Gelonghui January 4th 丨Laimei Pharmaceutical (300006.SZ) announced that recently, the company received the “Drug Supplement Application Approval Notice” for triprorelin acetate injection with specifications of 1ml: 0.1 mg, approved and issued by the Drug Administration.

After review, the application for this product met the relevant requirements for drug registration, and it was agreed to approve the change of the marketing license holder of this product from “Hainan Shuangcheng Pharmaceutical Co., Ltd. (address: No. 16, Xingguo Road, Xiuying District, Haikou City)” to “Chongqing Laimei Pharmaceutical Co., Ltd. (address: No. 99, Yuma Road, Nan'an District, Chongqing)”. The drug approval number remained unchanged. The production site, prescriptions, production process, quality standards, etc. of the transferred drugs are consistent with the original drug, and there are no changes. Transferred drugs can be marketed and sold if they meet the product release requirements after passing the compliance inspection with pharmaceutical production quality management standards.

Triptorelin acetate injections are suitable for pituitary lowering regulation required for infertility treatment (e.g. in vitro fertilization (IVF), gamete intra-tubal transplantation (GIFT), and stimulation of follicle maturation without adjuvant treatments).

Triptorelin acetate injection was first developed by Debiopharm (Swiss Debiopharmaceutical Company), produced by Ferring GmbH (Swedish Pfizer Pharmaceuticals), approved for marketing in Germany in 1986, and approved by the Drug Administration in 1995. Up to now, in addition to the company, 3 domestic manufacturers and 1 original drug manufacturer have obtained marketing approval for triptorelin acetate injections.