香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性或 完整性亦不發表任何聲明，並明確表示，概不會對因本公告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。 （於開曼群島註冊成立的有限公司） （股份代號: 9688） 海外監管公告 – 表格 10-Q 本公告乃由再鼎醫藥有限公司（「本公司」）根據香港聯合交易所有限公司證券上 市規則第13.10B條而作出。 本公司於2025年11月6日向美國證券交易委員會（「SEC」）遞交了截至2025年9月 30日止季度的季度報告表格10-Q（「表格10-Q」）。詳情請參閱隨附表格10-Q，其 已於SEC網站www.sec.gov及本公司網站www.zailaboratory.com刊發。 承董事會命 再鼎醫藥有限公司 董事長兼首席執行官 杜瑩 Zai Lab Limited 再鼎醫藥有限公司* 香港，2025年11月6日 於本公告日期，本公司董事會包括董事杜瑩博士；以及獨立董事 John Diekman 博士、 Richard Gaynor 博士、梁頴宇女士、 William Lis 先生、 Scott W. Morri ...

Financial Performance - Zai Lab Limited reported revenue of $106.49 million for the quarter ended March 2025, reflecting a year-over-year increase of 22.2% [1] - The earnings per share (EPS) for the quarter was -$0.45, an improvement from -$0.55 in the same quarter last year [1] - The reported revenue was below the Zacks Consensus Estimate of $117.09 million by 9.06% [1] - The EPS exceeded the consensus estimate of -$0.50 by 10.00% [1] Key Metrics - Product revenue for ZEJULA was $49.53 million, surpassing the average estimate of $48.32 million from three analysts [4] - Product revenue for OPTUNE reached $11.36 million, exceeding the average estimate of $8.35 million [4] - Product revenue for VYVGART was $18.11 million, falling short of the average estimate of $31.75 million [4] - Product revenue for NUZYRA was $15.12 million, slightly above the average estimate of $14.39 million [4] - Product revenue for QINLOCK was $8.51 million, exceeding the average estimate of $8.21 million [4] Stock Performance - Shares of Zai Lab Limited have returned +4.8% over the past month, compared to the Zacks S&P 500 composite's +11.3% change [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]

Financial Performance & Guidance - Zai Lab reported total revenue of $399.0 million for FY'24, a 50% year-over-year increase, and $109.1 million for 4Q'24, a 66% year-over-year increase[33, 34] - Adjusted loss from operations improved by 28% year-over-year for FY'24 and 53% year-over-year for 4Q'24[8] - The company's cash position was strong at $879.7 million as of December 31, 2024, compared to $806.5 million as of December 31, 2023[8, 46] - Zai Lab projects total revenue guidance of $560~$590 million for 2025 and targets profitability by 4Q'25[45] Product Performance & Pipeline - VYVGART/VYVGART Hytrulo revenue reached $93.6 million in FY'24, an 835% increase year-over-year, and $30.0 million in 4Q'24, a 492% increase year-over-year[33] - ZEJULA revenue was $187.1 million in FY'24, an 11% increase year-over-year, and $48.4 million in 4Q'24, a 16% increase year-over-year[33] - NUZYRA revenue was $43.2 million in FY'24, a 99% increase year-over-year, and $11.0 million in 4Q'24, an 81% increase year-over-year[33] - The company anticipates launching three new potential blockbuster drugs in China in 2025-26: Bemarituzumab, KarXT, and TTFields[13, 15, 17] Clinical Development & Regulatory Milestones - KarXT's NDA was accepted by the NMPA in January 2025 for schizophrenia[7, 16, 99] - ZL-1310 (DLL3 ADC) showed a 74% ORR in 2L+ SCLC patients in Phase 1 trials and was granted Orphan Drug Designation by the FDA for SCLC in Jan'25[8, 21, 22, 150] - The company plans to initiate a pivotal study for ZL-1310 in SCLC and a Phase 1 study in other DLL3-expressing tumors in 2025[26]