ESMO Asia | 复宏汉霖乳腺癌管线双进击：帕妥珠单抗HLX11与拉索昔芬片HLX78两项研究数据亮相

HLX11是复宏汉霖遵照中国、欧盟和美国生物类似药相关法规自主开发的帕妥珠单抗生物类似药，其适应症包括HER2阳性早期乳腺癌的新辅助和辅助治疗，以及HER2阳性转移性乳腺癌治疗。2025年11月，基于NCT05346224等一系列头对头比较原研的研究，HLX11（美国商品名：POHERDY^®）获美国食品药品监督管理局（FDA）批准上市，成为美国首个帕妥珠单抗生物类似药，并可与原研药互换使用。目前，其上市许可申请亦已获得中国国家药监局（NMPA）、加拿大卫生部（Health Canada）与欧洲药品管理局（EMA）受理。

在本次ESMO大会小型口头报告（Mini Oral, 65MO）中，由中山大学孙逸仙纪念医院刘强教授牵头开展的HLX11关键III期等效性试验（NCT05346224）公布了最新分析结果。NCT05346224是一项多中心、随机、双盲、平行对照的III期临床试验，旨在比较HLX11与原研帕妥珠单抗用于HER2阳性、HR阴性的早期或局部晚期乳腺癌患者新辅助治疗的疗效和安全性。合格的受试者按1:1的比例随机分为两组，分别接受HLX11或原研帕妥珠单抗联合曲妥珠单抗和多西他赛的治疗，每三周一次，共四个周期。研究的主要终点为由独立评审委员会（IRC）评估的总体病理完全缓解（tpCR）率。此次分析的次要终点包括由研究者评估的tpCR率、乳腺组织病理完全缓解（bpCR）率、客观缓解率（ORR）、无事件生存期（EFS）、无病生存期（DFS）、安全性、药代动力学和免疫原性。

在2022年4月25日至2024年1月30日期间，共有908例HER2阳性、HR阴性早期或局部晚期乳腺癌受试者入组，研究结果显示：HLX11在tpCR方面达到与欧盟来源参考帕妥珠单抗的等效性标准，相对风险比值（RR）为1.01（90% CI: 0.90–1.14），相对风险差值（RD）为0.47%（95% CI: -5.99%–6.92%）。两组在bpCR、ORR、EFS等次要终点方面亦表现出相似趋势。HLX11的安全性、药代动力学（PK）及免疫原性与原研帕妥珠单抗高度一致，且从原研帕妥珠单抗单次转换至HLX11未观察到额外风险。

在乳腺癌内分泌治疗方向，HLX78（拉索昔芬片）是复宏汉霖自 Sermonix Pharmaceuticals 引进的一款新型选择性雌激素受体调节剂（SERM），已在既往ELAINE-1与ELAINE-2研究中显示出对ESR1突变人群的抗肿瘤活性。目前，HLX78的国际多中心III期临床已完成中国首例患者给药，并在美国、加拿大和欧盟等地同步推进。

在线壁报展示（192eP）环节中，由东莞市人民医院关灵教授牵头的I期研究公布了HLX78的PK与安全性数据。本研究旨在评价拉索昔芬片在中国健康成人女性受试者中的安全性和药代动力学特征，并与既往研究中的白种人和日本人数据进行对比，从药代动力学角度进一步评估拉索昔芬在不同种族人群（中国人、日本人及高加索人）中的敏感性和 III期关键研究（Elaine 3）拟定剂量（5mg）对于中国受试者的合理性，并为拉索昔芬片在中国受试者中的临床应用提供依据。本研究共入组16名受试者，研究结果显示，口服单剂量5 mg拉索昔芬片后，绝经前/围绝经与绝经后人群之间的药物暴露差异不显著，与既往研究中的白种人和日本人数据趋势亦一致，提示种族敏感性风险较低；所有治疗期间不良事件（TEAE）均为1–2级，无≥3级不良事件或严重不良事件报告，安全性良好。

复宏汉霖深耕乳腺癌治疗领域，通过自主研发与合作引进，已建立覆盖乳腺癌全程全域的多元化治疗管线。公司的核心产品曲妥珠单抗汉曲优^®（美国商品名：HERCESSI^™，欧洲商品名：Zercepac^®）已在全球50多个国家和地区获批上市；HER2阳性强化辅助治疗药物汉奈佳^®（奈拉替尼）可与汉曲优^®实现续贯协同；帕妥珠单抗POHERDY^®为美国首款且唯一获批的PERJETA生物类似药，并同步推进中国、欧洲及加拿大注册进程；创新CDK4/6抑制剂复妥宁^®在中国已获批用于晚期HR+/HER2-乳腺癌治疗。与此同时，公司加速推进HER2新表位单抗HLX22、创新内分泌疗法HLX78、KAT6A/B抑制剂HLX97、LIV-1靶点ADC HLX41、HER2xHER2双表位ADC HLX49、HER2 ADC HLX87等创新分子的开发，持续强化管线协同，为全球乳腺癌患者构建贯穿全域全程的综合治疗生态。

Henlius Highlights Dual Progress in Breast Cancer Pipeline as HLX11 and HLX78 Data Release at ESMO Asia 2025

At the ESMO Asia Congress 2025, Henlius announced data readouts from two breast cancer–related studies: results from the phase 3 equivalence study (NCT05346224) of HLX11 (trade name: POHERDY^® in U.S.), the first and only FDA-approved biosimilar to PERJETA^®, and the phase 1 pharmacokinetic (PK) and safety findings of the innovative endocrine therapy HLX78 (lasofoxifene) in healthy Chinese female adults. The data readouts reinforce the Henlius’ comprehensive, full-spectrum strategy in breast cancer and reflects its commitment to advancing high-quality, accessible therapeutic options for patients worldwide.

