Shijiazhuang Sihua Pharmaceutical Group’s API Development Enters a “Fast Track” of Growth


发布时间:2024-02-07

【概要描述】 On January 31, isoprenaline hydrochloride submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. This makes the company the second domestic manufacturer to receive approval for its production, and also marks the group’s third newly approved API product since the start of the year, signaling that API development has entered a “fast track” of growth.
On January 31, isoprenaline hydrochloride submitted by Shijiazhuang Sihua Pharmaceutical Group was approved by the National Medical Products Administration and registered as an active pharmaceutical ingredient for use in marketed dosage forms. This makes the company the second domestic manufacturer to receive approval for its production, and also marks the group’s third newly approved API product since the start of the year, signaling that API development has entered a “fast track” of growth.
Since the beginning of this year, the Group has obtained approval for three new active pharmaceutical ingredients—lidocaine hydrochloride, rasagiline mesylate, and isoprenaline hydrochloride—bringing the company’s total number of approved API varieties to 49 and further diversifying its product portfolio.
In recent years, Shijiazhuang Sihua Pharmaceutical Group has been driven by innovation, aligning its strategies with national development priorities and market demands, while focusing on cutting-edge drug R&D and internationalization. The company has actively advanced an integrated “API–formulation” business strategy, strategically linking the innovation chain to the industrial value chain and leveraging the former to enhance the latter. Through multidisciplinary integration and a collaborative “industry–university–research–application” innovation model, it has not only deepened the R&D and commercial translation of high-end, complex generic drugs—including microspheres, microcrystals, liposomes, lyophilized formulations, and sustained- and controlled-release products—as well as improved new drugs and innovative medicines, but also proactively developed specialty API product lines in response to market needs. Currently, among the pipeline of new products under development, the proportion dedicated to specialty APIs is steadily increasing, emerging as a new highlight of the company’s innovation-driven growth.
“In less than two years, all 23 newly developed products that have received regulatory approval have been successfully commercialized, creating new opportunities for the company to accelerate its growth,” said Cui Yongbin, Chairman of Guangxiang Pharmaceutical Group. He added that the company is driven by technological innovation, continuously strengthening its efforts to attract top-tier talent and increase R&D investment. While building high-level innovation platforms, Guangxiang is also leveraging digital transformation to bring new-product commercialization projects to fruition, using high-quality supply to both create and lead demand. As a result, the company’s products are becoming increasingly attractive in both domestic and international markets, further solidifying and enhancing its competitive edge and overall growth momentum.
“Innovation is driving transformation, optimizing the industrial structure, and elevating capabilities, enabling us to break out of existing boundaries and achieve breakthroughs, while accelerating the extension of the API innovation value chain toward the mid- to high-end segments,” said a spokesperson for the group. Under the group’s umbrella, Guolong Pharmaceutical and Guangxiang Pharmaceutical are stepping up efforts to enhance the quality and efficiency of API R&D, innovation, and technology transfer, resulting in a growing portfolio of signature, high-value products. The role of these specialized, refined, distinctive, and innovative “little giants” has been significantly strengthened, with many now serving as affiliated suppliers to well-known formulation manufacturers. This has powerfully propelled the company’s transformation from a business model dominated by a single injectable product to a diversified product mix—a remarkable metamorphosis.

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