Trial Profile
A Randomized, Double-blind, Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of IBI306 in Patients With Hypercholesterolemia in China (CREDIT-4)
Status:
Recruiting
Phase of Trial:
Phase III
Latest Information Update: 21 Aug 2023
Price :
$35
*
At a glance
- Drugs Tafolecimab (Primary)
- Indications Hypercholesterolaemia
- Focus Registrational; Therapeutic Use
- Acronyms CREDIT-4
- Sponsors Innovent Biologics
- 17 Aug 2023 According to Innovent Biologics media release, based on results from three Phase 3 registrational clinical trials (CREDIT-1, CREDIT-2, and CREDIT-4); Chinas National Medical Products Administration (NMPA) has approved SINTBILO (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia
- 13 Jun 2022 According to Innovent Biologics media release, China's National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection for the treatment of primary hypercholesterolemia including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia and mixed dyslipidemia. The NDA submission was based on the study results of three phase 3 registration clinical trials (CREDIT-1, CREDIT-2 and CREDIT-4).
- 16 Feb 2022 According to an Innovent Biologics media release, the company plans to communicate with the Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) on the submission of a new drug application (NDA) for IBI306 in patients with primary hypercholesterolemia and combined hyperlipidemia.