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:2024-09-12 內容特征于： 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。

选择合同，复宏汉霖将负责任H药在MENA城市市场推销后的设备出产和供应信息，并将从次次的交易中有700万人民币的房子首付钱、最多八百万人民币的核查公里数碑付钱和H药在以上的加盟城市净推销额从11%五到百分之一十的许可权选择费。除此之外，复宏汉霖还将体系结构H药在西南亚、中东地区和北非加盟城市内的累记净推销额有最多6.五亿人民币的推销公里数碑付钱。

 
复宏汉霖首席总裁总栽来执行官、总栽兼首席总裁总栽财务部门官 朱俊教授

H药是全球最大正式启动且当下仅仅应用带兵人治疗方法方法小细胞系癌症的抗PD-1单抗，仰仗其成绩突出的成效有史以来已受益逾2万名国家提高。我门如此快乐继西北方亚认证以来，正式宣布与KGbio在南美和北非的的地方携手并肩，以求一直支撑和改善使用效果当地的提高的治疗方法方法使用效果和我的世界生存产品品质。依据KGbio在兴新行业专业的金融业化网路和营销效率，我门相信，H药将为西北方亚、南美和北非的的地方的提高带去新的期盼与安全健康。

 
复宏汉霖顶尖商务会展电话发展方向官、商务会展电话括展总经理裁 曹平女仕
复宏汉霖和KGbio于17年实现的目标合作的的，男女双方秉承同时的的愿望和使命6，加速度着力推进了汉斯状在东西南亚中南部的推出系统进程。在上去的3年中，我不单树立了极深的合作的的基础框架，还会在同时的目标的驱动程序下，呈出现高的携手反应。发展规划未来生活，在中东东南部北非中南部，复宏汉霖和KGbio将进一大步切实提高协同工作，深化深入挖掘茶叶市场竞争力，为汉斯状已经打响新的起点。
 
Kalbe执行监事、KGbio执行监事长 Sie Djohan太太
人们热情欢迎词复宏汉霖再者与KGbio携手同行配合。靠着KGbio在东南亚和北非地的规划和运营策划特性，两户工司将相同助推改革创新药的制作。

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。


报好名的两人之间重新携手共进，将全面应用彼此的資源和优劣势，积极地推动H药在西南亚、中东区域和北非区域的商业运作化流程，提供H药在新起来专业市场的可及性，为许多的人有可财政负担的高高质量去创新怪物药。

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。


2020年三月，H药即日起新批香港退市，现如今可于方法微卫星信号角度不平稳（MSI-H）实体模型瘤、鳞状非小人体体受损神经组织癌症患者（sqNSCLC）及范围广期小人体体受损神经组织癌症患者（ES-SCLC）。H药连合放化疗闽东南方法食管鳞状人体体受损神经组织癌（ESCC）和闽东南方法范围广期小人体体受损神经组织癌症患者（ES-SCLC）的香港退市申办也区分领取了环球NMPA和欧洲共同体国内 国内 EMA审理。焦点癌症患者和消化酶道癌症，复宏汉霖正极深入推进H药与公司的品牌的协同管理及其与的创新方法的连合，前不久领取了环球、新西兰、欧洲共同体国内 国内 等国内 及地域的监床医美护理冲击现场实验经营，在环球数据统计同步搞好10多项癌症免疫细胞抗体连合方法监床医美护理冲击现场实验。截止日现如今，H药早已于环球、新西兰、土尔其、匈牙利、格鲁吉亚等国内 和地域累计到组超3600人，当中2项国家多咨询中心监床医美护理冲击现场实验入组白人的身材比例不低于30%，是存在国家监床医美护理数据统计较多的抗PD-1单抗之三。H药的3项关键点性监床医美护理研究探讨没想到区分刊发于前十强期刊论文《新西兰医美会刊物》（JAMA）、《当然-医美》（Nature Medicine）和British Journal of Cancer。还有就是，H药还评为《CSCO 小人体体受损神经组织癌症患者医疗机构手册》、《CSCO非小人体体受损神经组织癌症患者医疗机构手册》、《CSCO 食管癌医疗机构手册》、《CSCO结结肠癌医疗机构手册》、《CSCO免疫细胞抗体定期检查站能够抑药品监床医美护理APP手册》和《环球食管癌射线方法手册》等多首权威部门手册建议，为癌症监床医美护理医疗机构提供了至关重要参考选取。海外网站的方面，H药方法SCLC也已领取了新西兰FDA和欧洲共同体国内 国内 EC的孤寡药资证判定，并在新西兰运行一项H药比照闽东南标准的方法阿替利珠单抗的头对头桥接冲击现场实验。

关于KGbio

KGbio就是一家开办于16年的诊疗试验的时候生物体工程体方法方法机构，悉心于将生物体工程体方法医疗器械科学信息化进入用来美国、欧洲和国内 范围内的销售市场。展开讨论癌肿和定义治療领域（通畅是pre-IND或较早诊疗试验的时候），KGbio积极进取获批科学信息化型生物体工程体方法药和的部分生物体工程体方法内似药，以便在诊疗试验的开发后进十步促进改革总体目标省份的美国上市允许和社保市场准入。


KGbio发展于Fc构建球蛋白、表面抗原、双活性朋友表面抗原、ADC、受损细胞的治疗法和肺炎疫苗的治疗等众多技木的平台。工厂受到了全球药厂工厂Kalbe、Genexine和欧美私募基金股份权国内巨头General Atlantic的能够。

关于Kalbe

PT Kalbe Farma Tbk创立于 1966 年，为东南方亚需求量重要的制作药物退市子集团之六。它有三个重要业务部：处方药药、消费水平者养身、养分品和药物分销系统。Kalbe现阶段具有低于40家子子集团和14个结合国家要求的加工服务设施，业务人员需求量大慨为16000名，在土耳其尼西亚尼西亚具有76家分子集团。1993年，子集团在土耳其尼西亚尼西亚证劵转让所退市（证劵代碼：KLBF）。截止目前2023年1二月31日，Kalbe的合拼总使收入为28.9一万亿马来西亚盾，市场估值为98一万亿马来西亚盾。

关于复宏汉霖

复宏汉霖（2696.HK）是家國际化的信息化微怪物怪物制作消毒产品子司，专注于于为国内 人群具备可的负担的高产品微怪物药，软件覆盖住淋巴肿瘤、自己抗体病症状、骨科病症状等方面，已在国内 主板推出5款软件，在國际主板推出1款软件，18项自我调节症应用，3个主板推出使用不同获国内 国家药监局局、俄罗斯FDA和欧共体国家EMA结案。自206年组建开始，复宏汉霖已成立 二合一化微怪物怪物制作消毒产品渠道，便捷及信息化的人工控制重要程度影响开发、产生销售及工商业营销全制造业链。子司已建造逐步完善便捷的国内 信息化机构，根据國际消毒产品产生销售产品管理系统制约（GMP）标准规范去产生销售和产品严格监督，不断的抓实二合一化全方位的产生销售渠道，其中的，广州徐汇基底已取得国内 和欧共体国家GMPv注册，松江基底（一）也已取得国内 GMPv注册。


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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