2026年1月27日，復宏漢霖（2696.HK）宣布，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聯合H藥 漢斯狀（斯魯利單抗，抗PD-1單抗）及其自研的重組抗EGFR單克隆抗體HLX07用于晚期實體瘤治療的臨床試驗申請獲中國國家藥品監督管理局（NMPA）批準。
近年來，免疫檢查點抑制劑（以抗PD-1/L1抗體為代表）已成為癌癥治療的重要手段之一。然而，部分患者對該療法無響應，或者從單藥中獲益有限1，由此推動了聯合治療策略的發展，其中免疫聯合化療已成為多種腫瘤的一線標準治療方案。隨著新型療法的涌現，免疫聯合用藥的選擇日益豐富。抗體偶聯藥物（ADC）在腫瘤治療中已展現出卓越的臨床療效，其與免疫療法的組合（IO+ADC）不僅能產生協同抗腫瘤效應，更有望提升應答率并克服耐藥，成為最具潛力的免疫聯用方向2。目前，IO+ADC的治療方案已在尿路上皮癌中率先獲批3，在胃癌、非小細胞肺癌、乳腺癌、頭頸鱗癌等實體瘤中，多項IO+ADC的聯合療法也顯示出突出治療潛力，有望成為未來腫瘤免疫治療的主線療法4-5。
EGFR（表皮生長因子受體）過表達被認為是肺癌、結直腸癌、頭頸鱗癌等惡性腫瘤發展的重要驅動機制，成為實體瘤治療中已驗證的關鍵靶點之一6。盡管EGFR靶向療法包括西妥昔單抗等已顯著改變了多種癌癥的治療格局，但EGFR的異常激活可導致免疫逃避，創造免疫抑制的微環境，單一藥物靶向治療效果有限。已有研究表明，西妥昔單抗與伊立替康（一類拓撲異構酶抑制劑）的聯合療法在轉移性結直腸癌的治療中展現出顯著優勢，目前已獲批用于該病的一線及后線治療7-8。此外，“抗PD-1/L1單抗+抗EGFR抗體”、“抗PD-1/L1單抗+抗EGFR抗體+化療”的聯合用藥方案也在頭頸鱗癌、皮膚鱗癌、結直腸癌等多種實體瘤的后線、輔助及新輔助治療領域進行探索9-12。
展開剩余95%HLX43是一款潛在同類最優的廣譜抗腫瘤PD-L1 ADC，兼具免疫檢查點阻斷與載荷細胞毒性的雙重作用機制。目前，HLX43在NSCLC等實體瘤中展現出“高效、低毒”的初步臨床療效，尤其在NSCLC的治療上展現了全人群覆蓋的潛力。H藥 漢斯狀（斯魯利單抗）是全球首個且唯一胃癌圍手術期III期注冊研究成功的抗PD-1單抗，同時是全球首個一線治療小細胞肺癌的抗PD-1單抗。憑借其差異化的機制，H藥在多種實體瘤的治療中展現出獨特優勢。HLX07是復宏漢霖自主開發的創新型抗EGFR的單抗，相比西妥昔單抗該產品具備更低的免疫原性和更好的靶點親和力。此前，公司已啟動HLX43與斯魯利單抗以及HLX43與HLX07聯合用于晚期實體瘤治療的臨床探索。基于H藥 漢斯狀（斯魯利單抗）、PD-L1 ADC HXL43展現出的廣譜治療潛力，抗EGFR單抗HLX07聯合斯魯利單抗±化療積極的臨床數據，公司計劃在兩藥聯合治療方案（HLX43聯合斯魯利單抗、HLX43聯合HLX07）的基礎上，進一步拓展至三藥聯合方案，有望通過雙免疫阻斷和精準靶向的協同機制，最大化公司多款核心創新分子的治療潛力。
未來，復宏漢霖將繼續秉持“以患者為中心”的初心和理念，深耕實體瘤這一重要疾病領域，通過不斷挖掘患者未滿足的臨床需求，持續夯實更多創新分子的差異化布局，為更多腫瘤患者帶來高質量、可負擔的新型治療方案。
【參考文獻】
Attili I， et al. Strategies to overcome resistance to immune checkpoint blockade in lung cancer[J]. Lung cancer: Journal of the International Association for the Study of Lung Cancer， 2021(154-):154.
