{"success":true,"data":{"pressRelease":{"id":"164991","rtpr_id":"nPn3mHcFKa-20261009","ticker":"1801","exchange":"HKEX","all_tickers":["1801"],"title":"Innovent Announces Phase 3 RESTORE-3 Study of SYCUME® (Teprotumumab N01 Injection) Met Primary Endpoint in Inactive Thyroid Eye Disease","author":"PR Newswire","published_at":"2026-10-09T00:00:00.298Z","article_body":"Innovent Announces Phase 3 RESTORE-3 Study of SYCUME® (Teprotumumab N01 Injection) Met Primary Endpoint in Inactive Thyroid Eye Disease\nPR Newswire\n\nSAN FRANCISCO and SUZHOU, China, Oct. 8, 2026\n\n * SYCUME(®) Significantly Improved Proptosis (Response Rate 60.4% / LS Mean\nChange from Baseline -1.88 mm) with Favorable Safety Profile in Participants\nwith Inactive Thyroid Eye Disease(TED)\nSAN FRANCISCO and SUZHOU, China, Oct. 8, 2026 /PRNewswire/ -- Innovent\nBiologics, Inc. (\"Innovent\") (HKEX: 01801), a world-class biopharmaceutical\ncompany that develops, manufactures and commercializes high-quality medicines\nfor the treatment of oncologic, autoimmune, cardiovascular and metabolic,\nophthalmologic and other major diseases, announced today that its\nindependently developed recombinant anti-insulin-like growth factor 1 receptor\n(IGF-1R) antibody, SYCUME(®) (Teprotumumab N01 Injection, R&D code:\nIBI311), has achieved its primary study endpoint at Week 24 in a multicenter,\nrandomized, double-blind, placebo-controlled Phase 3 clinical study\n(RESTORE-3) in Chinese participants with inactive thyroid eye disease (TED).\nIn this study, SYCUME(®) demonstrated remarkable efficacy in reducing\nproptosis in participants with inactive TED, with a favorable safety profile.\n\nSYCUME(®) is the first IGF-1R antibody drug in China and the second one\napproved worldwide, filling a 70-year treatment gap in the domestic TED field.\nOfficially included in China's National Reimbursement Drug List on January 1,\n2026, SYCUME(®) substantially alleviates the financial burden on patients\ncompared to the high cost of overseas counterparts, significantly enhancing\ndrug accessibility. Patients with inactive TED account for approximately\ntwo-thirds of the overall TED population(1). Thus, the positive Phase 3\nclinical trial results in inactive TED participants mark another milestone\nbreakthrough for SYCUME(®) in full-course disease management and precision\ntherapy for TED, providing novel clinical evidence for the treatment of\ninactive TED in China.\n\nRESTORE-3 is a multicenter, randomized, double-blind, placebo-controlled Phase\n3 clinical trial designed to evaluate the efficacy and safety of IBI311 in\nChinese participants with inactive TED. A total of 116 eligible participants\nwere randomized in an approximate 2:1 ratio to receive either IBI311 or\nplacebo. The primary efficacy endpoint was the proptosis response rate of the\nstudy eye at Week 24, and the key secondary endpoint was the change from\nbaseline in proptosis of the study eye at Week 24.\n\nThe study enrolled 116 participants with inactive TED (bilateral CAS ≤ 2\npoints), with a mean disease duration of 4.3 years, a baseline mean proptosis\ndistance of 22.16 mm in the study eye, and approximately 74.1% of patients\npresenting with a baseline CAS of 0 or 1 point. Within this baseline\npopulation, IBI311 demonstrated clinically meaningful efficacy, successfully\nachieving all primary and key secondary endpoints:\n\n * Primary Endpoint Achieved: At Week 24, the proptosis response rate in the\nstudy eye was significantly higher in the IBI311 group compared with the\nplacebo group (60.4% vs. 23.5%; treatment difference: 36.9 percentage points;\np = 0.0003).\n * Key Secondary Endpoint Achieved: At Week 24, the least squares mean (LS Mean)\nchange from baseline in study eye proptosis distance in the IBI311 group was\n-1.88 mm, demonstrating statistically significant superiority over placebo\n(-0.88 mm; treatment difference: -1.00 mm; p < 0.0001).\n * Multidimensional Secondary Benefits: At Week 24, the proptosis response rate\nin non-study eyes was higher in the IBI311 group than in the placebo group\n(46.0% vs. 19.8%; p = 0.0071). The LS Mean change from baseline in proptosis\ndistance in non-study eyes reached -1.77 mm in the IBI311 group versus -0.91\nmm in the placebo group (p < 0.0001), consistent with the trend observed in\nstudy eyes.