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I-MAB (Nasdaq: IMAB) Transitions to NovaBridge Biosciences (Nasdaq: NBP) with Trading Effective October 30, 2025 New Brand and Logo to Reflect Strategic Transformation to a Global Biotech Platform
Globenewswire· 2025-10-29 13:00
Core Viewpoint - NovaBridge Biosciences, formerly known as I-Mab, has undergone a corporate name change and will begin trading under the new ticker symbol "NBP" on Nasdaq starting October 30, 2025, as part of its strategic transformation into a global biotechnology platform company focused on innovative medicines [1][2][3] Corporate Transformation - The new corporate brand and website signify a strategic shift towards becoming a global biotechnology platform committed to accelerating access to innovative medicines for patients worldwide [2] - The name change was overwhelmingly approved by shareholders and the Board of Directors during an Extraordinary General Meeting held on October 24, 2025 [1] Business Strategy - The company plans to pursue a dual listing on both Nasdaq and the Hong Kong Stock Exchange (HKEX) to broaden its investor base and enhance trading liquidity [6][7] - NovaBridge has adopted a "hub-and-spoke" business model, creating specialized subsidiary companies to maintain operational focus and agility [9] Pipeline and Product Development - The core asset, givastomig, is a potential best-in-class Claudin 18.2-directed therapy for gastric cancers, currently advancing towards a global randomized Phase 2 study with first patient enrollment expected in Q1 2026 [8][12] - VIS-101, acquired by the newly formed subsidiary Visara, is a bifunctional biologic targeting VEGF-A and ANG2, currently in Phase 2 development and anticipated to be Phase 3-ready in 2026 [11][16] Leadership and Expertise - The company is led by experienced professionals, including Dr. Emmett T. Cunningham, Jr., who has extensive expertise in infectious and inflammatory eye disease [11][12] - NovaBridge aims to leverage deep local insights and global capabilities to develop promising drug candidates across various therapeutic categories [8][13]
I-Mab To Present Positive Updated Givastomig Monotherapy Data at 2025 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Conference on October 23, 2025
Globenewswire· 2025-10-22 16:35
Core Insights - I-Mab announced updated data from the Phase 1 study of givastomig, a bispecific antibody targeting CLDN18.2 and 4-1BB, showing an 18% objective response rate (ORR) in heavily pre-treated gastroesophageal carcinoma patients [1][2][7] Study Data Summary - The Phase 1 study involved 45 patients with a median of 3 prior therapies, demonstrating an ORR of 18% with responses across a dose range from 5 mg/kg Q2W to 18 mg/kg Q3W [2][7][13] - No differences in efficacy were observed across varying levels of CLDN18.2 expression, with a disease control rate (DCR) of 49% [7][13] - The median progression-free survival (mPFS) was 2.96 months and median overall survival (mOS) was 7.49 months [13] Safety Profile - Givastomig was well tolerated, with no dose-limiting toxicities reported, and common treatment-related adverse events (TRAEs) included anemia (27%), white blood cell count decrease (22%), and nausea (20%) [10][13] Future Plans - I-Mab plans to report topline results from the Phase 1b dose expansion study and initiate a global randomized Phase 2 study in Q1 2026 [2][7] - The upcoming presentation at the Triple Meeting on October 23, 2025, will provide further insights into the safety and efficacy of givastomig [4][5] Market Potential - The treatment strategy for givastomig is anchored in the first-line gastric cancer market, which is estimated to be a $2 billion potential market [7]
云顶新耀召开公司发展战略交流会 未来6至12个月将再引进至少3个重磅产品
