SHENZHEN, China, Nov. 2, 2023 /PRNewswire/ — On Oct. 31, 2023, Shenzhen Chipscreen Biosciences Co., Ltd. (hereinafter referred to as “Chipscreen” and with stock code 688321.SH) received the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration (“NMPA”) through its wholly-owned subsidiary, Chengdu Chipscreen Pharmaceutical Co., Ltd. The notice grants approval for conducting clinical trials of CS32582 capsules in the treatment of psoriasis.
CS32582 is a novel small molecule and highly selective allosteric inhibitor of Tyrosine Kinase 2 (TYK2) independently developed by Chipscreen. It achieves selective inhibition of TYK2 by specifically binding to its regulatory pseudokinase JH2 domain. Importantly, CS32582 will not inhibit the JAK1, JAK2 and JAK3 of the same family at therapeutic doses. This characteristic ensures both therapeutic efficacy and a favorable safety profile.
CS32582 effectively inhibits TYK2, thereby blocking downstream signaling pathways mediated by cytokines such as interleukin (IL)-23, IL-12, and interferon (IFN) type I. This action contributes to its therapeutic effect in autoimmune diseases like psoriasis. Preclinical studies have demonstrated its significant therapeutic efficacy in mouse models of psoriasis.
Psoriasis is an immune-mediated, chronic, relapsing, inflammatory, and systemic disease induced by the combined effects of genetics and the environment. It is also associated with several potential comorbidities that can impact the patients’ health, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease, and depression, significantly affecting the patients’ quality of life.
Traditional systemic oral therapies are non-targeted drugs, often associated with undesired side effects and long-term safety concerns. Striking a balance between benefits and risks remains a significant challenge, and there is an urgent need for safe and effective new targeted oral therapies.
Small molecule targeted oral medications offer superior efficacy and safety compared to traditional systemic therapies. Currently, the TYK2 inhibitor Deucravacitinib tablet is the only globally approved oral medication for treating adult patients with moderate to severe plaque psoriasis who are candidates for systemic treatment or phototherapy.
Now, CS32582 holds potential therapeutic value for autoimmune diseases like psoriasis that are mediated by cytokines such as IL-23, IL-12, and type I IFN. It is expected to offer patients a treatment choice with better efficacy and safety compared to existing clinical drugs.
Chipscreen is a modern biopharmaceutical company founded in 2001 by a seasoned team of professionals who returned to China after studying in the United States. The company specializes in the development of original new molecular entity drugs and is committed to providing innovative drugs with revolutionary therapeutic effects that are affordable for patients worldwide and are in high clinical demand.
Leveraging its independently created state-of-the-art “Chemical Genomics-Based Integrated Drug Discovery and Early Evaluation Platform”, Chipscreen has developed multiple original drug product lines in five significant disease areas, including oncology, metabolic diseases, autoimmune diseases, central nervous system disorders, and antiviral therapies. These product lines include chidamide ( Tucidinostat marketed), chiglitazar ( Carfloglitazar marketed), chiauranib (Ibcasertib in pivotal phase III clinical trial), and CS12192 (phase I clinical trial currently underway).
Currently, Chipscreen has established a global presence through its headquarters and R&D center in Shenzhen, with a wholly-owned subsidiary “Shenzhen Chipscreen Pharmaceuticals Co., Ltd.” serving as a GMP production base. Additionally, it has a regional headquarters/R&D center/innovative drug production base – “Chengdu Chipscreen Pharmaceuticals Co., Ltd.” focusing on the field of small-molecule innovative drugs, and a subsidiary “Chengdu Chipscreen Newway Biosciences Co., Ltd.” dedicated to the development of large molecules and other novel therapeutic technologies. The company also maintains branches in Beijing (Clinical Research Center) and Shanghai (Business Center). Furthermore, Chipscreen extends its global footprint, with Chipscreen Biosciences (United States) Limited set up for global clinic development in the United States, embodying a comprehensive globalization strategy.
 Chinese Medical Association, Chinese Medical Journal, Dermatology Branch of Chinese Medical Association, etc. Guidelines for the Diagnosis and Treatment of Psoriasis (2022) [J]. Chinese Journal of General Practitioners, 2022, 21(8):705-714.
 Martin G. Novel Therapies in Plaque Psoriasis: A Review of Tyrosine Kinase 2 Inhibitors[J]. Dermatol Ther (Heidelb). 2023 Feb;13(2):417-435.
 FDA. SOTYKTU (deucravacitinib) tablets Label. 2022.9.
Source: Shenzhen Chipscreen Biosciences Co., Ltd.