Accessibility Statement Skip Navigation
  • Resources
  • Blog
  • Journalists
  • Client Login
  • Send a Release
Return to PR Newswire homepage
  • News
  • Products
  • Contact
When typing in this field, a list of search results will appear and be automatically updated as you type.

Searching for your content...

No results found. Please change your search terms and try again.
  • News in Focus
      • Browse News Releases

      • All News Releases
      • All Public Company
      • English-only
      • News Releases Overview

      • Multimedia Gallery

      • All Multimedia
      • All Photos
      • All Videos
      • Multimedia Gallery Overview

      • Trending Topics

      • All Trending Topics
  • Business & Money
      • Auto & Transportation

      • All Automotive & Transportation
      • Aerospace, Defense
      • Air Freight
      • Airlines & Aviation
      • Automotive
      • Maritime & Shipbuilding
      • Railroads and Intermodal Transportation
      • Supply Chain/Logistics
      • Transportation, Trucking & Railroad
      • Travel
      • Trucking and Road Transportation
      • Auto & Transportation Overview

      • View All Auto & Transportation

      • Business Technology

      • All Business Technology
      • Blockchain
      • Broadcast Tech
      • Computer & Electronics
      • Computer Hardware
      • Computer Software
      • Data Analytics
      • Electronic Commerce
      • Electronic Components
      • Electronic Design Automation
      • Financial Technology
      • High Tech Security
      • Internet Technology
      • Nanotechnology
      • Networks
      • Peripherals
      • Semiconductors
      • Business Technology Overview

      • View All Business Technology

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Financial Services & Investing

      • All Financial Services & Investing
      • Accounting News & Issues
      • Acquisitions, Mergers and Takeovers
      • Banking & Financial Services
      • Bankruptcy
      • Bond & Stock Ratings
      • Conference Call Announcements
      • Contracts
      • Cryptocurrency
      • Dividends
      • Earnings
      • Earnings Forecasts & Projections
      • Financing Agreements
      • Insurance
      • Investments Opinions
      • Joint Ventures
      • Mutual Funds
      • Private Placement
      • Real Estate
      • Restructuring & Recapitalization
      • Sales Reports
      • Shareholder Activism
      • Shareholder Meetings
      • Stock Offering
      • Stock Split
      • Venture Capital
      • Financial Services & Investing Overview

      • View All Financial Services & Investing

      • General Business

      • All General Business
      • Awards
      • Commercial Real Estate
      • Corporate Expansion
      • Earnings
      • Environmental, Social and Governance (ESG)
      • Human Resource & Workforce Management
      • Licensing
      • New Products & Services
      • Obituaries
      • Outsourcing Businesses
      • Overseas Real Estate (non-US)
      • Personnel Announcements
      • Real Estate Transactions
      • Residential Real Estate
      • Small Business Services
      • Socially Responsible Investing
      • Surveys, Polls and Research
      • Trade Show News
      • General Business Overview

      • View All General Business

  • Science & Tech
      • Consumer Technology

      • All Consumer Technology
      • Artificial Intelligence
      • Blockchain
      • Cloud Computing/Internet of Things
      • Computer Electronics
      • Computer Hardware
      • Computer Software
      • Consumer Electronics
      • Cryptocurrency
      • Data Analytics
      • Electronic Commerce
      • Electronic Gaming
      • Financial Technology
      • Mobile Entertainment
      • Multimedia & Internet
      • Peripherals
      • Social Media
      • STEM (Science, Tech, Engineering, Math)
      • Supply Chain/Logistics
      • Wireless Communications
      • Consumer Technology Overview

      • View All Consumer Technology

      • Energy & Natural Resources

      • All Energy
      • Alternative Energies
      • Chemical
      • Electrical Utilities
      • Gas
      • General Manufacturing
      • Mining
      • Mining & Metals
      • Oil & Energy
      • Oil and Gas Discoveries
      • Utilities
      • Water Utilities
      • Energy & Natural Resources Overview

      • View All Energy & Natural Resources

      • Environ­ment

      • All Environ­ment
      • Conservation & Recycling
      • Environmental Issues
      • Environmental Policy
      • Environmental Products & Services
      • Green Technology
      • Natural Disasters
      • Environ­ment Overview

      • View All Environ­ment

      • Heavy Industry & Manufacturing

      • All Heavy Industry & Manufacturing
      • Aerospace & Defense
      • Agriculture
      • Chemical
      • Construction & Building
      • General Manufacturing
      • HVAC (Heating, Ventilation and Air-Conditioning)
      • Machinery
      • Machine Tools, Metalworking and Metallurgy
      • Mining
      • Mining & Metals
      • Paper, Forest Products & Containers
      • Precious Metals
      • Textiles
      • Tobacco
      • Heavy Industry & Manufacturing Overview

