socrodeucitinib (HS-10374) / Jiangsu Hansoh Pharma - LARVOL DELTA

Hansoh Pharmaceutical…announced that HS-10374, a selective allosteric inhibitor of tyrosine kinase 2 (TYK2) self-developed by Hansoh Pharma, met the co-primary endpoints in the pivotal Phase 3 clinical trial for adult patients with moderate-to-severe plaque psoriasis (Hansoh Pharma Press Release) - "At week 16 of treatment, the proportion of participants in the HS-10374 group achieving at least a 75% reduction (PASI 75) from baseline in the Psoriasis Area and Severity Index (PASI) and the proportion achieving a static Physician's Global Assessment (sPGA) score of 0 or 1 with at least a 2-point improvement from baseline (sPGA 0/1) were both significantly higher than those in the placebo group. The trial also met multiple secondary endpoints. More than half of HS-10374-treated participants achieved PASI 90, and almost one-third achieved PASI 100 at week 16....Hansoh Pharma will initiate communications with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to advance preparations for New Drug Application in China. The results are scheduled to be presented at an upcoming congress in the dermatology therapeutic area."

Non-US regulatory • P3 data • Dermatology • Plaque Psoriasis

Oral TYK2 Inhibitor Socrodeucitinib Meets Primary Endpoint in Phase 2 Psoriasis Trial (HCPLive) - "Investigators reported statistically significant improvements with both active treatment groups, although responses were markedly greater with the higher dose. By week 12, PASI 75 was achieved by 72.1% of patients receiving socrodeucitinib 12 mg compared with 28.6% of those receiving the 6-mg dose and 7.5% of patients receiving placebo. Both treatment groups significantly outperformed placebo, with the strongest efficacy observed in the 12-mg cohort...Higher levels of skin clearance also favored the 12-mg dose. PASI 90 was achieved by 46.5% of patients receiving socrodeucitinib 12 mg compared with 7.1% in the 6-mg group and no patients receiving placebo....Additional efficacy measures also favored socrodeucitinib. At week 12, 65.1% of patients receiving the 12-mg dose achieved an sPGA score of 0 or 1 (clear or almost clear skin), compared with 33.3% in the 6-mg group and 10% in the placebo group."

P2 data • Immunology • Plaque Psoriasis

A Drug-Drug Interaction Study Between HS-10374 Tablets and Drospirenone and Ethinyl Estradiol Tablets(Yasmin®) (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Hansoh BioMedical R&D Company

New P1 trial • Dermatology • Immunology • Psoriasis

Hengbang Pharmaceuticals' HS-10374 tablets have started Phase I clinical trials for psoriasis. [Google translation] (Sina Corp) - "Data from the Drug Clinical Trial Registration and Information Disclosure Platform indicates that Changzhou Hengbang Pharmaceutical Co., Ltd. has initiated a Phase I clinical trial investigating the effect of fluvoxamine maleate tablets on the pharmacokinetics of HS-10374 tablets. The clinical trial registration number is CTR20253110, and the first public disclosure date is August 7, 2025....The primary endpoints of this trial include the main PK parameters of HS-10374 after HS-10374 tablets are used alone or in combination with fluvoxamine maleate tablets: Cmax, AUC0-t, and AUC0-∞; secondary endpoints include other PK parameters of HS-10374, such as Tmax, t1/2z, as well as clinical symptoms, vital signs, laboratory test indicators, 12-lead electrocardiogram, physical examination, etc."

Trial status • Psoriasis

A Study to Evaluate Efficacy and Safety of HS-10374 for Mild-to-moderate Plaque Psoriasis (clinicaltrials.gov) - P2 | N=305 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P2 trial • Dermatology • Immunology • Psoriasis

A multicenter, randomized, double-blind, placebo-controlled Phase III study evaluating the efficacy and safety of HS-10374 tablets in adults with moderate-to-severe plaque psoriasis (ChiCTR) - P3 | N=375 | Sponsor: Huashan Hospital, Fudan University; Huashan Hospital, Fudan University

New P3 trial • Dermatology • Immunology • Psoriasis

A Study to Confirm Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P3 | N=375 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P3 trial • Dermatology • Immunology • Psoriasis

EADV 2024 | Hansoh Pharma Released the Phase II Clinical Study Data of HS-10374，in Patients with Moderate-to-Severe Plaque Psoriasis (Hansoh Pharma Press Release) - P2 | N=120 | NCT06077331 | Sponsor: Hansoh BioMedical R&D Company | "The 33rd Annual Congress of the European Academy of Dermatology and Venereology (EADV 2024) was held in Amsterdam from September 25 to 28, 2024. The Phase II clinical trial data for Hansoh Pharma 's HS-10374 on plaque psoriasis were presented at the congress....Efficacy (data at Week 12): The primary endpoint was met, with a significantly greater proportion of patients in HS-10374 6 mg and 12 mg groups achieving PASI 75 responses compared with PBO (PBO: 7.5%; HS-10374 6 mg: 28.6%, P=0.013; HS-10374 12 mg: 72.1%, P<0.001). Significantly greater proportion of patients in HS-10374 6 mg and 12 mg groups achieved sPGA 0/1 responses compared with PBO as well (PBO: 10.0%; HS-10374 6 mg: 33.3%, P<0.05; HS-10374 12 mg: 65.1%, P<0.001)."

P2 data • Psoriasis

Efficacy and safety of HS-10374 in patients with moderate-to-severe plaque psoriasis: Results from a randomized, double-blind, placebo-controlled phase 2 trial (EADV 2024) - P2 | "HS-10374 showed significant clinical efficacy versus PBO in PASI 75 response rate and sPGA 0/1 response rate at oral doses ≥ 6 mg in patients with moderate-to-severe plaque psoriasis. The overall safety profile was similar to other TYK2 inhibitors with less risk of skin toxicity. Trials of longer treatment duration with a larger population are required to further confirm the efficacy and safety of HS-10374 in such patients."

Clinical • Late-breaking abstract • P2 data • Dermatology • Gastrointestinal Disorder • Immunology • Infectious Disease • Psoriasis • IL23A • TYK2

Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Hansoh BioMedical R&D Company | Not yet recruiting ➔ Recruiting

Enrollment open • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

Efficacy and Safety of HS-10374 Compared to Placebo in Adults With Active Psoriatic Arthritis (clinicaltrials.gov) - P2 | N=160 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P2 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Hansoh BioMedical R&D Company | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

A Study to Evaluate Efficacy and Safety of HS-10374 for Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P2 trial • Dermatology • Immunology • Psoriasis • CRP

A First in Human Study to Evaluate Safety, Tolerability, Pharmacology of HS-10374 in Healthy Subjects (clinicaltrials.gov) - P1 | N=84 | Completed | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Dermatology • Immunology • Psoriasis • CRP • CST3