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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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INNOVATIONSSY Group Limited has built a relatively perfect scientific research and innovation system with the development mode of “production, learning, research, and application” of multi-disciplinary integration and multi-directional combination.
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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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SUBSIDIARIESThe company has a diversified business development pattern of R&D, production and export of new drugs, generic drugs, characteristic APIs, advanced finished pharmaceutical products, biological preparations and pharmaceutical packaging materials.
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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
Good News! Shijiazhuang Sihua Pharmaceutical Group Receives Approval for Six New Finished-Product Drug Applications on the Same Day
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发布时间：2024-07-06
【概要描述】
Good news keeps pouring in, truly inspiring! On July 5, six new dosage-form products developed by Shijiazhuang Sihua Pharmaceutical Group—the Class 3 chemical drug Isoprenaline Hydrochloride Injection, the Class 4 chemical drugs Carbidopa–Levodopa Extended-Release Tablets, Dapagliflozin Tablets (5 mg and 10 mg), Isosorbide Dinitrate Injection, and Etomidate Medium- and Long-Chain Fat Emulsion for Injection—received drug production registration approvals from the National Medical Products Administration on the same day, and are deemed to have passed the consistency evaluation. Notably, the Carbidopa–Levodopa Extended-Release Tablets were the first such product approved in China; the Isoprenaline Hydrochloride Injection is the second in the country to receive approval; and the Etomidate Medium- and Long-Chain Fat Emulsion for Injection is the third.
Good news keeps pouring in, truly inspiring! On July 5, six new dosage-form products developed by Shijiazhuang Sihua Pharmaceutical Group—namely, Class 3 chemical drug Isoprenaline Hydrochloride Injection, Class 4 chemical drugs Carbidopa–Levodopa Extended-Release Tablets, Dapagliflozin Tablets (5 mg and 10 mg), Isosorbide Dinitrate Injection, and Etomidate Medium/Long-Chain Fat Emulsion for Injection—simultaneously received drug production registration approvals from the National Medical Products Administration, and are deemed to have passed the consistency evaluation. Notably, the Carbidopa–Levodopa Extended-Release Tablets were the first such product approved in China; the Isoprenaline Hydrochloride Injection is the second in the country to receive approval; and the Etomidate Medium/Long-Chain Fat Emulsion for Injection is the third.
According to available information, Isoprenaline Hydrochloride Injection is indicated for the treatment of cardiogenic or septic shock, complete atrioventricular block, and cardiac arrest; Carbidopa–Levodopa Sustained-Release Tablets are indicated for primary Parkinson’s disease, post-encephalitic Parkinsonism, symptomatic Parkinsonism, and other conditions; Dapagliflozin Tablets are primarily used in adult patients with type 2 diabetes and heart failure; Isosorbide Dinitrate Injection is indicated for symptomatic treatment of unstable angina in combination with standard therapy, for the long-term management of vasospastic angina (variant angina), for acute myocardial infarction, and for acute left ventricular failure (cardiac dysfunction associated with reduced left ventricular function); Etomidate Medium- and Long-Chain Fat Emulsion Injection is indicated for induction of general anesthesia in adults, infants aged 6 months and older, children, and adolescents.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has steadfastly pursued a path of innovative development that integrates generic drug production with original research and development, taking the needs of public health and the pharmaceutical industry chain as its starting point. The company has continuously increased its investment in innovation, advanced the integrated development of active pharmaceutical ingredients and finished dosage forms, and strategically positioned itself in key therapeutic areas—including anti-infectives, respiratory diseases, neurological disorders, cardiovascular and cerebrovascular conditions, gastroenterology, anesthesia, endocrinology, oncology, and dialysis—while actively building a high-performance innovation ecosystem. As a result, the group’s core competitiveness, driven by both high-end complex generics and innovative drugs, is rapidly taking shape. With the acceleration of corporate innovation, the product pipeline has become increasingly robust and well-structured: to date in 2024, Shijiazhuang Sihua Pharmaceutical has secured approval for 52 new products, bringing the total to 94 drug varieties comprising 126 dosage forms that have either passed or are deemed to have passed the consistency evaluation. R&D quality and efficiency have surpassed the levels recorded during the same period last year, and innovation has effectively facilitated the continuous optimization of the company’s supply structure, enhanced the quality and efficiency of scale-up, and elevated its industry influence and competitiveness to new heights. The company has thus established a distinctive product-chain layout and gained new competitive advantages in the market, setting it apart from its peers.
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