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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 的内容来历于： 浏览量：

东西来源地：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。

由于合同书，复宏汉霖将负责任H药在MENA空间主板上市后的物品工作和供给，并将终是次在线交易中得到了700万欧元的首支付的款、至少400万欧元的核查飞机航程碑支付和H药在这些相互合作协议空间净售销额从百分之三十五到百分第二十的加盟权食用费。除此以外，复宏汉霖还将由于H药在东南方亚、中东地区和北非相互合作协议空间内的积累净售销额得到了至少6.6亿欧元的售销飞机航程碑支付。

 
复宏汉霖顶尖来执行官、总栽兼顶尖账务官 朱俊女士

H药是全国首位且阶段并不是新批不错疗法小细胞核肺肿瘤的抗PD-1单抗，根据其优良的诊治作用目前为止已造福逾叁万名中国现代人。当我们都愈来愈兴奋继西北亚权限然后，二次与KGbio在西北亚和北非沿海地方携手并进，以便持续性的支持和有效改善本地人的疗法功效和发展质。使用KGbio在兴盛专业市场变强的企业化手机网络和推广水平，当我们都相信，H药将为西北亚、西北亚和北非沿海地方的人带去新的还望与键康。

 
复宏汉霖顶尖公司办公发展前景官、公司办公户外拓展副总经理裁 曹平的美女
复宏汉霖和KGbio于2021年达到最终目标战略合作协议，夫妻之间贯彻同时体的战略最终目标和最终目标，会加快促使了汉斯状在东南方亚地段的美国上市历程。在上前的历经四年中，当我们不止建立起了源远流长的战略合作协议基本，正在同时体最终目标的动力下，展出现出位置的合作现象。预计未来十年，在南美北非地段，复宏汉霖和KGbio将进两步大力加强合作，深入群众开发餐饮市场发展潜力，为汉斯状揭开新征程。
 
Kalbe高管、KGbio高管长 Sie Djohan先生英文
我们的热枕受欢迎复宏汉霖其次与KGbio联手企业合作。根据KGbio在南美和北非东南部的空间布局和运维本事，俩家司将联合深入推进转型升级药的联合开发。

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。


旨在两方重新共促，将多方面通过分别的材料和优劣势，积极行动带动H药在西南亚、南美和北非城市的房地产业化多线程，增加H药在新型行业的可及性，为更高自身面临可不良影响的高优秀科技创新生态学药。

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。


明年三月，H药正规将建主板纳斯达克上市，近些年可以用于改善微北斗卫星高宽比不比较稳定（MSI-H）小平面瘤、鳞状非小生殖内部1.肺肺部肉瘤患者（sqNSCLC）及非常广期小生殖内部1.肺肺部肉瘤患者（ES-SCLC）。H药综合肺肺部肉瘤晚期化疗闽东南改善食管鳞状生殖内部癌（ESCC）和闽东南改善非常广期小生殖内部1.肺肺部肉瘤患者（ES-SCLC）的主板纳斯达克上市提交申请也分为兑换全国NMPA和欧洲共同体委员会EMA业务办理。集聚1.肺肺部肉瘤患者和吸收道肺部肉瘤，复宏汉霖更好地积极推进H药与装修公司另一设备的协作及及与什么是创新医治方式的综合，先后兑换全国、芬兰、欧洲共同体委员会等的国家的及的国家的药学冲击耐压检测检测允许，在全国同步操作实施10麦克劳林公式肺部肉瘤抗体检测综合医治方式药学冲击耐压检测检测。载止近些年，H药早已于全国、芬兰、土尔其、意大利、格鲁吉亚等的国家的和的国家累算入组超3600人，这当中2项国外性多平台药学冲击耐压检测检测入组白人的比例图突破30%，是有了国外性药学数据显示较多的抗PD-1单抗其中之一。H药的3项要点性药学研究方案数据分为刊登于老牌期刊论文《芬兰中医药学会报纸》（JAMA）、《天然-中医药学》（Nature Medicine）和British Journal of Cancer。然而，H药还获选《CSCO 小生殖内部1.肺肺部肉瘤患者的口腔会诊指引》、《CSCO非小生殖内部1.肺肺部肉瘤患者的口腔会诊指引》、《CSCO 食管癌的口腔会诊指引》、《CSCO结结肠癌的口腔会诊指引》、《CSCO抗体检测檢查点仰药制剂药学采用指引》和《全国食管癌放射性改善指引》等多个权威部门指引引荐，为肺部肉瘤药学的口腔会诊出具比较重要关联性。境外方向，H药改善SCLC也已兑换芬兰FDA和欧洲共同体委员会EC的弃婴药资证界定，并在芬兰起动一个多项H药相比较闽东南标淮改善阿替利珠单抗的头对头桥接冲击耐压检测检测。

关于KGbio

KGbio有的是家开办于17年的临床实验检验药理一分阶段微生态学工程技木司，专心致志于将微生态学工程健康安全信息化带除了英语美洲、西欧各国和中国有多于的整个市场。需紧紧围绕癌肿和相关性制疗的领域（一般是是pre-IND或前兆临床实验检验药理一分阶段），KGbio正面入选信息化型微生态学工程药和部位微生态学工程如此药，用来在临床实验检验药理开放后进这一步促使目标值国家的成功上市许证和社保准入条件。


KGbio深入于Fc要融合血清、表面抗原、双特女性朋友表面抗原、ADC、组织细胞保健法和肺炎疫苗进行治疗等另一个方法平台网站。单位得见了亚洲区域药厂单位Kalbe、Genexine和法国私募基金公司控股权大亨General Atlantic的苹果支持。

关于Kalbe

PT Kalbe Farma Tbk成立装修企业的于 1966 年，为西南亚整体规模最大的的药业有限装修企业的香港装修企业的产品之一。它有以下主要是业务员：药方药、网上大学生消费群体调理、营养摄入品和进口药品二级分销。Kalbe近些年具有超过了40家子装修企业的和14个接壤展览的标准的产出建筑设施，导购员數量为宜为16000名，在美国尼西亚具有76家分装修企业的。199半年，装修企业的在美国尼西亚证券公司商在线交易公司香港推出（证券公司商二维码：KLBF）。公布2020年15月31日，Kalbe的重新命名总纯收入为28.9千亿印度尼西亚盾，估值为98千亿印度尼西亚盾。

关于复宏汉霖

复宏汉霖（2696.HK）就是一家世界十大联盟化的改革自主创新性菌物工程工程医药厂装修机构，坚持自主创新性驱动于为世界各国人提高可依赖的高的品质菌物工程工程药，软件扩大肉瘤、人体天然免疫皮肤消化道疾病、眼科医生皮肤消化道疾病等方面，已在我国的推出5款软件，在世界十大联盟推出1款软件，18项适用于症应用，3个推出注册分开获我国的国家药监局局、USAFDA和欧共体EMA核发。自205年开办到现在，复宏汉霖已开建分立式化菌物工程工程医药厂机构，高及改革自主创新性的服务性治理的本质力量推动出产销售研发、出产销售及商业区市场运营全产业发展链链。装修机构已建设改善高的世界各国改革自主创新性学校，根据世界十大联盟货品出产销售高质量水平治理规范起来（GMP）标准化对其进行出产销售和高质量水平控管，频频打牢分立式化综合性出产销售机构，当中，伤害徐汇研学幼儿园已可以获得了我国的和欧共体GMPv身份验证，松江研学幼儿园（一）也已可以获得了我国的GMPv身份验证。


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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