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Hengrui Pharmaceutical (01276): Leuprorelin acetate microspheres for injection approved for clinical trials

Zhitongcaijing·12/19/2025 12:09:05
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Zhitong Finance App News, Hengrui Pharmaceutical (01276) announced that recently, the company's subsidiary Shanghai Hengrui Pharmaceutical Co., Ltd. received approval from the State Drug Administration to issue a “Drug Clinical Trial Approval Notice” on injectable leuprorelin acetate microspheres, which will conduct clinical trials in the near future.

Leuprorelin acetate is known to be a GnRH analogue used to treat prostate cancer. Genken's product LEUPLIN® Pro was developed by Takeda Pharmaceutical Co., Ltd., approved by Japan's PMDA in November 2015, and has not yet been marketed domestically. The usage and dosage of this product is different from injectable leuprorelin microspheres that have already been marketed in China. It is a copy of the original research drug that has been marketed overseas but not domestically. Up to now, projects related to injectable leuprorelin acetate microspheres have invested about 24.68 million yuan in R&D.