SINTBILO

新特比洛

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(tafolecimab injection) monotherapy achieved significant reduction of LDL-C level, with > 60% mean LDL-C reduction after 12 weeks of treatment with 150 mg Q2W/450 mg Q4W

（tafolecimab注射液）单药治疗显著降低了低密度脂蛋白胆固醇（LDL-C）水平，在接受150 mg每两周一次或450 mg每四周一次治疗12周后，LDL-C平均降幅超过60%。

SINTBILO

SINTBILO

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注册商标

(tafolecimab injection) monotherapy significantly decreased non-HDL-C, vLDL-C, ApoB, and Lp(a) after 12-week treatment, comprehensively improving patients' blood lipids indicators.

（tafolecimab注射液）单药治疗12周后，显著降低非高密度脂蛋白胆固醇（non-HDL-C）、极低密度脂蛋白胆固醇（vLDL-C）、载脂蛋白B（ApoB）和脂蛋白(a) [Lp(a)]，全面改善患者的血脂指标。

SINTBILO

新特比洛

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(tafolecimab injection) showed favorable safety profiles, and no new safety signals were identified

（tafolecimab注射液）显示出良好的安全性特征，且未发现新的安全信号

PALO ALTO, Calif. and SUZHOU, China

加利福尼亚州帕洛阿尔托和中国苏州

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Nov. 8, 2026

2026年11月8日

/PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, announced today that its self-developed recombinant fully human anti-proprotein convertase subtilisin/kexin 9 (PCSK9) monoclonal antibody, SINTBILO.

/美通社/ -- 信达生物制药（苏州）有限公司（“信达生物”）（港交所：01801）是一家世界级的生物制药公司，致力于开发、生产和商业化用于治疗肿瘤、自身免疫、心血管及代谢、眼科及其他重大疾病的高质量药物。该公司今日宣布，其自主研发的重组全人源抗前蛋白转化酶枯草溶菌素9（PCSK9）单克隆抗体SINTBILO。

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(tafolecimab injection, R&D code: IBI306), has achieved its primary endpoint at week 12 in the multi-center, randomized, double-blind, placebo-controlled monotherapy Phase 3 clinical study (CREDIT-5) in Chinese participants with non-familial hypercholesterolemia and mixed hyperlipidemia. In this study, SINTBILO.

（tafolecimab注射液，研发代码：IBI306）在中国非家族性高胆固醇血症和混合性高脂血症患者中开展的多中心、随机、双盲、安慰剂对照单药治疗III期临床研究（CREDIT-5）中，于第12周达到了主要终点。在本研究中，SINTBILO。

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(tafolecimab injection) monotherapy showed significant lipid-lowering efficacy with favorable safety and tolerability.

（tafolecimab注射液）单药治疗显示出显著的降脂疗效，且安全性和耐受性良好。

SINTBILO

SINTBILO

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is the first domestically developed PCSK9 antibody therapy to be commercialized in China, and has been included in China's National Reimbursement Drug List, effective January 1, 2025. Since its launch, SINTBILO

是中国首个实现商业化的国产PCSK9抗体疗法，并已被纳入中国国家医保药品目录，自2025年1月1日起生效。自上市以来，SINTBILO

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has benefited more than 1 million patients and has been recommended in multiple authoritative Chinese guidelines and expert consensus statements. The positive Phase 3 CREDIT-5 clinical trial result marks another milestone breakthrough for SINTBILO

已惠及超过100万患者，并被纳入多部中国权威指南及专家共识。CREDIT-5 III期临床试验的阳性结果标志着SINTBILO的又一里程碑式突破。

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in the treatment of hyperlipidemia. Innovent plans to submit a New Indication Application for SINTBILO

在高脂血症的治疗中。信达生物计划提交SINTBILO的新适应症申请

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to China's National Medical Products Administration (NMPA) in the near future, which is expected to provide a more convenient first-line treatment option for the Chinese population with hyperlipidemia.

