Sycume (teprotumumab N01) / Innovent Biologics - LARVOL DELTA

In the updated NRDL, SYCUME (teprotumumab N01 injection) is newly listed for moderate-to-severe thyroid eye disease (PRNewswire) - "SYCUME (teprotumumab N01 injection) is China's first approved IGF-1R antibody drug, and this groundbreaking non-invasive therapy redefines the standard of care and serves the unmet needs for thyroid eye disease over past 70 years in China."

Reimbursement • Thyroid Eye Disease

Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=7 | Active, not recruiting | Sponsor: Shanghai Changzheng Hospital | Recruiting ➔ Active, not recruiting

Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study of Teprotumumab N01 in Subjects With Active Thyroid Eye Disease (clinicaltrials.gov) - P4 | N=92 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P4 trial • Ophthalmology • Thyroid Eye Disease

A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=111 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology • Thyroid Eye Disease

IGF-1R Inhibitor IBI311 for the Treatment of Active Thyroid Eye Disease in Chinese Patients: The RESTORE-1 Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P2/3 | "To assess efficacy and safety of IBI311, an IGF-1R inhibitor with an identical amino acid sequence to teprotumumab but a different dosage form, in Chinese patients with active TED. The results suggest that IBI311 represents a viable treatment option for Chinese patients with active TED. ClinicalTrials.gov Identifier: NCT05795621."

Clinical • Journal • Diabetes • Ophthalmology • Thyroid Eye Disease

A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=38 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Sep 2025 | Trial primary completion date: Aug 2025 ➔ Jan 2025

Trial completion • Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

Efficacy and Safety of Sequential Hormone Therapy and Tetuzumab Therapy in Patients With Moderate to Severe TAO in the Active Stage After Glucocorticoid Treatment. (clinicaltrials.gov) - P4 | N=96 | Recruiting | Sponsor: Shanghai Changzheng Hospital

New P4 trial • Ophthalmology • Thyroid Eye Disease

The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment. (clinicaltrials.gov) - P4 | N=64 | Recruiting | Sponsor: Shanghai Changzheng Hospital

New P4 trial • Ophthalmology • Thyroid Eye Disease

Evaluation of the Efficacy and Safety Observation of IBI311 Treatment in Patients With Inactive TAO (clinicaltrials.gov) - P4 | N=50 | Recruiting | Sponsor: Shanghai Changzheng Hospital

New P4 trial • Ophthalmology • Thyroid Eye Disease

A Clinical Study to Evaluate the Efficacy and Safety of IBI311 in Subjects With Inactive Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=111 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Ophthalmology • Thyroid Eye Disease

Efficacy and Safety of Teprotumumab N01 Injection in Subjects with Thyroid Eye Disease Exhibiting Significant Extraocular Muscle Inflammation on MRI but with CAS Scores in the Inactive Phase (ChiCTR) - P=N/A | N=15 | Not yet recruiting | Sponsor: Department of Ophthalmology, West China Hospital, Sichuan University; Department of Ophthalmology, West China Hospital, Sichuan University

New trial • Inflammation • Ocular Inflammation • Ophthalmology • Thyroid Eye Disease

Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined With Anti-PD-1 Monoclonal Antibody in Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=7 | Recruiting | Sponsor: Shanghai Changzheng Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Safety and Efficacy Evaluation of Anti IGF-1R Monoclonal Antibody Combined with Anti-PD-1 Monoclonal Antibody in Treatment in Patients with Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=7 | Not yet recruiting | Sponsor: Shanghai Changzheng Hospital

New P1 trial • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=91 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Trial primary completion date: Feb 2025 ➔ May 2026 | Recruiting ➔ Active, not recruiting | Trial completion date: Jul 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Trial primary completion date • Ophthalmology • Thyroid Eye Disease

A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=36 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=36 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Ophthalmology • Thyroid Eye Disease

A Study of IBI311 in Subjects With Inactive or Active Thyroid Eye Disease (clinicaltrials.gov) - P2 | N=36 | Not yet recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P2 trial • Ophthalmology • Thyroid Eye Disease

Innovent Announces the New Drug Application of IBI311 (IGF-1R antibody) has been Accepted by the NMPA of China for Thyroid Eye Disease (PRNewswire) - "Innovent Biologics...announced that the New Drug Application (NDA) for IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody, has been accepted and granted priority review designation by the Center for Drug Evaluation (CDE) of the China National Drug Administration (NMPA) for the treatment of Thyroid Eye Disease (TED). IBI311 is the first anti-IGF-1R antibody with NDA submitted in China....This NDA was accepted based on the positive results of a Phase 3 registration clinical study RESTORE-1 (CTR20223393) in subjects with TED in China."

China filing • Priority review • Thyroid Eye Disease

A PHASE 2 STUDY TO EVALUATE EFFICACY AND SAFETY OF IBI311 IN CHINESE SUBJECTS WITH ACTIVE THYROID EYE DISEASE (ICE-EDEC 2024) - "Among Chinese patients with active TED, IBI311 resulted in better outcomes with respect to proptosis, overall response and diplopia than placebo. IBI311 was safe and well tolerated in TED patients."

Clinical • P2 data • Endocrine Disorders • Grave’s Disease • Ophthalmology • Thyroid Eye Disease

A Study of IBI311 in Subjects With Steroid-resistant, Thyroid Associated Ophthalmopathy (clinicaltrials.gov) - P3 | N=54 | Active, not recruiting | Sponsor: Peking University People's Hospital

New P3 trial • Ophthalmology • Thyroid Eye Disease

Innovent Announces Primary Endpoint Met in the Phase 3 Clinical Trial (RESTORE-1) of IBI311 (Anti-IGF-1R Antibody) in Treating Thyroid Eye Disease and Plans to Submit NDA to the NMPA (PRNewswire) - P2/3 | N=NA | RESTORE-1 (CTR20223393) | "Innovent Biologics...announced that the primary endpoint has been achieved in the Phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA)....The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye...was significantly higher in subjects treated with IBI311 than in subjects treated with placebo: 85.8% vs. 3.8%, with a difference of 81.9% (95% CI: 69.8% to 93.9%, P < 0.0001)....Detailed results from the study will be released in medical conferences or journals in the future."

Non-US regulatory • P3 data • Thyroid Eye Disease

A Study of IBI311 in Subjects With Active Thyroid Eye Disease (clinicaltrials.gov) - P2/3 | N=115 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Ophthalmology • Thyroid Eye Disease

A Multicenter, Open-label Extension Study Evaluating the Efficacy and Safety of IBI311 in Subjects With Thyroid Eye Disease (clinicaltrials.gov) - P3 | N=114 | Recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

New P3 trial • Ophthalmology • Thyroid Eye Disease

A Study of IBI311 in Subjects With Active Thyroid Eye Disease (clinicaltrials.gov) - P2/3 | N=114 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Ophthalmology • Thyroid Eye Disease

A Study of IBI311 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Completed

Trial completion