2022年3月16日，复宏汉霖（2696.HK）公布了2021年度业绩，就公司重要进展和业绩成果进行了分享。作为一家国际化的创新生物制药公司，复宏汉霖致力于为全球病患提供质高价优的创新生物药，4款产品在中国上市，1款产品欧洲上市，共获批12项适应症，产品覆盖肿瘤、自身免疫性疾病、眼科疾病等领域，目前在全球范围累计惠及逾17万名患者。
2021年，复宏汉霖实现营业收入约人民币16.825亿元，较去年同期增长约186.3%，主要来自多款产品陆续商业化带来的销售收入及授权许可收入等。其中，重磅产品汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）于中国和欧洲销售规模稳健增长，实现国内销售收入约8.680亿元，较2020年涨幅约692.7%，海外销售收入约6220万元，海外授权许可及研发服务收入约3020万元。
在推动产品全球商业化的同时，复宏汉霖以未满足的临床需求为导向，快速推动项目高效进展，全年研发投入约为人民币17.637亿元。2021年，公司12项临床试验取得重要进展、6个产品及1个联合疗法于全球范围内获得多项临床试验批准。截至目前，公司已累计在全球范围内获得超过70项临床试验批准，并同步在中国、欧盟、美国、澳大利亚、菲律宾和土耳其等国家和地区开展20多项临床试验。
复宏汉霖董事长、执行董事兼首席执行官张文杰先生
“2021年是复宏汉霖全面创新升级的一年，我们持续推动从Biotech到Biopharma的进化历程。2021年，我们全速推进研发、生产及商业运营三个板块发展，努力向更高价值链延伸，加速形成增长新动能，不断构建发展新格局。我们真诚感念各位投资人和社会各界一路以来的支持与信任，我和汉霖同仁们将继续保持‘创业、创新、创建’的企业精神，共绘中国生物制药发展蓝图！”
商业化迈入新阶段，汉曲优销售创新高
汉曲优®（曲妥珠单抗，欧洲商品名：Zercepac®）是复宏汉霖抗肿瘤领域的核心产品，该药于2020年相继在欧洲和中国获批上市，用于治疗HER2阳性乳腺癌和胃癌患者，迄今已惠及逾4万名患者。在中国市场，汉曲优®是首款由公司自建商业化团队负责销售推广的产品，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。2021年，汉曲优®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乳腺癌患者进行个性化、更经济的治疗。此外，复宏汉霖积极构建汉曲优®国际化商业运营网络，与全球性制药公司Accord达成合作，推动Zercepac®在欧洲、中东及北非等地区的商业化进程。2021年，Zercepac®（150mg）在英国、德国、法国、瑞士、西班牙等近20个欧洲国家和地区成功上市，新增60mg及420mg规格也在欧盟获得批准。复宏汉霖亦同Accord母公司Intas签订协议，进一步增加美国、加拿大等地的商业化授权，该产品于美国的生物制品许可申请（BLA）预计将于2022年内递交。截至目前，汉曲优®对外授权已覆盖80多个国家和地区，全面覆盖欧美主流市场和众多新兴市场。
汉利康®（利妥昔单抗）是中国首个生物类似药，自2019年获批上市以来已惠及超10万名中国患者。汉利康®（利妥昔单抗）由江苏复星团队负责中国的销售推广，2021年公司基于与合作伙伴约定的利润分成安排获得销售收入约人民币5.425亿元，授权许可收入约1040万元。目前汉利康已获批用于非霍奇金淋巴瘤、慢性淋巴细胞白血病及原研在中国未获批的类风湿关节炎适应症的治疗，是中国获批适应症最多的利妥昔单抗。该产品具有100mg/10ml和500mg/50ml两种规格，便于患者组合使用实现灵活用药。2022年2月，汉利康®新增类风湿关节炎适应症，以低频次给药、药效持久等优势有效改善患者生活质量，惠及更广泛患者群体。
汉达远®（阿达木单抗）于2020年12月获批准上市，是公司首款自身免疫疾病领域的单抗生物药，用于类风湿关节炎、强直性脊柱炎、银屑病和葡萄膜炎的治疗。汉达远®国内商业销售由江苏万邦负责，截至2021年底，公司基于与合作伙伴约定的利润分成安排获得销售收入约2180万元及授权许可收入100万元。复宏汉霖积极拓展汉达远®的海外布局，于2022年2月与Getz Pharma达成合作，授予其在巴基斯坦、菲律宾、肯尼亚等11个国家汉达远®的商业化等权益，助推公司商业化全球布局。
