On October 16, 2025 I-Mab (NASDAQ: IMAB) (I-Mab or the Company), is a global biotechnology platform company committed to accelerating access to innovative medicines for patients worldwide, reported its new business model, focused on its global capabilities built to accelerate access to innovative medicines and to enable broad strategic growth. The Company announced its intention to pursue a Hong Kong IPO through dual listing on NASDAQ and Hong Kong Stock Exchange (HKEX). The Company intends to operate under the new name of NovaBridge Biosciences.
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The Company also announced the pending acquisition of VIS-101, a novel bifunctional biologic targeting VEGF-A and ANG2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) than current standard of care. The pending acquisition will be made by a newly formed subsidiary, Visara, Inc. (Visara), a clinical-stage biopharmaceutical company focused on developing ophthalmic therapeutics for serious eye disorders, and is expected to be completed later this month.
In addition, the Company reaffirmed its previously announced givastomig investment plans as part of its new strategy.
Mr. Kyler Lei has been named Chief Financial Officer (CFO) of I-Mab, bringing significant expertise in the Hong Kong and global capital markets.
The Company sees a significant growth potential from the Asia Pacific originated biopharma innovations. Confidence in this opportunity comes from emerging trends showing that the Asia Pacific region has generated more than 30% of global biopharma assets under development, and has achieved more than $80B in deal value through collaborations with leading multi-national pharmaceutical organizations. In addition, the Asia Pacific biopharmaceutical ecosystem has become increasingly agile and efficient, with significantly lower clinical trial costs and faster patient enrollment than the global median, while maintaining high quality standards1.
"We believe we are entering a new era of rapid growth in the global biotech economy, driven by greater innovation capability in China and Asia and a resurgence of investment in high growth international markets across Asia. With our new business model, we are uniquely positioned to strategically create significant value for patients and investors," said Mr. Fu Wei, Executive Chairman of I-Mab. "Through the strategic insight of our expanded Board, backing by CBC Group,
Asia’s largest dedicated healthcare asset management firm, and our dual listing strategy, I-Mab is ideally placed to partner with leading global innovators to identify and accelerate high-value assets. The proposed dual listing on both NASDAQ and HKEX is a key element of our global growth strategy. This move will enable us to broaden and diversify our investor base, and enhance trading liquidity and access to capital, while strengthening our presence with key stakeholders in the rapidly growing Asian market."
"2025 has been a time of significant progress for I-Mab. Presentation of compelling Phase 1b givastomig combination data reinforced our confidence in its potential to be a best-in-class Claudin 18.2-directed therapy for gastric cancer and drove our plans to initiate a global randomized Phase 2 study, expected to begin in Q1 2026. In addition, the Company recently secured additional capital, and has attracted seasoned biotech executives to the Board of Directors and Scientific Advisory Board," said Sean Fu, PhD, Chief Executive Officer (CEO) of I-Mab. "With the strong foundation from our work on givastomig, and excellent progress this year, we are optimistic about moving forward with our new strategy. Our new global platform allows us to uphold our commitment to value creation by realizing the full potential of innovative medicines and improving the lives of patients."
The NovaBridge Business Model and Pipeline
The Company intends to partner with leading innovators to identify and accelerate high-value assets. Our model integrates rigorous asset selection, bespoke translational strategies, and efficient clinical execution. With the backing of CBC Group, we leverage deep local insights and global capabilities to develop the most promising drug candidates across a range of therapeutic categories.
The Company will utilize a "hub-and-spoke" model to create and advance specialized subsidiary companies (spokes) which maintain operational focus and agility. By focusing each spoke on a specific asset or therapeutic area, the Company can optimally manage risk and create value through potential partnering transactions.
Pipeline:
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Givastomig, a potential best-in-class Claudin 18.2 X 4-1BB bispecific antibody, is in Phase 1b clinical trials for the potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. A global, randomized Phase 2 study is planned, with the enrollment of the first patient targeted in Q1 2026. Givastomig is being jointly developed through a global partnership with ABL Bio, in which I-Mab is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.
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Ragistomig is an anti-PD-L1 X 4-1BB bispecific antibody. Built on Phase 1 clinical data, an ongoing Phase 1b study designed to expand the therapeutic index is expected to yield results in 2H 2026. The program is being jointly developed with ABL Bio.