Eleonora. Nicolò， et al. "Combining antibody-drug conjugates with immunotherapy in solid tumors: current landscape and future perspectives." Cancer treatment reviews 106(2022):102395.
Maguire WF， Lee D， et al. FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2024 May 15;30(10):2011-2016.
Martin Reck， Jyoti D. Patel， et al. First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study， Journal of Thoracic Oncology， 2025，
Tolaney S M ， Azambuja E D ， et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study.[J].Journal of Clinical Oncology， 2025， 43(17_suppl):LBA109-LBA109.
Mitsudomi T， Yatabe Y. Epidermal growth factor receptor in relation to tumor development: EGFR gene and cancer[J]. Febs Journal， 2010， 277(2):301-308
E Van Cutsem， CH K?hne， E Hitre et al. Cetuximab and chemotherapy as initial treatment formetastatic colorectal cancer. N Engl J Med. 2009， 360: 1408-1417.
I LLC. Cetuximab FDA label. 2021.09.24.
AG Sacco， R Chen， FP Worden et al. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label， multi-arm， non-randomised， multicentre， phase 2 trial. Lancet Oncol. 2021， 22: 883-892.
{jz:field.toptypename/}JI D， SANG Y， et al. A phase Ⅱ clinical trial of camrelizumab combined with cetuximab and chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)［J］. Ann Oncol， 2024， 35: S626.
YAO Z W， WANG J S， et al. Pembrolizumab plus cetuximab with neoadjuvant chemotherapy for head and neck squamous cell carcinoma［J］. Head Neck， 2025， 47(1): 289-299.
Yi-Long Lung Cancer Wu et al. A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer. J Clin Oncol 43， 8561-8561(2025).
Attili I， et al. Strategies to overcome resistance to immune checkpoint blockade in lung cancer[J]. Lung cancer: Journal of the International Association for the Study of Lung Cancer， 2021(154-):154.
Eleonora. Nicolò， et al. "Combining antibody-drug conjugates with immunotherapy in solid tumors: current landscape and future perspectives." Cancer treatment reviews 106(2022):102395.
Maguire WF， Lee D， et al. FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Cisplatin-Ineligible Locally Advanced or Metastatic Urothelial Carcinoma. Clin Cancer Res. 2024 May 15;30(10):2011-2016.
Martin Reck， Jyoti D. Patel， et al. First-Line Sacituzumab Govitecan Plus Pembrolizumab in Metastatic NSCLC: PD-L1 TPS Less Than 50% and More Than or Equal to 50% Cohorts of the EVOKE-02 Study，太陽城娛樂 Journal of Thoracic Oncology， 2025，
Tolaney S M ， Azambuja E D ， et al. Sacituzumab govitecan (SG) + pembrolizumab (pembro) vs chemotherapy (chemo) + pembro in previously untreated PD-L1–positive advanced triple-negative breast cancer (TNBC): Primary results from the randomized phase 3 ASCENT-04/KEYNOTE-D19 study.[J].Journal of Clinical Oncology， 2025， 43(17_suppl):LBA109-LBA109.
Mitsudomi T， Yatabe Y. Epidermal growth factor receptor in relation to tumor development: EGFR gene and cancer[J]. Febs Journal， 2010， 277(2):301-308
E Van Cutsem， CH K?hne， E Hitre et al. Cetuximab and chemotherapy as initial treatment formetastatic colorectal cancer. N Engl J Med. 2009， 360: 1408-1417.
I LLC. Cetuximab FDA label. 2021.09.24.
AG Sacco， R Chen， FP Worden et al. Pembrolizumab plus cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma: an open-label， multi-arm， non-randomised， multicentre， phase 2 trial. Lancet Oncol. 2021， 22: 883-892.
