RemeGen wins China NMPA approval for disitamab vedotin in HER2-low breast cancer with liver metastases

Reuters03-23

RemeGen wins China NMPA approval for disitamab vedotin in HER2-low breast cancer with liver metastases

RemeGen said China’s National Medical Products Administration approved a new indication for disitamab vedotin (RC48) to treat HER2-low breast cancer with liver metastases.
The indication covers adult patients with unresectable or metastatic disease who have received at least one prior systemic therapy in the metastatic setting or relapsed within 12 months after adjuvant chemotherapy.
The approval was supported by results from the Phase III RC48-C012 trial conducted in China.
This is the fourth approved indication for disitamab vedotin in 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. RemeGen Co. Ltd. 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-20260323-12063372), on March 23, 2026, and is solely responsible for the information contained therein.

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