将于近期提交至中国国家药品监督管理局（NMPA），预计将为中国的高血脂人群提供一种更为便捷的一线治疗选择。

CREDIT-5 is a Phase 3 clinical study to evaluate the efficacy and safety of tafolecimab monotherapy in Chinese subjects with non-familial hypercholesterolemia and mixed hyperlipidemia. A total of 198 participants were randomized in a 2:1:2:1 ratio to receive subcutaneous injections of tafolecimab 150 mg Q2W, placebo Q2W, tafolecimab 450 mg Q4W, or placebo Q4W after a 4-week run-in period when any drug or product with lipid-lowering effects were prohibited.

CREDIT-5 是一项 III 期临床研究，旨在评估 tafolecimab 单药治疗在中国非家族性高胆固醇血症和混合性高脂血症患者中的疗效和安全性。在为期 4 周的导入期内，禁止使用任何具有降脂作用的药物或产品，之后共有 198 名参与者按 2:1:2:1 的比例随机分配，分别接受每两周一次（Q2W）皮下注射 tafolecimab 150 mg、每两周一次安慰剂、每四周一次（Q4W）皮下注射 tafolecimab 450 mg 或每四周一次安慰剂。

The primary endpoint was the percent change in LDL-C from baseline at week 12, and the key secondary endpoints were the proportion of participants with LDL-C <2.6 mmol/L, the proportion of participants with LDL-C <1.8 mmol/L, the proportion of participants with ≥50% reduction in LDL-C from baseline, and the mean change in LDL-C from baseline at week 12..

主要终点为第12周时低密度脂蛋白胆固醇（LDL-C）较基线的百分比变化，关键次要终点包括：LDL-C <2.6 mmol/L的受试者比例、LDL-C <1.8 mmol/L的受试者比例、LDL-C较基线降低≥50%的受试者比例，以及第12周时LDL-C较基线的平均变化。

Among the 198 participants enrolled in this study, 131 received tafolecimab and 67 received placebo. The mean baseline LDL-C levels were 3.7 mmol/L and 3.8 mmol/L, respectively. 61.1% and 53.7% of the participants had mixed dyslipidemia at baseline, respectively, and 67.9% and 79.1% of the participants had low cardiovascular risk at baseline.

在本研究纳入的198名参与者中，131人接受tafolecimab治疗，67人接受安慰剂治疗。基线时低密度脂蛋白胆固醇（LDL-C）的平均水平分别为3.7 mmol/L和3.8 mmol/L。基线时，分别有61.1%和53.7%的参与者患有混合型血脂异常，分别有67.9%和79.1%的参与者心血管风险较低。

Tafolecimab has demonstrated clinically significant efficacy and favorable safety in the above populations:.

Tafolecimab在上述人群中显示出具有临床意义的疗效和良好的安全性：

Primary Endpoint Achieved

达到主要终点

: At week 12, the percent reduction in LDL-C from baseline in the tafolecimab group was significantly higher than that in the placebo group (150 mg Q2W: −65.19% vs. −6.61%; 450 mg Q4W: −64.01% vs. −4.31%, p-value < 0.0001). A significant decrease in LDL-C was observed 2 weeks after the first dose in the tafolecimab group, showing rapid and strong LDL-C lowering efficacy..

在第12周，tafolecimab组LDL-C较基线的百分比降幅显著高于安慰剂组（150 mg Q2W：−65.19% vs. −6.61%；450 mg Q4W：−64.01% vs. −4.31%，p值 < 0.0001）。在tafolecimab组首次给药后2周即观察到LDL-C显著下降，显示出快速且强效的LDL-C降低作用。

Key secondary endpoints Achieved:

关键次要终点达成：

At week 12, the proportions of participants with LDL-C < 2.6 mmol/L, < 1.8 mmol/L, and ≥ 50% decrease from baseline in LDL-C, as well as the decrease in LDL-C from baseline in each tafolecimab group were significantly higher than those in the corresponding placebo group, and the p values of inter-group differences were all < 0.0001..

