Innovent Announces Two Registration Studies of IBI306 (anti-PCSK-9 antibody) Met Primary Endpoint

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Feb 16, 2022, 19:00 ET

SAN FRANCISCO and SUZHOU, China, Feb. 16, 2022 /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 that the primary endpoint was met in two Chinese registration studies of recombinant full-human anti-PCSK-9 monoclonal antibody (R&D code: IBI306, independently developed by Innovent), the CREDIT-1 study of non-familiar hypercholesterolemia (non-FH) patients at high / very high cardiovascular risk and the CREDIT-4 study of patients with hypercholesterolemia including non-FH and heterozygous familial hypercholesterolemia (HeFH) in China. The results of CREDIT-1 and CREDIT-4 related studies will be presented at international academic conferences in future.

As of February 2022, three key registration studies of IBI306 have been completed and successfully met the primary endpoint, where CREDIT-2 study for the treatment of Chinese HeFH patients was the first to meet the primary endpoint in August 2021. Innovent 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.

The results of CREDIT-1 study showed that after 48 weeks of continuous treatment with IBI306 in Chinese patients with non-FH at high / very high cardiovascular risk, the low-density lipoprotein cholesterol (LDL-C) levels of the control arm were significantly reduced compared with the placebo arm（LS mean difference of 450 mg Q4W= -65.04%, 97.5%CI: -70.22% ~ -59.86%, p<0.0001; LS mean difference of 600 mg Q6W=-57.31%, 97.5%CI: -63.95% ~ -50.68%, p<0.0001).

CREDIT-4 study has demonstrated that after 12 weeks of continuous treatment with IBI306 in Chinese patients with hypercholesterolemia including non-FH and HeFH, the LDL-C levels of control arm were also significantly reduced compared with the placebo arm (LS mean difference of 450 mg Q4W= -63.02%, 95%CI: -66.48% ~ -59.56%, p<0.0001). During the research period of both studies, IBI306 demonstrates a good safety profile in both studies, similar to the reported safety profile of other marketed PCSK-9 inhibitors.

Hypercholesterolemia is an independent risk factor for cardiovascular diseases such as atherosclerosis, coronary heart disease and stroke, which seriously threaten people's health. The prevalence of hypercholesterolemia in China is as high as 26.3%. For hypercholesterolemia, statins remain as the cornerstone of treatment. Nevertheless, many patients treated with statins still fail to achieve LDL-C reduction targets. Moreover, high - intensity statin therapy may post safety concerns in Chinese population due to ethnic differences in this disease.

PCSK-9 inhibitors, which can potently reduce LDL-C levels with a good safety profile, have been gradually recognized by clinicians as novel therapeutic regimens in recent years. Although there are various imported PCSK-9 inhibitors marketed in the Chinese market, there are some limitations in terms of economy and convenience. IBI306 is an innovative drug independently developed by Innovent. It is the PCSK-9 inhibitor that take the lead in carrying out long-term, large-scale, randomized and double-blind phase III clinical studies in China, and explored and optimized the treatment regimen with long-interval dosing.

The principal investigator of the CREDIT-1 and CREDIT-4 studies, Prof. Yong Huo, from the Peking University First Hospital stated, "The results of two clinical studies, CREDIT-1 and CREDIT-4, are encouraging, especially in CREDIT-1 IBI306 achieved long-interval dosing which showed the LDL-C levels of Chinese patients with hypercholesterolemia were significantly reduced after long-term administration of this regimen. It facilitates achieving better treatment compliance in clinical practice. And we look forward to the approval and marketing of IBI306, to provide a friendlier and accessible treatment option for patients with hypercholesterolemia in China."

