New Launch! Three New Pharmaceutical Preparations from Shijiazhuang Sihua Pharmaceutical Group Approved on the Same Day, Adding New Momentum to Innovation-Driven Development


发布时间:2025-03-31

【概要描述】 With a flourishing array of innovations and groundbreaking R&D achievements, Shijiazhuang Sihua Pharmaceutical Group continues to report one success after another. On March 31, three formulation products submitted by the group were approved on the same day, with each deemed to have passed the consistency evaluation. The approval of multiple new products this time vividly demonstrates the company’s strategic product portfolio in R&D and its sustained innovation capability.
With a flourishing array of innovations and groundbreaking R&D achievements, Shijiazhuang Sihua Pharmaceutical Group continues to report one success after another. On March 31, three formulation products submitted by the Group were approved on the same day, with each deemed to have passed the consistency evaluation. The approval of multiple new products underscores the Company’s strategic product portfolio in R&D innovation and its sustained capacity for innovation. The approved products include: Class 3 chemical drug Abidor Hydrochloride Tablets (50 mg) and Sodium Bicarbonate Injection (10 ml: 0.42 g), as well as Class 4 chemical drug Nicardipine Hydrochloride Injection (10 ml: 10 mg). Notably, the Abidor Hydrochloride Tablets represent the second approval nationwide. To date, the Group has cumulatively obtained approval or been deemed to have passed the consistency evaluation for a total of 122 drug varieties encompassing 162 dosage forms.
According to available information, the newly approved product, Abidor Hydrochloride Tablets, is indicated for the treatment of upper respiratory tract infections caused by influenza A and B viruses. Previously, the Group already marketed Abidor Hydrochloride Capsules and the corresponding active pharmaceutical ingredient; the recent approval of Abidor Hydrochloride Tablets further underscores the advantages of its integrated “API–formulation” development model.
According to data from MeneNet, in 2023 the sales of Arbidol Hydrochloride Tablets in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 199 million, with sales in the first half of 2024 reaching approximately RMB 78 million. Nicardipine Hydrochloride Injection, a third-generation dihydropyridine calcium channel blocker, is primarily used for the emergency management of intraoperative hypertensive crises and other hypertensive emergencies.
According to data from MeneNet, sales of nicardipine hydrochloride injection (10 mL: 10 mg) in China’s three major distribution channels—urban public hospitals, county-level public hospitals, and township health centers—totaled RMB 470 million in 2023, with RMB 250 million recorded in the first half of 2024.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has anchored itself in an integrated “API-plus-formulation” strategy, guided by the mission of “producing high-quality medicines for the people.” The company has continuously increased its R&D investment and, by focusing on the premiumization of injectables, the diversification of oral formulations, and the specialized transformation of APIs, has established a multi-tiered product pipeline spanning innovative drugs, first-generic drugs, and complex formulations. Currently, the number of approved and pipeline products ranks among the top in the industry, with markedly improved market translation efficiency, gradually fostering a virtuous cycle of R&D–manufacturing–sales. This is steadily strengthening the company’s development foundation and injecting strong momentum into the building of a Healthy China.

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