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Eli Lilly's "baricitinib" new indication was listed in domestic reports

 Last Update: 2022-01-25
 Source: Internet
 Author: User

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On January 10, the CDE official website showed that Eli Lilly’s JAK inhibitor, baricitinib, had a new indication for listing
.

From: CDE official website

Baricitinib is a tyrosine kinase (JAK) 1/2 inhibitor indicated for moderate-to-severe activity that is refractory or intolerant to one or more disease-modifying antirheumatic drugs (DMARDs).
In adults with rheumatoid arthritis, it can be used in combination with methotrexate or other nonbiologic disease-modifying antirheumatic drugs
.

In July 2019, the State Drug Administration approved the marketing of baricitinib tablets for the treatment of moderately to severely active rheumatoid arthritis in adults, with the trade name of elemin

Rheumatoid arthritis is a chronic inflammatory autoimmune disease that seriously affects the daily work and life of patients, thereby affecting the quality of life of patients
.

Epidemiological surveys show that the prevalence of rheumatoid arthritis in mainland China is 0.

The RA-BALANCE study, a registered clinical trial jointly completed by 22 research centers in China, showed that compared with the placebo group, baricitinib tablets had a significant therapeutic effect, achieved the primary endpoint, and showed good safety
.

In addition, two global multicenter studies showed that compared with the placebo group, the baricitinib 2 mg treatment group achieved the primary endpoint at 12 weeks, the proportion of patients with ACR20 response was statistically different, and multiple efficacy indicators were also statistically significant Improvements in academic meaning

Baricitinib is currently conducting 9 clinical trials in China, in addition to rheumatoid arthritis, it also targets systemic lupus erythematosus, juvenile idiopathic arthritis, and severe or very severe alopecia areata
.

In addition, Nanjing Ruckus Pharmaceuticals in China has completed the BE trial for baricitinib and submitted a generic drug marketing application in August 2021
.

According to the CDE patent registration platform, the patent for baricitinib will expire in 2029

Source: Insight database (http://db.

Note: The original text has been deleted

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