Stapokibart Approved by National Medical Products Administration for Moderate-to-Severe Adult Atopic Dermatitis

Keymed Biosciences Inc. (HKEX: 02162) has announced that the National Medical Products Administration (NMPA) of China has approved Stapokibart, an anti-IL-4Rα monoclonal antibody, for treating moderate-to-severe atopic dermatitis in adults. Marketed under the trade name Kangyueda (康悦达), this new drug's approval is grounded on the results of a comprehensive Phase III clinical trial.

The pivotal Phase III study was multi-centered, randomized, double-blind, and placebo-controlled. It primarily aimed to assess the improvement in patients' Eczema Area and Severity Index (EASI-75) by at least 75% from baseline, and a significant reduction in the Investigator’s Global Assessment (IGA) score to 0 or 1, with at least a 2-point reduction from baseline at the 16-week mark. The study successfully met these co-primary endpoints, showcasing the drug's efficacy and safety profile.

By week 52 of the trial, the Stapokibart group demonstrated impressive results. The EASI-75 achievement rates were 92.5% for the Stapokibart group and 88.7% for the placebo-to-Stapokibart group. For EASI-90, the response rates were 77.1% and 65.6%, respectively. Additionally, the rates of achieving an IGA score of 0 or 1, with a reduction of at least 2 points from baseline, were 67.3% and 64.2% in the respective groups. Long-term treatment with Stapokibart showed a consistent improvement in dermatitis symptoms and the quality of life for patients with moderate-to-severe atopic dermatitis. During the maintenance period, only one subject (0.9%) experienced a relapse, underscoring the drug's enduring efficacy. Safety assessments indicated that Stapokibart was well-tolerated over 52 weeks, with no new safety concerns emerging.

Stapokibart, also referred to by its research and development code CM310, is a humanized antibody that targets the interleukin-4 receptor alpha-subunit (IL-4Rα). As the first IL-4Rα antibody drug manufactured domestically to receive marketing approval from the NMPA, Stapokibart blocks the signaling of both interleukin-4 (IL-4) and interleukin-13 (IL-13), pivotal cytokines in type II inflammation initiation. Previous clinical trials have affirmed its safety and promising efficacy. The NMPA has also accepted new drug applications for Stapokibart to treat seasonal allergic rhinitis and chronic rhinosinusitis with nasal polyposis.

Keymed Biosciences Inc. is dedicated to addressing significant unmet clinical needs by providing innovative, high-quality, and affordable therapies to patients both in China and globally. The company's strategy revolves around an integrated platform that encompasses all vital functions in biological drug development, including target validation, lead molecule discovery and optimization, preclinical evaluation, process development, translational research, clinical development, and manufacturing. This comprehensive platform allows Keymed to efficiently and cost-effectively advance a diverse pipeline of innovative and differentiated antibody-based therapies, such as monoclonal antibodies, antibody drug conjugates (ADCs), and bispecific antibodies.