Hengrui Medicine (01276.HK): Marketing Authorization Application for Relugolix Tablets Accepted by EMA

NewTimeSpace News: Hengrui Medicine announced on June 22 that the company has been notified by the European Medicines Agency (EMA) of the official validation and acceptance of its marketing authorization application for Relugolix Tablets for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) with high tumour burden.

NewTimeSpace News: On June 22, 2026, Hengrui Medicine (01276.HK) issued an announcement stating that the European Medicines Agency has formally validated and accepted the marketing authorization application submitted by the company for Relugolix Tablets.

As disclosed in the announcement, Relugolix Tablets is a second-generation androgen receptor (AR) inhibitor, intended for use in combination with androgen deprivation therapy (ADT) in adult male patients diagnosed with metastatic hormone-sensitive prostate cancer with high tumour burden. The company reminded that the timeline and outcome of the EMA review remain uncertain. Drug development and commercialization involve a lengthy, multi-stage process with inherent risks and uncertainties.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.

×
Share to WeChat

Open WeChat, use the "Scan", and share to my Moments.