Kelun Secures First-to-File Status for Tofacitinib Citrate Extended-Release Tablets, a $2.4B Anti-Inflammatory and Antirheumatic Drug

Recently, the official website of the CDE indicated that the application for Tofacitinib Citrate Extended-Release Tablets, submitted for marketing approval as a Class 3 generic by Sichuan Kelun Pharmaceutical Research Institute | Sichuan Kelun Pharmaceutical Co., Ltd., has been accepted. Data from Menet shows that in 2020, global sales of tofacitinib citrate reached $2.437 billion; combined sales at public medical institution and urban physical pharmacy terminals in China exceeded 300 million RMB. Currently, only tofacitinib citrate tablets are marketed, with over 10 manufacturers including Pfizer, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Qilu Pharmaceutical, and Hunan Kelun Pharmaceutical Co.,Ltd.; however, no company has yet obtained approval for tofacitinib citrate extended-release tablets.

According to available data, tofacitinib, developed by Pfizer, is the world's first small-molecule targeted JAK inhibitor for the treatment of rheumatoid arthritis, and was approved by the U.S. FDA for marketing in November 2012.

Global Sales of Tofacitinib Citrate in Recent Years (Unit: 100 Million USD)

Source: Menet Multinational Listed Companies Sales Database

Data from Menet shows that in 2020, global sales of tofacitinib citrate reached USD 2.437 billion; in China, combined sales at terminals of urban public hospitals, county-level public hospitals, urban community health centers, and township health centers (collectively referred to as public medical institutions in China) and at urban physical pharmacy terminals exceeded RMB 300 million. Among them, sales at public medical institution terminals in China grew by over 200%, while sales at urban physical pharmacy terminals grew by over 150%.

Source: MENET One-Click Search

Only Tofacitinib Citrate Tablets are currently marketed for tofacitinib, with over 10 manufacturers including Pfizer, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Qilu Pharmaceutical, and Hunan Kelun Pharmaceutical Co., Ltd.; no company has obtained approval for Tofacitinib Citrate Extended-Release Tablets.

Currently, four companies have submitted marketing authorization applications for Tofacitinib Citrate Extended-Release Tablets, which are under review and approval. Among them, Sichuan Kelun Pharmaceutical Research Institute | Sichuan Kelun Pharmaceutical, Shanghai Sinta Pharmaceutical | Shanghai Sinta Haimen Pharmaceutical, and Qilu Pharmaceutical submitted applications under the Class 3 generic category. Based on the status start date, Qilu Pharmaceutical has the earliest timeline.

Source: CDE Official Website, MENET Database

Note: The China Urban Physical Pharmacy Terminal Competitive Landscape Database is an expanded version of the urban physical pharmacy database that covers physical pharmacies in 293 prefecture-level and above cities in China (excluding county, township, and village physical pharmacies) and continuously monitors all product categories. The aforementioned sales figures are calculated based on the average retail price of products at the terminal.