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China's first anti-hemophilic factor product approved

(chinadaily.com.cn) Updated: 2021-08-05

The recombinant coagulation factor VIII (SCT800) administered via injection, manufactured by Sino Cell Tech, a biological medicine provider located in the Beijing Economic-Technological Development Area, has recently been granted domestic market approval, according to the official website of National Medical Products Administration (NMPA).

Public information shows that it is China's first among the list of such products. 

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NMPA releases a list of newly approved drugs on July 23 on its official website. [Photo provided to Beijing Economic-Technological Development Area]

"Innovative pharmaceutical development requires large investment and a long experimental period, so is indeed a risky enterprise. I wish to spare all my efforts to make effective medicines."

As a representative of the area's unicorn enterprises, president of Sino Cell Tech, Xie Liangzhi, always hoped to lead his team to develop medicines that were beneficial to society and to patients through innovation.

After nearly 20 years of hard work, he achieved his vision of the self-developed 14-valent HPV vaccine entering stages of clinic trials, and the recombinant blood coagulation factor VIII product being domestically approved.

SCT800 is mainly used in the elective and preventive treatment of hemophilia A for patients over 12-years of age. It is currently undergoing a phase III preventive treatment study in children, teens and adult patients suffering this disease.

The company has built a 4,000-liter production line with a designed annual production capacity up to 10 billion IU. SCT800 will have sufficient production capacity to meet Chinese patients' needs.

At present, due to insufficient supply and the high price of drugs, the penetration rate of treatment in the country has only been 11.2 percent.

Within this context, the launch of the new product will bring great benefits to hemophilia patients. The penetration rate is expected to increase, and patients will have access to safer drugs.