复宏汉霖与Intas深化合作，携手护航H药扬帆欧洲、印度市场

发布时间:2023-10-27 东西來发源： 浏览量：

资源源于：复宏汉霖


  • H药 汉斯状®（斯鲁利单抗）对外授权覆盖美国、欧洲、东南亚、中东和北非、印度；

  • Intas拿到H药在欧州和伊朗的独门开发设计和业务地产化的权益，复宏汉霖将拿到4200万美元贷款款、能达到1.44亿美元的监督管理和业务地产化里程表碑支付及及两名数数量的进行合作区域内纯成本 特许经营权适用费。


2023年10月27日，复宏汉霖（2696.HK）宣布与Intas Pharmaceuticals Limited （以下简称“Intas”）达成合作，授予其在欧洲和印度对复宏汉霖自主开发的抗PD-1单抗 H药 汉斯状®（斯鲁利单抗）包括广泛期小细胞肺癌（ES-SCLC）在内的多项适应症及特定剂型进行独家开发和商业化的权利。复宏汉霖已于2018年6月与Intas子公司Accord展开合作，授予其汉曲优®在欧洲、部分中东及北非地区、部分独联体国家的独家商业化权利，并于2021年进一步授予Intas汉曲优®在美国及加拿大地区的独家开发与商业化权利。

我院加盟这不仅标志的意思着多家企业期间的方式夥伴密切关系进1步深入开展，更加H药中国布置图开启新的篇章的发展进步商机。随着商议，复宏汉霖将开展H药在德国和来自的临床实践开发建设及市场销售后的的产品制作和制造，并将从我院的交易中领取4200万英镑的分期支付帐、能达41000万英镑的系统化里程数数碑支付、能达3亿英镑的商业圈化里程数数碑支付及两个数分配比例的加盟城市纯毛利润加盟权操作费。


复宏汉霖实施力董事局、顶尖总裁实施力官兼顶尖总裁钱财官 朱俊工程师

用优质的见效和信息安全性能，H药加入了高度排名首届获准闽东南制疗小细胞系1.肺癌的抗PD-1单抗，现阶段在中已获准4项不适应症，受益逾4数十万中我们都，其澳大利亚经济共同体的退市许可证报考也于2019三月兑换澳大利亚货品管理制度局 (EMA) 审理。顺利通过与Intas进三步深化体制改革合伙，我们都期待快速积极推动H药在高度排名面积内控制更大范围的可及性，为改善功能地区我们都的治见功能和求生存安全性能贡献者勇气。


复宏汉霖中高级副首席总裁总裁裁兼首席总裁商务接待壮大官 曹平女仕

复宏汉霖和Intas子公司Accord于2018年达成合作。五年来，我们紧密协作，持续推动汉曲优®全球布局，使其成功在海外40多个国家和地区获批，惠及欧洲、中东和北非等地区患者。在汉曲优®成功合作的基础上，我们期待与Intas一起加速H药在欧洲和印度市场上市进程，延续并深化我们共同的愿景和承诺，向全球患者提供高品质、可负担的创新生物药。




Intas副董事局会成员长兼董事局会成员总先生

Binish Chudgar工程师

 “我们大家很快乐也能与复宏汉霖增加持久合作共赢合作伙伴密切关系。我院合作的将进步骤多Intas的世界十大最大癌肿产品的地埋管，贱行咱们在世界十大最大规模内出示多元化带动很好解决规划的约定。确保斯鲁利单抗在欧洲国家和印尼成功上市不是我们升级较为先进微生物药可及性的很重要取得成效，辅助中国更加客户实现有效、优线质量的开展。




Accord西方东南亚和北非地段连接总经理裁

Paul Tredwell男士

尤其高兴英文推进改革与复宏汉霖的配合合作伙伴相互影响。何时在另一方企业合作空间新批的斯鲁利单抗，还有机会进1步牢固Accord在特药前沿技术的一把手者位置，并是因为着，短短的三年大家即还有机会还推出第2款得票率信息化药，且也能与大家在该地产生总额达到了25%的放疗化疗口服药型成‘结合拳’。一些体现出了大家对科技创新和增速的保障，也充分体现了大家强院提生中药可及性、促活更多的人，令其收货对于使用价值的控制的任务担当作为。