在第12周，各tafolecimab组中低密度脂蛋白胆固醇（LDL-C）< 2.6 mmol/L、< 1.8 mmol/L以及较基线降低≥ 50%的受试者比例，以及LDL-C较基线的降幅，均显著高于相应的安慰剂组，组间差异的P值均< 0.0001。

Benefits in multi-dimensional secondary endpoints

多维次要终点指标的获益

: At week 12, the reductions in non-HDL-C, TC/HDL-C ratio, vLDL-C, ApoB, ApoB/ApoA1 ratio, and Lp(a) from baseline in each tafolecimab group were all higher than those in the corresponding placebo group, with Lp(a) reduced by nearly 50%; tafolecimab monotherapy can comprehensively improve lipid-related risk factors of arteriosclerotic cardiovascular disease (ASCVD) and is expected to reduce the cardiovascular risk of patients..

在第12周，各tafolecimab组的非高密度脂蛋白胆固醇（non-HDL-C）、总胆固醇/高密度脂蛋白胆固醇（TC/HDL-C）比值、极低密度脂蛋白胆固醇（vLDL-C）、载脂蛋白B（ApoB）、ApoB/ApoA1比值以及脂蛋白(a) [Lp(a)] 较基线的降幅均高于相应的安慰剂组，其中Lp(a)降低近50%；tafolecimab单药治疗可全面改善动脉粥样硬化性心血管疾病（ASCVD）的脂质相关危险因素，有望降低患者的心血管风险。

Favorable Safety Profile

良好的安全性特征

: During the study, tafolecimab showed favorable safety and tolerability, no severe or serious TEAE occurred; no AE led to discontinuation or interruption of the study drug; and no new safety signal was observed compared with previous studies.

在研究期间，tafolecimab显示出良好的安全性和耐受性，未发生严重或重度治疗期不良事件（TEAE）；无不良事件导致研究药物停药或中断；与既往研究相比，未观察到新的安全性信号。

Professor Yida Tang from Peking University Third Hospital, Lead Principal Investigator of the study,

北京大学第三医院的汤逸达教授，本研究的首席主要研究者，

stated: 'For a long time, statins have been the first-line standard of care for hypercholesterolemia. However, some patients still suffer from poor efficacy of statin monotherapy or combination therapy due to statin intolerance, insufficient long-term medication compliance, etc. Therefore, there is an urgent clinical need for more non-statin monotherapy options with sufficient evidence-based evidence.

指出：“长期以来，他汀类药物一直是高胆固醇血症的一线标准治疗。然而，由于对他汀类药物不耐受、长期用药依从性不足等原因，部分患者在他汀类单药治疗或联合治疗中仍疗效不佳。因此，临床上亟需更多拥有充分循证医学证据支持的非他汀类单药治疗选择。”

This Phase 3 clinical study met the primary and secondary endpoints, confirming that for patients with non-familial hypercholesterolemia and mixed hyperlipidemia, tafolecimab monotherapy can bring clinically significant reductions in LDL-C and improve lipid-related risk factors of ASCVD, without the need for combination therapy with statins.

这项III期临床研究达到了主要和次要终点，证实对于非家族性高胆固醇血症和混合性高脂血症患者，tafolecimab单药治疗可显著降低低密度脂蛋白胆固醇（LDL-C）并改善动脉粥样硬化性心血管疾病（ASCVD）的脂质相关风险因素，无需与他汀类药物联合治疗。

This not only further validates the therapeutic value of PCSK9 monoclonal antibody as an independent lipid-lowering regimen, but also provides new clinical evidence for patients and clinicians who need non-statin treatment. It is expected to expand the options for individualized treatment of hyperlipidemia, help more patients achieve effective control of blood lipids, and better meet the challenges of long-term blood lipid management.'.

