Shi Si Yao: New product doxofylline approved.


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Time:2020-02-17

Since the outbreak of the COVID-19 pandemic, products developed by Shijiazhuang Sihua Pharmaceutical Co., Ltd.—such as Abidol Hydrochloride Capsules and Moxifloxacin Hydrochloride Sodium Injection—have played a positive role in epidemic prevention and control. On February 6, the company also received the production approval certificate for Doxofylline Injection (10 ml: 0.1 g).
 
 
Since the outbreak of the COVID-19 pandemic, products developed by Shijiazhuang No.4 Pharmaceutical Co., Ltd.—such as Abidor Hydrochloride Capsules and Moxifloxacin Hydrochloride Sodium Injection—have played a positive role in epidemic prevention and control. On February 6, the company also received the production approval certificate for Doxofylline Injection (10 ml: 0.1 g). These encouraging news items have greatly inspired all employees of Shijiazhuang No.4 Pharmaceutical, especially the R&D personnel, further strengthening their confidence in doing a good job and winning the battle against the epidemic.
Sun Lijie, director of the Shiyao Pharmaceutical Research Institute, told reporters that doxofylline is a derivative of methylxanthine. Clinically, it is primarily used to treat bronchial asthma, chronic asthmatic bronchitis, and other respiratory difficulties caused by bronchospasm. This product is a bronchodilator that works by inhibiting phosphodiesterase within smooth muscle cells, thereby relaxing bronchial smooth muscles and effectively controlling asthma symptoms. The drug recently approved by Shiyao Pharmaceutical has received a manufacturing license under the new classification of chemical drugs—Category 4—and has successfully passed the National Medical Products Administration’s review and approval process, demonstrating quality and efficacy consistent with the originator drug.
 
 
▲ Employees at the Shijiazhuang No. 4 Pharmaceutical Research Institute are stepping up efforts to test new products.
 
According to big data statistics from Minenet, under the Southern Institute of Pharmaceutical Economic Research of the National Medical Products Administration, in 2018, the sales volume of aminophylline at the terminal level in China’s public medical institutions reached 3.15 billion yuan, ranking third among the top 10 generic drugs for respiratory system medications. From the perspective of dosage forms, injectables accounted for an overwhelming 97.04% of the market share, far ahead of other formulations. “This innovative achievement not only expands the variety of injectable products—our company’s flagship offerings—but also further optimizes the production and sales structure of our products, which will have a positive impact on promoting the company’s high-quality development,” said Su Xuejun, Chairman of Shiyao Group, with great enthusiasm.
This innovative achievement has greatly boosted the confidence of Shisi Pharmaceutical’s R&D personnel in their commitment to driving the company’s innovative development.
 
 
▲ Employees at the Shijiazhuang No. 4 Pharmaceutical Research Institute are stepping up efforts to test new products.
 
For days on end, more than 310 R&D personnel at Shisi Pharmaceutical have been working tirelessly on the development of new products. “After the Spring Festival, we reorganized and adjusted our ongoing R&D projects, prioritizing those related to epidemic prevention and control,” explained Dr. Sun Lijie, the hospital’s dean. “We’ve also accelerated the resumption of research and bioequivalence evaluations for generic drugs such as abidol hydrochloride and moxifloxacin hydrochloride—both antiviral and antibiotic medications.”
“Right now, everyone is working nearly ten hours a day on average, and even with that, we still feel short of time. We’re literally ‘racing against time,’ having to seize every minute and every second—this isn’t just a necessity for fighting the epidemic; it’s also a requirement for the company’s long-term development,” said Sun Lijie.
 

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