中歐美日澳開發再提速，復星醫藥子公司復宏漢霖PD-L1 ADC HLX43 全球...

• 全球開發提速：HLX43針對NSCLC的國際多中心II期臨牀在中歐美日澳等地啟動，加速產品全球開發進程

• NSCLC全人群覆蓋：HLX43在鱗狀/非鱗狀、有無EGFR突變、有無腦/肝轉移、PD-L1陽性/陰性的NSCLC患者中都展現療效，且安全性良好

• 「高效低毒」持續驗證：HLX43針對NSCLC更新數據即將以口頭報告形式亮相2026 ASCO，持續驗證「高效低毒」特質，提示其多線治療潛力

2026年5月21日，復星醫藥子公司復宏漢霖宣佈，公司創新型程序性死亡-配體1（PD-L1）抗體偶聯藥物（ADC）注射用HLX43在晚期非小細胞肺癌（NSCLC）患者中開展的國際多中心II期臨牀研究（HLX43-NSCLC201）已於西班牙完成歐盟首例受試者給藥。HLX43-NSCLC201 研究目前已在中國、歐盟、美國、日本、澳大利亞等地全面啟動並，標誌着這一全球首創 PD-L1 ADC 的臨牀開發實現全球主要市場的全面覆蓋。憑藉在全人群中展現出的廣泛療效與良好的安全性特徵，HLX43針對NSCLC的最新研究結果亦將於近期以口頭報告的形式重磅亮相2026年美國臨牀腫瘤學會（ASCO）年會。

據GLOBOCAN最新數據顯示，肺癌是全球發病率和死亡率最高的癌症，2022年全球約有超過248萬新發肺癌病例，佔所有癌症新發病例的12.4%¹。大部分肺癌患者確診時已處於疾病晚期階段²，存在巨大的尚未滿足的臨牀需求。非小細胞肺癌（NSCLC）是最常見的肺癌類型（約85%），主要包括鱗狀細胞癌（約30%）和肺腺癌（約50%）等。在全部NSCLC患者中，EGFR野生型佔比高達70%-85%，涵蓋幾乎所有的鱗癌患者和半數以上的肺腺癌患者（50-55%）³。當前療效優異的產品仍較少，特別在接受過標準治療的后線人群治療上，現行臨牀實踐仍高度依賴以多西他賽為基礎的化療方案，且臨牀獲益有限^4,5。

HLX43是一款靶向程序性死亡-配體1（PD-L1）的廣譜抗腫瘤ADC，由全人源IgG1抗PD-L1抗體與創新連接子-拓撲異構酶抑制劑荷載偶聯而成，藥物抗體比（drug-to-antibody ratio, DAR）約為8。HLX43兼具毒素精準殺傷（ADC）和腫瘤免疫治療（IO）的複合功能：其毒素不僅能夠藉靶點內吞進入腫瘤細胞后進行釋放，並在腫瘤微環境中釋放后藉助旁觀者效應進入腫瘤細胞，阻斷DNA複製，從而導致腫瘤細胞凋亡；此外，HLX43的PD-L1靶向抗體可激活免疫調節機制，發揮協同抗腫瘤效應。在2025 美國臨牀腫瘤學會（ASCO）年會上，HLX43的I期臨牀數據首次發佈，展現出令人鼓舞的初步療效和安全性，對鱗狀/非鱗狀非小細胞肺癌（NSCLC），有無EGFR突變、有無腦/肝轉移、PD-L1陽性/陰性的NSCLC患者都展現了優異的治療潛力，且安全性良好。2025年11月，HLX43肺癌領域的關鍵數據更新發布，並整合了HLX43-NSCLC201臨牀研究的初步結果。此次分析明確了2.0 mg/kg 或 2.5 mg/kg 作為HLX43用於治療NSCLC的II/III期推薦劑量（RP2/3D），並持續印證了HLX43在對應劑量下的療效和安全性。

