Indication: Acute diarrhea in children caused by rotavirus
There are over 250 million children aged 0-14 in China, and there is a severe shortage of specialized drugs for children.
SK08 is the first LBP drug in China to directly conduct Phase II clinical trials.
SK08 effectively improves the severity of diarrhea in neonatal mice infected with rotavirus, while also shortening the duration of diarrhea, reducing intestinal viral load and positivity rate, and showing a dose-response relationship.
The mechanism of action is to enhance intestinal barrier function and regulate antiviral immunity.
(sk08)Developed from a unique bacterial strain--Bacteroides fragilis
Class 1 of Therapeutic Biological Product (NMPA), undergoing Phase III clincial trial
the first oral LBP approved for clinical trial by NMPA after 2005
Most of preclinical studies were completed independently by our teams (strain safety assessment, pharmacokinetic, pharmacological and CMC studies, except GLP-compliant safety assessment)
established the development standards of LBP in China, through communication and interactions with CDE and NIFDC ( China national institutes for food and drug control)
Rresearch work has attained the attention from the world ——Nature/Frontiers in microbiology reported
(sk08)the first Bacteroides fragilis-based LBP that obtained FDA IND approval
world's first IND application of LBPs with CID as an indication
the first company in China to advance inactivated preparation of LBP to the clinical stage
Zhiyi has fully penetrated the technical and registration pathway of pre-clinical development of LBP to both FDA and NMPA
indication：chemotherapy induced diarrhea
innovative drug preparation, better safety, more convenient for commercialization
SK10 can inhibit the inflammatory reponse of intestinal epitheliel cells induced by chemotherapy. It protects tight junction protein ZO-1 and intestinal epitheliel barrier, reducing the toxicity and diarrhoea caused by chemotherapy.
(sk10)Indication: Acute diarrhea in children caused by rotavirus
There are over 250 million children aged 0-14 in China, and there is a severe shortage of specialized drugs for children.
SK08 is the first LBP drug in China to directly conduct Phase II clinical trials.
SK08 effectively improves the severity of diarrhea in neonatal mice infected with rotavirus, while also shortening the duration of diarrhea, reducing intestinal viral load and positivity rate, and showing a dose-response relationship.
The mechanism of action is to enhance intestinal barrier function and regulate antiviral immunity.
(sk08)Developed from a unique bacterial strain--Bacteroides fragilis
Class 1 of Therapeutic Biological Product (NMPA), undergoing Phase III clincial trial
the first oral LBP approved for clinical trial by NMPA after 2005
Most of preclinical studies were completed independently by our teams (strain safety assessment, pharmacokinetic, pharmacological and CMC studies, except GLP-compliant safety assessment)
established the development standards of LBP in China, through communication and interactions with CDE and NIFDC ( China national institutes for food and drug control)
Rresearch work has attained the attention from the world ——Nature/Frontiers in microbiology reported
(sk08)the first Bacteroides fragilis-based LBP that obtained FDA IND approval
world's first IND application of LBPs with CID as an indication
the first company in China to advance inactivated preparation of LBP to the clinical stage
Zhiyi has fully penetrated the technical and registration pathway of pre-clinical development of LBP to both FDA and NMPA
indication：chemotherapy induced diarrhea
innovative drug preparation, better safety, more convenient for commercialization
SK10 can inhibit the inflammatory reponse of intestinal epitheliel cells induced by chemotherapy. It protects tight junction protein ZO-1 and intestinal epitheliel barrier, reducing the toxicity and diarrhoea caused by chemotherapy.
(sk10)Indication: Acute diarrhea in children caused by rotavirus
There are over 250 million children aged 0-14 in China, and there is a severe shortage of specialized drugs for children.
SK08 is the first LBP drug in China to directly conduct Phase II clinical trials.
SK08 effectively improves the severity of diarrhea in neonatal mice infected with rotavirus, while also shortening the duration of diarrhea, reducing intestinal viral load and positivity rate, and showing a dose-response relationship.
The mechanism of action is to enhance intestinal barrier function and regulate antiviral immunity.
(sk08)