Ipilimumab biosimilar (Shanghai Henlius)

2025年8月25日，复宏汉霖（2696.HK）发布2025年中期业绩，公司2025上半年实现营收28.195亿元人民币，同比增长2.7%；毛利润约21.992亿元，同比增长10.5%，净利润3.901亿元，经营性现金流超7.709亿元，同比增长206.8%，持续正向流入。业绩期内，海外产品利润激增超200%，BD合同现金流入超10亿元，同比增长280%，随着海外商业化产品的销售放量，预计公司2025全年海外产品收入及利润将实现大幅增长，2026年有望持续高速增长。公司持续夯实创新与国际化的长期发展策略，加速构建全球商业化闭环，以稳健的增长态势强力支撑创新研发的可持续拓展。 截至目前，复宏汉霖已有6款产品在中国获批上市，4款产品在国际获批上市，触达近60个国家和地区，广泛覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲，惠及全球超85万患者。同时，公司不断拓展与优化在肿瘤、自免等疾病领域的创新布局，基于差异化的创新研发策略，积极打造更多具有同类最优（BIC）和同类首创潜力（FIC）的爆款分子。 复宏汉霖执行董事、首席执行官朱俊博士 2025是复宏汉霖加速‘全球化2.0’与创新全面升维的关键之年。我们不断夯实全链条闭环体系，持续推动海外营收突破，驱动全球价值释放。同时核心创新产品取得多项突破性进展，下一代高潜力分子蓄势待发。未来，复宏汉霖将继续聚焦‘以患者为中心’的未竟需求，加速带来更优的创新治疗方案。 全球化2.0：加速构建全球商业化闭环 2025年上半年，复宏汉霖全球化增长引擎全面发力，全球产品收入突破25.568亿元，同比增长3.1%。多款产品加速拓展海外市场，持续提升患者的用药可及性。 公司肿瘤领域核心创新产品、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗H药斯鲁利单抗（中国商品名：汉斯状®，欧洲商品名：Hetronifly®）于业绩期内实现全球产品销售收入5.977 亿元。2025年上半年，H药海外市场拓展提速，相继在欧盟、新加坡、马来西亚、英国及印度获批，用于一线治疗广泛期小细胞肺癌（ES-SCLC），并于印尼和泰国获批治疗鳞状非小细胞肺癌（sqNSCLC）。目前，该产品已成功在近40个国家和地区获批上市，覆盖全球近半数人口。H药头对头阿替利珠单抗一线治疗ES-SCLC的美国桥接试验也将于近期完成全部患者入组，计划于2026上半年向FDA递交生物制品许可申请（BLA）。 公司乳腺癌领域的核心产品汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）是中国、欧盟、美国获批的“中国籍”单抗生物类似药，2025年上半年共计实现产品全球销售收入14.442亿元。业绩期内，汉曲优®在墨西哥等国家获批，累计在全球50多个国家和地区获批上市。针对HER2阳性乳腺癌治疗，复宏汉霖强化辅助治疗药物汉奈佳®（奈拉替尼）与汉曲优®形成序贯治疗方案，以降低早期患者复发风险；同时，公司自研的帕妥珠单抗生物类似药HLX11已获中美欧监管机构受理上市申请，有望于下半年在美国获得批准。聚焦这一疾病领域，公司持续打造更完善的创新产品矩阵，新型内分泌疗法拉索昔芬片HLX78、新表位抗HER2单抗HLX22、HER2 ADC HLX87、早期潜力分子KAT6A/B靶向小分子抑制剂HLX97及LIV-1靶向ADC HLX41正在加速布局。 在更多疾病领域，公司与亿胜生物合作开发的重组抗VEGF单抗HLX04-O治疗湿性年龄相关性黄斑变性(wAMD)已于2025年8月在中国获上市注册申请（NDA）受理，为公司首款申报上市的眼科产品。