\n * Favorable Safety Profile: During the double-blind treatment and follow-up\nperiod, IBI311 exhibited good safety and tolerability. Most treatment-emergent\nadverse events were mild to moderate in severity, and no new safety signals\nwere identified.\nThe follow-up of this study is still ongoing, and the complete data will be\npublished in future academic conferences or peer-reviewed academic journals.\nAlthough the baseline mean proptosis in RESTORE-3 was lower than that in the\nTEPEZZA(®) study (indirect comparison), the proptosis response rate and the\nproptosis reduction of IBI311 were generally consistent with TEPEZZA(®)'s\ndata(2) in inactive TED.\n\nProfessor Zhongyan Shan from the First Hospital of China Medical University,\nLead Principal Investigator of the study stated: \"For a long time, effective\npharmacological interventions for inactive TED have been lacking. Following\nthe resolution of acute inflammation, patients frequently suffer from\npersistent proptosis and facial disfigurement. At this stage, surgical\nintervention has been virtually the sole recourse, leading many patients to\nforgo treatment and endure the chronic burden of the disease. Results from\nthis trial confirm that SYCUME(®) yields robust and clinically meaningful\nreductions in proptosis even in patients with chronic, inactive TED. This not\nonly validates the therapeutic value of targeting IGF-1R in long-duration\ninactive TED, but also offers tens of thousands of chronic TED sufferers and\nclinicians a novel non-surgical treatment paradigm—promising new hope and\nrestored quality of life for patients with inactive TED.\"\n\nDr. Lei Qian, Chief R&D Officer (General Biomedicine Pipeline) of Innovent\nBiologics indicates: \"As the first targeted therapy for TED approved and\nsuccessfully incorporated into the NRDL in China, SYCUME(®) has already\nbenefited a vast number of TED patients. With these positive Phase III trial\nresults, SYCUME(®) now achieves comprehensive disease coverage ranging from\n'early acute control' to 'chronic phase tissue remodeling.' This milestone\nunderscores Innovent's steadfast commitment to serving TED patients while\nreinforcing SYCUME(®)'s leading position in this therapeutic space. We will\nwork closely with medical experts to rapidly translate these clinical findings\ninto standard clinical practice, benefiting a broader patient population and\nelevating the overall standard of TED diagnosis and care in China.\"\n\nAbout Thyroid Eye Disease (TED)\n\nTED, an autoimmune disease involving ocular tissues, is the most common\norbital disease in adults. TED affects approximately 25% to 40% of\nGraves'disease patients, as well as individuals with other thyroid diseases\nand even those with normal thyroid function(3).\n\nThe annual incidence of TED is estimated at 16 per 100,000 women and 2.9 per\n100,000 men, with a prevalence of 0.1 to 0.3%(4,5). Based on disease severity,\nTED can be classified into mild, moderate to severe, or sight-threatening.\nWhile TED is more common in women, severe cases occur more frequently in men.\nThe exact pathogenesis of TED is not fully understood, but multiple studies\nsuggest that orbital fibroblasts (OFs) in muscle fibers and orbital connective\ntissue play a key role in orbital soft tissue hyperplasia in TED(6).\n\nThe natural progression of TED is divided into active and inactive stages(7).\nCommon symptoms include dry eye, foreign body sensation, photophobia,\nlacrimation, diplopia, and pressure behind the eyes. Typical signs include\nupper eyelid retraction, proptosis, periorbital soft tissue congestion and\nedema, and ocular motility disorders. While TED is usually mild to\nmoderate-to-severe, about 3-5% of patients develop sight-threatening TED,\nwhich can result in vision-threatening corneal ulcers or compressive optic\nneuropathy(8). In addition to affecting appearance and visual function, TED\nsignificantly impacts patients' social functioning and quality of life.\nHistorically, inactive TED was deemed non-responsive to medical therapies.