Bevacizumab biosimilar(Shanghai Henlius)

2025年3月27日，复宏汉霖（2696.HK）宣布，公司自主研发的创新型单抗H药 汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）用于治疗广泛期小细胞肺癌（ES-SCLC）的真实世界研究（ASTRUM-005R）最新数据以壁报形式在2025年欧洲肺癌大会（ELCC）上发布。该研究是截至目前中国ES-SCLC领域样本量最大的真实世界研究，由湖南省肿瘤医院邬麟教授和中南大学湘雅医院胡成平教授牵头开展。ASTRUM-005R证实了斯鲁利单抗一线治疗ES-SCLC良好的疗效和安全性，验证了ASTRUM-005研究结果，为斯鲁利单抗联合化疗一线治疗ES-SCLC补充有力证据。 肺癌是全球最常见的恶性肿瘤之一。其中SCLC约占肺癌总数的15%[1]，是肺癌中侵袭性最强的亚型，分为局限期小细胞肺癌（LS-SCLC）和ES-SCLC。H药 汉斯状®(斯鲁利单抗)是复宏汉霖首个自主研发的创新型单抗，也是全球首个获批一线治疗小细胞肺癌的的抗PD-1单抗和欧盟首个且唯一获批一线治疗ES-SCLC的抗PD-1单抗。截至目前，H药已在中国、欧洲和东南亚等30多个国家和地区获批上市，对外授权覆盖美国、欧洲、东南亚、中东和北非等100多个国家和地区，惠及超过10万名患者。 聚焦肺癌和消化道肿瘤等全球高发癌种，复宏汉霖在全球同步开展10余项以H药为核心的免疫联合疗法临床研究，于中国、美国、日本、土耳其、波兰、格鲁吉亚等国家和地区累计入组逾4900人，是拥有国际临床数据较多的抗PD-1单抗之一。在肺癌领域，公司临床布局已全面覆盖肺癌一线治疗。除已获批的鳞状非小细胞肺癌（sqNSCLC）、ES-SCLC和非鳞状非小细胞肺癌（nsNSCLC）外，公司正在全球范围内积极推动一项H药联合化疗同步放疗一线治疗局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床试验。 此次2025 ELCC大会发布的ASTRUM-005R研究数据结果如下： ASTRUM-005R研究 论文题目 ASTRUM-005R：斯鲁利单抗一线治疗广泛期小细胞肺癌的全国多中心真实世界研究 试验设计 研究纳入经病理学确诊的ES-SCLC，均接受至少2个周期的斯鲁利单抗进行一线治疗直至患者死亡或失访，主要终点为真实世界无进展生存期（rwPFS），次要终点包括总生存期（OS）、肿瘤缓解率和安全性(AEs)。 结果 研究共纳入635例患者进行分析，中位随访时间14.9个月。630例可评估患者中，7例达到完全缓解，428例达到部分缓解，ORR为69.0%。中位rwPFS为8.2个月（95% CI：7.4-9.2)；中位OS为17.2个月（95% CI：15.4-19.8)。伴脑转移患者的中位rwPFS数值低于无脑转移的患者（7.4个月 vs. 8.3个月，p=0.431),伴肝转移患者的中位rwPFS较无肝转移患者rwPFS更差（6.4个月 vs. 9.3个月，p＜0.001）。AE发生率为36.7%，其中3级AEs为12.8%，78例患者（12.3%）因不良反应导致治疗中断，3例患者（0.5%）发生了与不良反应相关的死亡。斯鲁利单抗相关不良事件发生率为20.5%，主要为1-2级（16.7%），未发现新的安全性信号。 结论 这项全国最大样本量的ES-SCLC真实世界研究证实了斯鲁利单抗一线治疗ES-SCLC良好的疗效和安全性，验证了ASTRUM-005研究结果，为斯鲁利单抗联合化疗一线治疗ES-SCLC补充有力证据。 【参考文献】 [1] Eskandar A, Ahmed A, Daughtey M, et al. Racial and sex differences in presentation and outcomes of small cell lung cancer in the United States: 1973 to 2010[J].Chest, 2015,147(4): e164-e165. 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，已有6款产品在中国获批上市，4款产品在国际获批上市，4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，公司商业化生产基地已相继获得中国、欧盟和美国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，涵盖约50个分子，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。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19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。 Latest RWS Results of Serplulimab for SCLC Released at 2025 ELCC March 27, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) announced that the latest results of the real-world study (ASTRUM-005R) of the company’s self-developed innovative anti-PD-1 monoclonal antibody (mAb), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe) for the treatment of extensive-stage small cell lung cancer (ES-SCLC) were released as poster presentation at the 2025 European Lung Cancer Congress (ELCC). The ASTRUM-005R study, led by Lin Wu from Hunan Cancer Hospital and Chengping Hu from Xiangya Hospital, Central South University, is the largest real-world study in the field of ES-SCLC in China to date. The study confirms the real-world efficacy and favorable safety of serplulimab in ES-SCLC, corroborating the results of the ASTRUM-005 study and providing strong supporting evidence for the use of serplulimab in combination with chemotherapy as a first-line treatment for ES-SCLC. Lung cancer is one of the most common malignancies around the world. SCLC is the most aggressive subtype of lung cancer, accounting for around 15% of all lung cancer cases[1]. The SCLC breaks down into limited stage small cell lung cancer (LS-SCLC) and ES-SCLC. HANSIZHUANG is the world’s first approved anti-PD-1 monoclonal antibody for first-line treatment of SCLC and the EU’s first and only approved anti-PD-1 monoclonal antibody for first-line treatment of ES-SCLC. To date, HANSIZHUANG has been approved in 30 countries and regions including China, Europe and Southeast Asia, licensed out to over 100 countries and regions including the U.S., Europe, Southeast Asia, the Middle East, and North Africa, benefiting over 100,000 patients. Focus on lung and gastrointestinal cancer, the synergy of HANSIZHUANG with in-house products of the company and innovative therapies are being actively