Core Viewpoint - NovaBridge Biosciences has received FDA alignment on givastomig's potential eligibility for an accelerated approval pathway in specific gastric cancer patients, paving the way for a Phase 3 trial to begin in Q4 2026 [1][7]. Company Overview - NovaBridge is a global biotechnology platform focused on accelerating access to innovative medicines, combining business development expertise with clinical development to advance breakthrough assets [6]. Givastomig Development - Givastomig is a bispecific antibody targeting Claudin 18.2-positive tumor cells, designed to activate T cells in the tumor microenvironment, and is being developed for gastric cancer and other gastrointestinal malignancies [4][10]. - The Phase 1b trial showed a 75% objective response rate (ORR), with 77% ORR at 8 mg/kg and 73% at 12 mg/kg, alongside a median progression-free survival (mPFS) of 16.9 months and an 82% six-month landmark PFS rate [8]. Regulatory Milestones - The FDA confirmed givastomig's eligibility for an accelerated approval pathway, with the primary endpoint for the upcoming Phase 3 trial being the objective response rate [7]. - The company plans to present detailed Phase 1b expansion data at a major medical conference in the second half of 2026 [3]. Collaborative Development - Givastomig is being developed in partnership with ABL Bio, with NovaBridge as the lead party sharing worldwide rights, excluding Greater China and South Korea [5].

Core Insights - NovaBridge Biosciences and its subsidiary Visara, Inc. announced positive topline results from the Phase 2a study of VIS-101, a dual VEGF-A X ANG-2 inhibitor for retinal vascular diseases, showing rapid and durable treatment responses in wet AMD [1][2][4] Group 1: Study Results - VIS-101 demonstrated rapid and robust efficacy with mean improvements in Best Corrected Visual Acuity (BCVA) of over 10 ETDRS letters and median central subfield thickness (CST) reductions of 100-150 mm [4][5] - Nearly half of treatment-naïve patients remained retreatment-free for more than six months after three loading doses, indicating potentially best-in-class durability [2][3][5] - The study enrolled 38 patients aged 50-80 years with wet AMD, randomized into 6 mg (n=25) and 3 mg (n=13) dosing groups, with baseline characteristics being similar [7][11] Group 2: Safety Profile - VIS-101 exhibited a favorable safety profile with no dose-limiting toxicity; treatment-related adverse events were 0% in the 3 mg group and 8% in the 6 mg group [9][4] - The data supports the potential of VIS-101 to provide significant benefits to patients with wet AMD and other retinal vascular diseases [3][6] Group 3: Future Development Plans - A Phase 2b dose-determining study is expected to begin in the second half of 2026, followed by a global Phase 3 program anticipated to start in 2027 [4][20] - The positive data from the Phase 2a study is seen as an important milestone for Visara and NovaBridge, enhancing the visibility of their value-creation potential [6][20]

Core Viewpoint - VIS-101 is a dual VEGF-A/ANG-2 inhibitor designed to offer more effective and durable treatment for patients with wet age-related macular degeneration (wet AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO) [1][2][11] Company Overview - NovaBridge Biosciences is a global biotechnology platform company focused on accelerating access to innovative medicines [7] - The company combines business development expertise with clinical development to advance breakthrough assets [7] - NovaBridge is the majority shareholder of Visara, which holds global rights to VIS-101 outside of Greater China and certain Asian territories [3][6] Product Development - VIS-101 is currently undergoing a randomized, dose-ranging Phase 2a study for wet AMD [2][11] - The product is designed to provide potent and durable treatment benefits for wet AMD, DME, and RVO [2][11] - The company will host a virtual business update call to review Phase 2a clinical data for VIS-101 on March 9, 2026 [1] Pipeline and Collaborations - NovaBridge's pipeline includes givastomig, a bispecific antibody targeting Claudin 18.2 for gastric cancer, and ragistomig, a bispecific antibody for solid tumors [8][10] - The company also owns worldwide rights to uliledlimab, an anti-CD73 antibody targeting immunosuppression in cancer [10]