地舒单抗生物类似药HLX14用于治疗骨质疏松症等的上市注册申请已获得美国、欧盟和加拿大受理，有望于2025下半年获得批准。 2025年上半年，复宏汉霖多款核心产品通过战略合作加速拓展全球主要市场，进一步提升公司国际影响力与商业转化能力：与Abbott签署协议，授予其在亚洲、拉美等69个国家和地区独家或半独家开发及商业化四款生物类似药和一款生物创新药；与Dr. Reddy’s达成HLX15（抗CD38抗体）授权，覆盖美国及欧洲共43个国家和地区；与Lotus就抗PD-1单抗 H药在韩国多项适应症达成独家商业化和半独家开发合作；与Sandoz签署协议，授予其HLX13（抗CTLA-4抗体）在美国、欧洲、日本、加拿大及澳大利亚的独家商业化权益。 2025上半年，公司基于在生物制药领域积累的先进技术和丰富资源，不断夯实集药品研发、临床、生产、质量、药政与商业化一体化的国际化创新生物制药平台。截至目前，复宏汉霖已在全球范围内完成800余项药政注册申请，并获得600余项批准，覆盖中国、美国、欧盟、加拿大、印尼和日本等多个国家和地区，并在美国、欧盟、东南亚、日本等国家和地区开展国际多中心临床试验，加速产品全球化进程。业绩期内，复宏汉霖持续提升生产与质量管理体系建设。松江基地欧盟GMP再下一城，2025年7月通过比利时联邦药品和保健产品管理局核查。2025年8月，复宏汉霖松江基地（二）项目一期顺利通过竣工验收，为复宏汉霖产能战略布局再添重要一环 。截至目前，公司商业化GMP生产批次超过1150批，实现全球产品常态化供应，覆盖中国、东南亚、欧洲及拉丁美洲等；公司商业化生产基地及配套的质量管理体系已通过近100项由各国药监机构和国际商业合作伙伴进行的多项实地核查及审计，获得中国、欧盟、美国及多个PIC/S成员国（印尼、巴西）GMP认证。 创新跃迁打开增长天花板 2025年上半年，公司持续贯彻创新驱动的发展战略，在前沿技术平台领域加速突破，引领创新管线爆发式增长，HLX43、HLX22、H药 汉斯状®等核心创新产品皆取得全球开发里程碑进展。 PD-L1靶向ADC HLX43是潜在BIC的广谱抗肿瘤ADC。2025年上半年，HLX43 I期首次人体临床研究数据在2025 ASCO 年会上首次读出，在非小细胞肺癌（NSCLC）、胸腺鳞癌（TSCC）等实体瘤中展现出“高效、低毒”的治疗潜力，且对于鳞状/非鳞状NSCLC，有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者人群都显示出优异疗效，不依赖生物标志物筛选。目前，公司正全力推进HLX43在NSCLC中的国际多中心II期临床研究，累计获得中、美、日、澳等国家药监机构的临床许可，并在中、美两国完成首例受试者给药。同时，HLX43作为全球首个布局胸腺癌（TC）的PD-L1 ADC，已在美国等地获得该适应症的临床试验许可，计划于近期启动国际多中心临床研究，加速填补这一罕见高侵袭癌种 ADC治疗的空白。此外，公司同步推进该产品在更多实体瘤，包括宫颈癌、肝细胞癌、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃/胃食管结合部癌等瘤种中的II期临床研究，持续挖掘其治疗潜力。单药之外，HLX43联用其他产品的临床试验也正在进行中，进一步探索“ADC+IO”的协同抗肿瘤疗效。 新表位HER2单抗HLX22头对头对比一线标准疗法（曲妥珠单抗+化疗±帕博利珠单抗）治疗HER2阳性胃癌的国际多中心III期临床研究（HLX22-GC-301）稳步推进，已在中国、美国、日本、澳大利亚和韩国完成首例受试者给药，研究不限PD-L1表达人群，致力于突破当前HER2阳性胃癌一线治疗的临床局限。同时，HLX22的研发潜力获得国际监管机构高度认可，于上半年相继被美国食品药品监督管理局（FDA）及欧盟委员会（EC）授予孤儿药资格认定（Orphan Drug Designation, ODD），用于胃癌的治疗，进一步彰显其临床价值和全球开发前景。