Efdamrofusp alfa

SAN FRANCISCO and SUZHOU, China, May 6, 2025 /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, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces the completion of first patient dosing in the Phase 2 clinical study of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, for the treatment of diabetic macular edema (DME). This randomized, double-masked, multi-center, active-controlled Phase 2 clinical study (NCT06908876) aims to evaluate the efficacy and safety of intravitreal injections of efdamrofusp alfa in DME patients. A total of 150 participants will be enrolled and randomized in a 1:1:1 ratio to the IBI302 4 mg group, the IBI302 8 mg group, and the Faricimab (anti-VEGF/ANG-2 bispecific antibody) 6 mg group. The primary endpoint is the change in best corrected visual acuity (BCVA) from baseline in the study eye at week 16. DME has become the leading cause of vision impairment among the diabetic population in China: According to statistics, China has over 140 million diabetic patients, with approximately one-third of them developing diabetic retinopathy (DR). Among patients with DR, the prevalence rate of DME ranges from 7% to 14%, indicating an estimated 4 to 5 million DME patients in China1. DME development is primarily driven by microvascular damage mediated by VEGF upregulation and inflammatory factors2. Complement activation is also involved in the development of DME by damaging the neurovascular units through cytolysis, opsonization, and promotion of proinflammatory microenvironment, leading to retinal microvascular lesions, neurodegeneration, and macular edema3. At present, intravitreal injections of anti-VEGF agents or glucocorticoids are key treatment strategies, effectively improving visual acuity and retinal edema. However, frequent intravitreal injections (every 4 to 8 weeks) can result in poor patient compliance and increased risk of complications such as cataract and elevated intraocular pressure, making it challenging to achieve sustained visual acuity benefits with long-term treatment4,5. In recent years, bispecific antibodies represented by Faricimab have demonstrated significant efficacy and extended dosing intervals in patients with DME; Faricimab currently represents the highest global treatment standard for DME. Efdamrofusp alfa, the first-in-class bispecific fusion protein targeting VEGF and complement, can simultaneously inhibit angiogenesis and vascular leakage mediated by VEGF, and inflammatory responses mediated by complement activation. To date, multiple clinical studies of efdamrofusp alfa have been conducted in patients with neovascular age-related macular degeneration (nAMD) and DME, among which high-dose (8 mg) efdamrofusp alfa has shown significant efficacy in improving visual acuity and retinal edema. Meanwhile, efdamrofusp alfa has demonstrated the potential for extended dosing intervals (up to 12-16 weeks), with favorable safety and tolerability. Professor Xiaodong Sun, the leading Principal Investigator of this Study, Deputy Director of Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, and Director of the Ophthalmology Center, stated, " DME is one of the most common ocular fundus diseases in China, affecting up to 4- to 5 million patients. With increasingly the aging of the population and the continuous rise in diabetes prevalence in China, DME has become one of the diseases that seriously endangers public health, imposing heavy burdens to the society and individuals. Anti-VEGF drugs are currently the first-line treatment for DME, but huge unmet medical needs remain, such as frequent injections, long-term efficacy attenuation, and suboptimal response in a subset of patients . As a global first-in-class anti-VEGF-complement bispecific drug, efdamrofusp alfa has shown favorable safety profile, substantial improvement in visual acuity and macular edema, and the potential of extended dosing interval in the completed Phase 1 clinical study in DME patients, which has brought great confidence to our investigator team. efdamrofusp alfa. We look forward to the success of this Phase 2 study, hoping to provide of a new treatment option for a large number of DME patients." Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent, stated, "Efdamrofusp alfa is an anti-VEGF-complement bispecific fusion protein self-developed by Innovent with global proprietary rights. This clinical study will be globally the first study comparing two dual-target agents, using Faricimab, the global standard of care in DME. We look forward to the success of this study, which could provide support for a Phase 3 clinical trial and a new treatment option for patients. Innovent's general biomedicine pipeline covers cardiovascular, endocrine and metabolic, ophthalmology, and autoimmune disease areas. We will continue to develop new therapies, providing physicians with more clinical treatment options and benefiting more patients." About diabetic macular edema Diabetic retinopathy (DR) is a series of lesions caused by retinal microvascular damage resulting from diabetes and is the main microvascular complication of diabetes. Diabetic macular edema (DME), featuring retinal edema, thickening and exudation, is caused by capillary leakage in the macular area. It is the result of the blood-retinal barrier (BRB) destruction and mainly affects central vision. At present, DR has become the leading cause of blindness among the working-age population worldwide, while DME has become the main cause of visual impairment among the diabetic population6. The pathological mechanisms of DR and DME are multifactorial, involving metabolic abnormalities related to hyperglycemia, oxidative stress, and inflammation. These processes lead to the upregulation of vasoactive factors such as VEGF, which subsequently disrupt the BRB and increase vascular permeability, manifesting clinically as retinal edema and exudation. When the macular area is involved, it develops into DME2. Additionally, complement system activation contributes to disease progression by damaging the neurovascular units through cytolysis, opsonization, and promotion of proinflammatory microenvironment, causing retinal microvascular lesions, neurodegeneration, macular edema, and retinal neovascularization3. About Effamrofusp Alfa (IBI302) Efdamrofusp alfa is a recombinant, fully human bispecific fusion protein developed by Innovent Biologics with global intellectual property rights. The N-terminal is the VEGF-binding domain, which can bind to the VEGF family to block the VEGF-mediated signaling pathway, inhibiting the survival and proliferation of vascular endothelial cells, thereby inhibiting angiogenesis, reducing vascular permeability, and reducing vascular leakage. The C-terminal is the complement binding domain, which can inhibit complement activation through the classical pathway and the bypass pathway by specifically binding to C3b and C4b, and thereby alleviate the inflammatory response mediated by complement activation. Through this dual mechanism, efdamrofusp alfa exerts its therapeutic effects by inhibiting both VEGF-mediated angiogenesis and complement activation pathways. About Innovent 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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. 