HLX22 / Fosun Pharma, AbClon, Alligator Biosci - LARVOL DELTA

HLX22 - Novel Epitope Anti-HER2 mAb with a Differentiated Modality (PRNewswire) - "Phase 2 data readout in HER2-low breast cancer in China is expected in the first half of 2026."

P2 data • HER2 Breast Cancer

A randomized, double-blinded, international phase III trial comparing HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab for first-line treatment for HER2-positive locally advanced or metastatic G/GEJ cancer. (ASCO-GI 2026) - P2, P3 | "HLX22 has shown improved progression-free survival (PFS) when added to trastuzumab plus oxaliplatin and capecitabine (XELOX) in a phase 2 study (NCT04908813). Secondary endpoints include investigator-assessed PFS, objective response rate, PFS on the subsequent line of therapy, duration of response, safety, pharmacokinetics, immunogenicity, and quality of life. This study is currently open for enrollment and has completed first dose of the first patient."

Clinical • Combination therapy • IO biomarker • Metastases • P3 data • Esophageal Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • HER-2 • PD-L1

ASCO GI 2026 | Henlius Accelerates Global Phase 3 Head-to-Head Development of HLX22 as First-Line Treatment for HER2-Positive Gastric Cancer (Henlius Press Release) - "Median OS was not reached (95% CI: 16.2, NE) compared with 16.4 months (95% CI: 10.7, NE) in the control group (HR = 0.60; 95% CI: 0.28–1.21). Median PFS was not reached (95% CI: 16.2, NE) versus 8.3 months (95% CI: 5.7–21.4), respectively (HR=0.20; 95% CI: 0.09–0.54). These results indicate an 80% reduction in the risk of disease progression or death, substantially exceeding historical trials, and provided important support for the design and implementation of the phase 3 head-to-head HLX22-GC-301 study."

P2 data • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A Hase II/III Clinical Study to Evaluate HLX22 in Combination With HLX87 as First-Line Treatment in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=706 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

A Phase II/III Clinical Study to Evaluate the Efficacy and Safety of HLX87in Combination With HLX22 or Pertuzumab in the Neoadjuvant Therapy of HER2-Positive Bresat Cancer (clinicaltrials.gov) - P2/3 | N=817 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2/3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor

Shanghai Henlius Biotech…is pleased to announce that, recently, the applications for phase 2/3 clinical trials of HLX22…in combination with HLX87 for injection…(1) for first-line treatment of HER2-positive breast cancer (BC); and (2) for neoadjuvant treatment for HER2-positive breast cancer (BC neo) have been approved by the National Medical Products Administration (NMPA), respectively (HKEXnews)

New P2/3 trial • HER2 Positive Breast Cancer

A Phase II Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy (clinicaltrials.gov) - P2 | N=45 | Active, not recruiting | Sponsor: Shanghai Zhongshan Hospital | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma

A Phase II Clinical Study to Evaluate the Efficacy and Safety of HLX22 (Recombinant Humanized Anti-HER2 Monoclonal Antibody Injection) in Combination with Trastuzumab and Chemotherapy for the First-Line Treatment of HER2-Positive Pancreatic Ductal Adenocarcinoma (ChiCTR) - P2 | N=45 | Not yet recruiting | Sponsor: ZHONGSHAN HOSPITAL; ZHONGSHAN HOSPITAL

New P2 trial • Gastric Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • HER-2

Strengthening Original Innovation Capability, Building a High-Value Pipeline Portfolio (PRNewswire) - "In terms of R&D investment, in the first three quarters of 2025, Fosun Pharma's R&D investment amounted to RMB3,998 million in total, up by 2.12% period-on-period. In particular, R&D expenses amounted to RMB2,730 million. In the third quarter of 2025, R&D expenses amounted to RMB1,013 million, up by 28.81% period-on-period. The investment primarily focused on cutting-edge technology platforms such as radiopharmaceuticals and cell therapy, as well as global multicenter clinical trials of high-value pipelines, including HLX22 (recombinant humanized anti-HER2 monoclonal antibody injection) and HLX43 (PD-L1-targeted antibody-drug conjugate)."

Commercial • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer • Thymic Epithelial Tumor

First Patient Dosed in Argentina for the Phase 3 Head-to-Head Trial of HLX22 in Gastric Cancer (Henlius Press Release) - "HLX22-GC-301 is a randomized, double-blind, international Phase 3 trial directly comparing HLX22 in combination with trastuzumab and chemotherapy versus the current first-line standard of care (trastuzumab + chemotherapy ± pembrolizumab) for HER2-positive advanced gastric cancer."

