:0013) ) has issued an update.
HUTCHMED has announced that China’s National Medical Products Administration has accepted and granted priority review to its New Drug Application for fanregratinib (HMPL-453), an oral inhibitor of FGFR1/2/3, for adult patients with advanced, metastatic or unresectable intrahepatic cholangiocarcinoma harboring FGFR2 fusions or rearrangements who have previously received systemic therapy. The filing, backed by positive Phase II registration data showing the study met its primary endpoint of objective response rate and supportive secondary outcomes such as progression-free survival, disease control rate, duration of response and overall survival, underscores HUTCHMED’s push to expand its oncology portfolio in a hard-to-treat form of liver cancer with rising incidence and poor survival, and highlights the company’s continued strategy to retain global rights to key assets like fanregratinib.
More about HUTCHMED (China)
HUTCHMED (China) Limited is an innovative, commercial-stage biopharmaceutical company focused on discovering, developing and commercializing targeted therapies and immunotherapies for cancer and immunological diseases. It advances drug candidates from in-house discovery to global markets, with three medicines already approved in China and one also marketed in the US, Europe and Japan.
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