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长春高新:子公司绒促卵泡激素αN02注射液在境内获批上市

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced the approval of its long-acting follicle-stimulating hormone injection, Jin Sai Jia®, which offers a new option for controlled ovarian stimulation in assisted reproductive technology [1][2]. Group 1 - Jin Sai Jia® has been approved for use in conjunction with gonadotropin-releasing hormone antagonists to induce multiple follicle development, replacing the need for daily injections with a single subcutaneous injection lasting seven days [1][2]. - The demand for assisted reproductive technology has been increasing, with the launch of the first domestically developed recombinant follicle-stimulating hormone in China, Jin Sai Heng®, in 2015, which required daily injections [1][2]. - The approval of Jin Sai Jia® will enhance the company's product portfolio in women's health, creating a complete range of recombinant follicle-stimulating hormone products, including powder, short-acting, and long-acting formulations [2]. Group 2 - Jin Sai Jia® utilizes gene fusion technology to achieve long-acting effects, significantly reducing the frequency of administration compared to short-acting formulations [2]. - The dosage of Jin Sai Jia® is customized based on age and weight, minimizing the risk of injection errors and improving patient compliance and treatment efficiency [2]. - Clinical trial results from Phase II and III indicate that Jin Sai Jia® demonstrates excellent efficacy and safety [2].