复宏汉霖创新PD-1抑制剂斯鲁利单抗一线治疗鳞状非小细胞肺癌国际多中心临床试验达到主要终点,上市注册申请获NMPA受理

复宏汉霖创新PD-1抑制剂斯鲁利单抗一线治疗鳞状非小细胞肺癌国际多中心临床试验达到主要终点,上市注册申请获NMPA受理
复宏汉霖创新PD-1抑制剂斯鲁利单抗一线治疗鳞状非小细胞肺癌国际多中心临床试验达到主要终点,上市注册申请获NMPA受理

2021年9月16日,复宏汉霖(2696.HK)宣布公司自主研制的创新型PD-1抑制剂斯鲁利单抗联合化疗一线治疗局部晚期或转移性鳞状非小细胞肺癌(sqNSCLC)的上市注册申请获得国家药监局受理。此次受理主要是基于一项在既往未接受治疗的局部晚期或转移性sqNSCLC患者中开展的比较斯鲁利单抗注射液联合化疗与化疗两组间临床疗效和安全性的随机、双盲、国际多中心III期临床试验。研究数据显示,斯鲁利单抗可显著延长患者无进展生存期(PFS),显示出优异的疗效及安全性。此前斯鲁利单抗“泛癌种”治疗MSI-H实体瘤的NDA已被纳入优先审评审批程序。

斯鲁利单抗鳞状非小细胞肺癌III期临床研究主要研究者,同济大学附属上海市肺科医院肿瘤科主任、同济大学医学院肿瘤研究所所长周彩存教授表示:“这是由中国研究者牵头开展的样本量最大的sqNSCLC国际性临床研究,全球范围共入组500余名受试者。试验结果表明斯鲁利单抗已达到预设的主要研究终点,疗效和安全性得到充分验证,期待该创新抗PD-1单抗能够及早获批,为全球患者带去新的治疗选择。”


复宏汉霖高级副总裁兼首席医学官朱俊表示:“斯鲁利单抗是复宏汉霖自主研制的创新单抗产品,sqNSCLC也是公司就斯鲁利单抗申报的第二项适应症。我们以患者需求为核心,重点关注全球及中国高发癌种的临床需求,将斯鲁利单抗作为基础实施差异化开发,积极推进免疫联合疗法和国际临床研究,并将全面加速产品在肺癌和消化道肿瘤的开发和应用,为全球更多患者带去福音。”

中国为肺癌第一高发大国

斯鲁利单抗显著延长鳞状非小细胞肺癌患者PFS

据Globocan数据显示,肺癌长期占据全球肿瘤发病率和死亡率榜首,2020年肺癌约占全球癌症发病率的11.4%[1],我国约有超过81万新发肺癌病例,死因居第1位[1-2]。非小细胞肺癌约占所有肺癌的85%,其中鳞状非小细胞肺癌约有30%,多数肺癌患者确诊时已处于疾病晚期,缺乏手术治疗机会。在免疫检查点抑制剂出现前,晚期sqNSCLC治疗可选药物十分有限,多以化疗作为主要治疗手段。近年来,肿瘤免疫治疗在肺癌进展较快,PD-1抑制剂联合卡铂+白蛋白紫杉醇治疗晚期或转移性sqNSCLC一致获得国内外权威指南NCCN、CSCO等推荐,已成为一线主流治疗方案之一,然而全球范围内仍未获得普及,治疗需求亟待满足。


复宏汉霖此次开展的为一项在既往未接受治疗的局部晚期或转移性鳞状非小细胞肺癌患者中比较斯鲁利单抗注射液联合化疗与化疗两组间临床疗效和安全性的随机、双盲、国际多中心III期临床试验。研究于全球多地包括中国、欧盟波兰、俄罗斯、土耳其、乌克兰等开设研究中心,其中纳入高加索人种的比例超过30%,充分的国际临床试验数据有望支持美国、欧盟等主流法规市场的申报,也为全球性临床应用奠定基础。现有数据显示研究已达到主要研究终点,可显著延长患者无进展生存期(PFS),次要终点较对照组的客观缓解率(ORR)更高、缓解持续时间(DoR)更长,安全性良好。

以患者需求为核心,覆盖全类型肺癌一线治疗

围绕“Combo+Global”(联合治疗+国际化)差异化开发战略,斯鲁利单抗已获得中国、美国、欧盟等国家及地区的临床试验许可,目前共开展10项肿瘤免疫疗法临床试验,适应症广泛覆盖肺癌、肝细胞癌、食管癌、头颈癌和胃癌等高发大癌种,全球范围内累计入组约2300名受试者,也印证了国际市场对斯鲁利单抗质量的信心与认可。以斯鲁利单抗为基础,公司依据全球及中国癌症发病人群特点,重点聚焦肺癌和消化道肿瘤领域。以我国肿瘤发病率和死亡率榜首的肺癌为例,复宏汉霖实现了肺癌一线的全面临床布局,在鳞状非小细胞肺癌、非鳞状非小细胞肺癌和小细胞肺癌均就斯鲁利单抗开展试验,覆盖了超过90%的肺癌患者,其中两项为国际多中心Ⅲ期临床试验。凭借丰富的国际临床研究数据,复宏汉霖将不断拓展国际合作,惠及全球更多患者。

