LIVZON PHARMA (01513.HK): Leuprorelin 3-Month Formulation Approved

NewTimeSpace News: On 29 September 2026, Livzon Pharmaceutical Group Inc. (stock code: 01513.HK) announced that Shanghai Livzon Pharmaceutical Manufacturing Co., Ltd., a controlling subsidiary of the Company, received the Drug Supplementary Application Approval Notice (Notice No.: 2026B06648) issued by the NMPA, and Leuprorelin Acetate Microspheres for Injection 11.25mg (three-month formulation) manufactured by Shanghai Livzon has been approved for marketing.

The Product is classified as a chemical drug in injection dosage form. Its National Drug Approval Number is NMPA H20269239, valid until 27 April 2029, and the approval permits the addition of the 11.25mg specification and the issuance of a National Drug Approval Number. Leuprorelin Acetate Microspheres for Injection is a Category B drug under the National Drug Catalogue for Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance, and the three-month formulation is indicated for premenopausal breast cancer, prostate cancer and central precocious puberty, administered by subcutaneous injection once every 12 weeks.

The three-month formulation uses poly (DL-lactide) as its core excipient and maintains a stable blood drug concentration for 12 weeks after injection. Poly (DL-lactide) is a polymer excipient independently developed by Shanghai Livzon; following the associated review, its registration status was changed to "A", making it the second polymer approved for the Company after PLGA7525. As at the date of this announcement, cumulative direct investment expenses in research and development for the formulation amount to approximately RMB 94.0548 million.

Shanghai Livzon is the only company in China holding an approval for the three-month formulation, excluding the originator product. According to IQVIA sampling statistical estimates, the domestic terminal sales value of long-acting GnRHa sustained-release formulations in China in 2025 was approximately RMB 10.9 billion, of which three-month formulations accounted for 27%. The Product is the world's first GnRH preparation approved following completion of a bioequivalence study conducted in accordance with the product-specific guidance of the United States Food and Drug Administration.

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