CHENGDU, China, Sept. 12, 2024 /PRNewswire/ -- Keymed Biosciences
Inc. (HKEX: 02162) today announced the National Medical Products
Administration (the "NMPA") of China has recently approved the new drug
application for Stapokibart (anti-IL-4Rα monoclonal antibody, trade
name: Kangyueda (康悦达), for the indication of moderate-to-severe
atopic dermatitis in adults.
The marketing approval of Stapokibart is based on a
multi-center, randomized, double-blind, placebo-controlled Phase
III study, with the co-primary endpoints being the achievement of
at least a 75% improvement in Eczema Area and Severity Index
(EASI-75) from baseline and an Investigator's Global Assessment
(IGA) score of 0 or 1 with a reduction of ≥2 points from baseline
at week 16. The results showed that this trial reached the
co-primary endpoints at week 16 with long-term treatment achieving
sustained clinical benefits with a good safety profile.
The study showed that at week 52, the rates of achieving EASI-75
for the Stapokibart group and the placebo-to-Stapokibart group were
92.5% and 88.7%, respectively. The EASI-90 response rates were
77.1% and 65.6%, respectively. The rates of achieving an IGA score
of 0 or 1 point with a reduction of ≥ 2 points from baseline were
67.3% and 64.2%, respectively. Long-term treatment with Stapokibart
can consistently improve dermatitis symptoms and quality of life in
subjects with moderate-to-severe AD. During the maintenance period,
only one subject (0.9%) experienced a relapse. In terms of safety,
Stapokibart was safe and well-tolerated after 52 weeks of
administration, with safety profiles consistent with those observed
at week 16 and no new safety signals identified.
About Stapokibart
Stapokibart (trade name: Kangyueda, R&D codename: CM310) is
a humanized and highly potent antibody against the interleukin-4
receptor a-subunit (IL-4Rα). It is the first domestically
manufactured IL-4Rα antibody drug granted marketing approval by the
NMPA. By targeting IL-4Rα, Stapokibart can lead to dual-blockade of
interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling. IL-4 and
IL-13 are two critical cytokines for initiating type II
inflammation. Stapokibart has demonstrated good safety and
encouraging efficacy in multiple previous clinical trials. As of
the date of this announcement, its new drug application for the
treatments of seasonal allergic rhinitis and chronic rhinosinusitis
with nasal polyposis have been accepted by the NMPA.
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