QX004N / Qyuns Therap, Jiangsu Hansoh Pharma - LARVOL DELTA

ENTERING PHASE III CLINICAL TRIAL OF QX004N AND PAYMENT RECEIVED FROM HANSOH PHARMA (HKEXnews) - "The board of directors (the 'Board') of the Company is pleased to announce that QX004N recently has entered Phase III clinical trial, being the fourth product in the Company’s pipeline to be successfully advanced to Phase III stage. Recently, the Company has received payments of RMB58.0 million from Hansoh Pharma according to the License Agreement, for reaching Phase III milestone of Ps and other payment terms."

Financing • New P3 trial • Psoriasis

Quanxin Biopharma HS-20137 Injection Starts Phase II Clinical Trial for Moderate to Severe Plaque Psoriasis in Adults [Google translation] (Sina Corp) - "Data from the Drug Clinical Trial Registration and Information Disclosure Platform show that an open-label study evaluating the safety and efficacy of HS-20137 injection in adult patients with moderate to severe plaque psoriasis has been launched by Jiangsu Quanxin Co., Ltd. The clinical trial registration number is CTR20252679, and the first public information date is July 17, 2025...The primary endpoints of this trial include the incidence, severity, relevance to the trial drug, duration and outcome of adverse events during the clinical trial; changes in laboratory test results before and after administration, physical examination, and changes in vital signs compared to the baseline period; and the incidence of clinically significant abnormalities in electrocardiogram and other tests after administration....Currently, the experiment is in progress (not yet recruited), with a target enrollment of 315 people."

Trial status • Psoriasis

Hansoh Pharma Announces Late-Breaking Presentation of Phase 2 Study on HS-20137 (Anti-IL-23p19 Antibody) in Moderate to Severe Psoriasis at AAD 2025 Annual Meeting (Hansoh Pharma Press Release) - P2 | N=160 | ChiCTR2300075645 | "A total of 159 subjects were enrolled in this study, and 156 completed the primary endpoint assessment. Eye-catching primary results: At week 16, PASI 75 and PASI 90 were achieved in 92.3% and 76.9% participants of 200mg Q8W group (NRI fill), respectively, and the proportion of participants achieving PASI 100 was up to 40% in the 200mg Q12W group.After week 16, proportion of patients achieved PASI 90 increased to 84.6%,89.7% and 87.2% at week 20,24 and 28 in 200mg Q8W group. Rapid response after first injection: HS-20137 had a rapid response, with PASI scores reduced from the baseline after the first injection, by more than 40% at week 4 and 70% by week 8. The mean PASI score decreased to below 3.3 by week 16 and continued to decline steadily, reaching below 3.0 by week 28."

Late-breaking abstract • P2 data • Psoriasis

Safety and Efficacy of Anti-IL-23 Monoclonal Antibody QX004N for Patients With Psoriasis: A Randomized Clinical Trial. (PubMed, JAMA Dermatol) - "In this randomized clinical trial, QX004N was well tolerated and demonstrated superior efficacy compared to placebo in patients with moderate to severe plaque psoriasis. Chinese Clinical Trial Registry Identifier: CTR20212313 and CTR20223457."

Clinical • Journal • Dermatology • Immunology • Psoriasis • IL23A