I-Mab's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by I-Mab (NBP).
Over the past two years, I-Mab has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
VIS-101. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
VIS-101 FDA Regulatory Events
VIS-101 is a drug developed by I-Mab for the following indication: in patients with wet age-related macular degeneration (wet AMD).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- VIS-101
- Announced Date:
- March 9, 2026
- Indication:
- in patients with wet age-related macular degeneration (wet AMD).
Announcement
NovaBridge Biosciences announced positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
AI Summary
NovaBridge’s VIS-101 is a tetravalent, dual VEGF‑A × ANG‑2 inhibitor designed for retinal vascular diseases. Topline Phase 2a results in wet AMD showed rapid, robust and durable responses: mean best-corrected visual acuity (BCVA) gains exceeded 10 ETDRS letters, with median central subfield thickness (CST) reductions of about 100–150 µm. Both 3 mg and 6 mg dose cohorts produced meaningful improvements, and the compound demonstrated potentially best‑in‑class durability with a favorable safety profile and no dose‑limiting toxicity.
The randomized Phase 2a trial enrolled 38 patients in China (ages 50–80), including treatment‑naïve and pre‑treated participants, randomized 2:1 to 6 mg (n=25) vs 3 mg (n=13). Treatment‑related adverse events were low (0% at 3 mg; 8% at 6 mg). A Phase 2b dose‑determining study is expected in H2 2026, with a global Phase 3 program planned for 2027.Read Announcement
- Drug:
- VIS-101
- Announced Date:
- March 3, 2026
- Indication:
- in patients with wet age-related macular degeneration (wet AMD).
Announcement
NovaBridge Biosciences announced that it will host a virtual business update call on Monday, March 9, 2026, at 9:00 AM ET to review Phase 2a clinical data for VIS-101 in patients with wet age-related macular degeneration (wet AMD).
AI Summary
NovaBridge Biosciences will host a virtual business update call on Monday, March 9, 2026, at 9:00 AM ET to review Phase 2a clinical data for VIS-101 in patients with wet age-related macular degeneration (wet AMD). Investors and the public can register and access the live webcast via the News & Events page on the NovaBridge website; a replay will be archived there for at least 90 days.
VIS-101 is a purpose-designed, bispecific, tetravalent dual VEGF-A/ANG-2 inhibitor being developed to provide more potent and durable treatment than current standard care. It is being evaluated for wet AMD and is also intended for diabetic macular edema (DME) and retinal vein occlusion (RVO). The candidate is completing a randomized, dose-ranging Phase 2a study for wet AMD.
NovaBridge is the majority shareholder of Visara, which holds global development and commercialization rights to VIS-101 outside of Greater China and certain other Asian territories.
Read Announcement
I-Mab FDA Events - Frequently Asked Questions
As of now, I-Mab (NBP) has not received any FDA approvals for its therapy in the last two years.
In the past two years, I-Mab (NBP) has reported FDA regulatory activity for VIS-101.
The most recent FDA-related event for I-Mab occurred on March 9, 2026, involving VIS-101. The update was categorized as "Top-line results," with the company reporting: "NovaBridge Biosciences announced positive topline results from the Phase 2a study of VIS-101, a purpose-designed tetravalent, dual VEGF-A X ANG-2 inhibitor in development for retinal vascular diseases including wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO)."
Currently, I-Mab has one therapy (VIS-101) targeting the following condition: in patients with wet age-related macular degeneration (wet AMD)..
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:NBP last updated on 3/9/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
