Innovent Announces the NMPA Approval of SINTBILO® (Tafolecimab Injection) for the Treatment of Adult Patients with Primary Hypercholesterolemia and Mixed Dyslipidemia

ROCKVILLE, Md. and SUZHOU, China, Aug. 16, 2023 /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, autoimmune, metabolic, ophthalmology and other major diseases, announces that China's National Medical Products Administration (NMPA) has approved SINTBILO^® (tafolecimab injection, anti-PCSK9 monoclonal antibody) for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. As the first domestic PCSK9 inhibitor approved in China, SINTBILO^® (tafolecimab injection) is Innovent's first drug entering the cardiovascular field, as well as the Company's tenth product in its commercial portfolio .

The prevalence of cardiovascular diseases is continuously increasing in China, among which atherosclerotic cardiovascular disease (ASCVD) is the leading cause contributing more than 40% of deaths in Chinese residents. Dyslipidemia is one of the most common and dangerous risk factors of ASCVD. In particular, elevated low-density lipoprotein cholesterol (LDL-C) is the major risk factor driving the occurrence and progression of ASCVD. SINTBILO^® (tafolecimab injection), as the first domestic fully human anti-PCSK9 monoclonal antibody approved in China, provides significantly and sustained LDL-C reduction, bringing a new treatment option for cholesterol management in China.

This approval is based on the results of three Phase 3 registrational clinical trials (CREDIT-1, CREDIT-2, and CREDIT-4). The approved dosing regimens include 150 mg Q2W, 450 mg Q4W, and 600 mg Q6W, all of which are effective in reducing LDL-C, total cholesterol (TC), non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and lipoprotein a（Lp(a)） levels as observed in the Phase 3 registrational clinical trials. The diverse treatment regimens will provide more individualized choices for cardiologists and patients.

Prof. Junbo Ge, Zhongshan Hospital Affiliated to Fudan University, stated, "Despite decades of efforts from Chinese cardiologists, we have not seen the turning point of decline in cardiovascular events yet. We urgently need more effective therapies to manage various cardiovascular risks, reduce the incidence and relieve the burden of cardiovascular diseases in China. LDL-C is a primary causal risk of cardiovascular disease death while the current clinical management can hardly reach guideline-recommended LDL-C targets in Chinese patients; PCSK9 inhibitors will play an important role in blood lipids management. I am glad to see the first innovative domestic PCSK9 inhibitor tafolecimab is approved in Chinese market, and hope that Innovent can bring more innovative medicines to the cardiovascular disease area in the future."

Prof. Yong Huo, Peking University First Hospital, stated,"PCSK9 inhibitors are a new class of cholesterol-lowering agents that potently lower LDL-C levels with a good safety profile. Tafolecimab has demonstrated strong lipid-lowering efficacy and favorable safety in multiple Phase 3 registrational trials. Moreover, compared with imported PCSK9 monoclonal antibodies on the market, tafolecimab could be dosed in longer interval. I hope tafolecimab will provide a more accessible and high-quality lipid-lowering treatment option for the broad patients with hypercholesterolemia and mixed dyslipidemia."

Professor Yujie Zhou, Beijing Anzhen Hospital Affiliated to Capital Medical University, stated, "Patients with familial hypercholesterolemia are characterized by early onset age and high cardiovascular risk, which are of great harm to them. Patients are unable to adequately lower their LDL-C level even with combination therapy of moderate-to-high-dose statins and ezetimibe, highlighting the need for alternative strong and safe lipid-lowering agents. CREDIT-2 is the first randomized, double-blind, placebo-controlled large-scale clinical study in Chinese patients with heterozygous familial hypercholesterolemia, and the results fully validate the efficacy and safety of tafolecimab. I am pleased to see that tafolecimab is approved in China based on the results of this study and other Phase 3 registration trials, and its clinical application will certainly benefit Chinese patients with heterozygous familial hypercholesterolemia."

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated," Tafolecimab has the advantage of a longer dosing interval compared with other PCSK9 monoclonal antibody agents and a significant decrease in Lp(a). As the first PCSK9 antibody with proprietary intellectual property rights in China, the clinical development of tafolecimab condensed the efforts of many domestic experts, demonstrated the recognition from the regulatory authorities, and the strength and capabilities of Innovent in the field of cardiovascular diseases. The approval of tafolecimab marks a meaningful milestone for Innovent's strategic position in the cardiovascular and metabolism (CVM) area. Innovent will uphold the mission of 'to develop high-quality biopharmaceuticals that are affordable to ordinary people ', and will bring more innovative medicines for patients with chronic diseases."

About Hypercholesterolemia

In recent years, the blood lipids 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 between 2010 ~ 2030. Dyslipidemia, characterized by elevated LDL-C or TC, is an important independent risk factor for atherosclerotic cardiovascular disease.

