ROCKVILLIE, Md. and SUZHOU, China, March 18, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ('Innovent') (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the primary endpoint has been met in the second Phase 2 clinical study of efdamrofusp alfa  high-dose, a recombinant human VEGFR-Fc-Human CR1 fusion protein injection (R&D code: IBI302), in Chinese subjects with neovascular age-related macular degeneration (nAMD)..

ROCKVILLIE，Md.和中国苏州，2024年3月18日/PRNewswire/--Innovent Biologics，Inc.（“Innovent”）（香港交易所：01801），一家世界一流的生物制药公司，开发，制造和商业化用于治疗癌症，代谢，自身免疫和其他主要疾病的高质量药物，今天宣布，在患有新生血管性年龄相关性黄斑变性（nAMD）的中国受试者中，重组人VEGFR-Fc-人CR1融合蛋白注射液（研发代码：IBI302）efdamrofusp alfa high-dose的第二阶段临床研究达到了主要终点。。

According to the results of the two Phase 2 clinical studies conducted in more than 360 subjects of nAMD, compared with Aflibercept, IBI302 can be administrated in long-interval (every 12 weeks), while providing a stable and robust visual benefit and anatomic improvements, as well as potential inhibition effect in macular atrophy.

根据对360多名nAMD受试者进行的两项2期临床研究的结果，与阿柏西普相比，IBI302可以长时间（每12周）给药，同时提供稳定而强大的视觉益处和解剖学改善，以及对黄斑萎缩的潜在抑制作用。

Based on those results, Innovent advanced IBI302 8mg into a Phase 3 clinical study STAR in October 2023..

基于这些结果，Innovent于2023年10月将IBI302 8mg提升为3期临床研究之星。。

This was a randomized, double-masked, active-controlled Phase 2 clinical study (NCT05403749), evaluating the longer interval of intravitreal injection of high-dose IBI302 in subjects with nAMD. A total of 132 subjects were randomized 1: 1: 1 to IBI302 6.4 mg group, IBI302 8.0 mg group, or Aflibercept 2.0 mg group.

这是一项随机，双盲，主动控制的2期临床研究（NCT05403749），评估了nAMD患者玻璃体内注射大剂量IBI302的较长时间间隔。共有132名受试者以1:1:1随机分配到IBI302 6.4 mg组，IBI302 8.0 mg组或阿柏西普2.0 mg组。

After the loading therapy, subjects in IBI302 6.4 mg group and 8.0 mg group were dosed with adjusted intervals of every 8 weeks (Q8W) or every 12 weeks (Q12W), depending on response to loading therapy. Subjects in Aflibercept 2.0 mg group were dosed Q8W after the loading therapy. The primary endpoint was the change in best corrected visual acuity (BCVA) in the study eye from baseline to week 40.

负荷治疗后，IBI302 6.4 mg组和8.0 mg组的受试者每8周（Q8W）或每12周（Q12W）调整一次给药间隔，具体取决于对负荷治疗的反应。阿柏西普2.0 mg组的受试者在负荷治疗后服用Q8W。主要终点是研究眼从基线到第40周的最佳矫正视力（BCVA）的变化。

The study lasted for 52 weeks..

这项研究持续了52周。。

The results showed that the primary endpoint was successfully met: at week 40, the IBI302 6.4 mg and 8.0 mg groups showed non-inferior BCVA gains to the Aflibercept 2.0 mg group. The mean BCVA improvement from baseline was 10.5 ETDRS letters for the IBI302 6.4 mg group, 11.0 ETDRS letters for the IBI302 8.0 mg group, and 9.8 ETDRS letters for the Aflibercept 2.0 mg group at week 40..

