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Accelerating the Leading Industries | “Made in Shijiazhuang” Innovative Drugs Take a New Step

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发布时间：2023-09-02

【概要描述】 “Data show that the drug’s bioavailability exceeds 90% and that it exhibits strong stability.” Li Lei, Deputy Director of the Innovation Department at the R&D Center of Shijiazhuang Sihua Pharmaceutical, is primarily responsible for the development of innovative pharmaceutical formulations. Recent breakthroughs in drug R&D have significantly bolstered his confidence in innovation and R&D efforts. During the development of this first-in-class new drug for treating liver fibrosis, Li Lei’s R&D team encountered a critical bottleneck—the drug’s poor solubility. Early in vitro studies indicated good efficacy, but its poor solubility resulted in extremely low in vivo absorption, thereby bringing the project to a standstill.

Accelerating the Leading Industries | “Made in Shijiazhuang” Innovative Drugs Take a New Step

“Data show that the drug’s bioavailability exceeds 90% and that it exhibits robust stability.” Li Lei, Deputy Director of the Innovation Department at the R&D Center of Shijiazhuang No.4 Pharmaceutical, is routinely responsible for the development of innovative pharmaceutical formulations. Recent advances in drug R&D have significantly bolstered his confidence in innovation and R&D efforts.

During the development of this novel drug for treating liver fibrosis, Li Lei’s research team encountered a critical bottleneck: poor drug solubility. Early in vitro studies had demonstrated promising efficacy, but the drug’s poor solubility resulted in extremely limited in vivo absorption, thereby stalling the project’s progress.

“To overcome this challenging problem, we explored a variety of cutting-edge formulation technologies,” said Li Lei. “Ultimately, we decided to adopt state-of-the-art nano-formulation technology and acquired high-end formulation equipment, which enabled us to resolve key bottlenecks such as the poor solubility of a series of drugs, significantly improving drug absorption while also addressing stability issues.” The R&D team independently completed the pharmaceutical development within a relatively short timeframe and has now concluded consultations with the drug regulatory authorities; clinical trial applications are imminent. If approved for market launch, this product will fill a critical gap in the domestic market.

The reporter followed Li Lei as he briskly entered a laboratory. “It feels like there’s never enough time each day,” he remarked. “We have to make the most of every minute and strive to complete the Phase I clinical trial application for this project as soon as possible, so that we can translate our research findings into practical applications that benefit both society and industry.”

Currently, Shijiazhuang Sihua Pharmaceutical has nearly 200 projects in development, including several Class 1 new drugs for the treatment of liver fibrosis and pulmonary arterial hypertension that have either been approved for clinical trials or submitted for such approval. Since the beginning of this year, the company has obtained approval for a total of 41 new products, including the nation’s first and exclusively approved sustained-release theophylline tablets and stiripentol dry suspension—exceeding last year’s total. These innovative achievements are now entering a concentrated “harvest period,” with the company’s R&D efficiency and output in specialty generic drugs ranking among the highest among pharmaceutical enterprises nationwide.

Innovation empowers the application and commercialization of intellectual property achievements. To date, Shijiazhuang Sihua Pharmaceutical has filed a total of 420 patent applications and has been recognized as a National Intellectual Property Advantage Enterprise and a Pilot Enterprise for the Application of Intellectual Property in Industrial Enterprises. Since last year, all 78 newly approved products have been successfully launched, achieving a 100% industrialization rate and injecting new momentum into the company’s high-quality development.

Today, 80% of Shijiazhuang Sihua Pharmaceutical’s profits are generated by new or upgraded products. Innovation has powerfully enabled the continuous optimization and upgrading of the company’s product mix and tiered structure, with its products now sold in 90 countries and regions worldwide, thereby driving the enterprise’s industrial chain toward the mid- to high-end of the value chain.

Shijiazhuang has continuously optimized its industrial development ecosystem and increased financial support, undertaking high-standard construction of the Shijiazhuang International Biopharmaceutical Park, which covers a total planned area of 28,000 mu. Currently, the park is home to more than 200 biopharmaceutical companies, with an increasing number of innovative, high-quality drugs being developed. Hebei Province is supporting Shijiazhuang in accelerating the establishment of a premier hub for biopharmaceutical innovation and development, attracting a large number of high-quality biopharmaceutical enterprises and projects that have taken firm root in the region. As a result, Shijiazhuang’s biopharmaceutical industry is advancing at an ever-faster pace on the path of high-quality development.

(Reprinted from Great Wall Net)

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“Roll Up Our Sleeves and Work Hard—Press On Undeterred by Wind and Rain” Hebei: Driving Innovation to Elevate Manufacturing to the Mid- to High-End of the Value Chain

The Digital Journey of a Bag of Large-Volume Infusion