LIVZON PHARMA(01513): Leuprorelin Acetate Microspheres for Injection 11.25mg (3-month formulation) receives the "Drug Supplementary Application Approval Notice"

LIVZON PHARMA (01513) announced that recently, its controlling subsidiary Shanghai Livzon Pharmaceutical Co., Ltd. (Shanghai Livzon) received the "Drug Supplementary Application Approval Notice" (Certificate No.: 2026B06648) approved and issued by the National Medical Products Administration. Leuprorelin Acetate Microspheres for Injection 11.25mg (3-month formulation) produced by Shanghai Livzon has been approved for marketing. Leuprorelin Acetate Microspheres for Injection is a Class B product in the "National Basic Medical Insurance, Work-Related Injury Insurance and Maternity Insurance Drug Catalog." The indications of the 3-month formulation include: (1) premenopausal breast cancer; (2) prostate cancer; (3) central precocious puberty. Leuprorelin Acetate Microspheres for Injection (3-month formulation) is administered subcutaneously once every 12 weeks. Unlike the already marketed 3.75mg specification 1-month formulation, the 3-month formulation has a different formulation process, different quality standards, different usage and dosage, and different indications. The 3-month formulation uses a completely different core excipient, poly-DL-lactide, and has the advantages of a longer duration of action and fewer administrations. After injection, it can maintain a stable blood drug concentration for 12 weeks, with more stable release behavior, greatly reducing the fluctuation in blood drug concentration after repeated administration of the 1-month formulation. It can alleviate patient suffering and medication burden, and improve medication tolerance and accessibility. Poly-DL-lactide is a polymer excipient independently developed by Shanghai Livzon and is the core excipient controlling microsphere release. After passing the associated review this time, the registration status of this excipient has changed to "A." Following PLGA7525, poly-DL-lactide is the company's second approved polymer, further enhancing the company's competitiveness in microsphere technology research and development. As of the disclosure date of this announcement, the cumulative direct R&D expenses invested in Leuprorelin Acetate Microspheres for Injection (3-month formulation) amounted to approximately RMB 94.0548 million.