Clinical Trial Commencement of GenSci098 Injection Approved

August 5, 2024, Shanghai, China—Recently, Changchun GeneScience Pharmaceutical Co., Ltd.(GenSci) announced that the clinical trial Commencement of GenSci098 injection has been approved by the National Medical Products Administration (NMPA). The drug is indicated for the treatment of Thyroid Eye Disease(TED).

TED is an orbital inflammatory disease associated with thyroid disease, caused by autoimmune dysfunction. It affects facial appearance, reduces quality of life, induces psychological distress, and in extreme cases, poses a risk to vision.

As a pioneering company renowned for contributions to Child Health and Women’s Health, GenSci provides services to encompass the entire life-cycle of children and a holistic approach to women's health management and expands into more therapeutic areas with unmet needs, including endocrinology, immunology, and oncology.

Now GenSci has achieved a series of breakthroughs in new fields like immunology and oncology. In the immunology field, the marketing application for Genakumab Injection (anti-IL-1β antibody), a Category 1 new biological drug, for acute gouty arthritis indication, has been accepted by the NMPA. Clinical studies are ongoing for indications such as systemic juvenile idiopathic arthritis and interstitial lung disease; Bioequivalence studies for the new formulation of Genakumab injection have also been approved in May 2024. In the oncology field, Megaxia® (megestrol acetate oral suspension) for treating AIDS-related cachexia and cancer-associated anorexia/cachexia, was introduced in June 2024. It is the first line of treatment endorsed by both domestic and international authorities. Notably, it is currently the only drug with a specific oral dose for treating cachexia in China.