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Shijiazhuang Daily | Shijiazhuang Sihua Pharmaceutical’s Drug for a Rare Disease Included in the New National Medical Insurance Catalog

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发布时间：2024-12-03

【概要描述】 On November 28, the National Healthcare Security Administration released the “National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2024),” under which Stiripentol Dry Suspension—a domestically exclusive first generic drug developed and manufactured by Shijiazhuang Sihua Pharmaceutical for the treatment of severe myoclonic epilepsy in infancy, a rare disease known as Dravet syndrome—was included following national medical insurance negotiations.

Shijiazhuang Daily | Shijiazhuang Sihua Pharmaceutical’s Drug for a Rare Disease Included in the New National Medical Insurance Catalog

On November 28, the National Healthcare Security Administration released the “National Basic Medical Insurance, Work Injury Insurance, and Maternity Insurance Drug List (2024),” under which Stiripentol Dry Suspension—a domestically exclusive first generic drug developed and manufactured by Shijiazhuang Sihua Pharmaceutical for the treatment of severe myoclonic epilepsy in infancy, a rare disease known as Dravet syndrome—was included following national medical insurance negotiations.

Dravet syndrome is a clinically rare, refractory epileptic syndrome of infancy and is listed by the International League Against Epilepsy as one of the most disabling forms of epilepsy. In 2018, Dravet syndrome was included in China’s first National Rare Disease Catalogue. Because the originator drug has not yet been approved for marketing in China, the combination of “rare disease” and “pediatric use” renders conventional antiepileptic medications ineffective in clinical practice.

To meet the public’s medication needs, Shijiazhuang No. 4 Pharmaceutical has leveraged its own research strengths to focus in recent years on the development of pediatric- and geriatric-friendly formulations. In April 2022, the company submitted a marketing application for sitagliptin dry suspension; in May of the same year, the application was placed under the National Medical Products Administration’s priority review and approval pathway, making Shijiazhuang No. 4 Pharmaceutical the sole domestic applicant for this product. In July 2023, sitagliptin dry suspension (500 mg and 250 mg) received China’s first approval for a generic version, providing a new, more cost-effective treatment option for pediatric patients.

Shijiazhuang Fourth Pharmaceutical 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. Its product pipeline is becoming increasingly clear, with R&D achievements steadily accumulating and culminating in breakthroughs; these efforts are being systematically integrated into a cohesive value chain, creating synergies and scaling up capabilities. The depth of its product portfolio continues to grow, and its R&D quality and efficiency consistently lead the national pharmaceutical industry. To date, a total of 108 drug varieties comprising 142 dosage forms have either passed or been deemed to have passed the evaluation of generic drug quality and therapeutic equivalence; 25 new dosage forms have received the nation’s first or exclusive approval; and 162 varieties have been included in the latest National Medical Insurance Catalogue. This continuously optimized product mix underscores the company’s vigorous vitality and provides strong impetus for enhancing market competitiveness and improving product accessibility.

(Originally published in the Shijiazhuang Daily on December 2)

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