Innovent announces that the Phase III clinical study of IBI306 (anti-PCSK-9 monoclonal antibody) for the treatment of Chinese heterozygous familial hypercholesterolemia has reached the primary research endpoint

August 12, 2021, San Francisco, USA and Suzhou, China-Cinda Biopharmaceutical Group (Hong Kong Stock Exchange stock code: 01801), a company dedicated to research and development, production and sales of major cancers, metabolic diseases, autoimmunity, etc.
A biopharmaceutical company, an innovative drug for diseases, announced today: a recombinant fully human anti-proprotein convertase subtilisin 9 (PCSK-9) monoclonal antibody injection (R&D code: IBI306) independently developed by Cinda Bio to treat China The phase III clinical study of heterozygous familial hypercholesterolemia (HeFH) (research code CREDIT-2) reached the primary endpoint
.

The analysis showed that after 12 weeks of continuous treatment with IBI306 in Chinese heterozygous familial hypercholesterolemia patients treated with statin and/or ezetimibe, compared with placebo, low-density lipoprotein cholesterol (LDL-C ) The level has been significantly improved
.

The overall safety of IBI306 during the entire study period was good , similar to the reported safety characteristics of other listed PCSK-9 inhibitors

Significant improvement in low-density lipoprotein cholesterol (LDL-C) levels and good overall safety

The main investigator of the CREDIT-2 study, Professor Zhou Yujie, deputy dean of Anzhen Hospital, Capital Medical University, said: "Although the prevalence of familial hypercholesterolemia is relatively low, considering the huge population of our country, the number of patients is still high.
Ranked among the top in the world
.

Heterozygous patients have an early age of onset, serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) levels increase significantly, the disease progresses rapidly, and the harm is particularly great.

The main investigator of CREDIT-2, Professor Zhou Yujie, deputy dean of Anzhen Hospital Affiliated to Capital Medical University

Dr.
Qian Lei, Executive Director of the Department of Medical Science and Strategic Special Diseases of Cinda Biopharmaceutical Group, said: “In China, patients with heterozygous familial hypercholesterolemia still have a great unmet need for drug treatment.

IBI306 is a letter.

Innovative biological drugs with independent intellectual property rights independently developed by TatBio.

Dr.

About the CREDIT-2 study

The CREDIT-2 study is a randomized, double-blind, placebo-controlled phase III clinical study (ClinicalTrials.
gov, NCT04759534) evaluating the efficacy and safety of IBI306 in subjects with heterozygous familial hypercholesterolemia in China
.

A total of 148 subjects were included in this study

About heterozygous familial hypercholesterolemia (HeFH)

About heterozygous familial hypercholesterolemia (HeFH)

In recent years, the level of blood lipids in the Chinese population has gradually increased, and the prevalence of dyslipidemia has increased significantly
.

The overall prevalence of dyslipidemia in Chinese adults is as high as 40.

Familial hypercholesterolemia refers to the increase in blood cholesterol caused by genetic abnormalities.
It has the characteristics of family aggregation and is inherited in autosomal dominant manner.
It is the main reason for patients with early-onset coronary heart disease
.

The vast majority of patients with familial hypercholesterolemia are caused by single allelic mutations and are classified as heterozygous familial hypercholesterolemia (HeFH)

The China Expert Consensus on Screening, Diagnosis and Treatment of Familial Hypercholesterolemia in China in 2018 recommends statins as the first choice for treatment, and ezetimibe as the first choice for combination therapy.
It can be added to patients with familial high cholesterol who still do not meet the above treatment standards.
PCSK-9 inhibitor
.

About IBI306 (anti-PCSK-9 monoclonal antibody)

About IBI306 (anti-PCSK-9 monoclonal antibody)

IBI306 is an innovative biological drug independently developed by Cinda Biopharmaceuticals.
It is an IgG2 monoclonal antibody that specifically binds to PCSK-9 molecules and reduces PCSK-9-mediated low-density lipoprotein receptor (LDLR) endocytosis.
To increase LDLR levels, which in turn increases LDL-C clearance and lowers LDL-C levels
.

At present, IBI306 has completed phase I clinical research in healthy subjects and phase IIa clinical research in hypercholesterolemia subjects, showing good efficacy and safety

About Cinda Bio

About Cinda Bio

"Starting from the letter, reaching the line", to develop high-quality biological drugs that the common people can afford is the ideal and goal of Cinda Bio
.

Founded in 2011, Cinda Bio is committed to the development, production and sales of innovative drugs for the treatment of tumors, autoimmune, metabolic diseases and other major diseases
.
On October 31, 2018, Cinda Biopharmaceuticals was listed on the main board of The Stock Exchange of Hong Kong Limited, stock code: 01801.

Since its establishment, the company has stood out among many biopharmaceutical companies with its innovative achievements and international operating model
.
A product chain including 25 new drug varieties has been established, covering multiple disease fields such as tumors, metabolic diseases, and autoimmunity.
Among them, 6 varieties have been selected for the national "Major New Drug Creation" project
.
The company has 5 products (sintilimab injection, trade name: Daboshu®, English trademark: TYVYT®; bevacizumab biosimilars, trade name: Dayotong®, English trademark: BYVASDA ®; Adalimumab biosimilar, trade name: Su Lixin®, English trademark: SULINNO®; Rituximab biosimilar, trade name: Dabohua®, English trademark: HALPRYZA®; pemigatinib oral inhibitor , Trade name: Daburtan®, English trademark: PEMAZYRE®) was approved for marketing, 1 product marketing application was accepted by NMPA, Sintilimab's application for marketing in the United States was accepted by FDA, and 5 varieties entered Phase III or critical Sexual clinical research, and another 14 products have entered clinical research
.
Sintilimab successfully entered the National Medical Insurance List in November 2019, becoming the country's first and the only PD-1 inhibitor to enter the National Medical Insurance List that year
.

Cinda Bio has established an internationally advanced high-end biopharmaceutical development and industrialization talent team, including many returned experts, and has cooperated with international partners such as Eli Lilly, Adimab, Incyte, MD Anderson Cancer Center and Hanmi of South Korea.
Reach strategic cooperation
.
Cinda Bio hopes to work with everyone to improve the development level of China's biopharmaceutical industry to meet the people's access to medicines and the people's pursuit of life and health
.
For details, please visit the company's website:
.

statement:

statement:

1.
The indication is the usage of the drug under study, which has not yet been approved in China;

2.
Cinda does not recommend any unapproved drugs/indications
.

3.
For communication and use by medical and health professionals only