结果显示，成功达到了主要终点：在第40周，IBI302 6.4 mg和8.0 mg组的BCVA增益不低于阿柏西普2.0 mg组。在第40周，IBI302 6.4 mg组的平均BCVA改善为10.5 ETDRS字母，IBI302 8.0 mg组为11.0 ETDRS字母，阿柏西普2.0 mg组为9.8 ETDRS字母。。

The mean change from baseline in central subfield thickness (CST) was -163.19 μm for the IBI302 6.4 mg group, -184.46 μm for the IBI302 8.0 mg group, and -108.23 μm for the Aflibercept 2.0 mg group at week 40.

在第40周，IBI302 6.4 mg组的中心亚区厚度（CST）与基线的平均变化为-163.19μm，IBI302 8.0 mg组为-184.46μm，阿柏西普2.0 mg组为-108.23μm。

In addition, approximately 81%, 88% of subjects in 6.4 mg IBI302 groups and 8.0mg IBI302 groups respectively were able to extend dosing interval to Q12W, similar to that in the proportion of subjects dosed Q12W or longer with Aflibercept 8.0 mg (83% in PULSAR trial)1 or Faricimab (TENAYA & LUCERNE trial, with 79.7% and 77.8% respectively)2 by indirect comparison.

此外，分别在6.4 mg IBI302组和8.0mg IBI302组中，大约81%，88%的受试者能够将给药间隔延长至Q12W，类似于用阿柏西普8.0 mg（PULSAR试验中为83%）1或法利单抗（TENAYA＆LUCERNE试验，分别为79.7%和77.8%）2间接比较Q12W或更长时间给药的受试者比例。

Based on the excellent long-interval dosing performance in the Phase 2 studies, the Phase 3 study STAR added Q16W dosing interval regimen for IBI302..

基于第二阶段研究中出色的长间隔给药性能，第三阶段研究STAR为IBI302添加了Q16W给药间隔方案。。

The overall safety profile of IBI302 was favorable, comparable to Aflibercept 2.0 mg, and consistent with previous studies. No new safety signals were identified. Detailed study data will be further analyzed and published in the near future.

IBI302的总体安全性良好，与阿柏西普2.0 mg相当，与之前的研究一致。没有发现新的安全信号。详细的研究数据将在不久的将来进一步分析和发布。

Professor Xiaodong Sun, Principal Investigator of the Study, Head of National Center for Clinical Ophthalmology, Shanghai General Hospital, stated: 'Intravitreal injection of anti-VEGF drugs is currently the first-line treatment for nAMD, but there are still unmet clinical needs given their frequent intravitreal injection and gradual loss of visual benefits.

该研究的首席研究员、上海总医院国家临床眼科中心主任孙晓东教授表示：“玻璃体内注射抗VEGF药物目前是nAMD的一线治疗方法，但由于其频繁的玻璃体内注射和视力逐渐丧失，临床需求仍未得到满足。

Exploring longer interval dosing and anti-macular atrophy are necessary and urgent. IBI302 is a global first-in-class anti-VEGF-anti-complement bispecific molecule. As the principal investigator for IBI302 trials, I am very pleased to see that this Phase 2 study met the primary endpoint and demonstrated the potential for long-interval dosing.

探索更长的间隔给药和抗黄斑萎缩是必要和紧迫的。IBI302是全球一流的抗VEGF抗补体双特异性分子。作为IBI302试验的主要研究者，我非常高兴地看到这项2期研究达到了主要终点，并证明了长时间间隔给药的潜力。

These results will be further validated in the pivotal trial of IBI302. I look forward to providing a new treatment option for nAMD patients.'.

这些结果将在IBI302的关键试验中进一步验证。我期待着为nAMD患者提供新的治疗选择。”。

Dr. Lei Qian, Vice President of Clinical Development of Innovent, stated: 'There are two major trends in drug development for nAMD: extending dosing intervals and reducing the occurrence of macular atrophy. In the results of two Phase 2 studies, which enrolled over 360 subjects, IBI302 improved BCVA and macular edema in patients with nAMD significantly, extended dosing intervals, and had the potential to prevent the development of macular atrophy.

