Bevacizumab biosimilar(Shanghai Henlius)

2025年8月26日，复宏汉霖（2696.HK）举行2025年度中期业绩交流会。会上，复宏汉霖管理层代表分享了公司于2025年上半年所取得的亮眼成绩，并回应了投资者们关注的热点问题。 2025年，复宏汉霖加速“全球化2.0”，不断夯实全链条闭环体系，业绩高质量稳健增长，海外产品利润激增。同时，公司全面升维创新，PD-L1靶向ADC HLX43、新表位HER2单抗HLX22等核心创新产品取得多项突破性进展，临床前管线储备丰富，下一代高潜力分子蓄势待发。公司持续贯彻“以患者为中心”的理念，以更多、更高质量的创新成果惠及全球患者。 发布会问答概要如下： Q 公司如何看待和评价这次中期业绩表现？对下半年业绩如何展望？ 复宏汉霖对此次中期业绩表现高度认可。公司从“财务业绩”与“创新业绩”两个维度综合评价自身发展：在财务方面，生物类似药作为当前收入主力，持续为公司提供稳定现金流，有力支持创新管线的研发投入，承担“赚钱养家”的战略职能；在创新方面，公司坚持认为管线建设是创新药企的核心竞争力，目前早研管线中多项潜力分子正加速推进，覆盖ADC、小分子、TCE等，逐步跻身全球创新舞台，拥有潜在爆款。公司凭借中国研发体系的高效率、优成本与高质量，正构建起与国际一线药企比肩的研发规模与创新能力，为未来持续增长奠定坚实基础。 展望下半年，公司对全年业绩保持积极乐观，创新研发与全球化战略将协同推进。在产品研发方面，重点推进的PD-L1 ADC药物HLX43已在全球入组超过300例患者，国际多中心II期临床试验已启动，并在中国、美国、日本等多国顺利推进患者入组，其临床疗效数据展现出成为重磅品种的潜力。 在全球化方面，中国区销售在上半年实现稳健增长，海外市场则逐步进入放量阶段，充分验证了公司全球化战略的有效实施：生物类似药业务贡献稳定收益，创新药H药 汉斯状（斯鲁利单抗）继在欧洲获批后，近日在印度获批，首批订单即达到10万支，并高效完成区域首张处方（上市12天即完成超过150例用药），有望成为业绩增长的重要动力。公司坚持以“全球化策略保障收益基础，研发创新驱动长期价值”的双轮发展模式，全年全球收入有望实现大幅提升。 Q HLX43在非小细胞肺癌领域的开发计划特别是海外临床计划，以及在其他癌种上的开发前景？HLX43下一个临床数据读出时间？ 在本次世界肺癌大会（WCLC）上，我们即将公布HLX43的更多临床数据。众所周知，EGFR野生型患者是非小细胞肺癌中占比最大的群体，目前二线以后仍以多西他赛等化疗为主。而我们的HLX43现在在末线治疗即对多西他赛耐药的非小细胞患者群体中展现出显著潜力，尤其在晚期鳞癌和腺癌患者中疗效突出，根据此次WCLC公布的 Ib期研究数据，HLX43在19例非鳞状非小细胞肺癌患者（≥3L）客观缓解率（ORR）为47.4%，响应率较高，进一步增强了我们的信心，这两个适应症预计将较快推进。 这只是针对该药物第一步的临床规划。随着HLX43在末线患者中的疗效逐步得到验证，我们将进一步将产品推向更前线的治疗，开展HLX43同多西他赛头对头的二线临床研究。在驱动基因野生型的非小细胞肺癌中，尤其是免疫经治的患者群体中，多西他赛仍是二线治疗的基石药物，特别在非鳞状非小细胞肺癌领域内，亟待更多新型方案填补治疗空缺。 同时，HLX43展现出的低毒及IO功能让我们对这个产品有了更高的期待，有潜力推进至一线治疗，I期研究报告了免疫相关不良事件（irAE），提示HLX43可通过免疫激活机制强化抗肿瘤疗效；同时报告irAE患者人群ORR得到提升。我们计划积极探索，开展一项包括单药、联合其他免疫药物以及对比现有标准治疗的三臂试验。 除非小细胞肺癌外，HLX43在头颈鳞癌、食管鳞癌和宫颈癌等经多线治疗（包括免疫治疗及化疗失败）的患者中也显示出优异的响应率。疗效的显著表现增强了研究者信心，目前我们正稳健推进其临床开发。 Q 新表位HER2单抗HLX22一线治疗HER2+胃癌国际III期目前的入组进展如何？与Enhertu联用于HER2 低表达乳腺癌的II期试验入组情况、数据读出时间及未来乳腺癌开发计划是什么？ HLX22和曲妥珠联用治疗一线HER2阳性胃癌的国际多中心III期临床试验在24年11月完成首例患者入组，已入组超150例患者，国内外试验正稳步推进，明年有望入组完成。此前在今年ASCO大会上公布的II期数据显示，中位随访超过28个月时，中位无进展生存期（PFS）和总生存期（OS）均尚未达到，预计完整数据读出仍需约两年时间；这一趋势提示该治疗方案有望为患者带来显著的生存获益。 在乳腺癌领域，HLX22与Enhertu（T-DXd）联用于HR阳性/HER2低表达未经化疗患者的II期试验已于今年4月完成国内首例患者入组，数据读出预计明年。公司还计划在日本开展三项IIT研究，进一步拓展HLX22在乳腺癌领域的治疗潜力。 Q 预计今年年底前，将有多款分子进入临床，其中KAT6 A/B抑制剂与同类产品相比有何差异化优势，未来临床开发如何与现有产品协同？ 我们对于KAT6 A/B抑制剂HLX97寄予厚望，它在临床前研究中表现出更优的活性、选择性，在乳腺癌模型中抑瘤效果更强，同时拥有更优的PK属性，有望显著降低血液毒性。我们将快速推进该分子进入临床，计划今年年底申报IND。 关于产品协同问题，乳腺癌是公司重点布局的治疗领域，我们在HER2 ADC及小分子药物方向均积极开展探索。KAT6 A/B作为在乳腺癌、前列腺癌等实体瘤中颇具潜力的下一代靶点，其抑制剂HLX97预计将与公司现有产品形成良好的协同效应。 Q 复宏汉霖国际化进入收获阶段，请展望今明两年海外收入的增长趋势？ 今年，复宏汉霖海外产品收入增长势头强劲。2025年海外产品收入和利润都有望取得大幅增长，2026年将在今年基础上继续增长。 具体来看，曲妥珠单抗有望在美国市场销售放量，该地区生物类似药定价环境具备优势；同时，新兴市场对创新药需求显著超出预期，斯鲁利单抗（PD-1）在印度获批一线小细胞肺癌并提前6个月实现商业化。该产品是印度目前唯一获批用于小细胞肺癌且已商业化的PD-1，合作伙伴要货需求超出预期。 Q 美国拟对进口药品加征高额关税，公司如何看待其可能对出海业务带来的影响？ 该关税政策是否落地尚不确定。公司已与合作方制定有效应对方案，无论政策如何，可通过调整供货价格与销售提成结构等方式，保障公司总体收益不受影响。 Q 公司对生物类似药集采的政策预期、业绩影响及应对准备是什么？ 生物类似药集采是大势所趋，目前由安徽省牵头的全国联盟采购仍处于企业报量阶段，具体政策尚未公布。 公司自五年前便前瞻布局，多措并举保障持续发展：通过持续优化生产工艺大幅降低生产成本；积极引进和开发创新药产品，不断夯实研发管线；并持续推进海外商业化进程，预计保持海外收入高速增长，从而增强整体抗风险能力。 Q 公司国际化进展展望与在美临床研究及产品上市计划如何？ 复宏汉霖始终将全球化作为核心发展战略之一，预计未来3年内将有更多产品在美国获批上市，包括斯鲁利单抗、HLX43、HLX22、帕妥珠单抗生物类似药（HLX11）、地舒单抗生物类似药（HLX14）、伊匹木单抗生物类似药（HLX13）和帕博利珠单抗生物类似药（HLX17）。 我们不仅注重产品数量，更强调临床价值与质量。以创新药HLX22为例，其有望成为美国、日本及欧洲市场HER2阳性胃癌治疗的突破性方案，延长患者治疗周期，从而有望使相关市场规模扩大3倍以上。 公司对临床研究质量的追求，也体现在所合作研究者的全球学术声誉上。HLX43非小细胞肺癌后线II期试验、斯鲁利单抗一线广泛期小细胞肺癌美国桥接试验和HLX22一线HER2阳性胃癌III期临床试验的主要研究者均为来自中国、美国、日本等国家的国际顶尖专家与关键意见领袖 。 在美国临床运营方面，公司坚持自建团队开展临床试验。从初期的行业关注有限，到后续数据逐步公布，已引发学术界广泛兴趣。目前，复宏汉霖在美国推进多项临床研究，包括HLX43用于非小细胞肺癌二线及以后的国际多中心II期试验、HLX43用于胸腺鳞癌的I期试验、斯鲁利单抗一线治疗广泛期小细胞肺癌的美国桥接试验（即将完成入组），以及HLX22联合疗法用于HER2阳性胃癌一线治疗的III期国际多中心试验。 值得注意的是，FDA近期提高对生物类似药的注册要求，虽不再一律要求大型III期临床试验，但需在美国本土入组患者。这一政策整体利于像复宏汉霖这样的国际化企业。 除美国市场外，公司在日本也在布局自有团队，着手建立全链条闭环运营。 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，6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。 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

