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Shijiazhuang Sihua Pharmaceutical: R&D and Innovation Continue Uninterrupted Amid the Pandemic

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发布时间：2021-01-22

【概要描述】 “Our three generic drug quality and therapeutic equivalence evaluation projects—ambroxol hydrochloride injection, ciprofloxacin lactate sodium chloride injection, and fluconazole sodium chloride injection—”

“Our three generic drug quality and therapeutic equivalence evaluation projects—the ambroxol hydrochloride injection, the ciprofloxacin lactate sodium chloride injection, and the fluconazole sodium chloride injection—have successively received approval from the National Medical Products Administration in recent days. Notably, the ciprofloxacin lactate sodium chloride injection was the first among 83 domestic manufacturers of the same product to pass the evaluation, while the fluconazole sodium chloride injection is the second in China to do so. These innovative achievements will play a crucial role in enhancing the market competitiveness of our products.” On January 21, a series of encouraging announcements boosted the morale of the extensive team of scientific and technical personnel at Shijiazhuang Sihua Pharmaceutical Co., Ltd., who have been steadfastly committed to R&D even amid the ongoing fight against the pandemic.

Having successfully navigated last year’s major test posed by the pandemic, the R&D team at Shijiazhuang No. 4 Pharmaceutical has remained calm and composed in the face of new epidemic challenges, showing no sign of complacency. Research projects are now progressing comprehensively and rapidly according to schedule.

Since the onset of the pandemic, researchers at Shijiazhuang Sihua Pharmaceutical have been diligently conducting research and experimentation on new products.

Sun Lijie, Executive President of Shijiazhuang Sihua Pharmaceutical and General Manager of the R&D Center, stated: “During the pandemic, our research teams for active pharmaceutical ingredients, injectables, solid dosage forms, and innovative drugs each fulfilled their respective roles and advanced in parallel. In response to the recurring waves of the epidemic, we re-evaluated and adjusted our ongoing R&D projects, prioritizing those related to pandemic prevention and control. At the same time, we strengthened collaboration with universities and pooled our resources to accelerate the development of new classes of antiviral and anti-infective drugs.”

“To achieve results as soon as possible and benefit the health of the general public, our core R&D team is now living and working at the company. While rigorously implementing epidemic prevention measures, they are putting in more than ten hours of work each day. Even so, they still feel there isn’t enough time—every minute counts in this race against time. This is not only a necessity for combating the current outbreak; it is also a critical requirement for the company’s long-term development,” said Sun Lijie.
Innovation is the future of enterprises, and we must never pause in our pursuit of it.

Since the onset of the pandemic, researchers at Shijiazhuang Sihua Pharmaceutical have been diligently conducting research and experimentation on new products.

“In the face of the current epidemic, our work will not only continue as scheduled—many projects are even likely to be advanced,” said Sun Lijie. He attributed their composure and confidence to meticulous planning and coordination across both the R&D system and project management. “We focus on what we should do and what we are capable of doing, while leaving other aspects to external innovation resources. This approach not only boosts efficiency but also helps diversify risk, thereby minimizing the adverse impact of the pandemic and other challenging factors on research and innovation. This year, we have launched more than 140 projects and aim to secure approval for nearly 30 new products. During the pandemic, we have already submitted three new-product applications to the national authorities: two for injectable formulations and one for solid dosage forms. By the end of January, we plan to submit another three new products to the Center for Drug Evaluation. All of these projects were ‘rushed’ into submission under extraordinary circumstances.”
Over the past two years, Shijiazhuang No. 4 Pharmaceutical has adhered to a development strategy that integrates generic and innovative drug R&D, built an innovative talent pool, and established a “five-in-one” innovation platform in collaboration with “Double First-Class” universities and research institutes. This platform covers the development of generic drugs, active pharmaceutical ingredients, innovative medicines, pharmaceutical packaging materials, and research on consistency evaluation of generic drugs. By leveraging both domestic and international innovation resources, the company has continuously accelerated its R&D efforts, expanded new avenues for kinetic energy transformation, and expedited the strategic deployment of its product lines for injectables, solid dosage forms, and APIs. As a result, it has cultivated new competitive advantages across product categories, strengthened its leading position in cutting-edge domestic injectable delivery systems and novel packaging formats—such as advanced microsphere and liposome-based injectables, lyophilized powders for injection, sterile powders for injection, dual-chamber bags, and multi-chamber bags—and thereby steadily reinforced the foundation for the company’s sustainable development.

Since the onset of the pandemic, researchers at Shijiazhuang Sihua Pharmaceutical have been diligently conducting research and experimentation on new products.

“Over the past two years, we have coordinated and advanced efforts in the development of innovative drugs, generic drugs, and active pharmaceutical ingredients, as well as in consistency evaluation studies, steadily building up our capabilities and yielding a steady stream of innovative achievements. Since the beginning of the year, in just three weeks we have successively received national approval documents for three product varieties; the Class 1 innovative anti-tumor drug NP-01 has been approved to enter Phase I clinical trials; and in the near future, another batch of New Category IV drugs will obtain manufacturing approvals,” said Sun Lijie. To date, Shijiazhuang Sihua Pharmaceutical has had a total of 14 specifications across 10 product varieties pass the National Generic Drug Quality and Therapeutic Equivalence Evaluation or be deemed to have passed such evaluation, placing the company among the industry leaders in both the number of approvals and the pace of progress.
Health is the foundation of productivity. To ensure effective prevention and control, the R&D Center of Shijiazhuang No. 4 Pharmaceutical Co., Ltd. strictly adheres to the company’s unified guidelines: disinfection and temperature checks are conducted twice daily, and meal times are staggered to avoid crowding. Sun Lijie explained, “Before entering their workstations, all departments must conduct a second round of temperature screening for researchers, enabling timely monitoring and safeguarding the health of our R&D personnel so that everyone can work in good health.”

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