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ABOUT USSSY Group Limited is a large high-tech pharmaceutical enterprise with coordinated development of R&D and industrialization in multiple fields such as new drugs, generic drugs, characteristic APIs
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RECRUITIt has established high-level innovation platforms such as engineering laboratory and technology research center jointly with Chinese Academy of Sciences, and now has nearly 400 high-level talents in drug research, analysis and clinical research.
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CONTACTWe will continue to strengthen innovation-driven development, will vigorously encourage the integration of production and research, strengthen and improve the five domains: new drugs, biological drugs, traditional Chinese medicine, generic drugs and APIs
Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Two Specifications of Stibene Dry Suspension
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发布时间：2023-07-27
【概要描述】
On July 27, good news came from the R&D Center of Shijiazhuang Sihua Pharmaceutical Group: the 250 mg and 500 mg formulations of stithiol dry suspension, developed and submitted for registration as a Class 3 chemical drug, have exclusively obtained domestic drug production registration approval from the National Medical Products Administration and are deemed to have passed the consistency evaluation.
On July 27, good news came from the R&D Center of Shijiazhuang Sihua Pharmaceutical Group: the sitagliptin dry suspension formulations in two strengths—250 mg and 500 mg—developed under Category 3 of chemical drug registration have exclusively obtained domestic drug production registration approval from the National Medical Products Administration and are deemed to have passed the consistency evaluation.
According to reports, stiripentol dry suspension is indicated for use in combination with clobazam and valproate as an add-on therapy for refractory generalized tonic–clonic seizures that are not adequately controlled by clobazam and valproate in infants with severe myoclonic epilepsy of infancy (SMEI, Dravet syndrome). In April last year, the Group’s application for stiripentol dry suspension was included on the National Medical Products Administration’s Priority Review List.
In recent years, the Group has accumulated a robust portfolio of innovation achievements, which have now begun to yield significant results. So far this year, the Group has received approval for 39 new products—exceeding last year’s total—and its efficiency and volume of developing specialty generic drugs rank among the highest in the national pharmaceutical industry, placing it firmly among the top 10 Chinese companies in chemical drug R&D. The product mix is becoming increasingly diversified, with an ever richer and more refined product pipeline, providing a powerful engine for the Group’s sustainable development.
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