復宏漢霖正全力推進HLX43臨牀開發進程，其用於晚期鱗狀非小細胞肺癌的II/III期國際多中心臨牀研究（HLX43-NSCLC302）將於中國、美國、日本等多國開展，其III期研究階段有望成為HLX43首個、同時也是其在非小細胞肺癌領域的關鍵註冊臨牀研究，為既往標準治療失敗后的sqNSCLC患者這一難治群體帶來新的治療選擇。除NSCLC外，公司積極探索其在多種實體瘤中的治療潛力，包括食管鱗癌、宮頸癌、乳腺癌、胃癌/胃食管交界部（G/GEJ）癌 、頭頸鱗癌等。單藥之外，HLX43聯用其他產品的臨牀試驗也正在進行中，進一步探索ADC與其他療法的協同抗腫瘤療效。HLX43不僅展現出克服PD-1/L1免疫療法不響應或耐藥問題的臨牀潛力，並對化療、TKI治療失敗的患者都具有潛在療效，有望為更多晚期/轉移性實體瘤患者帶來新的治療選擇。

關於HLX43-NSCLC201

本研究為一項評估HLX43在晚期非小細胞肺癌（NSCLC）患者的開放、國際多中心II期臨牀試驗，旨在評估HLX43在晚期非小細胞肺癌（NSCLC）患者中的有效性和安全性。研究分為兩個階段：第一階段將進行劑量探索，以選擇合適的HLX43劑量進行第二階段研究；第二階段為單臂、多中心II期臨牀研究。本研究的主要研究目的為評估HLX43在晚期非小細胞肺癌（NSCLC）中的臨牀療效；主要研究終點為由盲態獨立中心審查委員會（BICR）根據RECIST v1.1標準評估的客觀緩解率。

關於復宏漢霖

復宏漢霖（2696.HK）是一家國際化創新生物製藥企業，致力於為全球患者提供高品質、可負擔的生物藥，產品覆蓋腫瘤、自身免疫疾病、眼科疾病等領域。自2010年成立以來，公司已構建涵蓋全球研發、臨牀、註冊、生產及商業化的全產業鏈平臺，擁有全球員工近4,000人，並在中國、美國和日本等多地設有運營及分支機構。依託生物類似藥形成的穩健現金流反哺創新研發，復宏漢霖正穩步邁入「全球化2.0」階段，持續打造可複製、可持續的全球增長模式。截至2026年初，公司共有10款產品在全球60余個國家和地區獲批上市，其中7款已在中國獲批。在歐美主流生物藥市場，復宏漢霖亦取得多項里程碑式突破，已有4款產品獲得美國FDA批准、5款產品獲得歐盟EC批准，充分體現了公司在研發體系、質量管理及生產能力方面已全面對標國際最高標準。

在創新驅動方面，復宏漢霖依託上海、美國等多地協同佈局的研發體系，構建了多元化、平臺化的創新技術矩陣，覆蓋免疫檢查點抑制劑、免疫細胞銜接器（包括多特異性TCE）、抗體偶聯藥物（ADC）以及AI驅動的早期研發平臺等前沿方向。目前，公司擁有50余項處於早期階段的創新資產，其中約70%具備同類最佳（Best-in-Class）潛力，並在全球同步推進30余項臨牀研究。核心產品H藥 漢斯狀（斯魯利單抗，歐洲商品名：Hetronifly）作為全球首個獲批一線治療小細胞肺癌的抗PD-1單抗，正加速全球佈局，已在全球40余個市場獲批上市；同時，多款潛力創新資產，包括PD-L1 ADC HLX43及新表位HER2單抗HLX22正全面推進全球關鍵性臨牀研究。依託通過中、歐、美三地GMP認證的生產體系，復宏漢霖已建成總產能達84,000升的生物藥生產平臺，形成覆蓋全球六大洲的穩定供應網絡。未來，復宏漢霖將始終堅持以患者為中心，聚焦未滿足的臨牀需求，持續推動創新成果向臨牀價值與患者可及轉化，在全球生物醫藥創新生態中創造長期而穩健的價值。

Global Development Accelerates Further: Henlius’ PD-L1 ADC HLX43 Completes First Patient Dosing in EU for Phase 2 MRCT

• Global Development Accelerated:  Phase 2 MRCT for HLX43 in NSCLC fully initiated across      China, the U.S., Australia and Japan

• Broad Efficacy in NSCLC: HLX43      demonstrates broad efficacy in NSCLC patients, regardless of histology      (squamous or non-squamous), EGFR mutation status, presence of brain/liver      metastases, or PD-L1 expression, with a favorable safety profile

• Continued Validation of High Efficacy and Low Toxicity: Updated clinical data for HLX43 in NSCLC will be featured in an      upcoming oral presentation at the 2026 ASCO Annual Meeting, further      validating its exceptional efficacy, favorable tolerability, and immense      potential across multiple lines of therapy.