此外，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）更新结果于2025年美国临床肿瘤学会（ASCO）发布，数据显示经过长期随访（中位随访周期超2年），HLX22在HER2阳性胃癌治疗中依然展现出稳定的疗效获益，远超历史数据，为III期研究提供坚实数据基础。 聚焦肺癌和消化道肿瘤领域，复宏汉霖持续推进自研抗PD-1单抗H药的全球临床开发。肺癌领域，H药治疗小细胞肺癌的日本和美国桥接试验、及H药联合化疗同步放疗用于局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床正在同步开展，其中LS-SCLC的III期临床已完成患者入组，为后续海外注册申报奠定基础。消化道肿瘤领域，H药联合化疗新辅助/辅助治疗胃癌III期临床研究以及H药联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌（mCRC）患者的国际多中心临床研究（ASTRUM-015）III期研究皆完成患者入组。业绩期内，H药20余项肺癌和消化道肿瘤领域关键注册性临床研究、IIT以及真实世界研究最新结果相继入选ASCO GI、ELCC、IGCC、ASCO和WCLC等国际学术大会，并获登Cancer Immunology, Immunotherapy和Cancer Communications等学术杂志，广获权威认可。其中，H药联合化疗一线治疗ES-SCLC的III期临床研究（ASTRUM-005）研究结束分析首次发布于2025 ASCO，四年OS率达到21.9%，验证其长期生存获益。 全力推进爆款分子价值释放的同时，公司深耕未满足的临床需求，扩充高潜力分子组成的早期管线梯度储备，为中长期高质量发展注入强劲动能。业绩期内，公司持续搭建与优化具有全球竞争力的创新研发平台，包括拥有自主专利产权的ADC技术平台Hanjugator™、三特异性T细胞衔接器（T Cell Engager, TCE）平台、及一站式抗体药物早期研发平台HAI Club、自主搭建的模拟计算平台HAI PBD，不断提升创新研发的转化效率与成功率。与此同时，公司立足于抗体领域积累的核心技术优势，在靶点覆盖广度与分子多样性维度取得持续突破，加速推动潜在FIC的人唾液酸酶融合蛋白HLX79、较现有CD47靶向疗法更具安全性优势的新型SIRPα-Fc融合蛋白HLX701、创新抗PD-L1/VEGF双抗HLX37、潜在BIC的KAT6A/B口服小分子抑制剂HLX97、基于TCE平台开发的DLL3xCD3xCD28三抗TCE HLX3901、STEAP1xCD3xCD28三抗TCE HLX3902、基于Hanjugator™开发的EGFRxcMET双抗ADC HLX48、及潜在FIC的B7H3-唾液酸酶融合蛋白HLX316 等潜力创新分子的开发进程。 展望未来，复宏汉霖将持续贯彻“以患者为中心”的理念，加速全球化纵深布局，驱动创新成果高效落地，不断夯实产品全球供应与质量体系，以更多、更高质量的创新成果惠及全球患者。 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。 2025 WCLC：复宏汉霖3项口头报告，10项肺癌研究入选，多核心数据首次发布！ 2025-07-25 重磅揭秘！复宏汉霖2025全球研发日上的创新密码 2025-04-17 全年利润增幅50.3%！复宏汉霖2024年度业绩：创新&国际化双引擎驱动增长 2025-03-25 1.3亿美元！复宏汉霖与Dr.Reddy's达成合作，加速达雷妥尤生物类似药出海欧美市场 2025-02-07 速来，联合复宏汉霖抗PD-1单抗，探索免疫治疗“最优解”！ 2024-12-12 点击阅读原文，了解更多！

