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The IND Application of Henlius Daratumumab Biosimilar Accepted by NMPA

Shanghai, China, Nov, 12th, 2020 - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the Investigational New Drug (IND) application of the Company’s daratumumab biosimilar HLX15 (a recombinant anti-CD38 fully human monoclonal antibody injection) to be used in the treatment of multiple myeloma has been accepted by the National Medical Products Administration (NMPA). HLX15 is the Company’s second self-developed product in the area of blood tumor treatment.  

Multiple Myeloma is the second most common cancer among all types of hematologic malignancies and accounts for approximately 10% of hematologic malignant cases. Multiple myeloma is characterized by proliferative disorder of bone marrow plasma cells that can lead to bone marrow damage[1] . High expression of CD38 is present in all stages along disease progression of multiple myeloma. Considering the expression profile of CD38, it is thought to be an ideal target for the treatment of multiple myeloma[2-3]. HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody with unique mechanisms for cancer cell killing. On one hand, HLX15 can directly bind to CD38 expressed on the surface of tumor cells, inducing tumor cell lysis and apoptosis through complement-dependent cytotoxicity (CDC), antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP), and several other pathways such as Fc mediated cross linking to achieve a quick response of tumor cells. In addition, a subset of myeloid derived suppressor cells (CD38+MDSCs), regulatory T cells (CD38+Tregs) and B cells (CD38+Bregs) are decreased by daratumumab. Clinical studies have shown that daratumumab is effective in slowing down disease progression in patients with multiple myeloma and can significantly prolong patient progression free survival (PFS) and overall survial[4] . Daratumumab has been approved for the treatment of relapsed or refractory multiple myeloma adult patients by NMPA and its combinations have also been approved for the treatment of first-line and second-line and above multiple myeloma patients globally. According to estimates from IQVIA, total sales of daratumumab worldwide has reached USD 2.8 billion, indicating a huge medical needs for this drug. 

In accordance with the Technical Guidelines of Development and Evaluation of Biosimilar Drugs and EMA Guideline on Similar Biological Medicinal Products, HLX15 has been developed strictly following the principles of stepwise development, comparability and similarity assessment and has been compared head to head with reference daratumumab via analytical studies and preclinical studies. The results of these studies showed that HLX15 is highly similar to reference daratumumab, and the safety profiles is similar.

In February 2019, 汉利康Henlius’ first product in the field of hematologic malignancies, also the first domestic monoclonal antibody developed in accordance with Chinese Biosimilar Guidelines has been approved by the NMPA for the treatment of non-Hodgkin's lymphoma and other hematologic tumors. Henceforth, 汉利康has benefited an increasing number of  blood tumor patients in China. With the development of HLX15, Henlius will not only extend its enriched portfolio, but provide an alternative high-quality treatment option for multiple myeloma patients and alleviate the high cost of imported drugs and reduce the economic burden of patients. Looking forward, Henlius will continue advancing the development of innovative biologics on the basis of its established and integrated innovation platform, underscoring its long-term commitment to providing affordable and effective therapies for patients worldwide.

Reference Notes
[1] Rajkumar SV, Kumar S. Multiple Myeloma: Diagnosis and Treatment [J]. Mayo Clinic Proceedings, 2016, 91(1):101-119.
[2] Bonello, F., M. D'Agostino, M. Moscvin, C. Cerrato, M. Boccadoro, and F. Gay. 2018. 'CD38 as an immunotherapeutic target in multiple myeloma', Expert Opin Biol Ther, 18: 1209-21.
[3] Morandi, F., A. L. Horenstein, F. Costa, N. Giuliani, V. Pistoia, and F. Malavasi. 2018. 'CD38: A Target for Immunotherapeutic Approaches in Multiple Myeloma', Front Immunol, 9: 2722.
[4] Usmani S, Weiss B, Bahlis NJ, et al. Clinical efficacy of daratumumab monotherapy in patients with heavily pretreated relapsed or refractory multiple myeloma. Blood. 2015;126(23):abstract 29.