TRAD CHI MED (00570) has announced that its subsidiary, Guizhou Tongjitang Pharmaceutical Co., Ltd., has received official market authorization from the National Medical Products Administration (NMPA) for its Class 1.1 innovative traditional Chinese medicine.
The product, now formally named Xingpi Jieyu Tablets (previously disclosed under the tentative name "Yushuda Tablets" in an earlier filing), has successfully cleared the NMPA's comprehensive review process. This included technical evaluation, on-site inspection, and sampling testing. The marketing authorization holder is Tongjitang Pharmaceutical.
According to the company's statement, this newly approved drug is designed to address symptoms associated with mild-to-moderate depression. The medication's claimed therapeutic functions focus on invigorating the spleen to resolve dampness and regulating qi to alleviate mental stagnation.
The approved indications cover a specific range of clinical presentations, including persistent low mood, emotional distress, blunted affect, fatigue, insomnia and excessive dreaming, diminished speech with shortness of breath, poor appetite, a heavy sensation in the head and limbs, a sticky mouth feeling, a dull complexion, a pale tongue with a greasy white or gray coating, and a slippery or taut pulse.
The approval marks a significant step for the company in expanding its pipeline within the innovative traditional Chinese medicine sector, as the drug targets a common yet complex mental health condition using a novel therapeutic approach grounded in classical medical theories.