增加汉曲优®美国及加拿大授权，复宏汉霖携手Accord全面覆盖欧美市场
2020年9月30日，复宏汉霖（香港联交所代码：2696）宣布与Accord Healthcare Inc.（简称“Accord US”）达成合作共识，授予其在美国及加拿大地区对HLX02（曲妥珠单抗，中国商品名：汉曲优®，欧盟商品名：Zercepac®）的独家开发与商业化权益。本次合作的达成，标志着HLX02的商业化布局已全面覆盖欧美主流生物药市场，能够代表中国生物类似药参与国际竞争，有望为全球患者带来质高价优的治疗方案。
基于合作条款，Accord US将向复宏汉霖支付的主要里程碑款项包括：1）于正式许可协议签署后支付的首付款2700万美元；2）监管里程碑付款，共计不超过1300万美元，基于复宏汉霖取得的研究数据，Accord US将负责完成HLX02在美国和加拿大的注册申报工作及取得上市许可；3）销售里程碑付款，将依照区域内累计净销售额支付，每达到5亿美元净销售额则向复宏汉霖支付2500万美元。此外，复宏汉霖未来还将有资格获得两位数比例的净利润分级特许权使用费，最高可至50%。根据IQVIA报告显示，2019年曲妥珠单抗及其生物类似药在北美地区的市场规模已逾30亿美元，且患者用药需求逐年增长。当HLX02在美国和加拿大的销售额累计达到30亿美元时，复宏汉霖预计可获得销售里程碑付款1.5亿美元。
汉曲优®（欧盟商品名：Zercepac®）为复宏汉霖按照欧盟和中国生物类似药法规自主开发生产的曲妥珠单抗，于2020年7月及8月先后获得欧盟委员会与中国国家药监局批准上市，成为首个中欧双批的国产单抗生物类似药，且获批了原研曲妥珠单抗的所有适应症，包括：1）HER2阳性早期乳腺癌；2）HER2阳性转移性乳腺癌；3）HER2阳性转移性胃腺癌或胃食管交界腺癌。汉曲优®在国内市场的商业化由复宏汉霖自主商业化团队负责推进，目前其首张处方已落地，正式进入临床应用。该产品在欧盟的商业化由合作伙伴Accord Healthcare Ltd（Accord UK）负责，将陆续在全部欧盟成员国以及欧洲经济区国家挪威、冰岛和列支敦士登上市销售，近期已率先登陆英国、德国、葡萄牙和西班牙。
复宏汉霖前瞻性地就HLX02开展了全球商业化布局。2018年6月，公司与Accord UK签订许可协议，授予其HLX02在欧洲地区、部分中东及北非地区、部分独联体国家的独家商业化权利。此后，双方于2020年6月达成进一步合作，就HLX02新增规格及其对应里程碑付款安排、许可使用费调整等作出约定，以期降低患者单位剂量的用药成本，满足患者个性化的用药需求，为持续开拓海外市场做好铺垫。基于复宏汉霖与Accord UK的友好合作，Accord对复宏汉霖的产品质量和业界领军地位信心不断加强，并积极促成了此次复宏汉霖与Accord US的合作。这既是国际市场对于复宏汉霖自主研发的高质量生物药的进一步认可，更是复宏汉霖积极推进国际化布局的重要举措。Accord US总裁Jeff Hampton先生表示，“我们很高兴能与Henlius就HLX02进一步在北美市场的推广达成合作。本次合作的达成，是我们对提供优质可负担的产品，改善肿瘤患者用药可及性承诺的再次践行，而HLX02也将为Accord现有的丰富肿瘤治疗管线再添异彩。”
进军欧美主流生物药市场的同时，公司也将开拓新兴市场作为全球化战略的重点。除Accord之外，复宏汉霖还与雅各臣药业、Cipla及Mabxience等多家全球领先的医药公司达成战略商业化合作，截止目前已全面覆盖中国香港、中国澳门、马来西亚、澳大利亚、新西兰、哥伦比亚、阿根廷、乌拉圭、巴拉圭，以及欧洲、中东-北非及独联体80多个国家及地区。未来，复宏汉霖将以HLX02作为打造产品国际品质、走向国际市场的优秀案例，持续践行“可负担的创新·值得信赖的品质”的核心理念，不断拓展更多产品的国际化布局，让中国‘质’造的高品质生物药惠及全球更多病患，成为全球最受信赖的创新生物医药公司。
关于Accord
Accord US与Accord UK（复宏汉霖HLX02在欧盟等地区的合作伙伴）同为Intas Pharmaceuticals Limited的附属公司。Accord US于2005年在美国注册成立，专注于医院市场领域，且聚焦于肿瘤学，中枢神经和其他重症监护领域，目前已获得129项仿制药批准。Intas成立于1976年，总部位于印度，主要从事全球范围内的药物制剂成品、活性药 物成分、医疗器械和医疗用品的制造、营销、分销及销售。
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质高价优的创新生物药，产品覆盖肿瘤、自身免疫疾病等领域。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。公司在中国上海、中国台北和美国加州均设有研发中心，按照国际GMP标准进行生产和质量管控，位于上海徐汇的生产基地已获得中国和欧盟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HLX10的肿瘤免疫联合疗法。截至目前，公司已成功上市国内首个生物类似药汉利康Ⓡ（利妥昔单抗），首个中欧双批的国产生物类似药汉曲优Ⓡ（曲妥珠单抗，欧盟商品名：Zercepac），HLX03阿达木单抗与HLX04贝伐珠单抗上市注册申请正在审评中，其中HLX03已获得优先审评审批资格，有望于今年上市。复宏汉霖同步就10个产品、8个联合治疗方案于全球范围内开展20多项临床试验，产品对外授权覆盖全球近100个国家和地区。
Henlius granted exclusive development and commercialisation rights of HLX02 in the US and Canada to Accord
Shanghai, China, September, 30th, 2020 - Shanghai Henlius Biotech, Inc. (2696.HK) announced the Company entered into a collaboration with Accord Healthcare Inc. (Accord US), according to which Henlius will grant an exclusive license to Accord US to develop and commercialise HLX02 (trastuzumab biosimilar, Chinese brand name: 汉曲优®, EU brand name: Zercepac®) in the United States of America and Canada. With this collaboration, the commercialisation footprint of HLX02 has the potential to cover most of the global mainstream markets of biologics and to bring high-quality and affordable treatment options to global patients.