汉贝泰®（贝伐珠单抗）是复宏汉霖旗下肿瘤领域又一产品，于2021年12月获得中国国家药品监督局（NMPA）批准，用于治疗转移性结直肠癌及晚期、转移性或复发性非小细胞肺癌。复宏汉霖负责该产品在国内的销售推广，2022年将积极推进其医保准入、招标挂网和医院准入等工作，并实现医保双通道支付省市的逐步放量。此外，公司计划于2022年递交汉贝泰®新增复发性胶质母细胞瘤，肝细胞癌，上皮性卵巢癌、输卵管癌或原发性腹膜癌以及宫颈癌适应症的补充申请。
H药获批在即，PD-1国际III期临床数据亮眼
H药斯鲁利单抗（创新型抗PD-1单抗）是复宏汉霖首个自主研发的创新型单抗，是公司创新升级的重大成果，2个适应症有望于2022年获批上市。H药首个适应症高度微卫星不稳定型（MSI-H）实体瘤的上市注册申请（NDA）已被纳入优先审批审批程序，预计将于2022年上半年获批，另一适应症局部晚期或转移性鳞状非小细胞肺癌（sqNSCLC）的NDA也已获受理。围绕H药上市后的销售推广，公司提前组建专业资深团队，计划于2022年第一季度组建完成约200人的销售团队，产品上市后将迅速落实差异化布局并全面渗透中国市场。
公司以H药为契机和基础，在全球同步开展9项免疫联合疗法临床试验，广泛覆盖肺癌、食管癌、头颈癌和胃癌等高发大瘤种。在肺癌领域，公司针对一线治疗sqNSCLC、非鳞状非小细胞肺癌（nsNSCLC）和小细胞肺癌（SCLC）开展临床试验，全面布局，覆盖超过90%的肺癌患者。其中，sqNSCLC和SCLC为国际多中心III期临床试验，于中国、土耳其、波兰、格鲁吉亚等国家和地区开设研究中心，入组逾30%高加索人群。2021年12月，H药联合化疗一线治疗SCLC的III期研究ASTRUM-005达到主要终点总生存期（OS），公司计划于2022年在中国及欧盟递交该适应症的上市注册申请，H药有望成为全球首个一线治疗SCLC的抗PD-1单抗。截至2021年底，H药在全球已累计入组超2800人，积累了丰富的国际临床试验数据，可有力支持未来在美国、欧盟等主流法规市场的申报。
创新驱动价值增长，稳步推进全球研发布局
复宏汉霖着力推进自身创新研发能力的建设，以临床需求为导向，秉持“内外兼修”的研发策略，协同中美两地创新中心及全球产品开发团队，持续加码创新，夯实丰富的多元化产品管线，自主研发比例超过80%。公司大力推进早期研发，加速技术平台迭代升级，以抗体技术为核心，结合新型偶联技术，着力探索多种形式的抗体偶联分子；深耕肿瘤领域的同时，拓展非肿瘤疾病领域如代谢、心血管、炎症等，为公司技术创新和治疗领域布局储备“弹药”。
2021年，公司纵深推进临床研发，全力推进TIGIT、4-1BB、BRAF V600E、LAG-3、CD73等多个创新靶点产品的研发进展。两款潜在first-in-class双抗HLX301（创新型PD-L1×TIGIT双抗）和HLX35（创新型4-1BB×EGFR双抗）在澳大利亚的I期临床研究完成首例受试者给药。此外，公司在汉贝泰®基础上进行处方、规格和生产工艺优化，创新开发出眼科制剂产品HLX04-O（抗VEGF单抗），该产品已获批于中国、澳大利亚、美国、欧盟及新加坡等地区开展临床试验，2022年公司将加速推进HLX04-O国际多中心研究开展。HLX22（创新型抗HER2单抗）联合汉曲优®一线治疗HER2阳性胃癌患者的II期临床研究亦于2021年完成首例受试者给药。
复宏汉霖亦通过许可项目引进的方式，加速扩充创新潜力靶点，公司引进的创新产品HLX208（BRAF V600E抑制剂）已获NMPA批准开展临床试验，有潜力与公司自有管线的多个产品产生协同效应，并在肺癌、结直肠癌等疾病领域打造更优质的差异化创新产品组合。近期，HLX208已在罕见病BRAF V600E突变型成人朗格汉斯组织细胞增生症（LCH）和Erdheim-Chester病（ECD）患者中完成首例受试者给药，后续公司将挖掘更多潜在适应症，惠及更多患者。
加速产能扩增，增强商业化保障
复宏汉霖赓续综合一体化生产平台建设，为将研发成果转化为社会和商业价值提供重要保障。公司现有商业化总产能24000升，2022年预计可达48000升，2025年商业化总产能可达144000升。2021年，公司持续推动产能建设，此前已获中国和欧盟双GMP认证的徐汇基地商业化总产能从20000升提升至24000升，并推进生产关键物料耗材和设备的国产化研究及变更。松江基地（一）建设产能24000升，已获批用于汉曲优®生产，有望于2022年正式投入商业化生产，并计划于2023年上半年完成美国食品药品管理局（FDA）的GMP核查。松江基地（二）一期项目规划总产能96000升，有望为复宏汉霖全球产能布局注入长期发展动力，满足产品的全球商业化生产需求。其中，一期项目一阶段和二阶段规划产能36000升，有望于2022年下半年进入试生产及工艺验证阶段。一期项目三阶段设计产能60000升，计划于2022年全面进入工程施工阶段。
