Henlius Adalimumab Biosimilar Approved by NMPA

Shanghai Henlius Biotech, Inc. announced that the adalimumab biosimilar HLX03, developed and manufactured by the Company independently, has been approved by the National Medical Products Administration (NMPA) for the treatment of rheumatoid arthritis (RA), ankylosing spondylitis (AS) and plaque psoriasis (Ps). It is the third monoclonal antibody (mAb) developed by Henlius and approved in China, after the Company's rituximab biosimilar HLX01, the first China-developed biosimilar, and trastuzumab biosimilar HLX02 (EU brand name Zercepac), the first China-developed mAb biosimilar approved both in China and in the EU. HLX03 is also Henlius first product approved for the treatment of autoimmune diseases. Its successful development is based on the integrated biopharmaceutical platform of Henlius.

During the development process of HLX03, Henlius strictly followed the NMPA biosimilar guidelines and has taken multiple head-to-head comparisons between HLX03 and the reference adalimumab. Results from analytical studies, non-clinical studies and clinical studies showed that HLX03 is highly similar to the reference adalimumab in terms of quality, safety and efficacy. Henlius has reached an agreement with Wanbang Biopharma (Wanbang), which is a subsidiary of Fosun Pharma and has been deeply engaged in the field of rheumatology for many years. Under the agreement, Wanbang will be responsible for the commercialization of HLX03 in China.

Mr. Wenjie Zhang, Chief Executive Officer and President of Henlius, said, "The approval of this product marks the expansion of the Company's commercial pipeline into the field of autoimmune diseases and the scope of patients that can benefit from Henlius products is further broadened. Henlius will continue optimizing and upgrading the product, and cooperating with Wanbang Biopharma to promote the commercialization of HLX03, so as to bring high-quality treatment options to patients suffering from autoimmune diseases."

About Henlius

Henlius (2696.HK) is a global biopharmaceutical company 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. Henlius has pro-actively built a diversified and high-quality product pipeline covering over 20 innovative monoclonal antibodies and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as backbone. Products have been licensed out to nearly 100 countries and regions.