复宏汉霖扩大与KGbio的合作，共绘H药中东北非商业化蓝图

发布时间:2023-09-12 网站内容因素于： 浏览量：

内部源：复宏汉霖


  • H药 汉斯状®（斯鲁利单抗）对外授权覆盖东南亚、中东和北非22个新兴市场国家；
  • KGbio新增H药在中东和北非地区12个国家的独家开发和商业化权益，复宏汉霖将获得700万美元首付款、可达800万美元的监管里程碑付款及分级销售特许权使用费；
  • 复宏汉霖还将基于H药在合作区域的累计净销售额获得至多6.5亿美元的销售里程碑付款。


2023年9月12日，复宏汉霖（2696.HK）扩大与印度尼西亚制药公司PT Kalbe Farma Tbk.（以下简称“Kalbe”）旗下控股子公司PT Kalbe Genexine Biologics（以下简称“KGbio”）的独家许可与商业化合作，授予其在沙特阿拉伯、阿联酋、埃及、卡塔尔、约旦、摩洛哥等12个中东和北非地区（MENA）国家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）在内的两项适应症进行独家开发和商业化的权益。复宏汉霖与KGbio已于2019年达成协议，授予其H药在东盟十国的部分适应症及疗法的独家开发和商业化权利。

来源于协议模板，复宏汉霖将负责管理H药在MENA范围中纳斯达克上市后的物料分娩和供货，并将终是次交易所中获取700万澳元的房子首汇款款、恰有1000万澳元的政府监管里数碑汇款和H药在以上企业进行合作范围中净售卖员额从11%五到百分其二十的加盟权实用费。除此以外，复宏汉霖还将来源于H药在东西南亚、南美和北非企业进行合作范围中内的累记净售卖员额获取恰有6.5000万澳元的售卖员里数碑汇款。

 
复宏汉霖总截审理官、总截兼总截资金官 朱俊大先生

H药是全球性第一个且如今真正唯一的应用一二线冶疗小内部1.肺癌的抗PD-1单抗，单凭其优等的见效迄今为止已受惠逾5万名我国客户。让他们非常的快乐继东南方方亚软件授权之前，缘何与KGbio在南美省市和北非省市携手并进，用来持续性搭载和调节本土客户的冶见功能和存在水平。可以通过KGbio在新兴起来市场中更强的工商品化网络数据和运营策划的能力，让他们达致，H药将为东南方方亚、南美省市和北非省市的客户带去新的愿意与安全。

 
复宏汉霖总裁大人商务会展旅行壮大官、商务会展旅行括展副总经理裁 曹平女土
复宏汉霖和KGbio于2021已达成合伙，对方恪守共同体参与的愿景是什么和初心，加快促进了汉斯状在西北亚国家的什么时候上市tcp连接。在过的多年中，我国不只是建立起了扎实的合伙理论知识，就要共同体参与任务的win7驱动下，体出现出相对高度的联动负效应。纵览发展，在东南亚北非国家，复宏汉霖和KGbio将进这一步提高协同工作，深入研究发掘市面 竞争力，为汉斯状切换新篇章。
 
Kalbe高管、KGbio高管长 Sie Djohan先是
咱们谦逊喜欢复宏汉霖继续与KGbio联手相互合作。借助KGbio在东南亚和北非区域的布置图和管理专业能力，这两家工司将一致驱动创新发展药的设计规划。

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、鳞状非小细胞肺癌和广泛期小细胞肺癌。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《美国医学会杂志》（JAMA）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，全面覆盖肺癌一线治疗。H药全球累计入组患者超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。


这回两方悄然联手，将主动使用各种的资源量和其优势，主动统筹推进H药在东南方亚、南美和北非中北部的工业化系统进程，改善H药在新兴起来市扬的可及性，为更好地病患带动可负担过重的高端保证去创新生物技术药。

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3项适应症获批上市，2项适应症上市申请分别在中国和欧盟获受理，10余项临床试验同步在全球开展。