Innovent临床开发副总裁雷茜博士表示：“nAMD的药物开发有两个主要趋势：延长给药间隔和减少黄斑萎缩的发生。在招募了360多名受试者的两项2期研究的结果中，IBI302显着改善了nAMD患者的BCVA和黄斑水肿，延长了给药间隔，并有可能预防黄斑萎缩的发展。

Next, we will further investigate the long-interval dosing efficacy and safety of high-dose IBI302 in the Phase 3 STAR trial, hoping to bring a new generation of anti-VEGF agents to patients with nAMD.'.

接下来，我们将进一步研究大剂量IBI302在3期STAR试验中的长间隔给药疗效和安全性，希望为nAMD患者带来新一代抗VEGF药物。”。

About neovascular age-related macular degeneration (nAMD)

关于新生血管性年龄相关性黄斑变性（nAMD）

Age-related macular degeneration (AMD) is a progressive ocular disease involving the macular retina, leading to central visual impairment, the incidence of which increases with age. Neovascular age-related macular degeneration (nAMD) is one of the major forms of AMD, accounting for 15% to 20% of all AMD patients and is the leading cause of central vision loss in AMD patients over 65 years3.

年龄相关性黄斑变性（AMD）是一种累及黄斑视网膜的进行性眼部疾病，导致中枢视力障碍，其发病率随着年龄的增长而增加。新生血管性年龄相关性黄斑变性（nAMD）是AMD的主要形式之一，占所有AMD患者的15%至20%，是65岁以上AMD患者中心视力丧失的主要原因3。

The incidence of AMD is increasing year by year in China, and it has become the third leading cause of blindness in China..

AMD在中国的发病率逐年上升，已成为中国第三大致盲原因。。

The pathogenesis of nAMD has not been fully elucidated. It is generally accepted that angiogenesis induced by increased expression of VEGF is the main cause of nAMD, and inflammatory reaction mediated by abnormal activation of complement is also considered to be an important cause of AMD. Ocular anti-VEGF agents have led to significant visual benefits and changed the course of nAMD, but the frequent dosing (every 4 or 8 weeks) currently places a heavy burden on patients, families and society.

nAMD的发病机制尚未完全阐明。人们普遍认为，VEGF表达增加引起的血管生成是nAMD的主要原因，补体异常激活介导的炎症反应也被认为是AMD的重要原因。眼部抗VEGF药物已导致显着的视觉益处并改变了nAMD的病程，但频繁给药（每4或8周一次）目前给患者，家庭和社会带来沉重负担。

In addition, the visual benefits of anti-VEGF drug therapy are gradually diminished year by year. In approximately two thirds of nAMD patients with a follow-up for over 7 years, the visual gains from anti-VEGF treatment significantly diminish4. Macular atrophy or retinal fibrosis are important causes of vision loss after long-term anti-VEGF therapy.

此外，抗VEGF药物治疗的视觉益处逐年减少。在大约三分之二的随访超过7年的nAMD患者中，抗VEGF治疗的视觉增益显着降低4。黄斑萎缩或视网膜纤维化是长期抗VEGF治疗后视力丧失的重要原因。

Currently, drug development for nAMD is mainly focusing on extending the dosing intervals, and there are few drugs under investigation for macular atrophy or retinal fibrosis. Two drugs targeting complement have been approved by the US FDA in 20235,6 for the treatment of geographic atrophy secondary to dry AMD..

目前，nAMD的药物开发主要集中在延长给药间隔，目前很少有药物用于黄斑萎缩或视网膜纤维化。20235年，美国FDA批准了两种针对补体的药物，用于治疗继发于干性AMD的地理萎缩。。

About Efdamrofusp Alfa (IBI302)

关于Efdamrofusp Alfa（IBI302）

IBI302 is a recombinant fully human bispecific fusion protein of Innovent Biologics with global proprietary rights. The N-terminus is a VEGF domain that can bind to the VEGF family, block VEGF-mediated signaling pathway, inhibit vascular epithelium proliferation and angiogenesis, and improve vasopermeability and reduce leakage.

