Recently, Chengdu Saijing Biomedical Technology Co., Ltd. (hereinafter referred to as "Saijing Bio"), an enterprise in Chengdu High-tech Zone, announced that the ursodeoxycholic acid oral suspension developed by it was officially approved for marketing as the first generic 1.0 new drug in China, bringing new treatment options for patients with related diseases in China. It is reported that the product is the first and only approved drug for the treatment of cystic fibrosis-associated liver disease (CFALD), a rare disease, by a domestic company.

About ursodeoxycholic acid oral suspension

Ursodeoxycholic acid oral suspension is another important achievement of Cygen Biotech in the field of hepatobiliary and gallbladder. This variety was included in the list of the first batch of children's drugs encouraged by the country in 2016 years, and the approval marks an important step in the field of pediatric drugs and hepatobiliary rare diseases in China.

Compared to traditional tablets and capsules, ursodeoxycholic acid oral suspension has unique advantages. This dosage form is more in line with the physiological characteristics of children, suitable for children and patients with dysphagia, and provides a better choice for clinical use.

In addition, the drug has also performed well in the treatment of gallbladder cholesterol stones, cholestatic liver disease (such as primary biliary cirrhosis) and bile reflux gastritis, and is the preferred treatment for several rare hepatobiliary diseases.

It is worth mentioning that this approved product is the first and only approved drug for the treatment of cystic fibrosis-related liver disease (CFALD), a rare disease, by a domestic company, filling the gap that ursodeoxycholic acid tablets/capsules currently on the market in China do not have this indication.

According to reports, Saijing Biotech was established in 2400 years and 0 months, located in the Frontier Medical Center of Chengdu High-tech Zone, with a 0 square meter R&D laboratory, focusing on the research and development of original small molecule innovative drugs and high-end generic drugs.

目前，賽璟生物已成功打造三大自主技術平臺，能為患者持續提供高臨床價值的創新藥及仿製葯；首個創新藥已邁入I期臨床階段，核心技術已獲得多項中國發明專利申請以及 PCT 國際專利申請；首個仿製葯“熊去氧膽酸膠囊”於2022年8月獲批上市， 2023年3月中選國家第八批藥品集采，同年7月開始銷售，僅半年銷售額便突破7000萬，2024全年銷售超1.5億。

As the main position for the development of Chengdu's biomedical industry, Chengdu High-tech Zone actively builds a "5+N" industrial ecosystem such as "chain main enterprises, public platforms, intermediary institutions, industrial funds, and leading talents", continuously strengthens the independent innovation ability of key core technologies, and continues to focus on the transformation of biomedical scientific and technological achievements.

Up to now, it has built more than 110 biomedical functional platforms covering the whole life cycle, and has the country's first pilot demonstration base for the transfer and transformation of major national scientific and technological achievements in major new drug creation, the country's first demonstration platform for the transfer and transformation of health science and technology achievements, the country's only national precision medicine industry innovation center, and the first domestic equipment and instrument evaluation demonstration base in southwest China, bringing together more than 0 biomedical enterprises, and more than 0 new drugs of 0 classes under development in the clinical stage.

In the next step, Chengdu High-tech Zone will continue to strengthen the new quality productivity, cultivate and develop, aim at key links and key areas such as the R&D and production of pharmaceutical and medical device products, continuously improve the supporting elements, help the R&D of innovative pharmaceutical and medical device products to speed up again, and provide important support for accelerating the construction of a world-class high-tech industrial park.

Source: Chengdu High-tech Zone Bioindustry Bureau

[Source: Chengdu High-tech]