Luye Pharma Group announced that the Center for Drug Evaluation of the National Medical Products Administration of China has formally accepted the new indication marketing application for the Group's Class 1 innovative drug Ruoxinlin® ( toludivinlafaxine hydrochloride extended-release tablets), which is intended for the treatment of generalized anxiety disorder (GAD).

This application for a new indication marks another milestone for Ruoxin® since its approval for marketing in November 2022 for the treatment of depression. As the review process for the new indication progresses, this product is expected to become the first serotonin, norepinephrine, and dopamine triple reuptake inhibitor (SNDRI) for the treatment of GAD in China, benefiting more patients.

It rapidly and comprehensively improves anxiety symptoms and has a good safety profile.

Anxiety disorders are the most common mental disorders in China.1 Data from 2023 shows that approximately 58.67 million people in China suffer from this disease.2 GAD is a common subtype of anxiety disorder, with a lifetime prevalence of approximately 4.1%-6.6% in adults. However, its recognition and treatment rates are low, and it has a high comorbidity rate with other diseases, placing a heavy economic burden on patients, their families, and society.3

In clinical practice, selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) are widely used to treat anxiety spectrum disorders (GAD) and are currently first-line treatments .³ However, the efficacy of these two classes of drugs remains limited. Meta-analyses show that the overall response rate of SSRIs/SNRIs is 67.7%, with a remission rate of only 39.7%.⁴ Furthermore, these two classes of drugs are often accompanied by adverse reactions such as lipid metabolism disorders, weight gain, drowsiness, and sexual dysfunction, affecting patient adherence and treatment benefits, and becoming a common cause of treatment discontinuation.

The new indication application for Ruoxin® is based on an 8-week, multicenter, randomized, double-blind, placebo-controlled phase III clinical trial. The study included 555 patients, with the change in Hamilton Anxiety Rating Scale (HAM-A) total score from baseline as the primary endpoint, evaluating the efficacy and safety of Ruoxin® in treating GAD. Results showed that Ruoxin® rapidly and comprehensively improved anxiety symptoms, with an efficacy rate of over 80% and a remission rate of approximately 50%. Overall, it was well-tolerated and had no significant impact on weight or glucose and lipid metabolism. Adverse reactions such as drowsiness, insomnia, fatigue, and sexual dysfunction had a low incidence, with the vast majority of adverse reactions being mild to moderate, and most resulting in improvement or recovery.

Meeting unmet needs and continuously improving accessibility to innovation.

Despite the heavy burden of disease, the supply of innovative drugs for the treatment of anxiety in my country is extremely limited. According to IQVIA data, the market size of SSRIs and SNRIs was RMB 4.83 billion in 2024, and no innovative drugs of this class have been approved for marketing in the past 20 years.

Ruoxinlin® , China's first independently developed Class 1 innovative chemical drug for the treatment of depression with independent intellectual property rights, has served nearly 190,000 patients in the three years since its approval for marketing. Its efficacy and safety have gained widespread recognition, making it one of the fastest-growing new antidepressants in China in recent years. At the end of 2024, Ruoxinlin® was included in the National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug Catalog for the first time. In September 2025, the drug received a Grade 1A recommendation for first-line treatment in the "Chinese Guidelines for the Prevention and Treatment of Depression" under the new SNDRI mechanism category. With the advancement of the review process for the new indication of Ruoxinlin® , its accessibility is expected to be further improved.

Central nervous system (CNS) treatments, including those for depression and anxiety, are one of Luye Pharma's core strategic areas of long-term development. Around this field, the company has developed a portfolio of differentiated products covering a variety of diseases, including schizophrenia, bipolar disorder, and Alzheimer's disease. In addition to Ruoxin® , the portfolio includes: Erzofri® (paliperidone palmitate extended-release suspension injection) and Rykindo® (risperidone extended-release microsphere injection), both approved in the US; and rivastigmine transdermal patches (2 applications/week), approved in multiple European countries, Japan, and China. Meanwhile, the company is actively developing next-generation innovative drugs, with several Class 1 innovative drugs in clinical trials, including VMAT2/Sigma-1R dual-target drug LY03015, 5-HT 2AR /5-HT 2CR dual-target drug LY03017, TAAR1/5-HT 2CR dual-target drug LY03020, and NET/DAT/GABA AR tri-target drug LY03021.

About Luye Pharma Group

Luye Pharma Group is an international pharmaceutical company dedicated to the research, development, manufacturing, and marketing of innovative drugs. Luye Pharma has R&D centers in China, the United States, and Europe, and has achieved internationally advanced levels in advanced drug delivery technologies such as microspheres, liposomes, and transdermal drug delivery. It has also achieved numerous innovative results in the fields of new molecular entities and biological antibodies. From 2021 to 2025, the company has 15 new products approved for marketing in the United States, China, Japan, and multiple European countries.

Luye Pharma has eight major production bases worldwide and has established a GMP quality management and control system that is in line with international standards. The company currently has more than 30 marketed products, covering therapeutic areas such as oncology, central nervous system, and cardiovascular diseases; its business spans more than 80 countries and regions around the world, including major global pharmaceutical markets such as China, the United States, Europe, and Japan, as well as rapidly growing emerging markets.

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