According to the amendment, relevant milestone payments from Accord US to Henlius include 1) upfront payment of US$27 million upon signature of the definitive agreement; 2) regulatory milestone payments of no more than US$13 million in total and Accord US will be responsible for regulatory filing in the United States of America and Canada, based on research data from Henlius; 3) commercial sales milestone payments of US$25 million for every US$500 million of cumulative net sales. Henlius will also be eligible to receive a tiered double digit royalty up to 50% of future net profit of HLX02. According to data from IQVIA, the total sales of the trastuzumab originator and its biosimilars has exceeded US$3 billion in 2019 in North America, with patient demand increasing year by year. Once the cumulative net sales of HLX02 reach US$3 billion in the United States of America and Canada, Henlius shall recieve a total of US$150 million from commercial sales milestone payments.
汉曲优®(EU brand name: Zercepac®) is a trastuzumab biosimilar independently developed by Henlius. The development process strictly followed the European Medicines Agency (EMA) and National Medical Products Administration (NMPA) biosimilar guidelines, and the product has been approved by the European Commission (EC) and the NMPA successively in July and August 2020, making it the first China-developed monoclonal antibody (mAb) biosimilar approved both in China and in the EU. Indications approved for this product include HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer, which correspond to all the indications approved for the trastuzumab originator. Henlius has built an in-house commercial team to be responsible for the commercialisation of 汉曲优® in China and the product has already been prescribed and used in clinical practice in China. Henlius collaboration partner, Accord Healthcare Ltd (Accord UK), is responsible for the commercialisation of this product in the EU. Zercepac® will been launched in all EU Member States, Iceland, Norway and Liechtenstein, and has recently been launched in the UK, Germany, Portugal and Spain.
Henlius has formed multiple global partnership to accelerate the global commercialisation of HLX02. In June 2018, Henlius and Accord UK entered into a license agreement, under which Henlius granted Accord UK exclusive commercialisation rights of HLX02 in certain countries and regions in Europe, the Middle East, North Africa and the Commonwealth of Independent States. In June 2020, Henlius and Accord UK reached an amendment to the above-mentioned license agreement in regards of new dosage forms, arrangement of milestone payments and adjustment of royalties, with the aim to lower the unit cost for patients, enable flexible dosage combination and to satisfy customised dosing needs. The close collaboration between Accord UK and Henlius greatly strengthened Accord’s confidence in the quality of Henlius products, which has catalized the collaboration between Accord US and Henlius. The collaboration with Accord US is not only another recognition of Henlius’ independently developed and high-quality biologics from the global market but also an important step for Henlius to implement the Company’s global strategy. Jeff Hampton, President, Accord US said, “We are excited to expand our relationship with Henlius for the US and Canadian market for this product. This agreement further reinforces our commitment to bring high-quality, affordable medicines to improve patient access for the treatment of oncology, and this product will be a key addition to our already extensive oncology portfolio”.
Henlius will not only expand its footprint in the mature markets in Europe and North America, but also keep exploring emerging markets as its strategy focus. In addition to Accord, Henlius has also reached strategic collaboration agreements with many global leading pharmaceutical companies(including Jacobson Medical, Cipla and Mabxience) for HLX02, to access more than 80 countries and regions in Hong Kong (China), Macau (China), Malaysia, Australia, New Zealand, Colombia, Argentina, Uruguay, Paraguay and Europe, Middle East-North Africa and the Commonwealth of the Independent States. Consistently pursuing core values of "Affordable Innovation · Reliable Quality", Henlius will take HLX02 as a benchmark in developing high-quality products and exploring global markets. In the future, Henlius will carry on to expand the global layout of more products that are developed and made in China and are of international quality, highlighting the company’s vision of becoming the most trusted biotech company in the world.
About Accord
Accord US and Accord UK are both subsidiaries of Intas Pharmaceuticals Limited (“Intas”). Accord US has been incorporated in the United States since 2005, focusing on the hospital markets egment with emphasis on oncology, central nervous and other critical care segments.Currently, it has obtained 129 generic approvals. Intas founded in 1976 and headquartered in India. Intas is engaged in the manufacturing, marketing,distribution, and sale of finished pharmaceutical formulations, active pharmaceutical ingredients, medical appliances, and medical devices worldwide.
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 and autoimmune diseases. 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 commercialisation. It has three R&D facilities in Shanghai, Taipei and California and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).
Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAb) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to date, Henlius has launched two products, 汉利康® (HLX01, rituximab injection) , the first biosimilar approved in China and 汉曲优® (HLX02, trastuzumab injection, Zercepac® in the EU), the first Chinese mAb biosimilar launched in both China and Europe. 汉曲优® will bring more treatment options to patients with HER2 positive breast and gastric cancer worldwide. Two products (HLX03, adalimumab injection and HLX04, bevacizumab injection) were accepted for New Drug Application (NDA) review by the NMPA with HLX03 to be potentially launched within 2020. What’s more, Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide. Products have been licensed out to nearly 100 countries and regions.
联系方式
媒体：PR@Henlius.com
投资者：IR@Henlius.com
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