JI D， SANG Y， et al. A phase Ⅱ clinical trial of camrelizumab combined with cetuximab and chemotherapy in recurrent or metastatic head and neck squamous cell carcinoma (R/M HNSCC)［J］. Ann Oncol， 2024， 35: S626.
YAO Z W， WANG J S， et al. Pembrolizumab plus cetuximab with neoadjuvant chemotherapy for head and neck squamous cell carcinoma［J］. Head Neck， 2025， 47(1): 289-299.
Yi-Long Lung Cancer Wu et al. A phase 2 study of HLX07 plus serplulimab with or without chemotherapy versus serplulimab plus chemotherapy as first-line therapy in advanced squamous non-small cell lung cancer. J Clin Oncol 43， 8561-8561(2025).
關于HLX43
HLX43是一款潛在同類最優的廣譜抗腫瘤PD-L1 ADC，兼具免疫檢查點阻斷與載荷細胞毒性的雙重作用機制。臨床前研究顯示，HLX43在PD-1/PD-L1單抗耐藥的非小細胞肺癌、宮頸癌、食管鱗癌等多個瘤種中展現出治療潛力，開云且耐受性良好。其I期臨床數據于2025美國臨床腫瘤學會（ASCO）年會及2025 世界肺癌大會（WCLC）上先后發布，在NSCLC等實體瘤中展現出“高效、低毒”的顯著療效，尤其在NSCLC的治療上，HLX43展現了全人群覆蓋的潛力。此外，HLX43在宮頸癌、食管鱗癌等實體瘤中的II期POC驗證數據也陸續讀出，驗證了其在實體瘤領域的廣泛治療潛力。
關于H藥 漢斯狀
H藥 漢斯狀（斯魯利單抗）是全球首個且唯一胃癌圍手術期III期注冊研究成功的抗PD-1單抗，獲CDE突破性療法認定且其上市許可申請正式納入優先審評審批程序，同時是全球首個一線治療小細胞肺癌的抗PD-1單抗。自2022年上市以來，H藥已獲批用于治療鱗狀非小細胞肺癌（sqNSCLC）、廣泛期小細胞肺癌（ES-SCLC）、食管鱗狀細胞癌（ESCC）和非鱗狀非小細胞肺癌（nsNSCLC) 適應癥，在中國、英國、德國、新加坡、印度等40多個國家獲批上市，覆蓋全球近半數人口。憑借其差異化的機制，H藥在多種實體瘤的治療中展現出獨特優勢，在肺癌和胃癌領域皆斬獲全球突破性進展，其關鍵性臨床研究結果發表于JAMA、Nature Medicine、Cancer Cell和British Journal of Cancer等頂級學術期刊，并獲得美國、歐盟、瑞士、韓國、墨西哥孤兒藥資格認定。
關于HLX07
HLX07是復宏漢霖自主開發的創新型抗EGFR的單抗，相比西妥昔單抗該產品具備更低的免疫原性和更好的靶點親和力。目前，公司圍繞肺鱗癌、皮膚鱗癌、鼻咽癌、食管鱗癌等多個實體瘤適應癥，積極開展HLX07單藥或聯合H藥 漢斯狀（斯魯利單抗）的II期臨床探索。根據2025 WCLC最新數據發布，HLX07聯合斯魯利單抗及化療在EGFR高表達sqNSCLC患者一線治療中展現出顯著的抗腫瘤活性和持久療效，在中位隨訪18.6個月時實現了約70%的客觀緩解率（ORR）和超過90%的疾病控制率（DCR），高劑量組的中位無進展生存期（PFS）更達到17.4個月，表明抗EGFR單抗與PD-1/L1抑制劑的聯用，不僅阻斷EGFR生長信號，更同步激活免疫應答，極具聯合協同治療潛力。
關于復宏漢霖
復宏漢霖（2696.HK）是一家國際化的創新生物制藥公司，致力于為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，已在全球獲批上市10款產品，6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制藥平臺，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范（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。
復宏漢霖前瞻性布局了一個多元化、高質量的產品管線，涵蓋約50個分子，并全面推進基于自有抗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）、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）、國內首個生物類似藥漢利康（利妥昔單抗）、地舒單抗生物類似藥Bildyos和Bilprevda，以及帕妥珠單抗POHERDY。公司亦同步就19個產品在全球范圍內開展30多項臨床試驗，對外授權全面覆蓋歐美主流生物藥市場和眾多新興市場。
Henlius Receives an IND Approval for Its PD-L1-Targeting ADC HLX43 in Combination with Anti-PD-1 mAb Serplulimab and Novel Anti-EGFR mAb HLX07
Shanghai， China， January 27， 2026—Shanghai Henlius Biotech， Inc. (2696.HK) announced that the investigational new drug (IND) application for a clinical trial of HLX43， the innovative programmed death-ligand 1 (PD-L1) targeting antibody-drug conjugate (ADC)， in combination with the company's anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab) and independently developed innovative anti-EGFR mAb HLX07 has been approved by the China National Medical Products Administration (NMPA)， for the treatment of advanced solid tumors.
