复宏汉霖与intas深化合作，携手护航h药扬帆欧洲、印度市场
内容来源：复宏汉霖
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h药 汉斯状®（斯鲁利单抗）对外授权覆盖美国、欧洲、东南亚、中东和北非、印度；
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intas获得h药在欧洲和印度的独家开发和商业化权益，复宏汉霖将获得4200万欧元首付款、可达1.43亿欧元的监管和商业化里程碑付款及及两位数比例的合作区域净利润特许权使用费。
2023年10月27日，复宏汉霖（2696.hk）宣布与intas pharmaceuticals limited （以下简称“intas”）达成合作，授予其在欧洲和印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）包括广泛期小细胞肺癌（es-sclc）在内的多项适应症及特定剂型进行独家开发和商业化的权利。复宏汉霖已于2018年6月与intas子公司accord展开合作，授予其汉曲优®在欧洲、部分中东及北非地区、部分独联体国家的独家商业化权利，并于2021年进一步授予intas汉曲优®在美国及加拿大地区的独家开发与商业化权利。
此次合作不仅标志着两家公司之间的战略伙伴关系进一步深化，更为h药全球布局打开崭新的发展机遇。根据协议，复宏汉霖将负责h药在欧洲和印度的临床开发及上市后的产品生产和供应，并将从此次交易中获得4200万欧元的首付款、可达4300万欧元的监管里程碑付款、可达1亿欧元的商业化里程碑付款及两位数比例的合作区域净利润特许权使用费。
复宏汉霖执行董事、首席执行官兼首席财务官
朱俊先生
凭借优异的疗效和数据质量，h药成为了全球首个获批一线治疗小细胞肺癌的抗pd-1单抗，目前在中国已获批4项适应症，惠及逾4万名中国患者，其欧盟的上市许可申请也于今年3月获得欧洲药品管理局 (ema) 受理。通过与intas进一步深化合作，我们希望加速推动h药在全球范围内实现更广泛的可及性，为改善当地患者的治疗效果和生存质量贡献力量。
复宏汉霖高级副总裁兼首席商务发展官
曹平女士
复宏汉霖和intas子公司accord于2018年达成合作。五年来，我们紧密协作，持续推动汉曲优®全球布局，使其成功在海外40多个国家和地区获批，惠及欧洲、中东和北非等地区患者。在汉曲优®成功合作的基础上，我们期待与intas一起加速h药在欧洲和印度市场上市进程，延续并深化我们共同的愿景和承诺，向全球患者提供高品质、可负担的创新生物药。
intas副董事长兼董事总经理
binish chudgar先生
“我们很高兴能够与复宏汉霖加强长期pg电子试玩网站免费的合作伙伴关系。此次合作将进一步丰富intas的全球肿瘤产品管线，践行我们在全球范围内提供创新驱动pg电子试玩网站免费的解决方案的承诺。推动斯鲁利单抗在欧洲和印度上市是我们提升先进生物药可及性的重要举措，帮助全球更多患者得到及时、高质量的治疗。
accord欧洲中东和北非地区执行副总裁
paul tredwell先生
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、广泛期小细胞肺癌和食管鳞状细胞癌。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jama、nature medicine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，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。
2022年，h药治疗sclc相继获得美国食品和药品监督管理局（fda）和欧盟委员会（ec）授予的孤儿药资格认定，有助于h药在美国和欧洲的研发、注册及商业化等方面享受一定的政策支持。h药一线治疗es-sclc的欧盟上市许可申请（maa）已于2023年3月获得欧洲药品管理局 (ema) 受理，有望于2024年上半年获得批准。此外，公司稳步推进h药对比一线标准治疗阿替利珠单抗用于治疗es-sclc的头对头美国桥接试验，以进一步支持h药在美国的上市申报。
与此同时，复宏汉霖全速推进h药在海外市场的商业化进程。此前，公司已与pt kalbe genexine biologics（kgbio）达成合作协议，授予其h药在东盟十国和中东和北非地区12个国家的独家开发和商业化权利。除此之外，复宏汉霖与复星医药就h药达成美国市场商业化合作。截止目前，h药对外授权已覆盖美国、欧洲、东南亚、中东和北非、印度等国家和地区。未来，公司将携手各位pg电子试玩网站免费的合作伙伴全力推动h药的全球开发进程，令h药能够覆盖更广泛的国家和地区，为更多患者提供更广泛的治疗选择。
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henlius deepens collaboration with intas
to bring henlius’ novel anti-pd-1 mab serplulimab to europe and india
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the footprint of serplulimab now includes the united states, europe, southeast asia, mena, and india
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intas to develop and commercialise serplulimab in europe and india; henlius to receive €42 million upfront payment, double-digit royalties and up to €143 million in regulatory and commercial milestone payments
shanghai, china, october 27, 2023 - shanghai henlius biotech, inc. (2696.hk) has entered into an exclusive license agreement with intas pharmaceuticals limited ("intas") for the development and commercialisation in europe and india for several indications including es-sclc, and specific formulation of hansizhuang (serplulimab injection), henlius’ novel anti-pd-1 mab. in june 2018, henlius and accord healthcare ltd., a subsidiary of intas, entered into a license agreement, under which henlius granted accord exclusive commercialisation rights of hlx02 (trastuzumab for injection, trade name in china: hanquyou; trade name in europe: zercepac®; trade names in australia: tuzucip®/trastucip®) in certain countries and regions in europe, the middle east, north africa, and the commonwealth of independent states. in 2021, henlius granted intas the exclusive rights to develop and commercialize hlx02 in the united states (u.s.) and canada.
