3年迎来4款生物药!复宏汉霖贝伐珠单抗汉贝泰®获批!

年迎来4款生物药!复宏汉霖贝伐珠单抗汉贝泰®获批!"


2021年12月3日,复宏汉霖(2696.HK)宣布,公司自主研制的贝伐珠单抗注射液汉贝泰®上市注册申请(NDA)获得国家药品监督管理局(NMPA)批准,用于治疗:1)转移性结直肠癌;2)晚期、转移性或复发性非小细胞肺癌。汉贝泰®是公司第四款获批上市的产品,此前,利妥昔单抗汉利康®、曲妥珠单抗汉曲优®(欧盟商品名:Zercepac®)以及阿达木单抗汉达远®已成功上市,覆盖血液肿瘤、实体瘤、自身免疫疾病等领域,公司商业化产品管线日渐丰富。


 年迎来4款生物药!复宏汉霖贝伐珠单抗汉贝泰®获批!"


复宏汉霖董事长、执行董事兼首席执行官张文杰表示:

很高兴复宏汉霖第四款产品获得上市批准,该产品的成功获批离不开所有参与该项目临床研究的医护人员、患者及各级药监机构、主管部门给予的大力支持。复宏汉霖将在最大化生物类似药价值的同时,积极拓展该药与自有创新免疫治疗产品如斯鲁利单抗的联合用药,快速推进临床进展,向更具创新能力的全球化生物制药企业迈进,造福全球病患。


 年迎来4款生物药!复宏汉霖贝伐珠单抗汉贝泰®获批!"


复宏汉霖总裁朱俊先生表示:

肺癌和结直肠癌分别位列全球癌症高发第二、三位,在中国更是位居第一和第二位,存在巨大的治疗需求。汉贝泰®与原研的相似性比对研究显示出疗效及安全性与原研高度相似,相信该产品获批上市将进一步提升贝伐珠单抗的可及性,为肺癌、结直肠癌患者提供新的优质用药选择。


年迎来4款生物药!复宏汉霖贝伐珠单抗汉贝泰®获批!"


完整证据链支持汉贝泰®与原研无临床差异,未满足临床需求巨大


汉贝泰®是复宏汉霖按照《生物类似药研发与评价技术指导原则(试行)》自主开发的生物类似药,获得“十二五”、“十三五”国家科技重大专项(重大新药创制)立项支持。此次产品获批主要基于一系列研究数据,包括药学比对研究、非临床比对研究、临床比对研究。区别于目前国内已上市的贝伐珠单抗生物类似药,汉贝泰®在临床安全有效性III期比对研究上选择了转移性结直肠癌适应症,成为国内目前唯一拥有转移性结直肠癌III期临床数据的贝伐珠单抗生物类似药,为贝伐珠单抗在中国结直肠癌患者人群中的应用积累了更多临床证据与经验。该研究的详细数据在第23届全国临床肿瘤学大会暨2020年CSCO学术年会以口头报告形式首次发布,并获评优秀论文,随后于国际知名期刊BioDrugs正式刊出。汉贝泰® I期临床研究结果也已于Cancer Chemotherapy and Pharmacology发表。


据GLOBOCAN数据显示,肺癌是全球发病率第二大高发癌种,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,位居肿瘤发病率和死亡率榜首[2]。其中,非小细胞肺癌是肺癌中最常见的类型,占所有肺癌患者达80%-85%[3]。结直肠癌为我国第二高发的恶性肿瘤,发病率仅次于肺癌。2020年我国新增结直肠癌病例55.5万人[2]。研究表明,在传统化疗方案基础上联合贝伐珠单抗,可显著延缓晚期结直肠癌患者的疾病进展,延长生存期,是目前晚期结直肠癌的主要治疗方案之一。


该药通过特异性结合血管内皮生长因子(vascular endothelial growth factor, VEGF),阻断VEGF与其受体结合,抑制肿瘤新生血管的形成,防止肿瘤生长和扩散[4]。原研贝伐珠单抗在国内获批的适应症包括结直肠癌、肺癌、胶质母细胞瘤、肝细胞癌、卵巢癌和宫颈癌,并在全球范围内获批肾细胞癌、乳腺癌等多种实体瘤。由于药物可及性等原因,贝伐珠单抗的临床用药需求仍未得满足。复宏汉霖将继续拓展其他适应症的申报上市,惠及更多患者。


