全球研發 | 從全球首個到本土可及，H藥 漢斯狀日本小細胞肺癌橋接試驗完成首例患者入組

轉自：復星醫藥

2025年6月25日，復宏漢霖（2696.HK）宣佈，公司自主研發的H藥 漢斯狀®（斯魯利單抗，歐洲商品名：Hetronifly®）在日本開展的橋接臨牀試驗（NCT06812260）完成首例患者入組。

H藥 漢斯狀®是全球首個獲批用於一線治療小細胞肺癌（SCLC）的抗PD-1單抗，已在中國、英國、德國、新加坡、印度等近40個國家和地區獲批上市，惠及逾11萬患者。NCT06812260研究由關西醫科大學附屬醫院Takayasu Kurata教授擔任牽頭主要研究者，此次橋接試驗旨在評估該產品聯合化療一線治療廣泛期小細胞肺癌（ES-SCLC）在日本患者中的療效及安全性，爲後續H藥在日本市場的註冊申報奠定基礎。

肺癌是全球發病率和死亡率最高的癌症，據GLOBOCAN最新數據顯示，肺癌是日本發病率第二大高發癌種，2022年日本肺癌新發病例13.6萬餘例，肺癌死亡病例逾8.3萬例，位居該國癌症死亡人數第一[1]。SCLC佔肺癌總數的15%-20%，具有惡性程度高、轉移早、疾病進展迅速等特點，預後極差。SCLC分爲侷限期和廣泛期，在被確診爲SCLC的日本患者中，約40-50%爲ES-SCLC，而其中在確診後存活5年的患者不足4%[2,3]。

此前，復宏漢霖已針對H藥漢斯狀®用於一線治療ES-SCLC開展一項隨機、雙盲、安慰劑對照的國際多中心III期臨牀研究（ASTRUM-005）。該研究結果於2022年美國臨牀腫瘤學會（ASCO）年會以口頭報告方式首次發佈，並於全球四大頂級醫學期刊之一的《美國醫學會雜誌》（JAMA）在線發表，成爲全球首個登上JAMA主刊的小細胞肺癌免疫治療臨牀研究。2025年美國臨牀腫瘤學會（ASCO）年會上，ASTRUM-005研究公佈研究結束分析結果，截至2024年12月31日（中位隨訪時間42.4個月），斯魯利單抗組的4年總生存期（OS）率達21.9%，對照組爲7.2%，且安全性可控，進一步夯實了H藥能爲ES-SCLC患者帶來顯著的長期生存獲益。

基於ASTRUM-005研究的優異結果，H藥用於治療ES-SCLC陸續在中國、東南亞多國、歐洲、英國和印度獲批用於一線治療ES-SCLC。復宏漢霖在全球範圍內積極推進H藥在獲批上市進程，目前，公司正在美國開展一項H藥對比一線標準治療阿替利珠單抗用於ES-SCLC的頭對頭橋接試驗，以進一步支持H藥在美國的上市申報。

復宏漢霖將持續以科學證據爲核心，通過本土化開發，推動精準治療策略的落地，爲日本乃至全球患者提供更貼合臨牀需求的治療選擇。

參考文獻

[1] Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834

[2] Sawabata N, Asamura H, Goya T, et al; Japanese Joint Committee for Lung Cancer Registry. Japanese Lung Cancer Registry Study: first prospective enrollment of a large number of surgical and nonsurgical cases in 2002. J Thorac Oncol. 2010 Sep;5(9):1369-75.

[3] Oze I, Ito H, Nishino Y, et al. Trends in Small-Cell Lung Cancer Survival in 1993-2006 Based on Population-Based Cancer Registry Data in Japan. J Epidemiol. 2019 Sep 5;29(9):347-353.

關於日本橋接研究（NCT06812260）

本研究爲一項在日本初治廣泛期小細胞肺癌（ES-SCLC）患者中進行的單臂、開放、II期的橋接研究。合格的患者將每三週接受一次HLX10（重組人源化抗PD-1單克隆抗體注射液）聯合化療（卡鉑-依託泊苷）治療。主要研究目的爲評價HLX10聯合化療在日本初治ES-SCLC患者中的療效，次要目的爲評估HLX10聯合化療的安全性、藥代動力學（PK）和免疫原性。主要研究終點爲第24周緩解（完全緩解[CR]或部分緩解[PR]）率。次要研究終點包括總生存期（OS）、無進展生存期（PFS）、客觀緩解率（ORR）、緩解持續時間（DOR）、生活質量、安全性、PK和免疫原性指標。

關於復宏漢霖

復宏漢霖（2696.HK）是一家國際化的創新生物製藥公司，致力於爲全球患者提供可負擔的高品質生物藥，產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域，已有6款產品在中國獲批上市，4款產品在國際獲批上市，5個上市申請分別獲中國藥監局、美國FDA和歐盟EMA受理。自2010年成立以來，復宏漢霖已建成一體化生物製藥平臺，高效及創新的自主核心能力貫穿研發、生產及商業運營全產業鏈。公司已建立完善高效的全球創新中心，按照國際藥品生產質量管理規範（GMP）標準進行生產和質量管控，不斷夯實一體化綜合生產平臺，其中，公司商業化生產基地已相繼獲得中國、歐盟和美國GMP認證。

