Shanghai / PRNewswire / - Shanghai Henlius Biotech, Inc. (2696.HK) announced that the biosimilar adalimumab HLX03, independently developed and manufactured by the company, has received approval from the National Medical Products Administration (NMPA) for the treatment of rheumatodid arthritis (RA), ankylosing spondylitis (SA) and plaque psoriasis (Ps). It is the third monoclonal antibody (mAb) developed by Henlius and approved in China , after the company's rituximab HLX01 biosimilar, the first biosimilar developed in China , and the trastuzumab biosimilar HLX02 (EU brand name, Zercepac). , the first biosimilar mAb developed in China and approved in Chinaand the EU. HLX03 is also the first Henlius product approved for the treatment of autoimmune diseases. It has successfully developed based on Henlius' integrated biopharmaceutical platform.
During the HLX03 development processes, Henlius strictly followed the NMPA biosimilar guidelines and has initiated multiple comparisons between HLX03 and the reference adalimumab. Results from analytical studies, non-clinical studies, and clinical trials have shown that HLX03 is very similar to the adalimumab benchmark in terms of quality, safety, and efficacy. Henlius has reached an agreement with Wanbang Biopharma (Wanbang), which is a subsidiary of Fosun Pharma and which has been very dedicated to the field of rheumatology for many years. Under the agreement, Wanbang will be responsible for the marketing of HLX03 in China .
Wenjie Zhang , CEO and CEO of Henlius, explained: "The approval of this product marks the expansion of the company's business range in the field of auto-immune diseases and the spectrum of patients who can benefit from the products. of Henlius as we expand further. Henlius will continue to optimize and improve the products, and cooperate with Wanbang Biopharma to promote the commercialization of HLX03, to bring high-quality treatment options to patients suffering from auto-immune diseases. "
Henlius is a global biopharmaceutical company with a vision of providing high-quality, affordable and innovative biologics for patients around the world with a focus on oncology and autoimmune diseases. Since its inception in 2010, Henlius has built an integrated biopharmaceutical platform with core capabilities for high efficiency and innovation throughout the entire product lifecycle, including R&D, manufacturing and marketing. Henlius has proactively created a diversified, high-quality product range that covers 20 innovative monoclonal antibodies and has continued to explore immuno-oncology combination therapies with proprietary HLX10 (anti-PD-1 mAb) as the backbone. . The products have been licensed by about 100 countries and regions. www.henlius.com.