Innovent's Partner Ollin Biosciences Announces Positive Topline Data with Superior Outcomes from a Randomized Head-to-Head Study of IBI324 Compared to Faricimab (Vabysmo®) in Diabetic Macular Edema and Wet Age-Related Macular Degeneration
MWN-AI** Summary
Innovent Biologics, partnered with Ollin Biosciences, announced promising topline results from the Phase 1b JADE clinical study, which aimed to compare its next-generation VEGF/Ang2 bispecific antibody, IBI324 (Ollin R&D code: OLN324), to the existing treatment, faricimab (Vabysmo®), in patients suffering from diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). This randomized head-to-head trial involved over 160 patients and found that OLN324 exhibited significantly superior efficacy.
Key results indicated that OLN324 delivered faster and greater reductions in retinal thickness, a measure of retinal drying, compared to faricimab. Specifically, patients receiving a 4mg dose of OLN324 experienced approximately 75% more improvement in central subfield thickness after one week and about 50% more by week 12. Close to 90% of OLN324-treated patients achieved a complete absence of DME at week 12, a stark contrast to the 57% success rate observed in those treated with faricimab.
Importantly, while both treatments showed similar anatomical outcomes for wAMD, OLN324 demonstrated numerically greater vision improvements by week 12. The study also reported a favorable safety profile for OLN324, with no intraocular inflammation cases compared to one instance in the faricimab group.
These findings suggest that OLN324 has the potential to set a new standard in the approximately $15 billion global retinal therapeutics market, validated by its dual mechanism of action targeting both VEGF and Ang2. Innovent is optimistic about the future development of OLN324 and plans to advance it into global Phase 3 trials for DME and wAMD following consultations with health authorities. The results will be formally presented at the upcoming Angiogenesis, Exudation, and Degeneration 2026 symposium.
MWN-AI** Analysis
Innovent Biologics’ partner, Ollin Biosciences, has reported promising topline results for IBI324 in a head-to-head trial against faricimab (Vabysmo®), potentially setting the stage for a significant shift in the treatment landscape for diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). The data reveals that IBI324 offers faster and more effective retinal drying in DME patients, suggesting that this therapy may establish itself as a new standard of care, especially given its enhanced potency and dosing strategy.
Investors should take note of the clinical significance of these findings. IBI324's impressive outcomes—where treated patients achieve a 75% greater reduction in central subfield thickness compared to faricimab after just one week—indicate strong therapeutic potential. The differentiation in efficacy alone may be pivotal in driving adoption among healthcare providers. With a market worth around $15 billion globally for retinal therapeutics, IBI324’s success could catalyze substantial revenue growth for Innovent and its partners.
Given that clinical trials pave the way for regulatory discussions and potential commercialization, stakeholders should monitor the progression into Phase 3 studies and subsequent regulatory submissions closely. The positive safety profile reported during the Phase 1 trials further strengthens the case for IBI324, reducing potential market entry barriers associated with safety concerns.
Furthermore, with Ollin Biosciences planning to present detailed study results at key industry conferences, investor sentiment is likely to remain bullish, fueling interest in Innovent’s broader pipeline, which already includes multiple late-stage assets. As the competitive landscape evolves in the ophthalmic market, maintaining a close watch on future data releases and strategic collaborations will be essential for making informed investment decisions in this promising therapeutic area.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
PR Newswire
SAN FRANCISCO and SUZHOU, China, Jan. 8, 2026 /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, autoimmune, cardiovascular and metabolic, ophthalmology and other major disease areas, today announced that the company's partner Ollin reported positive topline results from its randomized, head-to-head Phase 1b JADE clinical study comparing IBI324 (Ollin R&D code:OLN324), a next-generation VEGF/Ang2 bispecific antibody, to faricimab (Vabysmo®), in over 160 patients with diabetic macular edema (DME) or wet (neovascular) age-related macular degeneration (wAMD). OLN324's up to 60-fold higher anti-Ang2 potency together with a smaller protein format and a higher molar dose gives OLN324 a differentiated, first-line standard of care profile.
OLN324 demonstrated both faster and greater retinal drying versus faricimab in patients with DME, with OLN324 4mg treated patients experiencing mean improvements in retinal drying that were ~75% greater than faricimab at Week 1 (-79 µm vs. -45 µm mean change in central subfield thickness or CST, respectively), and ~50% greater at Week 12 (-180 µm vs. -121 µm), measured using optical coherence tomography (OCT). Additionally, nearly 90% of OLN324 4mg treated patients achieved absence of DME at Week 12, defined as CST < 325 µm, as compared to 57% of faricimab patients.
All treatment groups yielded equivalent anatomic outcomes in patients with wAMD, with rapid improvements in OCT mean CST as early as Week 1 that were sustained through Week 12. Patients across all treatment groups experienced rapid and sustained mean gains in vision (best-corrected visual acuity, or BCVA) with numerically greater improvements at Week 12 with OLN324 than faricimab in both DME and wAMD.
"DME is among the most challenging retinal diseases to treat and has long served as a proving ground for therapies that ultimately become first-line standard of care in retinal diseases. The difference in speed and extent of retinal drying observed with OLN324 versus faricimab, the highest bar comparator in DME, is compelling and clinically significant. In real-world practice, this best-in-disease outcome could lead to broad utility for OLN324 across all the major retinal diseases," said Arshad M. Khanani, M.D., M.A., FASRS, Managing Partner and Director of Clinical Research at Sierra Eye Associates, JADE study investigator and Ollin Scientific Advisory Board member.