H药 汉斯状®为复宏汉霖自主研发的重组人源化抗PD-1单抗注射液，自2022年3月获批上市以来，H药已在中国获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌。凭借突破性疗效和差异化优势，H药展现出了强大的市场竞争力，获得了业内广泛认可，其多项关键性临床研究结果发表于JAMA、Nature Medicine等国际知名期刊。复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，在全球同步开展十余项肿瘤免疫联合疗法临床试验，广泛覆盖肺癌、食管癌和胃癌等适应症，累计入组患者超3600人，其中2项国际多中心临床试验入组白人的比例超过30%，充分的国际临床试验数据有望支持海外市场的申报，也为全球性临床应用奠定基础。 


202五年，H药制疗SCLC依次赢得芬兰肉制品和otc医疗耗材督查的监管局（FDA）和国外联盟委会会（EC）授勋的遗孤药员证申报纳税，有助H药在芬兰和国外的新产品开发、注册会员及行业化等问题拥有千万的证策能够。H药带兵人制疗ES-SCLC的国外联盟出现同意使用（MAA）己经202五年6月赢得国外otc医疗耗材的监管局 (EMA) 立案，有机会于2021年上一段时间赢得许可。因此，品牌有序深化深化H药可比性带兵人基准制疗阿替利珠单抗中用制疗ES-SCLC的头对头芬兰桥接可靠性试验，以进一歩能够H药在芬兰的出现申报纳税。


与此同一，复宏汉霖全速积极推进H药在国际茶叶餐饮市场的房地产业化流程。已经，子有限公司已与PT Kalbe Genexine Biologics（KGbio）获得协议范本协议范本，颁授其H药在东盟自由贸易区十国和东南方亚和北非东北部12国内的的的独家首发的开发技术和房地产业化机会。除此外，复宏汉霖与银河集团官网 健康安全就H药获得法国茶叶餐饮市场房地产业化协议范本。截止日期现下，H药境内外代理权已重叠面法国、南美洲、东南方亚、东南方亚和北非、印度尼西亚等国内的的和东北部。未来的发展，子有限公司将风雨同舟很多的协议范本同伴全力以赴持续推进H药的世界十大的开发技术流程，令H药都可以重叠面更具有广性的国内的的和东北部，为多人群作为更具有广性的开展挑选。

关于H药 汉斯状®

H药 汉斯状®为重组人源化抗PD-1单抗注射液（通用名：斯鲁利单抗注射液），是全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，目前已有4项适应症获批上市，1项适应症上市申请在欧盟获受理，10余项临床试验同步在全球开展。


2022年3月，H药正式获批上市，目前可用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌（sqNSCLC）、广泛期小细胞肺癌（ES-SCLC）及食管鳞状细胞癌（ESCC）。H药联合化疗一线治疗广泛期小细胞肺癌（ES-SCLC）的上市申请也获得欧盟EMA受理。聚焦肺癌和消化道肿瘤，复宏汉霖积极推进H药与公司其他产品的协同以及与创新疗法的联合，相继获得中国、美国、欧盟等国家及地区的临床试验许可，在全球同步开展10余项肿瘤免疫联合疗法临床试验。截至目前，H药已于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超3600人，其中2项国际多中心临床试验入组白人的比例超过30%，是拥有国际临床数据较多的抗PD-1单抗之一。H药的3项关键性临床研究结果分别发表于知名期刊《美国医学会杂志》（JAMA）、《自然-医学》（Nature Medicine）和British Journal of Cancer。此外，H药还荣获《CSCO 小细胞肺癌诊疗指南》、《CSCO 非小细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO 结直肠癌诊疗指南》、《CSCO 免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。海外方面，H药治疗SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国启动了一项H药对比一线标准治疗阿替利珠单抗用于ES-SCLC的头对头桥接试验。

关于Intas

Intas是家遥遥领先的的全世界用量药物制剂定制开发、制造厂和线上营销战略子企业。该子企业建设了了个名字叫做Accord的子子企业网络上，首要用于在欧共体委员会、美利坚、新西兰、纳米比亚、新西兰、华东各地及其独联体和中东城市和北非各地的相对间距风险防控的专业领域中对其进行线上营销战略和銷售。时迄现今，Intas已在全世界已超86个发达国家和各地实施服务，其69%大于的薪水产于跨国专业领域，首要集中化于相对间距风险防控的欧共体委员会和美利坚专业领域。


Intas当前在俄罗斯药厂行业中子公司第二排名第七（选择IQVIA数据源），也是俄罗斯较大的私企仿药厂子公司。在关联度范围上，Intas在CNS、气动脉、糖尿病的风险、消化道病和泌尿科等关键因素治愈范围均已确定领先于认知度，但正宗让其环球闻名于世的是在欧洲共同体和新西兰的癌肿学和其它医院门诊治愈范围的医疗器械新产品。


