Thederma Shanghai Ltd, a Chinese commercial-stage biotech company, announced on Wednesday that the National Medical Products Administration has approved the use of its proprietary new drug Zedman for patients with atopic dermatitis aged 2 and above.
Chen Genhui, CEO of TSL, said: "We are pleased about NMPA's approval of Zedman as a new therapy for patients with eczema, especially, for pediatric patients who have limited drug options available to help treat their conditions."
"This accelerated decision from the NMPA means patients now have an innovative, efficacious medicine available to manage this challenging disease. The NMPA's decision will make a significant impact on and benefit millions of people suffering from this disease in China," Chen said.
According to Zhang Jianzhong, leading investigator of Zedman's clinical studies at Peking University People's Hospital, eczema is the number one skin disease that affects over 80 million people in China.
As a non-steroidal topical treatment, the approval of Zedman was supported by a comprehensive clinical trial program evaluating its efficacy and safety in patients with eczema aged 2 and above.
With the approval, Gao Xinhua, president of the Chinese Society of Dermatology, noted that with Zedman available as a first-line topical treatment for eczema, now physicians have another much-needed tool for treating their patients, which is great news to a community serious for more treatment options.