      • View All Heavy Industry & Manufacturing

      • Telecomm­unications

      • All Telecomm­unications
      • Carriers and Services
      • Mobile Entertainment
      • Networks
      • Peripherals
      • Telecommunications Equipment
      • Telecommunications Industry
      • VoIP (Voice over Internet Protocol)
      • Wireless Communications
      • Telecomm­unications Overview

      • View All Telecomm­unications

  • Lifestyle & Health
      • Consumer Products & Retail

      • All Consumer Products & Retail
      • Animals & Pets
      • Beers, Wines and Spirits
      • Beverages
      • Bridal Services
      • Cannabis
      • Cosmetics and Personal Care
      • Fashion
      • Food & Beverages
      • Furniture and Furnishings
      • Home Improvement
      • Household, Consumer & Cosmetics
      • Household Products
      • Jewelry
      • Non-Alcoholic Beverages
      • Office Products
      • Organic Food
      • Product Recalls
      • Restaurants
      • Retail
      • Supermarkets
      • Toys
      • Consumer Products & Retail Overview

      • View All Consumer Products & Retail

      • Entertain­ment & Media

      • All Entertain­ment & Media
      • Advertising
      • Art
      • Books
      • Entertainment
      • Film and Motion Picture
      • Magazines
      • Music
      • Publishing & Information Services
      • Radio & Podcast
      • Television
      • Entertain­ment & Media Overview

      • View All Entertain­ment & Media

      • Health

      • All Health
      • Biometrics
      • Biotechnology
      • Clinical Trials & Medical Discoveries
      • Dentistry
      • FDA Approval
      • Fitness/Wellness
      • Health Care & Hospitals
      • Health Insurance
      • Infection Control
      • International Medical Approval
      • Medical Equipment
      • Medical Pharmaceuticals
      • Mental Health
      • Pharmaceuticals
      • Supplementary Medicine
      • Health Overview

      • View All Health

      • Sports

      • All Sports
      • General Sports
      • Outdoors, Camping & Hiking
      • Sporting Events
      • Sports Equipment & Accessories
      • Sports Overview

      • View All Sports

      • Travel

      • All Travel
      • Amusement Parks and Tourist Attractions
      • Gambling & Casinos
      • Hotels and Resorts
      • Leisure & Tourism
      • Outdoors, Camping & Hiking
      • Passenger Aviation
      • Travel Industry
      • Travel Overview

      • View All Travel

  • Policy & Public Interest
      • Policy & Public Interest

      • All Policy & Public Interest
      • Advocacy Group Opinion
      • Animal Welfare
      • Congressional & Presidential Campaigns
      • Corporate Social Responsibility
      • Domestic Policy
      • Economic News, Trends, Analysis
      • Education
      • Environmental
      • European Government
      • FDA Approval
      • Federal and State Legislation
      • Federal Executive Branch & Agency
      • Foreign Policy & International Affairs
      • Homeland Security
      • Labor & Union
      • Legal Issues
      • Natural Disasters
      • Not For Profit
      • Patent Law
      • Public Safety
      • Trade Policy
      • U.S. State Policy
      • Policy & Public Interest Overview

      • View All Policy & Public Interest

  • People & Culture
      • People & Culture

      • All People & Culture
      • Aboriginal, First Nations & Native American
      • African American
      • Asian American
      • Children
      • Diversity, Equity & Inclusion
      • Hispanic
      • Lesbian, Gay & Bisexual
      • Men's Interest
      • People with Disabilities
      • Religion
      • Senior Citizens
      • Veterans
      • Women
      • People & Culture Overview

      • View All People & Culture

      • In-Language News

      • Arabic
      • español
      • português
      • Česko
      • Danmark
      • Deutschland
      • España
      • France
      • Italia
      • Nederland
      • Norge
      • Polska
      • Portugal
      • Россия
      • Slovensko
      • Suomi
      • Sverige
  • Overview
  • Distribution by PR Newswire
  • AI Tools
  • Multichannel Amplification
  • Guaranteed Paid Placement
  • SocialBoost
  • All Products
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Hamburger menu
  • PR Newswire: news distribution, targeting and monitoring
  • Send a Release
    • ALL CONTACT INFO
    • Contact Us

      888-776-0942
      from 8 AM - 10 PM ET

  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • News in Focus
    • Browse All News
    • Multimedia Gallery
    • Trending Topics
  • Business & Money
    • Auto & Transportation
    • Business Technology
    • Entertain­ment & Media
    • Financial Services & Investing
    • General Business
  • Science & Tech
    • Consumer Technology
    • Energy & Natural Resources
    • Environ­ment
    • Heavy Industry & Manufacturing
    • Telecomm­unications
  • Lifestyle & Health
    • Consumer Products & Retail
    • Entertain­ment & Media
    • Health
    • Sports
    • Travel
  • Policy & Public Interest
  • People & Culture
    • People & Culture
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • Overview
  • Distribution by PR Newswire
  • AI Tools
  • Multichannel Amplification
  • SocialBoost
  • All Products
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices
  • Send a Release
  • Client Login
  • Resources
  • Blog
  • Journalists
  • RSS