Core Insights - NovaBridge Biosciences is a global biotechnology platform company focused on accelerating access to innovative medicines [2] - The company will participate in the Leerink Partners 2026 Global Healthcare Conference from March 8-11, 2026, with a presentation scheduled for March 11 at 8:00 AM ET [1] Company Overview - NovaBridge combines business development expertise with agile translational clinical development to advance breakthrough assets [2] - The company aims to bridge science, strategy, and execution to facilitate the rapid progression of transformative therapies from discovery to patients [2] Product Pipeline - The leading product in NovaBridge's pipeline is givastomig, a bispecific antibody targeting Claudin 18.2, currently in a global Phase 2 study for gastric cancer [3][4] - VIS-101, another key product, targets VEGF-A and ANG-2 for treating wet age-related macular degeneration and diabetic macular edema, and is completing a Phase 2a study [5] Collaborations and Rights - NovaBridge collaborates with ABL Bio for the development of ragistomig, a bispecific antibody for solid tumors [4] - The company holds worldwide rights outside of China for uliledlimab, an anti-CD73 antibody targeting immunosuppression in cancer [4]

Core Viewpoint - NovaBridge Biosciences has appointed Dr. Emmett T. Cunningham, Jr. as Vice Chairman of the Board, which is expected to enhance the company's strategic direction and shareholder value through his extensive biopharma experience [1][3][7]. Company Overview - NovaBridge is a global biotechnology platform focused on accelerating access to innovative medicines, combining business development expertise with agile clinical development to advance breakthrough assets [9]. - The company operates a unique hub-and-spoke business model aimed at bridging the gap between unmet patient needs and transformative care [3][7]. Leadership Appointment - Dr. Cunningham brings over 25 years of experience in biopharma, having held leadership roles in venture capital and major pharmaceutical companies, including Blackstone Group and Pfizer [2][5][6]. - His appointment is seen as a positive endorsement of NovaBridge's mission to create shareholder value by expediting the development of transformative medicines [7]. Research and Development Focus - Dr. Cunningham will also join the Research and Development Committee of the Board, which is established to expedite innovation and long-term growth [7]. - The company is currently developing several drug candidates, including givastomig and VIS-101, targeting various cancers and eye diseases [10][12]. Pipeline Highlights - Givastomig is a bispecific antibody being evaluated in a Phase 2 study for Claudin 18.2-positive gastric cancer, following positive results from a Phase 1b study [11]. - VIS-101 is in a Phase 2a study for wet age-related macular degeneration and diabetic macular edema, aiming to provide more durable treatment benefits [12].

Core Insights - Fu Wei, Executive Chairman of NovaBridge Biosciences, intends to purchase up to $5,000,000 of the Company's American Depository Shares (ADSs) in open market transactions, starting from January 15, 2026 [1] - The Company has executed a new business strategy in 2025, which has positioned it for growth, supported by positive Phase 1b dose expansion data for its drug candidate, givastomig [2][3] Company Overview - NovaBridge is a global biotechnology platform focused on accelerating access to innovative medicines, combining business development expertise with clinical development to advance breakthrough assets [4] - The Company’s pipeline includes givastomig, a bispecific antibody targeting Claudin 18.2, and VIS-101, a bifunctional biologic targeting VEGF-A and ANG2 [5] Drug Development - Givastomig is designed to treat Claudin 18.2-positive gastric cancer and is currently in clinical development [6] - VIS-101 is completing a Phase 2 study for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) [7]

Core Viewpoint - NovaBridge Biosciences has been included in the Nasdaq Biotech Index, highlighting its status as an industry leader and enhancing its visibility in the biotechnology sector [3][8]. Company Overview - NovaBridge is a global biotechnology platform focused on accelerating access to innovative medicines by combining business development expertise with agile clinical development [3]. - The company aims to bridge science, strategy, and execution to advance transformative therapies from discovery to patients [3]. Key Developments - Fu Wei, Executive Chairman, and Sean Fu, CEO, will ring the Nasdaq Opening Bell on January 2, 2026, marking a significant milestone for the company [2][9]. - The inclusion in the Nasdaq Biotech Index became effective on December 19, 2025, which is seen as a validation of NovaBridge's strategic vision and pipeline [3][8]. Product Pipeline - The leading product in NovaBridge's pipeline is givastomig, a bispecific antibody targeting Claudin 18.2, aimed at treating gastric cancer and other gastrointestinal malignancies [4][5]. - VIS-101, another key product, targets VEGF-A and ANG-2 for treating wet age-related macular degeneration and diabetic macular edema, currently in a Phase 2 study [6]. Strategic Collaborations - NovaBridge is collaborating with ABL Bio on ragistomig, a bispecific antibody designed for solid tumors, and holds worldwide rights outside of China for uliledlimab, an anti-CD73 antibody [5].