Shanghai, China, May 21, 2026 — Shanghai Henlius Biotech, Inc. (2696.HK) today announced that the first patient in the European Union (EU) has been successfully dosed in Spain in the international multi-center Phase 2 clinical trial (HLX43-NSCLC201) evaluating HLX43, an innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC), for the treatment of advanced non-small cell lung cancer (NSCLC). The HLX43-NSCLC201 study has now been fully initiated across China, the EU, the United States, Japan, and Australia, marking comprehensive coverage of major global markets for the clinical development of this first-in-class PD-L1 ADC. Building on its broad efficacy and favorable safety profile across diverse patient populations, the latest research results of HLX43 in NSCLC are also scheduled for a highly anticipated oral presentation at the 2026 ASCO Annual Meeting.

Lung cancer is the most common cancer worldwide in terms of incidence and mortality. According to GLOBOCAN 2022, there were over 2.48 million new cases of lung cancer globally in 2022, accounting for 12.4% of all new cancer cases.¹ The majority of lung cancer patients are diagnosed at advanced stages,² indicating a significant unmet clinical need. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer (approximately 85%). By histology, NSCLC can be classified into squamous cell carcinoma (approximately 30%), adenocarcinoma (approximately 50%) and other subtypes including large cell carcinoma. EGFR wild-type cases account for 70%-85% of all NSCLC patients, including nearly all squamous cell carcinoma cases and 50-55% of adenocarcinoma cases.³ Currently, the treatment landscape of EGFR wild-type NSCLC remains limited by a scarcity of highly effective options, particularly in second-line and later (2L+) therapy, where docetaxel-based chemotherapy continues to serve as the standard of care despite its suboptimal efficacy.^4,5

HLX43 is a broad-spectrum anti-tumor ADC candidate targeting PD-L1, composed of a fully humanized anti-PD-L1 IgG1 antibody, a novel tripeptide linker and topoisomerase inhibitor payload. The drug-to-antibody ratio (DAR) is around 8. Its mechanisms of action integrate targeted cytotoxic delivery and immune checkpoint activation through PD-L1/PD-1 blockade. Upon bonding to tumor cells with PD-L1 expression, the cytotoxic payload of HLX43 will be delivered into tumor cells via dual mechanisms. HLX43 will undergo receptor-mediated endocytosis, releasing the cytotoxic payload intracellularly via linker cleavage, and the payload further diffuses into neighboring tumor cells via bystander effect, thereby blocking DNA replication and triggering tumor cell apoptosis. Meanwhile, the anti-PD-L1 antibody of HLX43 activates immune modulation and blocks immune checkpoints, driving synergistic anti-tumor efficacy. The results from the phase 1 clinical trial of HLX43 has been first released at the 2025 ASCO Annual Meeting, demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC, including squamous and non-squamous NSCLC patients (sqNSCLC and nsqNSCLC), patients with or without EGFR mutation, patients with or without brain/liver metastasis, and PD-L1 positive or negative patients. In November 2025, updated data in lung cancer—integrating preliminary results from the HLX43-NSCLC201 study—were released. This analysis established 2.0 mg/kg or 2.5 mg/kg as the recommended Phase 2/3 dose (RP2/3D) for HLX43 in NSCLC, consistently validating the drug's efficacy and safety at these dose levels.

Henlius is vigorously advancing the clinical development of HLX43. An international multi-center Phase 2/3 study (HLX43-NSCLC302) for advanced squamous NSCLC (sqNSCLC) is slated to launch across multiple countries, including China, the US, and Japan. The Phase 3 portion of this study is poised to become the first pivotal registrational trial for HLX43 in NSCLC, potentially offering a novel therapeutic option for the hard-to-treat population of sqNSCLC patients who have failed prior standard therapies. Beyond NSCLC, the company is actively exploring the potential of HLX43 across various solid tumors, including esophageal squamous cell carcinoma (ESCC), cervical cancer, breast cancer, gastric/gastroesophageal junction (G/GEJ) cancer, and head and neck squamous cell carcinoma (HNSCC). In addition to monotherapy, clinical trials investigating HLX43 in combination with other agents are ongoing to further explore the synergistic anti-tumor efficacy of ADCs with complementary therapies. HLX43 demonstrates the clinical potential to overcome primary or acquired resistance to PD-1/L1 immunotherapies and offers potential efficacy for patients who have failed chemotherapy or TKI treatments, bringing hope for a new generation of treatments to patients with advanced or metastatic solid tumors.