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 , or follow Innovent on Facebook and LinkedIn. Statement: Innovent does not recommend the use of any unapproved drugs/indications. Forward-Looking Statement 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. References 1. 中华医学会眼科学分会眼底病学组, 中国医师协会眼科医师分会眼底病学组. 我国糖尿病视网膜病变临床诊疗指南（2022年）. 中华眼底病杂志. 2023;39(02):99-124. 2. Kusuhara S, Fukushima Y, Ogura S, Inoue N, Uemura A. Pathophysiology of Diabetic Retinopathy: The Old and the New. Diabetes Metab J. 2018;42(5):364-376. 3. Jiang F, Lei C, Chen Y, Zhou N, Zhang M. The complement system and diabetic retinopathy. Surv Ophthalmol. 2024;69(4):575-584. 4. Ehlken C, Ziemssen F, Eter N, et al. Systematic review: non-adherence and non-persistence in intravitreal treatment. Graefes Arch Clin Exp Ophthalmol. 2020;258(10):2077-2090. 5. Ciulla TA, Bracha P, Pollack J, Williams DF. Real-world Outcomes of Anti-Vascular Endothelial Growth Factor Therapy in Diabetic Macular Edema in the United States. Ophthalmol Retina. 2018;2(12):1179-1187. 6. Tan GS, Cheung N, Simó R, et al. Diabetic macular oedema. Lancet Diabetes Endocrinol, 2017, 5(2): 143-155. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SAN FRANCISCO, CA, USA and SUZHOU, China I May 5, 2025 I 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, announces that the latest 1-year results from its Phase 2 clinical trial of efdamrofusp alfa (R&D code: IBI302), a recombinant human vascular endothelial growth factor receptor (VEGFR)-antibody human complement receptor 1 (CR1) fusion protein, in Chinese subjects with neovascular age-related macular degeneration (nAMD) were presented orally at the 2025 Annual Meeting of the Association for Research in Vision and Ophthalmology (ARVO). The ARVO Annual Meeting 2025 is the premiere gathering of researchers and physicians in vision and ophthalmology to share the latest research findings and collaborate on innovative solutions, to be held from May 4 – 8 in Salt Lake City, Utah, U.S.. Title: Intravitreal High-dose Efdamrofusp Alfa (IBI302) in Patients with Neovascular Age-related Macular Degeneration: A Randomized, Double-masked, Active-controlled, Phase 2 Study Presentation Number: 443 Presentation Format: Speech/Mini Oral Presentation Time: May 4, 2:15pm-2:30pm Presenter: Prof. Xiaodong Sun, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine The data were from the Phase 2 clinical study of high-dose IBI302 (NCT05403749) to evaluate the efficacy, safety and dosing intervals in patients with nAMD over a one-year treatment period. 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. After the loading therapy, IBI302 groups were administrated at personal treatment interval of Q12W or Q8W based on the disease activity assessed at Week 20. 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 and the study lasts 52 weeks. The results showed 6.4 mg/ 8.0 mg IBI302 competitive efficacy and safety profiles : Professor Xiaodong Sun, Principal Investigator of the Study, Deputy director, Head of National Center for Clinical Ophthalmology, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine , stated: “It is my privilege to present the latest research findings on IBI302 to the global ophthalmic community at the ARVO meeting as the principal investigator. While anti-VEGF drugs remain the first-line therapy for nAMD, the frequency of  intravitreal injections and follow-up visits can significantly impact patient compliance. Current drug development focuses on multi-target strategies and extended dosing intervals to reduce the treatment burden by decreasing injection frequency. Notably, IBI302—a novel global first-in-class bispecific molecule (anti-VEGF/anti-complement) —recently reported Phase 2 data showing that its high-dose cohorts met the primary endpoint. The treatment group achieved approximately 10-letters improvement in visual acuity from baseline at one year, with over 80% subjects demonstrating potential for at least 12-weeks extended dosing intervals. Additionally, preliminary observations in IBI302 group suggest potential efficacy in inhibition of macular atrophy. We anticipate this innovative therapy will successfully complete the Phase 3 registration trial, providing nAMD patients with more effective, patient-friendly options.” Dr. Lei Qian, Senior Vice President of Clinical Development of Innovent , stated: “We are honored to present the latest progress of IBI302 in its second Phase 2 clinical trial at the ARVO annual meeting. High dose IBI302 demonstrates positive efficacy in visual acuity and anatomical improvements, while extend dosing intervals and potential anti-macular atrophy effects. Additionally, no new safety signals were observed during the trial, further validating the favorable safety and tolerability profile of this agent. These encouraging results establish a robust foundation for subsequent development. We will continue collaborating with clinical experts to expedite the Phase 3 clinical trial program, and accelerate the availability of this innovative therapy for patients with nAMD.” About Efdamrofusp Alfa (IBI302) IBI302 is a recombinant fully human bispecific fusion protein of Innovent Biologics with global proprietary rights. The N- terminal 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. The C- terminal 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. About Innovent 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 15 products in the market. It has 3 new drug applications under regulatory review, 4 assets in Phase III or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. 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. Statement: （ 1 ） Innovent does not recommend the use of any unapproved drug (s)/indication (s). （ 2 ） Ramucirumab (Cyramza®) and Selpercatinib (Retsevmo®) and Pirtobrutinib (Jaypirca®) were developed by Eli Lilly and Company. SOURCE: Innovent Biologics