China's first domestically produced antidepressant approved for market sale

China's first domestically produced antidepressant recently received approval for market sale, making a major innovative breakthrough for domestic drugs in treating depression. 

The new medicine named Ruoxinlin, also known as Toludesvenlafaxine hydrochloride extended-release tablet with China's independent research and development (R&D) and intellectual property rights was developed and produced based on the industry-university-institute cooperation between Yantai University in Yantai city, East China's Shandong Province and Luye Pharma Group, an international pharmaceutical company with a focus on targeting central nervous system (CNS), according to media reports. 

The sales approval for the medicine indicates that China has made a step forward in the field of CNS innovative drug development which has traditionally suffered from high failure rates. 

According to Tian Jingwei, professor from the School of Pharmacy in Yantai University who led the R&D project of the medicine, it took over 500 professionals 12 years to develop, conduct application researches and clinical testing on the medicine before it got approved by China's National Medical Products Administration on November 3, 2022. 

Depression has the characteristics of high incidence, high disability rate and high recurrence rate. Statistics from the World Health Organization show that about 3.8 percent of the global population suffer from depression, and the incidence of depression in China is 3.4 percent. More than 50 million Chinese patients need standardized medication whereas the consultation rate is only 20 percent. 

Besides, the recurrence rate of depression is as high as 50 to 85 percent and 50 percent patients will suffer a relapse within two years of the onset of the disease.

According to clinical studies, though the existing antidepressants are generally effective, their cure rate is low. After treatment, the patients still have anxiety, cognitive impairment, fatigue, anhedonia and other residual symptoms, which seriously damages the patients' social function, and significantly accelerates relapse, and easy to cause sexual dysfunction, weight gain, emotional retardation, lethargy and other adverse reactions.

However, for a long time, almost all the antidepressants in the domestic market were developed by multinational pharmaceutical companies, with local pharmaceutical companies mainly limited to generic medicines.

Zhang Hongyan, a professor at the Peking University Sixth Hospital who led the clinic testing of Ruoxinlin said clinical tests results showed that the medicine is able to meet patients' needs for relieving symptoms including anxiety, fatigue and cognitive disorders, marking a step forward in China's R&D of antidepressants as well as an important milestone in the development history of psychotropic drugs in China.