Core Insights - The company, CloudTop New Medicine, held a strategic investor meeting on October 21, where the new chairman, Wu Yifang, outlined the company's strategic direction focusing on key initiatives such as strategic transactions, R&D innovation, and stakeholder management [1] - The controlling shareholder, Kangqiao Capital, will not reduce its stake in the company in the short term [1] - The company aims to enhance its product pipeline through self-research, licensing, acquisitions, and capital empowerment, with a goal to maximize commercial value and expand globally [1] Product Pipeline and Financial Projections - CloudTop New Medicine's product pipeline in key therapeutic areas such as nephrology, infectious diseases, and autoimmune diseases is entering a critical harvest period [1] - The company estimates that sales for its product, Naisankang®, will reach between RMB 1.2 billion and RMB 1.4 billion for the year, with a target of RMB 2.4 billion to RMB 2.6 billion by 2026 [1] - The product Weishiping® (Aicuo Mod) is expected to become the next significant product for the company [1] Future Plans and Collaborations - The company plans to introduce more than three heavyweight products in the next 6 to 12 months, with potential domestic sales peak exceeding RMB 10 billion, aiming for an overall domestic sales peak of over RMB 20 billion [2] - CloudTop New Medicine has signed a cooperation development letter of intent with I-Mab for the treatment of retinal diseases, which will strengthen collaboration in innovative R&D and international development [2] - The global anti-VEGF ophthalmic drug market is projected to reach approximately USD 40 billion by 2030, indicating significant growth potential in this sector [2]
云顶新耀召开公司发展战略交流会:加强全球布局 实现跨越式发展战略
Zheng Quan Ri Bao· 2025-10-22 06:16
Core Insights - CloudTop New Horizon (云顶新耀) held a strategic investor communication meeting on October 21, 2023, with key management team members present, including the new chairman Wu Yifang [2] - The company aims to enhance its product pipeline and maximize commercial value through a "dual-driven" strategy, focusing on self-research, licensing, acquisitions, and capital empowerment [2] - CloudTop plans to introduce more than three significant products in the next 6 to 12 months [2] Product Development - The company has entered a critical harvest period in its product pipeline, particularly in nephrology, infectious diseases, and autoimmune diseases, with sales revenue from the product Renfu Kang® nearing RMB 1 billion by Q3 2025 [3] - The product Weishiping® (艾曲莫德) is expected to become a significant growth driver for the company [3] - CloudTop is leveraging its mRNA tumor therapeutic vaccine platform and autologous CAR-T platform to strengthen its self-research capabilities and explore high-growth areas like ophthalmology [3] Clinical Trials and Collaborations - The new generation covalent reversible BTK inhibitor EVER001 (希布替尼) has shown promising results, with sustained benefits observed in patients during a 104-week follow-up period [3] - The company plans to initiate pivotal registration clinical trials for EVER001 in 2026 and is set to start human trials for its autologous CAR-T project by the end of 2025 [3] - CloudTop has signed a collaboration agreement with I-Mab for the development of the eye disease treatment VIS-101 in Greater China, South Korea, and Southeast Asia, aiming to enhance cooperation in innovative research and international development [4]
云顶新耀(01952.HK)召开公司发展战略交流会 加强全球布局 实现跨越式发展战略
Ge Long Hui· 2025-10-22 02:15
Core Insights - The company, CloudTop New Drug (01952.HK), held a strategic investor communication meeting on October 21, 2023, to discuss its latest strategic planning, R&D progress, and long-term development blueprint [1] Group 1: Leadership and Strategic Direction - The new chairman, Wu Yifang, will lead the board in setting the strategic direction and providing guidance to the executive team, focusing on strategic transactions, R&D innovation, and stakeholder management [2] - The major shareholder, Kangqiao Capital, has expressed confidence in the company's strategic outlook and will not reduce its stake in the short term, enhancing shareholder structure stability [2] Group 2: Strategic Focus and Market Expansion - The company will implement a "dual-engine" strategy, focusing on self-research and external collaborations to enrich its product pipeline and maximize commercial value [3] - CloudTop New Drug aims to accelerate its global expansion and