Immune checkpoint inhibitors represented by anti-PD-1/PD-L1 monoclonal antibodies have become a cornerstone of cancer treatment. However， there are still many patients who do not respond to or derive limited benefit from monotherapy1， which has fueled the development of combination strategies. Among these， immunochemotherapy has become a first-line standard of care for multiple tumor types. As novel therapies expand the combination immunotherapy landscape， antibody-drug conjugates (ADCs) have emerged as a highly effective option. Their combination with immunotherapy (IO) may create synergy for more potent and durable responses while overcoming resistance， thereby addressing critical unmet clinical needs2. A major breakthrough has been the approval of an IO-ADC combination as first-line treatment for advanced urothelial cancer3. This success has accelerated exploration in other solid tumors like gastric cancer (GC)， non-small cell lung cancer (NSCLC)， breast cancer (BC)， and head and neck squamous cell carcinoma (HNSCC)， positioning it as a key next-generation approach4-5.
EGFR (Epidermal Growth Factor Receptor) overexpression is considered a crucial driving mechanism in the development of various malignant tumors， including lung cancer， colorectal cancer (CRC)， and HNSCC， establishing it as one of the validated key targets in solid tumor treatment6. Although EGFR-targeted therapies， such as cetuximab， have significantly altered the treatment landscape for many cancers， abnormal EGFR activation can lead to immune evasion and create an immunosuppressive microenvironment， resulting in limited efficacy for single agent targeted therapy. Previous studies have shown that combination of cetuximab and irinotecan (a topoisomerase inhibitor) demonstrates potent efficacy in metastatic colorectal cancer， and is now approved for both first-line and later-line treatment of the disease7-8. Furthermore， strategies of "anti-PD-1/L1 mAb plus anti-EGFR mAb" and "anti-PD-1/L1 mAb plus anti-EGFR mAb plus chemotherapy" are widely explored in the later-line， adjuvant， and neoadjuvant settings for various solid tumors， including HNSCC， cutaneous squamous cell carcinoma (CSCC) and CRC9-12.
HLX43 is a potentially best-in-class pan-tumor ADC candidate targeting PD-L1， which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Preliminary clinical data has indicated a manageable safety profile and encouraging efficacy in various solid tumors， with notable anti-tumor activity observed in various NSCLC patient subgroups. Serplulimab (HANSIZHUANG) is the world’s first and only anti-PD-1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer， and the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). It has shown unique advantages in various solid tumors via its differentiated mechanism. HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab， HLX07 demonstrates lower immunogenicity and higher target affinity. The company has initiated clinical trials of HLX43 in combination with serplulimab， as well as HLX43 combined with HLX07， for the treatment of advanced solid tumors. Leveraging the broad therapeutic potential of serplulimab and the PD-L1 ADC HLX43， along with encouraging clinical data for the anti-EGFR mAb HLX07 plus serplulimab with or without chemotherapy， the company plans to expand from two ongoing dual combination therapies—HLX43 plus serplulimab and HLX43 plus HLX07—into a triple-combination regimen. This strategy aims to maximize the clinical value of its core innovative products by harnessing the synergistic effects of dual immune checkpoint blockade and precision targeting.