Intas工作的生机勃发发展和她的在研发管理项目管理和制作业各方面的水平密无法分。Intas 现具备着16个制作业厂商，中间10个处于来自，另一个处于德国、希腊和阿根廷，均获取美利坚FDA、EMA、MHRA、TGA等全国排名頂級风险管控机购的认可的。子公司第二年研发管理项目管理投身比重关业使收入约6-7%。截止日期现在，Intas在全国排名具备着10,000多个食品报名，并还推出了300四种高实用价值FTF/FTM、生物技术仿制药和NDDS食品。

关于复宏汉霖

复宏汉霖（2696.HK）就是一家世界各国化的研究开发动物制品药业集团大公司，奠定基础于为世界各国自己的提拱可负荷的高的品质动物制品药，產品网络覆盖癌症、自己的免疫力患病、眼科整形患病等教育领域，已在全国推出5款產品，在世界各国推出1款產品，19项适应的能力症新批，4个推出注册主要获荷兰FDA和欧共体成员国EMA核发。自2012年确立至今以来，复宏汉霖已起建合二为一化动物制品药业电商网络平台，高效益能及研究开发的自己军事基地网的能力紧密结合研究开发、产量方式及商家运行全产业结构链。集团大公司已树立逐步完善高效益能的世界各国研究开发军事基地网，，并按照世界各国消毒产品产量方式的品质方法国家标准单位（GMP）标准单位来进行产量方式和的品质管理工作，持续不断打牢合二为一化总体产量方式电商网络平台，这之中，上海市徐汇军事基地网已荣获全国和欧共体成员国GMP实名安全认证，松江军事基地网（一）也已荣获全国GMP实名安全认证。


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H药 汉斯状®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，欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品汉斯状®（斯鲁利单抗）已获批用于治疗微卫星高度不稳定（MSI-H）实体瘤、鳞状非小细胞肺癌、广泛期小细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗。公司亦同步就16个产品在全球范围内开展30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 Deepens Collaboration with Intas

to bring Henlius’ Novel anti-PD-1 mAb Serplulimab to Europe and India

  • The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India 
  • Intas to develop and commercialise serplulimab in Europe and India; Henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commercial milestone payments 


Shanghai, China, October 27, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with Intas Pharmaceuticals Limited ("Intas") for the development and commercialisation in Europe and India for several indications including ES-SCLC, and specific formulation of HANSIZHUANG (serplulimab injection), Henlius’ novel anti-PD-1 mAb. In June 2018, Henlius and Accord Healthcare Ltd., a subsidiary of Intas, entered into a license agreement, under which Henlius granted Accord exclusive commercialisation rights of HLX02 (trastuzumab for injection, trade name in China: HANQUYOU; trade name in Europe: Zercepac®; trade names in Australia: Tuzucip®/Trastucip®) in certain countries and regions in Europe, the Middle East, North Africa, and the Commonwealth of Independent States. In 2021, Henlius granted Intas the exclusive rights to develop and commercialize HLX02 in the United States (U.S.) and Canada.


This collaboration marks a deepening of the strategic partnership between the two companies and opens up new development opportunities for serplulimab's global layout. Under the terms of the agreement, Henlius will be responsible for clinical development, manufacturing and supply upon launch and will receive a €42 million upfront payment, up to €43 million in regulatory milestones, up to €100 million in commercial sales milestones, and double-digit royalties on net profit from Intas in the licensed territory.


“With superior efficacy and data quality, HANSIZHUANG (serplulimab) has become the world's first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for 4 indications in China, benefiting over 40,000 Chinese patients. Its marketing application has been validated by the European Medicines Agency (EMA) in March 2023,” said Jason Zhu, Executive Director, Chief Executive Officer, and Chief Financial Officer of Henlius. “By continuously partnering with Intas, we hope to accelerate serplulimab's wider accessibility globally and contribute to the improvement of patient outcomes.”


Ping Cao, Senior Vice President and Chief Business Development Officer of Henlius, said, “Henlius and Intas first entered into a collaboration in 2018. Over the past 5 years, we have worked closely together and expanded the internationalisation of HANQUYOU (Zercepac® in Europe), which has been successfully approved in 40+ overseas countries, benefiting patients in Europe and MENA. Building on the successful collaboration, we look forward to working with Intas to accelerate the launch of serplulimab in Europe and India, and to continue our mission to offering high-quality and affordable biologics to patients around the world.”


Binish Chudgar, Vice-Chairman & Managing Director, Intas Pharmaceuticals Ltd., said, "We are excited to reinforce our long-standing partnership with Henlius. This collaboration will further bolster Intas' global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide. The forthcoming launch of serplulimab in Europe and India will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve."