"OLN324 is the first and only therapy to demonstrate superior anatomic efficacy compared to the market leader, faricimab, in a head-to-head, randomized clinical trial," said Jason Ehrlich, M.D., Ph.D., Co-founder and Chief Executive Officer of Ollin Biosciences. "These data validate that a higher potency, higher molar dose, smaller format VEGF/Ang2 bispecific can more fully realize the therapeutic potential of dual VEGF and Ang2 inhibition. By achieving faster and greater retinal drying in DME, OLN324 has the potential to become the new standard of care in the ~$15 billion worldwide market for retinal therapeutics."
"We are excited about by the progress of OLN324 (IBI324), driven forward by our partner Ollin, especially the successful results of the JADE Phase 1b trial in head-to-head comparison with faricimab," stated Dr. Lei Qian, Chief R&D Officer of General Biomedicine of Innovent Biologics. "As a next-generation VEGF/Ang-2 bispecific antibody, OLN324 holds the potential to deliver differentiated clinical value for patients with retinal diseases. We look forward to continuing our close collaboration with Ollin to accelerate the global development of this best-in-disease drug."
Dr. Ehrlich added, "We look forward to discussing these data with health authorities and moving OLN324 quickly into global Phase 3 studies in both DME and wet AMD."
In a previously-completed Phase 1 single and multiple dose escalation study, IBI324 (OLN324) demonstrated promising vision and anatomic improvements in Chinese DME patients along with a favorable safety profile. IBI324 (OLN324) was discovered by Innovent and is being developed in collaboration with Ollin.
Ollin plans to discuss the JADE study and additional pipeline and corporate progress during its upcoming presentation at the 44th Annual J.P. Morgan Healthcare Conference, on Tuesday, January 13, 2026. Full results of the study will be presented for the first time at the upcoming Angiogenesis, Exudation, and Degeneration 2026 symposium on February 7, 2026.
About JADE
More than 160 patients with wAMD or DME were enrolled at sites in the United States in the JADE study. All patients initially received three monthly doses of either OLN324 2mg, OLN324 4mg, or faricimab 6mg. Patients were evaluated at Weeks 1, 4, 8, 12, 16, and 20. Primary efficacy outcomes were evaluated at Week 12; results achieved at Week 12 with OLN324 2 mg were similar to 4 mg.
A favorable safety profile was observed with OLN324, with no cases of intraocular inflammation (IOI) observed at either dose level during the study. One case of IOI was observed in a patient treated with faricimab. There were no cases of retinal vasculitis or occlusive retinal vasculitis.
About OLN324?IBI324?
Building on the clinical success of intravitreal VEGF/Ang2 inhibition, IBI324 is a next-generation VEGF/Ang2 bispecific antibody engineered with substantially higher Ang2 potency relative to faricimab, increased molar dosing relative to both faricimab and aflibercept (including Eylea HD®), and a smaller protein format. VEGF and Ang2 are central drivers of retinal vascular diseases such as DME and wAMD, with Ang2 playing a key role in vascular instability, leakage, inflammation, and fibrosis. OLN324 was discovered by Innovent and is being developed in collaboration with Ollin Biosciences (Ollin R&D code: OLN324).
About Diabetic Macular Edema (DME)
Diabetic macular edema, a vision-threatening complication of diabetic eye disease, is a leading cause of vision loss among working-age adults in the developed world. In diabetic macular edema, progressive microvasculature damage, ischemia, and microvascular inflammation results in vascular leakage and retinal swelling that compromise vision.
About Wet Age-Related Macular Degeneration (wAMD)
AMD, a chronic and progressive retinal disease, is the leading cause of vision loss among older adults in the developed world. In wet (or neovascular) AMD, abnormal blood vessels growing beneath the retina leak and bleed, resulting in significant vision impairment.
About Ollin Biosciences
Established in 2023, Ollin Biosciences™ is a clinical-stage biopharmaceutical company dedicated to acquiring and developing best-in-disease therapies for vision-threatening diseases. With a differentiated pipeline, world-class team, and strong investor syndicate, Ollin is redefining what's possible in ophthalmology. For more information, please visit us at www.ollin.bio and follow us on LinkedIn and X.
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 18 products in the market. It has 4 assets in Phase 3 or pivotal clinical trials and 15 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including 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 www.innoventbio.com, or follow Innovent on Facebook and LinkedIn.
Disclaimer: Innovent does not recommend any off-label usage.
Vabysmo® is a registered trademark of Genentech, Inc.; Eylea® and Eylea HD® are registered trademarks of Regeneron Pharmaceuticals, Inc.
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 Biologics ("Innovent"), are intended to identify certain of such forward-looking statements. The Company 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 the Company with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond the Company's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, the Company's competitive environment and political, economic, legal and social conditions.
The Company, the Directors and the employees of the Company assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialise or turn out to be incorrect.
SOURCE Innovent Biologics
FAQ**
How do the positive topline results from Ollin Biosciences' study of IBI324 (Innovent Biologics Inc ADR IVBIY) impact the competitive landscape for retinal therapeutics, particularly against established treatments like faricimab (Vabysmo®)?
Given the reported 60-fold higher anti-Ang2 potency of IBI3(Innovent Biologics Inc ADR IVBIY), what are the implications for patient outcomes and potential shifts in treatment protocols for diabetic macular edema and wet age-related macular degeneration?
Considering the favorable safety profile of IBI324 (Innovent Biologics Inc ADR IVBIY) observed in the JADE study, what steps will Ollin Biosciences take to ensure ongoing monitoring and compliance as they approach global Phase 3 trials?
In light of the findings from the clinical trial showing improved retinal drying rates with IBI324 (Innovent Biologics Inc ADR IVBIY), how might this influence Collaborations or partnerships Innovent pursues in the field of ophthalmology?
**MWN-AI FAQ is based on asking OpenAI questions about Innovent Biologics Inc ADR (OTC: IVBIY).
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