重大事件
外國發行人報告
6-K
2026-07-24
報告日期:2026年7月24日
AI 繁中摘要
📄 **申報類型**:6-K(外國私營發行人報告)
📅 **報告日期**:2026年7月24日
**重點事件**:
- 臨床階段生物製藥公司 NovaBridge Biosciences(納斯達克代號:NBP)宣佈,將於 **2026年9月8日上午10:00(上海時間)** 在上海辦公室舉行股東週年大會(AGM)。
- 股權登記日:2026年7月27日(上海時間)收市前持有普通股或美國存託憑證(ADS)的股東方有權出席及投票。
- AGM通知及委託書已上載至公司官網。
**財務及監管文件**:
- 公司已向美國證監會提交截至 **2025年12月31日** 的20-F年度報告(已修訂),審計財務報表可在SEC或公司網站查閱。
**業務亮點**:
NovaBridge 專注於未滿足醫療需求領域,核心管線包括:
- **Givastomig**:潛在首創 Claudin 18.2 × 4-1BB 雙特異性抗體,用於治療 Claudin 18.2 陽性胃癌及其他消化道惡性腫瘤。已公佈的全球隨機Phase 1b一線胃癌研究取得正面頂線結果,目前正進行Phase 2研究。
- **VIS-101**:針對 VEGF-A 及 ANG-2 的雙重抑制劑,用於濕性黃斑病變、糖尿病黃斑水腫等視網膜血管疾病。已完成濕性AMD的隨機Phase 2a研究,預計 **2026年下半年** 啟動劑量確定Phase 2b研究。NovaBridge 為 Visara 主要股東,持有大中華及亞洲部分地區以外的全球權利。
- **Ragistomig**:與 ABL Bio 合作,結合 PD-L1 及 4-1BB 的雙特異性抗體。
- **Uliledlimab**:抗 CD73 抗體,針對腫瘤腺苷路徑免疫抑制,NovaBridge 持有中國以外的全球權利。
**潛在影響**:
- 股東需留意AGM日期及投票安排,特別是ADS持有人須通過存託銀行花旗行使投票權。
- 管線進展正面,尤其 givastomig 及 VIS-101 的臨床數據為後期開發奠定基礎,惟仍屬臨床階段,需關注監管及商業化風險。
- 公司提到宏觀經濟、地緣政治等不確定因素,投資者應參閱20-F報告中的風險因素。
**管理層展望**(來自前瞻性陳述):
公司對管線開發時程及監管審批持審慎樂觀態度,但強調臨床結果、資金狀況及市場環境均可能影響實際成果。
🔍 **總結**:NovaBridge 正處於關鍵臨床推進期,AGM 為股東參與公司治理的重要機會。短期焦點在VIS-101 Phase 2b啟動及givastomig Phase 2數據。投資者宜關注後續監管及合作動態。
展開英文正文
EX-99.1 2 nbp-ex99_1.htm EX-99.1 EX-99.1 Exhibit 99.1 NovaBridge Biosciences to Hold Annual General Meeting on September 8, 2026 ROCKVILLE, MD, July 24, 2026 (GLOBE NEWSWIRE) – NovaBridge Biosciences (Nasdaq: NBP) (“NovaBridge” or the “Company”), a clinical-stage biopharmaceutical company advancing innovative medicines for areas of significant unmet need, today announced that it will hold its annual general meeting of shareholders (the “AGM”) at NovaBridge Biosciences Shanghai office, 38F, AIA Tower, No. 866 Dongchangzhi Road, Shanghai, China on September 8, 2026 at 10:00 a.m. (Shanghai time). Holders of record of ordinary shares of a par value of US$0.0001 each of the Company at the close of business on July 27, 2026 (Shanghai time) are entitled to notice of, to attend and to vote at, the AGM or any adjournment(s) or postponement(s) thereof. Holders of the Company’s American depositary shares (“ADSs”) as of the close of business on July 27, 2026 (New York time) who wish to exercise their voting rights for the underlying ordinary shares must act through the depositary of the Company’s ADSs, Citibank, N.A. The Notice of AGM, which sets forth the resolution to be submitted to shareholder approval at the AGM, and the form of proxy for the AGM are available on the Company’s website at https://www.novabridge.com. The Company has filed its annual report on Form 20-F (as amended by Amendment No. 1 to the annual report on Form 20-F, the “Annual Report”), including its audited financial statements, for the fiscal year ended December 31, 2025, with the U.S. Securities and Exchange Commission (“SEC”). The Annual Report can be accessed on the Company’s website at https://www.novabridge.com, as well as on the SEC’s website at https://www.sec.gov. About NovaBridge Biosciences NovaBridge is a clinical-stage biopharmaceutical company advancing innovative medicines for areas of significant unmet need. The Company combines deep business development expertise with agile translational clinical development to identify, accelerate, and advance breakthrough assets, enabling transformative therapies to progress rapidly from discovery toward patients in need. The Company’s differentiated pipeline is led by givastomig, a potential first-in-class Claudin 18.2-Targeted Immuno Amplifier (CTIA) — a Claudin 18.2 × 4-1BB bispecific antibody — and VIS-101, a purpose-designed, potential best-in-class dual VEGF-A × ANG-2 inhibitor. Givastomig conditionally activates T cells via the 4-1BB signaling pathway in the tumor microenvironment where Claudin 18.2 is expressed, and is being developed to treat Claudin 18.2-positive gastric cancer and other gastrointestinal malignancies. It is being evaluated in a global, randomized Phase 2 study, following positive topline results from a Phase 1b, multicenter, open-label study in first-line gastric cancer. NovaBridge is also