The 16th New Product of the Year: Agaritaband Injection Approved by Shijiazhuang Sihua Pharmaceutical Group


发布时间:2023-03-25

【概要描述】 On March 25, it was learned that Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug application for Argatroban Injection (2 mL: 10 mg) has been granted a Drug Registration Certificate by the National Medical Products Administration and is deemed to have passed the Consistency Evaluation. This marks the group’s 16th new product approved this year, signaling a strong start to the first quarter in terms of R&D innovation.
On March 25, it was learned that Shijiazhuang Sihua Pharmaceutical Group’s Class 4 chemical drug application for Argatroban Injection (2 mL: 10 mg) has been granted a Drug Registration Certificate by the National Medical Products Administration and is deemed to have passed the Consistency Evaluation. This marks the group’s 16th new product approved this year, signaling a strong start to the first quarter in terms of R&D innovation.
According to reports, argatroban injection is a thrombin inhibitor and can be used for the acute-phase treatment of ischemic stroke within 48 hours of onset.
To date, Shijiazhuang Sihua Pharmaceutical Group has achieved consistency evaluation—or is deemed to have achieved such evaluation—for a total of 43 drug varieties encompassing 55 dosage forms and strengths.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation, actively implementing a “API-plus-formulation” development strategy. The company has aligned its innovation chain with the industrial value chain, comprehensively advancing the research and development of high-end, complex generic drugs, innovative medicines, specialty APIs, and products undergoing bioequivalence evaluation. It is also accelerating its strategic positioning in key therapeutic areas such as antiviral, antibacterial, cough-and-phlegm-relieving, anti-tumor, central nervous system, cardiovascular, gastrointestinal, and anesthetic therapies.
Leveraging a comprehensive package of business-friendly policies at the national, provincial, and municipal levels, the group has adopted an innovation mechanism that integrates industry, academia, research, and application, establishing an innovation consortium led by the enterprise, supported by universities and research institutes, and characterized by close collaboration among all relevant innovation players. This initiative continuously empowers the enterprise to enter new growth areas, build new competitive advantages, forge a new development paradigm, generate new momentum, and create new opportunities.
Continuous innovation has enabled Shijiazhuang Sihua Pharmaceutical to establish a new paradigm of product iteration and development—“developing a batch, stockpiling a batch, and commercializing a batch.” Its R&D achievements have accumulated steadily and are now being translated into tangible results, with its R&D efficiency in specialty generic drugs and the number of applications filed ranking among the top in the domestic industry. Currently, the company has nearly 200 projects in development and more than 100 new products awaiting approval. This ever-expanding portfolio of innovative outcomes provides a stronger foundation and a powerful growth engine for the company’s high-quality development, helping it move up the value chain toward the mid- to high-end segments of the industry.
 

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