Shisi Pharmaceutical: New Product Doxofylline Approved


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发布时间:2020-02-17

【概要描述】 Since the onset of the COVID-19 pandemic, products developed by Shijiazhuang Sihua Pharmaceutical Co., Ltd., including Arbidol Hydrochloride Capsules and Moxifloxacin Hydrochloride Sodium Chloride Injection, have played a positive role in epidemic prevention and control. On February 6, the company further obtained the production approval certificate for Doxofylline Injection (10 mL: 0.1 g).
 
 
Since the onset of the COVID-19 pandemic, products developed by Shijiazhuang Sihua Pharmaceutical Co., Ltd.—including Arbidol Hydrochloride Capsules and Moxifloxacin Hydrochloride Sodium Chloride Injection—have played a positive role in epidemic prevention and control. On February 6, the company further secured a production approval certificate for Doxofylline Injection (10 mL: 0.1 g). These encouraging developments have greatly inspired all employees of Shijiazhuang Sihua, particularly the R&D team, reinforcing their confidence in delivering outstanding performance in their current work and in ultimately winning the battle against the epidemic.
Sun Lijie, Director of the Shisi Pharmaceutical Research Institute, told reporters that doxofylline is a methylxanthine derivative primarily used in clinical practice to treat bronchial asthma, chronic asthmatic bronchitis, and other respiratory difficulties caused by bronchospasm. As a bronchodilator, it exerts its therapeutic effect by inhibiting phosphodiesterase in smooth muscle cells and thereby relaxing bronchial smooth muscle, ultimately suppressing asthma attacks. The drug recently approved for Shisi Pharmaceutical was granted a production license under Category 4 of the new classification of chemical drugs and has successfully passed the National Medical Products Administration’s review and approval, demonstrating quality and efficacy equivalent to the originator product.
 
 
▲ Employees at the Shijiazhuang No. 4 Pharmaceutical Research Institute are stepping up trials of new products.
 
According to big-data analysis by MeneNet, a subsidiary of the Southern Institute of Pharmaceutical Economics under the National Medical Products Administration, sales of doxofylline at the end-user level in China’s public medical institutions reached RMB 3.15 billion in 2018, ranking third among the top 10 generic respiratory drugs. In terms of dosage-form distribution, injectables overwhelmingly dominate, accounting for 97.04% of the market share. “This innovative achievement not only expands the range of injectable formulations that are the company’s flagship products but also further optimizes the product mix and sales structure, which will have a positive impact on promoting the company’s high-quality development,” said Su Xuejun, Chairman of Shisi Pharmaceutical, with great enthusiasm.
This innovative achievement has greatly boosted the confidence of Shisiyao’s R&D personnel in dedicating themselves to the company’s innovation and development.
 
 
▲ Employees at the Shijiazhuang No. 4 Pharmaceutical Research Institute are stepping up trials of new products.
 
Over the past few days, more than 310 R&D personnel at Shisi Pharmaceutical have been working intensively on the development of new products. “Following the Spring Festival, we conducted a thorough review and adjustment of our ongoing R&D projects, prioritizing those related to epidemic prevention and control while accelerating follow-up research and bioequivalence evaluations for generic versions of antiviral and antibiotic drugs such as arbidol hydrochloride and moxifloxacin hydrochloride,” said Dr. Sun Lijie, the institute’s president.
“These days, everyone is working roughly ten to twelve hours a day, and even that isn’t enough—time feels perpetually short. We’re in a race against time, leaving no minute unaccounted for. This isn’t just a necessity in the fight against the epidemic; it’s also a critical requirement for the company’s long-term development,” said Sun Lijie.
 

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