2025年3月26日男同 性愛，复星医药子公司复宏汉霖（2696.HK）晓谕，公司翻新式抗HER2单抗HLX22的外洋多中心III期辩论（HLX22-GC-301）在日本完成首例患者给药，拟用于相关曲妥珠单抗及化疗一线调治东说念主类表皮助长因子受体2（HER2）阳性晚期胃癌。HLX22-GC-301由北京大学肿瘤病院沈琳担任牵头主要辩论者，此前已在中国完成人人首例患者给药，并于好意思国、澳大利亚等地得到临床锻练开展许可。2025年3月，HLX22获好意思国FDA孤儿药经历认定，用于调治胃癌。当今，人人尚无同类用于调治HER2阳性胃癌的HER2双靶向疗法获批准上市。

迄今为止，胃癌/胃食管接壤部（G/GEJ）癌依旧组成了一大人人健康问题。据GLOBOCAN数据披露，2022年人人约有100万新发病例[1]。而在日本，G/GEJ的新发和亏蚀病例在一齐恶性肿瘤中均位居第3位，其中2022年新发病例12.7万，亏蚀病例4.4万[1]。大宗G/GEJ癌患者确诊时已处于疾病晚期，总体预后不良，5年生涯率仅为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]。当今，对于HER2阳性的局部晚期/回荡性G/GEJ患者，其范例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，一些指南亦推选进一步重复联用免疫调治，但执续疗效和预后仍有待进一步改善[5]。HLX22为靶向HER2的翻新式单克隆抗体，可引诱在HER2的胞外亚结构域IV，但引诱表位与曲妥珠单抗有所不同，使得HLX22和曲妥珠单抗大要同期与HER2引诱，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受体阻断扫尾。HLX22相关汉曲优（曲妥珠单抗，好意思国商品名：HERCESSI，欧洲商品名：Zercepac）调治HER2阳性胃癌II期临床辩论（HLX22-GC-201）扫尾披露，在汉曲优联用化疗的基础上加入HLX22可擢升HER2阳性G/GEJ癌患者一线调治的生涯期和抗肿瘤响应，且安全性可控[6-8]。该辩论最新扫尾已于2025年好意思国临床肿瘤学会胃肠说念肿瘤推敲会（ASCO GI）发布[9]。

HLX22-GC-301临床辩论是一项双盲、外洋多中心立时对照III期辩论，旨在比拟HLX22相关曲妥珠单抗和化疗对比曲妥珠单抗和化疗相关或不相关帕博利珠单抗，一线调治HER2阳性局部晚期或回荡性胃癌/胃食管引诱部癌患者的疗效和安全性。顺应条目的受试者将以1:1的比例立时候拨至锻练组（领受HLX22（15 mg/kg）相关曲妥珠单抗和化疗）或对照组（领受安危剂相关曲妥珠单抗和化疗，相关或不相关帕博利珠单抗）。该辩论的主要特殊为平安影像评估委员会（IRRC）基于RECIST v1.1评估的无弘扬生涯期（PFS）和总生涯期（OS）。次要特殊包括辩论者评估的PFS、IRRC或辩论者评估的客不雅缓解率（ORR）、下一线调治的PFS2、缓解执续技巧（DOR）、生活质料、安全性、免疫原性和药代能源学特征。

翌日，公司将不时以患者需求为中枢，在更多国度加快鼓吹HLX22-GC-301辩论，为更多患者带去福音。

【参考文件】

[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/s108-7

[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

对于复宏汉霖

复宏汉霖（2696.HK）是一家外西化的翻更生物制药公司，尽力于为人人患者提供可做事的高品性生物药，居品笼罩肿瘤、本人免疫疾病、眼科疾病等限制，已有6款居品在中国获批上市，4款居品在外洋获批上市，4个上市恳求差别获中国药监局、好意思国FDA和欧盟EMA受理。自2010年设立以来，复宏汉霖已建成一体化生物制药平台，高效及翻新的自主中枢才略邻接研发、坐蓐及买卖运营全产业链。公司已建设完善高效的人人翻新中心，按照外洋药品坐蓐质料贬责范例（GMP）范例进行坐蓐和质料管控，逼迫夯实一体化抽象坐蓐平台，其中，公司买卖化坐蓐基地已接踵得到中国、欧盟和好意思国GMP认证。

复宏汉霖前瞻性布局了一个多元化、高质料的居品管线，涵盖约50个分子，并全面鼓吹基于自有抗PD-1单抗H药汉斯状的肿瘤免疫相关疗法。松手当今，公司已获批上市居品包括国内首个生物近似药汉利康（利妥昔单抗）、自主研发的中好意思欧三地获批单抗生物近似药汉曲优（曲妥珠单抗，好意思国商品名：HERCESSI，欧洲商品名：Zercepac）、汉达远（阿达木单抗）、汉贝泰（贝伐珠单抗）、人人首个获批一线调治小细胞肺癌的抗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个居品在人人领域内开展30多项临床锻练，对外授权全面笼罩泰西主流生物药市集和宽敞新兴市集。

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/s108-7

[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.

(复星医药)男同 性愛