According to Yiling Pharmaceutical’s notice on Thursday (UTC+8), the Depression-resolving and Restlessness-relieving Capsules have been approved for marketing via the obtained Drug Registration Certificate issued by China’s National Medical Products Administration (NMPA). The Company owns the full intellectual property rights of the drug.
The drug is an innovative traditional Chinese medicine (TCM) independently developed by Yiling Pharmaceutical based on clinical practices, applicable to mild and moderate depression with symptoms of moodiness, dysphoria, loss of appetite, insomnia and dreaminess, dizziness and tinnitus, etc.
A multicenter, randomized, double-blind, double-simulated, placebo-fluoxetine hydrochloride tablet controlled clinical trial has been conducted for the drug. The results showed that: According to the decreased values for main efficacy indicators of the Hamilton Depression Scale (HAMD-17) scores from the baseline, the efficacy of the test group was better than that of the placebo group, and also not inferior to that of the fluoxetine hydrochloride tablet group; with batter performance in the scores for individual TCM syndromes such as mental depression, restlessness, insomnia and dreaminess, dizziness and tinnitus as well as in Hamilton Anxiety Scale (HAMA) scores.
It is reported that 11 new TCMs have been approved in China this year, a new high in recent years, and the two innovative patent TCMs of “Depression-resolving and Restlessness-relieving Capsules” and “Kidney-tonifying and Heart-nourishing Tranquilization Tablets” developed by Yiling Pharmaceutical are in the list. Up to now, Yiling Pharmaceutical boasts 13 patent TCMs, covering cardiovascular and cerebrovascular diseases, respiratory diseases, tumors, diabetes, nervous system diseases, etc., featuring unique product portfolios. In addition, the TCM of Lianhua Qingwen Capsules has become a top brand for tackling colds, and Tongxinluo Capsules, Shensong Yangxin Capsules and Qiliqiangxin Capsules are the leading drugs for treating cardiovascular and cerebrovascular diseases