转自：复星医药
汉曲优®是获批上市国家和地区最多的国产生物类似药，惠及全球41国
汉曲优®开辟了中国制药企业参与单抗生物类似药“世界杯”比赛的先河
复宏汉霖持续拓展海外布局，加速为全球患者提供可负担的高品质生物药
2020年7月27日，复宏汉霖自主研发的首个国产曲妥珠单抗汉曲优®（欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）正式获欧盟委员会（European Commission，EC）批准，率先登陆欧盟市场，开辟了中国制药企业参与单抗生物类似药“世界杯”比赛的先河。历经三载非凡旅程，汉曲优®已在全球41个国家和地区获批上市，累计发货量超300万支。如今，汉曲优®凭借卓越的国际品质、安全有效的临床表现、良好的产品可及性，获得了海内外医生与患者高度认可，并在生物药主流市场及新兴市场接连取得重要里程碑，向全球患者传递着温暖和希望。
嘹亮“曲”声响彻世界
商业化成绩硕果累累
汉曲优®是复宏汉霖按照中国、欧盟和美国等生物类似药法规自主研发的曲妥珠单抗类似药。2020年7月及8月，汉曲优®先后于欧盟和中国获批上市，用于治疗HER2阳性乳腺癌和胃癌，覆盖原研所有获批的适应症，标志着其进军全球生物药市场的征程正式拉开帷幕。三年来，汉曲优®已成功于中国、英国、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯等41个国家和地区获批上市，成为获批上市国家和地区最多的国产生物类似药。2023年2月，汉曲优®美国上市许可申请正式获得美国食品药品监督管理局（FDA）受理，为其全球商业化网络构建嵌入关键一环，汉曲优®有望成为首个中美欧三批的国产生物类似药。
目前，复宏汉霖已在国内针对该产品建设了一支超550余人的专业销售团队，并持续构筑汉曲优®销售网络，加强市场渗透，以高效的执行力，全面拓展中国市场。三年来，凭借双规格、不含防腐剂、“即配即用”等优势，汉曲优®广泛应用于临床，市场打开率快速攀，商业化增长态势迅猛，2022年实现国内销售收入约人民币16.9亿元，今年一季度实现国内销售收入人民币5.386亿元，较去年同期增幅约66.7%。截至目前，汉曲优®累计惠及中国患者约14 万名。
围绕汉曲优®，复宏汉霖前瞻性地开展了国际商业化布局，携手Accord、Abbott、Cipla、Eurofarma、Elea、Jacobson和KG Bio等国际一流的生物制药企业，在进军欧美主流生物药市场的同时，加快落子新兴市场。继150mg规格于2020年7月获批在欧盟上市后，汉曲优® (Zercepac®) 60mg、420mg规格也分别于2021年4月、6月在欧盟获批并上市销售。2021年7月汉曲优® (Zercepac®) 150mg规格的上市申请获瑞士药品监督管理局批准。目前汉曲优® (Zercepac®) 已于约20个欧洲国家成功上市销售，并进入英国、法国和德国等多个国家的医保。2022年，汉曲优®在柬埔寨、澳大利亚、新加坡、阿根廷等国家成功获批上市，进一步拓展国际“T台”。截至2022年底，汉曲优®海外总销售收入超人民币1.2亿元，海外授权许可收入逾2.8亿元。
精益生产厚植发展优势
科研成果领航国际品质
得益于复宏汉霖国际一流的质量管理体系与快速提升的生产能力，汉曲优®全球市场稳健扩张，在全球上市国家与地区发货已超300万支。目前，复宏汉霖已建立一套符合中国、欧盟及美国等国际质量标准的质量管理体系，覆盖从项目研发到物料管理、产品生产、质量控制、产品供应链管理以及产品上市后跟踪的全生命周期。相关生产基地及配套的质量管理体系多次通过中国国家药监局、欧洲药品管理局、欧盟质量受权人及国际商业合作伙伴的实地核查及/或审计并获得中国和欧盟GMP认证。2020年4月，复宏汉霖徐汇基地顺利通过欧盟GMP现场核查，汉曲优®正式成为国内首个获得欧盟GMP认证的国产生物类似药，打破了国产单抗生物药在海外上市的GMP壁垒。2022年，松江基地（一）24,000升产能正式投入汉曲优®商业化生产，与拥有24,000升商业化产能的徐汇基地形成协同和规模效应，实现中国和欧盟市场的常态化供应, 产能的不断升级也有利保障了汉曲优®在全球商业化竞争中的持续放量。公司已陆续建立徐汇、松江基地（一）和松江基地（二）三大生产基地，现有商业化产能达48,000升，预计2026年总产能可达144,000升。复宏汉霖还将持续精益生产运营，助力汉曲优®增效扩产，为中长期全球商业化生产及业务发展构筑坚实基础，满足日益增长的全球用药需求。