这不仅进一步验证了PCSK9单克隆抗体作为独立降脂方案的治疗价值，也为需要非他汀类治疗的患者和临床医生提供了新的临床证据。预计这将扩大高脂血症个体化治疗的选择，帮助更多患者实现血脂的有效控制，并更好地应对长期血脂管理的挑战。

Dr. Lei Qian, Chief R&D Officer (General Biomedicine) of Innovent,

信达生物首席研发官（一般生物医学）钱雷博士，

stated, 'As the first innovative drug in Innovent's general biomedicine portfolio to receive regulatory approval and be included in China's NRDL, SINTBILO

表示，“作为信达生物普通生物医药产品组合中首个获得监管批准并被纳入中国国家医保目录（NRDL）的创新药物，SINTBILO

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has been developed with a strong focus on addressing the unmet medical needs of patients with hyperlipidemia. This Phase 3 clinical study further demonstrated the therapeutic value of SINTBILO

该药物的开发高度聚焦于满足高脂血症患者尚未被满足的医疗需求。这项III期临床研究进一步证实了SINTBILO的治疗价值。

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in achieving significant lipid-lowering as monotherapy, providing robust clinical evidence for treatment of hyperlipidemia. We will continue to work closely with clinical experts to accelerate the translation of research findings into clinical practice, so that more patients can benefit from innovative therapist, contributing to improved long-term management of hyperlipidemia in China.'.

在作为单药治疗实现显著降脂方面，为高脂血症的治疗提供了强有力的临床证据。我们将继续与临床专家紧密合作，加速将研究成果转化为临床实践，使更多患者受益于创新疗法，从而助力改善中国高脂血症的长期管理。

About Hyperlipidemia

关于高脂血症

The burden of dyslipidemia in Chinese adults is still heavy. National survey data from 2020 to 2022 showed that the prevalence of dyslipidemia among Chinese adults aged ≥18 years was 38.1%. Elevated low-density lipoprotein cholesterol (LDL-C) is a pathogenic risk factor for atherosclerotic cardiovascular disease (ASCVD), and LDL-C reduction is still the primary goal of blood lipid management and ASCVD prevention and treatment..

中国成年人的血脂异常负担仍然沉重。2020年至2022年的全国调查数据显示，中国18岁及以上成年人血脂异常的患病率为38.1%。低密度脂蛋白胆固醇（LDL-C）升高是动脉粥样硬化性心血管疾病（ASCVD）的致病性危险因素，降低LDL-C仍然是血脂管理以及ASCVD防治的首要目标。

The awareness rate, treatment rate, and control rate of dyslipidemia in China are still low; statins are still the basis for lipid-lowering therapy, and patients who do not meet the target can be treated with statin in combination with cholesterol absorption inhibitors or PCSK9 inhibitors according to the risk and treatment response.

中国血脂异常的知晓率、治疗率和控制率仍然偏低；他汀类药物仍是降脂治疗的基础，对于未达标的患者，可根据风险和治疗反应，采用他汀类药物联合胆固醇吸收抑制剂或PCSK9抑制剂进行治疗。

Monotherapy with a PCSK9 inhibitor is more effective in reducing LDL-C levels than cholesterol absorption inhibitors in statin-naïve or statin-intolerant populations. PCSK9 inhibitors are potent lipid-lowering agents that reduce LDL-receptor degradation and promote LDL-C clearance, some of which have been shown to reduce the risk of cardiovascular events..

在他汀类药物初治或他汀类药物不耐受人群中，PCSK9抑制剂单药治疗在降低低密度脂蛋白胆固醇（LDL-C）水平方面比胆固醇吸收抑制剂更有效。PCSK9抑制剂是强效的降脂药物，可减少低密度脂蛋白受体的降解并促进LDL-C的清除，其中部分药物已被证实可降低心血管事件的风险。

About SINTBILO

关于 SINTBILO

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SINTBILO

新特比洛

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(tafolecimab Injection) is a fully human IgG2 monoclonal antibody independently developed by Innovent Biologics that specifically binds to PCSK9 (proprotein convertase subtilisin/kexin type 9) molecules. It increases LDLR levels by reducing PCSK9-mediated endocytosis of the low-density lipoprotein receptor (LDLR), thereby increasing LDL-C clearance and reducing LDL-C levels..

