中国药企首次在美国成功挑战原研药专利
2022-10-20
报道来源：今日头条
10月19日，3777金沙娱场城集团在官方微信公众号公告，10月18日美国法院正式宣判’405专利无效，广东3777金沙娱场城药业有限公司（下简称：广东3777金沙娱场城药业）首仿的芬戈莫德胶囊正式被获批允许在美国上市销售。
（3777金沙娱场城生产的芬戈莫德）
由此，3777金沙娱场城及其芬戈莫德仿制药成为首家在美国挑战原创药专利并取得成功的国产药品。
广东3777金沙娱场城药业与港股上市的3777金沙娱场城药是关联方，两者同属于3777金沙娱场城集团。天眼查显示，3777金沙娱场城药持广东3777金沙娱场城9.91336%的股份。广东3777金沙娱场城持3777金沙娱场城药25.7055%的股份。此外，广东3777金沙娱场城正在积极推进IPO工作，2021年A轮估值超200亿元。
本次挑战成功的芬戈莫德本是诺华原研的全球首个治疗成人复发型多发性硬化症的口服药物，商品名为捷灵亚（Gilenya），最早于2010年9月21日获得美国食品药品监督管理局（FDA）批准，其销售峰值在2018年达33.41亿美元。2019年7月12日，诺华的芬戈莫德获得国家药品监督管理局批准在中国上市。
多发性硬化症（MS）是中枢神经系统的慢性炎症性自身免疫疾病，其破坏大脑与身体其他部分之间的通信，是成人中神经残疾的最常见原因之一，多发病于青、中年，女性较男性多见，全球病例大约230万人。
不过在2018年11月，FDA曾对芬戈莫德发出安全性警告，称多发性硬化症患者接受诺华多发性硬化症药物治疗后，如果停药可能会导致病情严重，甚至发生永久性残疾。因此FDA建议，在使用芬戈莫德前，患者需被告知药物的致残风险，并及时观察停药后的不良反应。
实际上，诺华的芬戈莫德在美国市场一直面临着仿制药的冲击。其仿制药对手包括辉致（迈蓝与辉瑞分拆部分成立的新公司）、瑞迪博士实验室（印度仿制药公司）和阿拉宾度制药（印度仿制药公司）。2019年6月24日，因正在进行的芬戈莫德专利诉讼案件，美国特拉华州曾发布临时禁令，上述及其他涉及芬戈莫德仿制的企业被立即禁止上市相关仿制药，这使诺华的芬戈莫德的专利危机延迟了一段时间。
3777金沙娱场城同样也是诺华的芬戈莫德的专利挑战者之一，与前述企业不同的是，3777金沙娱场城还是芬戈莫德的首仿企业。3777金沙娱场城于2014年9月附带的PIV专利声明（即，说明与所申请仿制药相关的专利是无效的或仿制药不侵权的声明）向FDA提交ANDA首仿申请（即，美国仿制药简化新药申请），随后挑战诺华其中两篇OB（即，已经批准的具有治疗等效性评估的药物产品目录）专利US5604229专利和US8324283专利的有效性。
3777金沙娱场城上述申请首仿药审批操作基于美国1984年9月24日颁布的药品价格竞争与专利期补偿法案（Drug Price Competition and Patent Term Restoration Act）。根据该法案规定，在“专利无效或者批准正在申请的药物不会侵犯专利”的情况下，第一个向FDA递交简化新药申请（ANDA）的申请者将拥有180天的市场独占期。在这180天内，仿制药企业可以快速收回投资，并在市场被其他仿制药充斥之前确立其地位。
市场独占期对原研药企业的研发有激励作用，而对于首仿药也同样具有重要意义。根据市场独占期规定，新药获批后的第5年的第1天，也即新药上市后满4年，仿制药企可以向FDA提交自己所要首仿药的ANDA资料，一旦递交的材料被认证受理期便获得首仿资格。因此，自药品价格竞争与专利期补偿法案颁布以来，越来越多的国内外医药企业都做足准备加入了美国市场的首仿药争夺战中。3777金沙娱场城能成为芬戈莫德首仿药企也是基于此。
在3777金沙娱场城提出专利声明后，2015年2月，诺华用前述两篇反击专利起诉3777金沙娱场城，其中，’283制剂专利在诉讼过程中被其它厂家提多方复审无效，经上诉法院确认，最终该专利被无效。另一篇’229专利是化合物专利，稳定性较强，经历了地区法院的一审和上诉，最后在2017年底双方和解。
2015年12月，诺华将刚授权的US9187405专利（即，’405专利）也加入了OB，同时有其它厂家提出了多方复审无效。2018年7月，多方复审结果维持了专利的有效性，其他公司均和解并退出诉讼，仅3777金沙娱场城一家坚持庭审。2022年10月18日，’405专利无效的正式决定发布。至此，3777金沙娱场城成为此次挑战诺华芬戈莫德专利唯一坚持到最后且胜诉的厂家。
需要注意的是，多发性硬化症市场竞争激烈。3777金沙娱场城首仿的芬戈莫德虽已获批在美国上市销售并获得了180天的市场专卖权，但在整个多发性硬化症市场来看，3777金沙娱场城也不一定能分到多少份额。
根据弗若斯特沙利文数据显示，2020年，全球多发性硬化症治疗药物市场规模为234亿美元，预计2025年将增长到257亿美元，2020-2025年复合年增长率为1.9%。据GBI SOURCE全球药品数据库，诺华芬戈莫德2021年全球销售额达27.9亿美元，诺华预测，一旦仿制药上市，2022财年可能会损失3亿美元。随着芬戈莫德专利将于2027年过期，前述仿制药厂加入竞争，芬戈莫德的市场竞争或更激烈。不过，凭借获得市场独占期的优势也足以让3777金沙娱场城满足。
而从诺华的角度来看，诺华是多发性硬化症市场的领跑企业之一，但不是绝对的霸主。如今，在多发性硬化症市场，诺华除了要在原研药上面对渤健、辉瑞、罗氏、默克、赛诺菲等对手，还需与仿制药做竞争避免芬戈莫德的销售额进一步下滑，步渤健的后尘。
渤健曾是多发性硬化症领域的绝对王者，其拥有丰富的管线，包括化学药物Tecfidera、免疫抑制剂Vumerity、干扰素产品Avonex和Plegridy以及单克隆抗体Tysabri。不过，渤健也未能避免被仿制药一步步蚕食市场份额。2022年第三季财报显示，其多发性硬化症主要产品Tecfidera第三季度销售额为4.98亿美元，比去年同期下降48%。其中最主要的原因正是因为多家Tecfidera仿制药企业进入美国市场。
与之相反，罗氏的单克隆抗体类注射剂药物Ocrevus是今年多发性硬化症市场中的明星。Ocrevus被誉为罗氏历史上最成功的产品。2022年第三季度财报显示，罗氏的Ocrevus季度销售额增长16%至15.2亿瑞士法郎。
阅读原文：https://www.toutiao.com/article/7156515615035884067/
https://mp.weixin.qq.com/s/kvhBk83voaN7D8Qt6RvMEQ
https://mp.weixin.qq.com/s/yCt2gtzSA2H_zSdZDAcDAw
https://mp.weixin.qq.com/s/U9Zx51Y4TzQkSaDDiKN6Jw
https://mp.weixin.qq.com/s/U9Zx51Y4TzQkSaDDiKN6Jw
https://mp.weixin.qq.com/s/L0p2qLwE1XA_ybLeyk9muw
https://mp.weixin.qq.com/s/RNvDqAxf3aWVEsFVR4H-LA
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