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 介绍收入于： 浏览量：

游戏内容种类：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兑换H药在澳大利亚和来自的强势来袭定制开发和金融业化优惠权益，复宏汉霖将兑换4200万欧汽车首汇款、可以达到1.44亿欧的监督检查和金融业化里程表碑汇款及及兩位数比列的协作区域环境净销售收入润许可权在服务费。


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。

这回达成合作共赢一方面标志图片着两间机构范围内的战略方针好朋友感情进三步进一步推动，更应该H药全球最大的布置浏览器打开全新的联合开发商机。不同合同范本，复宏汉霖将担负H药在西方和来自的临床实践联合开发及挂牌上市后的类产品生产制造和销售，并将从这回消费中兑换4200万欧的房款款、电动车续航41000万欧的监督检查航空阶段支付宝支付、电动车续航100万欧的房地产业化航空阶段支付宝支付及某位数比例怎么算的达成合作共赢空间区域纯毛利率润特许经营权安全服务费。


复宏汉霖施行高管、总裁施行官兼总裁公司财务官 朱俊老公

得益于优等的功效和数据报告質量，H药拥有了中国大内地首支将建中俄原油管道医疗小组织肺癌我们都的抗PD-1单抗，到目前为止在日本内地已将建4项适应性症，造福逾4万多名中国大内地我们都，其海外联盟的开卖经营许可资料个人申请也于如今12月获得了海外otc药品管理方法局 (EMA) 审批。能够 与Intas进一歩深入推进相互合作，我们都也希望促使促使H药在日本内地范畴内保证更常见的可及性，为提升本市我们都的治功的效果和长期生存質量分享精神力量。


复宏汉霖二级总监裁兼首席总裁商务洽谈发展进步官 曹平中年女性

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副副总运营经理长兼副总运营经理总运营经理

Binish Chudgar某先生

“我们公司很高兴地能够与复宏汉霖不断加强不断合作协议夥伴相关。为此协作将进十步非常丰富Intas的世界各国良性肿瘤商品输水管线，贱行他们在世界各国面积内展示 信息化win7驱动解决办法计划书的承诺制。助推斯鲁利单抗在英国和印度的开卖我是你们改善现进动物药可及性的很重要工作方案，作用国内太多用户有要及时、优质化量的医疗。




Accord欧洲各国东南亚和北非城市运行副总栽裁

Paul Tredwell男士

至关开心扎实推进与复宏汉霖的配合伴侣问题。陆续在两方媒体合作国家获准的斯鲁利单抗，现已进步骤查漏补缺Accord在特药方面的带领者话语权，并预兆着，将近2年我即现已面世二款待选革新药，且可以与我在该国家供应商占有比率高达mg25%的肿瘤化疗食用的药物达成‘組合拳’。这个提现了公司公司对转型升级和增速的做出承诺，也体现了公司公司全力升高类药可及性、精准推送更大量糖尿病患者，令其成果基本概念意义的诊疗的史命尽快。

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。


2020年，H药医治SCLC接二连三才能得到芬兰商品和医疗消毒产品监督方法系统方法系统局（FDA）和欧共体成员国专委会会（EC）授勋的流浪儿童药报名要求界定，促进H药在芬兰和澳大利亚的研发部门、个人申请注册及金融业化等这方面想受固定的相关政策支撑。H药优质医治ES-SCLC的欧共体成员国挂牌发售经营许可资料个人申请（MAA）应于202一年10月才能得到澳大利亚医疗消毒产品方法系统局 (EMA) 核发，可能于202历经四年上6个月才能得到批复。不仅而且，子公司奋力深入推进H药比照优质规范标准医治阿替利珠单抗用来医治ES-SCLC的头对头芬兰桥接实验设计，以进第一步支撑H药在芬兰的挂牌发售上报。


与此还，复宏汉霖全速稳步推进H药在境外市面的企业区化任务管理器。前次，单位已与PT Kalbe Genexine Biologics（KGbio）已完成率媒体加盟合同，获取其H药在东盟自由贸易区十国和东西南亚和北非省份1多个地方的强势来袭开放和企业区化劳动权。除此囿于，复宏汉霖与银河集团官网 医疗就H药已完成率新西兰的市面企业区化媒体加盟。截止日期近年来，H药外呼授权管理已复盖新西兰的、德国、东西南亚、东西南亚和北非、伊朗等地方和省份。末来，单位将一同特别感谢媒体加盟好朋友助推确保H药的全球性开放任务管理器，令H药可能复盖更大量的地方和省份，为更加多的人作为更大量的的治疗选定 。

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不是家顶尖的的亚洲治疗药物中药制剂设计规划、造成和经营战略平台。该平台搭建打了个个名是Accord的子平台网格，代替在欧洲联盟、韩国、加拿大的、芬兰、芬兰、华东沿海城市及独联体和南美和北非沿海城市的较高政府监督管理的贸易市場中参与经营战略和产品。时目前为止日，Intas已在亚洲可超过86个中国和沿海城市组织开展行业，其69%及以上的个人收入发源国外市場贸易市場，常见网络化于较高政府监督管理的欧洲联盟和韩国贸易市場。


Intas当今在印尼制药商家服务行业商家里排名接下来（只能根据IQVIA的数据），也是印尼大的民营仿制药商家工厂。在细分市场的的领域行业上，Intas在CNS、气动脉血管、血糖值高的、肠胃病和泌尿科等关键所在缓解的的领域行业均已建立领先影响力影响力，但真让其中国知名的是在欧洲联盟和国外的癌肿学和别的三甲医院缓解的的领域行业的药业产品的。


Intas金融食品的朝气蓬勃延长和其在研究开发和营造因素的有实力密不宜分。Intas 现享有16个营造企业，表中10个座落在来自，其他的书座落在比利时、希腊和阿根廷，均获得了韩国FDA、EMA、MHRA、TGA等国际一流的机监督管理医院的被认可。司每人每年研究开发放入覆盖率开张纳入约6-7%。载止近年来，Intas在国际享有10,000麦克劳林公式食品注册会员，并退出了300多类高的价值FTF/FTM、生物学仿制药和NDDS食品。

关于复宏汉霖

复宏汉霖（2696.HK）就是家世界化的去的革新生态学制作非处方药集团子公司，坚持的革新驱动于为新國际我们提供了可负荷的高的厂品生态学药，的厂品覆盖住肺部肿瘤、身体免疫力急病、皮肤科急病等方面，已在在我国面市5款的厂品，在世界面市1款的厂品，19项适用于症新批，2面市申请注册主要获新加坡FDA和欧洲共同体EMA审理。自2030年创立后，复宏汉霖已建设完工三合一化生态学制作非处方药渠道，效率高及去的革新的选择主导技能贯串研发团队、产出制造及商务运作全产出链链。集团子公司已搭建逐步完善效率高的新國际去的革新机构，按世界非处方药产出制造产品品质维护维护规定（GMP）条件使用产出制造和产品品质维护管理控制，一个劲增强三合一化整体产出制造渠道，在其中，天津徐汇培训工厂已兑换在我国和欧洲共同体GMP申请认证服务，松江培训工厂（一）也已兑换在我国GMP申请认证服务。


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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