Shanghai, China, Jan, 13th, 2021 - 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, for the treatment of multiple myeloma (MM) has been approved by the National Medical Products Administration (NMPA).?

HLX15 is a fully human anti-CD38 IgG1¦Ê monoclonal antibody independently developed by Henlius. 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, HLX15 can also reduce multiple myeloma cells by reducing myeloid-derived suppressor cells and depleting CD38-positive immunomodulatory T and B cells. 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.

Multiple Myeloma is the second most common hematologic malignancies and accounts for approximately 10% of hematologic malignant cases[1] ?. High expression of CD38 is present in varied of hematologic malignancies and 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-1. Daratumumab is the first CD38-directed monoclonal antibody approved globally and has been approved for the single-agent treatment of adult patients with recurrent and refractory multiple myeloma by NMPA. Its combinations have also been approved for the treatment of first-line, 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 2019£¬Henlius has launched the first domestic monoclonal antibody biosimilar ººÀû¿µ^® to treat non-Hodgkin's lymphoma and chronic lymphocytic lleukemia. HLX15 is the second product in the area of hematologic malignancies developed by Henlius, further extending the Company¡¯s enriched portfolio. Meanwhile, HLX15 has the potential to reduce the financial burden of patients with multiple myeloma and provide them an alternative high-quality treatment option, especially for recurrent and refractory patients. Looking forward, Henlius will continue expanding the well-established biosimilar products pipeline and promoting the development of innovative biologics. On the basis of its established and integrated innovation platform, the Company will underscore its long-term commitment to providing affordable and effective therapies for patients worldwide.

About Henlius
Henlius (2696.HK) is a global biopharmaceutical company with the vision to offer high-quality, affordable and innovative biologic medicines for patients worldwide with a focus on oncology, autoimmune diseases and ophthalmic diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities of high-efficiency and innovation embedded throughout the whole product life cycle including R&D, manufacturing and commercialisation. It has established global R&D centers and a Shanghai-based manufacturing facility certificated by China and the European Union (EU) Good Manufacturing Practice (GMP).

Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies (mAbs) and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Up to date, Henlius has launched three mAbs developed independently: ººÀû¿µ^® (HLX01, rituximab), the first China-developed biosimilar, ººÇúÓÅ^® (HLX02, trastuzumab, Zercepac^® in the EU), the first China-developed mAb biosimilar approved both in China and in the EU and ºº´ïÔ¶^® (HLX03, adalimumab), the Company's first product indicated for autoimmune diseases. In addition, the New Drug Applications of HLX04 (bevacizumab) and HLX01 (rituximab) for the treatment of rheumatoid arthritis are under review, and Henlius has conducted over 20 clinical studies for 10 products and 8 combination therapies worldwide, expanding its presence in major market as well as emerging market.

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[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.