ECNP 2026 | HANSOH PHARMA ANNOUNCES PHASE 2B DATA OF OBUPRAZINE(HS-10380) IN SCHIZOPHRENIA
- Obuprazine(HS-10380) has shown promising efficacy in acute schizophrenia with marked improvements in PANSS total, positive and negative symptoms as well as cognitive factors , along with favorable overall safety and tolerability.
SHANGHAI, October 12，2026— Hansoh Pharmaceutical Group Co., Ltd. (“Hansoh Pharma,” 03692.HK) today announced that the encouraging results from the phase 2b of HS-10380, in patients with schizophrenia ,were presented at the poster sessions at the 2026 European College of Neuropsychopharmacology (ECNP 2026), held on October 10 in Munich, Germany.
HS-10380 is an orally administered multi-target agent acting on dopamine and 5-HT (5-hydroxytryptamine, also known as serotonin) pathways and designed to address the positive, negative and cognitive symptoms of schizophrenia. At ECNP 2026, the data were generated from a randomized controlled phase 2b study evaluating the efficacy and safety of HS-10380 in adult patients with acute schizophrenia in China.
Details of the poster presentation are as follows:
● Poster Title: Efficacy and Safety of Obuprazine (HS-10380) in Patients with Schizophrenia: A Phase 2b Randomized Placebo- and Active-Controlled Trial
● Session: Poster Session 1
● Poster No.: PS01-1227
● Date/Time: 10 October 2026, 12:00 - 13:25 [CEST]
● Presenter: Huafang Li, Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine, Shanghai, China
The study results showed:
A total of 363 participants were randomized to HS-10380 1.5–3 mg (n=81), HS-10380 4.5–6 mg (n=80), HS-10380 6–9 mg (n=81), aripiprazole (n=40), or placebo (n=81). Demographics and baseline characteristics were well balanced across groups.
● Promising Efficacy: Least squares mean differences (95% CI) of change from baseline in PANSS total score versus placebo at Day 42 were -16.7 (-22.5, -10.9) for HS-10380 1.5–3 mg, -13.2 (-18.9, -7.4) for HS-10380 4.5–6 mg, -14.7 (-20.5, -8.8) for HS-10380 6–9 mg, and -12.1 (-19.1, -5.1) for aripiprazole. HS-10380 also demonstrated greater improvements versus placebo and favorable efficacy trends compared to aripiprazole across positive, negative and cognitive symptom (PANSS Marder Cognitive Factors) domains.
● Favorable Safety Profile: The safety profile for HS-10380 was generally favorable, with no new significant safety concerns identified. Most TEAEs were mild to moderate in severity.
The successful Ph2b results support moving this program forward into Ph3, and detailed results will be submitted for publication in a peer-reviewed journal.
About HS-10380
HS-10380 is a partial agonist of D₂/D₃ and 5-HT1A receptors with potent antagonism at 5-HT₂A receptors, which may improve positive and negative symptoms, as well as cognitive symptoms of schizophrenia and reduce adverse effects.
About schizophrenia
Schizophrenia is a severe, chronic psychiatric disorder that ranks as the third leading cause of global disability.[1,2 ]The disorder typically emerges in late adolescence or early adulthood and is characterized by positive symptoms (hallucinations, delusions, and thought disorder), negative symptoms (apathy, social withdrawal, and diminished emotional expression), and cognitive impairments that affect multiple aspects of functioning.[3,4 ]
References
1. Zhan Z, Wang J, Shen T. Results of the Global Burden of Disease study for schizophrenia: trends from 1990 to 2021 and projections to 2050. Front Psychiatry. 2025;16:1629032. doi:10.3389/fpsyt.2025.1629032
2. Charlson FJ, Ferrari AJ, Santomauro DF, et al. Global Epidemiology and Burden of Schizophrenia: Findings From the Global Burden of Disease Study 2016. Schizophr Bull. Oct 17 2018;44(6):1195–1203. doi:10.1093/schbul/sby058
3. Owen MJ, Sawa A, Mortensen PB. Schizophrenia. Lancet. Jul 2 2016;388(10039):86–97. doi:10.1016/s0140-6736(15)01121-6
4. Lim DXE, Yeo SY, Chia ZYA, Fernandis AZ, Lee J, Chua JJE. Schizophrenia: Genetics, neurological mechanisms, and therapeutic approaches. Neural Regen Res. Mar 1 2026;21(3):1089–1103. doi:10.4103/nrr.Nrr-d-24-01375
Hansoh Pharma is a leading innovation-driven pharmaceutical enterprise in China. With the mission of "continuous innovation for better life", the company focuses on major disease therapeutic areas such as oncology, metabolism, immunology, central nervous system (CNS) and anti-infectives. Hansoh Pharma has launched 7 innovative medicines that generate product sales in China, with the revenue from innovative medicines and collaborative products exceeding 80%, forming a rich product pipeline. The company has consistently ranked among the top 100 global pharmaceutical companies and is recognized as one of the top 3 pharmaceutical R&D enterprises in China, and is designated as a National Key High-Tech Enterprise and a National Technology Innovation Demonstration Enterprise. Hansoh Pharma was listed on the Hong Kong Stock Exchange in June 2019 (stock code: 03692.HK).
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