持续探索更多疗法


基于贝伐珠单抗在广谱抗肿瘤领域的优势,复宏汉霖正积极探索汉贝泰®联合公司核心免疫治疗产品斯鲁利单抗(创新抗PD-1单抗)在肿瘤免疫联合疗法的研究。目前,斯鲁利单抗联合汉贝泰®已在一线非鳞状非小细胞肺癌、一线结直肠癌均开展临床试验,非鳞状非小细胞肺癌处于关键III期临床阶段,在结直肠癌的II期临床研究也同步推进中。通过公司持续探索,希望使癌症患者及早获得肿瘤免疫联合治疗,进一步延缓患者的疾病进展,改善生存现状。


复宏汉霖在汉贝泰®的基础上,根据眼科用药的需求对该药处方、规格和生产工艺进行优化,开发活性成份不变的新的眼科制剂产品HLX04-O(重组抗VEGF人源化单克隆抗体注射液),拟用于治疗眼科疾病湿性年龄相关性黄斑变性(wAMD)的治疗。2021年上半年,HLX04-O陆续于澳大利亚,美国,拉脱维亚、匈牙利、西班牙等欧盟国家及新加坡获批开展III期临床试验,国际多中心临床试验将加速推进。此外,HLX04-O用于wAMD治疗的III期临床研究亦于中国完成首例患者给药。


未来,复宏汉霖将持续践行“可负担的创新,值得信赖的品质”的核心理念,积极推动更多高品质生物药的研发与商业化,持续丰富创新靶点布局,并积极开展双特异性抗体、抗体偶联药物(ADC)等产品的开发,为全球患者带去高质量、可负担的创新治疗方案。


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4款产品,在欧盟上市1款产品,3个产品上市注册申请获得中国药监局受理。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,按照国际药品生产质量管理规范(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®)、汉达远®(阿达木单抗)和汉贝泰®(贝伐珠单抗)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,HLX01利妥昔单抗类风湿关节炎新适应症、斯鲁利单抗鳞状非小细胞肺癌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个免疫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。



Henlius’ 4th Biologics: Bevacizumab Biosimilar 汉贝泰® Approved by National Medical Products Administration


Shanghai, China, 3rd December, 2021Shanghai Henlius Biotech, Inc. (2696.HK) announced that bevacizumab biosimilar 汉贝泰®, developed and manufactured by Henlius independently, has been approved by the National Medical Products Administration (NMPA). It is indicated for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). 汉贝泰® is the company’s fourth monoclonal antibody (mAb) approved in China, following rituximab biosimilar 汉利康, trastuzumab biosimilar 汉曲优 (Zercepac in the EU), and adalimumab biosimilar 汉达远. The pipeline has been further replenished with widened indication coverage including hematological malignancies, solid tumors, auto-immune diseases, etc.


Mr. Wenjie Zhang, Chairman, Executive Director, and CEO of Henlius, said, “We are excited to have 汉贝泰® get approved as our fourth product. The credit goes to all the healthcare professionals, patients and regulatory authorities that have contributed to the studies of 汉贝泰®. While maximizing the value of biosimilar drugs, we will continue advancing the clinical trial process of its combination with in-house immunotherapy products, such as serplulimab, and growing into a more innovative global biopharmaceutical company.”


Mr. Jason Zhu, President of Henlius, said, “Lung cancer and colorectal cancer are ranked second and third with high incidence of cancers in the world, respectively. They are also ranked first and second in China, and there is a huge demand for treatment. The similarity studies showed no statistically significant difference in efficacy, and the safety are highly similar to the originator. It is believed that the approval of 汉贝泰® will further improve the accessibility of bevacizumab and provide a high-quality option for patients with lung cancer and colorectal cancer.”