自汉曲优®研发之初，复宏汉霖就定位国际市场，致力以国际品质开启中国生物制药企业国际化之门。复宏汉霖针对汉曲优®开展了一系列的头对头比对研究，充分证明了汉曲优®与原研曲妥珠单抗在质量、安全性和有效性方面高度相似。汉曲优®多项质量对比研究、临床前研究及临床I期和国际多中心临床III期研究结果相继荣登BioDrugs、Cancer Chemotherapy and Pharmacology、Journal of Oncology等国际知名期刊。在临床实践中，汉曲优®多项真实世界研究先后于复旦大学肿瘤医院、南京鼓楼医院、牡丹江市肿瘤医院开展。2021年，汉曲优®联合吡咯替尼和白蛋白紫杉醇新辅助治疗II-III期HER2阳性乳腺癌的前瞻性、开放、多中心研究以摘要及壁报形式正式亮相国际性大会圣安东尼奥乳腺癌研讨会（SABCS）。一年后，汉曲优®联合帕妥珠单抗双靶新辅助治疗HER阳性乳腺癌的真实世界研究亮相于2022 SABCS，该研究共纳入85例患者，总体病理学完全缓解率达到64.7%，与原研药的真实世界研究和既往的III期临床试验的疗效结果都高度相似。科学的临床研究及真实世界应用数据充分验证了汉曲优®优质的疗效和可靠的安全性，进一步夯实临床使用的信心。
上市三年来，汉曲优®在临床护理、药物经济学等方面的优势为患者提供了经济便捷的用药选择，得到肿瘤领域内的广泛认同。汉曲优®获得了《中国生物类似药专家共识（2020版）》、《CSCO乳腺癌诊疗指南（2023版）》、《CSCO胃癌诊疗指南（2023版）》、《中国抗癌协会乳腺癌诊治指南与规范（2022版）》等多个权威指南和共识推荐。同时，汉曲优®广获社会各界认可，荣获“十二五”/“十三五” 国家重大新药创制专项项目、上海医药行业名优产品、《2022年度上海市生物医药“新优药械”产品目录》-名优产品、人民日报健康客户端及健康时报第十三届健康中国年度论坛·十大新药等殊荣。
医患需求出发高效可及
生态圈关爱患者公益随行
从汉曲优®研发到上市，复宏汉霖聚焦抗HER2治疗领域，以坚持满足临床未尽之需、解决患者用药之困为创新目的。2021年8月，汉曲优®60mg规格获批上市，与先前上市的150mg规格形成“双规格”配伍，更符合国人的体重区间，并通过灵活的用药搭配，实现即配即用，免去了“余液保存”的烦恼，避免药液过期的情况。同时得益于双规格精准用药设计，汉曲优®无需添加防腐剂，为疗效进一步保驾护航。
为让更多患者获益，复宏汉霖以高效的市场拓展和准入执行，持续提升汉曲优®产品可及性。汉曲优®上市后即被纳入国家医保目录中，2021年上半年，汉曲优®150mg规格完成中国境内所有省份的招标挂网和医保准入，60mg规格也于2022年底完成所有省份的医保准入和29个省份的招标挂网。
此外，复宏汉霖还携手多方合作伙伴共同打造“不让一个HER2阳性患者落下”一体化患者医疗生态圈，将患者及家属、医疗机构及医生、专业协会、政府相关部门、相关企业等紧密集合，通过药品准入、医疗大数据、HER2检测、患者管理和教育等领域的合作，打通并优化HER2阳性医疗的完整产业链，整体提升中国HER2阳性患者诊疗水平，使患者最大化获益。同时，公司在乳腺癌知识科普、临床诊疗、患者关爱等多个领域持续耕耘，积极开展以“优医相助-乡村医疗公益行”、“肿瘤抗HER2治疗精粹行”、“乳腺癌患者优伴一生”、“与爱共舞 纵享芳华”母亲节乳腺癌患者公益沙龙为代表的多个公益项目。2020年，由复宏汉霖联合复星基金会、北京市希斯科临床肿瘤学研究基金会，同时联合人民日报健康客户端和人民日报社《健康时报》推出“优医相助—乡村医疗关爱公益行”活动。三年来，公益团队已走过安徽金寨县、海南琼中县、江西广昌县、云南德钦县等地，约162位临床专家参与，近3400位患者和1500余位基层医务人员获益，共计捐赠19万余物资支援当地村卫生室，为改善中国偏远乡村医疗条件，提升更多村民群众对肿瘤等重大疾病的认知做出了不懈努力。
宏愿三载，不断前行。复宏汉霖坚持从患者获益出发，始终秉持“不让一个HER2阳性患者落下”的宏愿，助力越来越多的HER2肿瘤患者跨越疾病鸿沟，用真诚拨动传递患者福祉的音符，奏响一曲悠扬四海的生命乐章。海阔潮平曲正劲，奋楫越洋正当时，复宏汉霖将持续聚焦提升全球创新研发、生产及商业化的全产业链综合实力, 深化赋能汉曲优®全球布局，推动该产品及更多国际品质创新药带着期盼和希望继续远航。
关于汉曲优®
汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®，澳大利亚商品名：Tuzucip®和Trastucip®）为复宏汉霖按照中国和欧盟等生物类似药相关法规开发和生产的曲妥珠单抗，该药于2020年相继在欧盟和中国获批上市，用于治疗HER2阳性乳腺癌和胃癌。汉曲优®在中国境内的销售推广由公司自建商业化团队主导，该团队高效的市场布局为汉曲优®销量的全面提升提供了有利基础，迄今已惠及约14万名患者。汉曲优®于2021年8月新增60mg规格获批上市，可与150mg规格实现灵活剂型组合，方便不同体重区间的患者进行个性化、更经济的治疗。此外，复宏汉霖携手海外商业合作伙伴，全面布局美国、加拿大、澳大利亚、欧洲以及众多新兴国家市场，对外授权覆盖约100个国家和地区。截至目前，汉曲优®已在中国、英国、法国、德国、瑞士、澳大利亚、芬兰、西班牙、阿根廷、沙特阿拉伯等40多个国家获批上市，其美国上市许可申请也已获得美国FDA受理，有望成为首个在中国、欧盟、美国获批的“中国籍”生物类似药。
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。
HANQUYOU Marks 3rd Anniversary with Brilliant Achievements
HANQUYOU is the China-developed biosimilar with the most marketing approvals, covering 41 countries and regions
The launch of HANQUYOU kicks off the competition between Chinese pharmaceutical companies and the world's bio-pharmaceutical companies in biosimilar monoclonal antibodies
Henlius will continue to expand its overseas footprint and accelerate the delivery of high-quality and affordable biological medicines to patients worldwide
HANQUYOU (trastuzumab, trade name in Europe: Zercepac®; trade names in Australia: Tuzucip® and Trastucip®), the first China-developed trastuzumab biosimilar independently developed by Shanghai Henlius Biotech, Inc. (2696.HK), welcomes the 3rdanniversary of its launch in the European Union today. Dating back to July 27, 2020, the approval of HANQUYOU by the European Commission (EC) signalled that Henlius took the lead among the Chinese biopharmaceutical companies in breaking into the European Union market and kicks off the competition between Chinese pharmaceutical companies and the world's bio-pharmaceutical companies in biosimilar monoclonal antibodies. Up to date, HANQUYOUhas received marketing approvals in 41 countries and regions globally with a cumulative global shipment volume totaling over 3 million units. With world-class quality, clinically-proven safety and efficacy, and high accessibility, HANQUYOU is highly recognized by doctors and patients at home and abroad. It has also achieved significant milestones in major and emerging biopharmaceutical markets to deliver warmth and hope to patients all over the globe.