Trial status • Gastric Cancer

Henlius’ HLX22 International Multicentre Phase 3 Head-to-Head Trial Administers First Dose to US Patient in HER2+ GC (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the first patient in the United States has been dosed in the company’s international multicentre phase 3 head-to-head clinical trial (HLX22-GC-301) comparing its novel anti-HER2 monoclonal antibody (mAb) HLX22 in combination with trastuzumab and chemotherapy with the current first-line standard of care therapy (trastuzumab + chemotherapy ± pembrolizumab) as the first-line treatment for HER2-positive advanced gastric cancer....The study...has previously dosed first patients in China, Japan, Australia, and South Korea, with investigational new drug (IND) approvals obtained in Chile, Brazil, Argentina and other countries and regions."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

Henlius Unveils…Phase 3 Trial Design for Anti-HER2 mAb HLX22 in First-Line HER2+ Gastric Cancer (Henlius Press Release) - "On June 2, 2025, Henlius...announced that the latest research results of novel anti-HER2 monoclonal antibody (mAb) HLX22 were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....This randomized, double-blinded, two-arm international phase 3 clinical study aims to compare the efficacy and safety of HLX22 in combination with trastuzumab and XELOX versus trastuzumab and XELOX with or without (±) pembrolizumab in patients with HER2-positive, advanced G/GEJ cancer and no prior antitumor therapy in the advanced setting.....Notably, HLX22-GC-301 has set up trial sites across China, Australia, the European Union, Japan, the United States, South America, and other countries and regions. As of now, the first patient was dosed in China, Japan, and Australia, and the study has obtained investigational new drug (IND) approvals in countries and regions including the United States (U.S.), Chile and Korea."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Henlius Unveils Updated Phase 2 Results…for Anti-HER2 mAb HLX22 in First-Line HER2+ Gastric Cancer (Henlius Press Release) - P2 | N=150 | NCT04908813 | Sponsor: Shanghai Henlius Biotech | "On June 2, 2025, Henlius...announced that the latest research results of novel anti-HER2 monoclonal antibody (mAb) HLX22 were presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting....As of December 6, 2024, 62 patients were randomized to the respective groups (31 vs 31), of whom 51 (82.3%) were male. Median follow-up duration was 28.5 and 28.7 months for the respective groups....The updated results of HLX22-GC-201 again demonstrated that combination of chemotherapy and dual HER2 blockade with HLX22 and trastuzumab conferred survival benefit to HER2-positive G/GEJC patients along with a manageable safety profile."

P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Updated results of HLX22 plus trastuzumab and XELOX for first-line treatment of human epidermal growth factor receptor 2 (HER2)–positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC). (ASCO 2025) - P2 | "Combination of chemotherapy and dual HER2 blockade with HLX22 and trastuzumab conferred survival benefit to HER2-positive G/GEJC patients along with a manageable safety profile. Table 1. Updated efficacy*CI, confidence interval."

Clinical • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

A randomized, double-blinded, international phase III trial comparing HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab for first-line treatment for HER2-positive locally advanced or metastatic G/GEJ cancer. (ASCO 2025) - P2, P3 | "HLX22 has shown improved progression-free survival (PFS) when added to trastuzumab plus oxaliplatin and capecitabine (XELOX) in a phase 2 study (NCT04908813). Secondary endpoints include investigator-assessed PFS, objective response rate, PFS on the subsequent line of therapy, duration of response, safety, pharmacokinetics, immunogenicity, and quality of life. This study is currently open for enrollment and has completed first dose of the first patient."

Clinical • Combination therapy • IO biomarker • Metastases • P3 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • HER-2 • PD-L1

Anti-HER2 mAb HLX22 in the European Union for Gastric Cancer (Henlius Press Release) - "Shanghai Henlius Biotech, Inc...announced that the European Commission (EC) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer. The Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC has obtained investigational new drug (IND) approvals in China, the U.S, Japan, Australia, Korea and EU Germany, etc., and has completed its first patient dosing in China, Japan, and Australia."

Orphan drug • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer

Henlius’ Innovative Anti-HER2 mAb HLX22 in Combination with T-Dxd Advances to a Phase 2 Clinical Trial for the Treatment of HER2-low, HR-positive BC with First Patient Dosed (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the first patient has been dosed in China in HLX22-BC201, a phase 2 clinical trial of the company’s novel anti-HER2 monoclonal antibody (mAb), HLX22, in combination with trastuzumab deruxtecan (T-DXd) for the treatment of HER2-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer....This is a multicenter phase 2 study aimed to evaluate the efficacy and safety of HLX22 combined with trastuzumab deruxtecan for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-low, hormone receptor (HR)-positive locally advanced or metastatic breast cancer who have progressed on or are intolerant to standard therapy."