self-research initiatives, particularly in key therapeutic areas such as nephrology, infectious diseases, and autoimmune diseases [3] Group 3: Product Pipeline and Financial Projections - The company’s products, including Nefukang® and Yijia®, have shown sustainable commercialization capabilities, with Nefukang® expected to achieve sales of approximately RMB 12 to 14 billion in 2025, and projected to grow to RMB 24 to 26 billion by 2026 [3] - The company plans to introduce over three significant products in the next 6 to 12 months, with potential domestic sales peak exceeding RMB 100 billion, aiming for an overall domestic sales peak of over RMB 200 billion [4] Group 4: R&D Innovations and Collaborations - The company is leveraging its mRNA cancer vaccine platform and CAR-T technology to establish a strong R&D foundation, with plans to enter high-growth areas such as ophthalmology [4] - A collaboration with I-Mab on the innovative product VIS-101 aims to enhance the company's presence in the ophthalmology market, which is projected to grow significantly [5][6] - VIS-101 has shown promising results in initial studies and is expected to enter Phase III trials by 2026, indicating a strong potential for market entry [5][6] Group 5: Overall Market Position and Future Outlook - The meeting highlighted the company's systematic progress in capital empowerment, innovation breakthroughs, and global expansion, reinforcing its competitiveness in the global innovative drug sector [6] - As core pipelines enter the value realization phase, the company is on a steady path toward becoming a leading comprehensive biopharmaceutical enterprise globally [6]
云顶新耀召开公司发展战略交流会 加强全球布局实现跨越式发展战略
Zhi Tong Cai Jing· 2025-10-22 00:49
Core Insights - CloudTop New Drug Company (云顶新耀) held a strategic investor communication meeting on October 21, 2023, to discuss its latest strategic planning, R&D progress, and long-term development blueprint [1] Group 1: Leadership and Strategic Direction - The new chairman, Wu Yifang, will lead the board in setting the strategic direction and providing guidance to the management team, focusing on strategic transactions, R&D innovation, and stakeholder management [2] - The major shareholder, Kangqiao Capital, has expressed confidence in the company's strategic outlook and long-term value, indicating no plans for short-term share reduction, which stabilizes the shareholder structure [2] Group 2: Dual-Engine Strategy and Market Expansion - The company will implement a "dual-engine" strategy, focusing on both independent R&D and partnerships, acquisitions, and capital empowerment to enhance its product pipeline and maximize commercial value [3] - Key therapeutic areas include nephrology, infectious diseases, and autoimmune diseases, with products like Naisikan and Yijia showing sustainable commercialization capabilities [3] - The sales forecast for Naisikan is projected to reach approximately RMB 1 billion for the first nine months of 2025, with an annual target of RMB 1.2 to 1.4 billion, and a growth target of RMB 2.4 to 2.6 billion for 2026 [3] Group 3: R&D Advancements and New Growth Areas - The company is leveraging its mRNA cancer vaccine platform and autologous CAR-T platform to strengthen its R&D capabilities and explore high-growth areas like ophthalmology [4] - The new generation covalent reversible BTK inhibitor, EVER001, has shown promising clinical results, with plans for pivotal registration trials starting in 2026 [4] - The company aims to introduce over three significant products in the next 6 to 12 months, with potential domestic sales peaks exceeding RMB 10 billion, contributing to an overall sales peak of over RMB 20 billion [4] Group 4: Strategic Collaboration with I-Mab - CloudTop has signed a collaboration agreement with I-Mab for the development of VIS-101, a dual-specificity biologic targeting VEGF-A and ANG2, enhancing its portfolio in the ophthalmology market [5][6] - The global anti-VEGF ophthalmic drug market is projected to grow from approximately $23 billion in 2024 to over $40 billion by 2030, indicating significant potential for VIS-101 [5][6] - The collaboration aims to accelerate the clinical development of VIS-101 in the Asia-Pacific and U.S. markets, enhancing R&D efficiency and global expansion [6] Group 5: Overall Market Position and Future Outlook - The meeting highlighted the systematic progress in capital empowerment, innovation breakthroughs, and global expansion, positioning the company to enhance its competitiveness in the global innovative drug sector [6] - As core pipelines enter the value realization phase, the company is steadily moving towards its goal of becoming a leading comprehensive biopharmaceutical enterprise globally [6]
