Shandong Wit Dyne Health Co.Ltd(000915) it was announced on January 10 that the company’s subsidiary Shandong Dayin marine biopharmaceutical Co., Ltd. (hereinafter referred to as “Dayin pharmaceutical”) recently received the notice of approval for drug clinical trial approved and issued by the State Drug Administration (hereinafter referred to as “the State Drug Administration”), which was submitted by Dayin pharmaceutical for injection, According to the drug administration law of the people’s Republic of China and relevant regulations, it is approved to carry out phase I clinical trial for the treatment of children’s hand, foot and mouth disease according to the submitted scheme after examination and meeting the relevant requirements of drug registration.
It is reported that on October 22, 2021, the application for clinical trial of lycorine thioester hydrochloride for injection submitted by dyne pharmaceutical to the State Drug Administration was accepted. The drug is intended for the treatment of children’s hand, foot and mouth disease.
After inquiry, there is no specific anti enterovirus drug for the treatment of hand, foot and mouth disease outside China. At present, the drugs for the treatment of hand, foot and mouth disease declared by other companies in China and intended to continue to be developed are mainly oral dosage forms. As an injection type, the declared product can provide a new treatment option for high-risk people with severe hand, foot and mouth disease or who may progress to severe disease.
According to the requirements of laws and regulations related to drug registration in China, after obtaining the approval documents for clinical trials, the drugs need to carry out clinical trials and be reviewed and approved by the State Food and drug administration before they can be produced and put on the market.
(source: China Securities Journal · China Securities Network)