Innovent Announces IBI306 (anti-PCSK-9 antibody) Meets the Primary Endpoint in a Phase 3 Clinical Study for Chinese Heterozygous Familial Hypercholesterolemia


News provided by

Innovent Biologics

Aug 11, 2021, 20:00 ET

Share this article

Share toX

Share this article

Share toX

SAN FRANCISCO and SUZHOU, China, Aug. 11, 2021 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune and other major diseases, announces today that the primary endpoint was met in the phase 3 study CREDIT-2 of recombinant fully human anti-PCSK-9 monoclonal antibody (R&D code: IBI306, independently developed by Innovent) for the treatment of Chinese heterozygous familial hypercholesterolemia (HeFH).

The analysis showed that after 12 weeks of continuous treatment with IBI306 in Chinese patients with heterozygous familial hypercholesterolemia who have been previously treated with statins and/or ezetimibe, their low-density lipoprotein cholesterol (LDL-C) levels were significantly reduced compared with the placebo arm. Throughout the study, IBI306 demonstrates a favorable safety profile, similar to the reported safety profiles of other marketed PCSK-9 inhibitors.

The principal investigator of the CREDIT-2 study, Prof. Yujie Zhou, Vice President of Anzhen Hospital, from the Capital Medical University stated, "Although the prevalence of familial hypercholesterolemia is relatively low, due to the large population in China, the absolute number of patients still ranks among the highest in the world. Heterozygous patients often progress rapidly with an early onset, resulting in the significant increase of the serum total cholesterol (TC) and low density lipoprotein (LDL-C) levels. Patients may experience severe atherosclerotic cardiovascular disease (ASCVD) or even death in early and middle ages. Recently, PCSK-9 inhibitors, as a new class of effective therapy to treat familial hypercholesterolemia, have been recommended by the US, EU and China guidelines. Although there are imported PCSK-9 inhibitors on the China market, there is a lack of evidence in Chinese heterozygous familial hypercholesterolemia. We are very pleased to announce that as one of the key registration studies of a Chinese innovative anti-PCSK-9 monoclonal antibody IBI306, CREDIT-2 has met its primary endpoint. For the first time, Chinese researchers have confirmed that anti-PCSK-9 monoclonal antibody can significantly reduce LDL-C levels with an overall favorable safety profile in such patient population through a randomized, double-blind, controlled study. This study provides new high-quality clinical evidence for the treatment of Chinese heterozygous familial hypercholesterolemia population."

Dr. Lei Qian, Executive Director of Medical Sciences and Strategies of Special Diseases of Innovent, stated: " There remains a great unmet medical need in Chinese patients with heterozygous familial hypercholesterolemia. As a novel PCSK-9 inhibitor developed by Innovent with independent intellectual property rights, previous study results showed that IBI306 could effectively reduce TC and LDL-C levels in patients with hypercholesterolemia, and the success of CREDIT-2 further validated the efficacy of IBI306 and was also a key step in the registration of IBI306. We hope to provide clinicians with an effective, safe, and more accessible treatment option through innovative development strategies and solid research design, so as to achieve the goal of benefiting more patients with hypercholesterolemia. I am confident and looking forward to the results of other pivotal registrational studies of IBI306."

About CREDIT-2 study

The CREDIT-2 study is a randomized, double-blind, placebo-controlled phase 3 study to evaluate the efficacy and safety of IBI306 in Chinese subjects with heterozygous familial hypercholesterolemia (ClinicalTrials.gov, NCT04759534). A total of 148 eligible patients were enrolled. The primary efficacy endpoint was the percentage reduction from baseline in LDL-C after 12-week treatment.

About Heterozygous Familial Hypercholesterolemia (HeFH)

In recent years, the blood lipid level of Chinese population has gradually increased. As a result, the prevalence of dyslipidemia has increased significantly. The overall prevalence of dyslipidemia in Chinese adults is as high as 40.4%. The increase of serum cholesterol level in the population will lead to an increase of about 9.2 million cardiovascular diseases in China from 2010 ~ 2030. Dyslipidemia characterized by elevated LDL-C or TC is a well-established risk factor for atherosclerotic cardiovascular disease

Familial hypercholesterolemia, the main cause of premature coronary heart disease, refers to elevated blood cholesterol due to genetic abnormalities, which is characterized by familial aggregation and autosomal dominant inheritance. The vast majority of patients with familial hypercholesterolemia are caused by single allele mutation and are classified as heterozygous familial hypercholesterolemia. The incidence of HeFH is about 1 in 500 to 1 in 200.

