GenSci's Innovative IL-1α/β Bispecific Antibody Receives First FDA Clinical Approval

Recently, GenSci161 Injection, a fully human bispecific antibody, has obtained FDA approval to initiate clinical trials in the United States for hidradenitis suppurativa (HS), marking its first FDA-approved clinical indication in the country.

Hidradenitis suppurativa is a chronic inflammatory disorder, which affects the intertriginous skin and is associated with numerous systemic comorbidities. Typically starting in early adulthood, cutaneous inflamed nodules, abscesses and pus-discharging tunnels develop in axillary, inguinal, gluteal and perianal body sites.

Epidemiologic studies have found the prevalence of hidradenitis suppurativa ranging from 0.05% to 4.1% in Europe and America^[1-3], and about 0.033% in China^[4]. Although Biofutures have emerged as a new therapeutic approach, substantial unmet medical needs still exist in clinical practice.

As a fully human bispecific antibody, GenSci161 targets IL-1α and IL-1β, the two subtypes of the key pro-inflammatory cytokine interleukin-1 (IL-1). It inhibits the activation of downstream inflammatory signaling pathways and blocks the initiation and amplification of local skin inflammation, and is expected to provide a novel long-term systemic therapeutic option for patients with moderate to severe disease.

Based on Fc engineering designed on the EvoMab™ Platform, GenSci161 can significantly prolong its half-life period, supporting dosing every 8–12 weeks and improving patient compliance.

Previously, the clinical trial application of GenSci161 Injection for the treatment of endometriosis, moderate to severe hidradenitis suppurativa and non-infectious uveitis has been approved by NMPA.

GenSci will conduct multi-center clinical trials in compliance with FDA requirements and U.S. regulations to advance the registration and clinical development of additional indications.

Disclosure Notice：

1. Innovative drug research and development entails high risks and uncertainties.

2. This press release is provided as a medical information source for healthcare experts only and is not used for commercial purposes.

3. GenSci does not recommend the use of any unapproved drugs or indications.

Reference:

[1]. Cosmatos, I., Matcho, A., Weinstein, R., et al. (2013). Analysis of patient claims data to determine the prevalence of hidradenitis suppurativa in the United States. Journal of the American Academy of Dermatology, 68(3), 412–419.

[2]. Vinding, G. R., Miller, I. M., Zarchi, K., et al. (2014). The prevalence of inverse recurrent suppuration: A population-based study of possible hidradenitis suppurativa. British Journal of Dermatology, 170(4), 884–889.

[3]. Jemec, G. B. E., & Kimball, A. B. (2015). Hidradenitis suppurativa: Epidemiology and scope of the problem. Journal of the American Academy of Dermatology, 73(5), S4–S7.

[4]. Wang, Z. - S., Li, J., Ju, Q., et al. (2022). Prevalence of acne inversa (hidradenitis suppurativa) in China: A nationwide cross - sectional epidemiological study. International Journal of Dermatology and Venereology, 5(1), 1–7.