Commercialization sees bountiful accomplishments
HANQUYOUis a trastuzumab biosimilar developed in accordance with the guidelines from the National Medical Products Administration (NMPA), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and other international biosimilar regulations. In July and August 2020, it was approved in European Union and China successively for the treatment of HER2-positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer, which covers all indications of the trastuzumab originator, and embarked on a new journey in global pharmaceutical market. HANQUYOU is the China-developed biosimilar with the most marketing approvals covering 41 countries and regions, including China, the United Kingdom, France, Germany, Switzerland, Australia, Finland, Spain, Argentina, and Saudi Arabia. The Biologics License Application (BLA) for HANQUYOU was accepted by the FDA in February 2023, which makes HANQUYOU potentially the first Chinese biosimilar approved in China, the EU, and the U.S., and further consolidates its global commercialization network.
Up to now, Henlius has established a specialized commercial team with more than 550 sales agents to make full efforts to develop and further tap into China market. With the advantages of dual-dosage form, no preservatives and "ready-to-use" formulation, HANQUYOU has been widely used in clinical practice and achieved rapid market acceptance and strong commercial growth. In 2022, the domestic sales revenue of HANQUYOU reached approximately RMB1.69 billion, and in the first quarter of 2023, its domestic sales revenue surged approximately 66.7% year-on-year to RMB538.6 million during the same period. As of now, HANQUYOU has benefitted about 140,000 patients in China.
Henlius has aggressively pursued overeseas commercialization of HANQUYOU, collaborating with global renowned partners such as Accord, Abbott, Cipla, Eurofarma, Elea, the Jacobson Group, and KG Bio to bring its therapeutics to patients in major biopharmaceutical markets in the U.S. and Europe, as well as emerging markets. After HANQUYOU (Zercepac®) in 150mg dosage forms was approved for marketing in EU in July 2020, HANQUYOU (Zercepac®) in 60mg and 420mgdosage forms were approved for marketing in EU, respectively. The marketingapplication of HANQUYOU (Zercepac®) in 150mg dosage forms was also approved by Swissmedic in July 2021. Up to date, HANQUYOU (Zercepac®) has been launched in approximately 20 European countries, andit is reimbursed nationally in countries and regions including the United Kingdom (UK), France and Germany.Henlius further expanded its overseas presence in 2022, with the launch of HANQUYOUin Cambodia, Australia, Singapore, and Argentina. As of the end of 2022, the overseas sales revenue of HANQUYOU exceeded RMB120 millon and its overseas license revenue was in excess of RMB280 million.
