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 资源种类于： 浏览量：

方式特征：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。

选择合同协议，复宏汉霖将责任H药在MENA地区香港上市后的品牌的生产和供给，并将从此以后次交易所中刷快700万外币的房子首汇款、恰有400万外币的监管部门里数数碑汇款和H药在以上的媒体协作地区净消售额从百分之三十五到百分第二十的加盟权用到费。还有就是，复宏汉霖还将应用于H药在西北亚、南美和北非媒体协作地区内的累加净消售额刷快恰有6.五亿外币的消售里数数碑汇款。

 
复宏汉霖小说总裁履行官、小说总裁兼小说总裁财务会计官 朱俊先森

H药是世界各国首只且如今一个新批超一线手术手术治疗小组织细胞肺肿瘤的抗PD-1单抗，依靠自己其比较好的药效现今已劳有所得逾20万名.我.我。.我异常开心快乐继西北亚认证后面，悄然与KGbio在中东沿海地区位置和北非位置一同，用长期持续不断认可和调节本地人.我的手术治药效果好和荒岛生存效率。确认KGbio在新兴起来行业坚强的工商品化网洛和推广专业能力，.我达致，H药将为西北亚、中东沿海地区位置和北非位置的.我带去新的还望与健康生活。

 
复宏汉霖首席小说总裁商务活动旅行壮大官、商务活动旅行拓展活动总监裁 曹平女人
复宏汉霖和KGbio于二零一九年形成相互企业合作，两方坚持双方的规划和责任，促使驱动包了汉斯状在东西南亚省份的发行程序。在去的多年中，我并不是建立起了深的成语的相互企业合作基础上，在双方方向的驱动包下，展露出位置的区域合作调节作用。构想未来生活，在中东东南部北非省份，复宏汉霖和KGbio将进三步增进区域合作，渗入开发股票市场优势，为汉斯状启动新的起点。
 
Kalbe高管、KGbio高管长 Sie Djohan太太
我真诚受欢迎复宏汉霖再度与KGbio携手并肩配合。凭着KGbio在南美和北非地方的调整布局和推广能力素质，三家平台将共同的统筹推进创新发展药的规划设计。

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。


旨在两方缘何共话，将全面合理利用各有的材料和特点，正面积极推动H药在西北亚、东南亚和北非地域的业务化多线程，增强H药在新的市场的可及性，为一些病患分享可负荷的高品行创新发展生物体药。

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。


22年11月，H药首次新批开卖，近几年可作于治療微通讯卫星相对高度不不稳定性（MSI-H）企业瘤、鳞状非小細胞系非小細胞1.1.肝癌症（sqNSCLC）及常见期小細胞系非小細胞1.1.肝癌症（ES-SCLC）。H药整合1.肝癌症晚期化疗中俄原油管道治療食管鳞状細胞系癌（ESCC）和中俄原油管道治療常见期小細胞系非小細胞1.1.肝癌症（ES-SCLC）的开卖申请书也各为取得中NMPA和欧洲共同体EMA审理。焦聚非小細胞1.1.肝癌症和化解道癌症，复宏汉霖充分推进项目建设H药与厂家许多商品的分工协作以其与自主创新中医療法的整合，先后取得中、瑞典、欧洲共同体等国及祖国的监床测试可证，在有名云同步开始10多个癌症免疫系统性整合中医療法监床测试。累计近几年，H药现已中、瑞典、土尔其、芬兰、格鲁吉亚等国和祖国累算作组超3600人，这其中2项有名多公司监床测试入组白人的数量不低于30%，是拥有着有名监床参数较多的抗PD-1单抗一个。H药的3项主要性监床探究效果各为发布于有名杂质《瑞典分子生物学专业会杂质》（JAMA）、《生态-分子生物学专业》（Nature Medicine）和British Journal of Cancer。除外，H药还评选为《CSCO 小細胞系非小細胞1.1.肝癌症医疗服务须知》、《CSCO非小細胞系非小細胞1.1.肝癌症医疗服务须知》、《CSCO 食管癌医疗服务须知》、《CSCO结十二指肠癌医疗服务须知》、《CSCO免疫系统性体检点遏剂型监床用途须知》和《中食管癌放射学治療须知》等两部公信力须知推存，为癌症监床医疗服务具备重要性考生。在海外工作方面，H药治療SCLC也已取得瑞典FDA和欧洲共同体EC的弃婴药机会核实，并在瑞典再启动新一项H药比对中俄原油管道标淮治療阿替利珠单抗的头对头桥接测试。

关于KGbio

KGbio就是一家解散于2018年的诊疗实践的关键期菌物技术设备企业，主要是于将菌物医药业特色化带进去不仅北美洲、西欧各国和国家之间的销售市场。努力实现肺部肿瘤和占比治疗方法范畴（普通是pre-IND或所以，金星由于这些原因诊疗实践的关键期），KGbio更好地扶植特色化型菌物药和一些菌物近似于药，以求在诊疗实践规划设计后进那步促进改革要求的地方的面市准许和医保卡准入条件。


KGbio发展壮大于Fc溶合蛋清、抗原、双炎症因子朋友抗原、ADC、癌细胞自然疗法和狂犬疫苗医疗等两个高技术APP。有限大公司拥有了亚太地区制药企业有限大公司Kalbe、Genexine和英国私募基金公司股份权科技巨头General Atlantic的适用。

关于Kalbe

PT Kalbe Farma Tbk开办于 1966 年，为西南亚经营规模较大 的药厂发行子集团最为。它有3个最主要金融产品：药方药、消费需求者按摩保健、营养价值品和医疗药品二级分销。Kalbe当前存在已超40家子子集团和14个融入时代国际规范标准的制造的设施，员工离职总数大致需要为16000名，在印度尼西亚是尼西亚存在76家分子集团。1992年，子集团在印度尼西亚是尼西亚证券基金公司买卖交易公司发行（证券基金公司代码是什么：KLBF）。到2020年1二月31日，Kalbe的并入总盈利为28.95亿菲律宾盾，估值为985亿菲律宾盾。

关于复宏汉霖

复宏汉霖（2696.HK）是家亚太上化的多元化海洋生物技术工程海洋生物技术药业有限集团机构，秉承于为亚太患有带来可付出的高品控海洋生物技术工程药，企业物料设备复盖淋巴肿瘤、自身业务免疫检测慢性病、眼科整形慢性病等研究方向，已在我国的市场销售5款企业物料设备，在亚太成功开卖场销售1款企业物料设备，18项适合症获准，3个市场销售个人申请各获我国的国家药监局局、新西兰FDA和欧盟委员会国家EMA审理。自20十年成立集团建国以来，复宏汉霖已建造混合式化海洋生物技术工程海洋生物技术药业有限集团app游戏平台，有效及多元化的自动主要实力影响产出制造、产出及企业运作全服务业链。机构已建立起更加完善有效的亚太多元化重心，依照亚太上医疗耗材产出效率管理工作管理工作实验室管理的标准（GMP）的标准对其进行产出和效率管理工作监督控制，一个劲压实混合式化总体产出app游戏平台，里面，成都徐汇幼儿园已刷快我国的和欧盟委员会国家GMP注册，松江幼儿园（一）也已刷快我国的GMP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.



讲解
上一条：2023Protechting科创研讨会：汇聚青春力量，驱动科技创新 下一条：Fosun for Love「99公益日」感谢一块做好事的你！
x

抖音二维码

扫解决