在加速产能扩增的同时，公司始终站在先进生产技术应用前沿，持续探索连续化生产技术等先进技术的开发和产业化，降低单位生产成本，精简生产流程。2021年，公司已成功建立中国首个连续化临床生产车间，实现端对端连续化生产，单批次产能较传统批次生产大幅提升，质量稳定可控。
前行路上，在继续卓越商业化的同时，复宏汉霖将以未被满足的临床需求为创新方向，进一步夯实“内外兼修”的多元化开发策略，深耕创新研发的同时提升“研产销一体化”能力，向更具规模化和市场竞争力的Biopharma进化。
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4款产品，在欧洲上市1款产品，12项适应症获批，2个上市注册申请获得中国药监局受理。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，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单抗斯鲁利单抗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，欧盟商品名：Zercepac®）、汉达远®（阿达木单抗）和汉贝泰®（贝伐珠单抗）相继获批上市，创新产品斯鲁利单抗MSI-H实体瘤的上市注册申请已纳入优先审评审批程序，斯鲁利单抗鳞状非小细胞肺癌适应症的上市注册申请也正在审评中。公司亦同步就12个产品、9个免疫联合治疗方案在全球范围内开展20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。
Henlius 2021 Annual Results:
New Record in Performance, Evolving to Biopharma
Shanghai, China, March 16th, 2022—Henlius (2696.HK) announced its annual results for the year ended December 31st, 2021, sharing the company’s recent noteworthy progress and achievements. As a global innovative biopharmaceutical company, Henlius is committed to offering high-quality, affordable and innovative biopharmaceuticals to patients worldwide with 4 products launched in China, 1 in Europe, and 12 indications around the globe, focusing on oncology, autoimmune diseases, ophthalmic diseases, etc. Up to date, the company has benefited over 170,000 patients worldwide. In 2021, Henlius’ revenue increased by 186.3% year-on-year (YoY) to RMB 1.68 billion, primarily from sales of various products and licensing revenue. Among them, HANQUYOU (trastuzumab, Zercepac® in Europe) delivered solid growth in China and Europe, reaching a sales revenue of RMB 868.0 million with a 692.7% YoY increase and RMB 62.2 million from the Chinese market and international market, respectively. The company also received an oversea licensing revenue and revenue from R&D services of RMB 30.2 million.