2025年8月25日，复星医药子公司复宏汉霖（2696.HK）发布2025年中期业绩，公司2025上半年实现营收28.195亿元人民币，同比增长2.7%；毛利润约21.992亿元，同比增长10.5%，净利润3.901亿元，经营性现金流超7.709亿元，同比增长206.8%，持续正向流入。业绩期内，海外产品利润激增超200%，BD合同现金流入超10亿元，同比增长280%。随着海外商业化产品的销售放量，预计公司2025全年海外产品收入及利润将实现大幅增长，2026年有望持续高速增长。公司持续夯实创新与国际化的长期发展策略，加速构建全球商业化闭环，以稳健的增长态势强力支撑创新研发的可持续拓展。2025上半年，公司研发支出为9.954亿元，费用化研发支出同比增长21.3%，重点投向差异化创新分子的临床前开发及核心创新平台的建设。 截至目前，复宏汉霖已有6款产品在中国获批上市，4款产品在国际获批上市，触达近60个国家和地区，广泛覆盖亚洲、欧洲、拉丁美洲、北美洲和大洋洲，惠及全球超85万患者。同时，公司不断拓展与优化在肿瘤、自免等疾病领域的创新布局，基于差异化的创新研发策略，积极打造更多具有同类最优（BIC）和同类首创潜力（FIC）的爆款分子。 复宏汉霖执行董事、首席执行官朱俊博士 2025是复宏汉霖加速‘全球化2.0’与创新全面升维的关键之年。我们不断夯实全链条闭环体系，持续推动海外营收突破，驱动全球价值释放。同时核心创新产品取得多项突破性进展，下一代高潜力分子蓄势待发。未来，复宏汉霖将继续聚焦‘以患者为中心’的未竟需求，加速带来更优的创新治疗方案。 全球化2.0：加速构建全球商业化闭环 2025年上半年，复宏汉霖全球化增长引擎全面发力，全球产品收入突破25.568亿元，同比增长3.1%。多款产品加速拓展海外市场，持续提升患者的用药可及性。 公司肿瘤领域核心创新产品、全球首个获批一线治疗小细胞肺癌的抗PD-1单抗H药斯鲁利单抗（中国商品名：汉斯状®，欧洲商品名：Hetronifly®）于业绩期内实现全球产品销售收入5.977 亿元。2025年上半年，H药海外市场拓展提速，相继在欧盟、新加坡、马来西亚、英国及印度获批，用于一线治疗广泛期小细胞肺癌（ES-SCLC），并于印尼和泰国获批治疗鳞状非小细胞肺癌（sqNSCLC）。目前，该产品已成功在近40个国家和地区获批上市，覆盖全球近半数人口。H药头对头阿替利珠单抗一线治疗ES-SCLC的美国桥接试验也将于近期完成全部患者入组，计划于2026上半年向FDA递交生物制品许可申请（BLA）。 公司乳腺癌领域的核心产品汉曲优®（曲妥珠单抗，美国商品名：HERCESSI™，欧洲商品名：Zercepac®）是中国、欧盟、美国获批的“中国籍”单抗生物类似药，2025年上半年共计实现产品全球销售收入14.442亿元。业绩期内，汉曲优®在墨西哥等国家获批，累计在全球50多个国家和地区获批上市。针对HER2阳性乳腺癌治疗，复宏汉霖强化辅助治疗药物汉奈佳®（奈拉替尼）与汉曲优®形成序贯治疗方案，以降低早期患者复发风险；同时，公司自研的帕妥珠单抗生物类似药HLX11已获中美欧监管机构受理上市申请，有望于下半年在美国获得批准。聚焦这一疾病领域，公司持续打造更完善的创新产品矩阵，新型内分泌疗法拉索昔芬片HLX78、新表位抗HER2单抗HLX22、HER2 ADC HLX87、早期潜力分子KAT6A/B靶向小分子抑制剂HLX97及LIV-1靶向ADC HLX41正在加速布局。 在更多疾病领域，公司与亿胜生物合作开发的重组抗VEGF单抗HLX04-O治疗湿性年龄相关性黄斑变性(wAMD)已于2025年8月在中国获上市注册申请（NDA）受理，为公司首款申报上市的眼科产品。