Lansheng Pharma Receives CDE Approval for Phase I Clinical Trial of LS21031, a Novel PDE4 Allosteric Modulator for Depression

In March 2023, the Center for Drug Evaluation (CDE) of the National Medical Products Administration approved the clinical trial application for LS21031, a novel antidepressant drug developed by Lansheng Pharmaceutical. The intended clinical indication is depression, making it the first PDE4 allosteric modulator designed to improve depression and cognition-related disorders.

LS21031 is the second entirely novel product from Lancome Pharma to enter clinical development, with nearly a decade of research and validation conducted independently by our team. LS21031 efficiently crosses the blood-brain barrier and allosterically modulates and inhibits the activity of its target, phosphodiesterase 4 (PDE4), thereby improving depressive symptoms and cognitive function. Throughout the entire process—from initial target identification and validation to drug design, optimization, and refinement, culminating in the final candidate selection—the Lancome Pharma team has adhered to the principle of balancing both quality and efficacy. Compared with traditional inhibitors, this highly selective allosteric modulator offers greater target selectivity, significantly enhanced potency, reduced off-target risks, and fewer adverse reactions, making it suitable for long-term use in patients.

Depression is the single most prevalent mental disorder. In recent years, the prevalence of depression in China has been on the rise, with a particularly significant increase among adolescents and young adults. According to the Blue Book on National Mental Health in China (2019–2022), 30 million children and adolescents under the age of 17 in China are affected by various emotional and psychological behavioral problems. Among the surveyed population, the prevalence of depression was 30.28% in adolescents under 18 years of age and 35.32% in those aged 18–24. Despite substantial advances in the research, development, and clinical application of antidepressants over the past half-century, the lack of rapidly acting medications remains a prominent challenge affecting hundreds of millions of people worldwide and constitutes a significant barrier in the field of antidepressant drug development. Through novel targets and mechanisms of action, Lansheng Pharmaceutical has pioneered a new solution and therapeutic avenue for depression and cognition-related disorders. With its rapid onset of action, LS21031 holds promise for overcoming the limitations of delayed efficacy and treatment resistance associated with existing antidepressants, thereby addressing the most urgent needs of patients in clinical practice.

Lansheng Pharma is a biotech company focused on new drug R&D in the CNS sector, having received investment from well-known institutions such as Northern Light Venture Capital and Yipu Capital. Adhering to the R&D philosophy of “innovation as the foundation, products as the root,” Lansheng pursues source innovation. Leveraging its proprietary high-efficiency brain-penetrant drug discovery technology and comprehensive screening and evaluation systems, the company continuously delivers high-quality novel drug candidates.