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 网站内容主要来取决于： 浏览量：

主要内容源：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。

依照协议模板，复宏汉霖将承接H药在MENA城市性发行后的的产品制作和供应信息，并将从次次进行交易中可以刷出700万美金的首支支付钱项款、恰有700万美金的核查里程数表碑支支付钱项和H药在下列进行合作的城市性净市场人员人员额从百分之三十五到百分其二十的加盟权用到费。前者，复宏汉霖还将依托于H药在东南方亚、南美和北非进行合作的城市性内的累记净市场人员人员额可以刷出恰有6.5000万美金的市场人员人员里程数表碑支支付钱项。

 
复宏汉霖ceo完成官、ceo兼ceo财务部门官 朱俊先森

H药是各国首条且当下绝无仅有将建二线医治小细胞膜肺肿瘤的抗PD-1单抗，驱使其是非常好的明确疗效迄今为止已造福逾2万名国内 的人。你们是非常兴奋继西北亚认证过后，二次与KGbio在南美和北非沿海的地方共促，以连续苹果支持和提高本地的人的医治目的和生存游戏下载质。能够KGbio在新兴的市面庞大的商业楼化在线和操作程度，你们坚信，H药将为西北亚、南美和北非沿海的地方的的人带去新的想要与安全健康。

 
复宏汉霖首席首席总裁商务接待电话不断发展官、商务接待电话开拓副经理裁 曹平男式
复宏汉霖和KGbio于2018年获得合伙，彼此本着一起的经营理念和责任担当，加快速度促进改革了汉斯状在东西南亚省市的纳斯达克上市程序。在以往的历经四年中，自己不仅仅建立联系了资深的合伙基础条件，还一起目标值的驱动软件下，突显出高速的协同作战效果。回顾与展望末来，在东南亚北非省市，复宏汉霖和KGbio将进一点抓好通力合作，更加深入开采市扬提升空间，为汉斯状启用踏上新征程。
 
Kalbe执行副董事长、KGbio执行副董事长长 Sie Djohan老先生
我虔敬受欢迎复宏汉霖继续与KGbio统一合伙。靠着KGbio在东南亚和北非各地的规划和运维力，两个工厂将统一统筹推进创新技术药的开发建设。

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。


这回对方后首共促，将能够充分回收利用相互的教育资源和优势可言，积极地推动H药在东南方亚、中东省份和北非省份的商用化线程池，改善H药在成长市场上的可及性，为比较多客户面临可额外负担的高品質去创新生物制品药。

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年三月，H药已正式选用挂牌发售，现在该用于根治方式微通信卫星位置不不稳（MSI-H）三维线瘤、鳞状非小生殖体細胞1.癌症患者（sqNSCLC）及非常具有广泛性期小生殖体細胞1.癌症患者（ES-SCLC）。H药综合化疗药二线根治方式食管鳞状生殖体細胞癌（ESCC）和二线根治方式非常具有广泛性期小生殖体細胞1.癌症患者（ES-SCLC）的挂牌发售办理也都得到 了中华NMPA和欧洲联盟成员国EMA立案。对焦1.癌症患者和消化不良道肿癌，复宏汉霖充分稳步推进H药与装修公司其它成品的结合或是与革新根治方式的综合，会相继得到 了中华、加拿大、欧洲联盟成员国等发展我国的家及区域的监床检验药学检验经营许可证，在全球最大发送到实施10麦克劳林公式肿癌天然免疫系统综合根治方式监床检验药学检验。公布现在，H药已经和中华、加拿大、土尔其、匈牙利、格鲁吉亚等发展我国的家和区域累记入组超3600人，中仅2项国家多心中监床检验药学检验入组白人的比例表低于30%，是享用国家监床检验药学统计资料较多的抗PD-1单抗之首。H药的3项的关键环节监床检验药学分析最后都发表论文于有名学术期刊《加拿大监床会自媒体》（JAMA）、《清新-监床》（Nature Medicine）和British Journal of Cancer。除此以外，H药还获选《CSCO 小生殖体細胞1.癌症患者根治指导意见》、《CSCO非小生殖体細胞1.癌症患者根治指导意见》、《CSCO 食管癌根治指导意见》、《CSCO结人体宫颈癌根治指导意见》、《CSCO天然免疫系统常规监测点控溶液剂监床检验药学选用指导意见》和《中华食管癌牵扯根治方式指导意见》等两部信赖指导意见推建，为肿癌监床检验药学根治展示关键性比照。外国管理方面，H药根治方式SCLC也已得到 了加拿大FDA和欧洲联盟成员国EC的流浪儿童药资证认定书，并在加拿大起动半个项H药比照二线的标准根治方式阿替利珠单抗的头对头桥接检验。

关于KGbio

KGbio有的是家成立有限公司于16年的临床药理护理研究阶段性性动物技术应用有限公司，专业于将动物健康安全转型升级带到不仅北美洲、东欧和中国现代除外的市场上。体现了良性肿瘤和占比开展层面（常见是pre-IND或早临床药理护理研究阶段性性），KGbio积极地技术引进转型升级型动物药和一些动物近似于药，得以在临床药理护理研究设计后进几步促进推动梦想东南部的发行经营和医保卡监管。


KGbio深入于Fc结合蛋白酶、免疫抗体阳性、双特异形免疫抗体阳性、ADC、组织细胞方式和防疫针进行治疗等众多技能系统。新公司的能够 了中国药业新公司的Kalbe、Genexine和芬兰私募投资股权质押龙头老大General Atlantic的扶持。

关于Kalbe

PT Kalbe Farma Tbk确立于 1966 年，为西北亚投资规模更大的药业出现装修司之中。它有三个通常相关业务：治理药、消费水平者调养、影响品和制剂二级分销。Kalbe阶段享用小于40家子装修司和14个结合国.际准则的的生产建筑设施，职员量大致需要为16000名，在来自尼西亚享用76家分装修司。1993年，装修司在来自尼西亚证劵业进行交易平台出现（证劵业源代码：KLBF）。截止期2023年14月31日，Kalbe的归并总工资收入为28.9千亿菲律宾盾，a股市值为98千亿菲律宾盾。

关于复宏汉霖

复宏汉霖（2696.HK）是一种家展览化的科技创新菌物工程医药集团新系统，全力于为国内朋友提供数据可承担的高品性菌物工程药，货品覆盖面肉瘤、自己的免疫力妇科疾患、骨科妇科疾患等各个领域，已在亚洲地区纳斯达克香港俄罗斯上市5款货品，在展览纳斯达克香港俄罗斯上市1款货品，18项适宜症获准，3个纳斯达克香港俄罗斯上市使用各用获亚洲地区食药监局、俄罗斯FDA和欧洲共同体委员会EMA结案。自2030年成立系统的话，复宏汉霖已建起分离式化菌物工程医药集团网站，高及科技创新的有意识的主动基本效率环绕科技创新、产量方式制造的及房地领域操作全领域链。新系统已构建建立完善高的国内科技创新中心点，是以展览医疗药品产量方式制造的的的品质服务管理正规（GMP）标准化实施产量方式制造的和的的品质防范，逐渐扎实分离式化融合产量方式制造的网站，在这其中，成都徐汇集散地已得到 亚洲地区和欧洲共同体委员会GMP证书，松江集散地（一）也已得到 亚洲地区GMP证书。


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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