IBI302是具有全球专有权的Innovent Biologics重组全人双特异性融合蛋白。N末端是VEGF结构域，可与VEGF家族结合，阻断VEGF介导的信号通路，抑制血管上皮细胞增殖和血管生成，改善血管通透性并减少渗漏。

The C-terminus of IBI302 is the complement binding domain that can inhibit the activation of the classic pathway and alternative pathway of complement through the specific binding of C3b and C4b, and reduce the inflammatory response mediated by the complement. IBI302 may exert its therapeutic effect by inhibiting both VEGF-mediated angiogenesis and complement activation pathways..

IBI302的C末端是补体结合结构域，可通过C3b和C4b的特异性结合抑制补体经典途径和替代途径的激活，并减少补体介导的炎症反应。IBI302可能通过抑制VEGF介导的血管生成和补体激活途径发挥其治疗作用。。

About Innovent

关于Innovent

Innovent is a leading biopharmaceutical company founded in 2011 with the mission to provide high-quality biologics that are affordable to all. The company discovers, develops, manufactures and commercializes innovative medicines that treat some of the most intractable diseases. Its pioneering therapies to treat cancer, cardiovascular and metabolic, autoimmune and eye diseases.

Innovent是一家领先的生物制药公司，成立于2011年，其使命是提供所有人都能负担得起的高质量生物制剂。该公司发现、开发、制造和商业化治疗一些最难治疾病的创新药物。它开创性的治疗癌症，心血管和代谢，自身免疫和眼部疾病的疗法。

Innovent has 10 products in the market, 3 new drug applications under the NMPA review, 5 assets in Phase 3 or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare leaders, including Eli Lilly, Roche, Sanofi, Adimab, Incyte and MD Anderson Cancer Center..

Innovent在市场上有10种产品，在NMPA审查下有3种新药应用，在3期或关键临床试验中有5种资产，在临床早期还有18种分子。Innovent与30多位全球医疗保健领导者合作，其中包括礼来、罗氏、赛诺菲、阿迪玛、Incyte和MD安德森癌症中心。。

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. For more information, visit www.innoventbio.com, or follow Innovent on Facebook and LinkedIn..

Innovent秉承“从诚信做起，通过行动取得成功”的座右铭，保持行业实践的最高标准，并合作推进生物制药行业，使一流的药物可以广泛使用。有关更多信息，请访问www.innoventbio.com，或在Facebook和LinkedIn上关注Innovent。。

Statement: Innovent does not recommend the use of any unapproved drug (s)/indication (s).

声明：Innovent不建议使用任何未经批准的药物/适应症。

Forward-looking statement

前瞻性声明

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 Biologics ('Innovent'), are intended to identify certain of such forward-looking statements.

本新闻稿可能包含某些前瞻性声明，这些声明本质上具有重大风险和不确定性。与Innovent Biologics（“Innovent”）相关的“预期”、“相信”、“估计”、“期望”、“打算”等词语旨在识别某些此类前瞻性陈述。

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

公司不打算定期更新这些前瞻性声明。。

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of the Company 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 the Company's control and are difficult to predict.

这些前瞻性陈述是基于公司管理层在做出这些陈述时对未来事件的现有信念、假设、期望、估计、预测和理解。这些声明并不能保证未来的发展，并受到风险、不确定性和其他因素的影响，其中一些因素超出了公司的控制范围，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, the Company's competitive environment and political, economic, legal and social conditions..

因此，由于我们业务、公司竞争环境以及政治、经济、法律和社会条件的未来变化或发展，实际结果可能与前瞻性声明中包含的信息存在重大差异。。

The Company, the Directors and the employees of the Company 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 is otherwise inaccurate.

公司、董事和员工不承担（a）纠正或更新本网站中包含的前瞻性声明的义务；（b）如果任何前瞻性声明没有实现或不准确，则不承担任何责任。

References:

参考文献：

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SOURCE Innovent Biologics

来源Innovent Biologics