云顶新耀(01952)召开公司发展战略交流会 加强全球布局实现跨越式发展战略
智通财经网· 2025-10-22 00:09
Core Insights - The company, CloudTop New Medicine (01952), held a strategic investor meeting on October 21, 2023, to discuss its latest strategic planning, R&D progress, and long-term development blueprint [1] Group 1: Leadership and Strategic Direction - The new chairman, Wu Yifang, will lead the board in setting the strategic direction and providing guidance to the management team, focusing on strategic transactions, R&D innovation, and stakeholder management [2] - The major shareholder, Kangqiao Capital, has expressed confidence in the company's strategic outlook and will not reduce its stake in the short term, which stabilizes the shareholder structure [2] Group 2: Dual-Engine Strategy and Market Expansion - The company will implement a "dual-engine" strategy, focusing on both in-house R&D and external collaborations, acquisitions, and capital empowerment to maximize commercial value [3] - Key therapeutic areas include nephrology, infectious diseases, and autoimmune diseases, with products like Nefukang® and Yijia® showing sustainable commercialization capabilities [3] - Nefukang® is projected to achieve sales of approximately RMB 1 billion in the first nine months of 2025, with an annual forecast of RMB 1.2 to 1.4 billion and a target of RMB 2.4 to 2.6 billion by 2026 [3] Group 3: R&D Advancements - The company is leveraging its mRNA cancer vaccine platform and autologous CAR-T platform to strengthen its R&D capabilities and explore high-growth areas like ophthalmology [4] - The new generation covalent reversible BTK inhibitor, EVER001, has shown promising clinical results and is set to enter pivotal trials in 2026 [4] - The company plans to introduce over three significant products in the next 6 to 12 months, with potential domestic sales peaks exceeding RMB 10 billion [4] Group 4: Strategic Collaboration with I-Mab - CloudTop New Medicine has signed a collaboration agreement with I-Mab for the development of VIS-101, a dual-specificity biologic for retinal diseases, enhancing its portfolio in the ophthalmology sector [5][6] - The global anti-VEGF ophthalmic drug market is projected to reach approximately $23 billion in 2024 and exceed $40 billion by 2030, indicating significant growth potential for innovative therapies [5][6] - The collaboration aims to accelerate the development of VIS-101 in the Asia-Pacific and the U.S., enhancing R&D efficiency and global expansion [6]
I-Mab (IMAB) Discusses Business Transformation Strategy and Plans for Accelerated Growth Transcript
Seeking Alpha· 2025-10-17 22:16
Core Viewpoint - I-Mab held a business update call to discuss recent developments and future outlook, emphasizing the importance of the information shared during the call [2][4]. Group 1: Company Updates - The call was initiated by PJ Kelleher from LifeSci Advisors, indicating a structured approach to investor communication [2]. - The presentation and discussion are recorded and will be accessible on the company's website for 30 days, ensuring transparency and availability of information for investors [2]. Group 2: Forward-Looking Statements - The company made forward-looking statements in accordance with the Private Securities Litigation Reform Act of 1995, highlighting the potential for actual results to differ due to various risks and uncertainties [3]. - I-Mab clarified that any forward-looking statements reflect the company's views as of October 16, 2025, and there is no obligation to update these statements post-call [4].
