MY004567 tablets was approved by the FDA US. for clinical trials implied

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Recently, Createrna Development Co., Ltd. declared a Class 1 chemical drug MY004567 tablets by the State Medical Products Administration clinical implied approval (acceptance number: CXHL2200176, CXHL2200177), will carry out clinical research。


图1 MY004567片获临床试验默示许可

MY004567 tablets is an IRAK (interleukin receptor-associated kinase) inhibitor for rheumatoid arthritis, and is also the first IRAK4 inhibitor to be declared in China. Interleukin-1 receptor-associated kinase 4 (IRAK-4) is involved in innate immune regulation and is primarily responsible for transduction of signals from TLRS and members of the IL-1β receptor family. IRAK4 plays a key role in many important signaling pathways such as NF-κB and MAPK, so it has a broad clinical application prospect.

According to incomplete statistics, more than 30 IRAK4 drugs are currently under research worldwide, most of which are in the early clinical stage. Among them, 19 were preclinical, 7 were phase I clinical, 1 was phase I/II clinical and 3 were phase II clinical.

In terms of indications, the most commonly developed IRAK4 is autoimmune diseases, followed by cancer, including hidradenitis suppurative, atopic dermatitis, chronic kidney disease, rosacea, pelvic inflammatory disease, COVID-19 infection, sepsis and other fields.

Research companies, including Pfizer, Rigel, Nimbus, Kymera, Bayer, Sanofi, Bristol-Myers Squibb, Aurigene, TG Therapeutics, Ligand Pharmaceuticals, etc., are all in the field.

Preclinical studies showed that MY004567 tablets had better pharmacokinetic behavior and better efficacy compared with the same target drugs in clinical research. The study found that MY004567 has good therapeutic potential for autoimmune diseases and tumor diseases.