\nPatients with proptosis, strabismus, or eyelid disfigurement affecting\naesthetics, visual function, or quality of life typically relied on corrective\nsurgeries, including strabismus surgery, eyelid reconstruction, and orbital\ndecompression(9). Nevertheless, these surgical procedures are complex, less\naccessible, and yield only partial clinical improvement, making full\nrestoration to pre-disease status exceptionally difficult to achieve. Recent\nChinese and international treatment guidelines and joint consensus have\nrecommended the use of IGF-1R-targeted biologics as a second-line treatment\nfor TED(9-11). Particularly for patients with significant proptosis or\ndiplopia, IGF-1R-targeted biologics can be considered the first-line treatment\nin such cases(11).\n\nAbout SYCUME(® )\n\nSYCUME(® )(teprotumumab N01) is a recombinant anti-insulin-like growth factor\n1 receptor (IGF-1R) antibody developed by Innovent for the treatment of TED.\nIGF-1R is a transmembrane tyrosine kinase receptor involved in development,\nmetabolism, and immune regulation, and is overexpressed in Orbital Fibroblasts\n(OFs), B cells, and T cells of TED patients(12). SYCUME(® )blocks the\nactivation of IGF-1R signaling pathway mediated by IGF-1 and related ligands\nor agonistic antibodies, reducing the expression of downstream inflammatory\nfactors. This inhibition decreases the synthesis of hyaluronic acid and other\nglycosaminoglycans caused by OFs activation, thereby alleviating inflammation.\nIt also prevents OFs differentiation into adipocytes or myofibroblasts,\nconsequently reducing disease activity and improving clinical manifestations\nsuch as proptosis, diplopia, orbital congestion and edema.\n\nIn March 2025, SYCUME(® )was approved by the NMPA for the treatment of TED.\nOn January 1, 2026, SYCUME(®) was officially included in the National\nReimbursement Drug List.\n\nAbout Innovent Biologics\n\nInnovent is a leading biopharmaceutical company founded in 2011 with the\nmission to empower patients worldwide with affordable, high-quality\nbiopharmaceuticals. The company discovers, develops, manufactures and\ncommercializes innovative medicines that target some of the most intractable\ndiseases. Its pioneering therapies treat cancer, cardiovascular and metabolic,\nautoimmune and eye diseases.  Innovent has launched 20 products in the\nmarket. It has 1 asset under NDA review, 5 assets in phase 3 or pivotal\nclinical trials, and 19 more molecules in early clinical stage.\n\nInnovent has entered into more than 30 strategic partnerships with global\nplayers such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD\nAnderson Cancer Center, representing an aggregate value of over RMB 350\nbillion. These efforts have set a benchmark for the high-quality outbound\ninternationalization of China's innovative drug industry.\n\nGuided by the motto, \"Start with Integrity, Succeed through Action,\" Innovent\nmaintains the highest standard of industry practices and works collaboratively\nto advance the biopharmaceutical industry so that first-rate pharmaceutical\ndrugs can become widely accessible.\n\nFor more information, visit www.innoventbio.com (http://www.innoventbio.com) ,\nor follow Innovent on Facebook and LinkedIn.\n\nForward-looking statement\n\nThis news release may contain certain forward-looking statements that are, by\ntheir nature, subject to significant risks and uncertainties. The words\n\"anticipate\", \"believe\", \"estimate\", \"expect\", \"intend\" and similar\nexpressions, as they relate to Innovent, are intended to identify certain of\nsuch forward-looking statements. Innovent does not intend to update these\nforward-looking statements regularly.\n\nThese forward-looking statements are based on the existing beliefs,\nassumptions, expectations, estimates, projections and understandings of the\nmanagement of Innovent with respect to future events at the time these\nstatements are made. These statements are not a guarantee of future\ndevelopments and are subject to risks, uncertainties and other factors, some\nof which are beyond Innovent's control and are difficult to predict.\nConsequently, actual results may differ materially from information contained\nin the forward-looking statements as a result of future changes or\ndevelopments in our business, Innovent's competitive environment and\npolitical, economic, legal and social conditions.