promoted. The company has initiated over 10 clinical trials on immuno-oncology combination therapies in a wide variety of indications with more than 4,900 subjects enrolled in China, the U.S., Japan, Turkey, Poland, Georgia and other countries and regions, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. Notably, Henlius covers the full range of first-line treatment of lung cancer. In addition to squamous non-small cell lung cancer (sqNSCLC), ES-SCLC and non-squamous non-small cell lung cancer (nsNSCLC), the company is conducting a phase 3 international multi-centre clinical trial of HANSIZHUANG combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC). The latest data of the ASTRUM-005R study released at 2025 ELCC is as follows: Title Real-world outcomes in extensive-stage small cell lung cancer treated with first-line serplulimab: The nationwide observational ASTRUM-005R study Study Design This nationwide observational study was conducted in China and included patients with pathologically confirmed ES-SCLC who received serplulimab as first-line treatment. All patients were managed according to current clinical guidelines and followed until death or loss to follow up. Real-world progression-free survival (rwPFS), overall survival (OS), tumor response, and adverse events (AEs) were assessed to evaluate the real-world outcomes. Results Clinical data from 635 patients were analyzed, with a median follow-up of 14.9 months. Among 630 patients with measurable disease and at least one post-treatment evaluation, 7 achieved complete response, and 428 achieved partial response, representing an overall response rate (ORR) of 69.0%. The median rwPFS was 8.2 months (95% CI, 7.4-9.2). The median OS was 17.2 months (95% CI, 15.4-19.8). Patients with baseline brain metastases had a numerically lower median rwPFS than those without brain metastases (7.4 vs. 8.3 months, log-rank p = 0.431). Patients with liver metastases had a worse median rwPFS compared to those without liver metastases (6.4 vs. 9.3 months, log-rank p< 0.001). AEs were reported in 233 patients (36.7%),with 81 patients(12.8%) experiencing grade 3AEs. Treatment interruptions due to AEs were documented in 78 patients (12.3%), and 3 patients (0.5%) reported AE-related deaths. Serplulimab-related AEs were observed in 20.5% of patients, predominantly grade 1-2 (16.7%), with no new safety signals. Conclusion This large-scale, nationwide observational study confirms the real-world efficacy and favorable safety of serplulimab in ES-SCLC. The results support serplulimab-based immunochemotherapy in broader patient populations for this setting. 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, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 4 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets. 联系方式 媒体：PR@Henlius.com 投资者：IR@Henlius.com 喜欢本文内容 点击下方按钮·分享 ·收藏 ·点赞 ·在看

2025年3月26日，复星医药子公司复宏汉霖（2696.HK）宣布，公司创新型抗HER2单抗HLX22的国际多中心III期研究（HLX22-GC-301）在日本完成首例患者给药，拟用于联合曲妥珠单抗及化疗一线治疗人类表皮生长因子受体2（HER2）阳性晚期胃癌。HLX22-GC-301由北京大学肿瘤医院沈琳担任牵头主要研究者，此前已在中国完成全球首例患者给药，并于美国、澳大利亚等地获得临床试验开展许可。2025年3月，HLX22获美国FDA孤儿药资格认定，用于治疗胃癌。目前，全球尚无同类用于治疗HER2阳性胃癌的HER2双靶向疗法获批准上市。 迄今为止，胃癌/胃食管交界部（G/GEJ）癌依旧构成了一大全球健康问题。据GLOBOCAN数据显示，2022年全球约有100万新发病例[1]。而在日本，G/GEJ的新发和死亡病例在全部恶性肿瘤中均位居第3位，其中2022年新发病例12.7万，死亡病例4.4万[1]。多数G/GEJ癌患者确诊时已处于疾病晚期，总体预后不良，5年生存率仅为6%[2,3]，这其中HER2 阳性患者占比约为12%-23%，且其预后较HER2阴性患者更差[2,4]。目前，对于HER2阳性的局部晚期/转移性G/GEJ患者，其标准一线疗法为曲妥珠单抗联用化疗，针对PD-L1 阳性（PD-L1 CPS≥1）的患者，一些指南亦推荐进一步叠加联用免疫治疗，但持续疗效和预后仍有待进一步改善[5]。 HLX22为靶向HER2的创新型单克隆抗体，可结合在HER2的胞外亚结构域IV，但结合表位与曲妥珠单抗有所不同，使得HLX22和曲妥珠单抗能够同时与HER2结合，促进HER2二聚体（HER2同源二聚体及HER2/EGFR异源二聚体）的内吞和降解，从而产生更强的HER2受体阻断效果。HLX22联合汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™️，欧洲商品名：Zercepac®）治疗HER2阳性胃癌II期临床研究（HLX22-GC-201）结果显示，在汉曲优®联用化疗的基础上加入HLX22可提高HER2阳性G/GEJ癌患者一线治疗的生存期和抗肿瘤反应，且安全性可控[6-8]。该研究最新结果已于2025年美国临床肿瘤学会胃肠道肿瘤研讨会（ASCO GI）发布[9]。 HLX22-GC-301临床研究是一项双盲、国际多中心随机对照III期研究，旨在比较HLX22联合曲妥珠单抗和化疗对比曲妥珠单抗和化疗联合或不联合帕博利珠单抗，一线治疗HER2阳性局部晚期或转移性胃癌/胃食管结合部癌患者的疗效和安全性。符合条件的受试者将以1:1的比例随机分配至试验组（接受HLX22（15 mg/kg）联合曲妥珠单抗和化疗）或对照组（接受安慰剂联合曲妥珠单抗和化疗，联合或不联合帕博利珠单抗）。