HLX11 is a pertuzumab biosimilar independently developed by Henlius in accordance with regulatory requirements in China, the EU and the United States. Its indications include neoadjuvant and adjuvant treatment for HER2-positive early breast cancer and treatment of HER2-positive metastatic breast cancer. In November 2025, HLX11 was approved by the U.S. Food and Drug Administration based on a series of comparative clinical studies, including NCT05346224, becoming the first and only pertuzumab biosimilar in the United States with interchangeable designation. Marketing applications have also been accepted for review by the National Medical Products Administration (NMPA), Health Canada and the European Medicines Agency (EMA).

At the Mini Oral session (65MO) of ESMO Asia 2025, the phase 3 equivalence study (NCT05346224) led by Prof. Qiang Liu of Sun Yat-sen Memorial Hospital was presented for the first time. The multicenter, randomized, double-blind, parallel-controlled phase 3 clinical study (NCT05346224) aimed to compare the efficacy and safety of HLX11 with reference Perjeta^® (pertuzumab) as a neoadjuvant therapy in patients with HER2-positive, HR-negative early, or locally advanced breast cancer as part of a complete treatment regimen. Eligible patients were randomized 1:1 to receive either HLX11 or reference Perjeta® (pertuzumab) in combination with trastuzumab and docetaxel every three weeks for four cycles. The primary endpoint of this study was the total pathological complete response (tpCR) rate assessed by Independent Review Committee (IRC).  The secondary endpoints currently being analyzed included tpCR rate assessed by investigators, breast pathologic complete response (bpCR) rate, objective response rate (ORR), event-free survival (EFS), disease-free survival (DFS), safety, pharmacokinetics, and immunogenicity.

Between April 25, 2022 and January 30, 2024, a total of 908 patients were enrolled. HLX11 met the predefined equivalence criteria for tpCR, with a relative risk of 1.01 (90% CI: 0.90–1.14) and a risk difference of 0.47% (95% CI: −5.99%–6.92%) compared with the EU-sourced reference product. Secondary endpoints—including bpCR rates, ORR, EFS—showed consistent trends between the two treatment arms. HLX11 also demonstrated comparable safety, PK and immunogenicity profiles to reference pertuzumab, and no clinically meaningful impact was observed on safety, PK, or risk of immunogenicity from a single transition of treatment from EU-pertuzumab to HLX11.

In the field of endocrine therapy for breast cancer, HLX78 is a clinical-stage oral selective estrogen receptor modulator (SERM) licensed by Henlius from Sermonix Pharmaceuticals, Inc. It has demonstrated robust target engagement in ER+/HER2- metastatic breast cancer, particularly in the presence of estrogen receptor α gene (ESR1) mutations. To date, an international multi-center phase 3 clinical trial of HLX78 in patients with ER+/HER2- metastatic breast cancer and have an ESR1 gene mutation has completed dosing of the first patient in China sites. This clinical trial is currently recruiting subjects in the U.S., Canada, the EU, China, in addition to other countries and regions.

During the Poster Display session (192eP), the phase 1 study of HLX78, led by Dr. Ling Guan from Dongguan People’s Hospital, was presented. This study is a phase 1 study evaluated the PK and safety of a single dose of lasofoxifene in healthy Chinese female adults and compared the results with data previously reported in healthy Japanese and Caucasian adult women. A total of 16 participants received one oral administration of lasofoxifene at 5 mg. No marked differences in drug exposure were observed between pre- or perimenopausal and postmenopausal participants. Besides, no clinically relevant differences in PK of lasofoxifene were observed for the Chinese healthy females in this study when compared cross-trial to data from Japanese and Caucasian healthy females. All treatment-emergent adverse events were Grade 1 or 2, with no Grade ≥3 events reported, demonstrating a favorable safety and tolerability profile.

Henlius has built a robust and diversified breast cancer pipeline through both internal innovation and strategic partnerships, covering the full continuum of disease management. Its core product, HANQUYOU (trastuzumab, trade name: HERCESSI™ in the U.S., Zercepac^® in Europe), has been approved in more than 50 countries and regions worldwide; neratinib (HANNAIJIA), a HER2-positive extended adjuvant therapy, strengthens post-surgical risk reduction when used sequentially after trastuzumab; POHERDY^® is the first and only pertuzumab biosimilar approved in the U.S.; and the company’s CDK4/6 inhibitor FUTUONING (fovinaciclib citrate) has been approved in China for first- and second-line treatment of HR+/HER2- advanced breast cancer. In parallel, Henlius is accelerating development of multiple high-potential innovative assets, including novel-epitope HER2 antibody HLX22, endocrine therapy candidate lasofoxifene HLX78, KAT6A/B inhibitor HLX97, LIV-1-targeting ADC HLX41, HER2×HER2 biparatopic ADC HLX49, and HER2 ADC HLX87. The company aims to strengthen its synergistic pipeline and build an end-to-end therapeutic ecosystem covering the entire disease course, bringing comprehensive solutions to breast cancer patients worldwide.

媒体：PR@Henlius.com

投资者：IR@Henlius.com