免疫性血小板减少症 （ Immune thrombocytopenia， ITP） 是一种自身免疫疾病，其特征为自身抗体介导的血小板破坏。使用 抗 CD38 单克隆抗体 ，有望通 过 对 CD38 阳性细胞 （包括浆细胞） 的靶向清除来治疗该疾病。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 2024 年 6 月 20 日， 中国医学科学院血液病医院 张磊 教授团队在国际顶尖医学期刊《 新英格兰医学杂志 》 （NEJM） 发表临床研究论文 【1】 ，这项 1/2 期临床研究显示，国产新药—— 抗 CD38 单克隆抗体 （CM313，由 康诺亚 开发） 治疗免疫性血小板减少症的安全性良好，显示出持久的疗效反应。在 研究纳 入的 22 例患者中，21 例 （95%） 在治疗期间连续两次血小板计数至少达到50× 10 9 /L，出血患者比例从基线的 68% 分别下降到第 8 周的 5% 和第 24 周 的 10%，而且长期缓解率高达 60% 以上。 值得一提的是，这是《 新英格兰医学杂志 》 （NEJM） 首次发表 中国原创新药 的 1/2 期临床试验结果。 2025 年 5 月 29 日， 张磊 教授团队 （ 孙婷 ...

Core Insights - The article discusses the challenges faced by patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and seasonal allergic rhinitis (SAR), highlighting the limitations of traditional treatments and the emergence of innovative therapies like Dupilumab [1][2][3] Group 1: Patient Challenges - Many patients with CRSwNP and SAR experience inadequate treatment outcomes, with about 50% of CRSwNP patients facing recurrence of symptoms despite standardized medical and surgical interventions [1] - A significant percentage of patients with moderate to severe SAR do not achieve effective symptom control even when using potent nasal corticosteroids and antihistamines [1][3] Group 2: Innovative Treatment Development - The approval of Supilumab (康悦达) by the National Medical Products Administration (NMPA) for CRSwNP in December 2024 marks a significant advancement in treatment options [2] - Supilumab is the first IL-4Rα biological agent approved for SAR, expanding its therapeutic applications [2][3] Group 3: Clinical Efficacy - In clinical trials, Supilumab demonstrated significant efficacy, with 72% of patients showing notable reduction in nasal polyps within two weeks of treatment, and 81% achieving at least a 50% reduction by 24 weeks [3][4] - For SAR, 52% of patients achieved nasal airflow within four days of treatment, and 84% reported mild or no nasal symptoms after four weeks [4] Group 4: Market Potential - The global market for IL-4Rα-targeted drugs is projected to grow significantly, with estimates reaching $12.2 billion by 2024 and $28.7 billion by 2030, reflecting a compound annual growth rate of 15.2% [5] - The competitive landscape is evolving, with domestic companies like 康诺亚 gaining traction in the IL-4Rα drug market, challenging established players [5][6] Group 5: Future Directions - 康诺亚 is actively exploring additional indications for Supilumab, including adolescent atopic dermatitis and nodular prurigo, aiming to address unmet clinical needs and reduce treatment costs [9][11] - The company is also developing a diverse pipeline of therapies, including second-generation bispecific antibodies and ADCs, to enhance treatment options for various diseases [10][11]