Shanghai, January 8, 2026 — Luye Pharma Group today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Ruoxinlin® (Toludesvenlafaxine Hydrochloride Sustained-Release Tablets) for the new indication of Generalized Anxiety Disorder (GAD). Ruoxinlin is a Class 1 innovative drug in China.
The NDA submission for the new indication marks another milestone for Ruoxinlin after it was approved in November 2022 for the treatment of Major Depressive Disorder (MDD). Upon approval of the new indication, this drug will have the potential to become the first serotonin, norepinephrine, dopamine reuptake inhibitor (SNDRI) for treating GAD in China, bringing a novel therapeutic option to a broader patient population.
Delivering rapid and comprehensive relief of anxiety symptoms with a favorable safety profile
Anxiety disorders are the most common mental disorders in China, 1affecting approximately 58.67 million people nationwide in 2023.2 GAD is a common subtype, with a lifetime prevalence of 4.1%–6.6% in adults. However, the disease remains underdiagnosed and undertreated, and its high comorbidity with other conditions imposes a substantial economic and social burden on patients, their family members, and society in general. 3
In clinical practice, selective serotonin reuptake inhibitors (SSRIs) and serotonin, norepinephrine reuptake inhibitors (SNRIs) are widely used for treating anxiety spectrum disorders and are considered the first-line standard of care for GAD.3 However, the efficacy of these treatments remains limited. A meta-analysis shows that SSRIs/SNRIs yield an overall response rate of 67.7% and a remission rate of 39.7%. 4Furthermore, these medications are often associated with adverse effects such as lipid metabolism disturbances, weight gain, somnolence and sexual dysfunction. These side effects can negatively impact patient adherence and overall clinical benefit, frequently leading to treatment discontinuation.
The NDA submission for the new indication of Ruoxinlin is supported by results from an 8-week, multicenter, randomized, double-blind, placebo-controlled Phase Ⅲ study involving 555 patients. The study evaluated the efficacy and safety of the drug for GAD patients, with the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score as the primary endpoint. The results of this study demonstrated that Ruoxinlin delivered rapid and comprehensive relief of anxiety symptoms, achieving a response rate of over 80% and a remission rate of approximately 50%. The drug exhibited a favorable safety and tolerability profile, showing no significant impact on body weight or glucose and lipid metabolism, with a low incidence of adverse events such as somnolence, insomnia, fatigue, and sexual dysfunction. Most adverse events were mild to moderate, with the majority of them being resolved or improved over time.
Addressing unmet needs with more accessible innovative drugs
Despite the substantial disease burden, the availability of innovative therapies for anxiety disorders in China remains very limited. Data from IQVIA shows that the market size for SSRIs and SNRIs was RMB 4.83 billion in 2024, and no Class 1 innovative drug for the treatment of anxiety disorders has been approved in China over the past 20 years.
As China’s first locally developed proprietary Class 1 chemical antidepressant approved for marketing, Ruoxinlin has served nearly 190,000 patients since it was approved over three years ago. Its efficacy and safety profile has been widely recognized, making it one of China’s fastest-growing antidepressants in recent years. At the end of 2024, Ruoxinlin was put on China’s National Reimbursement Drug List (NRDL) for the first time. In September 2025, it received a Class 1A recommendation as a first-line treatment for depression in the Chinese Guidelines for the Diagnosis and Treatment of Depressive Disorders under the new mechanism category of SNDRI. As the review of this new indication progresses, the accessibility of Ruoxinlin is expected to be further increased.
The Central Nervous System (CNS) therapeutic area, which includes depression and anxiety, is a strategic focus for Luye Pharma. The company has built a differentiated product portfolio covering multiple conditions such as schizophrenia, bipolar disorder, and Alzheimer’s disease. In addition to Ruoxinlin, this portfolio also includes Erzofri® (paliperidone palmitate) extended-release injectable suspension and Rykindo® (risperidone) for extended-release injectable suspension, both approved for marketing in the U.S., as well as Rivastigmine Twice Weekly Transdermal Patch, which has been approved for marketing in Japan, China, and several European countries. Luye Pharma is also developing next-generation innovative drugs and conducting clinical trials for several Class 1 new drugs including LY03015, which targets VMAT2/Sigma-1R; LY03017, which targets 5-HT2AR/5-HT2CR; LY03020, which targets TAAR1/5-HT2CR; and LY03021, which targets NET/DAT/GABAAR.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to developing, manufacturing, and selling innovative medications. With R&D centers in China, the U.S., and Europe, the company is an international leader in novel drug delivery systems such as microspheres, liposomes, and transdermal patches. It also has multiple innovative products under development in two categories: new chemical entities and antibodies. From 2021 to 2025, the company had 15 new drugs approved for marketing with each in one or several markets such as the U.S., Japan, China, and several European countries.
Luye Pharma has 8 manufacturing facilities worldwide, which follow internationally accepted, GMP-compliant quality management and control systems. To date, the company has launched over 30 products in the central nervous system, oncology, cardiovascular, and other therapeutic areas. It conducts business in over 80 countries and regions, including major pharmaceutical markets such as China, the U.S., Europe, and Japan, as well as fast-growing emerging markets.
references:
Shanghai, January 8, 2026 — Luye Pharma Group today announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for Ruoxinlin® (Toludesvenlafaxine Hydrochloride Sustained-Release Tablets) for the new indication of Generalized Anxiety Disorder (GAD). Ruoxinlin is a Class 1 innovative drug in China.
