The 110th Approved Generic Drug! Shijiazhuang Sihua Pharmaceutical Group’s Deferiprone Dispersible Tablets Have Been Approved


发布时间:2024-12-11

【概要描述】 Continuous innovation fuels sustained development. On December 10, Shijiazhuang Sihua Pharmaceutical Group received registration approval from the National Medical Products Administration for its Class 4 chemical drug—deferasirox dispersible tablets (125 mg)—which is deemed to have passed the bioequivalence evaluation, making it the group’s 110th product to either pass or be deemed to have passed such an evaluation.
Innovation never stops, and development gains new momentum. On December 10, Shijiazhuang Sihua Pharmaceutical Group’s application for Class 4 chemical drug—Deferasirox Dispersible Tablets (125 mg)—received registration approval from the National Medical Products Administration and was deemed to have passed the consistency evaluation, making it the group’s 110th product to either pass or be deemed to have passed such an evaluation.
According to reports, deferasirox is primarily indicated for the treatment of chronic iron overload resulting from frequent blood transfusions in β-thalassemia patients aged 2 years and older, as well as for the management of chronic iron overload in non-transfusion-dependent thalassemia syndromes in patients aged 10 years and older. This iron-chelating agent was developed by Novartis of Switzerland and represents the first orally administered iron chelator approved by the U.S. Food and Drug Administration for routine use; it was approved for marketing in China in 2010.
According to data from MeneNet, sales at the end-user level—covering urban public hospitals, county-level public hospitals, urban community health centers, and township health clinics—in China reached RMB 160.54 million in 2023, with sales exceeding RMB 84.08 million in the first half of 2024, demonstrating a sustained growth trend.
Shijiazhuang Fourth Pharmaceutical Group steadfastly pursues an R&D strategy that integrates generic drug development with innovative research. Leveraging a robust innovation team, a well-established innovation platform, and mature research mechanisms, the company adopts targeted, strategic initiatives and relentlessly drives innovation with a relentless, forward-moving momentum. As a result, its product pipeline has become increasingly clear, R&D achievements have accumulated steadily and begun to yield significant results, creating a seamless value chain and fostering synergistic clusters of capabilities. The depth of its product portfolio continues to grow, and its R&D quality and efficiency remain at the forefront of the national pharmaceutical industry. To date, a total of 110 drug varieties comprising 145 dosage forms have either passed or been deemed to have passed the evaluation of generic drug quality and therapeutic equivalence, demonstrating the company’s vibrant vitality through a continuously optimized product mix and providing strong impetus for market competition and enhanced product accessibility.
 

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