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【Pharmaceutical network market analysis】Recently, Astellas JAK3 inhibitor pixitinib hydrobromide tablets domestic declaration and listing was accepted by the State Food and Drug Administration for the treatment of rheumatoid arthritis, which is also the first JAK3 inhibitor
declared for listing in China.
In addition to Astellas, since the beginning of this year, there have been a number of JAK3 inhibitors such as Eli Lilly's baritinib, Pfizer's tofatinib, Abbvie's uppatinib and so on to apply for
the listing of new indications in China.
JAK inhibitors can selectively inhibit JAK kinases, block JAK/STAT pathways, and are mainly used clinically to screen for therapeutic drugs
such as hematologic diseases, tumors, rheumatoid arthritis and psoriasis.
JAK has four subtypes of JAK1, JAK2, JAK3 and TYK2, of which JAK3 inhibitors are popular targets for autoimmune diseases
.
The Insight database shows that the current target JAK new drug research and development is hot, about 200 models in research, of which 7 have been approved for listing, in the domestic market, there have been 6 approved, including Pfizer's abucitinib tablets, citrate tofacib tablets and citrate tofatib extended-release tablets, Novartis rucotinib phosphate tablets, EliLly barritinib tablets and Ebervie's uppatinib extended-release tablets
.
According to intranet data, only tofatibub, rucortinib, and baretinib, three JAK inhibitors, will have terminal sales of nearly 400 million yuan in China's public medical institutions in 2020, and sales in the first half of 2021 will continue to grow, with a total of more than 300 million yuan
.
The domestic targeted JAK drug market space is vast, in recent years, in addition to the entry of multinational pharmaceutical companies, it has also attracted many local pharmaceutical companies, including Hengrui Pharmaceutical, Zejing Biological, Huadong Pharmaceutical, etc
.
The Insight database shows that there are 50 new DRUGS of JAK inhibitors in China
.
From the perspective of domestic research and development progress, the local pharmaceutical company with faster research and development progress is Hengrui, whose self-developed JAK1 inhibitor SHR0302 is being carried out in phase III clinical trials
for the treatment of atopic dermatitis, ulcerative colitis and alopecia areata.
Hengrui is also developing several indications for the drug, including psoriatic arthritis, ankylosing spondylitis, rheumatoid arthritis, ulcerative colitis, moderate to severe atopic dermatitis, active radiation-negative axial spondyloarthritis and alopecia areata, and indications for atopic dermatitis have been included in breakthrough treatment
.
In addition, the drug is simultaneously carrying out clinical trials for ulcerative colitis in the United States and Europe; Clinical trials
for moderate to severe atopic dermatitis in Canada.
In addition to SHR0302, Zejing Bio's AK inhibitor Jacktinib also has indications that have entered Phase III clinical trials
.
Jack tinib is one of the core new drugs under research in Zejing Bio, which has obtained clinical trial licenses from the State Food and Drug Administration and the US FDA, and has been granted orphan drug qualification
by the FDA.
The drug inhibits JAK1, JAK2, JAK3 and TYK2, as well as FLT-3 and c-Kit
.
At present, Zejing Pharmaceutical is developing Jack tinib for multiple indications
such as bone marrow fibrosis.
Zejing Bio accepted a survey of 153 institutions on August 23, in the interactive part of the survey, the company mentioned that Jacktinib and other products have achieved a number of results, including: first-line treatment, high-risk myelofibrosis Phase III clinical trial period analysis reached the main endpoint of the trial, after the cde completed the new drug listing application before communication, the company will submit NDA application; The multiple sensitivity analysis results of the phase IIB clinical trial for the safety and efficacy of patients with myelofibrosis intolerant rucortinib for the main efficacy endpoints were consistent with the trend of the main analysis results, reaching the preset statistical standards, and the results were stable
.
After communicating with CDE before completing the new drug listing application, the company will submit an NDA application; The treatment of moderate and severe atopic dermatitis has entered the phase III clinical trial stage
.
In general, at present, the pharmaceutical companies that currently lay out JAK inhibitors in China are mainly multinational pharmaceutical companies, the number of local pharmaceutical companies is still relatively small, and the progress is relatively slow, and no domestic JAK inhibitors have been approved
.
In the future, with the acceleration of the progress of clinical trials of domestic products, and more pharmaceutical companies entering the market, it is expected to grab the market space
.
Disclaimer: In no event shall the information or opinions expressed herein constitute investment advice
to any person.