Mabwell Presents Promising Clinical Data of 9MW2821 at 2026 ASCO Annual Meeting
Key Highlights
- Groundbreaking Clinical Results: Mabwell (Shanghai) Bioscience Co., Ltd. has announced that it will present oral and poster presentations of the latest clinical data for its innovative Nectin-4 targeting ADC drug, 9MW2821 (Bulumtatug Fuvedotin, BFv), in combination with toripalimab, at the prestigious 2026 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago from May 29 to June 2, 2026.
- Two Key Presentations:
- Oral presentation of Phase Ib/II data for 9MW2821 + toripalimab in locally advanced or metastatic urothelial carcinoma (la/mUC).
- Poster presentation of Phase II data for 9MW2821 + toripalimab in perioperative muscle-invasive bladder cancer (MIBC).
- Strong Efficacy Results in Advanced Urothelial Carcinoma:
- 52 patients enrolled; efficacy analysis on 47 subjects as of Dec 1, 2025.
- Overall Objective Response Rate (ORR): 83.0% (95%CI: 69.2-92.4).
- Confirmed ORR: 74.5%.
- Complete Response (CR) Rate: 12.8%.
- Disease Control Rate (DCR): 89.4% (95%CI: 76.9-96.5).
- For previously untreated patients: ORR 87.5%, confirmed ORR 80.0%, CR rate 12.5%, DCR 92.5%.
- Median Progression-Free Survival (PFS): 12.9 months (95%CI: 6.5-NR).
- Median Duration of Response (DoR) and Overall Survival (OS) not yet reached.
- No new safety signals related to 9MW2821 or toripalimab observed.
- Promising Data in Muscle-Invasive Bladder Cancer:
- 32 subjects enrolled in Phase II study for perioperative MIBC; 7 completed neoadjuvant therapy as of Jan 4, 2026.
- 6 completed radical cystectomy and lymph node dissection; 1 refused surgery after achieving clinical CR.
- Pathological Complete Response (pCR): 66.7% (4/6, 95%CI: 22.3-95.7).
- Pathological Downstaging (pDS) Rate: 83.3% (5/6, 95%CI: 35.9-99.6).
- No new safety signals observed.
- Extensive Clinical Pipeline:
- 9MW2821 is an innovative, site-specific ADC drug targeting Nectin-4, with proprietary conjugation technology.
- Over 2,000 subjects enrolled across multiple indications: urothelial carcinoma, cervical cancer, esophageal cancer, and breast cancer.
- Four pivotal Phase III trials underway, including monotherapy and combination therapy for urothelial carcinoma, cervical cancer, and triple-negative breast cancer (TNBC).
- Multiple Phase I/II trials in China and the US, with interim analyses and pre-NDA meetings planned for 2026.
Key Information for Shareholders
- Potential Price-Sensitive Implications: The oral and poster presentations at the ASCO Annual Meeting are likely to attract significant attention from the global oncology and investment communities, given the strong efficacy data and safety profile demonstrated to date.
- Development and Regulatory Risks: Despite promising results, the company notes there is no guarantee that the clinical data will lead to successful marketing approval or commercialization of 9MW2821. The process remains subject to clinical, regulatory, and commercial uncertainties.
- Upcoming Milestones: Interim analyses for pivotal Phase III studies and regulatory submissions (pre-NDA meetings) are planned for 2026, potentially serving as value inflection points.
- Regulatory Caution: As required by the Hong Kong Stock Exchange, the company emphasizes that 9MW2821 may not ultimately be successfully developed or marketed. Investors are advised to exercise caution in trading Mabwell’s shares in light of these risks.
Conclusion
With robust clinical data and an expanding pipeline, Mabwell is positioned as a potential leader in the ADC oncology landscape. The upcoming ASCO presentations and regulatory milestones in 2026 could be significant catalysts for the company’s share price. However, investors should remain aware of the inherent risks associated with drug development and regulatory approval.