Based on unmet clinical needs, Henlius also continues to unleash innovation potential by enhancing in-house capabilities and strengthening collaboration on external innovative assets. In 2021, the company's R&D expenditure reached approximately RMB 1.76 billion. During the Reporting Period, the company saw robust clinical progress in 12 projects and received multiple clinical approvals on 6 candidates and 1 combination therapy worldwide. As of the Latest Practicable Date, more than 70 clinical trials have been approved worldwide, and more than a total of 20 clinical trials have been carried out in various countries and regions, including China, the European Union (EU), the United States (U.S.), Australia, the Philippines, and Turkey.
Wenjie Zhang, Chairman, Executive Director and Chief Executive Officer of Henlius, remarked: “In 2021, we made significant progress on our innovation agenda as well as the evolution from a biotech company to a biopharma. We will continue to extend the breadth of our value chain and refuel our momentum for development. Our heartfelt gratitude goes to shareholders and communities for your great support and trust. Staying true to our spirit of ‘entrepreneurship, innovation and creation,’ we will do all we can for the development of China biopharmaceuticals.”
Accelerating the commercialization to step into a new stage
HANQUYOU (trastuzumab, Zercepac® in Europe) is the core anti-tumour product of Henlius indicated for the treatment of HER2 positive breast and gastric cancer patients, benefiting more than 40,000 patients to date. It is the first product commercialized by the company’s in-house commercial team that lays a favorable foundation for the overall increase in the sales of HANQUYOU. In 2021, HANQUYOU launched a new dosage form of 60mg. Together with the 150 mg form, HANQUYOU can flexibly meet the clinical medication needs of breast cancer patients with different body weights through more dosage forms and provide patients with personalized and more economical treatment plans. Moreover, Henlius is actively building an international commercial network for HANQUYOU and has joined forces with overseas partners such as Accord, a global pharmaceutical company, to promote the commercialization of Zercepac® in Europe, the Middle East and North Africa. In 2021, Zercepac® (150mg) has been successfully launched in nearly 20 European countries and regions, including the United Kingdom, Germany, France, Switzerland, and Spain. The new dosage forms of 60mg and 420mg were also approved in 2021 for marketing in the EU region. In addition, Henlius signed an agreement with Accord's parent company, Intas, to further increase commercialization licenses in U.S. and Canada and its BLA is expected to be submitted to U.S. Food and Drug Administration (FDA) in 2022. To date, HANQUYOU has access to more than 80 countries and regions, spanning both mature and emerging markets.
HANLIKANG (rituximab injection) is the first-ever China-manufactured biosimilar approved by the National Medical Products Administration (NMPA) in 2019. As of now, it has benefited more than 100,000 Chinese patients. The domestic commercial sales of HANLIKANG is being handled by Jiangsu Fosun, a subsidiary of Fosun Pharma. In 2021, HANLIKANG (rituximab) received a profit-sharing of RMB 542.5 million from Fosun Pharma and licensing revenue of RMB 10.4 million. Up to date, HANLIKANG has been approved by NMPA for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis (RA) for which the originator rituximab has not been approved in China, making it the rituximab with the most approved indications in China. This product is available with 2 dosage forms, 100mg/10ml and 500mg/50ml, allowing for more flexible drug dosing. In February 2022, HANLIKANG was approved for RA as the first rituximab approved for this indication in China. It will effectively improve patients’ quality of life with the advantages of low-frequency administration and long-lasting efficacy, reaching a broader patient population.
