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Up to now, the three major key registration clinical studies of IBI306 have all been completed and have successfully reached the primary study endpoints, of which the CREDIT-2 study (treatment of heterozygous familial hypercholesterolemia [HeFH]) has reached the clinical stage in August 2021.
The results of the CREDIT-1 study showed that in Chinese non-familial hypercholesterolemia (non-FH) patients with high-risk/very high-risk cardiovascular risk, after 48 weeks of continuous treatment with each dose group of IBI306, low-density lipoprotein cholesterol (LDL- C) Compared with the baseline reduction level, there was a significant improvement compared with the placebo group (450mg Q4W group: the difference between the groups by least squares estimate was -65.
The results of the CREDIT-4 study showed that in Chinese non-FH and HeFH patients, the relative baseline reduction of LDL-C after 12 weeks of IBI306 treatment was also significantly improved compared with the placebo group (450mg Q4W group The least squares estimated between-group difference was -63.
Hypercholesterolemia is an independent risk factor for cardiovascular diseases such as atherosclerosis, coronary heart disease, and stroke, which seriously threatens people's health.
PCSK-9 inhibitors are gradually recognized by clinicians as a new treatment plan that can effectively reduce LDL-C levels and have good safety in recent years.
The principal investigator of the CREDIT-1 and CREDIT-4 studies, Professor Huo Yong, Peking University First Hospital, said: "The results of the two registered clinical studies of CREDIT-1 and CREDIT-4 are very encouraging
Dr.
Three pivotal registrational clinical studies on IBI306
The CREDIT-1 study is a randomized, double-blind, placebo-controlled Phase III clinical trial evaluating the efficacy and safety of IBI306 in Chinese patients with non-familial hypercholesterolemia (hypercholesterolemia with high/very high risk cardiovascular risk) study (ClinicalTrials.
The CREDIT-2 study is a randomized, double-blind, placebo-controlled Phase III clinical study evaluating the efficacy and safety of IBI306 in Chinese heterozygous familial hypercholesterolemia subjects (ClinicalTrials.
The CREDIT-4 study is a randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of IBI306 in Chinese patients with hypercholesterolemia (including non-familial hypercholesterolemia and heterozygous familial hypercholesterolemia).
About Hypercholesterolemia
In recent years, the blood lipid level of the Chinese population has gradually increased, and the prevalence of dyslipidemia has increased significantly
At present, the treatment of hyperlipidemia in China is not optimistic
About IBI306 (PCSK-9 inhibitor)
IBI306 is an innovative biological drug independently developed by Innovent Biopharmaceuticals.
So far, the three registered clinical studies of IBI306 have all met their primary endpoints
About Innovent
"Begins with faith, achieves in action", and developing high-quality biological drugs affordable to the common people is the ideal and goal of Innovent
Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
.
A product chain including 29 new drug varieties has been established, covering tumor, metabolic diseases, autoimmunity and other disease fields, of which 7 varieties have been selected for the national "Major New Drug Creation" project
.
The company has 6 products (Sintilimab injection, trade name: Daboshu®, English trademark: TYVYT ® ; Bevacizumab biosimilar, trade name: Dayutong® , English trademark: BYVASDA ® ; Adalimumab biosimilars, trade name: Su Lixin® , English trademark: SULINNO® ; Rituximab biosimilars, trade name: Dabohua® , English trademark: HALPRYZA® ; pemigatinib oral inhibitor , trade name: Darbotan® , English trademark: PEMAZYRE® ; Orebatinib tablets, trade name: Nerlik® ) was approved for marketing, 5 varieties entered phase III or pivotal clinical studies, and 18 more A product has entered clinical research
.
Innovent Bio has established a high-end biopharmaceutical development and industrialization talent team with international advanced level, including many returnee experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center and Hanmi in South Korea.
reach a strategic cooperation
.
Innovent Biotechnology hopes to work together with everyone to improve the development level of China's biopharmaceutical industry to meet the availability of medicines and the pursuit of people's good wishes for life and health
.
For more information, please visit the company's website: or the company's LinkedIn account at .
statement:
1.
This indication is a drug under investigation and has not been approved in China;
2.
Innovent does not recommend the use of any unapproved drug/indication
.
3.
For communication use by healthcare professionals only
Forward-Looking Statements
Information published in this press release may contain certain forward-looking statements
.
These statements are inherently subject to considerable risk and uncertainty
.
The use of words such as "anticipates," "believes," "forecasts," "expects," "intends," and other similar words in relation to the Company is intended to identify forward-looking statements
.
The Company undertakes no obligation to continually update these forward-looking statements
.
These forward-looking statements are based on the Company's management's current beliefs, assumptions, expectations, estimates, projections and understanding of future events at the time the statements are made
.
These statements are not guarantees for future development and are subject to risks, uncertainties and other factors, some of which are beyond the control of the company and are difficult to predict
.
Accordingly, actual results may differ materially from those contained in forward-looking statements as a result of future changes and developments in our business, competitive environment, political, economic, legal and social conditions
.