Paul Tredwell, Executive Vice President of EMENA., Accord, said, “I am delighted to strengthen our partnership with Henlius. The launch of serplulimab will further solidify Accord as a leader in providing specialty medicines. This marks our second novel launch in just two years, adding to our existing platform of supplying up to 25% of chemotherapy medicines in our region, exemplifying our commitment to innovation and growth and our mission to improve access to value-based medicines for patients.”


The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. At present, HANSIZHUANG has been approved for 4 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). With its breakthrough efficacy and differentiation advantages in the relevant treatment fields, HANSIZHUANG has earned wide recognitions and its pivotal clinical research results have been published in leading medical journals such as the Journal of the American Medical Association (JAMA) and Nature Medicine. Its synergy with in-house products of the company and innovative therapies are being actively promoted and over 10 clinical trials on immuno-oncology combination therapies are in progress in a wide variety of indications, such as lung cancer, esophageal carcinoma, gastric cancer, etc., enrolling more than 3,600 subjects globally. And the proportion of Caucasians is over 30% in two multi-regional clinical trials (MRCTs). Its global clinical trial data will further support marketing applications in global markets and lay a foundation for clinical applications all over the world in the future.


In 2022, serplulimab was successively granted orphan drug designations by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of SCLC, which will enable it to benefit from certain policy support for research and development, registration, and commercialisation in the U.S. and Europe. The EMA has validated the application for serplulimab and it is expected to be approved in the first half of 2024. The company is also steadily advancing the bridging head-to-head trial in the U.S. to compare serplulimab to standard-of-care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC to propel the product towards U.S. market approval.


In the meantime, Henlius pro-actively advances the commercialisation of HANSIZHUANG in overseas markets at high speed. Henlius granted KGbio exclusive rights to develop and commercialize HANSIZHUANG in 10 ASEAN member countries and 12 MENA countries. Furthermore, Henlius and Fosun Pharma have entered into an exclusive license agreement for HANSIZHUANG in the U.S. HANSIZHUANG’s coverage footprint now includes the U.S., Europe, Southeast Asia, MENA, and India.


In the future, Henlius will join hands with its international partners to make full use of their respective resources and advantages to actively promote the development and commercialisation of HANSIZHUANG globally, to enable it to cover a wider range of countries and regions and to provide more therapeutic choices for more patients.


About HANSIZHUANG (serplulimab)

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first anti-PD-1 mAb for the first-line treatment of SCLC. Up to date, 4 indications are approved for marketing in China, 1 marketing application is under review in the EU, and more than 10 clinical trials are ongoing across the world.


HANSIZHUANG was launched in March 2022 and has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). Its marketing applications of the first-line treatment for ES-SCLC are under review by the EMA. Focusing on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. It has successively obtained clinical trial approvals in China, the U.S., the EU and other countries and regions to initiate more than 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications. As of now, the company has enrolled more than 3,600 subjects in China, the U.S., Turkey, Poland, Georgia and other countries and regions, and the proportion of White is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The results of 3 pivotal trials of HANSIZHUANG were published in the Journal of the American Medical Association (JAMA), Nature Medicine and the British Journal of Cancer, respectively. Furthermore, HASIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for Esophageal Cancer, the CSCO Guidelines for Colorectal Cancer, the CSCO Clinical Practice Guidelines on Immune Checkpoint Inhibitor, the China Guidelines for Radiotherapy of Esophageal Cancer, and other definitive guides, providing valuable references for clinical diagnosis and treatment of tumours. On the other hand, serplulimab was granted orphan drug designations by the U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.


About Intas

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, Canada, South Africa, Australia, Asia Pacific, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of the EU and the US.


Currently ranked 6th (As per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology and Oncology in India, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US.


Intas' success and growth are a direct influence of Intas' extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are in India, and the rest in the U.K., Greece, and Mexico. Between them, the facilities are accredited by top global regulators such as the US FDA, EMA, MHRA, TGA, and others. Every year, the company invests 6-7% of its revenues in R&D. Currently, Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products.

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, 5 products have been launched in China, 1 has been approved for marketing in overseas markets, 19 indications are approved worldwide, and 2 marketing applications have been accepted for review in the U.S., and the EU, respectively. 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 commercialization. It has established global innovation centers and Shanghai-based manufacturing facilities in line with global Good Manufacturing Practice (GMP), including Xuhui Plant certificated by China and the EU GMP and Songjiang First Plant certificated by China 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 HANSIZHUANG (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab for injection, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the innovative product HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.






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