复宏汉霖扩大与KGbio的合作，共绘H药中东北非贸易化蓝图_新闻动态_新闻及媒体资源

复宏汉霖扩大与KGbio的合作，共绘H药中东北非贸易化蓝图

颁布功夫:2023-09-12 内容起源于：浏览量：

20230913105946_5353

内容起源：复宏汉霖

H药汉斯状^{^®}（斯鲁利单抗）对表授权覆盖东南亚、中东和北非22个新兴市场国度；
KGbio新增H药在中东和北非地域12个国度的独家开发和贸易化权利，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）扩大与印度尼西亚造药公司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”）的独家许可与贸易化合作，授予其在沙特阿拉伯、阿联酋、埃及、卡塔尔、约旦、摩洛哥等12个中东和北非地域（MENA）国度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）蕴含宽泛期幼细胞肺癌（ES-SCLC）在内的两项适应症进行独家开发和贸易化的权利。复宏汉霖与KGbio已于2019年达成和谈，授予其H药在东盟十国的部门适应症及疗法的独家开发和贸易化权势。

凭据和谈，复宏汉霖将掌管H药在MENA区域上市后的产品出产和供给，并将从这次买卖中获得700万美元的首付款、至多800万美元的监管里程碑付款和H药在上述合作区域净销售额从百分之十五到百分之二十的特许权使用费。此表，复宏汉霖还将基于H药在东南亚、中东和北非合作区域内的累计净销售额获得至多6.5亿美元的销售里程碑付款。

复宏汉霖首席执行官、总裁兼首席财政官

朱俊先生

H药是全球首个且目前唯一获批一线医治幼细胞肺癌的抗PD-1单抗，凭借其优异的疗效迄今已惠及逾3万名中国患者。我们极度欣喜继东南亚授权之后，再杜纂KGbio在中东和北非地域携手，以期持续支持和改善本地患者的医治成效和生计质量。通过KGbio在新兴市场壮大的贸易化网络和运营能力，我们坚信，H药将为东南亚、中东和北非地域的患者带去新的但愿与健康。

复宏汉霖首席商务发展官、商务拓展副总裁

曹平女士

复宏汉霖和KGbio于2019年达成合作，双方秉持共同的愿景和使命，加快推动了汉斯状在东南亚地域的上市过程。在从前的4年中，我们不仅成立了深厚的合作基础，还在共同指标的驱动下，展示出高度的协同效应。瞻望未来，在中东北非地域，复宏汉霖和KGbio将进一步加强合作，深刻挖掘市场潜力，为汉斯状开启新的篇章。

Kalbe董事、KGbio董事长

Sie Djohan先生

我们周到欢迎复宏汉霖再次与KGbio携手合作。凭借KGbio在中东和北非地域的布局和运营能力，两家公司将共同推动创新药的开发。

H药汉斯状^®为复宏汉霖自主研发的沉组人源化抗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医治微卫星高度不不变（MSI-H）实体瘤、鳞状非幼细胞肺癌和宽泛期幼细胞肺癌。凭借突破性疗效和差距化优势，H药展示出了壮大的市场竞争力，获得了业内宽泛认可，其多项关键性临床钻研了局颁发于〖国医学会杂志》（JAMA）等国际驰名期刊。复宏汉霖积极推动H药与公司其他产品的协同以及与创新疗法的结合，在全球同步发展十余项肿瘤免疫结合疗法临床试验，宽泛覆盖肺癌、食管癌和胃癌等适应症，全面覆盖肺癌一线医治。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表市场的申报，也为全球性临床利用奠定基础。

这次双方再度携手，将充分利用各自的资源和优势，积极推动H药在东南亚、中东和北非地域的贸易化过程，提高H药在新兴市场的可及性，为更多患者带来可职守的高品质创新生物药。

关于H药汉斯状^®

H药汉斯状^{^®}为沉组人源化抗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医治幼细胞肺癌的抗PD-1单抗，目前已有3项适应症获批上市，2项适应症上市申请别离在中国和欧盟获受理，10余项临床试验同步在全球发展。

