RegulationBreakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Priority Review (Australia), Orphan Drug (Japan)

Structure/Sequence

Sequence Code 140450L

Source: *****

Sequence Code 140493H

Source: *****

Clinical Trials associated with Teprotumumab-TRBW

ChiCTR2500108068

/ Not yet recruitingNot ApplicableIIT

Clinical outcome of Anti-IGF-1R monoclonal antibody(Teprotumumab) for the treatment of thyroid eye disease.

Start Date31 Aug 2025

Sponsor / Collaborator-

NCT07142642

/ Active, not recruitingPhase 1

A Phase 1, Randomized, Placebo-controlled, Double-blind, Single-dose Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Teprotumumab (AMG 632) Administered Intravenously in Healthy Chinese Participants

The primary objective of the study is to evaluate the pharmacokinetics (PK) of teprotumumab after a single intravenous (IV) infusion of teprotumumab in healthy Chinese participants.

Start Date26 Aug 2025

Sponsor / Collaborator

Amgen, Inc.

NCT07085117

/ CompletedNot Applicable

Real World Use, Effectiveness and Safety of Teprotumumab Among Thyroid Eye Disease Patients Treated in China BOAO Pilot Zone: A Retrospective Cohort Study

The main objective of this study is to assess the number of participants with proptosis response as of last intravenous infusion of teprotumumab.

Start Date02 Jul 2025

Sponsor / Collaborator

Amgen, Inc.

100 Clinical Results associated with Teprotumumab-TRBW

100 Translational Medicine associated with Teprotumumab-TRBW

100 Patents (Medical) associated with Teprotumumab-TRBW

341

Literatures (Medical) associated with Teprotumumab-TRBW

01 Nov 2025·EXPERIMENTAL EYE RESEARCH

Teprotumumab reduces the proliferation and viability of pterygium fibroblasts

Article

Author: Zahavi, Alon ; Massalha, Jawad ; Richard, Stephen ; Obied, Basel ; Vardizer, Yoav ; Goldenberg-Cohen, Nitza ; Abu-Dbai, Jawad ; Rabinovich, Yakov

Pterygium is a fibrovascular overgrowth on the ocular surface. There is no effective medical treatment, and the high rate of postoperative recurrence remains a major clinical challenge. We aimed to investigate the ability of teprotumumab (TPT), an insulin-like growth factor 1 receptor antagonist, to reduce human pterygium fibroblast (HPF) viability and proliferation. Primary HPF cultures were derived from excised pterygium tissues from 10 patients scheduled for pterygium surgery, and treated with 10 mg/mL TPT. Cell viability and proliferation were evaluated. DNA damage was measured with TUNEL staining, and ultrastructural changes were visualized by electron microscopy. Quantitative polymerase chain reaction was used to assess the expression of genes involved in growth factor signaling, angiogenesis, and extracellular matrix remodeling. Primary HPF cell lines were successfully established from 5/10 patients. Treatment with TPT significantly reduced HPF viability (29.5 %-50 %) and proliferation (32 %-67 %) across all tested lines. Ki-67-positive cell counts decreased markedly, corroborating the reduced proliferative capacity. TUNEL staining and electron microscopy revealed extensive DNA damage, nuclear fragmentation, and vacuolization. TPT modulated gene expression by downregulating FGF2, VEGFA, and PAI-1 expression while upregulating MMP2 and MMP3 expression, suggesting reduced fibroblast activity and angiogenesis with enhanced extracellular matrix remodeling. TPT demonstrated robust antifibrotic effects on HPFs by reducing their viability and proliferation, inducing DNA damage, and altering the expression of genes associated with fibrosis and angiogenesis. These findings position TPT as a promising therapeutic agent for pterygium, potentially addressing postoperative recurrence and progression. Future animal studies and clinical trials are needed to confirm its efficacy and safety in clinical settings.

01 Oct 2025·OPHTHALMOLOGY

Long-term Cardiovascular, Renal, and Safety Outcomes of Teprotumumab versus Systemic Glucocorticoids in Thyroid Eye Disease

Article

Author: Ma, Kevin Sheng-Kai ; Lo, Jui-En ; Barbesino, Giuseppe ; Liu, Catherine Y ; Freitag, Suzanne K

PURPOSE:

The insulin-like growth factor-1 receptor inhibitor teprotumumab is effective for thyroid eye disease (TED), but there is limited evidence on its long-term safety. We studied the long-term cardiovascular, renal, infectious, and safety outcomes of teprotumumab compared with intravenous (IV) glucocorticoids (GCs), oral GCs, and conservative treatment in patients with TED.

