Innovent Releases Results of a Phase 3 Clinical Study of Tafolecimab（IBI306）in Chinese Patients with non- Familial Hypercholesterolemia at the American Heart Association (AHA) Scirntific Sessions 2022

ROCKVILLE, M.D. and SUZHOU, China, Nov 6, 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, ophthalmology and other major diseases, announces that the results of a phase 3 clinical study (CREDIT-1) of tafolecimab (IBI306), a recombinant fully human anti-PCSK-9 monoclonal antibody, in Chinese patients with non-familial hypercholesterolemia (non-FH) were presented at the American Heart Association (AHA) Scientific Sessions 2022 as an e-poster (VP173).

Cardiovascular disease is currently the leading cause of death in China, and hypercholesterolemia is one of the most important risk factors leading to cardiovascular disease. Chinese guidelines for the prevention and treatment of dyslipidemia in adults recommend the use of statin therapy for lipid control. However, most patients, especially those who are at high or very-high cardiovascular risk with hypercholesterolemia, still need additional non-statin therapy to achieve lipid-lowering goals. In recent years, PCSK9 inhibitors have shown significant lipid-lowering efficacy and provided new treatment options for these patients. Tafolecimab is an innovative PCSK9 monoclonal antibody developed by Innovent. It is also the first PCSK9 inhibitor that performed a large-scale randomized phase 3 clinical study in China.

CREDIT-1 is a randomized, double-blind, placebo-controlled phase 3 clinical study (ClinicalTrials.gov, NCT04289285) to assess the efficacy and safety of tafolecimab in Chinese subjects with non-familial hypercholesterolemia. Patients on stable lipid-lowering therapies for at least 4 weeks were randomized 2:2:1:1 to receive subcutaneous tafolecimab 450 mg every 4 weeks (Q4W), tafolecimab 600 mg every 6 weeks (Q6W), placebo Q4W or placebo Q6W for 48 weeks. The primary endpoint was the percent change from baseline to week 48 in LDL-C levels.

A total of 618 subjects (baseline LDL-C level: 2.85mmol/L) were enrolled and 614 received at least one dose of the study treatment. Results show that both regimens of tafolecimab treatment induced significant reductions in LDL-C levels. 

• Compared with placebo, the treatment difference of mean change in LDL-C level from baseline to week 48 was –65.0% with tafolecimab 450 mg Q4W group and –57.3% with tafolecimab 600 mg Q6W group (both P < 0.0001).
• About the 450mg Q4W of the tafolecimab group: 87.8% of subjects receiving tafolecimab achieved ≥50% reduction from baseline to week 48 in LDL-C levels; 91.7% of subjects receiving tafolecimab achieved LDL-C <1.8 mmol/L; 83.4% of subjects receiving tafolecimab achieved LDL-C <1.4 mmol/L.
• About the 600mg Q6W of the tafolecimab group: 82.1% of subjects receiving tafolecimab achieved LDL-C <1.8 mmol/L; 68.7% of subjects receiving tafolecimab achieved LDL-C <1.4 mmol/L. 

Meanwhile, significant reductions in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB) and lipoprotein(a)（Lp(a)）levels were achieved with both dose regimens of tafolecimab versus placebo at week 48. Tafolecimab was well tolerated and the safety profile was similar to those of other PCSK9 monoclonal antibodies.

To conclude, tafolecimab administered at either 450 mg Q4W or 600 mg Q6W yielded significant and durable reductions in LDL-C levels and showed a favorable safety profile in Chinese patients with non-familial hypercholesterolemia. In June 2022, the 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. Tafolecimab will potentially be the first approved locally-developed PCSK9 monoclonal antibody in China.

Prof. Yong Huo, principal investigator of the CREDIT-1 study, Peking University First Hospital, stated, "CREDIT-1 is the large-scale phase 3 trial in China to evaluate the efficacy and safety of PCSK-9 inhibitors in Chinese patients with non-familial hypercholesterolemia. The results of this study demonstrated that long dosing intervals (Q4W or Q6W) treatment of tafolecimab significantly reduced LDL-C levels and improved other lipid parameters. Significant therapeutic benefits and favorable safety were found in Chinese patients with non-FH who received tafolecimab treatment. I am very confident in the clinical application of tafolecimab and looking forward to its approval and launch-to-market earlier next year, bringing significant efficacy, good safety, more friendly and accessible treatment options for Chinese patients with hypercholesterolemia."

Dr. Lei Qian, Vice President of Innovent, stated: " In CREDIT-1, tafolecimab showed significant efficacy and favorable safety in Chinese patients with non-familial hypercholesterolemia. Tafolecimab is a pioneer of local PCSK9 inhibitors independently developed in China. The CREDIT-1 study, as the first pivotal study of PCSK9 inhibitors in China to appear on the international academic stage, shows the excellent scientific research level of Chinese researchers as well as the solid research and development capabilities of Innovent. Meanwhile, the new drug application for tafolecimab has been officially accepted by the CDE and is currently under review. We hope that this high-quality biological drug will benefit the majority of patients with hypercholesterolemia in China early next year."

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 in serum cholesterol levels in the population will lead to an increase of about 9.2 million cardiovascular disease events in China from 2010 to 2030.

At present, the management of hyperlipidemia in China is not optimistic. According to the 2020 China Cardiovascular Health and Disease Report, the diagnostic, treatment and control rate of dyslipidemia in Chinese adults remain low. The anti-PCSK-9 monoclonal antibody 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 pivotal trials have been finished. The results from phase 1 and 2 clinical studies have been published in JACC Asia, an internationally renowned journal of cardiology. The results of the CREDIT-2 phase 3 study have been accepted and presented as a poster at the American Cardiology Association Annual Congress 2022 (ACC 2022). The results of the CREDIT-1 phase 3 study have also been accepted and presented as a poster at the American Heart Association (AHA) Scientific Sessions 2022.

About Three Pivotal 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. Results of this study were presented as a poster at the American Heart Association (AHA 2022) Scientific Session 2022 .

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, NCT04179669). The primary efficacy endpoint was the percentage reduction from baseline in LDL-C after 12-week treatment. Certain findings of this study were presented as a poster at the American Cardiology Association Annual Congress 2022 (ACC 2022).

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 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 disease, metabolic disorder 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 35 valuable assets in the fields of cancer, metabolic disorder, autoimmune disease and other major therapeutic areas, with 8 approved products on the market. These include: TYVYT (sintilimab injection), BYVASDA (bevacizumab biosimilar injection), SULINNO (adalimumab biosimilar injection), HALPRYZA (rituximab biosimilar injection), Pemazyre (pemigatinib oral inhibitor), olverembatinib （BCRABLTKI, Cyramza (ramucirumab) and selpercatinib. An additional 2 assets are under NMPA NDA review, 4 assets are in Phase 3 or pivotal clinical trials, and 21 more molecules are 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, Sanofi, Adimab, Incyte, MD Anderson Cancer Center 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.

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.

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