About HLX43-NSCLC201

This is an open-label, multi-centre, international phase 2 clinical study to evaluate HLX43 in patients with advanced non-small cell lung cancer (NSCLC). This study aims to evaluate the efficacy and safety of HLX43 in advanced non-small cell lung cancer (NSCLC) patients. It consists of two parts: Part 1, which focuses on dose exploration to identify the optimal HLX43 dosage for Part 2; and Part 2, which is a single-arm, multi-centre phase 2 clinical trial. The primary objective of this study is to evaluate the clinical efficacy of HLX43 in advanced non-small cell lung cancer (NSCLC) patients. The primary endpoint of the study is objective response rate evaluated by the Blinded Independent Central Review (BICR) according to RECIST v1.1.

About Henlius

Shanghai Henlius Biotech, Inc. (2696.HK) is a global, innovation-driven biopharmaceutical company committed to delivering high-quality, affordable biologic therapies to patients worldwide. The Company focuses on major disease areas including oncology, autoimmune diseases, and ophthalmic diseases. Founded in 2010, Henlius has established an integrated, end-to-end biopharmaceutical platform encompassing global R&D, clinical operations, regulatory affairs, manufacturing, and commercialisation. The Company employs nearly 4,000 people globally and operates across multiple regions, including China, the United States, and Japan. Leveraging the stable cash flow generated from its biosimilar portfolio to support innovation, Henlius is steadily advancing into its 「Globalisation 2.0」 phase, building a scalable and sustainable global growth model. As of early 2026, Henlius has achieved regulatory approvals for 10 products across over 60 countries and regions worldwide, including seven approvals in China. The Company has also reached multiple milestones in major biopharmaceutical markets, with four products approved by the U.S. Food and Drug Administration (FDA) and five products approved by the European Commission (EC), reflecting its globally aligned R&D capabilities, quality systems, and manufacturing standards.

Driven by innovation, Henlius has built a diversified, platform-based technology ecosystem through coordinated R&D efforts across Shanghai, the United States, and other regions. Its innovation platforms span immune checkpoint inhibitors, immune cell engager technologies (including multispecific T cell engagers), antibody-drug conjugates (ADCs), and AI-enabled early discovery platforms. The Company currently has more than 50 early-stage innovative assets, approximately 70% of which are expected to be best-in-class, with over 30 clinical trials ongoing globally. Henlius’ core product, serplulimab (trade name: Hetronifly in Europe), is the world’s first anti–PD-1 mAb approved for first-line treatment of small cell lung cancer and has been approved in more than 40 markets worldwide with an accelerated globalisation process. In parallel, multiple high-potential innovative assets—including the PD-L1 ADC HLX43 and the novel epitope anti-HER2 mAb HLX22—are advancing through global pivotal clinical development. Supported by a biologics manufacturing network with a total capacity of 84,000L and GMP certifications from regulatory authorities in China, Europe, and the United States, Henlius has established a stable global supply system serving six continents. Guided by a patient-centred mission, Henlius remains focused on addressing unmet medical needs and translating scientific innovation into meaningful clinical value and patient access, contributing sustainably to the global biopharmaceutical ecosystem.

To learn more about Henlius, visit and connect with us on LinkedIn at >

參考文獻

References

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2. Robinson CG, et al. Postoperative Radiotherapy for Pathologic N2 Non–Small-Cell Lung Cancer Treated with Adjuvant Chemotherapy: A Review of the National Cancer Data Base. Journal of Clinical Oncology 2015, 33(8): 870-876.

3. Chan BA, Hughes BG. Targeted therapy for non-small cell lung cancer: current standards and the promise of the future. Transl Lung Cancer Res. 2015 Feb;4(1):36-54.

4. 中國臨牀腫瘤學會 中國臨牀腫瘤學會(CSCO).(2024)非小細胞肺癌診療指南

5. NCCN Guidelines Version 3. 2025, Non-Small Cell Lung Cancer.