HLX13 (ipilimumab biosimilar) / Fosun Pharma, Organon, Sandoz, Shanghai Henlius Biotech - LARVOL DELTA

Shanghai Henlius Biotech has dosed the first patient in the United States in an international, randomized phase 1 trial of HLX13, its biosimilar version of immunotherapy drug ipilimumab, as a first-line treatment for unresectable advanced hepatocellular carcinoma. (TipRanks) - "The study compares HLX13 with U.S.-sourced Yervoy, both in combination with Opdivo, and aims primarily to establish pharmacokinetic similarity while also assessing efficacy, safety and immunogenicity."

Trial status • Hepatocellular Cancer

Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=246 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

Shanghai Henlius Biotech…announced that the first subject was dosed for a phase 1 multi-centre clinical trial (HLX13-HCC102) of the company's independently developed investigational ipilimumab biosimilar HLX13 in China (Henlius Press Release) - "HLX13-HCC102 is a multicenter, randomized, double-blind, parallel-controlled Phase 1 clinical study to evaluate the similarity in pharmacokinetic (PK) profiles, safety, efficacy, and immunogenicity between HLX13 and its reference product YERVOY (US-sourced), each in combination with OPDIVO (EU-sourced, generic name: nivolumab), in patients with previously untreated, unresectable advanced hepatocellular carcinoma (HCC)."

Trial status • Hepatocellular Cancer

THE INVESTIGATIONAL NEW DRUG APPLICATION OF AN IPILIMUMAB BIOSIMILAR HLX13 (RECOMBINANT ANTI-CTLA-4 FULLY HUMAN MONOCLONAL ANTIBODY INJECTION) AS A FIRST-LINE TREATMENT FOR PATIENTS WITH UNRESECTABLE HEPATOCELLULAR CARCINOMA (HCC) WAS APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION (FDA) (HKEXnews)

IND • Hepatocellular Cancer

Phase I Clinical Study To Evaluate Pharmacokinetic Profile, Safety, Efficacy and Immunogenicity Of Ipilimumab Biosimilar HLX13 Vs. YERVOY® (US-Sourced YERVOY®) As A First-Line Treatment For Patients With Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P1 | N=246 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Hepatocellular Cancer • Oncology • Solid Tumor

THE FIRST PATIENT HAS BEEN DOSED IN A PHASE 1/3 CLINICAL STUDY OF IPILIMUMAB BIOSIMILAR HLX13 (RECOMBINANT ANTI CTLA-4 FULLY HUMAN MONOCLONAL ANTIBODY INJECTION) AS THE FIRST-LINE TREATMENT FOR PATIENTS WITH UNRESECTABLE ADVANCED HEPATOCELLULAR CARCINOMA (HKEXnews) - "The board of directors of the Company (the 'Board') is pleased to announce that, recently, the first patient has been dosed in a phase 1/3 clinical study of Ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) ('HLX13') independently developed by the Company as the first-line treatment for patients with unresectable advanced hepatocellular carcinoma (HCC) in mainland China....This study is a multicenter, randomized, double-blind, parallel-controlled Phase 1/3 clinical study to evaluate the similarity of pharmacokinetic (PK) profiles, efficacy, safety, and immunogenicity among HLX13 and its reference product YERVOY (US-sourced and EU-sourced) as treatment for patients with unresectable advanced hepatocellular carcinoma (HCC) who have not received prior systemic therapy."

Trial status • Hepatocellular Cancer

Sandoz enters global collaboration license agreement with Henlius to commercialize leading oncology therapy, ipilimumab, in multiple indications (The Manila Times) - "Sandoz...announced today that it has signed a global collaboration agreement with Shanghai Henlius Biotech, Inc...to commercialize a biosimilar of leading oncology therapy, ipilimumab. The agreement is milestone-based for a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, and will target net reference-medicine sales of USD 2.5 billion....Under the terms of the agreement, Sandoz has exclusive commercial rights for a biosimilar of ipilimumab in Australia, Canada, Europe, Japan and the US. The core sequence patent for ipilimumab expired in March 2025 in the US and will expire no later than February 2026 in the EU....The reference medicine, ipilimumab, is a monoclonal (CTLA-4) antibody-blocking medication, which is used alone or with other medicines to treat certain types of colorectal cancer, esophageal cancer, hepatocellular carcinoma (a type of liver cancer), malignant pleural mesothelioma, melanoma, non-small cell lung cancer,..."

Licensing / partnership • Patent • Colorectal Cancer • Esophageal Cancer • Hepatocellular Cancer • Melanoma • Non Small Cell Lung Cancer • Pleural Mesothelioma

A Study to Compare the Efficacy, Safety, Immunogenicity, and Pharmacokinetic Profile of HLX13 with YERVOY As a First-Line Treatment for Patients with Unresectable Hepatocellular Carcinoma (clinicaltrials.gov) - P3 | N=656 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P3 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX13 With YERVOY in Male Subjects (clinicaltrials.gov) - P1 | N=304 | Recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial

Henlius (02696): The clinical trial application of ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) was approved by the National Medical Products Administration [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, Henlius...announced that it has recently conducted clinical trials of the company’s independently developed ipilimumab biosimilar HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) (HLX13). The application was approved by the National Medical Products Administration. HLX13 is intended for the treatment of melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, non-small cell lung cancer, malignant pleural mesothelioma and esophageal squamous cell carcinoma."

New trial • Colorectal Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Gastrointestinal Cancer • Genito-urinary Cancer • Hepatocellular Cancer • Kidney Cancer • Liver Cancer • Lung Cancer • Malignant Pleural Mesothelioma • Melanoma • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Skin Cancer • Solid Tumor

Shanghai Henlius Biotech, Inc. Announces that Ipilimumab Biosimilar HLX13 (Recombinant Anti-CTLA-4 Fully Human Monoclonal Antibody Injection) Clinical Trial Application has been approved by the National Medical Products Administration (Market Screener) - "The Board of Directors of Shanghai Henlius Biotech, Inc. announced that the clinical trial application of the biosimilar Ipilimumab HLX13 (recombinant anti-CTLA-4 fully human monoclonal antibody injection) (acyHLX13aco), independently developed by the Company for the treatment of hepatocellular carcinoma, has recently been approved by the National Medical Products Administration."

New trial • Gastrointestinal Cancer • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor

Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta (Pertuzumab) and Prolia/Xgeva (Denosumab) Biosimilar Candidates (Businesswire) - "Organon...announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan....The agreement also includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy® (ipilimumab, HLX13)."

Licensing / partnership • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Giant Cell Tumor of Bone • HER2 Breast Cancer • HER2 Positive Breast Cancer • Melanoma • Microsatellite Instability • Oncology • Renal Cell Carcinoma • Solid Tumor

Nivolumab (N) as monotherapy or in combination with ipilimumab (I) in patients (pts) with platinum-pretreated metastatic urothelial carcinoma (mCU): Extended follow-up of CheckMate 032 (SEOM 2020) - P3, N=1,290; CheckMate901 (NCT03036098); Sponsor: Bristol-Myers Squibb; "With more follow, all arms continue to show significant antitumor activity and manageable security profiles. The risk profile: benefit of N1I3 is promising and supports the development of this regimen vs chemotherapy in the ongoing phase 3 study CheckMate 901 in untreated CUm sts (NCT03036098)."

P3 data