HANDAYUAN (adalimumab injection) is the company’s first monoclonal antibody for autoimmune diseases and was approved by the NMPA in December 2020. It is indicated for RA, ankylosing spondylitis, plaque psoriasis and uveitis. Jiangsu Wanbang is responsible for the commercial sales of HANDAYUAN in China. By the end of 2021, the company received a profit-sharing of RMB 21.8 million and licensing revenue of RMB 1.0 million. Henlius actively expands the overseas distribution of HANDAYUAN, in February 2022, it entered into a collaboration agreement with Getz Pharma to commercialize HANDAYUAN in 11 emerging markets such as Pakistan, the Philippines, Vietnam, Nigeria, Kenya, Sri Lanka, Kazakhstan and Uzbekistan, thereby speeding up the company’s faster global commercialisation layout.
HANBEITAI (bevacizumab), approved by the NMPA in December 2021, is another marked product of Henlius in the field of oncology. It is indicated for the treatment of metastatic colorectal cancer (mCRC) and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC). Henlius is responsible for the commercial sales of HANBEITAI in China. In 2022, the company will actively promote the product's access to basic medical insurance and hospitals, and gradually increase the sales under the ‘dual-channel’ scheme. Besides, Henlius plans to file a supplemental application for additional indications, including glioblastoma, hepatocellular carcinoma, cervical cancer, and recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in 2022.
PD-1 inhibitor serplulimab is about to be approved with outstanding readouts from Phase 3 trial in small cell lung cancer
The serplulimab (innovative anti-PD-1 monoclonal antibody) is the first innovative monoclonal antibody independently developed by Henlius and also a significant milestone in the company’s evolution toward Biopharma. Two indications of serplulimab are expected to be approved by NMPA in 2022, in which the NDA of its first indication for the treatment of microsatellite instability-high (MSI-H) solid tumours has been accepted with priority review and is expected to be approved in the first half of 2022. An NDA for another indication, locally advanced and metastatic squamous non-small cell lung cancer (sqNSCLC), has also been accepted. In preparation for the launch of serplulimab, Henlius aimed to recruit around 200 people within 2022 and quickly implement a differentiated strategy for market penetration.
With serplulimab as the backbone, a total of 9 immuno-oncology combination therapies clinical trials are ongoing worldwide in a wide variety of high-incidence solid tumours, including lung cancer (LC), hepatocellular cancer, esophageal carcinoma, head and neck carcinoma, gastric cancers, etc. Henlius has carried out a comprehensive first-line treatment layout for LC in sqNSCLC, nsNSCLC and small cell lung cancer (SCLC), which covers more than 90% of lung cancer patients. Two international multi-center Phase 3 clinical trials are ongoing for sqNSCLC and SCLC in China, Turkey, Poland, Georgia and other countries and regions, enrolling more than 30% of Caucasians. In December 2021, the Phase 3 clinical study (ASTRUM-005) of serplulimab in combination with chemotherapy for the treatment of SCLC met the primary study endpoint of the overall survival (OS) with remarkable readouts and the NDA in China and the EU are expected to be submitted in 2022, making serplulimab potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. By the end of 2021, over 2,800 patients have been enrolled worldwide. The company has accumulated abundant international clinical research data that can strongly support future fillings in mainstream markets such as U.S. and the EU.
The pipeline expansion is fueled by innovation, resulting in a robust global R&D layout
Rooted in unmet medical needs, Henlius strives to promote its innovation and R&D capabilities. Synergising the Innovation centres in China and the US, the company continues the momentum for a diversified innovation with independent development accounts for over 80% of the product pipeline by enhancing internal innovation capacities and reaching out to more strategic partners. The company aggressively pushes its early R&D research capabilities further while also upgrading its technology platform. Henlius is currently looking into novel coupling techniques in effort to grow its presence in antibodies and oncology, while also focusing on the non-oncology therapeutic areas such as metabolism, cardiovascular, inflammation, etc., with the aim of advancing candidates for a promising pipeline.