I-Mab (NasdaqGM:IMAB) Update / Briefing Transcript
2025-10-16 21:45
I-Mab Business Update Call Summary Company Overview - **Company**: I-Mab - **Industry**: Biotechnology - **Focus**: Transitioning from a clinical-stage China biotech to a global biotech platform with operations in both China and the U.S. [5][8] Key Points and Arguments Business Transformation Strategy - I-Mab is evolving into a global operating business, emphasizing a platform approach rather than a single molecule focus [6][8] - The company aims to leverage China's biotech innovation capabilities and U.S. clinical resources to enhance productivity and efficiency [8][9] Market Dynamics - China has become the leading country for clinical trials, surpassing the U.S. with a total transaction value of $94 billion in 2024, contributing over 60% of global licensing deal value in Q1 2025 [6][7] - The company is positioned to capitalize on this trend, recognizing the efficiency and quality of Chinese biotech by global pharmaceutical companies [7] Pipeline Overview - **Jewa Stomach**: A bispecific antibody targeting Claudin 18.2/4-1BB, showing a 71% overall response rate (ORR) compared to 47% for Nevo chemo and 40% for zolbetuximab [20][23] - Ongoing studies include a randomized phase two trial with 180 patients, expected to start in Q1 2026 [25] - **VIS 101**: Acquired for $37 million, targeting wet AMD and DME, with a potential market size of $20 billion to $30 billion [29][30] Financial Projections - Forecasted top sales for Jewa are approximately $2 billion, with additional opportunities in gastric, pancreatic, and biliary tract cancers potentially exceeding $3 billion [28] - The company aims to create value through licensing agreements post-proof of concept, with expected upfront payments around $50 million and potential total values reaching $1 billion for successful molecules [63] Strategic Partnerships - Collaboration with CBC Group, Asia's largest healthcare asset manager, enhances I-Mab's business development capabilities and governance practices [40][41] - The company has a systematic approach to screening assets, having identified over 550 opportunities and engaged with 116 [42] Future Directions - I-Mab plans to expand its therapeutic areas, with ophthalmology as the first focus, and aims to introduce 2 to 4 new molecules annually [53][54] - The hub-and-spoke model will allow for efficient resource allocation and faster turnaround times compared to traditional R&D models [58][59] Additional Important Content - The call emphasized the importance of a strong management team with diverse backgrounds in biotech and investment, which is crucial for executing the new strategy [18][36] - The company is committed to maintaining its existing clinical programs while expanding its portfolio, ensuring that current investors see continued value [46][47] This summary encapsulates the key insights from the I-Mab Business Update Call, highlighting the company's strategic transformation, market positioning, pipeline developments, and future growth plans.
I-Mab Announces Intention to Undertake Strategic Transformation to Global Biotech Platform, to Pursue Hong Kong IPO, and Rebrand as NovaBridge Biosciences
Globenewswire· 2025-10-16 20:05
Core Insights - I-Mab has announced a new business model aimed at accelerating access to innovative medicines and enabling strategic growth, including plans for a dual listing on NASDAQ and the Hong Kong Stock Exchange (HKEX) under the new name NovaBridge Biosciences [1][6][18] Business Model and Strategy - The new business model reflects a strategic transition to a global biotech platform focused on business development and translational clinical development [6] - The company intends to utilize a "hub-and-spoke" model to create specialized subsidiary companies, allowing for optimal risk management and value creation [8] - I-Mab aims to partner with leading innovators to identify and accelerate high-value assets, leveraging insights from the CBC Group to develop promising drug candidates [7][5] Financial and Leadership Changes - Kyler Lei has been appointed as Chief Financial Officer, bringing extensive experience in global capital markets and healthcare [13][14] - The company has secured additional capital and attracted seasoned biotech executives to its Board of Directors and Scientific Advisory Board [7] Acquisition and Pipeline Developments - I-Mab is in the process of acquiring VIS-101, a bifunctional biologic targeting VEGF-A and ANG2, which is expected to provide more durable treatment benefits for patients with wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) [2][10] - The acquisition will be completed by a newly formed subsidiary, Visara, which will focus on developing ophthalmic therapeutics [10][21] - The pipeline includes givastomig, a potential best-in-class therapy for gastric cancer, with a global Phase 2 study expected to begin in Q1 2026 [11][19] Market Potential and Growth Opportunities - The Asia Pacific region has generated over 30% of global biopharma assets under development and achieved more than $80 billion in deal value through collaborations with multinational pharmaceutical organizations [4] - The biopharmaceutical ecosystem in Asia Pacific is becoming increasingly efficient, with lower clinical trial costs and faster patient enrollment compared to global medians [4]