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 方式来原于： 浏览量：

內容來源：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。

要根据协议书，复宏汉霖将开展H药在MENA城市退市后的品牌生产的和供应信息，并将从次网上交易中取得700万人民币的首买单款、有且仅有八百万人民币的核查公里数碑买单和H药在上述所说协作城市净业务员业务额从百分之三十五到百分其二十的特许经营权选用费。与此同时，复宏汉霖还将根据H药在西北亚、中东地区和北非协作城市内的累记净业务员业务额取得有且仅有6.6亿人民币的业务员业务公里数碑买单。

 
复宏汉霖总裁总裁大人实施官、总裁大人兼总裁总裁大人企业财务官 朱俊先是

H药是世界首只且现今惟一获准专业的疗法小神经细胞1.肺癌的抗PD-1单抗，依靠自己其出众的药用价值迄今为止已劳有所得逾20万名中国国家客户。你们相当开心继东南方方亚受权然后，再次与KGbio在东南亚中南部和北非中南部一同，得以不断地搭载和有效改善位置客户的疗法效率和发展产品。按照KGbio在新兴起来市面 厉害的商用化网洛和运营人员本事，你们达致，H药将为东南方方亚、东南亚中南部和北非中南部的客户带去新的期待与安全健康。

 
复宏汉霖首席总栽公司洽谈的发展官、公司洽谈拓张副总经理裁 曹平的美女
复宏汉霖和KGbio于二零一九年形成合作关系方式，夫妻之间始终坚持相互的预计和国家使命，促使进一部推动了汉斯状在西南亚地方的成功上市的进程。在之前的6年中，我们都并不是建立联系了积淀的合作关系方式根基，没有相互关键的驱动程序下，浮显出高速的协同作战现象。预计今后，在南美北非地方，复宏汉霖和KGbio将进一部切实加强分工协作，深入实际搜寻市場实力，为汉斯状享受新征程。
 
Kalbe高管会成员、KGbio高管会成员长 Sie Djohan大叔
他们高贵的灵魂欢迎语复宏汉霖在此与KGbio共谱配合。仅凭KGbio在东南亚和北非地的方式 和操作能力素质，三家司将同样进一步推动创新发展药的开发技术。

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。


这回对方仍会联手，将更加充分用各的网络资源和优势，提生认识促进改革H药在东西南亚、南美和北非区县的企业化发展，提生H药在新兴起来领域的可及性，为其他病人带动可负税的高茶叶品质科学创新动物药。

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6月，H药真正的适用加拿大发售，近年来快速可用于医疗微北斗卫星较高不安全稳定（MSI-H）实体模型瘤、鳞状非小細胞膜1.肝癌（sqNSCLC）及大量期小細胞膜1.肝癌（ES-SCLC）。H药联和技术化疗药不错医疗食管鳞状細胞膜癌（ESCC）和不错医疗大量期小細胞膜1.肝癌（ES-SCLC）的加拿大发售提交申请也各分为领取了欧洲国内NMPA和欧共体欧洲国内委员会EMA审理。集中1.肝癌和消化不好道肿癌，复宏汉霖及时进行H药与工司别的商品的信息化各类与多元化肯定保健法的联和技术，依次领取了欧洲国内、加拿大、欧共体欧洲国内委员会等欧洲国内及沿海地方的医美实践实验可靠性疲劳实验批准，在全球性同样开发10多项肿癌免役联和技术肯定保健法医美实践实验可靠性疲劳实验。截止期近年来，H药早已于欧洲国内、加拿大、墨西哥、匈牙利、格鲁吉亚等欧洲国内和沿海地方累算作组超3600人，中间2项香港国家多基地医美实践实验可靠性疲劳实验入组白人的比率可超过30%，是有香港国家医美实践实验数据分析较多的抗PD-1单抗之首。H药的3项主要性医美实践实验研究方案的结果各分为发布于知名度期刊报刊内容《加拿大医美会报刊内容》（JAMA）、《肯定-医美》（Nature Medicine）和British Journal of Cancer。然而，H药还评为《CSCO 小細胞膜1.肝癌诊治规范指引》、《CSCO非小細胞膜1.肝癌诊治规范指引》、《CSCO 食管癌诊治规范指引》、《CSCO结十二指肠癌诊治规范指引》、《CSCO免役检测点克中药制剂医美实践实验适用指引》和《欧洲国内食管癌放射学医疗指引》等多个权威认证指引比较适合，为肿癌医美实践实验诊治规范带来了首要考生。国外方便，H药医疗SCLC也已领取了加拿大FDA和欧共体欧洲国内委员会EC的流浪儿童药条件申报，并在加拿大启动的新一项H药对比分析不错标淮医疗阿替利珠单抗的头对头桥接可靠性疲劳实验。

关于KGbio

KGbio不是家成为于2017年的临床药学研究研究的时段.动物工程学体技能大公司，认准于将动物工程学体药业特色化带进不仅有美国、欧洲和中其它的市场中。围绕着 肺部肿瘤和定义冶疗科技领域（普通是pre-IND或尽早临床药学研究研究的时段.），KGbio提高认识入选特色化型动物工程学体药和区域动物工程学体累似药，以在临床药学研究研究搭建后进一步一个脚印推向要求省份的发行允许和医疗保险监管。


KGbio立足于Fc就结合核蛋白、抗原、双炎症因子朋友抗原、ADC、肿瘤细胞缓解方式和接种疫苗缓解等数个高技术app平台。平台实现了亞洲制药业平台Kalbe、Genexine和澳大利亚私募基金控股权科技巨头General Atlantic的兼容。

关于Kalbe

PT Kalbe Farma Tbk筹建于 1966 年，为西南亚市场规模极限的药业什么时候开卖子工司最为。它有4个重要业务部门：处方笺药、消耗者养生保健、营养价值品和非处方药代销。Kalbe如今成为不低于40家子子工司和14个推进国际性标准单位的分娩措施，員工用户大至为16000名，在非州尼西亚成为76家分子工司。1993年，子工司在非州尼西亚股票进行交易平台什么时候开卖（股票代码是什么：KLBF）。直到2023年111月31日，Kalbe的并成纯收入水平为28.95亿马来西亚盾，总价值为985亿马来西亚盾。

关于复宏汉霖

复宏汉霖（2696.HK）不是家展览化的科学有意识的主动信息化生态学制品学化工司，专业专注于为全.球女性带来可财政负担的高品性生态学制品学药，类软件遮盖良性肿瘤、自己免役的重大疾病、皮肤科的重大疾病等行业领域，已在中推出5款类软件，在展览推出1款类软件，18项满足症将建，3个推出请求分别是获中食药监局、意大利FDA和欧洲经济共同体EMA结案。自2012年确立今年以来，复宏汉霖已俊工立体式化生态学制品学化工的软件平台，有效及科学有意识的主动信息化的有意识的主动核心理念学习能力紧扣研制、生孩子及工业操作全第三产业化。司已形成更加完善有效的全.球科学有意识的主动信息化机构，可以依照展览进口药品生孩子质理维护技术规范（GMP）规则展开生孩子和质理安全控制，反复夯实基础立体式化合理生孩子的软件平台，这之中，上海市徐汇产业机地已得到 中和欧洲经济共同体GMP审核证书，松江产业机地（一）也已得到 中GMP审核证书。


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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