Make solid strides in manufacturing and innovation to further improve competitiveness
By virtue of Henlius' world-class quality management systems and increasing manufacturing capabilities, HANQUYOU is seeing a robust expansion in the global market, with a total supply over 3 million units worldwide. Henlius has established a quality management system in line with international quality standards of China, the U.S., and the EU, which covers the entire product life cycle, from research and development to material management, product manufacturing, quality control, product supply management and particularly, product post-marketing surveillance. The company's commercial production facility and supporting quality management system have been certificated by China and the EU Good Manufacturing Practice (GMP). They have also passed on-site inspections and audits conducted by the NMPA, the EMA, the EU Qualified Person (QP), and multiple international business partners. In April 2020, Henlius' Xuhui Facility successfully passed the on-site inspection for EU GMP certification, making HANQUYOU the first domestically produced biosimilar in China to receive such certification and breaking the GMP barriers for China-developed mAb biologics launched in global market. In 2022, the Songjiang First Plant was approved for the commercial production of HANQUYOU, which works in synergy with the Xuhui Facility in manufacturing and product supply. To meet ever-expanding market demand, Henlius has established three manufacturing facilities: Xuhui Facility, Songjiang First Plant, and Songjiang Second Plant, with the total commercial production capacity of 48,000 liters so far, and it is expected to reach 144,000 liters by 2026. A giant leap in productivity also promotes the global sales growth of HANQUYOU. Notably, Henlius has achieved a stable supply in the Chinese and EU markets to meet the growing demand for clinical medication worldwide, and will continue to adhere to international high standards to improve the production efficiency and capacity of HANQUYOU, thereby establishing a solid foundation for medium- to long-term global commercial production and business development.
Henlius planned to pitch HANQUYOU to the global market at the early-stage of research and was heading for the global commercialization. Therefore, Henlius has initiated a series of head-to-head clinical studies that compared HANQUYOU with the trastuzumab originator. The clinical results demonstrated the remarkable similarity between HANQUYOU and the trastuzumab originator in terms of quality, safety, and efficacy. The results of some comparative studies, preclinical research, as well as Phase 1 and international multicenter Phase 3 clinical trials on HANQUYOU have been published on many prestigious international journals such as BioDrugs, Cancer Chemotherapy and Pharmacology, and the Journal of Oncology. Several real-world studies on HANQUYOU conducted at esteemed medical institutions, including Fudan University Shanghai Cancer Center, The Affiliated Drum Tower Hospital of Nanjing, and Mudanjiang Tumor Hospital. In 2021, the results of a prospective, open, multi-center clinical study of pyrotinib combined with trastuzumab (HANQUYOU) and nab-paclitaxel in neoadjuvant treatment for stage II-III HER2-positive breast cancer patient was released as the abstract and poster at the San Antonio Breast Cancer Symposium (SABCS). What's more, the results of a real-world study featuring trastuzumab (HANQUYOU) plus Pertuzumab as dual-target neoadjuvant therapy for HER2-positive breast cancer was published at the 2022 SABCS. This study included 85 patients, and the overall pathologic complete response rate reached 64.7%, aligning closely with the efficacy results observed in real-world studies and previous Phase 3 clinical trials of the originator. With these scientific study data, HANQUYOU is proved as a world-class monoclonal antibody with outstanding efficacy and reliable safety, which boosts the confidence in clinical practice.
Over the past three years, HANQUYOU has provided economical and convenient options to patients with its advantages in clinical care, pharmacoeconomics, gaining wide recognition in the field of oncology. Many authoritative guidelines and regulations, such as the Chinese Consensus on Biosimilars (2020), CSCO Guidelines for Breast Cancer (2023), CSCO Guidelines for Gastric Cancer (2023), and CACA Breast Cancer Guideline (2022), recommend HANQUYOU. Moreover, HANQUYOU is highly recoginzied by all walks of life. It was honored with a national key new drug creation program during the "12th Five-Year Plan" and "13th Five-Year Plan" , "Famous and Excellent Products" by Shanghai Pharmaceutical Profession Association, listed in the "2022 Shanghai Biomedical 'New Excellent Medical Equipment' Product Catalog" by Shanghai Municipal Commission of Economy and Informatization, and the "13th China Health Annual Forum – Top 10 New Medicine" by People's Daily Health APP.
