TYK Medicines NDA for Asandeutertinib Accepted by China’s NMPA

Reuters

Feb 06

TYK Medicines NDA for Asandeutertinib Accepted by China’s NMPA

TYK Medicines Inc. announced that its New Drug Application (NDA) for Asandeutertinib (TY-9591) has been accepted by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in China. The application is for the registration of Asandeutertinib as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations, including those with central nervous system metastases. The acceptance follows a review under Article 32 of the Administrative License Law of the People’s Republic of China.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. TYK Medicines Inc. published the original content used to generate this news brief via IIS, the Issuer Information Service operated by the Hong Kong Stock Exchange (HKex) (Ref. ID: HKEX-EPS-20260206-12017800), on February 06, 2026, and is solely responsible for the information contained therein.

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The application is for the registration of Asandeutertinib as a first-line treatment for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletion or exon 21 (L858R) substitution mutations, including those with central nervous system metastases. The acceptance follows a review under Article 32 of the Administrative License Law of the People’s Republic of China.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. 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TYK Medicines Inc. published the original content used to generate this news brief via IIS, the ","collect":0,"end_time":0,"defaultTopTitle":"","property":[],"viewcount":null,"language":"en","relate_stocks":{"02410":"同源康医药-B","BK1161":"生物科技"},"translate_title":"TYK Medicines Asandeutertinib NDA获中国国家药监局受理","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"02410":0.9},"content_text":"TYK Medicines NDA for Asandeutertinib Accepted by China’s NMPA\n    \n\n        TYK Medicines Inc. announced that its New Drug Application (NDA) for Asandeutertinib (TY-9591) has been accepted by the Center for Drug Evaluation of the National Medical Products Administration (NMPA) in China. 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