Lizhu Pharmaceuticals (01513): Leuprorelin acetate microspheres 11.25mg for injection (3-month dosage form) obtained the “Drug Supplement Application Approval Notice”

Zhitong Finance App News, Lizhu Pharmaceutical (01513) issued an announcement. Recently, the company's holding subsidiary Shanghai Lizhu Pharmaceutical Co., Ltd. (Shanghai Lizhu) received the “Drug Supplement Application Approval Notice” (certificate number: 2026B06648) approved and issued by the State Drug Administration, and 11.25mg (3-month dosage form) of injectable leuprorelin acetate microspheres produced by Shanghai Lizhu was approved for listing.

Leuprorelin acetate microspheres for injection are a Class B variety in the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue”. The indications for the 3-month dosage are: (1) premenopausal breast cancer; (2) prostate cancer; and (3) central precocious puberty.

Leuprorelin acetate microspheres for injection (3-month dosage form) are injected subcutaneously every 12 weeks. Unlike the 3.75mg 1-month formulation that has already been marketed, the 3-month formulation has different prescription processes, different quality standards, different usage and dosage, and different indications. The 3-month dosage form uses a completely different core ingredient, poly-DL-prolactone, which has the advantages of long action time and fewer doses. After injection, stable blood concentrations can be maintained within 12 weeks, and the release behavior is more stable. Fluctuations in blood concentration after repeated administration of the 1-month dosage form can be greatly reduced, reducing patients' pain and burden of medication use, and improving drug tolerability and accessibility.

Poly-DL-lactalcate is a polymer excipient independently developed by Lizhu Shanghai, and is a core adjuvant for controlling microsphere release. After passing the relevant review, the registration status of this auxiliary material changed to “A”. Following PLGA7525, polyDL-prolactone is the second polymer approved by the company, further enhancing the company's competitiveness in microsphere technology research and development.

As of the disclosure date of this announcement, the total direct R&D cost of injectable leuprorelin acetate microspheres (3-month dosage form) is approximately RMB 94.554,800.