复宏汉霖与Intas深入合作，携手护航H药扬帆欧洲、印度市场_新闻动态_新闻及媒体资源

复宏汉霖与Intas深入合作，携手护航H药扬帆欧洲、印度市场

颁布功夫:2023-10-27 内容起源于：浏览量：

20231030105600_6321

内容起源：复宏汉霖

H药汉斯状^{^®}（斯鲁利单抗）对表授权覆盖美国、欧洲、东南亚、中东和北非、印度；
Intas获得H药在欧洲和印度的独家开发和贸易化权利，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贸易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）颁发与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）蕴含宽泛期幼细胞肺癌（ES-SCLC）在内的多项适应症及特定剂型进行独家开发和贸易化的权势。复宏汉霖已于2018年6月与Intas子公司Accord发展合作，授予其汉曲优^{^®}在欧洲、部门中东及北非地域、部门独联体国度的独家贸易化权势，并于2021年进一步授予Intas汉曲优^®在美国及加拿大地域的独家开发与贸易化权势。

这次合作不仅标志取两家公司之间的战术同伴关系进一步深入，更为H药全球布局打开崭新的发展机缘。凭据和谈，复宏汉霖将掌管H药在欧洲和印度的临床开发及上市后的产品出产和供给，并将从这次买卖中获得4200万欧元的首付款、可达4300万欧元的监管里程碑付款、可达1亿欧元的贸易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。

20231030105559_3248

复宏汉霖执行董事、首席执行官兼首席财政官

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医治幼细胞肺癌的抗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月获得欧洲药品治理局 (EMA) 受理。通过与Intas进一步深入合作，我们但愿加快推动H药在全球领域内实现更宽泛的可及性，为改善本地患者的医治成效和生计质量贡献力量。

20231030105559_4983

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，我们缜密合作，持续推动汉曲优^®全球布局，使其成功在海表40多个国度和地域获批，惠及欧洲、中东和北非等地域患者。在汉曲优^{^®}成功合作的基础上，我们等待与Intas一路加快H药在欧洲和印度市场上市过程，一连并深入我们共同的愿景和承诺，向全球患者提供高品质、可职守的创新生物药。

20231030105559_7030 Intas副董事长兼董事总经理

Binish Chudgar先生

“我们很欣喜可能与复宏汉霖加强持久合作同伴关系。这次合作将进一步丰硕Intas的全球肿瘤产品管线，践行我们在全球领域内提供创新驱动解决规划的承诺。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沉要行动，援手全球更多患者得到实时、高质量的医治。

0?wx_fmt=png Accord欧洲中东和北非地域执行副总裁

Paul Tredwell先生

极度欣喜深入与复宏汉霖的合作同伴关系。即将在双方合作区域获批的斯鲁利单抗，有望进一步坚韧Accord在特药领域的辅导者职位，并意味着，短短两年我们即有望推出第二款候选创新药，且可能与我们在该地域供给占比高达25%的化疗药物形成‘组合拳’。这些体现了我们对创新和增长的承诺，也彰显了我们致力提高药物可及性、触达更宽泛患者，令其收成基于价值的医治的使命担任。

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、宽泛期幼细胞肺癌和食管鳞状细胞癌。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JAMA、Nature Medicine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，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。

2022年，H药医治SCLC相继获得美国食品和药品监督治理局（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、注册及贸易化等方面享受肯定的政策支持。H药一线医治ES-SCLC的欧盟上市许可申请（MAA）已于2023年3月获得欧洲药品治理局 (EMA) 受理，有望于2024年上半年获得核准。此表，公司稳步推动H药对比一线尺度医治阿替利珠单抗用于医治ES-SCLC的头仇家美国桥接试验，以进一步支持H药在美国的上市申报。

与此同时，复宏汉霖全速推动H药在海表市场的贸易化过程。此前，公司已与PT Kalbe Genexine Biologics（KGbio）达成合作和谈，授予其H药在东盟十国和中东和北非地域12个国度的独家开发和贸易化权势。除此之表，复宏汉霖与BB贝博艾弗森官网医药就H药达成美国市场贸易化合作。截止目前，H药对表授权已覆盖美国、欧洲、东南亚、中东和北非、印度等国度和地域。未来，公司将携手各位合作同伴全力推动H药的全球开发过程，令H药可能覆盖更宽泛的国度和地域，为更多患者提供更宽泛的医治选择。

