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Shijiazhuang Daily | “Front-Row Insights into Science and Innovation Platforms: Hebei Provincial Research Institute of Technology for Sterile Chemical Pharmaceutical Preparations—An Innovation Engine Accelerating Product Upgrades and Iterations”

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发布时间：2025-05-21

【概要描述】 In early summer, all things are lush and teeming with vitality. In the laboratories of the Hebei Provincial Research Institute of Sterile Pharmaceutical Preparations Technology, rows of test tubes are neatly arranged on the workbenches, while researchers meticulously operate equipment and record analytical data.

Shijiazhuang Daily | “Front-Row Insights into Science and Innovation Platforms: Hebei Provincial Research Institute of Technology for Sterile Chemical Pharmaceutical Preparations—An Innovation Engine Accelerating Product Upgrades and Iterations”

In early summer, all things are lush and teeming with vitality. In the laboratories of the Hebei Provincial Research Institute of Sterile Pharmaceutical Preparations Technology, rows of test tubes are neatly arranged on the workbenches, while researchers meticulously operate equipment and record analytical data.

Over the past two months, this region has repeatedly reported positive news: six new sterile dosage forms—namely epinephrine hydrochloride injection, citicoline sodium injection, sodium bicarbonate injection, and others—have successively obtained registration approvals from the National Medical Products Administration.

Soon, these new products will be put into production at Shijiazhuang Sihua Pharmaceutical Group, a key pillar enterprise in Shijiazhuang’s pharmaceutical industry, and will be distributed nationwide.

Biopharmaceuticals are Shijiazhuang’s leading and advantageous industry, underpinned by a robust industrial foundation. To enhance coordination across the biopharmaceutical value chain—both upstream and downstream—accelerate overall supply-chain upgrading, expedite the market launch of new products, and improve their quality, the Hebei Provincial Research Institute for Sterile Pharmaceutical Preparations Technology has been established within Shijiazhuang Sihua Pharmaceutical Group.

Conduct R&D by focusing on the cutting edge of industry

Recently, a reporter visited the Institute of Industrial Technology and gained a deep sense of the innovative atmosphere here. In the raw-materials laboratory, researchers operated a wide array of instruments—large and small—to conduct meticulous experiments; in the high-performance liquid chromatography (HPLC) testing room, more than 100 HPLC units were neatly arranged and running at high speed, while analysts moved briskly between the instruments, loading and unloading samples; and in the AI-plus-new-drug R&D workspace, computer screens flickered as researchers used computers to review and organize the latest AI-driven drug-screening data…

“Focusing on the cutting edge of the industry and accelerating the iterative upgrading and industrialization of sterile pharmaceutical preparations are the key priorities of the Industrial Technology Research Institute,” said Sun Lijie, Executive President of Shijiazhuang Sihua Pharmaceutical Group and Director of the Hebei Provincial Research Institute for Industrial Technology of Chemical Sterile Preparations. He added that the institute is currently vigorously advancing the R&D of more than 20 new dual-chamber bag infusion products, which represent the institute’s flagship R&D initiative for 2025. The development of such novel products is highly challenging, with numerous technical barriers in critical core processes such as sterilization, filling, and low-temperature welding; globally, only a handful of developed countries are capable of producing them, and they have been included in the National Catalogue for Guiding Industrial Structure Adjustment as encouraged projects.

Sun Lijie told reporters that double-chamber bag infusion, as a new fully enclosed infusion preparation system, enables fully closed, sterile preparation on-site without the need for a dedicated compounding area, allowing for immediate preparation and use. Moreover, it effectively addresses key pain points in the healthcare industry, such as secondary contamination, and boasts a wide range of application scenarios. Once put into production, it will fill a manufacturing gap within the province and hold significant market development potential.

Continuously achieving innovation and breakthroughs

Technology innovation platforms effectively aggregate innovative resources and accelerate the commercialization of scientific and technological advances, serving as a fertile ground for enterprises to break through critical core technologies. Sun Lijie has firsthand experience of this. He told reporters that over the past two years, the Industrial Technology Research Institute has conducted R&D across multiple areas—including sterile API formulations for chemical drugs, packaging materials, and finished dosage forms—and has collaborated with numerous universities and research institutions, such as China Pharmaceutical University, Lanzhou University, and Hebei Medical University, yielding remarkable innovative results. At the same time, leveraging generic drugs as a foundation and focusing on unmet clinical needs, the institute has comprehensively advanced the development of small-molecule chemical drugs, novel drug-delivery systems, and generic product lines, thereby establishing itself as a key player in domestic new-drug discovery and the development of specialty generics.

Inside the formulation production facility of Shijiazhuang Sihua Pharmaceutical Group in the High-tech Zone, reporters observed robotic arms seamlessly maneuvering and rotating along the production line, handling processes such as solution preparation, filling, sterilization, and visual inspection—entirely under the control of an automated system.

“This is our dual-chamber bag infusion production line. We are currently piloting a new product: a neutral peritoneal dialysis solution in a dual-chamber bag, which is also a key R&D project for 2025. At present, we are conducting stability studies on the product in accordance with the planned schedule, and once it enters full-scale production, it will fill a gap in local manufacturing capacity within the province,” said Sun Lijie.

Leveraging Innovation to Drive Business Growth

“Innovation is the lifeblood of an enterprise; continuous innovation provides the ‘golden key’ to high-quality development. Therefore, we must make proactive and strategic moves in technological innovation,” said Sun Lijie. In recent years, Shijiazhuang Sihua Pharmaceutical Group has steadily strengthened the development of its technological innovation platforms and consistently increased its R&D investment, with annual R&D expenditures accounting for nearly 10% of sales revenue.

During interviews, reporters learned that Shijiazhuang Sihua Pharmaceutical Group currently has 200 new products in development, with high-end complex formulations, improved new drugs, and innovative drugs accounting for nearly 30% of the pipeline. To date, a total of 124 drug varieties comprising 168 dosage forms have either passed or been deemed to have passed the bioequivalence evaluation, including 26 newly approved dosage forms that are either the first in China or exclusively approved. This increasingly diversified product portfolio has powerfully propelled the company’s transformation from a business model dominated by injectables to a multi-faceted, value-chain-driven growth strategy, enabling it to rank among the top 50 Chinese pharmaceutical R&D enterprises.

“To sustain this momentum and break through existing boundaries, we must continue to invest heavily in the development of innovative drugs, ensuring that generic drug R&D and innovative drug development advance in tandem,” said Sun Lijie. He added that the company will leverage its science-and-tech innovation platform to further drive high-quality development of Shijiazhuang’s biopharmaceutical industry through innovative growth, thereby enhancing the reputation of the “Good Chinese Medicines Made in Shijiazhuang” brand.

Originally published in the Shijiazhuang Daily on May 17. Reporter: Li Liya

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