Disclaimer
This article is for informational purposes only and does not constitute investment advice. Drug development is subject to significant risks and uncertainties, and past clinical results do not guarantee future regulatory or commercial success. Investors should conduct their own due diligence and consult professional advisors before making investment decisions.
脈博生物於2026年ASCO年會公佈9MW2821創新臨床數據
重點摘要
- 突破性臨床成果：脈博（上海）生物科技有限公司宣佈，將於2026年5月29日至6月2日在芝加哥舉行的美國臨床腫瘤學會（ASCO）年會上，口頭及海報發表其創新Nectin-4靶向ADC藥物9MW2821（Bulumtatug Fuvedotin, BFv）聯合托瑞帕利單抗的最新臨床數據。
- 兩大重要報告：
- la/mUC（局部晚期或轉移性尿路上皮癌）患者9MW2821+托瑞帕利單抗的Ib/II期口頭報告。
- MIBC（肌層浸潤性膀胱癌）圍手術期患者的II期海報數據。
- 先進尿路上皮癌療效突出：
- 共52例患者入組，至2025年12月1日，47例納入療效分析。
- 總客觀緩解率（ORR）：83.0%（95%CI: 69.2-92.4）。
- 確證ORR：74.5%。
- 完全緩解（CR）率：12.8%。
- 疾病控制率（DCR）：89.4%（95%CI: 76.9-96.5）。
- 未經治療患者ORR 87.5%，確證ORR 80.0%，CR率12.5%，DCR 92.5%。
- 中位無進展生存期（PFS）12.9個月（95%CI: 6.5-NR）。
- 中位緩解持續期及總生存期尚未達到。
- 未見新的安全性風險。
- 膀胱癌新療法效果顯著：
- 圍手術期MIBC II期研究納入32例，至2026年1月4日，7例完成新輔助治療。
- 6例完成根治性膀胱切除及淋巴結清掃，1例因新輔助治療達臨床CR而拒絕手術。
- 病理完全緩解（pCR）率為66.7%（4/6，95%CI: 22.3-95.7）。
- 病理降期（pDS）率為83.3%（5/6，95%CI: 35.9-99.6）。
- 未見新的安全性信號。
- 豐富臨床管線：
- 9MW2821為公司首個Nectin-4靶向位點特異性ADC創新藥，技術具有自主知識產權。
- 已在尿路上皮癌、宮頸癌、食管癌及乳腺癌等多適應症中展開臨床，全球入組超2,000例。
- 4項關鍵III期臨床推進中，包括尿路上皮癌單藥及聯合療法、宮頸癌、三陰乳腺癌等。
- 多項I/II期研究在中美開展，2026年將有多項數據中期分析及預NDA會議。
股東須知及潛在敏感因素
- 股價敏感事項：ASCO年會的口頭及海報發表將吸引全球腫瘤界和投資者高度關注，尤其是數據顯示強勁的療效和安全性，對公司估值有潛在正面推動。
- 研發及監管風險：儘管數據樂觀，公司提醒臨床數據能否最終支持上市申請及獲批仍存不確定性，臨床、監管及商業化風險較高。
- 即將到來的重要里程碑：多項關鍵III期臨床的中期分析及監管申報將於2026年啟動，有望成為價值催化劑。
- 監管風險提示：根據聯交所規定，公司強調不保證9MW2821最終能成功上市，股東及潛在投資者應審慎處理公司股份。
總結
憑藉穩健的臨床數據和豐富的研發管線，脈博生物有望成為ADC腫瘤治療領域的領先者。2026年ASCO年會及多項監管推進有潛力成為公司股價的重大催化劑。但投資者需留意新藥研發和監管核准的不確定性與風險。
免責聲明
本文僅供參考，並不構成任何投資建議。新藥研發具有高度風險和不確定性，過往臨床結果不代表未來能夠獲批或商業成功。投資者請自行審慎評估及諮詢專業顧問。