2030年1月，H药确认选用成功发售，近年来可以用于进行根治微小行星长度不安全稳定（MSI-H）片体瘤、鳞状非小组织1.癌症（sqNSCLC）及宽泛期小组织1.癌症（ES-SCLC）。H药整合癌症化疗不错进行根治食管鳞状组织癌（ESCC）和不错进行根治宽泛期小组织1.癌症（ES-SCLC）的成功发售申请办理也不同刷快我们NMPA和欧洲共同体EMA核发。集聚1.癌症和化解道癌症，复宏汉霖主动有序推进H药与公司各种品牌的信息化各类与的创新方法的整合，争相刷快我们、英国、欧洲共同体等一个地方及城市的药学检验经营许可资料，在欧洲同歩积极开展10麦克劳林公式癌症免疫力力整合方法药学检验。截止日近年来，H药在我们、英国、俄罗斯、瑞典、格鲁吉亚等一个地方和城市累记到组超3600人，至少2项国际联盟联盟多咨询中心药学检验入组白人的比率高达30%，是有国际联盟联盟药学数据表格较多的抗PD-1单抗之1。H药的3项关键点性药学学习但是不同刊发于着名异物《英国临床护理实验医学界会异物》（JAMA）、《很自然-临床护理实验医学界》（Nature Medicine）和British Journal of Cancer。于此，H药还赚取《CSCO 小组织1.癌症口腔操作须知》、《CSCO非小组织1.癌症口腔操作须知》、《CSCO 食管癌口腔操作须知》、《CSCO结结肠癌口腔操作须知》、《CSCO免疫力力定期检测点治理和改善剂药学选用须知》和《我们食管癌射线进行根治须知》等多个信赖须知推送，为癌症药学口腔操作给予注重参考使用。境外层面，H药进行根治SCLC也已刷快英国FDA和欧洲共同体EC的孤寡药基础查证，并在英国启用好几个项H药比不错标准进行根治阿替利珠单抗的头对头桥接检验。

关于KGbio

KGbio一家建立于2020年的医学检验护理过程动物技术水平子公司，专业主要是将动物国药科技不断创新带到也可以南美、东欧和在我国意外的股票市场。紧紧围绕良性肿瘤和相关性分析方法区域（常常是pre-IND或晚期医学检验护理过程），KGbio多方面引进人才科技不断创新颖动物药和有些动物这样药，以在医学检验护理建设后进一大步推动对方地方的市场销售批准和医保报销准入的。


KGbio发展于Fc溶合蛋清、抗原、双非特异朋友抗原、ADC、内部自然疗法和接种疫苗方法等诸多技术工艺渠道。大新公司受到了亚洲地区医药大新公司Kalbe、Genexine和USA私募基金股份行业大佬General Atlantic的可以。

关于Kalbe

PT Kalbe Farma Tbk成为于 1966 年，为西南亚投资额上限的药业发行总部一种。它有七个一般销售：处方单药、进行消费者心理保健品、营养物质品和货品分销系统。Kalbe现在有着着高出40家子总部和14个对接时代国际规范标准的生产的安全设施，普通员工数据大概为16000名，在还有国内各地尼西亚有着着76家分总部。1993年，总部在还有国内各地尼西亚证券商公司合作所发行（证券商公司源代码：KLBF）。直到2020年110月31日，Kalbe的重新命名总使收入为28.95亿菲律宾盾，总市值为985亿菲律宾盾。

关于复宏汉霖

复宏汉霖（2696.HK）是家高度化的的自己企业创新海洋菌物技术制药业厂企业，全力于为高度病患给予可承担的高食品海洋菌物技术药，食品复盖肺部肿瘤、自个免疫力的患病、骨科的患病等行业，已在国内退市5款食品，在高度退市1款食品，18项不适应症应用，3个退市申请注册分开获国内食药监局、法国FDA和欧盟国家委员会EMA审理。自20多年集团公司设立的话，复宏汉霖已成立 立体式化海洋菌物技术制药业厂机构，效率高性及的自己企业创新的自己本质的能力引向研究开发、产出及企业产品运营全产业的发展链。企业已建设全面效率高性的高度的自己企业创新中心局，遵照高度保健药品产出安全性能方法规定（GMP）要求去产出和安全性能风险管控，不断的夯实基层基础立体式化综合管理产出机构，这其中，郑州徐汇产业基地网已拥有国内和欧盟国家委员会GMP审核，松江产业基地网（一）也已拥有国内GMP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、鳞状非小细胞肺癌和广泛期小细胞肺癌，成为全球首个获批一线治疗小细胞肺癌的抗PD-1单抗，其食管鳞状细胞癌适应症的上市注册申请也正在审评中。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 Expands Collaboration with KGbio to Develop, Commercialize and Supply Henlius' novel anti-PD-1 mAb HANSIZHUANG in MENA

  • HANSIZHUANG’s coverage footprint includes 22 emerging market countries across Southeast Asia and MENA -
  • KGbio to develop and commercialise HANSIZHUANG in 12 MENA countries; Henlius to receive US$7 million upfront payment plus royalties and up to US$8 million in regulatory milestone payments - 
  • Henlius is eligible to receive up to US$650 million upon the achievement of sales milestones in the Southeast Asia and MENA - 


