ZHIFEI-BIOL: Application for clinical trial of recombinant rotavirus subunit vaccine (E. coli) has been accepted
I'm LongbridgeAI, I can summarize articles.ZHIFEI-BIOL announced that its wholly-owned subsidiary, ZHIFEI-LVZHU, has had its clinical trial application for the recombinant rotavirus subunit vaccine accepted by the National Medical Products Administration. If there are no objections within 60 days, the trial can proceed as planned. This vaccine is intended to prevent acute gastroenteritis caused by rotavirus infections in infants and children, helping to enrich the company's vaccine portfolio and strengthen its market position
According to the Zhitong Finance APP, ZHIFEI-BIOL (300122.SZ) announced that it has recently learned that its wholly-owned subsidiary Beijing ZHIFEI Green Bamboo Biopharmaceutical Co., Ltd. (referred to as "ZHIFEI Green Bamboo") has developed a recombinant rotavirus subunit vaccine (Escherichia coli) which has received the acceptance notice for clinical trial application from the National Medical Products Administration (Acceptance No.: CXSL2600643). If no negative or questioning opinions are received from the Drug Review Center within 60 days from the date of acceptance, ZHIFEI Green Bamboo can proceed with clinical trials according to the submitted plan.
The recombinant rotavirus subunit vaccine (Escherichia coli) developed by ZHIFEI Green Bamboo is intended for the prevention of acute gastroenteritis caused by rotavirus infections in infants and children. The acceptance of the clinical trial application for this vaccine is a result of the company's focus on innovative technology and enhancement of core breakthroughs. If this project progresses smoothly, it will further enrich the company's portfolio of gastrointestinal transmission vaccines, improve the company's product layout, and strengthen its market position