Qilu Pharmaceutical's Posaconazole Enteric-Coated Tablets Approved for Market Launch in China

Recently, Qilu Pharmaceutical's anti-infective drug, Posaconazole Enteric-Coated Tablets, has been approved for marketing by the National Medical Products Administration and is deemed to have passed the consistency evaluation. So far, Qilu Pharmaceutical has a total of 134 products that have passed the consistency evaluation, 51 of which are the first in China.

Posaconazole belongs to the second-generation triazole antifungal drugs. It can efficiently inhibit lanosterol 14α-demethylase, thereby blocking the synthesis of ergosterol, which disrupts the structure of the fungal cell membrane and ultimately exerts its antifungal effect. Compared with other triazole drugs, posaconazole has a stronger affinity for fungi, higher stability, and is more easily absorbed into tissues and released. It offers advantages such as a broader antimicrobial spectrum, stronger antimicrobial activity, and better tolerance.

Posaconazole Enteric-Coated Tablets are mainly released and absorbed in the intestines. The absorption in the body is minimally affected by food, almost unaffected by gastric pH and gastrointestinal motility, further enhancing oral bioavailability and allowing for better antibacterial effects. It can be administered once daily, offering greater convenience, making it the optimal choice for clinical prevention and treatment of invasive fungal diseases.

With the continuous increase in various immunodeficient populations, especially patients receiving long-term treatment, the high incidence and risks of fungal infections have drawn increasing attention to antifungal therapeutic drugs. To meet clinical medication needs, Qilu Pharmaceutical Co., Ltd. initiated the development of posaconazole enteric-coated tablets in 2020. Researchers adhered to the R&D concept of "quality by design" and adopted hot-melt extrusion technology to enhance the oral bioavailability of posaconazole. Comprehensive pharmaceutical comparisons and bioequivalence studies were conducted between the self-produced product and the reference formulation. Results demonstrated that the self-produced product is equivalent in quality and bioequivalent in vivo to the reference formulation, ensuring the safety and efficacy of the product for clinical use.

Anti-infective drugs are a key focus area for Qilu Pharmaceutical. The approval and market launch of posaconazole enteric-coated tablets will add another significant product to the anti-infective drug pipeline. Together with the previously approved posaconazole injection, it will provide more high-quality treatment options produced in China for the clinical prevention and treatment of invasive fungal diseases, meeting more diverse clinical treatment needs. In the future, Qilu Pharmaceutical will continue to offer more high-quality medications, serving patients and contributing to the construction of a healthier China.

Editor: Mu Mian

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