China Traditional Chinese Medicine Holdings Co. Limited (abbreviated as “TRAD CHI MED”) announced that its subsidiary, Sinopharm Group Tongjitang (Guizhou) Pharmaceutical Co., Ltd., has received National Medical Products Administration (NMPA) approval to commercialise Xingpi Jieyu Tablets, a Class 1.1 innovative traditional Chinese medicine.

The drug—standardised under the name “Xingpi Jieyu Tablets” and previously referred to as “Yushuda Tablets”—is indicated for patients with mild-to-moderate depression characterised by damp-turbidity distressing the spleen with qi stagnation syndrome. Following completion of technical review, on-site inspection and quality testing, the NMPA granted full marketing authorisation, making Tongjitang Pharmaceutical the marketing authorisation holder.

Phase III clinical data finalised in 2024 demonstrated that Xingpi Jieyu delivered superior efficacy versus placebo while maintaining a favourable safety profile. The tablet’s therapeutic mechanism centres on invigorating the spleen, resolving dampness and regulating qi to alleviate emotional stagnation.

TRAD CHI MED expects the new approval to broaden its Chinese patent medicine portfolio and contribute positively to future operating results. Management notes, however, that ultimate sales performance will depend on factors such as medical-insurance inclusion, tender procurement outcomes, competitive dynamics and academic-promotion progress.

Shareholders and potential investors are advised to exercise caution when dealing in the company’s shares, given the inherent uncertainties surrounding product launch uptake.