Ministry of Science and Technology said Benvitimod cream used for treating mild to moderate psoriasis had been approved by the National Medical Products Administration, China Economy Weekly reported.
The cream is a global first-in-class drug for the disease developed by Beijing Wenfeng Tianji Pharma Ltd and supported by China’s major new drug development program.
Benvitimod is categorised as a “first-in-class” drug, as it uses a new and unique mechanism of action for treating a medical condition. Such drugs are considered to be at the highest-level in terms of breakthrough in the pharmaceutical industry.
The birth of China-made Benvitimod highlights the fast development of an innovation-driven bio-pharmaceutical industry, said Song Ruilin, executive president of China Pharmaceutical Innovation and Research Development Association, at a conference on drug innovation and development on July 16.
Psoriasis is a chronic skin condition that can cause red, scaly patches of skin to appear and there is no cure. More than eight million people in China and more than 125 million worldwide suffer from psoriasis.
Calcipotriol, a form of vitamin D, is the first choice for many patients. It is called the gold-standard therapy for psoriasis patients. Compared with Calcipotriol, Benvitimod cream should be called the diamond-standard therapy, industry insiders said.
The Phase III clinical trial showed that Benvitimod cream has the same and even better curative effect as Calcipotriol, according to the Ministry of Science and Technology. There were no systemic adverse reaction in Phase III study, and Benvitimod has significant advantages over Calcipotriol as it has a rapid onset of effect and long duration of action, as well as a low recurrence rate when patients stop using the medicine.
Behind the new drug are years of continuous efforts by Chen Genghui, co-inventor of Benvitimod and CEO of Beijing Wenfeng Tianji Pharma Ltd, and Zhang Jianzhong, head of the dermatology department of Peking University People’s Hospital, who led the clinical trial of Benvitimod.
In 1999, Chen Genghui’s team obtained the patent for Benvitimod. After 10 years of research and development of Benvitimod, Chen received approval to begin clinical trials in 2009.
After dermatologists of several top hospitals turned him down, he met Zhang Jianzhong at Peking University People’s Hospital.