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康诺亚(2162.HK):销售表现亮眼 创新研发稳步推进
Ge Long Hui· 2025-09-03 18:57
投资要点 根据公司公告,公司核心管线产品司普奇拜单抗(商品名:康悦达,IL-4Rα抗体)成人中重度特应性皮 炎(AD)、慢性鼻窦炎伴鼻息肉(CRSwNP)和季节性过敏性鼻炎(SAR)三项适应症已获批上市, 25H1收入约1.69 亿元。 司普奇拜单抗销售商业化顺利,看好大单品长期放量。司普奇拜单抗的三项成人适应症中重度AD、 CRSwNP 和SAR 分别于2024 年9 月/12 月和2025 年1 月获批。考虑到竞争压力下公司产品定价受到影 响,我们认为25H1 司普奇拜单抗销售业绩符合预期。一方面得益于公司商业化团队拓展出色,另一方 面也反映国内在皮肤科和呼吸科仍存在庞大的患者需求亟待满足。公司的司普奇拜单抗系国产首个,全 球唯二的获批上市的IL-4Rα抗体药物,从竞争格局来看,预计后发者会落后1-2 年左右的时间获批上 市。同时公司的注射笔已在审评中,青少年中重度AD 和结节性痒疹预计在2026 H1 进行NDA,进一步 惠及皮肤科的患者人群,增厚自身壁垒。鼻科角度来看,司普奇拜单抗填补了国内CRSwNP 和SAR 的 生物制剂的治疗空白,有望重塑治疗格局。综上,我们看好公司司普奇拜单抗在皮肤科和鼻科惠 ...
IL-4Rα靶点的“中国答案”:重塑治疗格局,引领鼻科治疗进入生物制剂新时代
2 1 Shi Ji Jing Ji Bao Dao· 2025-05-28 07:50
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]