復宏漢霖前瞻性佈局了一個多元化、高質量的產品管線，涵蓋約50個分子，並全面推進基於自有抗PD-1單抗H藥漢斯狀®的腫瘤免疫聯合療法。截至目前，公司已獲批上市產品包括國內首個生物類似藥漢利康®（利妥昔單抗）、自主研發的中美歐三地獲批單抗生物類似藥漢曲優®（曲妥珠單抗，美國商品名：HERCESSI™，歐洲商品名：Zercepac®）、漢達遠®（阿達木單抗）、漢貝泰®（貝伐珠單抗）、全球首個獲批一線治療小細胞肺癌的抗PD-1單抗漢斯狀®（斯魯利單抗，歐洲商品名：Hetronifly®）以及漢奈佳®（奈拉替尼）。公司亦同步就19個產品在全球範圍內開展30多項臨牀試驗，對外授權全面覆蓋歐美主流生物藥市場和衆多新興市場。

Henlius Doses First Patient in Japanese Bridging Study of Serplulimab for Extensive-Stage Small Cell Lung Cancer

Shanghai, China, June 25, 2025 — Shanghai Henlius Biotech, Inc. (2696.HK) announced that the first patient has been dosed in its Japanese bridging study (NCT06812260) of its self-developed innovative anti-PD-1 monoclonal antibody, serplulimab (trade name in Europe: Hetronifly®).

Serplulimab is the world’s first anti-PD-1 monoclonal antibody approved for the first-line treatment of small cell lung cancer. It has been approved in nearly 40 countries and regions, including China, the UK, Germany, Singapore, and India, benefiting over 110,000 patients to date. The Japanese bridging studyis, led by Professor Takayasu Kurata of Kansai Medical University Hospital, aims to evaluate the efficacy and safety of serplulimab in combination with chemotherapy for the first-line treatment of extensive-stage SCLC (ES-SCLC) in Japanese patients. This milestone lays a foundation for future regulatory submissions in Japan.

Lung cancer is the leading cause of cancer-related deaths worldwide. According to the latest GLOBOCAN data, it is the second most commonly diagnosed cancer in Japan, with over 136,000 new cases and more than 83,000 deaths reported in 2022, making it the country’s top cause of cancer-related mortality[1]. SCLC accounts for 15%–20% of all lung cancers and is characterized by high malignancy, early metastasis, and rapid disease progression, with a dismal prognosis. ES-SCLC accounts for 40%–50% of SCLC cases in Japan, and fewer than 4% of these patients survive five years post-diagnosis[2,3].

Henlius previously conducted ASTRUM-005, a randomized, double-blind, placebo-controlled, global phase 3 study evaluating serplulimab in combination with chemotherapy as a first-line treatment for ES-SCLC. The results were first presented as an oral presentation at the 2022 ASCO Annual Meeting and subsequently published in JAMA, one of the world's top four medical journals—marking the first SCLC immunotherapy study to be published in the journal's main issue. At the 2025 ASCO Annual Meeting, final analysis results of the study were presented: as of December 31, 2024 (median follow-up: 42.4 months), the 4-year overall survival (OS) rate was 21.9% in the serplulimab group versus 7.2% in the control group, with a manageable safety profile, further underscoring the long-term survival benefit of serplulimab for ES-SCLC patients.

Driven by the strong clinical data from ASTRUM-005, serplulimab has been approved for first-line treatment of ES-SCLC in China, Europe, UK, India and multiple Southeast Asian countries. In parallel, Henlius is conducting a head-to-head bridging study in the U.S. comparing serplulimab to the current standard-of-care, atezolizumab, to support its potential U.S. regulatory submission.

Henlius remains committed to science-based development and will continue advancing localized strategies to enable precision treatment, aiming to deliver clinically relevant therapeutic options for patients in Japan and around the world.

About NCT06812260

This is a single-arm, open-label, phase 2 bridging trial conducted in Japanese patients with previously untreated extensive-stage small-cell lung cancer (ES-SCLC). Eligible patients will be administrated once every three weeks with HANSIZHUANG in combination with chemotherapy (carboplatin-etoposide). The primary objective of the study is to evaluate the efficacy of HANSIZHUANG in combination with chemotherapy in Japanese patients with previously untreated ES-SCLC. The secondary objectives are to evaluate the safety, pharmacokinetics, and immunogenicity of HANSIZHUANG in combination with chemotherapy. The primary endpoint is the response (complete response (CR) or partial response (PR)) rate at week 24. Secondary endpoints include overall survival (OS), progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), quality of life, safety, pharmacokinetics, and immunogenicity parameters.

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 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.

（轉自：復星醫藥）

轉自：市場資訊