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.

中国深圳，2023年11月2日/PRNewswire/-2023年10月31日，深圳市奇普屏生物科技有限公司（以下简称“Chipscreen”，股票代码688321.SH）收到“药品”国家医疗产品管理局（'NMPA'）通过其合资子公司成都奇普屏制药有限公司发布的临床试验批准通知“。

The notice grants approval for conducting clinical trials of CS32582 capsules in the treatment of psoriasis..

该通知授予批准进行CS32582胶囊治疗牛皮癣的临床试验。。

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.

CS32582是由Chipscreen独立开发的新型小分子和高选择性酪氨酸激酶2（TYK2）变构抑制剂。它通过特异性结合其调节性假激酶JH2结构域实现对TYK2的选择性抑制。重要的是，CS32582在治疗剂量下不会抑制同一家族的JAK1，JAK2和JAK3。

This characteristic ensures both therapeutic efficacy and a favorable safety profile..

该特征确保了治疗功效和有利的安全性。。

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..

CS32582有效抑制TYK2，从而阻断由细胞因子如白细胞介素（IL）-23，IL-12和I型干扰素（IFN）介导的下游信号传导途径。该作用有助于其在自身免疫疾病如牛皮癣中的治疗效果。临床前研究已经证明其在牛皮癣小鼠模型中的显着治疗功效。。

About Psoriasis

关于牛皮癣

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[1]..

牛皮癣是由遗传和环境的综合作用诱导的免疫介导的，慢性的，复发的，炎性的和全身性的疾病。它还与几种可能影响患者健康的潜在合并症有关，包括银屑病关节炎，心血管疾病，代谢综合征，肥胖，糖尿病，炎症性肠病和抑郁症，显着影响患者的生活质量[1]。。

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[2].

传统的全身口服疗法是非靶向药物，通常伴有不良副作用和长期安全性问题。在利益和风险之间取得平衡仍然是一项重大挑战，迫切需要安全有效的新型靶向口服疗法[2]。

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[3]..

与传统的全身治疗相比，小分子靶向口服药物具有更高的疗效和安全性。目前，TYK2抑制剂Deucravacitinib片剂是唯一获得全球批准的用于治疗中度至重度斑块状银屑病成人患者的口服药物，这些患者是全身治疗或光疗的候选者[3]。。

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.

现在，CS32582对由细胞因子如IL-23，IL-12和I型IFN介导的自身免疫性疾病如牛皮癣具有潜在的治疗价值。与现有的临床药物相比，预计将为患者提供具有更好疗效和安全性的治疗选择。

About Chipscreen

关于Chipscreen

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..

Chipscreen是一家现代生物制药公司，成立于2001年，由经验丰富的专业团队在美国学习后返回中国。该公司专门从事原始新分子实体药物的开发，致力于为全球患者提供具有革命性治疗效果的创新药物，并且临床需求量很大。。

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.

Chipscreen利用其独立创建的最先进的“基于化学基因组学的综合药物发现和早期评估平台”，在五个重要疾病领域开发了多种原始药物产品系列，包括肿瘤学，代谢疾病，自身免疫性疾病，中枢神经系统疾病和抗病毒治疗。

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)..

这些产品系列包括chidamide（市售Tucidinostat），chiglitazar（市售Carfloglitazar），chiauranib（关键III期临床试验中的Ibcasertib）和CS12192（目前正在进行的I期临床试验）。。

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.

目前，Chipscreen通过其总部和深圳研发中心在全球建立了业务，合资子公司“深圳Chipscreen制药有限公司”作为GMP生产基地。此外，还有一个区域总部/研发中心/创新药物生产基地-“成都奇普瑞恩制药有限公司”，专注于小分子创新药物领域，子公司“成都奇普瑞恩新威生物科学有限公司”。致力于开发大分子等新型治疗技术。

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..

该公司还在北京（临床研究中心）和上海（商业中心）设有分支机构。此外，Chipscreen扩大了全球足迹，为美国全球临床开发设立的Chipscreen生物科学（美国）有限公司体现了全面的全球化战略。。

REFERENCES

参考

[1] 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.[2] Martin G. Novel Therapies in Plaque Psoriasis: A Review of Tyrosine Kinase 2 Inhibitors[J].

[1] 中华医学会，中华医学杂志，中华医学会皮肤科等。银屑病诊断与治疗指南（2022）[J]。中国全科医生杂志，2022,21（8）：705-714。[2]Martin G.斑块状银屑病的新疗法：酪氨酸激酶2抑制剂的综述[J]。

Dermatol Ther (Heidelb). 2023 Feb;13(2):417-435.[3] FDA. SOTYKTU (deucravacitinib) tablets Label. 2022.9..

Dermatol Ther（Heidelb）。2023年2月；13（2）：417-435.[3]美国食品药品监督管理局。[UNK]SOTYKTU（去乙酰阿替尼）片剂标签。2022.9。。

SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

来源深圳奇普屏生物科技有限公司。