China Biopharmaceutical (01177): TQH3906 “TYK2/JAK1 JH2 allosteric inhibitor” patch psoriasis phase II clinical trial has made positive progress

Zhitong Finance App News, China Biopharmaceutical (01177) announced that the national Class 1 innovative drug TQH3906 “TYK2/JAK1 JH2 allosteric inhibitor” independently developed by the Group has recently completed phase II clinical trials for moderate to severe plaque psoriasis (PSO). The study results showed that all dosage groups of TQH3906 showed good safety and tolerability, and reached the main end point of the Phase II study.

This study is a randomized, double-blind, placebo-controlled, multicenter phase 2 study (NCT06542614) to evaluate the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis. The study finally enrolled 209 patients, including a placebo group and 5 different TQH3906 dosage groups, and administered orally once a day.

In terms of efficacy, TQH3906 showed a good dose-effect relationship and explored the platform period for efficacy at key endpoints. Under the expected recommended phase 2 dose (RP2D), after 12 weeks of treatment, the response rate of PASI 75 (psoriatic skin damage area and severity index improved ≥ 75% compared to baseline) was over 90%, and the PASI 90 (improvement ≥ 90%) response rate exceeded 70%, which was significantly superior to the response rate of PASI 75 and PASI 90 in the placebo group (about 10% and 5%, respectively). Its efficacy level is comparable to that of IL-17/IL-23 targeted biologics. Compared with other marketed oral psoriasis treatment drugs (such as deuterium clexitinib, apmister), it shows better efficacy. Detailed data from this study will be presented at subsequent international academic conferences.

In terms of safety, the overall safety of TQH3906 was good. The overall incidence of adverse events was comparable to that of the placebo group, and the severity of the majority of adverse events (TEAE) during treatment was grade 1-2. Its safety characteristics are similar to those of similar TYK2 inhibitors, and no new safety signals have emerged.

Compared with antibody-like biologics, oral small-molecule targeted drugs have advantages such as easy administration, high tolerability, and good patient compliance. Currently, the only oral small-molecule drugs approved for plaque psoriasis are PDE-4 inhibitors (apmister, momistate) and deuterocloxitinib (TYK2 JH2 variant inhibitors). However, current research data shows that the response rate of these drugs to PASI 75 is only about 60% and the PASI 90 response rate is only about 40% during 16 weeks of treatment. There is still a big gap between their efficacy and biological agents. Clinically, there is an urgent need for oral small molecule drugs with better curative efficacy and controllable safety.

Furthermore, TQH3906 significantly enhances its selectivity for JAK2, JAK3, and other kinases by targeting the TYK2/JAK1 pseudokinase domain (JH2). Compared with traditional JAK inhibitors acting on the kinase domain (JH1), TQH3906 has higher selectivity and potentially better safety. In addition to plaque psoriasis, the Group will also continue to explore new indications of TQH3906 in the field of self-prevention and skin, such as inflammatory bowel disease, psoriatic arthritis, etc.