HENGRUI PHARMA (01276.HK): Rezvilutamide Tablets Win Clinical Trial Approval for Prostate Cancer Phase III Study

NewTimeSpace News: On 22 October 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (the "Company") published an overseas regulatory announcement pursuant to Rule 13.10B of the Listing Rules, setting out the announcement published on the website of the Shanghai Stock Exchange. The announcement disclosed that the Company has recently received the Drug Clinical Trial Approval Notice for rezvilutamide tablets issued by the National Medical Products Administration and will commence clinical trials in the near future.

The announcement disclosed that the drug is in tablet form, the application is for clinical trials and the acceptance number is CXHL2600871. The review conclusion states that, in accordance with the Drug Administration Law of the PRC and relevant provisions, following review, the clinical trial application for rezvilutamide tablets accepted on 17 July 2026 meets the relevant requirements for drug registration, and the product is approved to conduct clinical trials for prostate cancer, specifically a multicentre, randomised, double-blind, placebo-controlled Phase III clinical study on the efficacy and safety of rezvilutamide in combination with androgen deprivation therapy (ADT) versus placebo in combination with ADT in the treatment of high-risk localised or high-risk biochemically recurrent (BCR) prostate cancer after radical surgery or radiotherapy.

The Company stated that rezvilutamide tablets are a second-generation AR inhibitor which, compared with first-generation AR inhibitors, has stronger AR inhibitory effects and no agonist activity. The Company's rezvilutamide tablets were approved for marketing in 2022 for the treatment of patients with high-volume metastatic hormone-sensitive prostate cancer (mHSPC). Several second-generation AR inhibitors, including enzalutamide, apalutamide and darolutamide, are currently marketed in China and overseas. According to the EvaluatePharma database, global sales of comparable products of rezvilutamide tablets totalled approximately US$12.89 billion in 2025. As at the date of the announcement, cumulative research and development investment in the rezvilutamide tablet project amounted to approximately RMB 740.40 million (unaudited). The announcement also cautioned that, after obtaining the Drug Clinical Trial Approval Notice, the drug still requires clinical trials and review and approval by the National Medical Products Administration before it can be manufactured and marketed.