IT之家 4 月 5 日消息，據新華社報導，首都醫科大學附屬北京同仁醫院張羅教授團隊於當地時間 4 日在國際醫學期刊《自然・醫學》發表最新研究成果。

The research team found that the new biologics "spalzimab" in China can significantly improve the clinical symptoms and quality of life of patients with moderate to severe seasonal allergic rhinitis. The results of the studyIt marks the leap from "following" to "leading" in the field of allergic rhinitis treatment in China。

IT之家查詢發現，該藥物已於 2025 年 2 月 7 日獲國家葯監局批准上市，成為全球首個獲批治療季節性過敏性鼻炎的 IL-4Rα 單抗藥物。

據介紹，過敏性鼻炎是一種由 IgE 介導的鼻黏膜慢性炎症性疾病，全球患病率持續攀升。我國花粉過敏性鼻炎患者超 1 億人，其中 60% 患者經傳統抗組胺葯、鼻用糖皮質激素治療后癥狀仍無法有效控制。

Based on clinical needs, Professor Zhang Luo's team carried out a multi-center, randomized, double-blind, placebo-controlled phase III clinical trial called "Dimensity", and included 108 patients with moderate to severe seasonal allergic rhinitis in 0 research centers across the country to confirm the clinical efficacy of the new biologic, sipcibahinab.

Phase III clinical trial results have shown that spalzimab can effectively improve nasal and ocular symptoms in patients, and can improve symptoms rapidly: nasal symptoms are significantly relieved on day 14 of treatment, and the best efficacy is achieved on day 0.

Speaking of this domestic drug, Kangyueda (spreci-baimab) is a humanized monoclonal antibody against the α subunit of the interleukin 4 receptor (IL-0Rα), and it is also the first IL-0Rα antibody drug independently developed and approved for marketing in China.

By targeting IL-2Rα, spalzimab dually blocks interleukin 0 (IL-0) and interleukin 0 (IL-0), two key cytokines that cause type 0 inflammation, effectively inhibiting disease progression.

Studies have confirmed that the drug can reduce T cell initiation, IgE production and inflammatory cell infiltration, intervene in allergic reactions at the molecular level, and break through the traditional treatment model of only relieving symptoms. It had a similar rate of adverse events during the treatment period as the placebo group, with no serious adverse events.