\n\nInnovent, the Directors and the employees of Innovent assume (a) no obligation\nto correct or update the forward-looking statements contained in this site;\nand (b) no liability in the event that any of the forward-looking statements\ndoes not materialize or turn out to be incorrect.\n\nREFERENCES\n\n 1. Schuh A, Ayvaz G, Baldeschi L, et al. Presentation of Graves' orbitopathy\nwithin European Group On Graves' Orbitopathy (EUGOGO) centres from 2012 to\n2019 (PREGO III). Br J Ophthalmol. 2024 Jan 29;108(2):294-300.\n 2. Douglas RS, et al. Efficacy and Safety of Teprotumumab in Patients With\nThyroid Eye Disease of Long Duration and Low Disease Activity. J Clin\nEndocrinol Metab. 2023 Dec 21;109(1):25-35.\n 3. Li Z, Cestari D M, Fortin E. Thyroid eye disease: what is new to know? Curr\nOpin Ophthalmol. 2018;29(6):528-534.\n 4. Bartley G. The epidemiological characteristics and clinical course of\nophthalmology associated with autoimmune thyroid disease in Olmsted Country,\nMinnesota. Trans Am Ophthalmol Soc 1994;92:477-588.\n 5. Hiromatsu Y, Eguchi H, Tani J, Kasaoka M, Teshima Y. Graves' ophthalmopathy:\nepidemiology and natural history. Intern Med. 2014;53(5):353-60.\n 6. Ali F, Chorsiya A, Anjum V, Ali A. Teprotumumab (TEPEZZA): from the discovery\nand development of medicines to USFDA approval for active thyroid eye disease\n(TED) treatment. Int Ophthalmol. 2021;41(4):1549-1561.\n 7. Dolman P J. Evaluating Graves' orbitopathy. Best Pract Res Clin Endocrinol\nMetab.2012;26(3):229-248.\n 8. Bahn R S. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738.\n 9. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves'\norbitopathy (EUGOGO) clinical practice guidelines for the medical management\nof Graves' orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67.\n 10. 中华医学会眼科学分会眼整形眼眶病学组,\n中华医学会内分泌学分会甲状腺学组.\n中国甲状腺相关眼病诊断和治疗指南\n（2022年）.中华眼科杂志. 2022;58(9).\n 11. Burch HB, et al. Management of thyroid eye disease: a Consensus Statement by\nthe American Thyroid Association and the European Thyroid Association. Eur\nThyroid J. 2022;11(6):e220189.\n 12. Douglas RS, Naik V, Hwang CJ, et al. B cells from patients with Graves'\ndisease aberrantly express the IGF-1 receptor: implications for disease\npathogenesis. J Immunol 2008;181:5768-5774.\nView original\ncontent:https://www.prnewswire.com/news-releases/innovent-announces-phase-3-restore-3-study-of-sycume-teprotumumab-n01-injection-met-primary-endpoint-in-inactive-thyroid-eye-disease-302902606.html\n(https://www.prnewswire.com/news-releases/innovent-announces-phase-3-restore-3-study-of-sycume-teprotumumab-n01-injection-met-primary-endpoint-in-inactive-thyroid-eye-disease-302902606.html)\n\nSOURCE Innovent Biologics\n\n\n\nMedia: pr@innoventbio.com, +86 512-69566088; Investor: ir@innoventbio.com, +86 512-69566088\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved.","article_body_html":"","raw_payload":{"data":{"id":"nPn3mHcFKa-20261009","title":"Innovent Announces Phase 3 RESTORE-3 Study of SYCUME® (Teprotumumab N01 Injection) Met Primary Endpoint in Inactive Thyroid Eye Disease","author":"PR Newswire","ticker":"1801","created":"2026-10-09T00:00:00.298Z","tickers":["1801"],"exchange":"HKEX","article_body":"Innovent Announces Phase 3 RESTORE-3 Study of SYCUME® (Teprotumumab N01 Injection) Met Primary Endpoint in Inactive Thyroid Eye Disease\nPR Newswire\n\nSAN FRANCISCO and SUZHOU, China, Oct. 8, 2026\n\n * SYCUME(®) Significantly Improved Proptosis (Response Rate 60.4% / LS Mean\nChange from Baseline -1.88 mm) with Favorable Safety Profile in Participants\nwith Inactive Thyroid Eye Disease(TED)\nSAN FRANCISCO and SUZHOU, China, Oct. 8, 2026 /PRNewswire/ -- Innovent\nBiologics, Inc. (\"Innovent\") (HKEX: 01801), a world-class biopharmaceutical\ncompany that develops, manufactures and commercializes high-quality medicines\nfor the treatment of oncologic, autoimmune, cardiovascular and metabolic,\nophthalmologic and other major diseases, announced today that its\nindependently developed recombinant anti-insulin-like growth factor 1 receptor\n(IGF-1R) antibody, SYCUME(®) (Teprotumumab N01 Injection, R&D code:\nIBI311), has achieved its primary study endpoint at Week 24 in a multicenter,\nrandomized, double-blind, placebo-controlled Phase 3 clinical study\n(RESTORE-3) in Chinese participants with inactive thyroid eye disease (TED).