In 2021, Henlius promoted in-depth research and development, unlocking the potential of the novel candidate targets including TIGIT, 4-1BB, BRAF V600E, LAG-3, CD73, etc. The two potential first-in-class bispecific antibodies, HLX301 (anti-PD-L1×TIGIT bispecific antibody) and HLX35 (anti-4-1BB×EGFR bispecific antibody), has completed the first subject dosing in Phase 1 clinical study in Australia. Meanwhile, the company’s new ophthalmic preparation product HLX04-O (anti-VEGF monoclonal antibody), independently developed through optimizing the prescription, specifications and production processes of HANBEITAI, was approved to carry out clinical trials in China, Australia, U.S., the EU, Singapore, and other countries. The company will advance the international multi-center clinical trials in 2022. In addition, a Phase 2 clinical trial of HLX22, an anti-human epidermal growth factor receptor-2 (HER2) humanized monoclonal antibody injection, in combination with HANQUYOU and chemotherapy as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients has completed the first subject dosing in 2021.
Henlius has also committed to replenishing the innovative candidate targets through in-licensing. The company’s in-licensed product HLX208 (BRAF V600E inhibitor) has been approved by the NMPA for conducting clinical trials. It has the potential to be used in combination with the company’s multiple candidate targets and create new combinations that unlock additional indications such as LC and mCRC. Recently, it has been dosed in patients with Langerhans cell histiocytosis (LCH) and Erdheim-Chester disease (ECD) with BRAF V600E mutation. Next, Henlius will tap its potential for a broader range of indications and patients.
Integrated manufacturing platform ensures high-quality large-scale production
The company continue to build an integrated manufacturing platform, translating its R&D efforts into social impact and commercial results. The company’s commercial capacity reached 24,000L in 2021, and that in 2022 is expected to double. Towards 2025, the design capacity is planned to rise from 84,000L to 144,000L. In 2021, Xuhui facility, certificated by China and the EU GMP earlier, has ramped up its capacity from 20,000L to 24,000L. The company is also exploring localized alternatives for key materials and process development approaches to mitigate the risk of supply shortages and a lack of supporting facilities under the current international situation. Moreover, the Phase I project of Songjiang First Plant was approved for the manufacturing of HANQUYOU with the goal of putting its constructed 24,000L capacity into operation in 2022 and passing the FDA GMP inspection in the first half of 2023. The Phase I project of Songjiang Second Plant has a planned total capacity of 96,000L to get Henlius well positioned for its fast-growing industry transformation and global commercialisation blueprint. In detail, the first and second stages of this project aim to achieve a total capacity of 36,000L. They are expected to enter trial production and relevant verifications in the second half of 2022. In addition, plans are underway for the third stage of this project. The construction of its 60,000L capacity is scheduled to commence in 2022.
While ramping up capacity progress, the company is determined to accelerate the development and industrialisation of advanced production techniques such as continuous manufacturing technology and achieve economies of scale, leading to a rapid decline in the cost of its products and a streamlined manufacturing process. In 2021, the company successfully launched China’s first continuous manufacturing clinical production workshop to achieve end-to-end continuous production and thus improving productivity with stable and controllable quality.
Going forward, Henlius will keep its innovation momentum pivoting on unmet clinical needs, continue to round out its diversified development strategy of enhancing in-house capabilities and strengthening collaboration on external innovative assets, and intensify efforts to foster innovation and make great progress in R&D, manufacturing and commercialisation, evolving into a more full-fledged biopharma with keener competitiveness.
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, 4 products have been launched in China, 1 in European, 12 indications approved worldwide, and 2 New Drug Applications (NDAs) accepted for review in China. 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 a Shanghai-based manufacturing facility certificated by China and the EU Good Manufacturing Practice (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 serplulimab (anti-PD-1 mAb) as backbone. Apart from the launched products HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, Zercepac® in in Europe), the first China-developed mAb biosimilar approved both in China and Europe, HANDAYUAN (adalimumab) and HANBEITAI (bevacizumab), the NDA of innovative product serplulimab indicated for MSI-H solid tumors has been granted priority review, and the NDA of serplulimab for the treatment of squamous non-small cell lung cancer is also under review. What's more, Henlius has conducted over 20 clinical studies for 12 products and 9 combination therapies worldwide, expanding its presence in major market as well as emerging market.