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Good News: Shijiazhuang Sihua Pharmaceutical Group Has Achieved Regulatory Approval for 100 Generic Drug Products

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Honors Announcement

发布时间：2024-08-13

【概要描述】 Through relentless innovation, the company has delivered good news: its efforts have borne rich fruit in both spring and autumn. On August 13, two products submitted by Shijiazhuang Sihua Pharmaceutical Group—the Class 3 chemical drug sodium-potassium-magnesium-calcium concentrated injection solution and the Class 4 chemical drug levodopa-benserazide tablets—both received drug production registration approvals from the National Medical Products Administration on the same day, and were deemed to have passed the consistency evaluation. To date, the Group has had 100 generic drug varieties comprising 133 specifications either pass or be deemed to have passed the consistency evaluation, bringing the total number of evaluated varieties to 100—a figure that places the Group among the leaders in the pharmaceutical industry and lays a solid foundation for driving high-quality corporate development.

Good News: Shijiazhuang Sihua Pharmaceutical Group Has Achieved Regulatory Approval for 100 Generic Drug Products

Through relentless innovation, the company has delivered good news: its efforts have borne rich fruit in both spring and autumn. On August 13, two products submitted by Shijiazhuang Sihua Pharmaceutical Group—the Class 3 chemical drug sodium-potassium-magnesium-calcium concentrated injection solution and the Class 4 chemical drug levodopa-benserazide tablets—received drug production registration approvals from the National Medical Products Administration on the same day, and were deemed to have passed the consistency evaluation. To date, the Group has had 100 generic drug varieties comprising 133 specifications either pass or be deemed to have passed the consistency evaluation, bringing the total number of evaluated products to 100—a figure that places the Group among the leaders in the pharmaceutical industry and lays a solid foundation for driving high-quality corporate development.

In recent years, the Group has taken it as its mission to “research, develop, and produce more ‘Chinese medicines’ that are tailored to the genetic heritage and physical characteristics of the Chinese population,” staying true to its original aspiration of “making quality medicines for the people.” Leveraging innovative mechanisms and platforms that integrate industry, academia, research, and application, the Group has focused on key therapeutic areas—including anti-infectives, respiratory diseases, neurological disorders, cardiovascular and cerebrovascular conditions, gastrointestinal diseases, anesthesia, endocrinology, oncology, and dialysis—and is relentlessly advancing integrated innovation across both active pharmaceutical ingredients and finished dosage forms. Through this relentless drive, the Group continues to cultivate new momentum and competitive advantages, accelerating the establishment of a multi-pronged business development model: led by innovative drugs, underpinned by specialty generic chemical drugs, APIs, and pharmaceutical packaging materials, distinguished by injectable formulations, and complemented by biologics and medical devices—thereby fostering the synergistic integration of the innovation chain, talent pipeline, and industrial value chain.

“In particular, with regard to the development of products that have passed the consistency evaluation, we have pooled our strongest resources—human, financial, and material—to systematically advance research on generic drug consistency. By raising the quality standards for domestically produced generics, we aim to ensure that their quality and therapeutic efficacy are on par with those of originator drugs imported from abroad. We are committed to developing and manufacturing more safe, affordable ‘Chinese medicines’ to meet the medication needs of the general public.” According to the head of the R&D Center at Shijiazhuang Sihua Pharmaceutical Group, in recent years the group has steadfastly pursued an R&D strategy that combines generic development with innovation. Leveraging a well-established innovation platform, mature research mechanisms, and a robust team of innovators, the company has adopted targeted strategies, resulting in an increasingly clear product pipeline. Cumulative R&D achievements are now being translated into tangible results, with individual innovations linking together to form a cohesive value chain, thereby continuously strengthening the depth of its product portfolio. As a result, the group’s efficiency and output in generic drug R&D consistently rank among the highest among pharmaceutical manufacturers nationwide. To date, 100 drug varieties comprising 133 dosage forms of generic products have either passed or been deemed to have passed the consistency evaluation, including 22 that were the first in China to do so. This vibrant R&D and innovation activity provides strong momentum for the company’s market competitiveness and for enhancing the accessibility of its products.

In recent years, Shijiazhuang Sihua Pharmaceutical Group has steadfastly pursued the “Four Orientations,” with a strong focus on developing pediatric- and geriatric-friendly pharmaceutical products. To date, the group has had 60 drug candidates approved through R&D, placing it among the top three in China; these include several blockbuster and best-selling formulations. Notably, the group was the first—and remains the sole—company to receive approval for stiripentol dry suspension, an orphan drug indicated for the treatment of severe myoclonic epilepsy in infants. Additionally, the company has launched a comprehensive portfolio of antihypertensive products, including nifedipine sustained-release tablets (II), felodipine sustained-release tablets, valsartan–amlodipine tablets (I), urapidil hydrochloride injection, and esmolol hydrochloride injection, as well as a robust lineup of anti-Parkinson’s medications, such as carbidopa–levodopa extended-release tablets, rasagiline mesylate tablets, entacapone–levodopa tablets (II), and levodopa–benserazide tablets. This diversified product pipeline has fostered a virtuous cycle of iterative innovation and continuous product upgrades, creating a promising momentum for sustainable growth. The group’s innovative strengths are gradually translating into market leadership, competitive advantage, and long-term development resilience.

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