collaborating with its partner, ABL Bio, on ragistomig, a bispecific antibody combining PD-L1 as a tumor engager with 4-1BB as a conditional T-cell activator, in solid tumors. In addition, NovaBridge holds worldwide rights outside of China to uliledlimab, an anti-CD73 antibody targeting adenosine-driven immunosuppression in cancer. VIS-101 targets VEGF-A and ANG-2 to provide more rapid, robust, and durable treatment responses for patients with retinal vascular diseases, including wet age-related macular degeneration, diabetic macular edema, and retinal vein occlusion. It has completed a randomized, dose-ranging Phase 2a study in wet AMD and expects to initiate a dose-determining Phase 2b study in the second half of 2026. NovaBridge is the majority shareholder of Visara, Inc., which controls global rights to VIS-101 outside of Greater China and certain countries in Asia. For more information, visit https://www.novabridge.com and follow NovaBridge on LinkedIn. Forward-Looking Statements This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “believes,” “designed to,” “anticipates,” “future,” “intends,” “plans,” “potential,” “estimates,” “confident,” “look forward” and similar terms or the negative thereof. NovaBridge may also make written or oral forward-looking statements in its periodic reports to the SEC, in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements in this press release include, without limitation, statements regarding: the Company’s expectations regarding the AGM; the strategic and clinical development of the Company’s drug candidates, including givastomig, VIS-101, ragistomig, and uliledlimab; the potential for these product candidates to receive regulatory approval from the FDA or equivalent foreign regulatory agencies, and whether, if approved, these product candidates will be successfully distributed and marketed and the potential market opportunity for these product candidates; and anticipated clinical milestones and results, and related timing. Forward-looking statements involve inherent risks and uncertainties that may cause actual results to differ materially from those contained in these forward-looking statements, including but not limited to the following: the Company’s ability to demonstrate the safety and efficacy of its drug candidates; the clinical results for its drug candidates, which may or may not support further development or New Drug Application/Biologics License Application (NDA/BLA) approval or eligibility for or achievement of Accelerated Approval Pathway; the content and timing of decisions made by the relevant regulatory authorities, including the FDA, regarding regulatory approval of the Company’s drug candidates; the Company’s ability to achieve commercial success for its drug candidates, if approved; the Company’s ability to obtain and maintain protection of intellectual property for its technology and drugs; the Company’s reliance on third parties to conduct drug development, manufacturing and other services; the Company’s limited operating history and the Company’s ability to obtain additional funding for operations and to complete the development and commercialization of its drug candidates; the impact of macroeconomic conditions, including inflation, tariffs, volatile interest rates, regulatory uncertainty, potential government shutdowns, volatility in the capital markets, and regional and other global events, including ongoing armed conflicts in different regions of the world; and those risks more fully discussed in the “Risk Factors” section in the Company’s annual report on Form 20-F filed with the SEC on April 7, 2026 as well as the discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All forward-looking statements are based on information currently available to the Company. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. NovaBridge Investor & Media Contacts NovaBridge Biosciences +1-240-745-6330 [email protected] Bill Begien, VP, Investor Relations [email protected] Jessica Zhang, Director, Public Relations [email protected]