（塔福利西单抗注射液）是由信达生物独立研发的一种全人源IgG2单克隆抗体，可特异性结合PCSK9（前蛋白转化酶枯草溶菌素9型）分子。它通过减少PCSK9介导的低密度脂蛋白受体（LDLR）内吞作用，提高LDLR水平，从而增加低密度脂蛋白胆固醇（LDL-C）的清除并降低其水平。

SINTBILO

新比洛

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has been approved and included in the NRDL in China for the treatment of adult patients with primary hypercholesterolemia (including heterozygous familial and non-familial hypercholesterolemia) and mixed dyslipidemia.

已在中国获批并被纳入国家医保目录（NRDL），用于治疗成人原发性高胆固醇血症（包括杂合子家族性和非家族性高胆固醇血症）及混合性血脂异常患者。

About Innovent

关于信达生物

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 20 products in the market. It has 1 asset under NDA review, 6 assets in Phase 3 or pivotal clinical trials, and 20 more molecules in early clinical stage..

信达生物是一家领先的生物制药公司，成立于2011年，其使命是为全球患者提供负担得起的高质量生物制药。该公司发现、开发、制造并商业化针对一些最难治疾病的创新药物。其开创性疗法用于治疗癌症、心血管和代谢疾病、自身免疫性疾病以及眼部疾病。信达生物已有20款产品上市。目前有1个资产处于新药上市申请（NDA）审评阶段，6个资产处于III期或关键性临床试验阶段，另有20多个分子处于早期临床阶段。

Innovent has entered into more than 30 strategic partnerships with global players such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD Anderson Cancer Center, representing an aggregate value of over RMB 350 billion. These efforts have set a benchmark for the highquality outbound internationalization of China's innovative drug industry..

信达生物已与礼来、罗氏、武田、辉瑞、赛诺菲、Incyte以及MD安德森癌症中心等全球知名企业建立了30多项战略合作伙伴关系，总价值超过人民币3500亿元。这些举措为中国创新药产业的高质量国际化出海树立了标杆。

Guided by the motto, 'Start with Integrity, Succeed through Action,' Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible.

秉承“始于诚信，成于行动”的座右铭，信达生物坚持行业最高标准，携手合作推动生物医药行业发展，让优质药物惠及更广泛的人群。

For more information, visit

更多信息，请访问

www.innoventbio.com

www.innoventbio.com

, or follow Innovent on Facebook and LinkedIn.

，或在 Facebook 和 LinkedIn 上关注信达生物。

Forward-Looking Statements

前瞻性陈述

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.

本新闻稿可能包含某些前瞻性陈述，这些陈述因其性质而受到重大风险和不确定性的影响。“预期”、“相信”、“估计”、“预计”、“打算”等类似表述，在与信达生物相关时，旨在识别此类前瞻性陈述。

Innovent does not intend to update these forward-looking statements regularly..

信达生物不打算定期更新这些前瞻性陈述。

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.

这些前瞻性陈述基于信达生物管理层在作出这些陈述时对未来事件所持有的信念、假设、预期、估计、预测和理解。这些陈述并非对未来发展的保证，并受风险、不确定性及其他因素的影响，其中某些因素超出信达生物的控制范围且难以预测。

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..

因此，由于我们的业务、信达生物的竞争环境以及政治、经济、法律和社会条件未来的变化或发展，实际结果可能与前瞻性陈述中所载信息存在重大差异。

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.

信达生物、信达生物的董事及员工（a）不承担更正或更新本网站所载前瞻性陈述的义务；且（b）在任何前瞻性陈述未能实现或被证明为不正确的情况下，不承担任何责任。

SOURCE Innovent Biologics

来源：信达生物