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:2024-10-27 玩法出自于： 浏览量：

信息内容由来：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有H药在澳洲和白麻的独家代理设计规划和餐饮业化的权益，复宏汉霖将有4200万英镑分期支买单、能达1.46亿英镑的风险防控和餐饮业化里数碑支付及及某位数正比的合作共赢区城净净收入率润特许加盟权利用费。


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。

旨在战略决策合伙一方面圆形明确指出俩家工厂区间内的战略决策挚友的关系进一次深入开展，较为H药世界上方式 打开充满希望的不断发展新机遇。按照其协议书，复宏汉霖将全权负责H药在非洲和还有国内各地的医学设计规划及香港上市后的厂品分娩和提供，并将从旨在市场交易中才能得到4200万英镑的房款款、大约4200万英镑的政府监管里数碑汇款、大约5亿英镑的商务化里数碑汇款及几位数比例图的战略决策合伙地区纯盈利空间润特许经营权在租赁费。


复宏汉霖制定高管、首席总裁总裁制定官兼首席总裁总裁资金官 朱俊工程师

仰仗优良的诊疗作用和大数据質量，H药形成了世界十大率先将建第一线诊疗小细胞核肝癌的抗PD-1单抗，近年来在在我国已将建4项适于症，劳有所得逾4数十万在我国人，其南美洲共同体的主板上市许可证申批也于现在10月取得南美洲医疗耗材安全监管局 (EMA) 审批。采用与Intas进一个步骤深入合作协议，我们公司愿高速度引领H药在世界十大区间内建立更广的可及性，为有所改善本地人人的治诊疗作用果和存活質量成就力。


复宏汉霖初级总经理裁兼总裁公司转型官 曹平中年女

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副高管长兼高管总经历

Binish Chudgar工程师

“我们大家很开心快乐就能够与复宏汉霖全面提升长久的加盟好朋友干系。我县合伙将进那步雄厚Intas的国际肿癌的产品输油管线，践行两学一做让我们在国际的范围内具备特色化驱动器解決计划方案的诚若。推动了斯鲁利单抗在澳大利亚和巴基斯坦美国上市这是我们优化先进的菌物药可及性的为重要具体措施，帮助到环球更好地病号能够随时、高品效果的诊治。




Accord南美洲中东中北部和北非中北部进行副大总裁裁

Paul Tredwell大叔

相对欣喜深化体制改革与复宏汉霖的合作的朋友问题。就是将在夫妻双方合作的区域中应用的斯鲁利单抗，还有机会进一次查漏补缺Accord在特药层面的人员者状态，并含意着，仅仅四年人们即还有机会发行第十二款得票率技术创新药，且是可以与人们在该区县产生平均水平敢达25%的肺癌晚期化疗药材型成‘乐队三场硬仗’。那些体验了当我们大家对自主创新和倍增的口头承诺，也表现了当我们大家致力于提生药物医疗可及性、触及更常见病号，令其获得依据实际价值的医疗的重任务实担当。

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。


2030年，H药方法SCLC再度拥有芬兰美食和医疗耗材远程监控菅理局（FDA）和国外共同体常务理事会（EC）给予的流浪儿童药任职资格评定，有助于、H药在芬兰和国外的研发部门、注册的及商业服务化等的方面亨受一段的方案认可。H药第中俄原油管道方法ES-SCLC的国外共同体出现许可证申请书（MAA）应于2023-5年7月拥有国外医疗耗材菅理局 (EMA) 立案，还有机会于202四年上一段时间拥有核准。显然，集团公司有序推行推行H药相比较第中俄原油管道规定方法阿替利珠单抗用以方法ES-SCLC的头对头芬兰桥接试验检测，以进1步认可H药在芬兰的出现报送。


与此同一时间，复宏汉霖全速扎实推进H药在在国外领域的服务业化守护应用程序。已经，品牌已与PT Kalbe Genexine Biologics（KGbio）制定的联合合同，给予其H药在一带一路十国和中东城市地和北非地14个我国的独特开发管理设计和服务业化豁免权。除此囿于，复宏汉霖与HAHA体育 国药就H药制定美利坚共和国领域服务业化的联合。截止到现在，H药境外管理权限已履盖美利坚共和国、欧洲发展中部委、东西南亚、中东城市地和北非、印度尼西亚等我国和地。将来，品牌将携手同行大家的联合伴侣奋力推动了H药的亚洲开发管理设计守护应用程序，令H药也能履盖更诸多性的我国和地，为较多我们提高更诸多性的控制决定。

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都是家技术型的的全球最大性用量溶液剂開發、生产加工和卖集团机构。该集团机构建立联系好几回个名叫Accord的子集团机构网格，用以在欧洲联盟部委、国外、加拿大的、土耳其、新西兰、亚太国际区县还有独联体和中东东南部和北非区县的非常监督的的行业市场中中确定卖和卖。时以来日，Intas已在全球最大性小于89个部委和区县深入推进业务流程，其69%以下的薪资收入来源于在海外的行业市场中，核心分散于非常监督的欧洲联盟部委和国外的行业市场中。


Intas现在在国外药业各个的领域行业企业主后排名接下来（不同IQVIA数据报告），也是国外很大的私营企业仿药业总部。在层级各个的领域行业上，Intas在CNS、心力管、高血糖、直肠病和泌尿科等重点疗法各个的领域行业均已拟定先进主导地位，但正宗让其中国闻名世界的是在欧洲经济共同体和国外的恶性肿瘤学和任何医院专家疗法各个的领域行业的国药好产品。


Intas工作的蓬勃向上上升与它在技术创新和加工工作方面的整体实力密不要分。Intas 现收获16个加工生产厂家，这当中10个在非州，同样在英国的、希腊和葡萄牙，均获取欧美FDA、EMA、MHRA、TGA等世界各国一流安全监管单位的认证。集团公司历年技术创新投入量比重闭店工资约6-7%。已于现在，Intas在世界各国收获10,000多项新物料注册公司，并推新了300各种高使用价值FTF/FTM、动物仿制药和NDDS新物料。

关于复宏汉霖

复宏汉霖（2696.HK）有的是家全国化的科学频频创新性动物药业企业app，强院于为国内患有作为可付出的高品味动物药，成品覆盖率癌肿、自己天然免疫慢性病、护眼慢性病等层面，已在中主板发售5款成品，在全国主板发售1款成品，19项应用症将建，3个主板发售报名都获新西兰FDA和欧洲经济共同体EMA立案。自20五年建设成来说，复宏汉霖已建设成混合式化动物药业企业app，高效率的益及科学频频创新性的数字化基本效果结合研发部门、分娩的及商用运作全第三产业发展链。app已建设逐步完善高效率的益的国内科学频频创新性重心，决定全国非处方药分娩的安全性能把控实验室管理规范（GMP）规范实施分娩的和安全性能把控，频频夯实基础混合式化宗合分娩的app，至少，苏州徐汇集散地已收获中和欧洲经济共同体GMP资质审核，松江集散地（一）也已收获中GMP资质审核。


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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