On October 17, 2025, China's National Medical Products Administration officially approved Chengdu Kelun Pharmaceutical's self-developed chemical drug "Rotigotine Patch" for market launch. As the world's first transdermal patch for Parkinson's disease treatment, this product fills a gap in domestic generic drugs, marking a critical step in China's neurogenerative disease research.
2025年10月17日,国家药品监督管理局正式批准成都科伦药业自主研发的化学药品“罗替高汀贴片”上市。这款全球首个透皮贴剂型帕金森病治疗药物,填补了国内仿制药空白,标志着我国在神经退行性疾病领域迈出关键一步。
According to the "China Parkinson's Disease Report 2025," China has over 5 million patients, accounting for 43.14% of global cases, with male incidence notably higher. The domestic market now exceeds 9.6 billion yuan annually, yet traditional oral medications suffer from unstable blood concentration and severe gastrointestinal side effects, creating urgent demand for innovative delivery methods.
据《中国帕金森病报告2025》显示,我国帕金森患者超500万,占全球病例43.14%,且男性发病率显著高于女性。当前国内市场年规模达96.16亿元,但传统口服药物存在血药浓度波动、胃肠道副作用大等痛点,患者对新型给药方式需求迫切。
As a non-ergot dopamine receptor agonist, the rotigotine patch achieves stable 24-hour blood concentration through once-daily transdermal administration. Clinical trials show a 60% reduction in "on-off" phenomena (sudden symptom worsening) and end-dose effects, particularly benefiting patients with dysphagia or cognitive impairment. Global sales reached $330 million in 2024.
罗替高汀贴片作为非麦角类多巴胺受体激动剂,通过每日一次的透皮给药,可稳定维持24小时血药浓度。临床试验表明,其能减少60%的“开关”现象(症状突然加重)与剂末效应,尤其适配吞咽困难或认知障碍患者。2024年该品种全球销售额达3.3亿美元。
This approval leverages Chengdu Tianfu International Bio-Town's ecosystem. The park hosts over 3,900 biopharmaceutical firms, forming a complete industrial chain from medical isotope supply to nuclear medicine hospitals. In 2024, Kinnora Biotech's IL-4Rα antibody drug achieved a "0-to-1" breakthrough here, demonstrating the park's full-cycle incubation capabilities.
此次获批依托成都天府国际生物城的产业生态。该园区已聚集3900余家生物医药企业,形成从医用同位素供应到核医疗专科医院的完整产业链。2024年康诺亚生物的IL-4Rα抗体药物在此实现“0到1”突破,凸显园区全周期孵化能力。
Chengdu's Regend Therapeutics is advancing cutting-edge therapies with its NouvNeu001 injection—the world's first iPSC-derived Parkinson's treatment—now in Phase II trials across Beijing, Anhui, and other regions. This technology replaces damaged neurons with transplanted dopamine cells, receiving dual approval from China and the U.S. in 2024, with a 360,000-dose/year factory operational.
成都睿健医药同步推进前沿疗法,其全球首个诱导多能干细胞(iPSC)衍生帕金森疗法NouvNeu001注射液,已在北京、安徽等地启动II期临床试验。该技术通过移植多巴胺神经元替代坏死细胞,2024年获中美双批临床,年产36万剂的超级工厂已投产。
Chengdu's biopharmaceutical cluster is reshaping the industry landscape. Tianfu International Bio-Town ranks among China's top three in competitiveness, nurturing 10 local listed firms including Kinnora and Betta Pharmaceuticals. With rotigotine patch mass production, it aims to capture 30% of China's Parkinson's market within three years while accelerating globalization through FDA certification, offering Chinese solutions worldwide.
成都生物医药集群正重塑产业格局。天府国际生物城综合竞争力位居全国前三,培育出康诺亚、倍特药业等10家本土上市公司。随着罗替高汀贴片量产,预计三年内将覆盖国内30%帕金森市场,同时通过FDA认证加速国际化,为全球患者提供中国方案。