2022年3月，H药正式获批上市，目前可用于医治微卫星高度不不变（MSI-H）实体瘤、鳞状非幼细胞肺癌（sqNSCLC）及宽泛期幼细胞肺癌（ES-SCLC）。H药结合化疗一线医治食管鳞状细胞癌（ESCC）和一线医治宽泛期幼细胞肺癌（ES-SCLC）的上市申请也别离获得中国NMPA和欧盟EMA受理。聚焦肺癌和消化路肿瘤，复宏汉霖积极推动H药与公司其他产品的协同以及与创新疗法的结合，相继获得中国、美国、欧盟等国度及地域的临床试验许可，在全球同步发展10余项肿瘤免疫结合疗法临床试验。截至目前，H药已于中国、美国、土耳其、波兰、格鲁吉亚等国度和地域累计入组超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%，是占有国际临床数据较多的抗PD-1单抗之一。H药的3项关键性临床钻研了局别离颁发于驰名期刊〖国医学会杂志》（JAMA）、《天然-医学》（Nature Medicine）和British Journal of Cancer。此表，H药还荣获《CSCO 幼细胞肺癌诊疗指南》、《CSCO非幼细胞肺癌诊疗指南》、《CSCO 食管癌诊疗指南》、《CSCO结直肠癌诊疗指南》、《CSCO免疫查抄点抑造剂临床利用指南》和《中国食管癌放射医治指南》等多部权威指南推荐，为肿瘤临床诊疗提供沉要参考。海表方面，H药医治SCLC也已获得美国FDA和欧盟EC的孤儿药资格认定，并在美国启动了一项H药对比一线尺度医治阿替利珠单抗的头仇家桥接试验。

关于KGbio

KGbio是一家成立于2016年的临床阶段生物技术公司，专一于将生物医药创新带入除了北美、西欧和中国以表的市场。萦绕肿瘤和细分医治领域（通常是pre-IND或早期临床阶段），KGbio积极引进创新型生物药和部门生物类似药，以期在临床开发后进一步推动指标地域的上市许可和医保准入。

KGbio深耕于Fc融合蛋白、抗体、双特异性抗体、ADC、细胞疗法和疫苗医治等多个技术平台。公司得到了亚洲造药公司Kalbe、Genexine和美国私募股权巨头General Atlantic的支持。

关于Kalbe

PT Kalbe Farma Tbk成立于 1966 年，为东南亚规模最大的造药上市公司之一。它有四个重要业务：处方药、消费者保健、养吩旆和药品分销。Kalbe目前占有超过40家子公司和14个接轨国际尺度的出产设施，员工数量约莫为16000名，在印度尼西亚占有76家分公司。1991年，公司在印度尼西亚证券买卖所上市（证券代码：KLBF）。截至2022年12月31日，Kalbe的归并总收入为28.9万亿印尼盾，市值为98万亿印尼盾。

关于复宏汉霖

复宏汉霖（2696.HK）是一家国际化的创新生物造药公司，致力于为全球患者提供可职守的高品质生物药，产品覆盖肿瘤、自身免疫疾病、眼科疾病等领域，已在中国上市5款产品，在国际上市1款产品，18项适应症获批，3个上市申请别离获中国药监局、美国FDA和欧盟EMA受理。自2010年成立以来，复宏汉霖已建成一体化生物造药平台，高效及创新的自主主题能力贯通研发、出产及贸易运营全产业链。公司已成立美满高效的全球创新中心，依照国际药品出产质量治理规范（GMP）尺度进行出产和质量管控，不休夯实一体化综合出产平台，其中，上海徐汇基地已获得中国和欧盟GMP认证，松江基地（一）也已获得中国GMP认证。

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，并全面推动基于自有抗PD-1单抗H药汉斯状^{^®}的肿瘤免疫结合疗法。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）已获批用于医治微卫星高度不不变（MSI-H）实体瘤、鳞状非幼细胞肺癌和宽泛期幼细胞肺癌，成为全球首个获批一线医治幼细胞肺癌的抗PD-1单抗，其食管鳞状细胞癌适应症的上市注册申请也在审评中。公司亦同步就16个产品在全球领域内发展30多项临床试验，对表授权全面覆盖欧美主流生物药市场和多多新兴市场。

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.