DESIGN:

Population-based cohort study.

PARTICIPANTS:

Patients with TED who initiated teprotumumab, GCs, or conservative treatment between January 1, 2020, and December 1, 2024, from 80 health care organizations in the United States.

METHODS:

Propensity scores were used to match baseline covariates including demographics, comorbidities, laboratory data, and medications. Cox proportional hazards models were used to calculate hazard ratios (HRs).

MAIN OUTCOME MEASURES:

Outcomes included all-cause mortality and the risks of new-onset cardiovascular diseases, renal diseases, infectious outcomes, and safety outcomes, including hearing loss, within 5 years after initiating treatments.

RESULTS:

Teprotumumab was associated with markedly lower all-cause mortality (teprotumumab vs IV GCs: HR 0.32, 95% CI 0.16-0.65; teprotumumab vs oral GCs: HR 0.20, 95% CI 0.10-0.39) and reduced risks of acute myocardial infarction (teprotumumab vs IV GCs: HR 0.37, 95% CI 0.15-0.95; teprotumumab vs oral GCs: HR 0.33, 95% CI 0.12-0.91), acute kidney failure (teprotumumab vs IV GCs: HR 0.54, 95% CI 0.31-0.94; teprotumumab vs oral GCs: HR 0.37, 95% CI 0.22-0.63), emergency department visits (teprotumumab vs IV GCs: HR 0.48, 95% CI 0.38-0.60; teprotumumab vs oral GCs: HR 0.60, 95% CI 0.48-0.75), hospitalizations (teprotumumab vs IV GCs: HR 0.31, 95% CI 0.23-0.40; teprotumumab vs oral GCs: HR 0.34, 95% CI 0.26-0.45), urinary tract infection (teprotumumab vs IV GCs: HR 0.60, 95% CI 0.41-0.89; teprotumumab vs oral GCs: HR 0.58, 95% CI 0.40-0.86), pneumonia (teprotumumab vs IV GCs: HR 0.37, 95% CI 0.22-0.61; teprotumumab vs oral GCs: HR 0.33, 95% CI 0.20-0.53), and severe sepsis (teprotumumab vs IV GCs: HR 0.24, 95% CI 0.10-0.64; teprotumumab vs oral GCs: HR 0.31, 95% CI 0.11-0.84). There was no difference in the risks of diabetes, chronic kidney disease, or inflammatory bowel disease, or complications requiring a hearing device, whereas there was a higher risk of hearing loss after starting teprotumumab compared with GCs (teprotumumab vs IV GCs: HR 2.43, 95% CI 1.67-3.55; teprotumumab vs oral GCs: HR 2.38, 95% CI 1.65-3.44). All-cause mortality was also markedly reduced in teprotumumab-treated patients when compared with patients receiving conservative treatment (HR 0.24, 95% CI 0.13-0.45).

CONCLUSIONS:

Treatment with teprotumumab compared with IV or oral GCs was associated with reduced risks of death and cardiovascular, renal, and infectious outcomes in patients with TED. Teprotumumab may result in fewer adverse outcomes than systemic GCs for treating TED.

FINANCIAL DISCLOSURE(S):

Proprietary or commercial disclosure may be found after the references.

01 Sep 2025·JOURNAL OF NEURO-OPHTHALMOLOGY

Observational Characterization of the Retreatment Course of Patients With Thyroid Eye Disease

Article

Author: Chen, Yuanyuan ; Linaburg, Taylor ; Merchant, Gibran ; Tamhankar, Madhura A ; Wang, Sarah ; Augello, Patrick Anthony ; Pradeep, Tejus ; Briceño, César A ; Ying, Gui-Shuang

Background::

To characterize the retreatment course of patients with thyroid eye disease (TED), who had reactivation after initial therapy with teprotumumab.