\nIn this study, SYCUME(®) demonstrated remarkable efficacy in reducing\nproptosis in participants with inactive TED, with a favorable safety profile.\n\nSYCUME(®) is the first IGF-1R antibody drug in China and the second one\napproved worldwide, filling a 70-year treatment gap in the domestic TED field.\nOfficially included in China's National Reimbursement Drug List on January 1,\n2026, SYCUME(®) substantially alleviates the financial burden on patients\ncompared to the high cost of overseas counterparts, significantly enhancing\ndrug accessibility. Patients with inactive TED account for approximately\ntwo-thirds of the overall TED population(1). Thus, the positive Phase 3\nclinical trial results in inactive TED participants mark another milestone\nbreakthrough for SYCUME(®) in full-course disease management and precision\ntherapy for TED, providing novel clinical evidence for the treatment of\ninactive TED in China.\n\nRESTORE-3 is a multicenter, randomized, double-blind, placebo-controlled Phase\n3 clinical trial designed to evaluate the efficacy and safety of IBI311 in\nChinese participants with inactive TED. A total of 116 eligible participants\nwere randomized in an approximate 2:1 ratio to receive either IBI311 or\nplacebo. The primary efficacy endpoint was the proptosis response rate of the\nstudy eye at Week 24, and the key secondary endpoint was the change from\nbaseline in proptosis of the study eye at Week 24.\n\nThe study enrolled 116 participants with inactive TED (bilateral CAS ≤ 2\npoints), with a mean disease duration of 4.3 years, a baseline mean proptosis\ndistance of 22.16 mm in the study eye, and approximately 74.1% of patients\npresenting with a baseline CAS of 0 or 1 point. Within this baseline\npopulation, IBI311 demonstrated clinically meaningful efficacy, successfully\nachieving all primary and key secondary endpoints:\n\n * Primary Endpoint Achieved: At Week 24, the proptosis response rate in the\nstudy eye was significantly higher in the IBI311 group compared with the\nplacebo group (60.4% vs. 23.5%; treatment difference: 36.9 percentage points;\np = 0.0003).\n * Key Secondary Endpoint Achieved: At Week 24, the least squares mean (LS Mean)\nchange from baseline in study eye proptosis distance in the IBI311 group was\n-1.88 mm, demonstrating statistically significant superiority over placebo\n(-0.88 mm; treatment difference: -1.00 mm; p < 0.0001).\n * Multidimensional Secondary Benefits: At Week 24, the proptosis response rate\nin non-study eyes was higher in the IBI311 group than in the placebo group\n(46.0% vs. 19.8%; p = 0.0071). The LS Mean change from baseline in proptosis\ndistance in non-study eyes reached -1.77 mm in the IBI311 group versus -0.91\nmm in the placebo group (p < 0.0001), consistent with the trend observed in\nstudy eyes.\n * Favorable Safety Profile: During the double-blind treatment and follow-up\nperiod, IBI311 exhibited good safety and tolerability. Most treatment-emergent\nadverse events were mild to moderate in severity, and no new safety signals\nwere identified.\nThe follow-up of this study is still ongoing, and the complete data will be\npublished in future academic conferences or peer-reviewed academic journals.\nAlthough the baseline mean proptosis in RESTORE-3 was lower than that in the\nTEPEZZA(®) study (indirect comparison), the proptosis response rate and the\nproptosis reduction of IBI311 were generally consistent with TEPEZZA(®)'s\ndata(2) in inactive TED.\n\nProfessor Zhongyan Shan from the First Hospital of China Medical University,\nLead Principal Investigator of the study stated: \"For a long time, effective\npharmacological interventions for inactive TED have been lacking. Following\nthe resolution of acute inflammation, patients frequently suffer from\npersistent proptosis and facial disfigurement. At this stage, surgical\nintervention has been virtually the sole recourse, leading many patients to\nforgo treatment and endure the chronic burden of the disease. Results from\nthis trial confirm that SYCUME(®) yields robust and clinically meaningful\nreductions in proptosis even in patients with chronic, inactive TED. This not\nonly validates the therapeutic value of targeting IGF-1R in long-duration\ninactive TED, but also offers tens of thousands of chronic TED sufferers and\nclinicians a novel non-surgical treatment paradigm—promising new hope and\nrestored quality of life for patients with inactive TED.