Shanghai November 19, 2024 /PRNewswire/ -- Sunshine Guojian Pharmaceutical (stock code: 688336.SH) announced that the application for market approval of the recombinant anti-IL-17A humanized monoclonal antibody injection (608) recently submitted to the National Medical Products Administration has been accepted on November 18, intended for the treatment of moderate to severe plaque psoriasis in adults.

608 is an innovative monoclonal antibody against IL-17A independently developed by Sunshine Guojian. In August of this year, the key registration phase III clinical study for treating moderate to severe plaque psoriasis in adults completed unblinding and final statistical analysis, successfully achieving all primary efficacy endpoints (PASI 75 and sPGA 0/1), key secondary efficacy endpoints (PASI 90, PASI 100, and sPGA 0), and all secondary efficacy endpoints. The maintenance treatment regimen is expected to achieve the longest dosing interval among similar products, with various efficacy indicators continuing to rise and remain stable during the maintenance treatment period. Compared with already marketed products targeting the same site, 608 shows strong competitive advantages in efficacy data for induction treatment (12 weeks) and maintenance treatment (52 weeks).

Psoriasis is a common, immune-related, chronic relapsing inflammatory skin disease, with significant variations in prevalence among different populations worldwide, approximately 1% to 3% in Europe and America, while in China it is about 0.5%. However, due to the large population base in China, the absolute number of psoriasis patients is quite high and is increasing year by year. Psoriasis has a long course, tends to relapse, and is difficult to treat, requiring lifelong treatment. It is also closely related to chronic diseases such as cardiovascular diseases, diabetes, and metabolic syndrome, significantly affecting patients' physical and mental health and quality of life. Although there are various treatment options available clinically, they all have their limitations. Biologics have become the main systemic medications for psoriasis, playing a positive and effective role in treating moderate to severe, refractory, and special types of psoriasis.

Dr. Lou Jing, chairman of Sunshine Guojian Pharmaceutical, stated: "We are pleased to see the market approval application for the recombinant anti-IL-17A humanized monoclonal antibody 608 developed independently by the company accepted by the National Medical Products Administration. There is a large number of psoriasis patients, and a huge unmet clinical need exists. We look forward to the early launch of this product to bring high-quality domestic biologics to Chinese patients. At the same time, we are also accelerating the development of 608 for the treatment of ankylosing spondylitis, radiologically negative axial spondyloarthritis, and other indications, striving to provide better treatment options for patients with related diseases."