Methods::

This was a single-center longitudinal cohort study of patients who received an initial course of teprotumumab for active TED and were followed for at least 6 months. Reactivation was defined as the increase of proptosis of 2 mm or more or an increase in Clinical Activity Score (CAS) of two points or more, as adapted from the Optic-X study. Data collection included patient age, sex, smoking status, history of thyroidectomy or radioactive iodine, proptosis measurements, clinical activity score (CAS) before initial infusion of teprotumumab, time interval to reactivation, diplopia assessment by the Bahn–Gorman scale, CAS at the time of reactivation, and CAS and proptosis measurements after completion of retreatment and retreatment modalities, including clinical monitoring, corticosteroids, teprotumumab, and/or surgery. Among the reactivated cohort, the treatment response of patients who received a second course of teprotumumab was compared with patients who were treated with intravenous (IV) steroids.

Results::

Twenty-six percent (11/42) of patients experienced reactivation of TED with an average time to reactivation of 9 (SD:5) months (range: 2–20 months), average CAS at reactivation of 4 (SD:1) (range: 3–7), and average increase in proptosis of 3 (SD:1) mm (range: 2–6 mm). Of the 11 patients who reactivated, 4 received a second course of teprotumumab, while 6 received IV steroids. One patient elected to monitor. The patients who received a second course of teprotumumab had a mean (SD) posttreatment CAS score of 0 reduction in proptosis of 4 (2) mm (range: 3–6). The patients who received IV steroids had a mean (SD) posttreatment CAS of 2 (1) (range: 1–4) and a reduction in proptosis of 0 (1) mm (range: [−1] to [2]). Univariate analyses to look at predictors of reactivation found no correlation between factors such as age, sex, duration of TED, smoking status, presence of diplopia, previous treatment with radioactive iodine, history of periorbital surgery, and/or thyroidectomy after initial completion of teprotumumab between the 2 cohorts. We found a significant correlation between the CAS scores before initial treatment (P = 0.036) and thyroid hormone dysregulation (P = 0.006) in those who experienced reactivation.

Conclusions::

Patients with TED may experience reactivation of the disease after initial therapy with teprotumumab. Reactivated disease responds to repeat therapy with teprotumumab with higher previous CAS and thyroid hormonal dysregulation being the variables that were significantly associated with reactivation. These data underscore the importance of long-term monitoring and exploring underlying triggers for disease reactivation. Understanding these factors could help predict which patients may require retreatment or chronic dosing with teprotumumab. Further studies are essential to advance our understanding of the immunomodulatory effects of teprotumumab, duration of its therapeutic benefit, and potential retreatment strategies to improve long-term patient outcomes.

214

News (Medical) associated with Teprotumumab-TRBW

17 Sep 2025

·endpoints.news

Ollin lands $100M to test eye drugs from Chinese partners and bring in more assets

Another US biotech has emerged with rights to experimental medicines that were created by China-based drug developers. On Wednesday, Austin, TX-based Ollin Biosciences debuted with $100 million in funding to create new ophthalmology treatments from two Chinese biopharmas, Innovent and VelaVigo. The company’s backers include life-science heavyweights ARCH Venture Partners, Mubadala Capital and Monograph Capital. Ollin is the latest Western biotech to build itself around assets from China’s bustling drug development landscape. It formed two years ago with the mission of becoming an asset-centered ophthalmology company that carries forward other drug developers’ candidates, CEO Jason Ehrlich said in an interview with Endpoints News . “For us, it’s really around finding the best scientific and clinical opportunities where we think there’s room for innovation,” Ehrlich said. Ollin’s board includes Travis Murdoch, another biotech executive with recent experience doing the China-to-US strategy. He leads Braveheart Bio, which got rights to a cardio drug from Hengrui earlier this month. China assets have made up more than a third of the pharma industry’s licensing deals through August of this year, according to bankers at Raymond James. Some of Ollin’s $100 million has already gone toward its two licensing deals, Ehrlich said, and the startup will look for more candidates to bring in-house from around the world. It has a broad remit across ophthalmology, including retinal diseases, cornea-focused conditions, glaucoma and other areas. “There’s been this Cambrian explosion of technologies for evaluating ophthalmic images,” Ehrlich said, making the space even more appealing for drug development. But gene therapies and dry eye disease are areas that Ollin won’t touch, he said. With two deals under its belt, Ollin looks to take on Roche’s Vabysmo in wet age-related macular degeneration and diabetic macular edema, as well as Amgen’s Tepezza and other biotechs in the thyroid eye disease field. Ehrlich spent about a decade at Genentech, eventually leading their late-stage development for programs including Vabysmo. Ollin’s drug, OLN324, is currently in a Phase 1b trial pitting it against Vabysmo. The experimental drug is a VEGF/Ang2 bispecific antibody from Innovent Biologics that will read out in the first quarter of 2026, the company said. The US-based Phase 1b has completed enrollment, with about 75 treatment-naive wet AMD patients and about 75 patients with DME, Ehrlich said. That represents the leading causes of vision loss in the elderly, he noted. “We’re testing the drug in this proof-of-concept study in both of the big indications, which will help us map out the path forward from here,” Ehrlich said. In thyroid eye disease, Ollin has ex-Greater China rights to a preclinical treatment candidate from its other China partner, VelaVigo. VelaVigo has an undisclosed stake in Ollin and the potential for up to $440 million from its US partner, it told Endpoints exclusively in April. That drug is a TSHR/IGF-1R bispecific, codenamed OLN102. It’s slated to enter human studies next year. “The idea is that by bringing these two pathways together, can we potentially have a similar, if not better, efficacy, but a nicer safety profile?” Ehrlich said. The CEO said the biotech could explore multiple paths for clinical and commercial development. Other drug developers have commercialized on their own in ophthalmology, with Regeneron getting its first big break in this market, and Apellis being a more recent example, Ehrlich said. Ollin is named after the Aztec word for forward movement, Ehrlich said. The ancient symbol includes an eye. And its pronunciation sounds like “all in.” “There haven’t been a lot of asset-centered development engines in ophthalmology,” Ehrlich said. “We’ve seen that in immunology, virology, oncology and many other areas.”

