Serplulimab

2025年4月17日，复宏汉霖（2696.HK）宣布，公司创新型抗HER2单抗HLX22单抗注射液联合德曲妥珠单抗治疗HER2低表达HR阳性的局部晚期或转移性乳腺癌的II期临床研究（HLX22-BC201）于中国境内完成首例患者给药。继HER2阳性胃癌之后，HLX22的治疗领域再度拓宽至乳腺癌疾病领域，有望为更多肿瘤患者带来新的治疗选择。乳腺癌是全球和中国发病率第二高的癌症，据GLOBOCAN数据显示，2022年全球乳腺癌新发病例约230万，中国乳腺癌新发病例逾35.7万[1]。其中，HER2低表达乳腺癌是对IHC 1+或2+且ISH阴性的乳腺癌提出的一个新的临床分类，此类患者约占全部乳腺癌的45%-55%[2]。目前，由于缺乏针对性的靶向治疗药物，HER2低表达HR阳性乳腺癌主要依赖内分泌治疗或化疗等治疗[3]。尽管T-DXd等分子在HER2低表达HR阳性乳腺癌中展现出抗肿瘤活性[4]，但该类患者群体的治疗选择仍相对有限，亟待进一步探索更加安全有效的创新治疗方案。HLX22作为一款靶向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。此前，HLX22联合曲妥珠单抗的HER2双靶疗法已在HER2阳性胃癌的治疗中展现出优异的疗效，一项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阳性胃癌的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[5-7]。目前，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期临床研究（HLX22-GC-301）分别获得中国、美国、日本和澳大利亚等地药监机构的新药临床试验（IND）许可，并完成首例患者给药。此外，HLX22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。基于HLX22在HER2阳性胃癌领域取得的优异成果，复宏汉霖积极探索HLX22在更广泛实体瘤中的疗效，持续拓宽惠及的患者群体。2024年，HLX22联合曲妥珠单抗和化疗或联合德曲妥珠单抗的II期临床试验申请获得中国国家药品监督管理局（NMPA）批准，拟用于治疗HER2表达实体瘤。HLX22联合德曲妥珠单抗的临床前动物试验显示，该抗HER2联合疗法展现出协同抗肿瘤作用和良好的安全性，有望为HER2表达肿瘤患者带来更多获益。未来，复宏汉霖也将持续探索新型抗HER2靶向疗法在肿瘤中的治疗潜力，高效推进HLX22的全球临床开发进展，为全球患者提供更多可负担、疗效更好的治疗方案。关于HLX22-BC201本研究是一项多中心的II期临床研究，旨在评估HLX22联合德曲妥珠单抗治疗经标准治疗后疾病进展或不可耐受毒性反应的，HER2低表达HR阳性的局部晚期或转移性乳腺癌患者的疗效和安全性。符合条件的受试者将接受HLX22联合德曲妥珠单抗治疗。该研究的主要终点为独立影像评估委员会（IRRC）基于RECIST v1.1评估的客观缓解率（ORR）和无进展生存期（PFS）；次要终点包括研究者评估的客观缓解率（ORR）和无进展生存期（PFS），总生存期（OS），独立影像评估委员会（IRRC）或研究者评估的缓解持续时间（DOR）、安全性、药代动力学、免疫原性和生物标志物。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' Innovative Anti-HER2 mAb HLX22 in Combination with T-Dxd Advances to a Phase 2 Clinical Trial for the Treatment of HER2-low, HR-positive BC with First Patient DosedShanghai, China, April 17, 2025 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in China in HLX22-BC201, a phase 2 clinical trial of the company’s novel anti-HER2 monoclonal antibody (mAb), HLX22, in combination with trastuzumab deruxtecan (T-DXd) for the treatment of HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer. Apart from its exploration in HER2-positive gastric cancer, the therapeutic scope of HLX22 has further expanded to the field of breast cancer, potentially providing new treatment options for broader tumour patients population.Breast cancer is the second most diagnosed cancer in the world, according to GLOBOCAN 2022. There were around 2.30 million new cases of breast cancer in 2022 globally, including more than 357,000 in China[1]. Among these, HER2-low breast cancer has been proposed as a novel clinical classification  for breast cancers demonstrating IHC 1+ or 2+ with negative ISH results. This category accounts for approximately 45%-55% of all breast cancer cases[2]. Currently, due to the lack of targeted therapies, HER2-low,hormone receptor (HR)-positive breast cancer primarily relies on treatments such as endocrine therapy or chemotherapy[3]. Despite novel regimens like trastuzumab deruxtecan (T-DXd) has demonstrated anti-tumour activity in HER2-low, HR-positive breast cancer[4], therapeutic options for this patient population remain relatively limited, indicating an unmet medical need to explore more safe and effective innovative treatment approaches.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. The phase 2 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-tumour efficacy in first-line treatment of HER2-positive gastric/gastroesophageal junction cancer (GC/GEJC) patients, with manageable safety profiles[5-7]. At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical 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 GC/GEJC, have been approved by regulatory authorities in China, the U.S, Japan and Australia, etc., and this international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally. Furthermore, HLX22 has received orphan drug designation (ODD) in 2025 from the U.S. Food and Drug Administration (FDA) for the treatment of gastric cancer. Based on the promising results showcased by HLX22 in the field of HER2-positive gastric cancer, Henlius is actively exploring the efficacy of HLX22 in a broader range of solid tumours, continuously expanding the patient groups who can benefit from it. In 2024, the phase 2 clinical trial of HLX22 in combination with trastuzumab and chemotherapy or combined with T-DXd was approved by the China National Medical Products Administration (NMPA) for the treatment of HER2-expressing solid tumours. Preclinical animal studies of HLX22 combined with T-DXd showed synergistic anti-tumour effect and good safety profiles, which may offer more benefits to patients with HER2-expressing tumours. Looking forward, Henlius will also continue to explore the therapeutic potential of its novel anti-HER2 targeted therapies in tumours and efficiently accelerate the global development of HLX22, offering more affordable and effective treatment options for patients worldwide.About HLX22-BC201This is a multicenter phase 2 study aimed to evaluate the efficacy and safety of HLX22 combined with trastuzumab deruxtecan for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer who have progressed on or are intolerant to standard therapy. Eligible subjects will receive HLX22 plus trastuzumab deruxtecan. The primary endpoints of this study are objective response rate (ORR) and progression-free survival (PFS) accessed by independent radiology review committee (IRRC) per RECIST 1.1; secondary endpoints include investigator-assessed objective response rate (ORR) and progression-free survival (PFS), overall survival (OS), IRRC or investigator-accessed duration of response (DOR), safety, pharmacokinetics, immunogenicity, and biomarkers.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] Tarantino, P., et al. (2021). HER2-Low Breast Cancer: Pathological and Clinical Perspectives. Journal of Clinical Oncology, 39(15), 3205-3214.[3] Gennari, A., et al. (2022). HER2-Low Breast Cancer: A New Entity with Therapeutic Implications. Nature Reviews Clinical Oncology, 19(6), 325-336.[4] Modi, S., et al. (2022). Trastuzumab Deruxtecan in Previously Treated HER2-Low Advanced Breast Cancer. New England Journal of Medicine, 387(1), 9-20.[5] 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).[6] 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.[7] Li N, et al. A randomized phase 2 study of HLX22 plus trastuzumab biosimilar HLX02 and XELOX as first-line therapy for HER2-positive advanced gastric cancer. Med. 2024;5(10):1255-1265.e2.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