Powerful Lipid-lowering Effect: the Results of Phase 3 Clinical Study (CREDIT-1) of SINTBILO® (Tafolecimab Injection) were Published in The Lancet Regional Health-Western Pacific

ROCKVILLE, U.S. and SUZHOU, China, October,11, 2023，— 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 Phase 3 clinical trial (CREDIT-1) of SINTBILO®( Tafolecimab injection, R&D code: IBI306), a recombinant fully-human anti-PCSK9 monoclonal antibody, in Chinese patients with non-familial hypercholesterolemia (non-FH) were published in The Lancet Regional Health-Western Pacific. The results was based on CREDIT-1 study, which is a randomized, double-blind, placebo-controlled phase 3 clinical study (ClinicalTrials.gov NCT0428928) to evaluate the efficacy and safety of tafolecimab in Chinese non-FH patients. The study showed tafolecimab dosed at both 450 mg Q4W and 600 mg Q6W was safe and demonstrated clinically meaningful lipid-lowering efficacy. PCSK9 inhibitors, which can potently reduce LDL-C levels with a good safety profile, have been gradually recognized by clinicians as novel therapies in recent years. Although there are various imported PCSK9 inhibitors marketed in China, there are some limitations in terms of convenience. SINTBILO® (Tafolecimab Injection) is an innovative drug independently developed by Innovent which has been approved for marketing in China，becoming the first approved domestic PCSK9 inhibitor and bringing a novel treatment option to the clinical management of blood lipids in China. SINTBILO® (Tafolecimab Injection) was developed for the treatment of primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia. SINTBILO® (Tafolecimab Injection) is the PCSK9 inhibitor that take the lead in carrying out long-term, large-scale, randomized and double-blind phase 3 clinical studies in China （CREDIT-1，CREDIT-2 and CREDIT-4）, and exploring treatment regimen with long-interval dosing. In CREDIT-1 study, non-FH patients on stable lipid-lowering therapy for at least 4 weeks, were randomized in a 2:2:1:1 ratio to receive subcutaneous tafolecimab 450 mg Q4W, tafolecimab 600 mg Q6W, placebo 450 mg Q4W, or placebo 600 mg Q6W, respectively, in the 48-week double-blind treatment period. The primary endpoint was the percent change from baseline to week 48 in LDL-C levels. A total of 618 subjects were enrolled in the study, and 614 subjects received at least one dose of study drug (tafolecimab or placebo). The results showed that both treatment regimens of tafolecimab can significantly reduce the LDL-C level. At week 48, tafolecimab induced significant reductions in LDL-C levels. The treatment differences versus placebo were –65.0% (97.5%CI: –70.2%, –59.9%） for 450 mg Q4W and –57.3% (97.5%CI: –64.0%, –50.7%）for 600 mg Q6W (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, as compared with 1.0%, 1% and 1.0% in placebo group, respectively. About the 600mg Q6W of the tafolecimab group: 71.8% of subjects receiving tafolecimab achieved ≥50% reduction from baseline to week 48 in LDL-C levels, 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, as compared with 2.0%, 9.9% and 2.0% in placebo group, respectively. Meanwhile, tafolecimab treatment also led to reductions in lipoprotein(a) levels , non-HDL-C and apolipoprotein B levels. The overall safety profile of tafolecimab was favorable, similar to that of previous studies of tafolecimab and other marketed PCSK9 inhibitors. Prof. Yong Huo, Principal Investigator of the CREDIT-4 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 CREDIT-1 providing high-quality medical evidence for the clinical treatment of hypercholesterolemia patients in China, demonstrating 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, providing a novel treatment option for Chinese hypercholesterolemia patients. The results were published in The Lancet Regional Health-Western Pacific, reflecting the excellent clinical research capabilities of Chinese researchers." Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: " In CREDIT-1 study, tafolecimab showed significant long-term efficacy and favorable safety in Chinese patients with non-familial hypercholesterolemia. The results were successfully published in an internationally renowned journal, manifesting the significance of the study for the clinic practice and the excellent scientific research capabilities of Chinese researchers, as well as the solid R&D execution of Innovent. SINTBILO® (Tafolecimab Injection) has been approved for marketing in China, hoping this high-quality biological drug to benefit the majority of Chinese hypercholesterolemia patients.” 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 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 –65.0% (97.5% CI: −70.2%, −59.9%) for tafolecimab 450 mg Q4W group and –57.3% (97.5% CI: −64.0%, −50.7%) 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 –57.4% (97.5% CI, −69.2%, −45.5%) for tafolecimab 150 mg Q2W group and –61.9% (97.5% CI: −73.4%, −50. 4%) 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 –63.0% (97.5% CI, −66.5%, −59.6%) 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 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[i], 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[ii], and the study was published in BMC Medicine[iii]. The CREDIT-4 study was published online in JACC: Asia in July 2023[iv]. [i] Huo Y, Li Y, Zhang P, et al. Efficacy and Safety of Tafolecimab in Chinese Patients With Non-Familial Hypercholesterolemia (CREDIT-1): A 48-Week Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. Circulation. 2022;146(Suppl_1):10111. [ii] Zhou Y, Chai M, He Y, et al. Efficacy and Safety of Tafolecimab in Chinese Patients with Heterozygous Familial Hypercholesterolemia (CREDIT-2): A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial. ACC. 2022;1188-005/5. [iii] Chai M, He Y, Zhao W, et al. Efficacy and safety of tafolecimab in Chinese patients with heterozygous familial hypercholesterolemia: a randomized, double-blind, placebo-controlled phase 3 trial (CREDIT-2). BMC Med. 2023;21(1):77. Published 2023 Feb 28. [iv] Qi L, Liu D, Qu Y, et al. Tafolecimab in Chinese Patients With Hypercholesterolemia (CREDIT-4). JACC: Asia. 2023 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 discover and develop, manufacture and commercialize high-quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to discovering and developing, manufacturing and commercializing high-quality innovative medicines for the treatment of oncology, autoimmune, cardiovascular and metabolic, and ophthalmology diseases to enhance the quality of the patients' lives. Innovent has 10 products in the market, including 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 Injection) and SINTBILO® (Tafolecimab Injection). Additionally, 7 assets are in Phase III or pivotal clinical trials, and 17 more molecules are in early clinical stage. Innovent has also entered into 30 strategic collaborations with Eli Lilly, Roche, Sanofi, Adimab, Incyte, MD Anderson Cancer Center and other international partners. We strive to work with many collaborators to help advance the 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/ 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. Contact Media： E-mail：[email protected] Tel：+86 512-69566088 Investors： E-mail：[email protected] Tel：+86 512-69566088

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