\"\n\nDr. Lei Qian, Chief R&D Officer (General Biomedicine Pipeline) of Innovent\nBiologics indicates: \"As the first targeted therapy for TED approved and\nsuccessfully incorporated into the NRDL in China, SYCUME(®) has already\nbenefited a vast number of TED patients. With these positive Phase III trial\nresults, SYCUME(®) now achieves comprehensive disease coverage ranging from\n'early acute control' to 'chronic phase tissue remodeling.' This milestone\nunderscores Innovent's steadfast commitment to serving TED patients while\nreinforcing SYCUME(®)'s leading position in this therapeutic space. We will\nwork closely with medical experts to rapidly translate these clinical findings\ninto standard clinical practice, benefiting a broader patient population and\nelevating the overall standard of TED diagnosis and care in China.\"\n\nAbout Thyroid Eye Disease (TED)\n\nTED, an autoimmune disease involving ocular tissues, is the most common\norbital disease in adults. TED affects approximately 25% to 40% of\nGraves'disease patients, as well as individuals with other thyroid diseases\nand even those with normal thyroid function(3).\n\nThe annual incidence of TED is estimated at 16 per 100,000 women and 2.9 per\n100,000 men, with a prevalence of 0.1 to 0.3%(4,5). Based on disease severity,\nTED can be classified into mild, moderate to severe, or sight-threatening.\nWhile TED is more common in women, severe cases occur more frequently in men.\nThe exact pathogenesis of TED is not fully understood, but multiple studies\nsuggest that orbital fibroblasts (OFs) in muscle fibers and orbital connective\ntissue play a key role in orbital soft tissue hyperplasia in TED(6).\n\nThe natural progression of TED is divided into active and inactive stages(7).\nCommon symptoms include dry eye, foreign body sensation, photophobia,\nlacrimation, diplopia, and pressure behind the eyes. Typical signs include\nupper eyelid retraction, proptosis, periorbital soft tissue congestion and\nedema, and ocular motility disorders. While TED is usually mild to\nmoderate-to-severe, about 3-5% of patients develop sight-threatening TED,\nwhich can result in vision-threatening corneal ulcers or compressive optic\nneuropathy(8). In addition to affecting appearance and visual function, TED\nsignificantly impacts patients' social functioning and quality of life.\nHistorically, inactive TED was deemed non-responsive to medical therapies.\nPatients with proptosis, strabismus, or eyelid disfigurement affecting\naesthetics, visual function, or quality of life typically relied on corrective\nsurgeries, including strabismus surgery, eyelid reconstruction, and orbital\ndecompression(9). Nevertheless, these surgical procedures are complex, less\naccessible, and yield only partial clinical improvement, making full\nrestoration to pre-disease status exceptionally difficult to achieve. Recent\nChinese and international treatment guidelines and joint consensus have\nrecommended the use of IGF-1R-targeted biologics as a second-line treatment\nfor TED(9-11). Particularly for patients with significant proptosis or\ndiplopia, IGF-1R-targeted biologics can be considered the first-line treatment\nin such cases(11).\n\nAbout SYCUME(® )\n\nSYCUME(® )(teprotumumab N01) is a recombinant anti-insulin-like growth factor\n1 receptor (IGF-1R) antibody developed by Innovent for the treatment of TED.\nIGF-1R is a transmembrane tyrosine kinase receptor involved in development,\nmetabolism, and immune regulation, and is overexpressed in Orbital Fibroblasts\n(OFs), B cells, and T cells of TED patients(12). SYCUME(® )blocks the\nactivation of IGF-1R signaling pathway mediated by IGF-1 and related ligands\nor agonistic antibodies, reducing the expression of downstream inflammatory\nfactors. This inhibition decreases the synthesis of hyaluronic acid and other\nglycosaminoglycans caused by OFs activation, thereby alleviating inflammation.