In 2023, Shijiazhuang Sihua Pharmaceutical Group Achieved a New Milestone in High-Quality Development
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发布时间:2023-12-30
【概要描述】
As 2023 draws to a close, Shijiazhuang Sihua Pharmaceutical Group, a pillar enterprise in Shijiazhuang’s biopharmaceutical industry, has taken innovation-driven development as its guiding principle and embraced the mission of “Great Chinese Medicines Made in Shijiazhuang.” Focusing on national strategic priorities and market demand, the company has firmly grasped the critical task of advancing new-style industrialization, cultivated and expanded new-quality productive forces, pursued emerging growth areas, and built new competitive advantages. As a result, it has accelerated its climb in the ranking of China’s Top 100 Pharmaceutical Companies, achieving a transformative leap toward innovative, high-quality development.
As 2023 draws to a close, Shijiazhuang Sihua Pharmaceutical Group, a pillar enterprise in Shijiazhuang’s biopharmaceutical industry, has taken innovation-driven development as its guiding principle and embraced the mission of “Great Chinese Medicines, Made in Shijiazhuang.” Focusing on national strategic priorities and market demand, the company has firmly grasped the critical task of advancing new-style industrialization, cultivated and expanded new-quality productive forces, pursued emerging growth areas, and built new competitive advantages. As a result, it has accelerated its climb in the ranking of China’s Top 100 Pharmaceutical Companies, achieving a transformative leap toward innovative, high-quality development.
Innovation Fuels High-Quality Development
Leveraging a series of provincial and municipal policies and initiatives designed to encourage and support the development of the biopharmaceutical industry—ranging from business-friendly measures to talent-development programs—Siyao is driving growth through a “four-wheel” approach encompassing talent, capital, institutional mechanisms, and a conducive business environment. Adhering to the principle of integrating generic and innovative drug development, the company aligns its innovation roadmap with the industrial value chain, continuously increases R&D investment intensity, and actively pursues a phased strategy of advancing multiple projects: conducting R&D on a batch, planning a batch, submitting applications for approval on a batch, and translating another batch into commercial products. This includes high-end, complex generic drugs, innovative medicines, specialty APIs, and bioequivalence evaluation projects. At the same time, Siyao is systematically expanding its presence in key therapeutic areas such as antivirals, antibacterials, respiratory diseases, mental and neurological disorders, and cardiovascular and cerebrovascular conditions, while continually refining its product-tier development framework. As a result, the company’s competitive advantages are further consolidated and strengthened.
In 2023, Siyao secured approval for more than twice the number of new products compared with the previous year. Notably, peritoneal dialysis solution (lactate—G2.5%), compound electrolyte injection (II) (1000 ml), stiripentol dry suspension and its active pharmaceutical ingredient, and pentoxifylline sustained-release tablets were among the first in China to receive regulatory approval. Meanwhile, significant progress was made in the research and development of products undergoing bioequivalence evaluation. To date, a total of 67 drug varieties comprising 87 dosage forms have either passed or been deemed to have passed such evaluations, laying a solid foundation for optimizing the product portfolio, enhancing market accessibility, and successfully participating in national and local centralized drug procurement initiatives.
While consolidating its foundation in the research and development of high-end and specialty generic drugs, Sihua Pharmaceutical has set its sights on the cutting edge of pharmaceutical innovation, leveraging advanced technologies such as artificial intelligence to enhance the pipeline layout and development efficiency for innovative drugs, improved new drugs, shortage medications, and treatments for rare diseases. Relying on a collaborative mechanism that integrates industry, academia, research, and application, Sihua has partnered with universities and research institutes to tackle key technical bottlenecks, successfully resolving a series of “chokepoint” challenges in the development of first-in-class innovative drugs and high-end dosage forms—including microspheres, microcrystals, liposomes, and lyophilized formulations—thereby significantly elevating its innovation capabilities. Currently, among nearly 200 new product projects in development, innovative drugs and improved new drugs account for 30%, with several first-in-class candidates, including NP-01, already undergoing or soon to enter clinical trials.
Through sustained and cumulative innovation in four key therapeutic areas, the company has ushered in a new phase of iterative product development, characterized by distinctive, high-end, complex generic drugs, innovative medicines, improved new drugs, and active pharmaceutical ingredients. The company’s R&D strategy is accelerating its shift from primarily iterative development of generics to a greater emphasis on the discovery and development of innovative and improved new drugs, thereby strengthening its momentum as it strives to join the forefront of domestic pharmaceutical innovation.
Leveraging New Projects to Smooth the “Dual Circulation”
At the construction site of the Sihua High-End Formulation Industrial Park in Shijiazhuang High-Tech Industrial Development Zone, towering cranes stand tall as construction is in full swing, with the project advancing rapidly. Sihua has firmly embraced the “projects are paramount” philosophy, leveraging high-end, high-quality projects to underpin high-quality development and striving to convert its advantages in innovation into competitive strengths for industrial growth.
Since the beginning of this year, Sihua Pharmaceutical has set its sights on building a “Lighthouse Factory,” aligning its efforts with Industry 4.0 and China’s Made in China 2025 initiative to address weaknesses, strengthen core competencies, and solidify foundational capabilities. The company has integrated automated, information-based, and intelligent equipment and technologies into its industrialization projects, thereby accelerating the transformation of traditional manufacturing toward smart manufacturing. The recently completed and commissioned upright soft-bag infusion smart digital workshop is benchmarked against world-class standards; the entire facility adopts the latest international integrated design philosophy and leverages cutting-edge automation, digitalization, and intelligent systems along with IoT technologies, achieving a significant leap in smart manufacturing capabilities. Moreover, the quality management practices underpinning the “21235” risk-control model for parameter-based release—established on the foundation of smart manufacturing—have been recognized as a national quality benchmark.
A growing portfolio of innovative achievements and robust, well-grounded industrialization projects continue to empower the company’s transformative growth. This year, all 12 specifications across the nine product varieties in which Sihua Pharmaceutical participated in the eighth and ninth rounds of national centralized drug procurement were successfully selected, firmly establishing the company as a true “winner” in these procurement initiatives. This has had a positive catalytic effect on regional sales and the company’s long-term development, further consolidating its competitive advantages. In terms of international market expansion, the company has adopted a multi-pronged approach—both “going global” and “bringing in” international partners—to broaden market engagement, concentrate resources on strengthening international certifications and registrations, remove bottlenecks, reconnect fragmented links, and ensure smooth circulation within both domestic and international markets, thereby continuously expanding its network of partnerships at home and abroad. To date, Sihua Pharmaceutical has secured international registration for more than 200 product specifications, with its products now marketed across China and nearly 100 countries and regions worldwide, steadily widening the path toward full-scale internationalization. In 2023, the company maintained industry-leading levels in the export and sales of finished dosage forms, propelling its high-quality development onto a fast track.
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