Focus on unmet clinical needs and push ahead with patient-centric ecosystem
Henlius is devoted to anti-HER2 studies to meet unmet clinical needs and address the challenges of medication. Following the launch of 150mg dosage form, HANQUYOUwas launched with another dosage form of 60mg in August 2021. Nowadays, it has been widely used in clinical practice due to its advantages such as dual-dosage form (150mg& 60mg), "ready-to-use" formulation and flexible combination in use. In addition, HANQUYOU has no preservatives, which plays a positive role in treatment.
To benefit more patients, Henlius is continuously enhancing the accessibility of HANQUYOU through efficient market access and expansion. HANQUYOU was included in the National Medical Insurance Catalog since it was launched. In 2021 H1, all the provincial medical insurance access work and tendering process completed for 150mg dosage form. By the end of 2022, the 60mg dosage form of HANQUYOU had completed the tendering process in 29 provinces and was included into the medical insurance procurement platform in all provinces in Chinese mainland.
To improve the diagnosis and treatment level in HER2-positive tumors and maximize the benefits for patients, Henlius collaborates with various partners to create an integrated medical ecosystem of "Leaving No HER2-positive Patients Behind". It connects patients and their families with medical institutions and doctors, associations, government, and relevant enterprises and tries to optimize the entire chain of HER2-positive treatment on leveraging the market access, big data analysis, HER2 testing, patient management and healthcare education, etc. On the other hand, Henlius actively practice corporate social responsibility and has initiated a series of public welfare projects in science popularization on breast cancer, clinical diagnosis and treatment and patient care, etc. As one of the key projects, the "Medical Care for Rural Patients" was initiated by the Fosun Foundation, the CSCO Foundation, People's Daily Health app, Health Times and Henlius in 2020, aiming to improve the medical infrastructure, diagnosis and treatment, and hospital management capabilities in remote villages in China, and to raise the awareness of health among villagers. Over the past three years, the project teams have visited 19 counties, involving 162 experts, benefiting near 3,400 patients and 1,500 local medical staff. They have also donated a total of more than RMB 190,000 to support local hospitals and village clinics.
With the vision of "Leaving no HER2-positive patient behind," Henlius will make all-round efforts to help patients achieve longer survival and improve the quality of life. In addition, the company will continue to enhance the capabilities of innovation, manufacturing and commercialization, steadily advancing the market expansion of HANQUYOU and bringing more hopes to patients across the world.
About HANQUYOU
HANQUYOU (trastuzumab, trade name in Europe: Zercepac® ; trade names in Australia: Tuzucip® and Trastucip®） is the trastuzumab biosimilar developed in accordance with the guidelines from the National Medical Products Administration (NMPA), the European Medicines Agency (EMA). In 2020 HANQUYOUwas launched in European Union and China successively. HANQUYOUis now indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastatic gastric cancer. Henlius has established a specialized commercial team with more than 550 sales agents to make full efforts to develop and further tap into China market.As of now,HANQUYOUhas benefitted about 140,000 patients in China. In August 2021,HANQUYOUwas launched with another dosage form of 60mg, which can be flexibly combined with 150 mg dosage form to provide a personalized and more cost-effective option for patients with different weights. On the another hand,Henlius has aggressively pursued overseas commercialization of HANQUYOU,actively collaborating with global partners to bring its therapeutics to patients in the United States,Canada,Europe, and other emerging markets,covering about 100 countries and regions. Up to date, HANQUYOUhas received marketing approvals globally covering over 40 countries and regions, including China, the United Kingdom, France, Germany, Switzerland, Australia, Finland, Argentina, and Saudi Arabia. Moreover, its Biologics License Application (BLA) was accepted by the U.S. FDA, which makes HANQUYOU potentially the first Chinese biosimilar approved in China, the EU, and the U.S.
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.
