HLX-22

©氨基观察-创新药组原创出品作者 | 黄恺百利天恒业绩回归常态。4月29日，百利天恒公告表示，公司2025年一季度营业收入为6744万元，同比下降98.77%，主要系上年同期确认了大额知识产权授权收入。一季度净亏损5.31亿元，去年同期净利润50.05亿元，主要系营业收入减少和研发费用增加。联影医疗出海美国。4月28日，联影医疗自主研发的数字减影血管造影系统（DSA）uAngioAVIVA获得美国药监局（FDA）批准，是首个且唯一获准进入美国市场的国产DSA设备。在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。/ 01 /市场速递1）复宏汉霖HLX13与Sandoz订立许可协议4月29日，复宏汉霖宣布，重组抗CTLA-4全人单克隆抗体注射液HLX13与Sandoz订立许可协议，后者获得美国、指定欧洲国家、日本、加拿大、澳大利亚的商业化权益。复宏汉霖获得3100万美元首付款、1.6亿美元开发里程碑款和1.1亿美元销售里程碑款，以及净利润2位数的销售分成。/ 02 /资本信息1）科伦药业一季度净利润同比下降43.07%4月29日，科伦药业公告表示，2025年第一季度营业收入为43.89亿元，同比下降29.42%；归属于上市公司股东的净利润为5.84亿元，同比下降43.07%。2）迈瑞医疗十年来首次出现双负增长4月28日，迈瑞医疗公告表示，2025年一季度实现营收82.37亿元，同比下降12.12%；净利润为26.29亿元，同比下降16.81%。这是迈瑞医疗十年来首次出现双负增长。3）迪哲医药一季度收入增长96%4月29日，迪哲医药公告表示，2025年一季度实现营收1.6亿元，同比增长96%；亏损额同比下降14%。4）百利天恒一季度净亏损5.31亿元4月29日，百利天恒公告表示，公司2025年一季度营业收入为6744万元，同比下降98.77%，主要系上年同期确认了大额知识产权授权收入。一季度净亏损5.31亿元，去年同期净利润50.05亿元，主要系营业收入减少和研发费用增加。/ 03 /医药动态1）康爱瑞浩自体淋巴细胞注射液获临床许可4月29日，据CDE官网，康爱瑞浩自体淋巴细胞注射液获临床许可，拟联合PD-1单抗和XELOX治疗局部晚期不可切除或转移性胃癌。2）诺华制药镥[177Lu]特昔维匹肽注射液拟优先审评4月29日，据CDE官网，诺华制药镥[177Lu]特昔维匹肽注射液拟优先审评，适应症为：用于治疗既往接受过雄激素受体通路抑制剂治疗的，前列腺特异性膜抗原阳性转移性去势抵抗性前列腺癌成年患者。3）复宏汉霖HLX22头对头国际多中心III期临床试验于欧盟获批4月29日，复宏汉霖宣布，HLX22头对头国际多中心III期临床试验于欧盟获批，具体为联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌患者。/ 04 /器械跟踪1）首个国产DSA设备获美国FDA批准4月28日，联影医疗自主研发的数字减影血管造影系统（DSA）uAngioAVIVA获得美国药监局（FDA）批准，是首个且唯一获准进入美国市场的国产DSA设备。/ 05 /海外药闻1）阿斯利康一季度收入135.88亿美元4月29日，阿斯利康公布2025Q1财报，第一季度总营收135.88亿美元，同比增长10%，其中产品收入128.75亿美元，同比增长9%，主要由肿瘤学和生物制药业务的双位数增长驱动。从地区分布来看，2025Q1美国市场收入56.46亿美元，同比增长10%，中国区收入18.05亿美元，同比增长5%，占据阿斯利康全球市场份额的13%。PS：欢迎扫描下方二维码，添加氨基君微信号交流。

2025年4月28日，复宏汉霖（2696.HK）宣布，公司创新型抗HER2单抗HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌患者的头对头国际多中心III期研究（HLX22-GC-301）的临床试验申请于欧盟国家德国获批。HLX22-GC-301由北京大学肿瘤医院沈琳担任牵头主要研究者，此前已于中国、日本、澳大利亚完成首例受试者给药，并已在美国、韩国等国家和地区获得临床试验开展许可。此外，HLX22已于2025年获得美国食品药品监督管理局（FDA）授予的孤儿药资格认定（Orphan Drug Designation, ODD），用于胃癌的治疗。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]。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，使得该产品能够与曲妥珠单抗同时结合至HER2，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，进而产生更强的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。除胃癌外，复宏汉霖近期亦启动一项HLX22联合德曲妥珠单抗二线治疗HER2低表达HR阳性乳腺癌的II期临床研究（HLX22-BC201）并于中国境内完成首例患者给药。未来，公司也将继续秉持以患者为中心，聚焦未满足的临床需求，积极探索优化HER2阳性肿瘤联合疗法并推进HLX22的全球开发进程，为更多患者带去福音。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，5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 Receives Clinical Approval in EU for Head-to-Head Phase 3 MRCT of Dual HER2 Blockade Therapy on First-Line HER2+ GCShanghai, China, April 28, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the application for clinical trial for head-to-head phase 3 international multicenter clinical study (HLX22-GC-301) of Henlius’ novel anti-HER2 mAb, HLX22, in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer has been approved in Germany. Previously, the first patient was dosed in China, Japan, and Australia, and the study has obtained investigational new drug (IND) approvals in countries and regions including the United States (U.S.) and Korea. Besides, HLX22 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA). 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 new cases in 2022 [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, an innovative anti-HER2 mAb, 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 internalization and HER2 dimer degradation. Results from HLX22-GC-201, a phase 2 study of HLX22 in combination with trastuzumab injection (HLX02) 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 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 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.Apart from gastric cancer, the company initiated a phase 2 clinical trial of HLX22, in combination with trastuzumab deruxtecan (T-DXd) for the treatment of HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer and completed the first patient dosage in China. Moving forward, the company will continue to uphold a patient-centric approach, focus on unmet medical needs, and actively explore the optimization of combination therapies for HER2-positive cancer. This includes advancing clinical development for HLX22 to bring hope to more patients around the world.About HenliusHenlius (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 5 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.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] Li, Jin, 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." (2025): 440-440.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