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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
Shijiazhuang Sihua Pharmaceutical Group Achieves a Strong Start in R&D Innovation, Securing Approval for Eight New Products in the First Month of the Year
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发布时间：2024-02-01
【概要描述】
On January 31, isoprenaline hydrochloride submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed formulations, making the company the second domestic manufacturer to receive approval for its production. Since the beginning of the year, the group has secured registration approvals for eight new products, marking a strong start to the year in research and development innovation.
On January 31, isoprenaline hydrochloride submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms, making the company the second domestic manufacturer to receive approval for its production. Since the beginning of the year, the group has secured registration approvals for eight new products, marking a strong start to the year in research and development innovation.
According to available information, isopropyl epinephrine hydrochloride is a β-adrenergic agonist, and its formulations are primarily used for the treatment of bronchial asthma and atrioventricular block. Currently, the approved dosage forms of isopropyl epinephrine hydrochloride in China include tablets, injections, and aerosols. Among these, the injectable formulation is classified as an emergency medication and is one of the most widely used dosage forms in clinical practice.
Over the past two years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation, aligning its strategies with national development priorities and market demands, while focusing on cutting-edge drug R&D and internationalization. The company has actively advanced an integrated “API-plus-formulation” business strategy, strategically linking innovation chains to industrial value chains and leveraging these innovation networks to enhance value creation. Through multidisciplinary integration and a robust “industry–university–research–application” innovation mechanism, it has vigorously promoted the R&D and commercial translation of high-end, complex generic drugs, improved new drugs, innovative medicines, and specialty APIs, including microspheres, microcrystals, liposomes, lyophilized formulations, and sustained- and controlled-release products. In 2023, the company secured approval for 88 new products, a year-on-year increase of 130%, with 17 of these representing the nation’s first or sole approvals. Several Class I new drugs were also approved to enter clinical trials, underscoring the company’s industry-leading R&D quality and efficiency. Currently, nearly 30% of its pipeline consists of high-end, complex formulations and innovative drug projects, reflecting a significant enhancement in its innovation capabilities and accelerating its ascent into the forefront of domestic pharmaceutical innovation.
“Innovation is driving transformation, optimizing the industrial structure, and elevating capabilities, enabling breakthroughs beyond traditional boundaries and accelerating the extension of the API innovation value chain toward the mid- to high-end segments,” said a spokesperson for the group. Under its umbrella, Guolong Pharmaceutical and Guangxiang Pharmaceutical are speeding up the R&D, commercialization, and performance enhancement of their APIs, with an increasing portfolio of specialty and competitive products. The supporting role of these “little giant” enterprises—specialized, refined, distinctive, and innovative—is becoming increasingly prominent, as they have established themselves as key suppliers to numerous well-known formulation manufacturers. This has powerfully propelled the company’s transformation from a business model dominated by a single injectable product to a diversified, full-chain development strategy.
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