近日,复宏汉霖(2696.HK)在日本东京成功举办HLX22-GC-301研究线下研究者会,聚焦公司在研创新型抗HER2单抗HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性晚期胃癌的国际多中心III期临床试验(HLX22-GC-301)。此次会议是公司首次日本线下研究者会,汇聚了来自日本20多家临床试验中心的50多位研究者和研究机构成员及复宏汉霖全球产品开发团队,共同探讨HLX22作为潜在同类首创(First-in-Class)候选药物的临床优势及日本开发策略,这是公司深化在日布局的重要一步,更彰显了公司以高质量创新撬动全球市场的决心。
日本国立癌症研究中心消化道内科
Ken Kato博士
“
这次会议非常有成效,大家展开了许多富有活力和前瞻性的讨论。试验能否顺利推进,离不开各参与研究中心研究人员的全力投入和紧密协作。我相信,通过大家的共同努力,我们一定能在这一领域取得重要突破。
”
市立丰中医院消化内科
Hiroshi Imamura博士
“
我非常荣幸能参与今天的会议,会上大家的讨论为试验提供了许多宝贵的思路。虽然我之前已经仔细研读了试验方案,但通过这次交流,我对研究的理解更加深入,也更有信心投入其中。接下来,我们机构将全力以赴,加快推进患者入组工作。
”
胃癌是日本高发癌种,其新发病率与死亡率均远超全球平均,新发病例及死亡人数分居世界第二和第三位[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]。全球尚无用于治疗HER2阳性胃癌的HER2双靶向疗法获批准上市。
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]。HLX22-GC-301研究旨在评估HLX22联合曲妥珠单抗及化疗一线治疗HER2阳性转移性GC/GEJC患者的疗效与安全性,其新药临床试验(IND)申请已相继获得中国国家药品监督管理局(NMPA)、美国食品药品监督管理局(FDA)许可,并已在多个国家和地区启动。作为关键研究区域之一,日本将承担HLX22-GC-301患者入组及临床数据质量把控的重要任务。本次研究者会通过深入交流,进一步明确了日本患者人群特征、诊疗标准与临床试验执行规范,为后续研究的高效推进奠定基础。
复宏汉霖全球产品开发部总经理李靖
“
日本胃癌负担沉重、临床研究体系成熟,是HLX22全球开发的重要支点。我们期待与本地研究者紧密合作,为患者提供更优治疗选择。
”
除HLX22-GC-301外,公司也在生物药关键市场日本积极推进更多创新管线临床研究。2024年,复宏汉霖已在日本启动H药 汉斯状®针对转移性结直肠癌的II/III期国际多中心临床研究ASTRUM-015 III期阶段研究并完成首例日本患者入组。复宏汉霖两项针对高发消化道肿瘤的III期研究在生物药关键市场日本的同步推进,不仅彰显了复宏汉霖临床开发的国际化能力,也将为后续管线产品在日本及全球市场的申报上市提供关键支持。
复宏汉霖药政事务部总经理李锦
“
日本是公司全球化战略的核心市场之一。我们将依托扎实的临床数据与高效的落地执行能力,推动创新疗法早日惠及当地患者。
”
未来,复宏汉霖将持续深化全球市场布局,以患者为中心,推动更多创新药研发,践行“持续创新,卓越运营;以优质生物药,造福全球病患”的使命。
【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
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50多个分子,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,欧盟商品名:Hetronifly®)以及汉奈佳®(奈拉替尼)。公司亦同步就16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 Successfully Holds First In-Person Investigator Meeting in Japan, Accelerating Global Clinical Research for Innovative Pipeline
Recently, Henlius successfully hosted an in-person clinical investigator meeting for the HLX22-GC-301 study in Tokyo, Japan. The meeting focused on the international phase 3 clinical trial (HLX22-GC-301) of HLX22, our innovative anti-HER2 monoclonal antibody (mAb), in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric cancer. As Henlius' inaugural in-person investigator meeting in Japan, it brought together over 50 leading Japanese oncologists and clinical researchers from more than 20 clinical sites in Japan, and Henlius team. Together, they explored the clinical advantages of HLX22 as a potential First-in-Class candidate and discussed strategies for its development in Japan. This meeting marks a significant step in our commitment to deepening our presence in Japan and underscores our determination to drive global market impact through high-quality innovation.