\nIt also prevents OFs differentiation into adipocytes or myofibroblasts,\nconsequently reducing disease activity and improving clinical manifestations\nsuch as proptosis, diplopia, orbital congestion and edema.\n\nIn March 2025, SYCUME(® )was approved by the NMPA for the treatment of TED.\nOn January 1, 2026, SYCUME(®) was officially included in the National\nReimbursement Drug List.\n\nAbout Innovent Biologics\n\nInnovent is a leading biopharmaceutical company founded in 2011 with the\nmission to empower patients worldwide with affordable, high-quality\nbiopharmaceuticals. The company discovers, develops, manufactures and\ncommercializes innovative medicines that target some of the most intractable\ndiseases. Its pioneering therapies treat cancer, cardiovascular and metabolic,\nautoimmune and eye diseases.  Innovent has launched 20 products in the\nmarket. It has 1 asset under NDA review, 5 assets in phase 3 or pivotal\nclinical trials, and 19 more molecules in early clinical stage.\n\nInnovent has entered into more than 30 strategic partnerships with global\nplayers such as Eli Lilly, Roche, Takeda, Pfizer, Sanofi, Incyte, and MD\nAnderson Cancer Center, representing an aggregate value of over RMB 350\nbillion. These efforts have set a benchmark for the high-quality outbound\ninternationalization of China's innovative drug industry.\n\nGuided by the motto, \"Start with Integrity, Succeed through Action,\" Innovent\nmaintains the highest standard of industry practices and works collaboratively\nto advance the biopharmaceutical industry so that first-rate pharmaceutical\ndrugs can become widely accessible.\n\nFor more information, visit www.innoventbio.com (http://www.innoventbio.com) ,\nor follow Innovent on Facebook and LinkedIn.\n\nForward-looking statement\n\nThis news release may contain certain forward-looking statements that are, by\ntheir nature, subject to significant risks and uncertainties. The words\n\"anticipate\", \"believe\", \"estimate\", \"expect\", \"intend\" and similar\nexpressions, as they relate to Innovent, are intended to identify certain of\nsuch forward-looking statements. Innovent does not intend to update these\nforward-looking statements regularly.\n\nThese forward-looking statements are based on the existing beliefs,\nassumptions, expectations, estimates, projections and understandings of the\nmanagement of Innovent with respect to future events at the time these\nstatements are made. These statements are not a guarantee of future\ndevelopments and are subject to risks, uncertainties and other factors, some\nof which are beyond Innovent's control and are difficult to predict.\nConsequently, actual results may differ materially from information contained\nin the forward-looking statements as a result of future changes or\ndevelopments in our business, Innovent's competitive environment and\npolitical, economic, legal and social conditions.\n\nInnovent, the Directors and the employees of Innovent assume (a) no obligation\nto correct or update the forward-looking statements contained in this site;\nand (b) no liability in the event that any of the forward-looking statements\ndoes not materialize or turn out to be incorrect.\n\nREFERENCES\n\n 1. Schuh A, Ayvaz G, Baldeschi L, et al. Presentation of Graves' orbitopathy\nwithin European Group On Graves' Orbitopathy (EUGOGO) centres from 2012 to\n2019 (PREGO III). Br J Ophthalmol. 2024 Jan 29;108(2):294-300.\n 2. Douglas RS, et al. Efficacy and Safety of Teprotumumab in Patients With\nThyroid Eye Disease of Long Duration and Low Disease Activity. J Clin\nEndocrinol Metab. 2023 Dec 21;109(1):25-35.\n 3. Li Z, Cestari D M, Fortin E. Thyroid eye disease: what is new to know? Curr\nOpin Ophthalmol. 2018;29(6):528-534.\n 4. Bartley G. The epidemiological characteristics and clinical course of\nophthalmology associated with autoimmune thyroid disease in Olmsted Country,\nMinnesota. Trans Am Ophthalmol Soc 1994;92:477-588.\n 5. Hiromatsu Y, Eguchi H, Tani J, Kasaoka M, Teshima Y. Graves' ophthalmopathy:\nepidemiology and natural history. Intern Med. 2014;53(5):353-60.\n 6. Ali F, Chorsiya A, Anjum V, Ali A. Teprotumumab (TEPEZZA): from the discovery\nand development of medicines to USFDA approval for active thyroid eye disease\n(TED) treatment. Int Ophthalmol. 2021;41(4):1549-1561.