HENGRUI PHARMA (01276.HK): NMPA accepts marketing application for atopic dermatitis antibody Zhuotuoqibai injection

NewTimeSpace News: On 3 September 2026, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (stock code: 01276) announced that its subsidiary, Guangdong Hengrui Pharmaceutical Co., Ltd., has received the acceptance notice issued by the National Medical Products Administration (NMPA) for the marketing application of Zhuotuoqibai injection (SHR-1819 injection) (acceptance number: CXSS2600144), with the proposed indication of treating moderate to severe atopic dermatitis (AD) in adults whose condition is inadequately controlled by or unsuitable for topical therapy.

The filing is mainly based on a multicentre, randomised, double-blind, placebo-controlled Phase III study (study number: SHR-1819-301) in adult patients with moderate to severe AD, led by Professor Xu Jinhua of Huashan Hospital, Fudan University as the principal investigator, with 652 patients with moderate to severe AD enrolled nationwide. The results showed that Zhuotuoqibai injection met both co-primary efficacy endpoints, both significantly superior to the placebo control group, with good safety and tolerability.

SHR-1819 injection is a recombinant humanised monoclonal antibody targeting human IL-4Rα independently developed by the Company, which can simultaneously block the signalling of IL-4 and IL-13, with investigational indications covering a range of type 2 inflammatory diseases including atopic dermatitis, prurigo nodularis and allergic rhinitis. Currently, only two drugs targeting the same target have been approved globally: Dupilumab (brand name: Dupixent), approved in the United States, the European Union, Japan and other countries and regions since 2017 and in China in 2020, and Stapokibart (brand name: Kangyueda), approved in China in 2024. According to the EvaluatePharma database, the combined global sales of Dupilumab and Stapokibart in 2025 were approximately USD 18.076 billion. As of the date of this announcement, the cumulative R&D investment in the SHR-1819 injection project amounts to approximately RMB 385.7 million (unaudited).

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