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Good News Abounds! Shijiazhuang Sihua Pharmaceutical Group’s Compound Sodium Acetate Ringer’s Injection (500 ml) Has Been Approved
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发布时间：2025-12-13
【概要描述】
On December 11, Shijiazhuang Sihua Pharmaceutical Group, following the recent approval of the drug registration certificate for Acetylcysteine Injection (25 ml: 5 g), received another approval for its Class 3 chemical drug—Compound Sodium Acetate Ringer’s Injection (500 ml)—which is also deemed to have passed the bioequivalence evaluation. To date this year, the Group has secured approvals for 92 new products, bringing the total to 165 product varieties and 216 dosage forms that have either passed or are deemed to have passed the bioequivalence evaluation for generic drugs in terms of quality and therapeutic efficacy.
On December 11, following the recent approval of the drug registration certificate for Acetylcysteine Injection (25 ml: 5 g), Shijiazhuang Sihua Pharmaceutical Group once again secured approval for its Class 3 chemical drug—Compound Sodium Acetate Ringer’s Injection (500 ml)—which is also deemed to have passed the bioequivalence evaluation. To date this year, the Group has obtained approval for 92 new products, bringing the total number of products that have either passed or are deemed to have passed the bioequivalence evaluation for generic drugs to 165 varieties and 216 dosage forms.
According to available information, Compound Sodium Acetate Ringer’s Injection is indicated for the replenishment of extracellular fluid in cases of reduced circulating blood volume and interstitial fluid depletion, as well as for the correction of metabolic acidosis. It is classified as a drug for the regulation of body fluids, electrolytes, and acid–base balance. As a fourth-generation electrolyte replacement solution, this product employs an acetate buffering system and its electrolyte composition—including sodium, potassium, magnesium, and calcium ions—is more closely aligned with human extracellular fluid. Consequently, it is widely used in clinical settings that require meticulous fluid management, such as anesthesia, surgery, intensive care, burn treatment, and emergency medicine.
According to data from MeneNet, sales of Compound Sodium Acetate Ringer’s Injection in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled approximately RMB 1.16 billion in 2023, about RMB 1.14 billion in 2024, and roughly RMB 570 million in the first half of 2025.
The newly approved Compound Sodium Acetate Ringer’s Injection (500 mL) complements the Group’s existing portfolio of Sodium Acetate Ringer’s Injection and Sodium Acetate Ringer’s Glucose Injection, creating a comprehensive product matrix that, through synergistic effects, will significantly enhance the company’s overall competitiveness in the market for drugs used to regulate fluid, electrolyte, and acid–base balance.
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Non-Commercial (Filing) – 2025-0091