Core Insights - NovaBridge Biosciences announced new data from the Phase 1 dosing study of ragistomig, a bispecific 4-1BB X PD-L1 antibody, showing consistent antitumor activity and improved safety profile with a new dosing schedule [1][2][3] Group 1: Study Results - The new Q6W dosing schedule demonstrated a disease control rate (DCR) of 58.8%, comparable to the 64.3% DCR observed with the previous Q2W schedule [7] - Only 5% of patients experienced Grade ≥3 liver function test (LFT) elevations with the Q6W regimen, compared to 40% with the Q2W regimen [13] - The study achieved its objective of extending the therapeutic window, supporting the advancement of ragistomig into combination studies [2][3] Group 2: Immunological Data - The Q6W dosing showed positive immunological data, including expansion of effector memory and CD8+ T cells, indicating durable immune engagement [7][13] - The study reported no cases of cytokine release syndrome (CRS) with either dosing schedule, highlighting the favorable safety profile [7][13] Group 3: Patient Characteristics - The study included 20 heavily pre-treated subjects receiving 3 mg/kg Q6W ragistomig, with 100% previously treated with immuno-oncology therapies [12] - Among the 17 evaluable patients on the Q6W regimen, the objective response rate was 11.8%, while the Q2W regimen had a 28.6% response rate [9] Group 4: Future Directions - The ongoing evaluation of the 5 mg/kg Q6W dosing cohort and future combination studies is anticipated to further assess the efficacy of ragistomig [8]

Core Insights - NovaBridge Biosciences announced new data from the expanded Phase 1 dosing study for ragistomig, a bispecific antibody targeting 4-1BB and PD-L1, to be presented at ESMO-IO 2025 [1][2] - The study successfully extended the therapeutic window for ragistomig, demonstrating strong anti-tumor efficacy and improved tolerability, including enhanced hepatic safety [2][3] - Ragistomig aims to provide new treatment options for patients resistant to checkpoint inhibitors, a significant drug class in cancer therapy [3][5] Company Overview - NovaBridge is a global biotechnology platform focused on accelerating access to innovative medicines, combining business development expertise with clinical development [8] - The company is developing a differentiated pipeline, including ragistomig and givastomig, targeting various cancers and conditions [8][9] - Ragistomig is being developed in collaboration with ABL Bio, utilizing advanced bispecific antibody technology to minimize off-tumor toxicity [5][6] Clinical Study Details - The Phase 1 study of ragistomig is ongoing in the U.S. and South Korea, with a primary focus on defining dose-limiting toxicity and adverse event profiles [5][6] - The new dosing schedule, Q6W, has shown promising results in PD-L1 non-responders, balancing safety and sustained efficacy [6][7] - Interim results, including immunological data, are expected to be presented at the upcoming ESMO-IO meeting [6][7]

Core Insights - NovaBridge Biosciences announced the appointment of Dr. Cadmus C. Rich as Chief Medical Officer and Dr. Carlos Quezada-Ruiz as Chairman of the Scientific Advisory Board for its subsidiary Visara, Inc. [1][2][3] Company Developments - The appointments of Dr. Rich and Dr. Quezada-Ruiz highlight Visara's commitment to developing innovative ophthalmic therapies, particularly the VIS-101 program targeting wet age-related macular degeneration (wet AMD) [2][5][12] - Dr. Rich aims to accelerate the development of new ophthalmology treatments and is focused on completing the Phase 2 study of VIS-101 [2][12] - Dr. Quezada-Ruiz brings extensive experience in retinal therapies and emphasizes the need for more durable treatment options for retinal diseases [2][10] Product Pipeline - VIS-101 is a bifunctional biologic targeting VEGF-A and ANG-2, with potential applications in wet AMD, diabetic macular edema (DME), and retinal vein occlusion (RVO) [5][12][17] - The drug is expected to be Phase 3-ready in 2026, following the completion of its current Phase 2 study [5][12] Leadership Expertise - Dr. Rich has a strong background in ophthalmology and drug development, having previously held leadership roles in various biopharmaceutical companies [4][6][7] - Dr. Quezada-Ruiz has significant experience in the global development of retinal therapies and has held senior positions at major pharmaceutical companies [8][9][10] Strategic Vision - The appointments are part of NovaBridge's strategic transformation into a global biotech platform, showcasing its ability to attract top-tier talent in the industry [3][5] - The company aims to deliver value to shareholders through its innovative "hub-and-spoke" strategy [3]