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北京时间2022??1日,君实生物?877.HK?88180.SH)宣布,由公司自主研发的抗PD-1单抗药物特瑞普利单抗用于治疗鼻咽癌(NPC)获得欧盟委员会(EC)授予的孤儿药资格认定,该决定基于欧洲药品管理局(EMA)的赞成意见。截至目前,特瑞普利单抗已累计获得欧盟和美国药品监管机构授予?项孤儿药资格认定,涉及黏膜黑色素瘤、鼻咽癌、软组织肉瘤、食管癌和小细胞肺癌治疗领域?/p>
君实生物首席医学官Patricia Keegan博士表示:“继美国FDA授予突破性疗法和孤儿药资格认定之后,欧盟委员会也对特瑞普利单抗用于治疗鼻咽癌授予孤儿药资格认定,这让我们备受鼓舞。鼻咽癌是一种侵袭性极强的恶性肿瘤,因其亚洲区域高发的特点,欧美国家在鼻咽癌创新疗法开发方面较为缓慢。尽管新兴的肿瘤免疫疗法已在多个瘤种当中取得了确证性的疗效,但尚未有任何免疫检查点抑制剂在欧美获批用于鼻咽癌的治疗。遵循‘立足中国,布局全球’的国际化战略,君实生物已率先将免疫疗法引入中国晚期鼻咽癌患者的治疗,期待在不远的未来,这一创新疗法也能让欧美乃至全球患者获益!?/p>
根据欧盟委员会的定义,孤儿药(Orphan Medicinal Product)被用于诊断、预防或治疗那些危及生命或者非常严重的疾病,并且患者比例不超过欧盟人口总数万分之五。欧盟《孤儿药法规》确立了孤儿药资格认定的集中审批程序,并为孤儿药的研发和上市制定了激励措施?/p>
获得孤儿药资格认定后,君实生物可从多项激励措施中获益,包括但不限于:?)获得方案协助(EMA为获得认定的孤儿药提供专门的科学建议);?)可享受药品集中审批程序(企业可直接向EMA提交上市/有条件批准申请,由此获得的欧盟委员会建议或决议在所有欧盟国家均有效);?)上市后享有10年市场独占权;(4)监管活动费用减免(涉及方案协助、上市许可申请与核查、上市后变更申请和年费)?/p>
在鼻咽癌治疗领域,君实生物已完成两项关键注册临床试验JUPITER-02(一项随机、双盲、安慰剂对照、国际多中心III期临床研究)和POLARIS-02(一项多中心、开放标签、II期临床研究),贯穿了复发/转移性鼻咽癌的一线至后线治疗。相关研究结果多次获得国际学界高度关注,曾以“重磅研究摘要”形式(#LBA2)入选美国临床肿瘤学会年会(ASCO 2021)全体大会,荣登国际顶尖期刊《自?医学?/a>杂志封面?em>Nature Medicine,影响因子:87.241),获得《临床肿瘤学杂志?/a>?em>Journal of Clinical Oncology,影响因子:50.717)在线发表?/p>
基于上述两项研究结果,特瑞普利单抗陆续受到中国和海外药品监管机构认可?021年,特瑞普利单抗的两项鼻咽癌新适应症获得国家药品监督管理局(NMPA)批准,成为全球首个获批鼻咽癌治疗的免疫检查点抑制剂。美国食品药品监督管理局(FDA)也针对其鼻咽癌适应症授?项突破性疗法认定和1项孤儿药资格认定,并于近期受理了该药物重新提交的生物制品许可申请(BLA)。如若批准,特瑞普利单抗也将成为美国首个且唯一用于鼻咽癌治疗的肿瘤免疫药物?/p>
关于鼻咽?/strong> 鼻咽癌是一种原发于鼻咽部黏膜上皮的恶性肿瘤,是常见的头颈部肿瘤之一。据世界卫生组织统计?020年全球鼻咽癌新发病例数超?3?a id="_ftnref1" href="#_ftn1">[1]
关于特瑞普利单抗注射液(拓益®?/strong>
特瑞普利单抗注射液(拓益®)作为我国批准上市的首个国产以PD-1为靶点的单抗药物,获得国家科技重大专项项目支持,并荣膺国家专利领域最高奖项“中国专利金奖”?/p>
特瑞普利单抗至今已在全球(包括中国、美国、东南亚及欧洲等地)开展了覆盖超过15个适应症的30多项由公司发起的临床研究。正在进行或已完成的关键注册临床研究在多个瘤种范围内评估特瑞普利单抗的安全性及疗效,包括肺癌、鼻咽癌、食管癌、胃癌、膀胱癌、乳腺癌、肝癌、肾癌及皮肤癌等?/p>
截至目前,特瑞普利单抗已在中国获?项适应症:用于既往接受全身系统治疗失败的不可切除或转移性黑色素瘤的治疗?018?2月);用于既往接受过二线及以上系统治疗失败的复?转移性鼻咽癌患者的治疗?021?月);用于含铂化疗失败包括新辅助或辅助化?2个月内进展的局部晚期或转移性尿路上皮癌的治疗(2021?月);联合顺铂和吉西他滨用于局部复发或转移性鼻咽癌患者的一线治疗(2021?1月);联合紫杉醇和顺铂用于不可切除局部晚?复发或远处转移性食管鳞癌患者的一线治疗(2022?月)?020?2月,特瑞普利单抗首次通过国家医保谈判,目前已?项适应症纳入?021年药品目录》,是国家医保目录中唯一用于治疗黑色素瘤和鼻咽癌的抗PD-1单抗药物。此外,特瑞普利单抗联合化疗用于一线治疗无EGFR或ALK突变的晚期非小细胞肺癌患者的新适应症上市申请目前正在接受国家药品监督管理局(NMPA)的审评?/p>
在国际化布局方面,特瑞普利单抗已在黏膜黑色素瘤、鼻咽癌、软组织肉瘤、食管癌、小细胞肺癌领域获得FDA授予2项突破性疗法认定?项快速通道认定?项优先审评认定和5项孤儿药资格认定,并在鼻咽癌领域获得欧盟委员会授予的孤儿药资格认定?022?月,FDA受理了重新提交的特瑞普利单抗联合吉西他滨/顺铂作为晚期复发或转移性鼻咽癌患者的一线治疗和单药用于复发或转移性鼻咽癌含铂治疗后的二线及以上治疗的生物制品许可申请(BLA),处方药用户付费法案(PDUFA)的目标审评日期定为2022?2?3日?/p>