Qilu Pharmaceutical's Capecitabine Tablets Receive First-in-China Generic Drug Consistency Evaluation Approval

On February 10, Qilu Pharmaceutical’s capecitabine tablets (0.5 g and 0.15 g) passed the consistency evaluation, becoming the first in China to do so.

Capecitabine Tablets are an antineoplastic agent indicated for adjuvant chemotherapy in colon cancer, primarily as monotherapy for patients with Dukes' C stage disease following curative resection of the primary tumor who are suitable for treatment with fluoropyrimidine alone. As a prodrug of 5-fluorouracil, capecitabine offers the advantage of selective targeting; it is non-cytotoxic per se and is activated to 5-fluorouracil predominantly within tumor cells. This mechanism maximally reduces 5-fluorouracil-induced damage to normal human cells, while the oral route of administration provides convenience.

As of now, Qilu Pharmaceutical has a total of 24 varieties that have passed the consistency evaluation, with 15 being the first in China. Among them, there are 22 oral preparations and 2 injectables.