Jinsai Pharmaceutical’s Self-Developed Innovative Drug IL-1α/β Bispecific Antibody Receives First FDA Clinical Approval

ShanghaiMay 18, 2026 /PRNewswire/ — Recently, the fully humanized bispecific antibody, GenSci161 Injection, independently developed by Changchun Jinsai Pharmaceutical Co., Ltd. (hereinafter referred to as “Jinsai Pharmaceutical”), has officially received permission from the U.S. Food and Drug Administration (FDA) to conduct clinical trials in the United States. The approved indication for this trial is hidradenitis suppurativa (HS), marking the first clinical approval for GenSci161 in the U.S.

Hidradenitis suppurativa is a chronic, recurrent, inflammatory skin disease caused by follicular occlusion affecting the pilosebaceous unit, commonly occurring in areas with apocrine sweat glands such as the armpits, groin, perineum, and perianal region. The condition typically begins in adolescence, presenting as deep skin lesions that can develop into abscesses, sinus tracts, and scars, often accompanied by multiple comorbidities, impacting patients’ quality of life.

Epidemiological data indicate that the prevalence of hidradenitis suppurativa is approximately 0.05% to 4.1% in Europe and the United States^[1-3], and about 0.033% in China^[4]. Existing conventional therapies offer limited benefits for patients with moderate to severe disease, and while biologics have provided new directions, unmet clinical needs remain.

As a fully humanized bispecific antibody independently developed by Jinsai Pharmaceutical, GenSci161 can simultaneously target two subtypes of the key pro-inflammatory cytokine interleukin-1 (IL-1)—IL-1α and IL-1β—inhibiting the activation of downstream inflammatory signaling pathways and blocking the initiation and amplification of local skin inflammation. This offers a potential new long-term systemic treatment option for patients with moderate to severe disease.

Leveraging the Fc engineering design of Jinsai Pharmaceutical’s independently developed EvoMab™ platform, GenSci161 can significantly extend its half-life, potentially supporting dosing every 8-12 weeks to improve patient compliance.

Previously, the clinical trial application for GenSci161 Injection for the treatment of endometriosis (EM), moderate to severe hidradenitis suppurativa (HS), and non-infectious uveitis (NIU) has been approved by China’s National Medical Products Administration for domestic drug registration.

Jinsai Pharmaceutical will proceed with subsequent multi-center clinical trials in an orderly manner in accordance with FDA requirements and U.S. laws and regulations, and actively promote registration and clinical activities for other related indications.

Disclaimer:

1. Innovative drug development carries high risks, and clinical trial results and final approvals are subject to uncertainty.
2. This news aims to share cutting-edge research information and is intended for reference by healthcare professionals only, not for advertising purposes.
3. Jinsai Pharmaceutical does not recommend the use of any unapproved drugs or indications.