At present, the disease 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 percentage of patients with dyslipidemia who met the LDL-C reduction goal is even more alarmingly low. Current lipid-lowering therapies do not meet the clinical needs in patients with hyperlipidemia. Anti-PCSK9 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 CREDIT Studies

CREDIT-1 is a randomized, double-blind, placebo-controlled phase 3 clinical study to assess the efficacy and safety of tafolecimab in Chinese subjects with non-familial hypercholesterolemia (hypercholesterolemia with cardiovascular risk) (ClinicalTrials.gov, NCT04289285). At week 48, compared with placebo, the treatment difference of mean change in LDL-C level from baseline was –65.04% (97.5% CI: −70. 22%, −59. 86%) for tafolecimab 450 mg Q4W group and –57.31% (97.5% CI: −63. 95%, −50. 68%) for tafolecimab 600 mg Q6W group (P < 0.0001 for both comparisons). The proportion of patients with a 50% or greater reduction in LDL-C from baseline was 87.8% and 71.8%, respectively, compared with 1.0% and 2.0% in placebo group, respectively, both P < 0.0001 in comparison with placebo.

CREDIT-2 is a randomized, double-blind, placebo-controlled phase 3 study evaluating the efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia (ClinicalTrials.gov, NCT04179669). At week 12, compared with placebo, the treatment difference of mean change in LDL-C level from baseline was –57.37% (97.5% CI, −69.21%, −45.54%) for tafolecimab 150 mg Q2W group and –61.90% (97.5% CI: −73.40%, −50. 41%) for tafolecimab 450 mg Q4W group (P < 0.0001 for both comparisons). The proportion of patients with a 50% or greater reduction in LDL-C from baseline was 59.6% and 75.0%, respectively, compared with both 0 in placebo group, both P < 0.0001 in comparison with placebo.

CREDIT-4 is a randomized, double-blind, placebo-controlled phase 3 clinical study to assess the efficacy and safety of tafolecimab in Chinese patients with hypercholesterolemia (including non-familial hypercholesterolemia and heterozygous familial hypercholesterolemia) (ClinicalTrials.gov, NCT04709536). At week 12, compared with placebo, the treatment difference of mean change in LDL-C level from baseline was –63.02% (97.5% CI, −66.48%, −59.56%) for tafolecimab 450 mg Q4W group (P < 0.0001 for comparison). The proportion of patients with a 50% or greater reduction in LDL-C from baseline was 90.5% in tafolecimab 450 mg Q4W group and 2.0% in placebo group (P < 0.0001 for comparison).

Clinically meaningful and statistically significant reductions from baseline in TC, non-HDL-C, ApoB, and Lp(a) level were observed in all 3 clinical studies.

In a pooled safety analysis of 1091 patients with primary hypercholesterolemia who received tafolecimab, adverse events during the double-blind treatment phase of tafolecimab included upper respiratory tract infection (9.6%), urinary tract infection (7.3%), injection site reaction (5.7%), arthralgia (3.1%), back pain (2.2%), and nasopharyngitis (2.0%).

The efficacy and safety of tafolecimab have also received recognition from the academic community. The main results of the CREDIT-1 study were presented in a poster at the American Heart Association (AHA) Scientific Sessions 2022^[1], and the study will be published in a peer-reviewed academic journal soon. The main results of the CREDIT-2 study were presented in a conference poster at the American College of Cardiology (ACC) Scientific Sessions 2022^[2], and the study was published in BMC Medicine^[3]. The CREDIT-4 study was published online in JACC: Asia in July 2023^[4].

About SINTBILO^® (Tafolecimab Injection)

SINTBILO^® (tafolecimab injection), independently developed by Innovent, is an lgG2 fully human monoclonal antibody that can specifically bind to PCSK9 and reduce LDL-C level by inhibiting PCSK9-mediated low-density lipoprotein receptor (LDLR) endocytosis, subsequently enhancing the clearance of LDL-C, resulting in a reduction in LDL-C level.

SINTBILO^® (tafolecimab injection) is indicated as adjunct to diet, in combination with statins or statins and other lipid-lowering therapies, for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia who have failed to achieve LDL-C goals by using moderate or higher doses of statins, to reduce LDL-C, TC and ApoB levels.

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.

Innovent has 10 products in the market. These include: TYVYT® (Sintilimab Injection), BYVASDA® (Bevacizumab Injection), SULINNO® (Adalimumab Injection), HALPRYZA® (Rituximab Injection), Pemazyre® (Pemigatinib Oral Inhibitor), olverembatinib, Cyramza® (Ramucirumab Injection), Retsevmo® (Selpercatinib Capsules), FUCASO® (Equecabtagene Autoleucel) and SINTBILO® (Tafolecimab Injection). In addition, one assets are under NMPA NDA review, six assets are in Phase III or pivotal clinical trials, and 18 more molecules are in clinical studies.

Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, 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.

Disclaimer: Innovent does not recommend any off-label usage.

Note:

TYVYT®, BYVASDA®, SULINNO®, HALPRYZA®, olverembatinib, FUCASO® and SINTBILO® are not approved products in the United States.

TYVYT® (sintilimab injection, Innovent)

BYVASDA® (bevacizumab injection, Innovent)

HALPRYZA® (rituximab injection, Innovent)

SULINNO® (adalimumab 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.

CYRAMZA® (ramucirumab injection, Eli Lilly). Cyramza® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

Retsevmo® (selpercatinib capsules, Eli Lilly). Retsevmo® was discovered by Eli Lilly and licensed to Innovent for commercialization in Mainland China.

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.

Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect.

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