跨国药企创新药率先在华获批上市，造福罕见皮肤病患者
中新网上海3月6日电 (记者 陈静) 记者6日获悉，罕见皮肤病创新靶向生物制剂圣利卓®家族皮下注射制剂(通用名：佩索利单抗)获得中国国家药品监督管理局批准上市，成为跨国药企中首个全球多中心同步研发并率先在华获批的全球创新药，早于美国、欧盟和日本。
圣利卓®家族皮下注射制剂用于治疗中重度斑块型银屑病、活动性银屑病关节炎、活动性强直性脊柱炎和活动性克罗恩病。该药的获批上市，为中国12岁及以上泛发性脓疱型银屑病(GPP)患者带来了新的治疗选择。
GPP是一种罕见的、慢性、复发性、严重炎症性皮肤病，其特点是反复发作的无菌性脓疱，伴有发热、畏寒、关节痛等全身症状。GPP的治疗一直是临床上的难题，目前尚无明确的治愈方法。
圣利卓®家族皮下注射制剂是一种靶向白介素-17A(IL-17A)的单克隆抗体，通过抑制IL-17A信号通路，从而达到抑制炎症反应、改善皮肤症状和关节疼痛的目的。
临床试验数据显示，圣利卓®家族皮下注射制剂在治疗GPP患者方面具有良好的疗效和安全性。在关键性III期临床试验中，接受圣利卓®治疗的患者在第12周时，脓疱面积和脓疱数明显减少，皮损面积和严重程度评分显著改善，且安全性良好。
圣利卓®家族皮下注射制剂的获批上市，填补了中国GPP治疗领域的空白，为患者提供了新的治疗选择，同时也为中国罕见病药物研发和创新提供了新的范例。
英语如下：
**Headline: China Approves World’s First Innovative Drug, Benefiting Patientswith Rare Skin Disease**
**Keywords: Innovative drug, China approval, rare disease**
**News Content:**
Shanghai, March 6 (China NewsService) – The innovative targeted biological agent Cosentyx® (generic name: secukinumab) subcutaneous injection for rare skin diseases has been approved for marketing by China’s National Medical Products Administration (NMPA). It is the first innovative drug developed synchronously in multiple centers worldwide and approved in China by a multinational pharmaceuticalcompany, ahead of the United States, the European Union, and Japan.
Cosentyx® subcutaneous injection is used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, active ankylosing spondylitis, and active Crohn’s disease. Its approval provides a new treatment option for Chinese patients aged 12 and above with generalized pustular psoriasis (GPP).
GPP is a rare, chronic, recurrent, and severe inflammatory skin disease characterized by recurrent sterile pustules accompanied by systemic symptoms such as fever, chills, and joint pain. The treatment of GPP has been a clinical challenge, and there is currently noclear cure.
Cosentyx® subcutaneous injection is a monoclonal antibody targeting interleukin-17A (IL-17A), which inhibits the IL-17A signaling pathway, thereby suppressing inflammatory reactions and improving skin symptoms and joint pain.
Clinical trial data show that Cosentyx® subcutaneous injection has good efficacy and safety in treating GPP patients. In a pivotal Phase III clinical trial, patients treated with Cosentyx® showed a significant reduction in pustule area and pustule count at week 12, a significant improvement in lesion area and severity score, and good safety.
The approval of Cosentyx® subcutaneous injection fills a gap in the treatment of GPP in China, providing patients with a new treatment option and setting a new example for the research and development of innovative drugs for rare diseases in China.
【来源】http://www.chinanews.com/sh/2024/03-06/10175498.shtml
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