地舒单抗生物类似药HLX14用于治疗骨质疏松症等的上市注册申请已获得美国、欧盟和加拿大受理，有望于2025下半年获得批准。 2025年上半年，复宏汉霖多款核心产品通过战略合作加速拓展全球主要市场，进一步提升公司国际影响力与商业转化能力：与Abbott签署协议，授予其在亚洲、拉美等69个国家和地区独家或半独家开发及商业化四款生物类似药和一款生物创新药；与Dr. Reddy’s达成HLX15（抗CD38抗体）授权，覆盖美国及欧洲共43个国家和地区；与Lotus就抗PD-1单抗 H药在韩国多项适应症达成独家商业化和半独家开发合作；与Sandoz签署协议，授予其HLX13（抗CTLA-4抗体）在美国、欧洲、日本、加拿大及澳大利亚的独家商业化权益。 2025上半年，公司基于在生物制药领域积累的先进技术和丰富资源，不断夯实集药品研发、临床、生产、质量、药政与商业化一体化的国际化创新生物制药平台。截至目前，复宏汉霖已在全球范围内完成800余项药政注册申请，并获得600余项批准，覆盖中国、美国、欧盟、加拿大、印尼和日本等多个国家和地区，并在美国、欧盟、东南亚、日本等国家和地区开展国际多中心临床试验，加速产品全球化进程。业绩期内，复宏汉霖持续提升生产与质量管理体系建设。松江基地欧盟GMP再下一城，2025年7月通过比利时联邦药品和保健产品管理局核查。2025年8月，复宏汉霖松江基地（二）项目一期顺利通过竣工验收，为复宏汉霖产能战略布局再添重要一环 。截至目前，公司商业化GMP生产批次超过1150批，实现全球产品常态化供应，覆盖中国、东南亚、欧洲及拉丁美洲等；公司商业化生产基地及配套的质量管理体系已通过近100项由各国药监机构和国际商业合作伙伴进行的多项实地核查及审计，获得中国、欧盟、美国及多个PIC/S成员国（印尼、巴西）GMP认证。 创新跃迁打开增长天花板 2025年上半年，公司持续贯彻创新驱动的发展战略，在前沿技术平台领域加速突破，引领创新管线爆发式增长，HLX43、HLX22、H药 汉斯状®等核心创新产品皆取得全球开发里程碑进展。 PD-L1靶向ADC HLX43是潜在BIC的广谱抗肿瘤ADC。2025年上半年，HLX43 I期首次人体临床研究数据在2025 ASCO 年会上首次读出，在非小细胞肺癌（NSCLC）、胸腺鳞癌（TSCC）等实体瘤中展现出“高效、低毒”的治疗潜力，且对于鳞状/非鳞状NSCLC，有无EGFR突变、有无脑/肝转移、PD-L1阳性/阴性的NSCLC患者人群都显示出优异疗效，不依赖生物标志物筛选。目前，公司正全力推进HLX43在NSCLC中的国际多中心II期临床研究，累计获得中、美、日、澳等国家药监机构的临床许可，并在中、美两国完成首例受试者给药。同时，HLX43作为全球首个布局胸腺癌（TC）的PD-L1 ADC，已在美国等地获得该适应症的临床试验许可，计划于近期启动国际多中心临床研究，加速填补这一罕见高侵袭癌种 ADC治疗的空白。此外，公司同步推进该产品在更多实体瘤，包括宫颈癌、肝细胞癌、食管鳞癌、头颈鳞癌、鼻咽癌、结直肠癌、胃/胃食管结合部癌等瘤种中的II期临床研究，持续挖掘其治疗潜力。单药之外，HLX43联用其他产品的临床试验也正在进行中，进一步探索“ADC+IO”的协同抗肿瘤疗效。 新表位HER2单抗HLX22 头对头对比一线标准疗法（曲妥珠单抗+化疗±帕博利珠单抗）治疗HER2阳性胃癌的国际多中心III期临床研究（HLX22-GC-301）稳步推进，已在中国、美国、日本、澳大利亚和韩国完成首例受试者给药，研究不限PD-L1表达人群，致力于突破当前HER2阳性胃癌一线治疗的临床局限。同时，HLX22的研发潜力获得国际监管机构高度认可，于上半年相继被美国食品药品监督管理局（FDA）及欧盟委员会（EC）授予孤儿药资格认定（Orphan Drug Designation, ODD），用于胃癌的治疗，进一步彰显其临床价值和全球开发前景。