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Uliledlimab targets CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. Progression free survival (PFS) data are expected in 2H 2026 from an ongoing randomized Phase 2 trial evaluating uliledlimab + toripalimab compared to pembrolizumab alone or toripalimab alone. I-Mab owns worldwide rights to uliledlimab outside of Greater China.
VIS-101, to be acquired by Visara, a newly formed I-Mab subsidiary, under the new business model, is a bifunctional biologic targeting VEGF-A and ANG2, currently in Phase 2 development
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VIS-101 is a novel bifunctional biologic targeting VEGF-A and ANG-2, and a more potent molecule that could potentially provide more durable treatment benefits for patients with wet AMD, DME, and retinal vein occlusion (RVO) than current standard of care. VIS-101 has completed initial safety and dose-escalation studies in both the US and China, and is currently completing a randomized, dose-ranging Phase 2 study in China. VIS-101 is anticipated to be Phase 3-ready in 2026.
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Acquisition will be completed by a newly formed subsidiary, Visara. Visara, a clinical-stage biopharmaceutical company focusing on the development of best-in-class ophthalmic therapeutics, will be launched with an approximately $37M capital infusion from I-Mab and the contribution of certain rights by AffaMed Therapeutics (HK) Limited. The capital contributions to Visara and its acquisition of VS-101 (collectively, the Transactions) are cross-conditioned, and are expected to close later this month. The Company has also signed a separate termsheet with Everest Medicines (HKEX 1952.HK) to potentially out-license greater China rights for VIS-101 and collaborate on global clinical development. Following completion of the Transactions, I-Mab will be the majority shareholder of Visara, and Visara will control global rights to VS-101.
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Visara is led by Co-Founder and Executive Chairman Emmett T. Cunningham, Jr., MD, PhD, MPH. Dr. Cunningham has been a physician, innovator, entrepreneur, and investor for more than 25 years, formerly serving as Senior Managing Director at Blackstone Group L.P. and Managing Director at Clarus Ventures, LLC. Dr. Cunningham is also an internationally recognized specialist in infectious and inflammatory eye disease with over 450 co-authored publications.
"VIS-101 is anticipated to be second-in-class with best-in-class potential, based on bioengineered, superior target neutralizing capabilities," said Dr. Cunningham, Co-Founder and Executive Chairman of Visara. "Leveraging the speed, quality, and unique advantages of dedicated teams in North America and Asia, Visara will seek accelerated global clinical development and regulatory approvals."
Organizational Overview
The Company will build on the strength of the I-Mab Board, led by Mr. Fu Wei, Executive Chairman, including the expanded Scientific Advisory Board and new Research and Development Committee. The Executive Leadership Team will include Sean Fu, PhD, Chief Executive Officer; Phillip Dennis, MD, PhD, Chief Medical Officer; Kyler Lei, Chief Financial Officer; and Claire Xu, MD, PhD, Senior Vice President, Clinical Development.
Kyler Lei has been appointed as the Chief Financial Officer of I-Mab, effective October 16, 2025. Kyler is a global capital markets and investor relations professional with extensive experience in healthcare, equity research, corporate communications, corporate finance and strategy. Kyler will be primarily responsible for overseeing overall financial strategy and management, corporate finance and capital markets, corporate development and operations. Prior to joining I-Mab, Kyler served as Deputy General Manager and Head of Capital Markets at Sino Biopharmaceutical Limited (HKEX: 1177.HK).
"I am enthusiastic about starting on this new chapter with Kyler, and leveraging his expertise in global capital markets and financial strategy to make our new business model a resounding success," said Dr. Fu, CEO.
Dr. Fu added, "I would like to extend our gratitude to Joseph Skelton for his tremendous contributions in shaping I-Mab’s success. We wish him all the best in his future endeavors."
Business Update Webinar
The Company will review its new business model, strategic focus and upcoming milestones by webcast on Thursday, October 16, 2025, and Friday, October 17, 2025
Webcast and Conference Call Details:
In English:
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Date: Thursday, October 16, 2025
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Time: 5:00 PM ET
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Dial-in number (US): 1-877-407-0784
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Dial-in number (International): 1-201-689-8560
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Webcast info: please click here
In Chinese:
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Date: Friday, October 17, 2025
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Time: 5:00 PM HKT/5:00 AM ET
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Webcast info: please click here, and note Kyler Lei as the CLSA contact
A replay of the webinar will be accessible on the Events page of the Company website for 90 days.
(Press release, I-Mab Biopharma, OCT 16, 2025, View Source [SID1234656702])