Livzon Pharmaceuticals (01513): Leuprorelin acetate microspheres for injection passed the consistency evaluation

Zhitong Finance App News, Lizhu Pharmaceutical (01513) issued an announcement. Recently, the company's holding subsidiary Shanghai Lizhu Pharmaceutical Co., Ltd. received the “Drug Supplement Application Approval Notice” (certificate number: 2024B04743) approved and issued by the State Drug Administration. The injectable leuprorelin acetate microspheres produced by Shanghai Lizhu Pharmaceutical Co., Ltd. passed a consistent evaluation of the quality and efficacy of injectable generic drugs.

Leuprorelin acetate microspheres for injection are a Class B variety in the “National Basic Medical Insurance, Work Injury Insurance and Maternity Insurance Drug Catalogue”. Indications: (1) endometriosis; (2) fibroids accompanied by excessive menstruation, lower abdominal pain, lower back pain, and anemia can reduce fibroids and/or improve symptoms; (3) premenopausal breast cancer with positive estrogen receptors; (4) prostate cancer; (5) central precocious puberty. Leuprorelin acetate microspheres for injection are injected subcutaneously every 4 weeks. They have characteristics such as long efficacy time and low frequency of use, which can reduce patients' pain and burden of medication, and improve tolerability and accessibility of medication.

According to inquiries, the company's injectable leuprorelin acetate microspheres are the world's first gonadotropin-releasing hormone (GnRH) long-term release formulation approved for bioequivalence studies in accordance with the US FDA drug guidelines. Passing the consistency evaluation this time is conducive to further enhancing the market competitiveness of this drug and consolidating the company's dominant position in domestic microsphere formulation development.