复宏汉霖扩大与kgbio的合作，共绘h药中东北非商业化蓝图-pg电子游戏官网官方网站

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。

h药是全球首个且目前唯一获批一线治疗小细胞肺癌的抗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。我们非常高兴继东南亚授权之后，再度与kgbio在中东和北非地区携手，以期持续支持和改善当地患者的治疗效果和生存质量。通过kgbio在新兴市场强大的商业化网络和运营能力，我们深信，h药将为东南亚、中东和北非地区的患者带去新的希望与健康。

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。

2022年3月，h药正式获批上市，目前可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（sqnsclc）及广泛期小细胞肺癌（es-sclc）。h药联合化疗一线治疗食管鳞状细胞癌（escc）和一线治疗广泛期小细胞肺癌（es-sclc）的上市申请也分别获得中国nmpa和欧盟ema受理。聚焦肺癌和消化道肿瘤，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，相继获得中国、美国、欧盟等国家及地区的临床试验许可，在全球同步开展10余项肿瘤免疫联合疗法临床试验。截至目前，h药已于中国、美国、土耳其、波兰、格鲁吉亚等国家和地区累计入组超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%，是拥有国际临床数据较多的抗pd-1单抗之一。h药的3项关键性临床研究结果分别发表于知名期刊《美国医学会杂志》（jama）、《自然-医学》（nature medicine）和british journal of cancer。此外，h药还荣获《csco 小细胞肺癌诊疗指南》、《csco非小细胞肺癌诊疗指南》、《csco 食管癌诊疗指南》、《csco结直肠癌诊疗指南》、《csco免疫检查点抑制剂临床应用指南》和《中国食管癌放射治疗指南》等多部权威指南推荐，为肿瘤临床诊疗提供重要参考。海外方面，h药治疗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药对比一线标准治疗阿替利珠单抗的头对头桥接试验。

关于kgbio

kgbio是一家成立于2016年的临床阶段生物技术公司，专注于将生物医药创新带入除了北美、西欧和中国以外的市场。围绕肿瘤和细分治疗领域（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分生物类似药，以期在临床开发后进一步推动目标地区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、细胞疗法和疫苗治疗等多个技术平台。公司得到了亚洲制药公司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制药上市公司之一。它有四个主要业务：处方药、消费者保健、营养品和药品分销。kalbe目前拥有超过40家子公司和14个接轨国际标准的生产设施，员工数量大约为16000名，在印度尼西亚拥有76家分公司。1991年，公司在印度尼西亚证券交易所上市（证券代码：klbf）。截至2022年12月31日，kalbe的合并总收入为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制药公司，致力于为全球患者提供可负担的高品质生物药，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个上市申请分别获中国药监局、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制药平台，高效及创新的自主核心能力贯穿研发、生产及商业运营全产业链。公司已建立完善高效的全球创新中心，按照国际药品生产质量管理规范（gmp）标准进行生产和质量管控，不断夯实一体化综合生产平台，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。

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.