SHANGHAI, Aug. 25, 2025 /PRNewswire/ -- Henlius (2696.HK) announced its 2025 interim results. In the first half of 2025, Henlius' revenue reached about RMB2.8195 billion, representing an increase of 2.7% YoY. The gross profit of RMB2.1992 billion, up by 10.5% YoY, with a net profit reached RMB390.1 million. Operating cash flow reached RMB770.9 million, with an increase of 206.8% YoY, maintaining a steady positive inflow. Overseas products profits surged over 200%. Cash inflows from BD agreements exceeded RMB 1 billion, surging 280% YoY. As the overseas sales volume of commercialized products continues to rise, the company expects significant growth in overseas revenue and profits for the full year of 2025, with strong momentum likely to continue into 2026. The company remains committed to reinforcing its strategic focus on innovation and globalisation, actively advancing its end-to-end ecosystem to drive sustainable R&D growth with robust growth momentum. During the reporting period, the company invested RMB995.4 million in R&D, with an increase of 21.3% YoY in expensed R&D expenditures, prioritizing preclinical development of differentiated innovative molecules and construction of core innovation platforms. Up to date, Henlius has 6 products launched in China, 4 approved for marketing in overseas markets, benefiting over 850,000 patients and reaching about 60 markets in Asia, Europe, Latin America, North America and Oceania. Meanwhile, the company is expanding its innovation pipeline in disease areas like oncology and autoimmune, advancing a differentiated portfolio of potential best-in-class (BIC) and first-in-class (FIC) candidates. Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, said "2025 is a pivotal year for Henlius. It is the year we shift into Globalisation 2.0 and step up the pace of innovation. We're strengthening our end-to-end ecosystem and driving overseas revenue growth with global value at scale. Meanwhile, our core innovative products have achieved significant milestones, with the next-generation of high-potential molecules underway. Looking ahead, Henlius will adhere to patient-centricity and accelerate the delivery of superior innovative treatment solutions." Globalisation 2.0: actively advancing the end-to-end ecosystem In the first half of 2025, Henlius' global growth engine was in full swing, with global product revenue exceeding RMB2.5568 billion, representing an increase of 3.1% YoY. Several products are accelerating their expansion into international markets, further improving patient access to essential therapies. The company's core innovative product serplulimab (trade name: HANSIZHUANG in China, Hetronifly® in Europe), the world's first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of small cell lung cancer (SCLC), has recorded a global sales revenue of RMB597.7million during the reporting period. The overseas market expansion of serplulimab has been accelerated in the first half of 2025. It has received approvals in the Europe, Singapore, Malaysia, the United Kingdom and India for first-line treatment of extensive-stage small cell lung cancer (ES-SCLC). Additionally, it has been approved in Indonesia and Thailand for the treatment of squamous non-small cell lung cancer (sqNSCLC). To date, serplulimab has been successfully approved in nearly 40 countries and regions, covering nearly half of the world's population. A head-to-head bridging trial of serplulimab versus first-line standard of care atezolizumab for ES-SCLC in the U.S will also complete patient enrolment soon. The company plans to submit the Biologics License Application (BLA) to the FDA in the first half of 2026. Henlius' core breast cancer product HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe), the "China-developed" mAb biosimilar approved in China, the EU, and the U.S., has recorded a global sales revenue of RMB1.4442 billion in the first half of 2025. During the reporting period, HANQUYOU (trastuzumab) was newly approved in countries including Mexico, bringing its cumulative approvals to over 50 countries and regions worldwide. In the HER2-positive breast cancer segment, Henlius has sequentially combined HANQUYOU (trastuzumab) with HANNAIJIA (neratinib) for extended adjuvant therapy to reduce recurrence risk in early-stage patients. Meanwhile, Henlius' independently developed pertuzumab biosimilar, HLX11, has been accepted for marketing applications by regulatory agencies in China, the U.S., and Europe, and is anticipated to receive approval in th U.S. during the second half of 2025. Focusing on the breast cancer field, Henlius continues to build a comprehensive innovative product portfolio — candidates including Henlius' HLX78 (lasofoxifene), an investigational novel endocrine therapy, the company's novel epitope anti-HER2 mAb HLX22, the next-gen innovative HER2 ADC HLX87, the KAT6A/B inhibitor HLX97 with BIC potential, and the LIV-1 ADC HLX41 are accelerating their research progress. In more disease fields, HLX04-O, a recombinant anti-VEGF humanised mAb injection jointly developed by the company and Essex, for the treatment of wet age-related macular degeneration (wAMD) has been accepted for the New Drug Application (NDA) in China in August 2025. This is the company's first ophthalmic product submitted for marketing approval. The marketing applications for the denosumab biosimilar HLX14, intended for the treatment of osteoporosis and other indications, have been accepted in the U.S., EU, and Canada, with expected approvals in the second half of 2025. In the first half of the 2025, Henlius accelerated the expansion of its core products into major global markets through strategic collaboration, further enhancing the company's international influence and commercial capabilities. The company has entered into agreement with Abbott, granting it exclusive or semi-exclusive licenses for the development and commercialization of four self-developed biosimilars and one innovative biologic in 69 emerging markets including Asia and Latin America. The company has granted Dr. Reddy's exclusive rights to HLX15, an anti-CD38 mAb, covering a total of 43 countries and regions across the U.S. and Europe. Besides, the company has also entered into an exclusive commercialization and semi-exclusive development collaboration with Lotus for the anti-PD-1 antibody serplulimab in multiple indications in South Korea. Additionally, the company has signed a licensing agreement with Sandoz, granting exclusive commercialization rights for HLX13, an CTLA-4 inhibitor, in the U.S., EU, Japan, Canada, and Australia. In the first half of 2025, leveraging the advanced technologies and extensive resources, the company continued to reinforce its integrated biopharmaceutical platform including R&D, clinical trials, manufacturing, quality management, regulatory affairs, and commercialization. Up to date, the company has submitted over 800 drug registrations, and received more than 600 approvals, covering multiple countries and regions including China, the U.S., the EU, Canada, Indonesia and Japan. It has also conducted MRCTs in the U.S., the EU, Southeast Asia, Japan and other countries and regions, accelerating the globalisation process of its products. During the reporting period, Henlius continues to optimize its