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 Insights - ABL Bio has entered into a collaboration agreement with Eli Lilly, which includes a USD 40 million upfront payment and a USD 15 million equity investment [1][3] Group 1: Collaboration and Funding - ABL Bio and Eli Lilly are conducting joint research and development on multiple therapeutic candidates utilizing the Grabody platform [2] - The newly secured funding will be used to accelerate R&D on ABL Bio's core technologies, including bispecific antibodies and dual-payload ADCs [2][3] - ABL Bio aims to expand the indications of its Grabody platform into areas with high unmet needs, such as obesity and muscle disorders [3] Group 2: Clinical Development and Pipeline - ABL Bio is developing various clinical and non-clinical assets based on the Grabody platform, with 8 pipelines currently in clinical projects across multiple countries [4] - ABL301 (SAR446159) has completed Phase 1 clinical trials, with Sanofi set to conduct subsequent studies [4] - ABL001 (tovecimig) has received Fast Track designation from the FDA, and ABL111 (givastomig) has shown promising results in a Phase 1b trial [4]

本文源自：金融界AI电报 礼来公司将向ABL Bio支付4000万美元用于许可、研究及合作，并进行1500万美元股权投资。ABL Bio 与礼来公司合作开展基于双特异性抗体平台"Grabody"的联合研究。 ...

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]

Biotech M&A Activity - Merck announced the acquisition of Cidara Therapeutics for approximately $9.2 billion, primarily for its antiviral drug aimed at preventing flu infections in high-risk patients, currently in late-stage clinical trials [1] - This acquisition follows Merck's earlier $10 billion deal to acquire Verona Pharma for respiratory drugs, indicating a trend of significant investments in biotech [1] - The dollar volume of M&A in the biotech sector reached $129 billion through October 31, 2025, a 43% increase compared to all of 2024, despite a 26% decrease in the number of deals, highlighting a shift towards larger, market-ready assets [3] Recursion's Challenges - Recursion has not successfully brought any drugs to market since its founding, with its shares dropping 86% since its IPO in April 2021, resulting in a current market cap of $2.2 billion [4] - The company reported a revenue decline of one-third to $44 million from $65 million over the last 12 months, while losses surged nearly 90% to $716 million [4] - Incoming CEO Najat Khan aims to tackle the challenges of AI in drug development, acknowledging the high failure rate in the industry [5] Infant Formula Outbreak - A botulism outbreak linked to ByHeart's organic infant formula affected 23 babies across 13 states, leading to multiple hospitalizations and five lawsuits from parents [6] - ByHeart had previously shut down its Pennsylvania manufacturing plant due to safety violations and announced a nationwide recall of its infant formula [7] Profluent's AI Innovations - Profluent, a startup focused on using AI for protein design, raised $106 million in new venture funding, bringing its total investment to $150 million and approaching a valuation of $1 billion [12] - The company aims to revolutionize drug development and agriculture by making biology programmable, which could lead to significant breakthroughs in therapeutics and diagnostics [11]

South Korea’s newest billionaire is Lee Sang-hoon, founder of Seoul-based ABL Bio, after it struck a $2.6 billion licensing and joint research deal with Eli Lilly for its bispecific antibody technology. https://t.co/AsPJpFZ2pp (Photo: Getty Images) https://t.co/9tdgfIBfXX ...

的申請版本 香港聯合交易所有限公司與證券及期貨事務監察委員會對本申請版本的內容概不負責，對 其準確性或完整性亦不發表任何意見，並明確表示概不就因本申請版本全部或任何部分內 容而產生或因倚賴該等內容而引致的任何損失承擔任何責任。 NovaBridge Biosciences 新橋生物 （根據開曼群島法律註冊成立的有限公司） 警告 本申請版本乃根據香港聯合交易所有限公司（「聯交所」）及證券及期貨事務監察委員會（「證 監會」）的要求而刊發，僅用作提供資料予香港公眾人士。 本申請版本為草擬本，其內所載資料並不完整，亦可能會作出重大變動。閣下閱覽本文件， 即代表閣下知悉、接納並向新橋生物（「本公司」）、其聯席保薦人、整體協調人、顧問或包 銷團成員表示同意： 本公司招股章程根據香港法例第32章公司（清盤及雜項條文）條例送呈香港公司註冊處處長 登記前，本公司不會向香港公眾人士提出要約或邀請。倘於適當時候向香港公眾人士提出 要約或邀請，有意投資者務請僅依據呈交香港公司註冊處註冊的本公司招股章程作出投資 決定；有關文本將於發售期內向公眾刊發。 52791 \ (Project Ion_Redacted) 00b. 警告_Red ...

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]

Core Insights - I-Mab announced that an abstract related to updated data from the Phase 1 study of givastomig has been accepted for presentation at the AACR-NCI-EORTC conference in Boston from October 22-26, 2025 [1][2] Group 1: Givastomig Development - Givastomig is a bispecific antibody targeting Claudin 18.2-positive tumor cells, designed to activate T cells through the 4-1BB signaling pathway in the tumor microenvironment [4][6] - The drug is being developed for first-line metastatic gastric cancers and other Claudin 18.2-positive gastrointestinal tumors, with promising anti-tumor activity observed in Phase 1 trials [4][6] - I-Mab is collaborating with ABL Bio for the development of givastomig, sharing worldwide rights excluding Greater China and South Korea [5] Group 2: Conference Presentation Details - The presentation at the conference will cover updated safety, efficacy, and biomarker analysis from the Phase I study of givastomig in Claudin 18.2 positive advanced gastroesophageal carcinoma [3] - The session is scheduled for October 23, 2025, from 6:20 to 6:35 PM ET at the Hynes Convention Center, with Dr. Samuel J. Klempner as the speaker [3]