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4项适应症获批上市，1项适应症上市申请在欧盟获受理，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）、宽泛期幼细胞肺癌（ES-SCLC）及食管鳞状细胞癌（ESCC）。H药结合化疗一线医治宽泛期幼细胞肺癌（ES-SCLC）的上市申请也获得欧盟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用于ES-SCLC的头仇家桥接试验。

关于Intas

Intas是一家当先的的全球药物造剂开发、造作和营销公司。该公司成立了一个名为Accord的子公司网络，用于在欧盟、美国、加拿大、南非、澳大利亚、亚太地域以及独联体和中东和北非地域的高度监管的市场中进行营销和销售。时至今日，Intas已在全球超过85个国度和地域发展业务，其69%以上的收入来自海表市场，重要集中于高度监管的欧盟和美国市场。

Intas目前在印度造药行业企业中排名第六（凭据IQVIA数据），也是印度最大的私营仿造药公司。在细分领域上，Intas在CNS、心血管、糖尿病、胃肠病和泌尿科等关键医治领域均已确立当先职位，但真正让其全球闻名的是在欧盟和美国的肿瘤学和其他医院医治领域的医药产品。

Intas业务的蓬勃增长与其在研发和造作方面的实力密不成分。Intas 现占有16个造作工厂，其中10个位于印度，其余位于英国、希腊和墨西哥，均获得美国FDA、EMA、MHRA、TGA等全球顶级监管机构的认可。公司每年研发投入占迸转业收入约6-7%。截至目前，Intas在全球占有10,000余项产品注册，并推出了300多种高价值FTF/FTM、生物仿造药和NDDS产品。

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，19项适应症获批，2个上市申请别离获美国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、宽泛期幼细胞肺癌和食管鳞状细胞癌，并成为全球首个获批一线医治幼细胞肺癌的抗PD-1单抗。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 Deepens Collaboration with Intas

to bring Henlius’ Novel anti-PD-1 mAb Serplulimab to Europe and India

The footprint of serplulimab now includes the United States, Europe, Southeast Asia, MENA, and India?
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)

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, 4 indications are approved for marketing in China, 1 marketing application is under review in 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 NMPA for the treatment of MSI-H solid tumours, squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC). Its marketing applications of the first-line treatment for ES-SCLC are under review by the EMA. Focusing 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 approvals in China, the U.S., the EU 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, HASIZHUANG was recommended by the CSCO Guidelines for Small Cell Lung Cancer, the CSCO Guidelines for Non-Small Cell Lung Cancer, the CSCO Guidelines for 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 U.S. FDA and the EC for the treatment of SCLC, and its bridging head-to-head trial in the United States to compare HANSIZHUANG to standard of care atezolizumab (anti-PD-L1 mAb) for the first-line treatment of ES-SCLC is well under way.

About Intas

Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing companies in the world. The company has set up a network of subsidiaries under the name Accord for marketing and selling in the highly regulated markets of EU, US, Canada, South Africa, Australia, Asia Pacific, CIS and MENA regions. Intas is present in 85+ countries worldwide with more than 69% of its revenue coming from global business, particularly the highly regulated markets of the EU and the US.

Currently ranked 6^th (As per IQVIA TSA AUGUST 2023 MAT) in the Indian pharmaceutical market, it is also the largest privately owned Indian generic pharmaceutical company. While Intas has established leadership in key therapeutic segments like CNS, Cardiovascular, Diabetology, Plasma Therapy, Cell and Gene Therapy, Gastroenterology, Urology and Oncology in India, the company is known for its range of products in Oncology and other hospital-based therapeutic segments in the EU and US.

Intas' success and growth are a direct influence of Intas' extensive R&D and manufacturing capabilities. Intas operates sixteen formulation manufacturing facilities, of which eleven are in India, and the rest in the U.K., Greece, and Mexico. Between them, the facilities are accredited by top global regulators such as the US FDA, EMA, MHRA, TGA, and others. Every year, the company invests 6-7% of its revenues in R&D. Currently, Intas has over 10,000 product registrations worldwide and a strategic pipeline of 300+ high-value FTF/FTM, Biosimilars and NDDS products.

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, 19 indications are approved worldwide, and 2 marketing applications have been accepted for review in 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 tumours, squamous non-small cell lung cancer (sqNSCLC) and extensive-stage small cell lung cancer (ES-SCLC), and esophageal squamous cell carcinoma (ESCC), making it the world's first anti-PD-1 mAb for the first-line treatment of SCLC. What's more, Henlius has conducted over 30 clinical studies for 16 products, expanding its presence in major markets as well as emerging markets.