this collaboration marks a deepening of the strategic partnership between the two companies and opens up new development opportunities for serplulimab's global layout. under the terms of the agreement, henlius will be responsible for clinical development, manufacturing and supply upon launch and will receive a €42 million upfront payment, up to €43 million in regulatory milestones, up to €100 million in commercial sales milestones, and double-digit royalties on net profit from intas in the licensed territory.
“with superior efficacy and data quality, hansizhuang (serplulimab) has become the world's first anti-pd-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer, and has been approved for 4 indications in china, benefiting over 40,000 chinese patients. its marketing application has been validated by the european medicines agency (ema) in march 2023,” said jason zhu, executive director, chief executive officer, and chief financial officer of henlius. “by continuously partnering with intas, we hope to accelerate serplulimab's wider accessibility globally and contribute to the improvement of patient outcomes.”
ping cao, senior vice president and chief business development officer of henlius, said, “henlius and intas first entered into a collaboration in 2018. over the past 5 years, we have worked closely together and expanded the internationalisation of hanquyou (zercepac® in europe), which has been successfully approved in 40 overseas countries, benefiting patients in europe and mena. building on the successful collaboration, we look forward to working with intas to accelerate the launch of serplulimab in europe and india, and to continue our mission to offering high-quality and affordable biologics to patients around the world.”
binish chudgar, vice-chairman & managing director, intas pharmaceuticals ltd., said, "we are excited to reinforce our long-standing partnership with henlius. this collaboration will further bolster intas' global oncology portfolio, underlining our commitment to delivering innovative healthcare solutions worldwide. the forthcoming launch of serplulimab in europe and india will mark a crucial landmark in our mission to enable access to advanced biologics, ensuring patients across the world receive the high-quality treatments they deserve."
paul tredwell, executive vice president of emena., accord, said, “i am delighted to strengthen our partnership with henlius. the launch of serplulimab will further solidify accord as a leader in providing specialty medicines. this marks our second novel launch in just two years, adding to our existing platform of supplying up to 25% of chemotherapy medicines in our region, exemplifying our commitment to innovation and growth and our mission to improve access to value-based medicines for patients.”
the company's first innovative product, hansizhuang (serplulimab), was approved in china in march 2022. at present, hansizhuang has been approved for 4 indications in china including msi-h solid tumour, squamous non-small cell lung cancer (sqnsclc), extensive-stage small cell lung cancer (es-sclc), and esophageal squamous cell carcinoma (escc). 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) and nature medicine. 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., enrolling more than 3,600 subjects globally. and the proportion of caucasians 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 applications all over the world in the future.
in 2022, serplulimab was successively granted orphan drug designations by the u.s. food and drug administration (fda) and the european commission (ec) for the treatment of sclc, which will enable it to benefit from certain policy support for research and development, registration, and commercialisation in the u.s. and europe. the ema has validated the application for serplulimab and it is expected to be approved in the first half of 2024. the company is also steadily advancing the bridging head-to-head trial in the u.s. to compare serplulimab to standard-of-care atezolizumab (anti-pd-l1 mab) for the first-line treatment of es-sclc to propel the product towards u.s. market approval.
in the meantime, henlius pro-actively advances the commercialisation of hansizhuang in overseas markets at high speed. henlius granted kgbio exclusive rights to develop and commercialize hansizhuang in 10 asean member countries and 12 mena countries. furthermore, henlius and fosun pharma have entered into an exclusive license agreement for hansizhuang in the u.s. hansizhuang’s coverage footprint now includes the u.s., europe, southeast asia, mena, and india.
in the future, henlius will join hands with its international partners to make full use of their respective resources and advantages to actively promote the development and commercialisation of hansizhuang globally, to enable it to cover a wider range of countries and regions and to provide more therapeutic choices for more patients.
about hansizhuang (serplulimab)
about intas
about henlius
