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

MC210808 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=16 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting | N=100 ➔ 16 | Trial completion date: Dec 2028 ➔ May 2027 | Trial primary completion date: Dec 2028 ➔ May 2026

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • 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 | Terminated | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Terminated

Trial termination • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P1 | N=258 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Shanghai Henlius Biotech has begun dosing the first patient in an international, multicenter phase 1 clinical study of HLX15-SC, a subcutaneous recombinant anti-CD38 fully human monoclonal antibody, in transplant-ineligible patients with newly diagnosed multiple myeloma in mainland China. (TipRanks)

Trial status • Multiple Myeloma

Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial (clinicaltrials.gov) - P2 | N=17 | Active, not recruiting | Sponsor: Mayo Clinic | Trial primary completion date: Nov 2027 ➔ Feb 2026

Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology • TP53

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 completion date: May 2028 ➔ Sep 2028 | Trial primary completion date: Mar 2026 ➔ Sep 2026

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

A Study to Compare the PK Characteristics, Safety, Tolerability, and Immunogenicity of HLX15-SC With DARZALEX FASPRO® in Combination With Lenalidomide and Dexamethasone (Rd) in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma (clinicaltrials.gov) - P1 | N=258 | Not yet recruiting | Sponsor: Shanghai Henlius Biotech

New P1 trial • Hematological Malignancies • Multiple Myeloma • Oncology • Transplantation

Shanghai Henlius Biotech…is pleased to announce that, recently, the investigational new drug (IND) application for phase 1 clinical trial of HLX15-SC (recombinant anti-CD38 fully human monoclonal antibody injection - subcutaneous injection) ('HLX15-SC') for the treatment of multiple myeloma independently developed by the Company was approved by the United States Food and Drug Administratio (HKEXnews)

IND • Multiple Myeloma

…Shanghai Henlius Biotech…is pleased to announce that, recently, the investigational new drug (IND) application for phase 1 clinical trial of HLX15-SC (recombinant anti-CD38 fully human monoclonal antibody injection - subcutaneous injection) ('HLX15-SC') for the treatment of multiple myeloma independently developed by the Company was approved by the National Medical Products Administration (HKEXnews)

New P1 trial • Multiple Myeloma

Combination Treatment Therapy Approaches for the Treatment of High-Risk Multiple Myeloma, REACH Trial (clinicaltrials.gov) - P2 | N=17 | Active, not recruiting | Sponsor: Mayo Clinic | Recruiting ➔ Active, not recruiting | N=75 ➔ 17

Enrollment change • Enrollment closed • Hematological Malignancies • Multiple Myeloma • Oncology • TP53

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: Mar 2026 ➔ Jun 2026

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

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