GenSci Advances Women's Health with the Approval of Two Key Products

Recently, the National Medical Products Administration (NMPA) of China announced that Gensci’s Corifollitropin alfa N02 for injection (Jin Saijia) and Tibolone tablets (Jin Saibei), both dedicated to women's health, have received approval.

Corifollitropin alfa N02 for injection is indicated for women undergoing fertility treatment. It stimulates the development of more than one mature egg at a time in the ovaries and is used together with a gonadotropin-releasing hormone(GnRH) antagonist. Utilizing gene fusion technology, Corifollitropin alfa N02 for injection achieves a long-acting profile by extending its half-life, significantly reducing the dosing frequency from once daily to just once weekly. In addition, it provides age- and weight-based personalized dosing, requiring only one injection per controlled ovarian stimulation cycle. This improves treatment adherence and clinical efficiency. Phase Ⅱ and Ⅲ clinical trials have also demonstrated its efficacy and safety. This therapy provides a new option to address unmet needs in assisted reproductive technology (ART).

Since launching China's first domestically developed recombinant human follicle-stimulating hormone (rhFSH), Recombinant human follitropin for injection (Jin SaiHeng), GenSci has been devoted to the assisted reproductive field, with a full range of products launched. In 2024, its Progesterone injection (Ⅱ) (Jin SaiXin) became China's first water-soluble progesterone. With the recent approval of Corifollitropin alfa N02 for injection, GenSci now offers a complete rhFSH portfolio—powder, short-acting, and long-acting aqueous formulations, delivering more comprehensive ovarian stimulation options and advancing its assisted reproductive technology (ART).

Another product, Tibolone tablets, are indicated for low oestrogen produced by a woman's body after the menopause, which can cause symptoms such as hot face, neck, and chest ("hot flushes"). Results from a completed clinical study in healthy postmenopausal women in China demonstrated bioequivalence to the original drug Livial, with a favorable safety profile. This product offers a new solution for menopausal hormone therapy (MHT).

The approvals underscore GenSci's ongoing commitment to advancing women's health. Through its wholly owned subsidiary, GeneDiva, which specializes in ART and gynecological diseases with a growing portfolio of approved products, GenSci supports women's health across every stage of life.