Phase 1License out/in

17 Sep 2025

·www.biopharmadive.com

Ollin debuts with $100M and plans to challenge top-selling eye drugs

A new biotechnology startup is launching with plans to challenge some of the worlds best-selling eye medicines, armed with a pair of prospects already in, or approaching, clinical testing.Called Ollin Biosciences, the startup emerged from stealth on Wednesday with $100 million in financing and medicines it aims to prove are superior to Roches vision loss drug Vabysmo and Amgens thyroid eye disease treatment Tepezza.Ollins lead prospect, dubbed OLN324, is being developed as part of a collaboration with Shanghai, China-based Innovent Biologics. The drug is a bispecific antibody that blocks a pair of proteins, VEGF and Ang2, involved in the progression of age-related macular degeneration and diabetic macular edema. Theyre also the targets of Vabysmo, which was approved in 2022and has since taken market share from Regeneron Pharmaceuticals blockbuster eye drug Eylea.Ollin claims that, because of its design, OLN324 could be more potent and have longer-lasting effects than Vabysmo. It also aims to show in testing that OLN324 could offer patients greater relief from long-term health problems associated with AMD and DME.We see how quickly physicians switched from say, Lucentis to Eylea back in the day, and from Eylea to Vabysmo now, said CEO Jason Ehrlich. So therapies that offer further improvement in treatment outcomes and disease control for patients are really desired by the market and physicians.The company has completed enrollment in a 150-patient, randomized Phase 1b study testing OLN324 directly against Vabysmo. Results are expected in the first quarter of 2026.Ollin licensed its other top candidate, named OLN102, from another Shanghai-based drugmaker called VelaVigoearlier this year.Like Tepezza, the drug inhibits IGF-1R, which helps drive inflammation in thyroid eye disease. But OLN102 also simultaneously blocks a second target, TSHR, associated with disease progression.Ehrlich said impacting both at the same time may have synergistic benefits and minimize some of the known side effects of Tepezza. Ollin hopes to show it could be administered subcutaneously, too, instead of via an infusion like Tepezza. Human testing should start next year.Ollin is building a drug portfolio through deals, rather than in-house research. Its leaning on a team of experienced leaders and advisers in ophthalmology drug development, hoping that expertise will enable it to spot and advance next-generation medicines for multiple eye conditions.There are relatively few of those types of company builds in ophthalmology, Ehrlich said. It seemed like there was an opportunity to put something like that together.“Arch Venture Partners,Mubadala Capital and Monograph Capital co-led Ollins financing. '