关于复宏汉霖

复宏汉霖(2696.HK)是一家国际化的创新生物制药公司,致力于为全球患者提供可负担的高品质生物药,产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域,已在中国上市3款产品,在欧盟上市1款产品,3款产品获得中国上市注册申请受理。自2010年成立以来,复宏汉霖已建成一体化生物制药平台,高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球研发中心,按照国际GMP标准进行生产和质量管控,位于上海徐汇的生产基地已获得中国和欧盟GMP认证。


复宏汉霖前瞻性布局了一个多元化、高质量的产品管线,涵盖20多种创新单克隆抗体,并全面推进基于自有抗PD-1单抗斯鲁利单抗的肿瘤免疫联合疗法。继国内首个生物类似药汉利康®(利妥昔单抗)、中国首个自主研发的中欧双批单抗药物汉曲优®(曲妥珠单抗,欧盟商品名:Zercepac®)、公司首个自身免疫疾病治疗产品汉达远®(阿达木单抗)相继获批上市,创新产品斯鲁利单抗MSI-H实体瘤的上市注册申请已纳入优先审评审批程序,HLX04贝伐珠单抗、斯鲁利单抗鳞状非小细胞肺癌适应症、HLX01利妥昔单抗类风湿关节炎新适应症的上市注册申请也正在审评中。公司亦同步就11个产品、8个联合治疗方案在全球范围内开展20多项临床试验,对外授权全面覆盖欧美主流生物药市场和众多新兴市场。

The NDA of Henlius Novel Anti-PD-1 mAb Serplulimab for First-Line Treatment of sqNSCLC Accepted by China’s NMPA, Phase 3 MRCT Met its Primary Endpoint


Shanghai, China, September 16th, 2021 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the New Drug Application (NDA) of Serplulimab Injection (HLX10), a novel anti-PD-1 monoclonal antibody (mAb) independently developed by the company, in combination with carboplatin and albumin-bound paclitaxel for first-line treatment of locally advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) has been accepted by China’s National Medical Products Administration (NMPA).


The NDA is based on the results from a randomised, double-blind, global multi-centre Phase 3 clinical trial in patients with locally advanced or metastatic squamous non-small cell lung cancer patients to compare Serplulimab Injection in combination with chemotherapy versus chemotherapy in respect of efficacy and safety. The study results demonstrated that Serplulimab can significantly extend the progression-free survival (PFS) of patients with good safety. In April 2021, the NMPA accepted and officially granted priority review for the NDA of Serplulimab Injection for the treatment of unresectable or metastatic microsatellite instability-high solid tumours that fail to respond to the standard therapy.


Prof. Caicun Zhou, the leading principal investigator and Chief of Oncology Department of Shanghai Pulmonary Hospital Affiliated to Tongji University and Director of Cancer Institute of Tongji University Medical School, said, “This is the largest sqNSCLC MRCT (Multi-Regional Clinical Trials) led by Chinese researchers, with more than 500 subjects enrolled globally. The study results demonstrated that the predefined primary study endpoint had been reached, providing evidence of safety and efficacy. This milestone takes us one step closer to bringing a much-needed treatment option to patients living with sqNSCLC. We are hoping that approval of Serplulimab comes soon.”


“Serplulimab Injection is an innovative anti-PD-1 mAb independently developed by Henlius, and sqNSCLC is its second listed indication after MSI-H,” said Mr. Jason Zhu, Chief Medical Officer and Senior Vice President of Henlius. “Underpinned by the patient-centric strategy, we focus on addressing the clinical needs of high-incidence cancers worldwide and in China. We remain committed to implementing our ‘Combo+Global’ differentiation strategy with Serplulimab as the backbone, promoting immuno-oncology combination therapies and MRCT, speeding up the development of products in lung cancer and gastrointestinal cancer, and bringing a more hopeful future to patients worldwide.”

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Up to date, 3 products have been launched in China, 1 in the European Union (EU), the New Drug Applications (NDAs) of 3 products accepted for review in China. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centres and a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (GMP).


Henlius has proactively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products 汉利康® (rituximab), the first China-developed biosimilar, 汉曲优® (trastuzumab, Zercepac® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and 汉达远® (adalimumab), the Company’s first product indicated for autoimmune diseases, the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of HLX04 (bevacizumab), HLX01 (rituximab) for the treatment of rheumatoid arthritis and serplulimab for the treatment of squamous non-small cell lung cancer are also under review. What’s more, Henlius has conducted over 20 clinical studies for 11 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.

【参考文献】

[1] Sung H,Ferlay J,Siegel RL,Laversanne M,Soerjomataram I,Jemal A,Bray F.Global cancer statistics 2020:GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries.CA Cancer J Clin.2021 Feb 4.

[2] Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021;134(7):783-791.

复宏汉霖创新PD-1抑制剂斯鲁利单抗一线治疗鳞状非小细胞肺癌国际多中心临床试验达到主要终点,上市注册申请获NMPA受理


 联系方式

媒体:PR@Henlius.com

投资者:IR@Henlius.com


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复宏汉霖创新PD-1抑制剂斯鲁利单抗一线治疗鳞状非小细胞肺癌国际多中心临床试验达到主要终点,上市注册申请获NMPA受理

复宏汉霖创新PD-1抑制剂斯鲁利单抗一线治疗鳞状非小细胞肺癌国际多中心临床试验达到主要终点,上市注册申请获NMPA受理点击这里,了解更多复宏汉霖

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