该研究的主要终点为独立影像评估委员会（IRRC）基于RECIST v1.1评估的无进展生存期（PFS）和总生存期（OS）。次要终点包括研究者评估的PFS、IRRC或研究者评估的客观缓解率（ORR）、下一线治疗的PFS2、缓解持续时间（DOR）、生活质量、安全性、免疫原性和药代动力学特征。 未来，公司将继续以患者需求为核心，在更多国家加速推进HLX22-GC-301研究，为更多患者带去福音。 【参考文献】 [1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. [2] Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. [3] Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. [4] Gravalos C. et al. Ann Oncol 2008;19(9):1523-9. [5] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.1.2024 [6] Zhu X, Ding Y, Wang Q, Yang G, Zhou L, Wang Q. HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial. Invest New Drugs. 2023;41(3):473-482. doi:10.1007/s10637-023-01338-7 [7] Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200/JCO.2024.42.3_suppl.354 [8] J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016/annonc/annonc1482 [9] Jin Li et al., HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients.. JCO 43, 440-440(2025). DOI:10.1200/JCO.2025.43.4_suppl.440 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，已有6款产品在中国获批上市，4款产品在国际获批上市，4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，公司商业化生产基地已相继获得中国、欧盟和美国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，涵盖约50个分子，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。截至目前，公司已获批上市产品包括国内首个生物类似药汉利康®（利妥昔单抗）、自主研发的中美欧三地获批单抗生物类似药汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）、汉达远®（阿达木单抗）、汉贝泰®（贝伐珠单抗）、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗汉斯状®（斯鲁利单抗，欧洲商品名：Hetronifly®）以及汉奈佳®（奈拉替尼）。公司亦同步就19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。 First Japanese Patient Dosed in Phase 3 MRCT of Dual HER2 Blockade Therapy for HER2+ GC Shanghai, China, March 26, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first Japanese patient has been dosed in the phase 3 international multi-centre clinical trial (HLX22-GC-301) of HLX22, an innovative anti-HER2 monoclonal antibody (mAb) in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer. The leading principal investigator is Lin Shen from Peking University Cancer Hospital. Previously, the study had completed its first patient dosing in China and the investigational new drug (IND) application have received regulatory approvals in the U.S, Australia, etc. In March 2025, the U.S. FDA granted orphan drug designation (ODD) to HLX22 for the treatment of gastric cancer. As of now, no similar dual HER2 blockade therapy for the treatment of HER2-positive gastric cancer has received approval for commercialization globally. Until now, gastric/gastroesophageal junction (G/GEJ) cancer still constitutes a major global health problem. Globally, there were around 1 million cases in 2022 [1]. While in Japan, the incidence and mortality of G/GEJ rank third among all malignant tumors, and, in 2022, there were 127,000 new cases and 44,000 deaths [1]. G/GEJ cancer generally carries a poor prognosis since it is often diagnosed at an advanced stage, with a 5-year relative survival rate of only 6% [2,3]. The reported rates of HER2 positivity in patients with gastric cancer range from 12% to 23%, and the prognosis for patients with HER2-positive disease used to be even worse than those with HER2-negative disease [2-4]. Currently, for patients with HER2-positive locally advanced/metastatic G/GEJ cancer, the current standard first-line treatment is trastuzumab plus chemotherapy. Immunotherapies are recommended to be added for tumours with PD-L1 expression levels by CPS (Combined Positive Score) of greater than 1. However, the effectiveness and prognosis for these treatments need to be further improved [5]. HLX22 is an innovative anti-HER2 mAb introduced from AbClon, Inc. and further investigated and developed by Henlius. HLX22 can bind to HER2 extracellular subdomain IV at a binding site different from that of trastuzumab, which allows simultaneous binding of HLX22 and trastuzumab to HER2 dimers (HER2 homodimer and HER2/EGFR heterodimer) on tumour cell surface, thereby promoting the internalisation and HER2 dimer degradation. Results from HLX22-GC-201, a phase 2 study of HLX22 in combination with HLX02 (trastuzumab injection, trade name: HANQUYOU in China, HERCESSI™️ in U.S., Zercepac® in Europe) and XELOX, as first-line therapy for HER2-positive locally advanced or metastatic gastric cancer patients showed that the addition of HLX22 to HLX02 (trastuzumab) plus chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety [6-8]. Updated results and study data were presented at the 2025 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) [9].  HLX22-GC-301 is a double-blind, randomized, controlled multicenter phase 3 study aims to compare the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab as first-line treatment in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced or metastatic gastric/gastroesophageal junction cancer. Eligible participants will be randomized at 1:1 to the experimental arm (treated with HLX22 (15 mg/kg, intravenous injection) plus trastuzumab and chemotherapy) or the control group (placebo plus trastuzumab and chemotherapy with or without pembrolizumab). The primary endpoints of this study are progression-free survival (PFS) accessed by independent radiology review committee (IRRC) per RECIST 1.1 and overall survival (OS), the secondary endpoints include investigator-assessed PFS, IRRC or investigator-accessed objective response rate (ORR), PFS2, duration of response (DOR), quality of life, safety, immunogenicity, and pharmacokinetic characteristics. In the future, the company will continue to focus on patient needs and accelerate the advancement of the HLX22-GC-301 study in more countries, thus bringing hope to more patients. References [1] Bray F, Laversanne M, Sung H, et al. CA Cancer J Clin. 2024: 1-35. [2] Ajani JA. et al. J Natl Compr Canc Netw 2022;20(2):167-92. [3] Alsina M. et al. Nat Rev Gastroenterol Hepatol 2023;20(3):155-70. [4] Gravalos C. et al. Ann Oncol 2008;19(9):1523-9. [5] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Gastric Cancer V.1.2024 [6] Zhu X, Ding Y, Wang Q, Yang G, Zhou L, Wang Q. HLX22, an anti-HER-2 monoclonal antibody, in patients with advanced solid tumors overexpressing human epidermal growth factor receptor 2: an open-label, dose-escalation, phase 1 trial. Invest New Drugs. 2023;41(3):473-482. doi:10.1007/s10637-023-01338-7 [7] Jin Li et al., HLX22 plus HLX02 and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer: A randomized, double-blind, multicenter phase 2 study.. JCO 42, 354-354(2024).DOI:10.1200/JCO.2024.42.3_suppl.354 [8] J. Li et al., 422P HLX22 plus HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric/gastroesophageal junction cancer: Updated results from a randomized, double-blind phase II study, Annals of Oncology,Annals of Oncology (2024) 35 (suppl_1): S162-S204. 10.1016/annonc/annonc1482 [9] Jin Li et al., HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients.. JCO 43, 440-440(2025). DOI:10.1200/JCO.2025.43.4_suppl.440 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, 6 products have been launched in China, 4 have been approved for marketing in overseas markets, and 4 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 centre and Shanghai-based commercial manufacturing facilities certificated by China, the EU and U.S. GMP. Henlius has pro-actively built a diversified and high-quality product pipeline covering about 50 molecules and has continued to explore immuno-oncology combination therapies with proprietary HANSIZHUANG (anti-PD-1 mAb) as the backbone. To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), a China-developed mAb biosimilar approved in China, Europe and U.S., HANDAYUAN (adalimumab), HANBEITAI (bevacizumab), HANSIZHUANG (serplulimab, trade name: Hetronifly® in Europe), the world’s first anti-PD-1 mAb for the first-line treatment of SCLC, and HANNAIJIA (neratinib). What’s more, Henlius has conducted over 30 clinical studies for 19 products, expanding its presence in major markets as well as emerging markets.