China-based CSPC Pharmaceutical Group Ltd (HKG: 1093) has announced receiving marketing approval in China for its Category 3 product, desvenlafaxine, signifying that it has passed the generic quality and consistency evaluation (GQCE).
Desvenlafaxine: A Third-Generation Anti-Depressant
Desvenlafaxine is a third-generation anti-depressant that functions by inhibiting the reuptake mechanism of 5-hydroxytryptamine norepinephrine, thereby increasing the concentration of 5-hydroxytryptamine and norepinephrine. This dual mechanism contributes to its effectiveness in treating adult depression. The drug is widely used for this purpose and is considered an important advancement in the treatment of mood disorders.
History and Market Context of Desvenlafaxine
Desvenlafaxine originated with Wyeth and is a nor-active product of venlafaxine, which was approved by the FDA for the treatment of severe depression in 2008. While the originator product has not yet been approved for import into China, Pfizer’s originator venlafaxine received marketing approval in the country in 2000, followed by the introduction of multiple generic versions. In November 2022, Luye Pharma’s toludesvenlafaxine became the first home-grown anti-depressant in China, marking a significant milestone in the domestic pharmaceutical industry.-Fineline Info & Tech
