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Shijiazhuang Sihua Pharmaceutical Group Scores Another Breakthrough in R&D and Innovation: Two New Products—Ornidazole Injection and Alpha-Lipoic Acid Injection—Have Been Approved

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Honors Announcement

发布时间：2023-02-03

【概要描述】 On February 2, Shijiazhuang Sihua Pharmaceutical Group’s applications for two Class III new chemical drugs—the ornidazole injection (3 mL: 0.5 g and 6 mL: 1 g) and the alpha-lipoic acid injection (24 mL: 600 mg)—were simultaneously granted drug production registration approvals by the National Medical Products Administration, which are deemed to have passed the consistency evaluation. This follows the group’s receipt of approval for five new products in the first month of this year, marking another significant achievement with three additional specifications across two new product categories and underscoring a strong start to the company’s R&D innovation efforts.

Shijiazhuang Sihua Pharmaceutical Group Scores Another Breakthrough in R&D and Innovation: Two New Products—Ornidazole Injection and Alpha-Lipoic Acid Injection—Have Been Approved

On February 2, Shijiazhuang Sihua Pharmaceutical Group’s applications for two Class III new chemical drugs—the ornidazole injection (3 mL: 0.5 g and 6 mL: 1 g) and the alpha-lipoic acid injection (24 mL: 600 mg)—were simultaneously granted drug production registration approvals by the National Medical Products Administration, which are deemed to have passed the consistency evaluation. This follows the group’s receipt of approval for five new products in the first month of this year, marking another significant achievement with three additional specifications across two new product varieties, thus securing a strong start for its R&D innovation efforts.

According to reports, ornidazole injection is primarily indicated for the treatment of severe intestinal and hepatic amebiasis, as well as postoperative infections caused by ornidazole-susceptible anaerobic bacteria and for the prevention of such infections following surgical procedures. Alpha-lipoic acid injection is mainly used to treat sensory abnormalities resulting from diabetic peripheral neuropathy.

According to the head of the R&D Center of Shijiazhuang Fourth Pharmaceutical Group, to date the group has achieved bioequivalence for 37 drug varieties encompassing 49 dosage forms and strengths, thereby gaining a competitive edge and creating room for optimizing its product portfolio, securing access to national centralized procurement, and enhancing the market competitiveness of its products.

Over the past two years, Shijiazhuang Sihua Pharmaceutical 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 R&D of high-end, complex generic drugs, innovative medicines, specialty APIs, pharmaceutical packaging materials, and products undergoing bioequivalence evaluation. At the same time, it has accelerated its strategic positioning in key therapeutic areas such as antivirals, antibacterials, cough and expectorant agents, anticancer therapies, neurological disorders, cardiovascular diseases, gastrointestinal conditions, and anesthesia.

In the just-concluded year of 2022, Shijiazhuang Sihua Pharmaceutical leveraged a comprehensive package of national, provincial, and municipal policies designed to benefit enterprises, continuously increased its R&D investment, and adopted an innovation mechanism that integrates industry, academia, research, and application. As a result, the company has established an innovation consortium led by the enterprise, supported by universities and research institutes, and characterized by close collaboration among all relevant innovation players. This collaborative framework has enabled the company to aggressively pursue new growth areas, build new competitive advantages, forge a new development paradigm, inject fresh momentum, and create new opportunities. Continuous innovation has allowed Shijiazhuang Sihua Pharmaceutical to accumulate a robust pipeline of R&D achievements, with nearly 200 projects currently under development and more than 100 new products awaiting approval. The company has thus entered a new phase of product iteration—developing a batch, stockpiling another, and commercializing a third—while in 2022 it secured a total of 37 product approvals. Its efficiency in developing specialty generic drugs and the number of applications submitted rank among the highest in the domestic industry, and its increasingly diverse portfolio of innovative outcomes provides a stronger foundation and a powerful engine for the company’s high-quality development.

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