IND acceptance by NMPA for SAL0119 tablets for the treatment of active ankylosing spondylitis and moderate-to-severe active rheumatoid arthritis

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Recently, Salubris announced that National Medical Products Administration (NMPA) has accepted the IND for SAL0119, a self-developed innovative small molecule.


SAL0119 is an oral small molecule immunosuppressant, and its potential indications include active ankylosing spondylitis and moderate-to-severe active rheumatoid arthritis.

SAL0119 has a unique mechanism of action that is different from JAK and a broad spectrum of cytokine inhibition. Preclinical data showed the potential efficacy and favorable safety of SAL0119. If it is successfully developed and approved for marketing, it will provide new drug options for AS and RA patients and meet the unmet clinical needs.


Basic Information

Drug name: SAL0119 tablets

Registry Classification: 1 category

Application information: Registered clinical trials of domestic manufactured drugs

Acceptance number: CXHL2200910, CXHL2200911, CXHL2200912, CXHL2200913, CXHL2200914, CXHL2200915 

Acceptance instructions: According to the provisions of Article 32 of the Administrative Licensing Law of the People's Republic of China, NMPA decided to accept the IND application after examination.


About ankylosing spondylitis and rheumatoid arthritis

Ankylosing spondylitis (AS) and rheumatoid arthritis (RA) are both autoimmune diseases. The cause of their pathogenesis is not completely clear, and they are temporarily incurable. AS and RA have the characteristics of long course of disease, easy to relapse, and most patients need lifelong treatment, which seriously affects the physical and mental health and quality of life.

At present, the main treatment drugs for RA and AS in China are non-steroidal anti-inflammatory drugs, glucocorticoids and disease-modifying anti-rheumatic drugs (DMARDs). But they all have their limitations. Biologics for targeted therapy and JAK inhibitors also have many deficiencies, such as treatment attenuation of macromolecular biologics, harsh preservation conditions, relatively expensive prices, and poor compliance of patients with subcutaneous administration; JAK inhibitors are associated with increased risk of heart disease, cancer, blood clots and death.