Dr. Lei Qian, Executive Director of Innovent, stated: " At present, cardiovascular diseases induced by hyperlipidemia, hypertension, and obesity are prevalent in China and have seriously affected the health of Chinese. Previous CREDIT-2 study has shown that IBI306 can effectively reduce LDL-C levels in Chinese HeFH patients. The results of these two clinical studies, CREDIT-1 and CREDIT-4, further confirmed the clinical significance of IBI306 in the treatment of patients with different types of hypercholesterolemia in China. With the successive completion of various clinical studies, it is expected to propose a new drug application for IBI306 this year. We are very confident that through solid scientific development and clinical research, we will strive to promote high-quality biopharmaceuticals to benefit patients with hypercholesterolemia in China as soon as possible."

About Three Registration Clinical Studies of IBI306

The CREDIT-1 study is a randomized, double-blind, placebo-controlled phase 3 clinical study to assess the efficacy and safety of IBI306 in Chinese patients with non-familial hypercholesterolemia (hypercholesterolemia with cardiovascular risk) (ClinicalTrials.gov, NCT04289285). The primary efficacy measure was the percentage reduction from baseline in LDL-C after 48 weeks of treatment.

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). The primary efficacy endpoint was the percentage reduction from baseline in LDL-C after 12-week treatment.

The CREDIT-4 study was a randomized, double-blind, placebo-controlled phase 3 clinical study to assess the efficacy and safety of IBI306 in Chinese patients with hypercholesterolemia (including non-familial hypercholesterolemia and heterozygous familial hypercholesterolemia) (ClinicalTrials.gov, NCT04709536). The primary efficacy measure was the percentage reduction from baseline in LDL-C after 12 weeks of treatment.

About Hypercholesterolemia

In recent years, the blood lipid level of the Chinese population has gradually increased, and the prevalence of dyslipidemia has increased significantly with an overall prevalence of 40.4% in Chinese adults. The increase of serum cholesterol level in the population will lead to an increase of about 9.2 million cardiovascular disease events in China during 2010 ~ 2030. Dyslipidemia characterized by elevated LDL-C or Total Cholesterol (TC) is an important independent risk factor for atherosclerotic cardiovascular disease.

At present, the treatment of hyperlipidemia in China is not optimistic. According to the 2020 China Cardiovascular Health and Disease Report, the diagnostic rate, treatment rate and control rate of dyslipidemia in Chinese adults is still low. The percentage of patients with dyslipidemia met the LDL-C reduction goal is even more alarming. Current lipid-lowering therapies do not meet the clinical needs in the field of hyperlipidemia. Anti-PCSK-9 monoclonal antibody has a mechanism of action different from existing lipid-lowering drugs and can effectively reduce LDL-C levels, which is expected to provide a better treatment option for Chinese patients with hypercholesterolemia.

About IBI306 (PCSK-9 inhibitor)

IBI306, developed by Innovent, is an lgG2 fully human monoclonal antibody that can specifically bind to PCSK-9 and reduce LDL-C level by inhibiting PCSK-9-mediated low-density lipoprotein receptor (LDLR) endocytosis, subsequently enhancing the clearance of LDL-C, resulting in a reduction in LDL-C level.

As of now, three IBI306 registration trials met the primary endpoint. The results of phase I and II clinical study are published in JACC Asia, an internationally renowned journal of cardiology. CREDIT-2 phase III study results will be disclosed at the ACC meeting 2022.

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 29 valuable assets in the fields of cancer, metabolic, autoimmune disease and other major therapeutic areas, with 6 products – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection), Pemazyre® (pemigatinib oral inhibitor) and Olverematinib (BCR TKI) – officially approved for marketing in China, 5 assets in Phase 3 or pivotal clinical trials, and an additional 18 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. and www.linkedin.com/company/innovent-biologics/.

Note:

TYVYT® (sintilimab injection) is not an approved product in the United States.

BYVASDA® (bevacizumab biosimilar injection), SULINNO®, and HALPRYZA® (rituximab biosimilar injection) are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)
BYVASDA® (bevacizumab biosimilar injection, Innovent)
HALPRYZA® (rituximab 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.

Disclaimer:

1. This indication is still under clinical study, which hasn't been approved in China or the U.S.
2. Innovent does not recommend any off-label usage.
3. For medical and healthcare professionals only.

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