pimurutamab (HLX07) / Fosun Pharma, Shanghai Henlius Biotech - LARVOL DELTA

Neoadjuvant short-course radiotherapy followed by HLX07, serplulimab, and CAPOX in RAS/BRAF wild-type locally advanced rectal cancer (LARC): A multicenter, single-arm, phase II trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Colorectal Cancer • Oncology • Rectal Cancer • Solid Tumor • BRAF

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. (ASCO 2025) - P2 | "Patients with stage IIIB/IIIC or IV sqNSCLC that was not amenable to surgery or radiation therapy and high tumor expression of epidermal growth factor receptor (H score≥150) and no prior systemic therapy were randomized 1:1 to receive intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300 mg) and chemotherapy (carboplatin and nab-paclitaxel), once every three weeks. First-line HLX07 plus serplulimab and chemotherapy showed encouraging preliminary efficacy with a manageable safety profile in patients with advanced sqNSCLC which warrants further investigation."

Clinical • IO biomarker • Metastases • P2 data • Alopecia • Anemia • Endocrine Disorders • Immunology • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

First-line HLX07 vs. placebo combined with serplulimab and chemotherapy for nasopharyngeal cancer: A randomised, double-blind, multicentre phase II study (ESMO Asia 2024) - P2 | "Serplulimab (300 mg), and chemotherapy (gemcitabine and cisplatin) were also given Q3W for up to 2 years, and 6 cycles, respectively. Conclusions The addition of HLX07 to serplulimab and chemotherapy showed preliminary efficacy along with a manageable safety profile. This treatment regimen warrants further investigation as a potential first-line option for R/M-NPC patients."

Clinical • IO biomarker • Late-breaking abstract • P2 data • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Results from Phase 2 Study of Pimurutamab (HLX07) in Advanced Cutaneous Squamous Cell Carcinoma Published in Therapeutic Advances in Medical Oncology (Henlius Press Release) - "Long-term follow-up showed encouraging antitumour activity and durable clinical benefit. Based on BICR assessments, the confirmed ORR was 19.0% in Group A, with all objective responses being partial responses (PRs). In Group B, the confirmed ORR reached 60.0%, including one complete response (CR). The DCR was 61.9% and 100%, respectively. The median PFS was 4.9 months in Group A and 7.9 months in Group B, while the median DOR was 5.0 months and 7.4 months, respectively. The median OS was 11.8 months in Group A and not reached in Group B at data cutoff."

P2 data • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

HLX07, a novel anti-EGFR antibody, for locally advanced and metastatic cutaneous squamous cell carcinoma: an open-label, multicenter, phase II trial. (PubMed, Ther Adv Med Oncol) - P2 | "HLX07 monotherapy has demonstrated promising efficacy and a favorable safety profile in treating aCSCC, warranting further investigation in large-scale clinical studies. ClinicalTrials.gov NCT05238363."

Journal • P2 data • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Phase II Clinical Study to Compare the Efficacy and Safety of HLX07 + Serplulimab +Chemotherapy Versus Placebo + Serplulimab + Chemotherapy in First-Line Treatment of Patients With Recurrent or Metastatic NPC (clinicaltrials.gov) - P2 | N=75 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed

IO biomarker • Trial completion • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1

Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX07+HLX10 +mFOLFOX6 or HLX07 Monotherapy in Patients With mCRC (clinicaltrials.gov) - P2 | N=50 | Terminated | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Terminated

IO biomarker • Monotherapy • Trial termination • Colorectal Cancer • Oncology • Solid Tumor • BRAF • KRAS • NRAS

A Clinical Study to Evaluate the Efficacy and Safety of HLX07 Combination Therapy in Patients With Extensive Small Cell Lung Cancer (clinicaltrials.gov) - P2 | N=20 | Terminated | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Terminated

IO biomarker • Trial termination • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • PD-L1

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=706 | Recruiting | Sponsor: Shanghai Henlius Biotech | Enrolling by invitation ➔ Recruiting

Enrollment status • Monotherapy • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=706 | Enrolling by invitation | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Monotherapy • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

First-line HLX07 vs placebo combined with serplulimab and chemotherapy for nasopharyngeal carcinoma: A randomized, double-blind, multicenter phase 2 study. (ASCO 2026) - P2 | "Patients with histopathologically confirmed, unresectable, R/M NPC that is not amenable to local or radical treatment and had no prior systemic therapy were randomized 2:1 to receive either HLX07 at 1000 mg (HLX07 group) or placebo (placebo group), along with serplulimab (300 mg) and chemotherapy (gemcitabine and cisplatin) Q3W intravenously. The addition of HLX07 to serplulimab and chemotherapy showed encouraging efficacy along with a manageable safety profile in patients with treatment-naïve R/M-NPC. Further investigation of this treatment regimen is warranted."

Clinical • IO biomarker • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1

HENLIUS...HLX07 International Multi-center Phase 2/3 Clinical Study Completes First Patient Dosing in China (iis.aastocks.com) - "HENLIUS announced that its self-developed pimurutamab HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) (HLX07), in combination with Hansizhuang and chemotherapy, versus placebo plus Hansizhuang or pembrolizumab and chemotherapy for first-line treatment of advanced squamous non-small cell lung cancer (sqNSCLC), has completed first patient dosing in China for its international multi-center Phase 2/3 clinical study."

