Qilu won the first imitation!

The editor said: Recently, the upsurge in the field of JAK inhibitors has continued: Qilu won the first imitation of tofacitinib citrate sustained-release tablets, Pfizer abrucitinib tablets were approved in China, and tofacitinib citrate tablets were newly adapted Symptoms.

Source: Minet original

Recently, the field of JAK inhibitors has been booming: Qilu won the first imitation of Tofacitinib Citrate Sustained-release Tablets, Pfizer Abraxitinib Tablets was approved in China, and Tofacitinib Citrate Tablets added new indications.

Qilu won the first imitation of tofacitinib sustained-release, Pfizer's second JAK inhibitor came

Following the approval of AbbVie's JAK inhibitor upadatinib extended-release tablets in China, and two new indications have been added, another JAK inhibitor has entered the domestic market

On April 11, the State Food and Drug Administration announced that Pfizer's class 1 innovative drug JAK1 inhibitor abroxitinib (trade name: Cipco/CIBINQO) was approved for marketing for use in other systemic treatments (such as hormones or biological drugs).

The first JAK inhibitor tofacitinib citrate tablets (trade name: Shangjie/Xeljanz) was approved for marketing in the United States in 2012 and approved for import in China in 2017.

In the domestic market, tofacitinib citrate tablets are falling into a fierce wave of imitation substitution.

On April 21, the official website of the State Food and Drug Administration showed that Qilu Pharmaceutical's tofacitinib citrate sustained-release tablets were approved for marketing, becoming the first domestic imitation + first review

9 JAK inhibitors in the world have been approved, and 5 major products have collected US$6.

JAK belongs to the family of non-receptor protein tyrosine kinases, consisting of four isoforms, JAK1, JAK2, JAK3 and TYK2

Among the 9 JAK inhibitors, 5 are first-generation JAK inhibitors, including ruxolitinib from Novartis, tofacitinib from Pfizer, baricitinib from Eli Lilly, Stella's peficitinib, Japan's Tobacco's delgocitinib; 4 are second-generation JAK inhibitors, including Celgene's fedratinib, AbbVie's upadacitinib, Gilead's filgotinib, and Pfizer's abrucitinib (abrocitinib)

According to data from Minet.

Global marketed JAK inhibitors

At present, five JAK inhibitors, including tofacitinib, ruxolitinib, baricitinib, upatinib, and abrucitinib, have been approved for marketing in China

According to the data of Minet.

17 Class 1 new drugs under development! Hengrui, Kelun.

Although the domestic JAK inhibitor market is still in its infancy, many local companies have already laid out the research and development of JAK target innovative drugs

At present, 17 new class 1 drugs of JAK inhibitors are in the clinical research stage
.
Among them, Hengrui Medicine's SHR0302 and Zejing Pharmaceutical's Jaketinib are in phase III clinical stage, and the research and development progress is the fastest; Kelun Pharmaceutical's KL130008 capsules, Chia Tai Tianqing's TQ05105 tablets, and Dizhe Medicine's TLL-018 tablets .
.
.
6 new drugs are in Phase II clinical stage
.

Research status of domestic JAK inhibitors

Hengrui Medicine's SHR0302 targets JAK1, and has developed two dosage forms of tablet and ointment, and has laid out a number of indications
.
At present, the indications of SHR0302 tablets for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, atopic dermatitis, alopecia areata, and colitis are all in the phase III clinical stage, and the indications for atopic dermatitis have been Include breakthrough therapy
.

Zejing Pharma's Jacktinib is a JAK inhibitor targeted small molecule, which has been developed in two dosage forms: tablet and cream
.
At present, the indications for myelofibrosis and severe alopecia areata of Jacktinib Hydrochloride Tablets are in Phase III clinical stage; the indications for Jacktinib Hydrochloride Cream for mild to moderate alopecia areata and mild to moderate atopic dermatitis are all in Phase I clinical trials stage
.

The KL130008 capsule of Sichuan Kelun Botai, a subsidiary of Kelun Pharmaceutical Holdings, is a selective inhibitor targeting JAK1 and JAK2 kinases.
The product is in the phase II clinical stage for rheumatoid arthritis indications, and severe alopecia areata The Phase II clinical trial was approved in March 2022
.
Chia Tai Tianqing's TQ05105 tablet is a JAK and ROCK inhibitor, and its indication for myelofibrosis is in the phase II clinical stage
.

From the perspective of research and development progress, Hengrui Medicine's SHR0302 is expected to become the first domestic innovative JAK inhibitor
.

Data source: Minet database, NMPA, etc.

Note: The statistics are as of April 21.
If there are any omissions, please correct me!