SINO BIOPHARM (01177): TQH3906 "TYK2/JAK1 JH2 variant inhibitor" has made positive progress in phase II clinical trials of plaque psoriasis.

Sino Biopharm (01177) announced that the company's independently developed national class 1 innovative drug TQH3906, a "TYK2/JAK1 JH2 pseudokinase inhibitor," has recently completed phase 2 clinical trials for moderate to severe plaque psoriasis (PsO). The study results showed that all dosage groups of TQH3906 exhibited good safety and tolerability, and met the primary endpoints of the phase 2 study. This study was a randomized, double-blind, placebo-controlled, multicenter phase 2 study (NCT06542614), aimed at evaluating the efficacy and safety of TQH3906 in subjects with moderate to severe plaque psoriasis. The study ultimately enrolled 209 patients, including a placebo group and 5 different dosage groups of TQH3906, administered orally once daily. In terms of efficacy, TQH3906 showed a good dose-response relationship and explored a therapeutic plateau period at the primary endpoints. With the recommended phase 2 doses (RP2D), after 12 weeks of treatment, the PASI 75 response rate (improvement in psoriatic skin lesions area and severity index 75%) exceeded 90%, and the PASI 90 response rate (improvement 90%) exceeded 70%, significantly better than the PASI 75 and PASI 90 response rates in the placebo group (approximately 10% and 5% respectively). The efficacy level is comparable to IL-17/IL-23 targeted biological agents and shows superior efficacy compared to other oral psoriasis treatments on the market (such as apremilast and tofacitinib). Detailed data from this study will be disclosed at upcoming international academic conferences. In terms of safety, TQH3906 demonstrated overall good safety with an adverse event incidence rate similar to the placebo group, and the majority of adverse events occurring during treatment were mild to moderate in severity. Its safety profile is similar to that of similar TYK2 inhibitors, with no new safety signals identified. Compared to antibody-based biological agents, oral small molecule targeted therapies offer the advantages of convenience of administration, high tolerability, and good patient compliance. Currently, the only oral small molecule drugs approved for plaque psoriasis in China are PDE-4 inhibitors (apremilast, mometasone) and tofacitinib (TYK2 JH2 pseudokinase inhibitor). However, existing research data shows that these drugs have a PASI 75 response rate of only about 60% at 16 weeks of treatment, and a PASI 90 response rate of only about 40%, with a significant gap in efficacy compared to biological agents. There is a clinical need for oral small molecule drugs with superior efficacy and controllable safety. Furthermore, TQH3906, by targeting the pseudokinase domain (JH2) of TYK2/JAK1, significantly enhances its selectivity for JAK2, JAK3, and other kinases. Compared to traditional JAK inhibitors that target the kinase domain (JH1), TQH3906 has higher selectivity and potentially superior safety. In addition to plaque psoriasis, the company will continue to explore the potential of TQH3906 in multiple new indications in the fields of autoimmunity, inflammation, and skin, such as inflammatory bowel disease and psoriatic arthritis.