By strategically prioritizing solid tumor domain as a core therapeutic area， Henlius continues to uphold its patient-centric mission， accelerating differentiated innovation to address unmet medical needs and delivering high-quality， affordable therapies to tumor patients worldwide.
About HLX43
HLX43 is a potential best-in-class pan-tumor ADC candidate targeting PD-L1， which exhibits dual mechanisms integrating immune checkpoint blockade and payload-mediated cytotoxicity. Preclinical data has shown that， HLX43 has promising anti-tumor activity and a favorable tolerability profile in NSCLC， cervical cancer (CC)， esophageal squamous cell carcinoma (ESCC) and other tumor types that were PD-1/L1 mAb-resistant. The results from the phase 1 clinical trial of HLX43 were released at the 2025 ASCO Annual Meeting and 2025 WCLC， demonstrating manageable safety profile and encouraging efficacy in various solid tumors especially in patients with NSCLC. In addition， phase 2 proof of concept (POC) data of HLX43 in CC and ESCC continue to emerge， providing compelling new evidence for its pan-tumor therapeutic potential.
About Serplulimab
Serplulimab is the world’s first and only anti-PD-1 mAb to have succeeded in a phase 3 registration study for perioperative gastric cancer， to receive Breakthrough Therapy Designation from the CDE as well as being granted Priority Review for the treatment of this indication. Meanwhile， it is the first anti-PD-1 mAb approved for the first-line treatment of small cell lung cancer (SCLC). Up to date， serplulimab has been approved for the treatment of squamous non-small cell lung cancer (sqNSCLC)， extensive-stage small cell lung cancer (ES-SCLC)， esophageal squamous cell carcinoma (ESCC)， and non-squamous non-small cell lung cancer (nsqNSCLC). It has been approved in over 40 countries and regions including China， the U.K.， Germany， Singapore， and India， covering nearly half of the global population and accelerating global accessibility. Serplulimab demonstrates unique advantages in various solid tumors via its differentiated mechanism， especially achieving groundbreaking progress in both lung and gastric cancers. The results of 4 pivotal trials of serplulimab were published in the Journal of the American Medical Association (JAMA)， Nature Medicine， Cancer Cell and British Journal of Cancer， respectively. It has also received orphan drug designations granted by the US FDA， the European Commission， Swissmedic， Korea MFDS and Mexico COFEPRIS.
About HLX07
HLX07 is an innovative anti-EGFR mAb developed by Henlius. Compared with cetuximab， HLX07 demonstrates lower immunogenicity and higher target affinity. Henlius is conducting phase 2 clinical trials to explore HLX07 as monotherapy or in combination with serplulimab for the treatment of solid tumors including sqNSCLC， CSCC， nasopharyngeal carcinoma (NPC) and ESCC. According to the updated results in 2025 WCLC， the combination of HLX07 with serplulimab and chemotherapy demonstrated remarkable antitumor activity and durable efficacy as first-line treatment for patients with EGFR overexpression sqNSCLC. At a median follow-up of 18.6 months， both dose groups achieved an objective response rate (ORR) of around 70% and a disease control rate (DCR) of over 90%. The median progression-free survival (PFS) reached 17.4 months in the high-dose group. This indicates that the combination of HLX07 and serplulimab blocks EGFR signaling while activating immune responses， supporting strong therapeutic synergy.
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. To date， 10 products have been approved for marketing across multiple countries and regions， and 6 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 HANSIZHUANG (serplulimab， trade name: Hetronifly in Europe)， the world’s first anti-PD-1 mAb for the first-line treatment of SCLC， HANQUYOU (trastuzumab， trade name: HERCESSI in the U.S.， Zercepac in Europe)， a China-developed mAb biosimilar approved in China， Europe and U.S.， HANLIKANG (rituximab)， the first China-developed biosimilar， denosumab Bildyos and Bilprevda， and pertuzumab Poherdy. What’s more， Henlius has conducted over 30 clinical studies for 19 products， expanding its presence in major markets as well as emerging markets.
發布于：北京市
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