Study showed 汉贝泰® is highly similar to the originator, addressing significant unmet clinical needs


汉贝泰® was developed in accordance with the NMPA Technical Guidelines for the Development and Evaluation of Biosimilars (Tentative), and has received support from National Science and Technology Major Project in the 12th & 13th Five-Year Plans of China-Major New Drug Research & Development Project. The approval is mainly supported by a series of study data, including comparative pharmaceutical quality studies, comparative non-clinical studies, comparative clinical studies. Different from approved bevacizumab biosimilars in China, the Phase 3 study of 汉贝泰® was conducted among Chinese patients with metastatic colorectal cancer (CRC), which helps to accumulate more clinical evidence and experience of bevacizumab in this patient population. The relevant Phase 3 clinical studies were published at the 23rd annual conference of Chinese Society of Clinical Oncology (CSCO) for the first time and awarded an “outstanding study paper”. And then the Phase 3 results were published on the world-renowned journal BioDrugs. The Phase 1 clinical study results were also published on Cancer Chemotherapy and Pharmacology.


According to GLOBOCAN data, lung cancer (LC) is the second commonly diagnosed cancer globally and accounts for 11.4% of the global cancer incidence in 2020[1]. It is estimated that 810,000 people are diagnosed with LC in China, and LC is the first leading cause of cancer incidence and mortality[2]. NSCLC is the most common type of LC, accounting for 80%-85%[3]. The incidence rate of CRC ranks second among all malignant tumours in China, with over 550,000 new cases in 2020[2]. Clinical studies showed that adding bevacizumab to traditional chemotherapies can significantly delay disease progression and prolong survival for patients with mCRC and is one of the standards of care for advanced CRC.


By specific binding with vascular endothelial growth factor (VEGF), 汉贝泰® can block the interaction between VEGF and its receptors. This will inhibit tumour angiogenesis, which is essential for the growth and metastases of tumour[4]. The originator has been approved for CRC, LC, glioblastoma, hepatocellular carcinoma (HCC), ovarian cancer, cervical cancer in China. For global the indications also include renal cell carcinoma and breast cancer, and so on. However, there are still significant unmet needs due to drug accessibility in China. Going beyond, Henlius will explore more indications to benefit more patients.


Exploring more therapies


Building upon the advantages in the field of broad-spectrum anti-tumour of bevacizumab, Henlius is actively developing combo therapies of 汉贝泰® and its anti-PD-1 mAb serplulimab for the treatment of various solid tumours. Clinical studies of this combo have been conducted in first-line nsNSCLC and first-line CRC. The first-line nsNSCLC study has entered the pivotal Phase 3 stage. The CRC Phase 2 clinical trial is on track. With the continuous exploration, Henlius aims to benefit patients with immuno-oncology mAbs combination therapies as early as possible, further delaying the disease progression and improving the survival status of patients with mCRC.


According to the requirements of ophthalmic drugs, Henlius is also developing a new ophthalmic preparation product, HLX04-O (recombinant anti-VEGF humanised monoclonal antibody injection), based on 汉贝泰®, through optimizing the prescription, specifications and production processes of 汉贝泰®, with active ingredients remaining unchanged. It is intended to be used for the treatment of wet age-related macular degeneration (wAMD). In the first half of 2021, HLX04-O has been approved to carry out Phase 3 clinical trials in Australia, the United States, Singapore, and EU countries such as Latvia, Hungary and Spain. In addition, the first patient was dosed in a HLX04-O Phase 3 clinical trial in China for the treatment of wAMD.


Looking forward, with its core values of “Affordable Innovation, Reliable Quality”, Henlius is actively accelerating the R&D and commercialisation of more biologics and enriching innovative target layouts. What’s more, the company will continue developing a forward-looking presence in bispecific antibodies and antibody-drug conjugates (ADC), and bringing more high-quality and affordable therapies 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, 4 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 pro-actively 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, 汉达远® (adalimumab) and 汉贝泰® (bevacizumab), the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDAs of 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.

[3] 蕾,魏素菊.KRAS突变的非小细胞肺癌的研究进展.中国肺癌杂志[J].2018.

[4] Kazazi-Hyseni F, Beijnen JH, Schellens JH. Bevacizumab. Oncologist. 2010;15(8):819‐825.

联系方式

媒体:PR@Henlius.com

投资者:IR@Henlius.com


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年迎来4款生物药!复宏汉霖贝伐珠单抗汉贝泰®获批!"

年迎来4款生物药!复宏汉霖贝伐珠单抗汉贝泰®获批!"

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