Changchun High-techChangchun High-Tech Industry (Group) Co., Ltd. (hereinafter referred to as " Changchun High-Tech ") issued an announcement stating that its subsidiary Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as "Jinsai Pharmaceutical") recently received the "Drug Registration Certificate" approved and issued by the State Food and Drug Administration. Its application for the choriofollicle-stimulating hormone αN02 injection has been approved for marketing in China. The approved indication is for use in combination with a gonadotropin-releasing hormone antagonist for controlled ovarian stimulation to induce the development of multiple follicles. A single subcutaneous injection of choriofollicle-stimulating hormone αN02 injection (Jinsaijia®) replaces the 7-day use of follicle-stimulating hormone for assisted reproduction .Ovarian stimulation therapy brings new options.
In recent years, demand for assisted reproductive technology has continued to grow. In 2015, Jinsai Pharmaceutical launched the first domestically developed recombinant human follicle-stimulating hormone (RFH) for injection (Jinsai Heng®). This short-acting formulation, administered daily, was launched in China. In 2010, Elonva, the world's first long-acting follicle-stimulating hormone, was approved in the European Union. However, Chinese patients still face the long-term burden of daily injections, making long-acting ovulation-stimulating drugs a key breakthrough in treatment.
It is understood that Jinsajia® achieves long-term efficacy through gene fusion technology, extending its half-life. Compared to short-acting formulations, a single injection can maintain effective effects for 7 days, significantly reducing the frequency of dosing. In addition, Jinsajia® customizes the dosage based on age and weight, with a single injection for each controlled ovulation induction cycle, thereby reducing the risk of injection errors caused by daily dosing and alleviating the psychological burden. At the same time, the weekly dosing cycle is less likely to cause missed injections, improving treatment compliance and enhancing the efficiency of diagnosis and treatment. According to the results of Phase II and Phase III clinical trials, Jinsajia® has demonstrated excellent efficacy and safety.
Changchun High-Tech mentioned in the announcement that the approval of this product will further enrich the company's product layout in the field of women's health, forming a complete recombinant human follicle-stimulating hormone product portfolio of FSH powder, short-acting aqueous solution and long-acting aqueous solution, providing patients with more comprehensive and convenient ovulation-stimulating products and enhancing the company's competitiveness in the pharmaceutical market.

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