In 2018, the Chinese Expert Consensus on Screening, Diagnosis and Treatment of Familial Hypercholesterolemia in China recommended statins as the first line of treatment and ezetimibe as the first choice of combination therapy. PCSK-9 inhibitors may be administered to patients with familial hypercholesterolemia who did not achieve favorable response after treated with statins and/or ezetimibe.

About IBI306 (Anti-PCSK-9 antibody)

IBI306, developed by Innovent, is an lgG2 monoclonal antibody that can specifically bind to PCSK-9 and reduce LDL-C level by inhibiting PCSK-9-mediated low-density lipoproteinreceptor (LDL-R) endocytosis, subsequently enhancing the clearance of LDL-C, resulting in the reduction of the LDL-C level. At present, a phase I clinical study in healthy subjects and a phase IIa clinical study in subjects with hypercholesterolemia have been completed for IBI306, demonstrating good efficacy and favorable safety. CREDIT-2 is the first phase 3 study, and several clinical studies are still ongoing to assess the efficacy and safety of IBI306 in patients with various types of hypercholesterolemia.

About Innovent

Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high-quality innovative medicines for the treatment of cancer, autoimmune, metabolic and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.

Since its inception, Innovent has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 25 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 5 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) and Pemazyre® (pemigatinib oral inhibitor) – officially approved for marketing, 1 asset's NDA under NMPA review, sintilimab's Biologics License Application (BLA) acceptance in the U.S., 5 assets in Phase 3 or pivotal clinical trials, and an additional 14 molecules in clinical studies.

Innovent has built an international team with advanced talent in high-end biological drug development and commercialization, including many global experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, MD Anderson Cancer Center, Hanmi and other international partners. Innovent strives to work with many collaborators to help advance China's biopharmaceutical industry, improve drug availability and enhance the quality of the patients' lives. For more information, please visit: www.innoventbio.com.

Note:

Sintilimab is not an approved product in the United States.
BYVASDA® (bevacizumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), and SULINNO® (adalimumab biosimilar injection) are not approved products in the United States.
TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
SULINNO® (adalimumab biosimilar injection, Innovent)
Pemazyre® (pemigatinib oral inhibitor, Incyte Corporation). Pemazyre® was discovered by Incyte Corporation and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions.

SOURCE Innovent Biologics

WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM?

icon3
440k+
Newsrooms &
Influencers
icon1
9k+
Digital Media
Outlets
icon2
270k+
Journalists
Opted In
GET STARTED

Modal title

Also from this source

Innovent Announces Mazdutide Received Approval from China's NMPA for Glycemic Control in Adults with Type 2 Diabetes

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes...

Innovent's Partner Ollin Announces Clinical Updates on IBI324 (OLN324, VEGF/ANG-2)

Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures, and commercializes...

More Releases From This Source

Explore

Biotechnology

Biotechnology

Health Care & Hospitals

Health Care & Hospitals

Pharmaceuticals

Pharmaceuticals

Medical Pharmaceuticals

Medical Pharmaceuticals

News Releases in Similar Topics

Contact PR Newswire

  • Call PR Newswire at 888-776-0942
    from 8 AM - 9 PM ET
  • Chat with an Expert
  • General Inquiries
  • Editorial Bureaus
  • Partnerships
  • Media Inquiries
  • Worldwide Offices

Products

  • For Marketers
  • For Public Relations
  • For IR & Compliance
  • For Agency
  • All Products

About

  • About PR Newswire
  • About Cision
  • Become a Publishing Partner
  • Become a Channel Partner
  • Careers
  • Accessibility Statement
  • APAC
  • APAC - Simplified Chinese
  • APAC - Traditional Chinese
  • Brazil
  • Canada
  • Czech
  • Denmark
  • Finland
  • France
  • Germany
  • India
  • Indonesia
  • Israel
  • Italy
  • Japan
  • Korea
  • Mexico
  • Middle East
  • Middle East - Arabic
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Russia
  • Slovakia
  • Spain
  • Sweden
  • United Kingdom
  • Vietnam

My Services

  • All New Releases
  • Platform
  • ProfNet
  • Data Privacy

Do not sell or share my personal information:

  • Submit via [email protected] 
  • Call Privacy toll-free: 877-297-8921

Contact PR Newswire

Products

About

My Services
  • All News Releases
  • Platform
  • ProfNet
Call PR Newswire at
888-776-0942
  • Terms of Use
  • Privacy Policy
  • Information Security Policy
  • Site Map
  • RSS
  • Cookies
Copyright © 2025 Cision US Inc.