Chia Tai Tianqing Succeeded in Patent Challenge against Pfizer!

Chia Tai Tianqing succeeded in the patent challenge, and the core patent—compound patent of Pfizer’s JAK inhibitor tofacitinib was fully declared invalid in China.

Tofacitinib—the JAK inhibitor with efficacy comparable to the "drug king" Humira

Tofacitinib Citrate (trade name: Xeljanz) is an oral inhibitor targeting JAK3 and JAK1 developed by Pfizer, the first JAK inhibitor approved by FDA to treat rheumatoid arthritis (RA), and also the first oral disease-modifying antirheumatic drug (DMARD) approved to treat RA in recent decade, of which the efficacy is considered to be comparable to the "drug king" Humira by insiders. Its approval process is as follows:

 (Source: Official websites of CFDA, FDA, and EMA)

Tofacitinib has so far been approved for marketing in over 80 countries; besides the indications of RA and UC, other indications such as psoriatic arthritis (PsA) and ankylosing spondylitis (AS) will be approved soon, and the clinical trials of its indications like Crohn's disease and alopecia areata have entered the mid- to late-stage clinical trials.

Patent application situation in China

Tofacitinib has been applied for many patents in China, and its patent declared invalid this time is the compound patent with application publication No. of CN1409712A. Its patent application situation in China is as follows:

 (Source: Official website of State Intellectual Property Office of China)

Global sales situation

The global sales of tofacitinib citrate have continued to rise since marketed, with astonishing annual growth rate; its global sales exceeded USD 1 billion to reach USD 1.345 billion in 2017, with the annual growth of 45%, and its annual sales are expected to continue to grow in 2018 as more indications are approved.

 (Source: Annual reports of the company)

Chia Tai Tianqing possibly to market the first generic after the relevant patent is invalid

There have so far been over 30 pharmaceutical enterprises that have applied for the tofacitinib generic drugs in China; from the perspective of the start time of review and approval status, the enterprise earliest in receiving clinical approval for API is Jiangsu Aosaikang Pharmaceutical, and that earliest in receiving clinical approval for preparation product is Chia Tai Tianqing. The tofacitinib of Chia Tai Tianqing will be likely to be the first generic and marketed in advance of 2020 if Pfizer does not prosecute.

 (Source: db.yaozh.com)

-----------------------------------------------------------------------------
Editor's Note:

To apply for becoming a contributor of En-CPhI.cn,

welcome to send your CV and sample works to us,

Email: Julia.Zhang@ubmsinoexpo.com.