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On July 12, the 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 should be called the diamond-standard therapy, industry insiders said.
The Phase III clinical trial showed that Benvitimod 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.
"At first, I also doubted what he said," Zhang said, "Over the years, I have seen too many people claiming to have the cure to psoriasis." But ambition and tenacity eventually brought the two together.
Between 2009 and 2016, Zhang led the clinical trial of Phases I, II and III on more than 1,200 patients. The Phase III clinical trial covered more than 730 patients from 22 major hospitals across China.
During the Phase III clinical trial, the Center for Drug Evaluation under NMPA required them to compare Benvitimod with the gold-standard Calcipotriol and conduct a double blind experiment. "When the result was announced, my heart was about to pop out," said Chen. The double blind experiment showed that Benvitimod is more effective.
At the annual meeting of American Academy of Dermatology in 2017, Zhang was invited to deliver a speech on their research on Benvitimod, drawing much attention from international counterparts.
"New drug research and development is mainly conducted in Western countries, but China also has advantages in some domains, like Benvitimod," said Zhang. "We should have faith in ourselves."
Researching and developing new drugs is widely considered to be the biggest gamble in the world. A report issued by Deloitte shows that the spending on a new drug, from research and development to putting it on sale, has risen from $1.2 billion in 2010 to $2 billion in 2017.
"The success rate in the pharmaceutical industry is 0.01 percent, and the chance of being rated as a first-in-class drug shrinks to 0.003 percent," Chen said.
"I never gave up because I always had faith that the drug is going to work," Chen said. "I thought, when we succeed, future generations will always remember Benvitimod cream is developed by the Chinese."
On July 19, the production of Benvitimod cream officially began.
"Theoretically speaking, doctors will be able to write prescriptions for the Benvitimod in the very near future," Chen said.personalized plastic braceletscustom photo braceletfibromyalgia bracelet siliconecheap silicone bracelets canadasilicone wrist bands