HLX15 (daratumumab biosimilar) / Fosun Pharma, Dr. Reddy’s - LARVOL DELTA

Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study (clinicaltrials.gov) - P1/2 | N=49 | Active, not recruiting | Sponsor: Mayo Clinic | Trial primary completion date: May 2027 ➔ Mar 2026

Trial primary completion date • Breast Cancer • Hematological Malignancies • Multiple Myeloma • Oncology

Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study (clinicaltrials.gov) - P1/2 | N=49 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • Hematological Malignancies • Multiple Myeloma • Oncology

AALL2331: Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) (clinicaltrials.gov) - P2/3 | N=1708 | Not yet recruiting | Sponsor: Children's Oncology Group | Initiation date: Sep 2025 ➔ Mar 2026

Trial initiation date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leukemia (T-ALL) and T-Cell Lymphoblastic Lymphoma (T-LL) (clinicaltrials.gov) - P2/3 | N=1708 | Not yet recruiting | Sponsor: Children's Oncology Group

New P2/3 trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Acute Lymphoblastic Leukemia

Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=37 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Evaluate the Efficacy and Safety of HLX15-IV Versus DARZALEX® in Combination with Lenalidomide-Dexamethasone (Rd) in Transplant-ineligible Patients with Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P3 | N=386 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P3 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Iberdomide, Daratumumab, Bortezomib, and Dexamethasone for Treatment of Newly Diagnosed Multiple Myeloma, IDEAL Study (clinicaltrials.gov) - P1/2 | N=49 | Recruiting | Sponsor: Mayo Clinic | N=18 ➔ 49

Enrollment change • Hematological Malignancies • Multiple Myeloma • Oncology

Henlius and Dr. Reddy's Ink Licensing Deal for HLX15 (investigational daratumumab biosimilar) Expansion in Europe and the U.S. (PRNewswire) - "Shanghai Henlius Biotech, Inc...today announced it has entered into a license agreement with Dr. Reddy's Laboratories SA...for the company's independently developed investigational daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection. Dr. Reddy's will gain exclusive rights to commercialize both subcutaneous and intravenous formulation of HLX15 in a total of 43 countries and regions, comprising 42 European countries and regions and the United States (U.S.). Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including a $33 million upfront payment and additional milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product."

Licensing / partnership • Oncology

Elotuzumab, Daratumumab, Iberdomide, and Dexamethasone for the Treatment of Relapsed Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=37 | Not yet recruiting | Sponsor: Mayo Clinic

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Henlius to Showcase Latest Results of 5 Clinical Trails at ESMO Asia 2024 (Henlius Press Release) - "From 6 to 8 December 2024, the European Society for Medical Oncology Asia (ESMO Asia) Congress will be held in Singapore. At this congress, Henlius will share the latest results of clinical trials of several products, including HANSIZHUANG (serplulimab), HLX07 (anti-EGFR mAb), and daratumumab biosimilar HLX15."

Clinical data • Nasopharyngeal Carcinoma • Non Clear Cell Renal Cell Carcinoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma

A randomised, double-blind, phase I study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of HLX15 and daratumumab in healthy male participants (ESMO Asia 2024) - P1 | "Conclusions PK similarity between HLX15 and daratumumab from different regions was demonstrated, along with comparable safety and immunogenicity profiles. HLX15 is a promising biosimilar of daratumumab that warrants further investigation."

Clinical • P1 data • PK/PD data • Hematological Malignancies • Multiple Myeloma • Oncology

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1 | N=15 | Recruiting | Sponsor: City of Hope Medical Center | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2027 ➔ May 2028 | Initiation date: Oct 2024 ➔ Jan 2025 | Trial primary completion date: Feb 2027 ➔ May 2028

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Daratumumab Maintenance Therapy for Improving Survival in Patients with Light Chain Amyloidosis, EMILIA Trial (clinicaltrials.gov) - P2 | N=96 | Recruiting | Sponsor: Mayo Clinic | Trial completion date: Nov 2024 ➔ Dec 2026 | Trial primary completion date: Nov 2024 ➔ Dec 2026

Trial completion date • Trial primary completion date • Amyloidosis

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: City of Hope Medical Center | Initiation date: Jun 2024 ➔ Oct 2024

Trial initiation date • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: National Cancer Institute (NCI) | Initiation date: Nov 2024 ➔ Jul 2024

Trial initiation date • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects (clinicaltrials.gov) - P1 | N=172 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed

Trial completion • Hematological Malignancies • Multiple Myeloma • Oncology

Henlius Announces Successful Completion of Phase 1 Clinical Study of Daratumumab HLX15 (Henlius Press Release) - "Shanghai Henlius Biotech...announced that a phase 1 clinical trial (NCT05679258) of the company’s daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection, met its primary endpoint. HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius. The indication to be developed for HLX15 is multiple myeloma (MM)."

Trial completion • Multiple Myeloma

Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma (clinicaltrials.gov) - P1 | N=100 | Recruiting | Sponsor: Mayo Clinic | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects (clinicaltrials.gov) - P1 | N=172 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology

225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: City of Hope Medical Center

New P1 trial • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation

Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P2 | N=70 | Recruiting | Sponsor: National Cancer Institute (NCI) | Not yet recruiting ➔ Recruiting | Trial completion date: Feb 2025 ➔ Sep 2026 | Initiation date: Feb 2024 ➔ Nov 2024 | Trial primary completion date: Feb 2025 ➔ Sep 2026

Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Mayo Clinic | Trial completion date: Sep 2028 ➔ Dec 2028 | Trial primary completion date: Sep 2028 ➔ Dec 2028

Combination therapy • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Comparing the Combination of Selinexor-Daratumumab-Velcade-Dexamethasone (Dara-SVD) With the Usual Treatment (Dara-RVD) for High-Risk Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P2 | N=82 | Not yet recruiting | Sponsor: National Cancer Institute (NCI)

New P2 trial • Hematological Malignancies • Multiple Myeloma • Oncology

Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) for the Treatment of Multiple Myeloma (clinicaltrials.gov) - P1 | N=100 | Not yet recruiting | Sponsor: Mayo Clinic

Combination therapy • New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology

A Study to Compare the PK , Safety, Tolerability, and Immunogenicity of HLX15 With Daratumumab in Male Subjects (clinicaltrials.gov) - P1 | N=234 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology