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 项目收入于： 浏览量：

信息内容种类：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荣获H药在德国和还有国内各地的獨家开发设计和服务业化权利，复宏汉霖将荣获4200万欧购车首付钱、能达1.4三亿欧的监督检查和服务业化里程数碑付钱及及三位数占比的协议区域环境净毛利率润特许经营权便用费。


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。

本次媒体战略合作不单标记着这两家大公司相互之间的不断发展战略夥伴联系进而一个脚印深入开展，会比较H药全.球的布置加载暂新的不断发展创业机会。要根据合同，复宏汉霖将否则H药在欧式和俄罗斯的临床上规划设计及开卖后的产品的制造和制造，并将从本次交易价格中兑换4200万英镑的房款款、达到4200万英镑的风险管控公里数碑付帐、达到3000万英镑的餐饮业化公里数碑付帐及俩位数占比的媒体战略合作部位净收入率润加盟权使用的费。


复宏汉霖施行董事会、顶尖施行官兼顶尖财富官 朱俊男士

借助非常好的的辽效和统计数据重量，H药作要为环球首届将建闽东南冶疗小组织细胞非小细胞肺癌的抗PD-1单抗，当今目前在国内内地已将建4项满足症，受益逾4万人国内地自身，其欧盟国家的纳斯达克上市许证申请办理也于几年6月可以获得南美洲医药监管局 (EMA) 审理。能够与Intas全面一个脚印持续推进战略合作，你们盼望t加速助推H药在环球位置内体现更范围广的可及性，为纠正本土自身的治辽的效果和生存游戏下载重量突出贡献活力。


复宏汉霖专业副总经理裁兼首席总裁商务洽谈趋势官 曹平男土

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副股东长兼股东总运营经理

Binish Chudgar老兄

“他们很开心就可以与复宏汉霖继续加强太久合作感情粉丝感情。报好名的合伙将进步骤充裕Intas的亚洲肿癌护肤品污水管，树立我在亚洲范畴内带来特色化安装驱动避免方案怎么写的承若书。积极推动斯鲁利单抗在澳大利亚和巴基斯坦市场销售也是我们发展先进性生物制品药可及性的关键举动，协助全球排名很多病人得出马上、优效率的改善。




Accord澳大利亚南美和北非中北部下达副总经理裁

Paul Tredwell先森

很高兴地积极推进与复宏汉霖的协作合作伙伴关心。现已在对方合作共赢区域性应用的斯鲁利单抗，还有机会拓宽渠道一个脚印查漏补缺Accord在特药方向的老板者位置，并含意着，整整这两年各位即还有机会还推出第十二款侯选革新药，且能与各位在该地区划分生产商增长率达到25%的肺癌晚期化疗药物剂量养成‘搭档拳’。这突显了自己的对企业创新和持续增长的承若书，也充分体现了自己的坚持创新驱动提生用量可及性、精准推送更常见病患者，令其收货应用场景实际价值的制疗的使命感务实担当。

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。


22年，H药缓解SCLC接二连三提升美利坚共和国食物和货品辅导标化管理系统局官方网站（FDA）和西方地区联盟理事会会（EC）授与的流浪儿童药资证评定，能够促进H药在美利坚共和国和西方地区的产品研发、注册厂家及企业化等各方面品尝必然的现行政策适用。H药标杆缓解ES-SCLC的西方地区联盟市场销售经营请求（MAA）于202两年多4月提升西方地区货品标化管理系统局官方网站 (EMA) 立案，即将于202历经四年上一个月提升批准书。然而，厂家再次骤推动项目建设推进项目建设H药对比图标杆标缓解阿替利珠单抗应用于缓解ES-SCLC的头对头美利坚共和国桥接实验室检测，以再次骤适用H药在美利坚共和国的市场销售企业申报。


与此此外，复宏汉霖全速进行H药在跨国的行业的业务性化过程中。最新，工司已与PT Kalbe Genexine Biologics（KGbio）获得战略进行的合作方案格式，发放其H药在东盟十国十国和东西南亚和北非各地13个各国的独家首发開發和业务性化支配权。除此认知能力，复宏汉霖与银河集团官网 药业就H药获得芬兰的行业业务性化战略进行的合作。截止期现下，H药对外经济受权已覆盖率率芬兰、澳大利亚、东西南亚、东西南亚和北非、还有国内各地等各国和各地。未来是什么，工司将风雨同舟广大战略进行的合作夥伴多措并举着力推进H药的中国開發过程中，令H药可能覆盖率率更好的各国和各地，为更好人群带来了更好的调理选用。

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一家领先地位的的全.球最大药物治疗注射剂開發、生产和企业提高机构。该机构组建好几个个名是Accord的子机构网上，应用于在欧洲经济共同体、意大利、荷兰、巴西、美式、华东城市还有独联体和中东东南部和北非城市的极高监督的市面 中做企业提高和卖出。时当时日，Intas已在全.球最大少于85-7个国家和城市开展调研业务员，其69%上的纳入存在萌宝市面 ，核心多于极高监督的欧洲经济共同体和意大利市面 。


Intas当前在来自制药业职业机构第二排名第十（随着IQVIA参数），也是来自最好的私立仿制药业新公司。在相关性分析方向上，Intas在CNS、心力管、糖尿病患者、肠道病和泌尿科等关健控制方向均已准确把握专业位置，但正宗让其国际知名的是在欧共体和澳大利亚的癌肿学和其他诊所控制方向的生物制药的产品。


Intas工作的蓬勃向上上涨与之在企业产品设备生产研发和手工制造厂方向的竞争力密必不可分。Intas 现享用16个手工制造厂工业区，另外10个属于印度尼西亚，之外属于澳大利亚、希腊和西班牙，均刷出俄罗斯FDA、EMA、MHRA、TGA等高度最高级监督检查培训机构的肯定。我司一年企业产品设备生产研发投放比率总建筑面积纳入约6-7%。载止近些年，Intas在高度享用10,000多项企业产品设备注册会员，并推广了300多个高意义FTF/FTM、微生物仿制药和NDDS企业产品设备。

关于复宏汉霖

复宏汉霖（2696.HK）是一个家全国化的特色化海洋动物制品医药总部，秉承于为环球性爱美者打造可的负担的高品質海洋动物制品药，货品遍及良性肿瘤、自个抗体妇科病、眼科整形妇科病等业务领域，已在我国香港推出5款货品，在全国香港推出1款货品，19项融入症应用，3个香港推出使用各是获美式FDA和欧洲经济共同体EMA受案。自20十多年成立装修公司来，复宏汉霖已建设成二合一化海洋动物制品医药网络网站，科学标淮规范化及特色化的自主经营基本功能深入产品研发、产生及商业地产营销推广全产业分析报告链。总部已建立联系完美科学标淮规范化的环球性特色化中间，以全国药物产生产销售销售品菅理标淮规范（GMP）标淮实行产生和产品严格监督，不停筑牢二合一化综合性产生网络网站，这其中，上海市徐汇基底已刷出我国和欧洲经济共同体GMP认证证书服务，松江基底（一）也已刷出我国GMP认证证书服务。


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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