production operations and quality management system. The Songjiang Site has once again received the EU GMP Certificate, issued by the Federal Agency for Medicines and Health Products in Belgium, in July 2025. The completion of the Phase 1 of Songjiang Site II in August 2025 has further enhanced the company's production capabilities. Up to now, the company has delivered over 1,150 batches of commercial GMP production, ensuring stable supply to countries and regions including China, Southeast Asia, Europe and Latin America. The company has successfully passed nearly 100 on-site inspections and audits conducted by global regulatory authorities and business partners, and has obtained GMP certifications from China, the EU, the U.S. and multiple PIC/S member countries, including Indonesia and Brazil. Innovation breaks through the growth ceiling In the first half of 2025, the company continued to advance its innovation-driven strategy, accelerating breakthroughs in cutting-edge technology platforms and driving robust growth in its innovative pipeline. Core products such as HLX43, HLX22, and serplulimab have each achieved significant global milestones. HLX43 is a broad-spectrum anti-tumor ADC candidate targeting PD-L1 with BIC potential. The results of the phase 1 clinical trial of HLX43 have been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC and thymic squamous cell carcinoma (TSCC). It shows encouraging efficacy in squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative NSCLC patients, indicating its biomarker-independent antitumor potential. Previously, HLX43 has already been approved to conduct phase 2 MRCT in patients with non-small cell lung cancer (NSCLC) in China, the U.S., Japan and Australia, with first patients successfully dosed in both China and the U.S. Simultaneously, as the world's first PD-L1 ADC indicated for thymic carcinoma (TC), HLX43 has received clinical trial approvals for the indication in the U.S. and other regions. A MRCT is planned to be initiated, aiming to fill the therapeutic gap in ADC treatment for this aggressive cancer type. In addition, the company is also accelerating the phase 2 clinical development of HLX43 in various solid tumors, including cervical cancer (CC), hepatocellular carcinoma (HCC), esophageal squamous cell carcinoma (ESCC), head and neck squamous cell carcinoma (HNSCC), nasopharyngeal cancer (NPC), colorectal cancer (CRC) and gastric/gastroesophageal junction cancer (GC/GEJC). Both monotherapy and combination therapies of HLX43 with other products are ongoing simultaneously to further exploit the synergistic effects of ADC-mediated cytotoxicity and immunotherapy-induced immune activation. A phase 3 head-to-head clinical trial of Henlius' novel enpitope anti-HER2 mAb HLX22 in combination with trastuzumab and chemotherapy comparing to current first-line standard of care therapy (trastuzumab + chemotherapy ± pembrolizumab) is steadily progressing. The first patient dosing has been completed in China, the U.S., Japan, Australia, and Korea, regardless of PD-L1 expression, with the aim of overcoming current limitations in first-line treatment of HER2-positive metastatic gastric cancer. Meanwhile, HLX22 has received Orphan Drug Designations from both the U.S Food and Drug Administration (FDA) and the European Commission (EC) in the first half the year for the treatment of gastric cancer, suggesting its significant therapeutic potential. Moreover, the updated data with over two years of follow-up from the phase 2 clinical study (HLX22-GC-201) evaluating HLX22 in combination with trastuzumab and chemotherapy as a first-line treatment for HER2-positive advanced gastric cancer were