Livzon Pharmaceutical Group Inc. (Livzon Pharma, 01513) announced that its controlling subsidiary, Shanghai Livzon Pharmaceutical Manufacturing Co., Ltd., has received a Drug Supplementary Application Approval Notice (No. 2026B06648) from China’s National Medical Products Administration (NMPA) for Leuprorelin Acetate Microspheres for Injection 11.25 mg, a three-month sustained-release formulation. The product’s National Drug Approval Number (H20269239) is valid through 27 April 2029.
The newly approved specification expands Livzon Pharma’s Leuprorelin portfolio—which already includes 3.75 mg and 1.88 mg doses—and offers extended 12-week dosing for premenopausal breast cancer, prostate cancer and central precocious puberty. Compared with the existing one-month 3.75 mg version, the three-month formulation uses a novel poly(DL-lactide) excipient developed in-house, delivering steadier plasma concentrations and reducing injection frequency, pain and treatment burden.
Development investment for the 11.25 mg product totaled approximately RMB 94.05 million (USD 13.0 million equivalent). According to IQVIA estimates, China’s long-acting gonadotropin-releasing hormone agonist (GnRHa) sustained-release market reached about RMB 10.90 billion (USD 1.50 billion) in 2025, with three-month formulations accounting for 27%. Excluding the originator, Shanghai Livzon is currently the sole domestic holder of marketing approval for this dosage strength.
This approval represents the world’s first GnRH preparation cleared on the basis of a bioequivalence study aligned with U.S. FDA product-specific guidance, closing China’s technological gap in three-month sustained-release microsphere formulations and reinforcing Livzon Pharma’s leadership in microsphere R&D.
Management cautions that pharmaceutical sales remain vulnerable to regulatory changes and market dynamics, advising investors to remain mindful of inherent industry risks.
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