Phase 1

27 Aug 2025

·www.prnewswire.com

Innovent Announces 2025 Interim Results and Business Updates

Robust revenue growth and substantial profit improvement Continued exceptional executions under a clear roadmap of dual-driven growth and global innovation SAN FRANCISCO and SUZHOU, China, Aug. 27, 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 cancer, cardiovascular and metabolic, autoimmune, ophthalmology and other major diseases, announces its 2025 interim results and major business updates. Continue Reading Dr. Michael Yu, Founder, Chairman of the Board and CEO of Innovent, stated: "We delivered an outstanding performance in the first half of 2025, driven by the comprehensive acceleration of our dual-engine growth model and global innovation strategy. Supported by our oncology leadership and successful commercial launch across our general biomedicine portfolio, we have expanded our product portfolio to 16 drugs and achieved a notable improvement in revenue and profitability, maintaining strong business momentum. On the innovation front, several core pipeline candidates with global potential achieved key proof-of-concept data, and are entering global registration trials. This demonstrates the depth of Innovent's innovation capabilities and lays a solid foundation for globalization. We firmly believe that a clear strategic vision combined with excellent execution will continue to drive Innovent's growth. Looking ahead, we will further consolidate our leadership in oncology, continue exploring and implementing diversified commercialization strategies across our general biomedicine product portfolio, and accelerate the global development of our next-generation innovative pipeline. Anchored by our strategic goals of achieving RMB 20 billion in product revenue by 2027 and advancing five pipeline programs into global Phase 3 trials by 2030, Innovent will continue striving to become a world-class biopharmaceutical company." Dual-driven revenue growth with execution excellence Robust revenue growth and substantial profit improvement[1] Total revenue: RMB 5.95 billion, up 50.6% year-on-year Product revenue: RMB 5.23 billion, up 37.3% year-on-year Net profit: RMB 1.21 billion; EBITDA: RMB 1.41 billion Gross margin: 86.8%, up 2.7 percentage points year-on-year Selling and administrative expenses ratio: 44.2%, down 7.9 percentage points year-on-year R&D investment: RMB 903 million Cash on hand: approximately USD 2 billion[2] Dual-engine growth supported by comprehensive and diversified product portfolio Expansion of oncology product portfolio with three new launches Dovbleron® (taletrectinib) : Potentially best-in-class ROS1 inhibitor Limertinib : Third-generation EGFR TKI Jaypirca®(pirtobrutinib) : First non-covalent BTK inhibitor Strengthening general biomedicine portfolio with innovative pipeline SINTBILO® (tafolecimab injection): First PCSK-9 inhibitor successfully included in the NRDL, received approval by Macau ISAF in May 2025 SYCUME ® ( teprotumumab N01 injection): First approved anti-IGF-1R monoclonal antibody, ending a 70-year drought of no new treatment options for thyroid eye disease (TED) in China Mazdutide (GCG/GLP-1) : Globally first and only GCG/GLP-1 dual receptor agonist for weight management, with another NDA for glycemic control of T2D adults under NMPA review Innovative commercial strategy with multi-channel coverage Actively responding to the national "Year of Weight Management": Participating in the development of the weight-loss industry ecosystem, promoting the concept of scientific weight management, and advancing obesity prevention and chronic disease management Deepening hospital presence and academic influence: Strengthening academic coverage in public hospitals, with the GLORY-1 study published in The New England Journal of Medicine, significantly enhancing academic influence Innovative multi-channel coverage: Leveraging a comprehensive sales team of over 1,000 people, integrating public hospitals, retail pharmacies, online medical platforms, and private clinic networks to facilitate convenient access to medications for chronic disease patients Emphasizing disease education and patient management: Integrating digital tools and professional activities to establish a patient-centric disease management system, enhancing chronic disease education and patient adherence Enhancing brand strength through the establishment of a lifecycle management system TYVYT ® : NDAs for renal and colorectal cancer are under regulatory review; Phase 3 study of neoadjuvant treatment in lung cancer is underway SYCUME ® ( teprotumumab N01 injection): new Phase 3 studies in plan for inactive TED and head-to-head comparison with steroid therapy in TED Mazdutide (GCG/GLP-1): second NDA for glycemic control of T2D adults is under regulatory review, alongside with two new Phase 3 studies for obstructive sleep apnea (OSA) and obesity with metabolic dysfunction-associated fatty liver disease (MAFLD, head-to-head with semaglutide 2.4mg). Additional PoC studies are ongoing for adolescent obesity, metabolic dysfunction-associated steatohepatitis (MASH), heart failure with preserved ejection fraction (HFpEF), etc. Picankibart (IL-23p19): a potent and long-acting IL-23p19 for moderate-to-severe plaque psoriasis pending NMPA approval; Phase 3 studies are ongoing for treatment withdrawal maintenance and psoriasis with prior inadequate response to IL-17 biologics Emerging value from globalization strategy, prioritizing novel pipeline's global R&D Flagship pipeline showcased at top-tier conferences, entering global registration studies IBI363 (PD-1/IL-2 α -bias ): Unleashing potential as a next-generation IO therapy with global first-in-class design Three oral presentations at ASCO highlighted breakthrough PoC data across difficult-to-treat tumors such as IO resistant cold tumors and low PD-L1 expression, demonstrating the unique advantages of dual immune activation and long-term survival benefits Three pivotal studies are underway or in plan: the first global Phase 3 study is initiating in China and the U.S. to address unmet needs in IO-resistant squamous NSCLC; the first pivotal Phase 2 study in melanoma was initiated, challenging Keytruda in first-line setting; and the first Phase 3 study in late-line colorectal cancer is about to initiate Continuous exploration in first-line settings and more cancer types, including first-line lung cancer, first-line colorectal cancer, neoadjuvant lung cancer, EGFR-mutated lung cancer, platinum-resistant ovarian cancer, and more BI343 (CLDN18.2 ADC): two registration trials in GC and PDAC; globally the first ADC to enter a Phase 3 trial in PDAC First MRCT Phase 3 study of GC has been initiated in China and Japan First Phase 3 study of PDAC has been initiated Global MRCT of PDAC is in plan NMPA CDE Breakthrough Therapy Designation (BTD) and FDA Fast-track Designation (FTD) granted Over 10 next-generation programs advancing into global development Oncology: IBI3009 (DLL3 ADC), IBI3001 (EGFR/B7H3 ADC), IBI3003 (GPRC5D/BCMA/CD3), IBI3005 (EGFR/HER3 ADC), IBI3014 (PD-L1/TROP2 ADC), IBI3020 (CEACAM5 dual-payload ADC), etc CVM: IBI3016 (AGT siRNA), IBI3032 (oral GLP-1), etc A uto immune: IBI356 (OX40L), IBI3002 (TSLP/ IL-4Rα), etc Hybrid models to accelerate innovation IBI3009 (DLL3 ADC): global rights granted to Roche, to benefit SCLC patients worldwide Enhance global presence with broader market access Six products (TYVYT®, BYVASDA®, Pemazyre®, Dupert®, SINTBILO®, SYCUME®) have been launched in markets including Hong Kong, Macau, Taiwan, and Southeast Asia More launches planned Brazil, Mexico, Columbia, India, etc Research innovation showcased at medical conferences Oncology pipeline: AACR, ASCO, Nature Medicine General biomedicine pipeline: ADA, NEJM Facilities and manufacturing capacity adhering to high-quality standards 7,500 employees globally Global R&D centers located in the San Francisco Bay Area, Shanghai, and Suzhou To date, Innovent has a total of 140,000L of operational capacity, accounting for 20% of China's total biopharmaceutical production capacity First manufacturing site: 60,000L antibody and ADC production capacity in operation, ensuring high-quality supply Second manufacturing site: first phase of 80,000L antibody production capacity in operation, for global supply and CDMO operations Committed to responsible business practices and enhancing ESG management practices Over 3,000 new oncology patients begin treatment with Innovent-developed therapeutics each day, and to date, more than 5 million patients have benefited from Innovent's innovative drugs Innovent has been graded 'AAA' rating in MSCI ESG rankings, positioning us at the forefront of the biotechnology industry We have supported over 200,000 patients through our dedicated patient assistance programs, with drug donations totaling RMB 3.6 billion Our commitment to medical philanthropy has been recognized through prestigious awards, including the "Medical Philanthropy Promoter" title and designation as a "China Philanthropic Enterprise" Provided over 2,200 job opportunities for recent graduates To date, Innovent Biologics has contributed more than RMB 6 billion in taxes and fees About Innovent Biologics 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 16 products in the market. It has 2 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, 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: （1）Innovent does not recommend the use of any unapproved drug (s)/indication (s). （2）Ramucirumab (Cyramza)，Selpercatinib (Retsevmo) and Jaypirca (pirtobrutinib) were developed by Eli Lilly and Company. Forward-Looking Statements 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. 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

