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Two New Standard-Format Products of Sodium Cytidine Diphosphate Choline Injection from Shijiazhuang Sihua Pharmaceutical Group Have Been Approved Simultaneously
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发布时间：2025-04-03
【概要描述】
On April 3, Shijiazhuang Sihua Pharmaceutical Group’s supplemental applications for two additional regulated products—Citicoline Sodium Injection (2 mL: 0.25 g and 2 mL: 0.1 g)—were simultaneously approved, with the approvals deemed to constitute passing the consistency evaluation. This follows the group’s earlier approval on March 31 of three new products—Arbidol Hydrochloride Tablets, Sodium Bicarbonate Injection, and Nicardipine Hydrochloride Injection—and marks the simultaneous approval of two more regulated products just three days later.
On April 3, Shijiazhuang Sihua Pharmaceutical Group’s supplemental applications for two additional regulated products—Citicoline Sodium Injection (2 mL: 0.25 g and 2 mL: 0.1 g)—were simultaneously approved and deemed to have passed the consistency evaluation. This follows the group’s earlier approval on March 31 of three new products—Arbidol Hydrochloride Tablets, Sodium Bicarbonate Injection, and Nicardipine Hydrochloride Injection—and marks the simultaneous approval of two more regulated products just three days later.
To date, the Group has received approval for 20 new products this year, surpassing the level recorded during the same period last year, and a total of 122 drug varieties comprising 164 dosage forms have either passed or been deemed to have passed the consistency evaluation.
According to reports, sodium citicoline injection is primarily indicated for consciousness disorders following acute traumatic brain injury and neurosurgical procedures. Previously, in June 2023, the 4 mL:0.5 g formulation of this product was approved for registration; with the recent approval of two additional dosage forms, a graduated dosing regimen can now be established, thereby further meeting clinical medication needs.
According to data from MeneNet, in 2023 the sales of citicoline sodium injection (2 mL: 0.25 g) and (2 mL: 0.1 g) at the three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—amounted to approximately RMB 180 million, RMB 60 million, and RMB 70 million, respectively. In the first half of 2024, these figures were approximately RMB 70 million and RMB 25 million, respectively.
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Non-Commercial (Filing) – 2025-0091