-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
[Pharmaceutical Network Industry News] Recently, the State Food and Drug Administration's public information shows that Qilu Pharmaceutical's Tofacitinib Citrate Sustained-Release Tablets has been approved for marketing, becoming the first domestic imitation + first over-reviewed pharmaceutical company
.
It is reported that Qilu Pharmaceutical is applying tofacitinib citrate sustained-release tablets according to Category 3 chemicals this time, which is also the first oral sustained and controlled-release preparation of osmotic pump technology approved by Qilu Pharmaceutical
.
Up to now, a total of 101 products of Qilu Pharmaceutical have passed or deemed to pass the consistency evaluation
.
The approval of the sustained-release dosage form will help further enhance the company's competitiveness in the field of JAK inhibitors
.
JAK belongs to the family of non-receptor protein tyrosine kinases and consists of four subtypes, JAK1, JAK2, JAK3 and TYK2.
In recent years, the research and development of JAK inhibitors has been hot, and 9 products have been approved for marketing in the world, namely Novartis' Luke Ruxolitinib, Eli Lilly's baricitinib, Pfizer's tofacitinib, Astellas' peficitinib, Tobacco's delgocitinib, Celgene's fedratinib, AbbVie's upatitinib Upadacitinib, Gilead's filgotinib, Pfizer's abrocitinib,
etc.
In China, Pfizer's tofacitinib citrate tablets were approved to enter China in March 2017, and the sustained-release tablet form was approved in August 2021
.
Sales of tofacitinib have grown steadily since its launch, reaching $2.
455 billion in 2021
.
Not long ago, Pfizer's class 1 innovative drug JAK1 inhibitor abrucitinib tablets (trade name: Cipco/CIBINQO) was also approved for marketing, which is also the second JAK inhibitor approved by Pfizer in China
.
Up to now, five JAK inhibitors, including ruxolitinib, tofacitinib, baricitinib, upatinib, and abrucitinib, have been approved for marketing in China
.
Among them, tofacitinib, ruxolitinib, and baricitinib are the first-generation JAK inhibitors.
According to Minet.
com data, the three JAK inhibitors, tofacitinib, ruxolitinib, and baricitinib, will be in the The cumulative sales of public medical institutions in China are about 400 million yuan, and the sales in the first half of 2021 will exceed 300 million yuan
.
It is worth mentioning that although the domestic inhibitor market is still in its infancy, the replacement of imitation is hot
.
As far as the research and development of generic tofacitinib citrate tablets is concerned, there are currently 16 domestic companies that have production approvals for tofacitinib citrate tablets.
Tofacitinib citrate was approved for marketing in October 2019, the second domestically produced product
.
In terms of tofacitinib citrate sustained-release tablets, in August 2020, Qilu Pharmaceutical was the first in China to submit a marketing application for tofacitinib citrate sustained-release tablets
.
At present, the product has been successfully approved as a review, becoming the first imitation + review in China
.
In addition, judging from the research status of domestic JAK inhibitors, pharmaceutical companies including Hengrui, Zejing Pharmaceuticals, Kelun Pharmaceuticals, Chia Tai Tianqing, Hisun Pharmaceuticals, and Microchip have all deployed JAK-targeted innovative drugs
.
In terms of the progress of the products under development, Hengrui Medicine's SHR0302 and Zejing Pharmaceutical's Jaketinib are progressing rapidly, and they are both in phase III clinical state
.
Among them, Hengrui Medicine's SHR0302 for psoriatic arthritis, rheumatoid arthritis and other indications are already in the phase III clinical stage, Zejing Pharmaceutical's Jaketinib for severe alopecia areata and myelofibrosis indications have been It is in phase III clinical stage
.
It is foreseeable that as more generic drugs and new drugs under research are approved for marketing, the domestic JAK inhibitor market competition will become more intense, and the market share of original research companies may also be affected
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
It is reported that Qilu Pharmaceutical is applying tofacitinib citrate sustained-release tablets according to Category 3 chemicals this time, which is also the first oral sustained and controlled-release preparation of osmotic pump technology approved by Qilu Pharmaceutical
.
Up to now, a total of 101 products of Qilu Pharmaceutical have passed or deemed to pass the consistency evaluation
.
The approval of the sustained-release dosage form will help further enhance the company's competitiveness in the field of JAK inhibitors
.
JAK belongs to the family of non-receptor protein tyrosine kinases and consists of four subtypes, JAK1, JAK2, JAK3 and TYK2.
In recent years, the research and development of JAK inhibitors has been hot, and 9 products have been approved for marketing in the world, namely Novartis' Luke Ruxolitinib, Eli Lilly's baricitinib, Pfizer's tofacitinib, Astellas' peficitinib, Tobacco's delgocitinib, Celgene's fedratinib, AbbVie's upatitinib Upadacitinib, Gilead's filgotinib, Pfizer's abrocitinib,
etc.
In China, Pfizer's tofacitinib citrate tablets were approved to enter China in March 2017, and the sustained-release tablet form was approved in August 2021
.
Sales of tofacitinib have grown steadily since its launch, reaching $2.
455 billion in 2021
.
Not long ago, Pfizer's class 1 innovative drug JAK1 inhibitor abrucitinib tablets (trade name: Cipco/CIBINQO) was also approved for marketing, which is also the second JAK inhibitor approved by Pfizer in China
.
Up to now, five JAK inhibitors, including ruxolitinib, tofacitinib, baricitinib, upatinib, and abrucitinib, have been approved for marketing in China
.
Among them, tofacitinib, ruxolitinib, and baricitinib are the first-generation JAK inhibitors.
According to Minet.
com data, the three JAK inhibitors, tofacitinib, ruxolitinib, and baricitinib, will be in the The cumulative sales of public medical institutions in China are about 400 million yuan, and the sales in the first half of 2021 will exceed 300 million yuan
.
It is worth mentioning that although the domestic inhibitor market is still in its infancy, the replacement of imitation is hot
.
As far as the research and development of generic tofacitinib citrate tablets is concerned, there are currently 16 domestic companies that have production approvals for tofacitinib citrate tablets.
Tofacitinib citrate was approved for marketing in October 2019, the second domestically produced product
.
In terms of tofacitinib citrate sustained-release tablets, in August 2020, Qilu Pharmaceutical was the first in China to submit a marketing application for tofacitinib citrate sustained-release tablets
.
At present, the product has been successfully approved as a review, becoming the first imitation + review in China
.
In addition, judging from the research status of domestic JAK inhibitors, pharmaceutical companies including Hengrui, Zejing Pharmaceuticals, Kelun Pharmaceuticals, Chia Tai Tianqing, Hisun Pharmaceuticals, and Microchip have all deployed JAK-targeted innovative drugs
.
In terms of the progress of the products under development, Hengrui Medicine's SHR0302 and Zejing Pharmaceutical's Jaketinib are progressing rapidly, and they are both in phase III clinical state
.
Among them, Hengrui Medicine's SHR0302 for psoriatic arthritis, rheumatoid arthritis and other indications are already in the phase III clinical stage, Zejing Pharmaceutical's Jaketinib for severe alopecia areata and myelofibrosis indications have been It is in phase III clinical stage
.
It is foreseeable that as more generic drugs and new drugs under research are approved for marketing, the domestic JAK inhibitor market competition will become more intense, and the market share of original research companies may also be affected
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