Trial status • Lung Non-Small Cell Squamous Cancer

Shanghai Henlius Biotech has received implied approval from Japan’s Pharmaceuticals and Medical Devices Agency to start an international multicenter phase 2/3 clinical trial of HLX43, an anti-PD-L1 antibody-drug conjugate, as a monotherapy or in combination with the anti-EGFR antibody HLX07 for advanced squamous non-small cell lung cancer (TipRanks)

New P2/3 trial • Non Small Cell Lung Cancer

Henlius (02696.HK) HLX07 Combined with HANSIZHUANG Clinical Trial Approved to Commence in Australia (iis.aastocks.com) - "Henlius..announced that a Phase 2/3 clinical trial of its self-developed pimurutamab HLX07 (recombinant anti-EGFR humanized monoclonal antibody injection) in combination with HANSIZHUANG (serplulimab injection) and chemotherapy, compared with placebo plus HANSIZHUANG or pembrolizumab and chemotherapy, as first-line treatment for advanced squamous non-small cell lung cancer, has been approved by the relevant Human Research Ethics Committee and has completed clinical trial notification filing with the Therapeutic Goods Administration of Australia."

New P2/3 trial • Lung Non-Small Cell Squamous Cancer

A Global Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX43 Monotherapy or HLX43 in Combination With HLX07 Versus Docetaxel in Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=671 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

Monotherapy • New P2/3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Phase II Clinical Study to Evaluate HLX43 in Subjects With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=167 | Recruiting | Sponsor: Shanghai Henlius Biotech | N=90 ➔ 167 | Trial completion date: Jul 2028 ➔ Jan 2029

Enrollment change • Trial completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Shanghai Henlius Biotech…is pleased to announce that, recently, the investigational new drug (IND) application for clinical trial of pimurutamab HLX07…in combination with HANSIZHUANG…and chemotherapy for the treatment of advanced squamous non-small cell lung cancer (sqNSCLC) has been approved by the National Medical Products Administration (the 'NMPA') (HKEXnews)

New trial • Lung Non-Small Cell Squamous Cancer

Shanghai Henlius Biotech…announced that the first patient has been dosed in China in a Phase 1b/2 trial (HLX43-mCRC202), for the company's innovative programmed death-ligand 1 (PD-L1) antibody-drug conjugate (ADC), HLX43, in combination with serplulimab…or independently developed recombinant anti-EGFR mAb HLX07 in patients with advanced or metastatic colorectal cancer (mCRC) (Henlius Press Release)

Trial status • Colorectal Cancer

Shanghai Henlius Biotech, Inc…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) (Henlius Press Release) - "...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."

New trial • Solid Tumor

A Phase Ib/II Study to Evaluate HLX43 Combined With HLX07 or Serplulimab in Patients With Advanced or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=126 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1/2 trial • Colon Adenocarcinoma • Colon Cancer • Colorectal Cancer • Oncology • Solid Tumor • BRAF • MSI

HLX07 - Anti-EGFR mAb with a Dual-Target Synergistic Effect, Expected to Open Up a New First-Line treatment Pathway for EGFR-overexpressing sqNSCLC (PRNewswire) - "Two studies are planned by the end of 2026: (i) A pivotal Phase 2 trial in cutaneous squamous cell carcinoma; (ii) A global multicentre Phase 2/3 trial in first-line sqNSCLC."

New trial • Lung Non-Small Cell Squamous Cancer • Squamous Cell Skin Cancer

A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=720 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2/3 trial • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • PD-L1

APPLICATION FOR PHASE 1B/2 CLINICAL TRIAL OF HLX43 FOR INJECTION (AN ANTI-PD-L1 ANTIBODY-DRUG CONJUGATE) IN COMBINATION WITH HLX07 (RECOMBINANT ANTI-EGFR HUMANISED MONOCLONAL ANTIBODY INJECTION) FOR THE TREATMENT OF ADVANCED/METASTATIC SOLID TUMOURS WAS APPROVED BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (HKEXnews)

New P1/2 trial • Solid Tumor

First-Line HLX07 Plus Serplulimab With or Without Chemotherapy in Squamous Non-Small Cell Lung Cancer: A Phase 2 Study (IASLC-WCLC 2025) - "Patients with stage IIIB/IIIC or IV sqNSCLC that was not amenable to surgery or radiation therapy and high tumor expression of epidermal growth factor receptor (H score≥150) and no prior systemic therapy were randomized 1:1 to receive intravenous HLX07 at 800 mg (group A) or 1000 mg (group B), in combination with serplulimab (300 mg) and chemotherapy (carboplatin and nab-paclitaxel), once every three weeks. 6 (46.2%) patients, and 8 (57.1%) in group A, and B reported immune-related adverse events, respectively. Conclusions : First-line HLX07 plus serplulimab and chemotherapy showed promising preliminary efficacy with a manageable safety profile in patients with advanced sqNSCLC which warrants further investigation."

Clinical • IO biomarker • P2 data • Alopecia • Anemia • Endocrine Disorders • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Henlius to Present Latest Results on ADC and IO Therapies in Lung Cancer at 2025 WCLC (Henlius Press Release) - "2025 World Conference on Lung Cancer (WCLC) hosted by the International Association for the Study of Lung Cancer(IASLC) will be held from September 6-9 in Barcelona, Spain‌. At the conference, Henlius will showcase 10 latest results from its innovative products on lung cancer, which includes 3 oral presentations and 2 poster tours, covering updated phase 1 clinical data‌ for PD-L1 ADC HLX43, the results(first release) from ASTRUM-002, a phase 3 clinical trial of serplulimab (anti-PD-1 monoclonal antibody) in the first line treatment of advanced non-squamous non small cell lung cancer (NSCLC) as oral presentation, along with further research findings on serplulimab in lung cancer, making it the Chinese biopharmaceautical with most oral presentations."

Clinical data • Lung Non-Squamous Non-Small Cell Cancer • Small Cell Lung Cancer