Qilu Pharmaceutical's Tofacitinib Citrate Tablets Pass Consistency Evaluation as China's Second Domestic Manufacturer

Source:PharmaCube InfoVernacular Chinese

On October 24, Qilu Pharmaceutical’s “Tofacitinib Citrate Tablets” passed the consistency evaluation, making it the second company in China to achieve this milestone for the product, following Chia Tai Tianqing.

Tofacitinib citrate is the world’s first small-molecule targeted JAK kinase inhibitor for the treatment of rheumatoid arthritis. It selectively inhibits JAK1/JAK3-associated combinations while exhibiting minimal inhibition of JAK2/JAK4 combinations, thereby enhancing both efficacy and safety.

Tofacitinib Structural Formula

The original manufacturer of tofacitinib is Pfizer, which first received FDA approval for market launch on November 6, 2012. It was approved in China on March 10, 2017, under the brand name Xeljanz. In 2018, global sales of tofacitinib reached USD 1.774 billion. Currently, in the Chinese domestic market, the median winning bid price for Pfizer’s tofacitinib is RMB 68.79 per tablet (5 mg).

According to the PharmaGo database by Medicine Cube, nine domestic companies, including Yangtze River Pharmaceutical, Chengdu Better Pharmaceutical, and Hunan Kelun Pharmaceutical, are currently applying for or are deemed to be applying for the consistency evaluation of this product.

Rheumatoid arthritis is a systemic autoimmune disease characterized primarily by chronic, progressive joint pathology, and it is one of the most common causes of disability in clinical practice. With nearly 5 million patients in China, the disease has a high disability rate, imposing a substantial burden on both society and patients.