Innovent Announces the NMPA Acceptance of the New Drug Application for Tafolecimab Injection (anti-PCSK-9 antibody)

SAN FRANCISCO and SUZHOU, China, June 13, 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, autoimmune, metabolic, ophthalmology and other major diseases, today announced that the China's National Medical Products Administration (NMPA) has formally accepted the New Drug Application (NDA) for tafolecimab injection (anti-PCSK-9 antibody, R&D code: IBI306) for the treatment of primary hypercholesterolemia (including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia) and mixed dyslipidemia.

In recent years, PCSK-9 monoclonal antibody has been gradually recognized by clinicians as a new therapeutic regimen that can potently reduce LDL-C levels with favorable safety profiles. Although there are imported products in the Chinese market, there is still room for improvement in terms of affordability, accessibility and convenience. Tafolecimab injection, which was supported by the National Science and Technology Major Project for "Major New Drug Development", whose new drug application is the first submitted and formally accepted by the NMPA, and it is expected to potentially be the first self-developed recombinant fully human anti-PCSK-9 monoclonal antibody launched in China.

The NDA submission was based on the study results of three phase 3 registration clinical trials (CREDIT-1, CREDIT-2 and CREDIT-4): compared with placebo, tafolecimab injection reduced low-density lipoprotein cholesterol (LDL-C) levels by about 57% ~ 65%, and maintained long-term therapeutic efficacy. In addition, tafolecimab injection also significantly reduced total cholesterol (TC), non-high-density lipoprotein cholesterol (Non-HDL-C), apolipoprotein B (ApoB), and lipoprotein a (Lp (a)) levels. With a high percentage of patients achieving lipid reduction goals, a long administration interval (once every 6 weeks), and overall favorable safety profiles, tafolecimab injection is expected to be a potent treatment for patients with primary hypercholesterolemia (including heterozygous familial hypercholesterolemia and non-familial hypercholesterolemia) and mixed dyslipidemia.

Professor Yong Huo from Peking University First Hospital stated: "In China, the prevalence of dyslipidemia in adults is increasing annually and has become an important risk factor threatening the health of Chinese population. Elevated TC and LDL-C are among the independent risk factors for coronary heart disease or ischemic stroke. Effective control of dyslipidemia is important for the prevention and control of atherosclerotic cardiovascular disease (ASCVD). The results from a series of clinical studies of tafolecimab injection in patients with primary hypercholesterolemia and mixed dyslipidemia are very encouraging. It is worth noting that in CREDIT-1 study, tafolecimab injection achieved long-interval administration and demonstrated significant long-term reduction of LDL-C levels in Chinese population with hypercholesterolemia, in addition, tafolecimab also exhibited more prominent advantages in reducing LP (a) over other similar anti-PSCK-9 agents, which may result in better compliance and additional cardiovascular risk control benefits. We look forward to the approval of tafolecimab injection to provide a better treatment option to the large number of patients with hypercholesterolemia in China.

Professor Yujie Zhou from Beijing Anzhen Hospital, Capital Medical University stated: Although the prevalence of familial hypercholesterolemia is relatively low in China, it is still ranked highest in the world due to the large population . Patients with heterozygous hypercholesterolemia have an early onset, significantly elevated serum levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C), and rapid progression of the disease. These symptoms significantly harm the patients' health and they may experience severe ASCVD and even die at young or middle age. Our research team has observed the favorable efficacy and safety profiles of tafolecimab injection in the first randomized, controlled, double-blind clinical study (CREDIT-2) in Chinese population with heterozygous familial hypercholesterolemia. Today, we are even more delighted to see that, as an innovative anti-PCSK-9 monoclonal antibody with proprietary intellectual property rights in China, the NDA of tafolecimab injection has been officially accepted by the China's NMPA. As a clinician, I really look forward to the approval of tafolecimab injection to benefit Chinese patients with heterozygous familial hypercholesterolemia. "

Dr. Lei Qian, Vice President of Clinical Development of Innovent stated: "At present, cardiovascular diseases caused by hyperlipidemia, hypertension and obesity in China are prominent and have seriously affected the national public health. The NDA submission is based on the results of the CREDIT-1, CREDIT-2 and CREDIT-4 clinical studies, which demonstrated that tafolecimab injection can effectively reduce LDL-C levels and significantly improve other lipid parameters in Chinese patients with hypercholesterolemia, among which Lp(a) can be reduced more compared with similar products. Tafolecimab injection is the first PSCK-9 antibody that can be administrated at long-interval dosing (once every 6 weeks), which will potentially provide more treatment options for Chinese patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. We look forward to the approval and launch-to market of the product in the near future, hoping to benefit the large number of patients with hypercholesterolemia in China with this high-quality medicine as soon as possible. "

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 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 alarming. Current lipid-lowering therapies do not meet the clinical needs in patients with 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 Tafolecimab Injection (anti-PCSK-9 antibody)

Tafolecimab injection, 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 registration trials of tafolecimab injection have met the primary endpoint. The results from phase I/II clinical study have been published in JACC Asia, an internationally renowned journal of cardiology. CREDIT-2 phase III study results have been presented at the ACC meeting 2022.

About Innoventas a new drug application

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, ophthalmology 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 32 valuable assets in the fields of cancer, autoimmune, metabolic, ophthalmology and other major therapeutic areas, with 7 products approved for marketing in China – TYVYT® (sintilimab injection), BYVASDA® (bevacizumab biosimilar injection), SULINNO® (adalimumab biosimilar injection), HALPRYZA® (rituximab biosimilar injection) , Pemazyre® (pemigatinib oral inhibitor) and olverembatinib (BCR-ABL TKI) and Cyramza® (ramucirumab), 3 asset under NMPA NDA review, 3 assets in Phase 3 or pivotal clinical trials, and an additional 19 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.

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

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Company Codes: HongKong:1801, OTC-PINK:IVBIY