The NDA submission for the new indication marks another milestone for Ruoxinlin after it was approved in November 2022 for the treatment of Major Depressive Disorder (MDD). Upon approval of the new indication, this drug will have the potential to become the first serotonin, norepinephrine, dopamine reuptake inhibitor (SNDRI) for treating GAD in China, bringing a novel therapeutic option to a broader patient population.
Delivering rapid and comprehensive relief of anxiety symptoms with a favorable safety profile
Anxiety disorders are the most common mental disorders in China, 1affecting approximately 58.67 million people nationwide in 2023.2 GAD is a common subtype, with a lifetime prevalence of 4.1%–6.6% in adults. However, the disease remains underdiagnosed and undertreated, and its high comorbidity with other conditions imposes a substantial economic and social burden on patients, their family members, and society in general. 3
In clinical practice, selective serotonin reuptake inhibitors (SSRIs) and serotonin, norepinephrine reuptake inhibitors (SNRIs) are widely used for treating anxiety spectrum disorders and are considered the first-line standard of care for GAD.3 However, the efficacy of these treatments remains limited. A meta-analysis shows that SSRIs/SNRIs yield an overall response rate of 67.7% and a remission rate of 39.7%. 4Furthermore, these medications are often associated with adverse effects such as lipid metabolism disturbances, weight gain, somnolence and sexual dysfunction. These side effects can negatively impact patient adherence and overall clinical benefit, frequently leading to treatment discontinuation.
The NDA submission for the new indication of Ruoxinlin is supported by results from an 8-week, multicenter, randomized, double-blind, placebo-controlled Phase Ⅲ study involving 555 patients. The study evaluated the efficacy and safety of the drug for GAD patients, with the change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) total score as the primary endpoint. The results of this study demonstrated that Ruoxinlin delivered rapid and comprehensive relief of anxiety symptoms, achieving a response rate of over 80% and a remission rate of approximately 50%. The drug exhibited a favorable safety and tolerability profile, showing no significant impact on body weight or glucose and lipid metabolism, with a low incidence of adverse events such as somnolence, insomnia, fatigue, and sexual dysfunction. Most adverse events were mild to moderate, with the majority of them being resolved or improved over time.
Addressing unmet needs with more accessible innovative drugs
Despite the substantial disease burden, the availability of innovative therapies for anxiety disorders in China remains very limited. Data from IQVIA shows that the market size for SSRIs and SNRIs was RMB 4.83 billion in 2024, and no Class 1 innovative drug for the treatment of anxiety disorders has been approved in China over the past 20 years.
As China’s first locally developed proprietary Class 1 chemical antidepressant approved for marketing, Ruoxinlin has served nearly 190,000 patients since it was approved over three years ago. Its efficacy and safety profile has been widely recognized, making it one of China’s fastest-growing antidepressants in recent years. At the end of 2024, Ruoxinlin was put on China’s National Reimbursement Drug List (NRDL) for the first time. In September 2025, it received a Class 1A recommendation as a first-line treatment for depression in the Chinese Guidelines for the Diagnosis and Treatment of Depressive Disorders under the new mechanism category of SNDRI. As the review of this new indication progresses, the accessibility of Ruoxinlin is expected to be further increased.
The Central Nervous System (CNS) therapeutic area, which includes depression and anxiety, is a strategic focus for Luye Pharma. The company has built a differentiated product portfolio covering multiple conditions such as schizophrenia, bipolar disorder, and Alzheimer’s disease. In addition to Ruoxinlin, this portfolio also includes Erzofri® (paliperidone palmitate) extended-release injectable suspension and Rykindo® (risperidone) for extended-release injectable suspension, both approved for marketing in the U.S., as well as Rivastigmine Twice Weekly Transdermal Patch, which has been approved for marketing in Japan, China, and several European countries. Luye Pharma is also developing next-generation innovative drugs and conducting clinical trials for several Class 1 new drugs including LY03015, which targets VMAT2/Sigma-1R; LY03017, which targets 5-HT2AR/5-HT2CR; LY03020, which targets TAAR1/5-HT2CR; and LY03021, which targets NET/DAT/GABAAR.
About Luye Pharma Group
Luye Pharma Group is an international pharmaceutical company dedicated to developing, manufacturing, and selling innovative medications. With R&D centers in China, the U.S., and Europe, the company is an international leader in novel drug delivery systems such as microspheres, liposomes, and transdermal patches. It also has multiple innovative products under development in two categories: new chemical entities and antibodies. From 2021 to 2025, the company had 15 new drugs approved for marketing with each in one or several markets such as the U.S., Japan, China, and several European countries.
Luye Pharma has 8 manufacturing facilities worldwide, which follow internationally accepted, GMP-compliant quality management and control systems. To date, the company has launched over 30 products in the central nervous system, oncology, cardiovascular, and other therapeutic areas. It conducts business in over 80 countries and regions, including major pharmaceutical markets such as China, the U.S., Europe, and Japan, as well as fast-growing emerging markets.
references:
