dulpatatug (HLX22) / Fosun Pharma, AbClon, Alligator Biosci, Shanghai Henlius Biotech - LARVOL DELTA

A Phase II Study of HLX22 in Combination With Trastuzumab and Chemotherapy in HER2-Positive Locally Advanced or Metastatic Breast Cancer Patients (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

On 23 July 2026 Alligator announced that it will discontinue all further independent development of mitazalimab, including preparations for and support of Phase 3 studies, and refocus on preserving the future royalty potential of its financial interest in the out-licensed HLX22 programme. (Alligator Bioscience Press Release) - "Alligator intends to continue to supply mitazalimab to ongoing externally funded investigator-initiated studies, including the randomised Phase 2/3 study in biliary tract cancer, subject to available funding. Alligator also intends to seek to out-license or divest mitazalimab as a broader immuno-oncology asset in the near term."

Discontinued • Pipeline update • Biliary Tract Cancer

Topline results from the global Phase 3 clinical trial of 'AC101' (development code; Henlius code: HLX22), a human epidermal growth factor receptor 2 (HER2)-targeted antibody licensed by AbClon to China's Henlius for the treatment of HER2-positive metastatic gastric cancer, are expected in the first half of 2027. (The Bio) - "...Commercialization targeted for 2028."

Launch • P3 data: top line • Gastric Cancer

Abclon announced that its HER2-targeted gastric cancer treatment, HLX22 (development code name AC101)…has once again demonstrated the potential for prolonged progression-free survival (PFS) in long-term follow-up of the global Phase 2 clinical trial. (The Asia Business Daily) - "According to the interview, the Phase 2 clinical trial of HLX22 has not yet reached the median progression-free survival (mPFS) even after approximately 39 months of long-term follow-up. According to the company, patients' progression-free survival continues to be extended to date."

P2 data • Gastric Cancer

…HLX22 (anti-HER2 monoclonal antibody) entered phase II clinical trials for the first-line treatment of HER2-positive recurrent or metastatic breast cancer in combination with HLX87 (The Manila Times)

Trial status • HER2 Positive Breast Cancer

A best-in-class HER2xHER2 novel biparatopic antibody-drug conjugate with an efficacious, low-toxicity design that maximizes antibody functionality (AACR 2026) - "When combined with HLX02 (a trastuzumab biosimilar), HLX22 increases internalization of HER2 homodimers and HER2/EGFR heterodimers, reducing cell proliferation signals. This combination shows stronger antitumor effects than HLX02 plus HLX11 (a pertuzumab biosimilar) both in vitro and in vivo...Preliminary toxicology in cynomolgus monkeys was assessed at 60 mg/kg, administered every three weeks for three cycles. The HER2xHER2 biparatopic ADC demonstrated superior internalization efficiency than KN026 (a HER2-targeted bispecific antibody) and trastuzumab deruxtecan in BT474 and NCI-N87 cell lines... We have developed a potential best-in-class HER2xHER2 novel biparatopic ADC that exhibits a superior therapeutic index, antibody-mediated signaling blockade. The preclinical findings support clinical development in breast and gastric cancers, with the hope that the improved therapeutic index of this agent confers survival benefit."

ADC • Gastric Cancer • Oncology • Solid Tumor • EGFR

A Study to Evaluate HLX22 in Combination With HLX87 in Patients With HER2-Positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov) - P2/3 | N=706 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2 • PGR

HLX22 is also being evaluated in a global phase 3 trial in first-line gastric cancer, HLX22-GC-301, across regions including the United States, Japan, Australia and South America. (Korea Biomedical Review) - "Henlius said at the J.P. Morgan Healthcare Conference in January that dosing progress in the gastric cancer study had surpassed 40 percent."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

…The first patient has been dosed in a phase 2/3 clinical study of HLX22 (recombinant humanised anti-HER2 monoclonal antibody injection) ('HLX22') in combination with HLX87 for injection (antibody-drug conjugate targeting HER2) ('HLX87') for first-line treatment of patients with HER2-positive recurrent or metastatic breast cancer (BC) in Chinese Mainland… (HKEXnews) - "This study is an open-label, randomised, multicenter phase 2/3 clinical study to evaluate HLX22 in combination with HLX87 for the first-line treatment of patients with HER2-positive recurrent or metastatic breast cancer."

Trial status • HER2 Positive Breast Cancer

AbClon also said Henlius has completed patient enrollment in China for HLX22-BC201, a phase 2 trial in patients with HER2-low, hormone receptor-positive locally advanced or metastatic breast cancer. (Korea Biomedical Review)

Enrollment closed • HER2 Breast Cancer • Hormone Receptor Positive Breast Cancer

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