presented at the 2025 ASCO Annual Meeting. The study data demonstrated that the efficacy benefit of HLX22 in HER2-positive gastric cancer remained stable with extended follow-up, outperforming previous data and providing solid data foundation for the subsequent phase 3 study. Focusing on lung and gastrointestinal cancer, Henlius is continuously advancing the global clinical development of its self-developed innovative anti-PD-1 mAb serplulimab. In the field of lung cancers, the U.S. and Japanese bridging trial of serplulimab for SCLC, and a phase 3 MRCT of serplulimab combined with chemotherapy and radiotherapy for limited-stage SCLC (LS-SCLC) are currently underway in parallel to establish a solid foundation for future overseas regulatory registration, among which the phase 3 MRCT in LS-SCLC has completed the subject enrollment. In the field of gastrointestinal cancers, a phase 3 clinical trial of serplulimab plus chemotherapy as neoadjuvant/adjuvant therapy for gastric cancer, as well as the phase 3 MRCT (ASTRUM-015) of serplulimab in combination with bevacizumab and chemotherapy in first-line treatment of metastatic colorectal cancer (mCRC) have also completed subject enrollment. During the reporting period, a total of over 20 pivotal studies, investigator-initiated trials (IITs), and real-world studies (RWS) on serplulimab in the fields of lung cancer and gastrointestinal cancer were presented at major international academic conferences such as ASCO GI, ELCC, IGCC, ASCO, and WCLC, and were published in scientific journals including Cancer Immunology, Immunotherapy and Cancer Communications. Among them, the end-of-study analysis of the phase 3 clinical trial (ASTRUM-005) of serplulimab as the first line treatment for ES-SCLC has been first released at the 2025 ASCO Annual Meeting, featuring a four-year OS data of 21.9% and thus validating its long-term survival benefit. While fully leveraging the value of its flagship molecules, the company is actively addressing unmet clinical needs and building an early-stage pipeline of high-potential candidates, creating strong momentum for sustainable, high-quality growth over the medium to long term. During the period, the company continued building and optimizing its competitive R&D platforms, including its ADC platform Hanjugator™ with independent intellectual property, T cell Engager (TCE) platforms, the one-stop drug discovery platform HAI Club, and the independently developed computing platform HAI PBD to enhance R&D capabilities. Meanwhile, building on its core antibody expertise, the company is making ongoing breakthroughs across target coverage and molecular diversity, accelerating multiple candidates toward clinical development, including the potential FIC human sialidase enzyme therapeutic HLX79, HLX701, the novel anti-CD47 SIRPα-Fc fusion protein with good safety profile, anti-PD-L1/VEGF bispecific antibody (BsAb) HLX37, potential BIC KAT6A/B small molecule inhibitor HLX97, TCE platform-derived DLL3xCD3xCD28 TCE HLX3901 and STEAP1xCD3xCD28 TCE HLX3902, Hanjugator™-based EGFRxcMET ADC HLX48, and potential FIC B7H3-sialidase enzyme HLX316. Looking ahead, Henlius will remain committed to its patient-centric mission, accelerate global expansion, drive the efficient implementation of innovation outcomes, and continuously enhance its global product supply as well as quality systems, aiming to bring more high-quality, affordable innovative treatment options to patients 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, 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 6 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. 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