Drug ApprovalBreakthrough TherapyPhase 3Phase 2Fast Track

100 Deals associated with Teprotumumab-TRBW

External Link

KEGG	Wiki	ATC	Drug Bank
-	Teprotumumab-TRBW	L01XC	DB06343

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Graves Ophthalmopathy	United States	Horizon Therapeutics Ireland DAC	21 Jan 2020

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 2	United States	Hoffmann-La Roche, Inc.	28 Jan 2009
Advanced Lung Non-Small Cell Carcinoma	Phase 2	United States	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Australia	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Belgium	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Canada	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	France	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Germany	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Ireland	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Italy	Hoffmann-La Roche, Inc.	10 Nov 2008
Advanced Lung Non-Small Cell Carcinoma	Phase 2	Poland	Hoffmann-La Roche, Inc.	10 Nov 2008

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


OPTIC and OPTIC-X (ENDO2024)	Phase 2	Graves Ophthalmopathy	112	Teprotumumab	xxfbjhfrup(mygcarwstt) = rpswfvuapx gnaxnmbssc (fgcosfldnf ) View more	Positive	01 Jun 2024
ENDO2024	Not Applicable	Graves Ophthalmopathy TSH \| T4 \| Total T3 ... View more	26	Teprotumumab	iodjdmrkpf(ilvydtcpnc) = 19% kdkoubjlqd (ptzladdhwr ) View more	-	01 Jun 2024
NCT01868997 \| NCT03298867 \| JPRN-jRCT2031210453 (Three Global Randomized, Double-masked, Placebo-controlled Trials, ENDO2024)	Not Applicable	Graves Ophthalmopathy	-	Teprotumumab	qylatyhczt(shdpozlfse) = eerfnzanpf ghwyfcrast (usshzykizg )	Positive	01 Jun 2024
				Placebo	qylatyhczt(shdpozlfse) = wcfgdrmber ghwyfcrast (usshzykizg )
OPTIC and OPTIC-X (ENDO2024)	Phase 2	Graves Ophthalmopathy	112	Teprotumumab	zmqjeubpbp(ttfurqkuxu) = djpcowutag ywgilgeehy (kefdebrddg ) View more	Positive	01 Jun 2024
NCT04478994 (CTgov)	Phase 1	Scleroderma, Diffuse	3	Placebo	bdhzswglyh = rkjpjwvcjd rmxlielwqy (otlasrqumh, hssldouysw - xfgzvcproo) View more	-	19 Apr 2024
NCT04583735 (OR27-04, ENDO2023)	Phase 4	Graves Ophthalmopathy	62	Teprotumumab	fgsrupnsjc(plgpfjxlrm) = two AE discontinuations: teprotumumab (left ear conductive hearing loss with congenital anomaly) and PBO (infusion related) qbuwypwfxk (qfquztyyin ) View more	Positive	05 Oct 2023
				Placebo
ARVO2023	Not Applicable	Graves Ophthalmopathy	19	Teprotumumab	ddsckjtsef(vcvksixipv) = rkiiomhaca mpriffqqbo (clgtvxlsql ) View more	-	23 Apr 2023
RF35 \| PSAT263 (ENDO2022)	Phase 2/3	Graves Ophthalmopathy low baseline FT4 levels	17	Teprotumumab	fkagiehzzw(xgeybgwrrm) = tjiajgamat owjucbkjwg (vbqqslrhic ) View more	Positive	01 Nov 2022
				Placebo	fkagiehzzw(xgeybgwrrm) = rmowazgtfa owjucbkjwg (vbqqslrhic ) View more
PSAT261 (ENDO2022)	Not Applicable	Graves Ophthalmopathy	565	Steroid Use Pre-Teprotumumab	oiyygnnjnn(bwivyhzdlh) = hhzhulgrjj nboxuuqujq (gysonedvle )	Positive	01 Nov 2022
				Steroid Use Post-Teprotumumab	oiyygnnjnn(bwivyhzdlh) = aqmogmkfjf nboxuuqujq (gysonedvle )
PSAT265 (ENDO2022)	Not Applicable	Graves Ophthalmopathy	-	Teprotumumab	wutystywlq(fwmyiadnln) = There were no cases of diabetic ketoacidosis or hyperosmolar hyperglycemic state ccqwreyzvt (nchhxuskdv ) View more	-	01 Nov 2022
				Placebo

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