Swiss bioJAK1 inhibitors are intended to be included in breakthrough therapeutic varieties

China's State Drug Administration Drug Review Center (CDE) recently announced that Hengrui Pharmaceutical subsidiary Ruishi Bio's class 1 new drug SHR0302 is to be included in the breakthrough treatment varieties, intended for 12 years and older in adolescents and adults with severe endexual dermatitis treatment.
public information shows that this is ruishi biological research in China's first, with independent intellectual property rights of the highly selective JAK1 inhibitor SHR0302, has previously reached the main and secondary end of the trial in the phase 2 clinical study of specific dermatitis.
the drug candidate not only significantly improved the clinical symptoms of patients, but also improved the effect of itching is very effective.
SHR0302 is a highly selective small molecule JAK1 kinase inhibitor.
studies have shown that JAK1 inhibitors control the condition by regulating a variety of cytokines associated with the pathology of endexual dermatitis.
it is known that the drug in study has a higher selectivity than pan-JAK inhibitors, and the treatment of moderate to severe idiotreatable dermatitis may have better safety and effectiveness.
At present, Ruishi Bio is carrying out a number of clinical studies on SHR0302 oral tablets and external ointments worldwide, involving a variety of immunoinflamed diseases such as specific dermatitis, ulcerative colitis, Crohn's disease and baldness.
includes a randomized, double-blind, endotment control, and phase 2/3 seamless adaptive design clinical study evaluating the efficacy and safety of SHR0302 alkali ointments in subjects with endexual dermatitis.
previously, SHR0302 had obtained positive results in a randomized, double-blind, placebo-controlled, multi-center Phase 2 clinical study called QUORTZ2.
the study included 105 adult subjects with moderate to severe endexual dermatitis, all of whom had previously had poor disease control.
the proportion of subjects who achieved the researcher's overall score (IGA, 0 for complete removal of skin damage and 1 for almost complete removal of skin damage) at the 12th week of the study.
results showed that the SHR0302 tablets of 8 mg or 4 mg of both therapeutic doses significantly improved the patient's clinical symptoms, 12 weeks of treatment, 8mg group 54.3% of the subjects received IGA response, this data in the 4mg group of 25.7%, compared with the control group 5.7%, both treatment doses were statistically significant.
In terms of improving itching in the skin, the improvement rate of itching digital scores NRS (Numerical Assessment Scale) in the 8mg, 4mg and placebo groups was 60.0%, 42.9% and 8.6%, respectively, suggesting that SHR0302 had a faster effect on itching.
addition, SHR0302 performed well in terms of safety and no serious infections, malignant tumors or thrombosis, death or life-threatening cases were reported.
The study's lead researcher, Professor Zhang Jianzhong, director of dermatology at Peking University People's Hospital, has pointed out that there are still many unsealed needs for the treatment of specific dermatitis, whether it is topical hormones or calcium phosphatase inhibitors local therapy, or oral glucocorticoids or immunosuppressant system therapy, there are certain limitations.
QUERTZ2 clinical study data show that SHR0302 can effectively remove skin lesions, improve itching, will greatly improve the quality of life of patients.
Wang Irwin, chief executive of Reshi Bio, said the QUARTZ2 study, designed and conducted based on rigorous international clinical research and development standards, had yielded encouraging results, enough to give it confidence in the upcoming Phase 3 clinical study.
will continue to push forward the SHR0302 in the United States, Australia and other countries are simultaneously conducting a number of international clinical trials involving a variety of immuno-inflammatory diseases, in an effort to reach more patients as soon as possible.
the new highly selective JAK1 inhibitors of Ruishi Bio to be incorporated into the breakthrough treatment varieties, and expressed the hope that the follow-up clinical development of the product will progress smoothly and bring innovative therapies to more patients at an early time.