China-based CSPC Pharmaceutical Group Co., Ltd (HKG: 1093) has announced that it has received market approval from the Center for Drug Evaluation (CDE) for its generic version of Pfizer’s Xeljanz (tofacitinib). This marks the second sustained-release tablet version of the drug (in 11mg dosage) to pass China’s generic quality consistency evaluation (GQCE) process, further expanding the availability of this important medication in the domestic market.
Tofacitinib: A Pioneering JAK Inhibitor
Tofacitinib is the world’s first oral small molecule Janus kinase (JAK) inhibitor, designed to block the signal transduction related to inflammation in cells with moderate to severe active rheumatoid arthritis (RA). Initially approved for marketing in the US in 2012, the drug was subsequently approved in China in 2017 to treat patients with moderate to severe active RA who have insufficient efficacy or intolerance to methotrexate. The drug has been widely recommended globally and was included in China’s National Reimbursement Drug List (NRDL) in 2019 following price negotiations.
Market Landscape and Competition
In September 2019, Chia Tai Tianqing Pharma’s TaiYan became the first generic version of tofacitinib in China, focusing on 5mg tablets. This version was included in the third round of China’s volume-based procurement (VBP) program, with Chia Tai Tianqing, Kelun Pharma, Qilu Pharma, and Simcere Pharma winning tender spots. The sustained-release tablets, which are osmotic pump-controlled release tablets, enable slow and continuous release of the drug into the bloodstream, allowing for once-daily oral administration. Pfizer’s tofacitinib sustained-release tablets were first approved in China in September 2021, while Qilu was the first to pass the GQCE for that form of the drug.
Conclusion
The approval of CSPC’s generic version of Xeljanz (tofacitinib) by the CDE highlights the ongoing efforts to increase the availability of high-quality, affordable medications in China. As the second sustained-release tablet version to pass the GQCE, CSPC’s product is expected to contribute to the treatment options for patients with rheumatoid arthritis, further enhancing competition in the domestic market.-Fineline Info & Tech