\n 7. Dolman P J. Evaluating Graves' orbitopathy. Best Pract Res Clin Endocrinol\nMetab.2012;26(3):229-248.\n 8. Bahn R S. Graves' ophthalmopathy. N Engl J Med. 2010;362(8):726-738.\n 9. Bartalena L, Kahaly GJ, Baldeschi L, et al. The 2021 European Group on Graves'\norbitopathy (EUGOGO) clinical practice guidelines for the medical management\nof Graves' orbitopathy. Eur J Endocrinol. 2021;185(4):G43-G67.\n 10. 中华医学会眼科学分会眼整形眼眶病学组,\n中华医学会内分泌学分会甲状腺学组.\n中国甲状腺相关眼病诊断和治疗指南\n（2022年）.中华眼科杂志. 2022;58(9).\n 11. Burch HB, et al. Management of thyroid eye disease: a Consensus Statement by\nthe American Thyroid Association and the European Thyroid Association. Eur\nThyroid J. 2022;11(6):e220189.\n 12. Douglas RS, Naik V, Hwang CJ, et al. B cells from patients with Graves'\ndisease aberrantly express the IGF-1 receptor: implications for disease\npathogenesis. J Immunol 2008;181:5768-5774.\nView original\ncontent:https://www.prnewswire.com/news-releases/innovent-announces-phase-3-restore-3-study-of-sycume-teprotumumab-n01-injection-met-primary-endpoint-in-inactive-thyroid-eye-disease-302902606.html\n(https://www.prnewswire.com/news-releases/innovent-announces-phase-3-restore-3-study-of-sycume-teprotumumab-n01-injection-met-primary-endpoint-in-inactive-thyroid-eye-disease-302902606.html)\n\nSOURCE Innovent Biologics\n\n\n\nMedia: pr@innoventbio.com, +86 512-69566088; Investor: ir@innoventbio.com, +86 512-69566088\n\nCopyright (c) 2026 PR Newswire Association,LLC. All Rights Reserved."},"type":"article","timestamp":"2026-10-09T00:00:00.34797284Z","server_sent_at_ms":1791504000347},"received_at":"2026-10-09T00:00:00.517Z","source_url":"https://www.prnewswire.com/news-releases/innovent-announces-phase-3-restore-3-study-of-sycume-teprotumumab-n01-injection-met-primary-endpoint-in-inactive-thyroid-eye-disease-302902606.html"},"analysis":{"id":"153391","press_release_id":"164991","analysis_json":{"industry":{"label":"Pharmaceuticals, Biotechnology & Life Sciences","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Innovent's Phase 3 RESTORE-3 trial of SYCUME (teprotumumab) met its primary endpoint in inactive thyroid eye disease, with a proptosis response rate of 60.4% versus 23.5% for placebo.\n\nThe 116-participant randomized trial also achieved key secondary endpoints, with LS mean proptosis reduction of -1.88 mm versus -0.88 mm for placebo, and a favorable safety profile.\n\nThe result expands SYCUME's addressable population to inactive TED patients, roughly two-thirds of the TED population, reinforcing the drug's leading position in China where it was added to the National Reimbursement Drug List on January 1, 2026.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"SYCUME extends proven efficacy into inactive TED -- label-expansion opportunity covering two-thirds of TED patients in China."},"keyFigures":{"drugName":"SYCUME (Teprotumumab N01 Injection, IBI311)","phaseOfTrial":"Phase 3","customDimensions":{"treatment_difference":"36.9 percentage points (p = 0.0003)","participants_randomized":116,"proptosis_response_rate":"60.4% vs 23.5% placebo","ls_mean_change_proptosis":"-1.88 mm vs -0.88 mm placebo"}},"quotedText":"SYCUME® yields robust and clinically meaningful reductions in proptosis even in patients with chronic, inactive TED","namedEntities":{"people":[{"name":"Zhongyan Shan","role":"Lead Principal Investigator, First Hospital of China Medical University"},{"name":"Lei Qian","role":"Chief R&D Officer (General Biomedicine Pipeline), Innovent Biologics"}],"products":["SYCUME","Teprotumumab N01 Injection","IBI311","TEPEZZA"],"companies":[{"name":"Innovent Biologics, Inc.","ticker":"01801","relationship":"filer"},{"name":"Eli Lilly","relationship":"partner"},{"name":"Roche","relationship":"partner"},{"name":"Takeda","relationship":"partner"},{"name":"Pfizer","relationship":"partner"},{"name":"Sanofi","relationship":"partner"},{"name":"Incyte","relationship":"partner"}],"dollarAmounts":[{"amount":"RMB 350 billion","context":"aggregate value of Innovent's strategic partnerships"}]},"materialImpact":{"score":3,"reasoning":"Positive Phase 3 trial for an already-approved lead commercial product (SYCUME), expanding label opportunity into inactive TED (~two-thirds of TED patients). 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