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 内部原因于： 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领取H药在法国和俄罗斯的独门建设和企业区化功能，复宏汉霖将领取4200万英镑首付钱款、相当于1.45亿英镑的管理和企业区化航空节点付钱及及两名数比率的的合作部位净成本润加盟权用费。


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。

契机相互合作方式往往标志图片着俩家新公司范围内的策略伴侣相互关系进步推进，非常H药西方构造打开文档绚烂的不断发展商机。依据合同范本，复宏汉霖将担负H药在西方和来自的监床开发建设及开卖后的物料生产加工和制造，并将从契机寄售中得到4200万美元的车子首支付、高达41000万美元的稽查行程碑支付、高达2亿美元的商务化行程碑支付及多位数的比例的相互合作方式空间区域纯盈利许可权使用的费。 


复宏汉霖实行制定董事、总裁实行官兼总裁税务官 朱俊男士

凭着表现出色的的作用和参数线高质量，H药变成 了环球首家将建不错中药开展小细胞膜肝癌的抗PD-1单抗，现在我国的已将建4项适用于症，造福逾4万多名我国的病员，其欧盟国家的纳斯达克上市经营审请也于在今年2月领取拉丁美洲放射性药品经营局 (EMA) 审批。经由与Intas进一部深化体制改革加盟，让我们想要迅速助推H药在环球范畴内实现目标更普遍的可及性，为减少位置病员的治的作用果和我的世界生存线高质量突出贡献魔力。


复宏汉霖一级总经理裁兼总裁商业發展官 曹平小姐

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副监事长兼监事总运营经理

Binish Chudgar丈夫

“你们很快乐要与复宏汉霖全面提升长期的合作项目夥伴的关系。圆满结束战略合作将进1步多样化Intas的亚洲淋巴肿瘤好产品线管，践行两学一做他们在亚洲依据内能提供什么是创新引领包处理计划书的誓言。积极推动斯鲁利单抗在非洲和还有国内各地主板上市也是我们升高先进的生物制品药可及性的重要性强化措施，帮忙中国比较多客户到按时、优质化量的治療。




Accord欧洲各国南美和北非省份继续执行总监裁

Paul Tredwell男士

愈来愈感到高兴深化体制改革与复宏汉霖的加盟挚友关系的。行将在男女双方联合省市将建的斯鲁利单抗，有希望进一步的一个脚印扎实Accord在特药行业的领导干部者实力，并意示着，不过两年左右.我就有希望开售二款得票率特色化药，且可能与.我在该省市供货比例独角兽高达25%的手术类药造成‘组合名字拳’。这种表现了咱们对革新和生长的誓言，也展现了咱们秉承延长制剂可及性、接触更多方面用户，令其收获英文应用于意义的改善的神圣职责责任。

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药方法SCLC接二连三拥有国外肉食品和保健中药饮片行政监督工作局（FDA）和欧共体理事会会（EC）赋予的弃婴药报名要求核实，促进企业H药在国外和欧州的研制、注册的及商用化等这方面品尝一段的策略可以。H药超第一线方法ES-SCLC的欧共体开卖可证报名（MAA）早已于2023-5年7月拥有欧州保健中药饮片工作局 (EMA) 授理，极可能于202几年上几年拥有批复。最后，工厂稳步发展促进H药相比较超第一线标准化方法阿替利珠单抗使用在方法ES-SCLC的头对头国外桥接做实验的时候，以进一次可以H药在国外的开卖审核。


与此此外，复宏汉霖全速积极推进H药在淘宝行业市面的餐饮业化系统线程池。当即，品牌已与PT Kalbe Genexine Biologics（KGbio）完成加盟协议范本，给予其H药在西北亚十国和西北亚和北非地段11个国的强势来袭开发设计建设和餐饮业化权。除此除这个之外，复宏汉霖与银河集团官网 国药就H药完成澳大利亚行业市面餐饮业化加盟。结束现今，H药外资软件授权已包裹澳大利亚、海外、西北亚、西北亚和北非、来自等国和地段。未来的发展，品牌将携手并肩大家加盟伙伴们全心全意助推H药的世界上开发设计建设系统线程池，令H药可以包裹更宽泛的国和地段，为太多朋友作为更宽泛的医疗的选择。

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是家最前沿的的全世界抗癫痫药物中药制剂规划设计、制造技术和网络营销管理司。该司构建半个个名是Accord的子司网洛，重要用于在欧共体、美利坚共和国、美利坚共和国、肯尼亚、澳洲、亚太国际省份已经独联体和东南亚和北非省份的程度监督管理机构的的领域中实施网络营销管理和产品。时于近期，Intas已在全世界可超过85-7个的国家和省份深入推进服务，其69%及以上的薪资收入发源国外投资的领域，重要集中点于程度监督管理机构的欧共体和美利坚共和国的领域。


Intas当今在伊朗生物制药职业制造业企业后排名第6（跟据IQVIA的数据），也是伊朗极大的民营仿生物制药企业。在划分方向上，Intas在CNS、先天之精管、高血压、消化道病和泌尿科等至关重要制疗方法方向均已创立前沿实力地位，但完全让其世界各国户晓的是在欧盟国家和新加坡的癌症学和别的机构制疗方法方向的生物制药企业产品。


Intas业务领域的蓬勃生机持续增长两者在新软件研发部门和制作业上的水准密不分。Intas 现拿到16个制作业厂，在当中10个坐落于非州，仅仅坐落于澳大利亚、希腊和葡萄牙，均拿到瑞典FDA、EMA、MHRA、TGA等世界十大知名监察构造的喜爱。装修公司每一年新软件研发部门资金投入占到比例开业薪资约6-7%。截止日期现下，Intas在世界十大拿到10,000多个软件注册申请，并发布了300多重高实用价值FTF/FTM、海洋生物仿制药和NDDS软件。

关于复宏汉霖

复宏汉霖（2696.HK）都是家国际英文级级化的多元化动物医药集团工厂，倾力于为世界十大提高能提供可损失的高品级动物药，设备包含淋巴肿瘤、品牌免疫抗体疾患、眼科医生疾患等领域，已在我国退市5款设备，在国际英文级级退市1款设备，19项适合症获准，6个退市使用各自获欧美FDA和欧盟成员国成员国EMA结案。自20十年组建起来，复宏汉霖已完工内置式式化动物医药集团app，有效率及多元化的服务性服务管理处性能紧扣产品研发、分娩及商业性运营推广全服务业链。工厂已形成成熟的有效率的世界十大多元化核心，依照规定国际英文级级保健药品分娩产品品质服务规范化管理规格（GMP）规格来分娩和产品品质电脑监控，反复狠抓内置式式化结合分娩app，在其中，昆明徐汇园区网已可以获得了我国和欧盟成员国成员国GMP认正，松江园区网（一）也已可以获得了我国GMP认正。


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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