Jiangsu Hengrui subsidiary gets clinical trial approval for prostate cancer drug

Jiangsu Hengrui Medicine Co., Ltd. announced today that its subsidiary, Shanghai Hengrui Medicine Co., Ltd., has received a "Drug Clinical Trial Approval Notice" from the National Medical Products Administration (NMPA) for Leuprorelin Acetate for Injection Microspheres. The drug is approved for clinical trials for prostate cancer.

The approval, filed on August 29, 2025, confirms that the clinical trial application meets the requirements for drug registration. Leuprorelin Acetate, a GnRH analog, is intended for prostate cancer treatment. The original product, LEUPLIN®Pro, developed by Takeda Pharmaceutical Company Limited, was approved in Japan by the PMDA in November 2015 but is not yet available in China.

As of now, the cumulative research and development investment for Leuprorelin Acetate for Injection Microspheres totals approximately CNY 24.68 million. The company cautioned investors that drug development involves a lengthy and complex process from research to market, with inherent uncertainties and investment risks.