China Net Finance, December 21 (Reporter Liu Xiaofei) Yuekang Pharmaceutical recently announced that the company's new drug application (NDA) for hydroxysafflower yellow A for injection was accepted.
The announcement mentioned that hydroxysafflower yellow pigment A is a monochalcone glycoside isolated and extracted from medicinal safflower, and it is also the most effective water-soluble ingredient in the effect of safflower to invigorate blood and eliminate stasis.
In January 2023, the phase 2023 clinical trial of Yuekang Pharmaceutical's product hydroxysafflower yellow pigment A for injection reached the primary endpoint preset by the protocol. In patients with acute ischemic stroke, the proportion of subjects with a modified Rankin Scale (MRS) score of 1 after 90 days of administration was significantly better than that of the placebo group in the main efficacy index. The rest of the secondary efficacy indicators after 90 days of medication showed significant statistical differences in the proportion of subjects with MRS score of 2, participants with daily living ability scale (BI) score of 95, participants with BI score of 75, the proportion of subjects with a score of 3 or less or more in the National Institutes of Health Stroke Scale (NIHSS) score of 3 or less or more than 4 points, the score of the Stroke Specific Quality of Life Scale (SS-QOL) score, and the efficacy of TCM syndrome compared with the placebo group. The safety profile of this product is good, and no new safety warnings have been reported.