Qilu Pharmaceutical's Antineoplastic Drug Hydroxyurea Tablets First in China to Pass Consistency Evaluation

On September 28, Qilu Pharmaceutical announced that the supplementary application for the consistency evaluation of the anticancer drug hydroxyurea tablets has been approved by the National Medical Products Administration (NMPA), marking it as the first product in China to pass the evaluation. To date, Qilu Pharmaceutical has a total of 89 products that have passed or are deemed to have passed the consistency evaluation, 38 of which are the first in China.

Hydroxyurea is a ribonucleotide reductase inhibitor that prevents the reduction of ribonucleotides to deoxyribonucleotides, selectively inhibits DNA synthesis, and rapidly controls white blood cell counts within a short period. Hydroxyurea Tablets are clinically primarily used for the treatment of chronic myeloid leukemia (CML), and may also be indicated for CML resistant to busulfan; they also demonstrate certain efficacy against melanoma, renal cancer, and head and neck cancer, and are effective when combined with radiotherapy for squamous cell carcinomas of the head, neck, and cervix.

Hydroxyurea Tablets developed by Qilu Pharmaceutical were launched in 1996 and are currently listed in the National Essential Medicines List. In February 2017, Qilu Pharmaceutical initiated the quality and efficacy consistency evaluation for Hydroxyurea Tablets. Studies have demonstrated that the in vitro quality parameters of this product are equivalent to those of the reference preparation, and it is bioequivalent to the reference preparation under fasting conditions in vivo.

In addition, the supplementary applications for the consistency evaluation of the new specifications of Qilu Pharmaceutical's Palonosetron Hydrochloride Injection and Granisetron Hydrochloride Injection were also recently approved. Both products are 5-HT3 receptor antagonists, clinically indicated primarily for the prevention and treatment of chemotherapy-induced nausea and vomiting.

Executive Editor: Liuli

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