Dr. Ken Kato, National Cancer Center, Department of Gastrointestinal Medical Oncology remarked, "This meeting was highly productive, fostering dynamic and forward-thinking discussions. The successful execution of this trial hinges on the dedication and collaboration of investigators at participating sites, and I am confident that our collective efforts will lead to meaningful advancements."
Dr. Hiroshi Imamura, Toyonaka Municipal Hospital, Department of Gastroenterology remarked, "It was a privilege to participate in today’s meeting, which offered invaluable insights into the trial. While I had thoroughly reviewed the protocol beforehand, the discussions further enhanced my understanding and deepened my engagement with the study. We remain fully committed to advancing patient enrollment at our institution."
Gastric cancer is a highly prevalent malignancy in Japan, with incidence and mortality rates significantly exceeding the global average. Japan ranks second in the number of new cases and third in the number of deaths globally[1]. The majority of patients with gastric/gastroesophageal junction (G/GEJ) cancer are diagnosed at an advanced stage, resulting in a poor overall prognosis, with a 5-year survival rate of only 6% [2,3]. Among these patients, approximately 12% to 23% are HER2-positive, and their prognosis is worse than that of HER2-negative patients[2,4]. Currently, the standard first-line treatment for HER2-positive locally advanced or metastatic G/GEJ cancer is trastuzumab in combination with chemotherapy. For patients who are PD-L1-positive (PD-L1 CPS ≥1), some guidelines also recommend the addition of immunotherapy. However, sustained efficacy and prognosis still require further improvement[5]. Globally, no dual HER2-targeted therapy has been approved for the treatment of HER2-positive gastric cancer.
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 tumor cell surface, thereby promoting the internalization and HER2 dimer degradation. Clinical data on the combination of HLX22 and HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac® in Europe) demonstrate that the addition of HLX22 to HANQUYOU® plus chemotherapy significantly improves survival and anti-tumor efficacy in first-line treatment of HER2-positive G/GEJ cancer patients, with manageable safety profiles[6-8]. The HLX22-GC-301 study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic gastric/gastroesophageal junction cancer (GC/GEJC). The Investigational New Drug (IND) application for this study has been approved by the National Medical Products Administration (NMPA) in China and the U.S. Food and Drug Administration (FDA), and the study has been initiated in multiple countries and regions worldwide. Japan, as one of the key countries of HLX22-GC-301 study, will play a vital role in patient enrollment and ensuring the quality of clinical data. This in-person investigator meeting, through in-depth discussions, has further clarified the patient population characteristics, diagnostic and treatment standards, as well as clinical trial protocol in Japan, laying a solid foundation for the efficient advancement of the study.
Jing Li, General Manager of Global Product Development at Henlius, stated: "Japan bears a significant burden of gastric cancer but has a well-established clinical research system, making it a crucial fulcrum for the global development of HLX22. We look forward to closely collaborating with local researchers to provide better treatment options for patients."
In addition to the HLX22-GC-301 study, the company is also actively advancing the clinical research of more innovative pipeline products in Japan, a key market for biologics. In 2024, Henlius initiated the phase 3 stage of the international multi-centre clinical trial (ASTRUM-015) for serplulimab in patients with metastatic colorectal cancer (mCRC) in Japan and has enrolled the first Japanese patient. The concurrent advancement of these two Phase 3 studies targeting high-incidence gastrointestinal tumors in Japan not only highlights Henlius' international clinical development capabilities but also provides crucial support for the future registration and launch of pipeline products in Japan and globally.
Jin Li, General Manager of Regulatory Affairs at Henlius, said: "Japan is one of the core markets in our global strategy. We will leverage our robust clinical data and efficient implementation capabilities to bring innovative therapies to local patients as soon as possible."
Looking forward, Henlius will continue to deepen its global market presence, centering on patient needs and driving the development of more innovative therapies. We remain committed to our mission of " To improve patients' lives by timely providing them with quality and affordable protein therapeutics through technical innovation and operational excellence. "
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 over 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 the EU), 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 16 products, expanding its presence in major markets as well as emerging markets.
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