Recently, Hengrui Biopharmaceuticals received the Drug Clinical Trial Approval Notice issued by the National Medical Products Administration, granting approval for the company's JAK1 inhibitor and innovative drug SHR0302 sustained-release tablets to conduct clinical trials for the indication of systemic lupus erythematosus (SLE). Currently, there is no globally approved medication targeting the same pathway for treating systemic lupus erythematosus.

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease with a complex etiology involving various factors such as genetics, sex hormones, and environmental factors like viral and bacterial infections. The prevalence of SLE in China is estimated to be around 30-70 per 100,000, with an estimated affected population of approximately one million. SLE manifests with complex clinical presentations, affecting multiple organ systems, including joints, skin, kidneys, lungs, blood systems, nervous systems, and blood vessels, potentially leading to severe complications and even death.

The situation of SLE in China is characterized by a large population, severe disease conditions, a high incidence of complications, and significant impacts on fertility, resulting in a substantial disease burden for patients. Current treatment options include glucocorticoids, antimalarial drugs, immunosuppressive agents, and biologics. However, existing treatments have limitations, such as insufficient overall remission rates, steroid dependence with associated toxicity, and adverse reactions like bone marrow suppression and liver damage with immunosuppressive agents.

Type I interferon (IFN) and interleukin-6 (IL-6) signaling pathways are among the signaling pathways associated with SLE disease activity. Both I-type IFN and IL-6 transmit signals through the JAK family proteins (JAK1, JAK2, JAK3, TYK2) and downstream effector signal transducers and activators of transcription (STAT) pathways. Therefore, the use of JAK inhibitors for treating SLE is an area of considerable interest.

SHR0302 is a highly selective JAK1 inhibitor independently developed by Hengrui Biopharmaceuticals. It is categorized as a Class 1 new drug in China and exerts anti-inflammatory and immunosuppressive biological effects by inhibiting JAK1 signal transduction.

The SHR0302 tablet has undergone clinical studies in various fields, including rheumatoid arthritis, ankylosing spondylitis, ulcerative colitis, atopic dermatitis, and alopecia areata. The majority of these indications have entered Phase III clinical trials, with market applications for ankylosing spondylitis, atopic dermatitis, and rheumatoid arthritis all being accepted by the National Medical Products Administration. Additionally, the innovative formulation of SHR0302 for mild to moderate atopic dermatitis, a topical cream, has entered Phase III clinical trials. In 2018, the company licensed the JAK1 inhibitor SHR0302 to the U.S. company Arcutis, expanding the reach of the innovative drug to benefit patients globally.

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