Shanghai, China, September 12, 2023 - Shanghai Henlius Biotech, Inc. (2696.HK) has entered into an exclusive license agreement with PT Kalbe Genexine Biologics ("KGbio"), an Indonesian pharmaceutical company and a holding subsidiary to PT Kalbe Farma, Tbk ("Kalbe"), for the development and commercialisation of HANSIZHUANG (serplulimab injection) as a treatment for two indications including ES-SCLC, Henlius’ novel anti-PD-1 mAb, in 12 Middle East and North African (MENA) countries including Saudi Arabia, the United Arab Emirates, Egypt, Qatar, Jordan, Morocco, etc. In 2019, Henlius reached a collaboration agreement with KGbio, upon which KGbio is granted exclusive rights to develop and commercialize HANSIZHUANG in certain therapies in 10 ASEAN member countries.   Under the terms of the agreement, Henlius will be responsible for manufacturing and supply and will receive a US$7 million upfront payment, up to US$8 million in regulatory milestones, and royalties from KGbio ranging from 15% to 20% of net sales of HANSIZHUANG in the licensed MENA territory. Henlius will also be eligible to receive up to US$650 million upon the achievement of sales milestones in the licensed 22 countries in Southeast Asia and MENA.   “HANSIZHUANG is the first and only anti-PD-1 therapy approved for first-line treatment of small cell lung cancer. More than 30,000 Chinese patients have benefited from its excellent efficacy. We are excited to join forces with KGbio in MENA after the license granted in Southeast Asia,” said Jason Zhu, Chief Executive Officer, President, and Chief Financial Officer of Henlius. “Our aim is to continue supporting and improving the treatment outcomes and quality of life for local patients. Through KGbio's commercial network and operational capabilities in MENA, we firmly believe that HANSIZHUANG will bring new hope and health to patients in Southeast Asia and MENA.”   Ms. Ping Cao, Chief Business Officer, and VP of Business Development of Henlius, said, “The collaboration between Henlius and KGbio since 2019 was driven by a shared vision and mission and has opened a vast potential market for HANSIZHUANG in Southeast Asia. In the past 4 years, both parties have demonstrated a high level of synergistic effect driven by shared objectives. It has laid a strong foundation for our continued collaboration and I'm confident that together, we will continue to achieve more success in MENA.”   “We welcome the collaboration between KGbio and Henlius. With KGbio's network and operational capabilities in the Middle East and North Africa, this collaboration is an effort for the two companies to develop the products, especially for innovative biological products,” said Sie Djohan, President Director of KGbio, who is also the Director of Kalbe, KGbio's holding company.   The company's first innovative product, HANSIZHUANG (serplulimab), was approved in China in March 2022. At present, HANSIZHUANG has been approved for 3 indications in China including MSI-H solid tumour, squamous non-small cell lung cancer (sqNSCLC) and extensive stage small cell lung cancer (ES-SCLC). 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). 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., covering full range of first-line treatments of lung cancers. As of now, the company has enrolled more than 3,600 subjects globally, and the proportion of White 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 application all over the world in the future.   In the future, the two companies will fully leverage their respective resources and advantages to promote the commercialisation of HANSIZHUANG in Southeast Asia and MENA. It is anticipated that this will enhance HANSIZHUANG's accessibility in emerging markets and bring high-quality, affordable, and innovative medicines to more patients.

About HANSIZHUANG

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, 3 indications are approved for marketing in China, 2 marketing applications are under review in China and 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 National Medicinal Products Administration (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). The marketing applications of the first-line treatment for esophageal squamous cell carcinoma (ESCC) and ES-SCLC are under review by the NMPA and the European Medicines Agency (EMA), respectively. Focus 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 licenses in China, the United States, the European Union 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, HANSIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines 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 FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to comparing HANSIZHUANG to standard of care Atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

About KGbio

KGbio is a clinical-stage biotechnology company established in 2016, focused on bringing biologics medical innovation to markets outside the US/Canada, Western Europe, and China. The business model revolves around in-licensing novel biologics and select biosimilars in oncology and high-specialty therapeutic areas (typically pre-IND or early clinical stage), with the objective to out-license them in target geographies after finishing clinical development as well as regulatory and reimbursement approvals.


Platforms of interest include Fc-fusion proteins, antibodies, bispecifics, ADCs, cell therapies and therapeutic vaccines. The company is backed by Asian pharma companies Kalbe Farma, Genexine, and US private equity giant General Atlantic.

About Kalbe

PT Kalbe Farma Tbk. (“Kalbe”) was established in 1966 and is one of the largest publicly-listed pharmaceutical companies in Southeast Asia. Kalbe has four main divisions managing a broad and strong portfolio of brands; Prescription Pharmaceuticals Division, Consumer Health Division comprising over-the-counter drugs, as well as supplement drink and ready to drink products, Nutritionals Division, and Distribution & Logistics Division. Kalbe currently has more than 40 subsidiaries and 14 production facilities with international standards, employed around 16,000 employees and have 72 branches of distribution & logistics across Indonesia.  Since 1991, Kalbe’s shares have been listed on the Indonesia Stock Exchange (IDX: KLBF). As of 31 December 2022, Kalbe has IDR 28.9 trillion total consolidated revenue and IDR 98.0 trillion market capitalization. 

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, 18 indications are approved worldwide, and 3 marketing applications have been accepted for review in China, 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 tumors, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), making it the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. Its NDA for the treatment of esophageal squamous cell carcinoma (ESCC) is under review. 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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