Livzon Pharmaceutical (01513) Secures NMPA Approval for 3-Month Leuprorelin Acetate Microspheres

Livzon Pharmaceutical Group (HKEX: 01513) has secured regulatory approval for a long-acting hormone therapy that could reshape treatment schedules for patients with breast cancer, prostate cancer, and a rare pediatric condition.

The company's controlled subsidiary, Shanghai Livzon Pharmaceutical Co., Ltd., received a Supplementary Drug Application Approval Certificate (No. 2026B06648) from China's National Medical Products Administration (NMPA), clearing the company's Leuprorelin Acetate Microspheres for Injection 11.25 mg in a three-month formulation for market launch.

A Different Approach to Dosing

The approved product is listed as a Category B drug under China's National Basic Medical Insurance, Work-Related Injury Insurance, and Maternity Insurance Drug Catalog. It carries three indications: premenopausal breast cancer, prostate cancer, and central precocious puberty.

Unlike the currently marketed 3.75 mg one-month formulation, the new 11.25 mg three-month version differs in formulation process, quality standards, dosage regimen, and approved indications. Patients receive a subcutaneous injection once every 12 weeks — a significant reduction in treatment frequency compared to monthly dosing.

Homegrown Technology

The extended-release formulation relies on a fundamentally different core excipient — poly DL-lactide — a high-molecular-weight polymer independently developed by Shanghai Livzon. This excipient is central to controlling the microsphere's drug-release profile.

According to the company, the three-month formulation maintains stable drug concentrations over the full 12-week dosing interval, with significantly smoother release kinetics compared to the monthly version. That design substantially reduces the peak-to-trough fluctuations associated with repeated monthly dosing, potentially easing patient burden and improving treatment tolerability and accessibility.

Following the associated regulatory review, the registration status of the poly DL-lactide excipient has been updated to "A" (Active). It becomes the company's second approved polymer excipient, after PLGA7525, further strengthening Livzon's competitive position in microsphere-based drug delivery.

Investment at a Glance

As of the disclosure date, the company has invested approximately RMB 94.05 million in direct research and development costs for the three-month leuprorelin acetate microsphere formulation.