此外，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）更新结果于2025年美国临床肿瘤学会（ASCO）发布，数据显示经过长期随访（中位随访周期超2年），HLX22在HER2阳性胃癌治疗中依然展现出稳定的疗效获益，远超历史数据，为III期研究提供坚实数据基础。 聚焦肺癌和消化道肿瘤领域，复宏汉霖持续推进自研抗PD-1单抗H药的全球临床开发。肺癌领域，H药治疗小细胞肺癌的日本和美国桥接试验、及H药联合化疗同步放疗用于局限期小细胞肺癌（LS-SCLC）的国际多中心III期临床正在同步开展，其中LS-SCLC的III期临床已完成患者入组，为后续海外注册申报奠定基础。消化道肿瘤领域，H药联合化疗新辅助/辅助治疗胃癌III期临床研究以及H药联合贝伐珠单抗联合化疗用于一线治疗转移性结直肠癌（mCRC）患者的国际多中心临床研究（ASTRUM-015）III期研究皆完成患者入组。业绩期内，H药20余项肺癌和消化道肿瘤领域关键注册性临床研究、IIT以及真实世界研究最新结果相继入选ASCO GI、ELCC、IGCC、ASCO和WCLC等国际学术大会，并获登Cancer Immunology, Immunotherapy和Cancer Communications等学术杂志，广获权威认可。其中，H药联合化疗一线治疗ES-SCLC的III期临床研究（ASTRUM-005）研究结束分析首次发布于2025 ASCO，四年OS率达到21.9%，验证其长期生存获益。 全力推进爆款分子价值释放的同时，公司深耕未满足的临床需求，扩充高潜力分子组成的早期管线梯度储备，为中长期高质量发展注入强劲动能。业绩期内，公司持续搭建与优化具有全球竞争力的创新研发平台，包括拥有自主专利产权的ADC技术平台Hanjugator™、三特异性T细胞衔接器（T Cell Engager, TCE）平台、及一站式抗体药物早期研发平台HAI Club、自主搭建的模拟计算平台HAI PBD，不断提升创新研发的转化效率与成功率。与此同时，公司立足于抗体领域积累的核心技术优势，在靶点覆盖广度与分子多样性维度取得持续突破，加速推动潜在FIC的人唾液酸酶融合蛋白HLX79、较现有CD47靶向疗法更具安全性优势的新型SIRPα-Fc融合蛋白HLX701、创新抗PD-L1/VEGF双抗HLX37、潜在BIC的KAT6A/B口服小分子抑制剂HLX97、基于TCE平台开发的DLL3xCD3xCD28三抗TCE HLX3901、STEAP1xCD3xCD28三抗TCE HLX3902、基于Hanjugator™开发的EGFRxcMET双抗ADC HLX48、及潜在FIC的B7H3-唾液酸酶融合蛋白HLX316 等潜力创新分子的开发进程。 展望未来，复宏汉霖将持续贯彻“以患者为中心”的理念，加速全球化纵深布局，驱动创新成果高效落地，不断夯实产品全球供应与质量体系，以更多、更高质量的创新成果惠及全球患者。 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。 Henlius Keeps Steady Growth in H1 2025: Overseas Product Profits Soar 200%+, Innovation Fuels Global Reach Shanghai, China, August 25, 2025 – 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 havebeen 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), ccolorectal 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.