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Luye Pharma’s LY03005 Approved by China’s CDE to Conduct Phase III Clinical Trial for the Treatment of Generalized Anxiety Disorder

2022 / 03 / 22 Publisher:Luye Life Sciences Group

Shanghai, China, March 21, 2022 – Luye Pharma Group announced today that its investigational drug, LY03005, has received approval from the Center for Drug Evaluation (CDE) at China's National Medical Products Administration (NMPA) to conduct a Phase III clinical trial for the treatment of generalized anxiety disorder (GAD). LY03005 is a China “Class 1 Chemical Drug”, defined by the NMPA as an innovative drug that contains new compounds with clear structures and pharmacological effects with clinical value.

LY03005 is a New Chemical Entity with a novel acting mechanism. It is a Serotonin-Norepinephrine-Dopamine Reuptake Inhibitor (SNDRI/TRI). The upcoming Phase III clinical trial will evaluate the efficacy and safety of LY03005 in patients with GAD. The investigational drug has previously completed Phase I to Phase III clinical trials for the treatment of Major Depressive Disorder (MDD), with a marketing authorization application for the new product accepted by the CDE in June 2021.

Anxiety disorders are one of the most common mental disorders1, frequently occurring as a comorbidity of depression2. Data from the U.S. National Comorbidity Survey shows that around 58% of MDD patients also had anxiety disorders3, and around 67% of GAD patients suffered unipolar depression in their lifetime4. A large number of clinical studies have reported the efficacy of antidepressants in treating anxiety symptoms2. First-line antidepressants-Selective Serotonin Reuptake Inhibitors (SSRIs) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs)-are also first-line treatments for GAD5. However, common adverse reactions of SSRIs and SNRIs, such as sexual dysfunction and somnolence, often lead to the discontinuation of treatment with those kinds of drugs, resulting in poor patient compliance and undesirable treatment outcomes.

Data from a completed Phase III clinical trial of LY03005 for the treatment of MDD showed that the drug has good efficacy, safety and tolerability, with no significant adverse effects on sexual function, weight, or somnolence observed. In addition, LY03005-treated subjects showed significant improvement in the Hamilton Anxiety Scale (HAM-A) total score, the HAM-A Psychic Anxiety Factor score and Somatic Anxiety Factor score, and the 17-item Hamilton Depression Rating Scale (HAM-D17) Anxiety/Somatization Factor score, which indicates that the drug has potential to reduce anxiety.

“Based on the therapeutic potential observed in previous studies, we’d like to further verify the efficacy and safety of LY03005 in treating GAD with this Phase III clinical trial,” said Dr. Tian Jingwei, Vice President of Non-Clinical Research, head of New Drug Discovery at Luye Pharma Group, and also head of the LY03005 project team. “We are committed to addressing the unmet needs of patients with central nervous system diseases, including anxiety disorders and MDD, with the hope of facilitating their return to normal life.”

Anxiety disorders are chronic diseases with a long duration and high recurrence rates, which have a great impact on the quality of life of patients5. According to the results of an epidemiological survey of mental disorders in China released in 2019, anxiety disorders were the most common mental disorders in China, with an annual prevalence of approximately 5.0%, and a lifetime prevalence of approximately 7.6%6. GAD is a common anxiety disorder with a lifetime prevalence of approximately 0.3%.  




[1] Ma N. Si T.M. Guideline on Primary Care for Patients with Generalized Anxiety Disorder (2021). Chinese Journal of General Practitioners, Vol. 20, No. 12, Dec. 2021. 2021: 1232-1241
[2] Li L.J. Ma X, et al. Guideline for Depression Prevention and Treatment in China (2nd Edition). Beijing. Chinese Medical Multimedia Press. 2015. 42-81
[3] R. C. KESSLER, et al. Comorbidity of DSM-III-R Major Depressive Disorder in the General Population: Results from the US National Comorbidity Survey[J]. British Journal of Psychiatry 1996; 168: 17-30. DOI:
[4] Judd LL, Kessler RC, et al. Comorbidity as a fundamental feature of generalized anxiety disorder: results from the National Comorbidity Study[J]. Acta Psychiatr Scaiid 1998; 393:6-11. DOI: 10.1111/J.1600-0447.1998.TB05960.X.
[5] National Health Commission of China. Guideline for Diagnosis and Treatment of Mental Disorders (Version 2020). 2020. 164-179
[6] Huang Y, Wang Y, Wang H, et al. Prevalence of mental disorders in China: a cross‑sectional epidemiological study[J]. Lancet Psychiatry, 2019, 6(3): 211‑224. DOI: 10.1016/S2215‑0366(18)30511‑X.

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