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Shijiazhuang Sihua Pharmaceutical Wins Bidding for Two Products in the Fifth Round of National Centralized Procurement

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Honors Announcement

发布时间：2021-06-24

【概要描述】 On June 23, the highly anticipated fifth round of national centralized drug procurement was officially opened for bidding in Shanghai. Two products manufactured by Shijiazhuang Sihua Pharmaceutical Co., Ltd., a major pharmaceutical enterprise in our province—fluconazole sodium chloride injection (100 ml: 0.2 g fluconazole and 0.9 g sodium chloride) and ropivacaine hydrochloride injection (10 ml: 100 mg in polypropylene ampoules)—both of which have passed or are deemed to have passed the bioequivalence evaluation, were successfully selected. To date, Shijiazhuang Sihua Pharmaceutical has had six active ingredients across nine dosage forms included in the national centralized drug procurement program.

On June 23, the highly anticipated fifth round of national centralized drug procurement was officially opened for bidding in Shanghai. Two products manufactured by Shijiazhuang Sihua Pharmaceutical Co., Ltd., a major pharmaceutical enterprise in our province—fluconazole sodium chloride injection (100 ml: 0.2 g fluconazole and 0.9 g sodium chloride) and ropivacaine hydrochloride injection (10 ml: 100 mg in polypropylene ampoules)—both of which have passed or are deemed to have passed the bioequivalence evaluation, were successfully selected. To date, Shijiazhuang Sihua Pharmaceutical has had six active ingredients across nine dosage forms included in the national centralized drug procurement program.

According to reports, the fifth round of nationally organized centralized drug procurement covers 62 products, marking the largest number of items ever included in such a program. In terms of dosage forms, this round encompasses 30 injectable formulations, accounting for nearly 50% of the total; these injectables recorded combined sales of RMB 40 billion in 2020, representing more than 70% of the total market value and thus serving as the mainstay dosage form in this procurement.
Industry insiders note that this round of centralized procurement represents a breakthrough in both the number of drug varieties covered and the scale of procurement. Unlike previous national centralized procurements, which limited injectable drugs to a one-year procurement cycle, this round extends the procurement period for injectables to match that of oral formulations, thereby intensifying competition among market players and pharmaceutical companies.

National centralized drug procurement serves as a key indicator of the pharmaceutical industry’s business environment, directly influencing companies’ product R&D and production operations, and thus attracting close attention from both the industry and the public. Achieving bioequivalence and therapeutic equivalence in generic drug evaluations is a crucial pathway for pharmaceutical firms to participate in national centralized procurement and accelerate market access. In recent years, Shijiazhuang No. 4 Pharmaceutical has adopted a “four-wheel-drive” innovation strategy that synergistically advances consistency evaluation research alongside the development of innovative drugs, generic drugs, and active pharmaceutical ingredients, yielding substantial and steadily growing innovation outcomes. To date, the company has had 13 drug products across 18 dosage forms approved through the National Generic Drug Quality and Therapeutic Equivalence Evaluation—or deemed to have met the standards—placing it among the leaders in the industry in terms of both the number of approvals and the pace of progress.

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