Trial status • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer

First Japanese Patient Dosed in Phase 3 MRCT of Dual HER2 Blockade Therapy for HER2+ GC (Henlius Press Release) - "Shanghai Henlius Biotech...announced that the first Japanese patient has been dosed in the phase 3 international multi-centre clinical trial (HLX22-GC-301) of HLX22, an innovative anti-HER2 monoclonal antibody (mAb) in combination with trastuzumab and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer....HLX22-GC-301 is a double-blind, randomized, controlled multicenter phase 3 study aims to compare the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy versus trastuzumab and chemotherapy with or without pembrolizumab as first-line treatment in patients with human epidermal growth factor receptor 2 (HER2)-positive, locally advanced or metastatic gastric/gastroesophageal junction cancer."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Fosun Pharma Announces 2024 Annual Results (PRNewswire) - "In 2024, Fosun Pharma further focused on the business development of innovative drugs and high-value devices, achieving operating revenue of RMB41.07 billion and net profit attributable to shareholders of RMB2.77 billion, representing an increase of 16.08% YoY. Fosun Pharma continuously optimize supply chain management to enhance operational efficiency, recording an operating cash flow of RMB4.48 billion with an increase of 31.13% YoY, surpassing the growth rate of operating profit...During the Reporting Period, the gross margin minus the selling and distribution expense ratio improved by 2.45 percentage points YoY; and, excluding the impact of newly acquired enterprises during the Reporting Period and the same period last year, administrative expenses declined by RMB355 million."

Commercial • Breast Cancer • Gastric Cancer • Neurofibromatosis • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Henlius Receives Orphan Drug Designation for Innovative Anti-HER2 mAb HLX22 in the U.S. for Gastric Cancer (PRNewswire) - "Shanghai Henlius Biotech...announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal antibody (mAb) for the treatment of gastric cancer....At present, the Investigational New Drug (IND) applications for HLX22-GC-301, a phase 3 clinical study aims to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy for the first-line treatment of patients with HER2-positive metastatic GC/GEJC have been approved in China, the U.S, Japan and Australia, etc. This international study has been initiated in multiple countries and regions worldwide and has completed its first patient dosing globally."

Orphan drug • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

A Phase II Study of HLX22 in Combination With Trastuzumab Deruxtecan in HER2-low, Hormone Receptor Positive Locally Advanced or Metastatic Breast Cancer Patients (clinicaltrials.gov) - P2 | N=50 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

HLX22 plus trastuzumab and XELOX for first-line treatment of HER2-positive locally advanced or metastatic gastric/gastroesophageal junction cancer (G/GEJC): Updated results with additional patients. (ASCO-GI 2025) - P2 | "With a manageable safety profile, the addition of HLX22 to first-line treatment with trastuzumab plus XELOX conferred survival benefit for HER2-positive G/GEJC patients. Updated efficacy, IRRC-assessed.CI, confidence interval. NE, not evaluable."

Clinical • Metastases • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

AppClon “AC101, Improved Survival Rate of HER2-Positive Gastric Cancer… Expectations for First-Line Treatment Rising” [Google translation] (AbClon Press Release) - P2 | N=150 | NCT04908813 | Sponsor: Shanghai Henlius Biotech | "The company has disclosed the abstract of its clinical study on therapeutic efficacy and safety to be presented at the Society of Clinical Oncology Gastrointestinal Cancers Symposium...According to the published clinical trial results, the group that received the HLX22∙ trastuzumab...combination therapy showed a significantly higher survival rate than the placebo trastuzumab (hereinafter placebo) group. The HLX22 combination therapy group has not yet reached progression-free survival (PFS) (NR), while the placebo group reported 8.3 months. The 12- month survival rate was also significantly higher in the HLX22 group at 73.8% than in the placebo group at 34.2%. The HLX22 group recorded an objective response rate (ORR) of 87.1%, while the placebo group showed 80.6%....As for the 24- month PFS rate, the HLX22 group was 61.5%, which significantly exceeded the placebo group’s 24.0% result."

P2 data • Gastric Cancer • HER-2

HLX22-GC-301: A Phase Ⅲ Clinical Study of HLX22 in Combination With Trastuzumab and Chemotherapy for the Treatment of Gastroesophageal Junction and Gastric Cancer (clinicaltrials.gov) - P3 | N=550 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor