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 - Total revenue for Q3 2025 increased by 14% year-over-year, reaching $116.1 million[6] - Operating loss for Q3 2025 was $48.8 million, a reduction of 28% compared to the previous year[6] - Adjusted operating loss narrowed by 42% to $28 million for Q3 2025[6] - In Q3 2025, product revenue net amounted to $115.4 million, a 13% increase year-over-year, driven by sales growth of Newzai and Dingyoule[11] - The net loss for Q3 2025 was $36 million, with a loss per share of $0.03, an improvement from a net loss of $41.7 million and a loss per share of $0.04 in the same period of 2024[11] - Total revenue for the three months ended September 30, 2025, was $116,095,000, representing a 13% increase compared to $102,265,000 in the same period of 2024[36] - Product revenue for the nine months ended September 30, 2025, reached $330,095,000, a 14% increase from $289,102,000 in the same period of 2024[38] - Operating loss for the three months ended September 30, 2025, was $(48,822,000), a 28% improvement compared to $(67,853,000) in the same period of 2024[39] - Net loss for the nine months ended September 30, 2025, was $(125,128,000), down from $(175,419,000) in the same period of 2024[37] - Adjusted operating loss for the three months ended September 30, 2025, was $(27,998,000), compared to $(48,187,000) in the same period of 2024[39] Guidance and Projections - The company has set a full-year revenue guidance of at least $460 million for 2025[6] - The company adjusted its full-year 2025 total revenue guidance to at least $460 million[22] - Future projections include expectations for revenue growth, profitability, and cash flow from commercialized products and clinical-stage candidates[31] Research and Development - Zocilurtatug Pelitecan (zoci) has shown a 68% overall response rate in the 1.6 mg/kg dose group for the treatment of extensive-stage small cell lung cancer[9] - The median duration of response (DoR) for patients in the same group is estimated at 6.1 months[9] - KarXT has been included in national treatment guidelines in China, highlighting the urgent need for new therapies in the schizophrenia field[6] - The company plans to submit a marketing authorization application for tumor treating fields therapy for pancreatic cancer in Q4 2025[9] - ZL-1503 (IL-13xIL-31R) has initiated a global Phase 1/1b study to evaluate its safety and pharmacokinetics[9] - The company is preparing for the anticipated launch of KarXT in the schizophrenia market[6] - KarXT was included in the "China Schizophrenia Prevention and Treatment Guidelines (2025 Edition)" as the first national-level guideline globally, highlighting its effectiveness in three symptom areas[11] - The company plans to submit a new drug clinical trial application for ZL-6201 for treating sarcoma patients in Q4 2025[15] - The company expects to announce key results from ongoing clinical studies in 2026, including updates on the efficacy of Zocilurtatug Pelitecan in treating various cancers[17] - The company is preparing to submit marketing authorization applications for several products, including a new treatment for first-line pancreatic cancer in Q4 2025[18] Financial Position - As of September 30, 2025, cash and cash equivalents totaled $81.72 million, down from $83.23 million as of June 30, 2025[12] - As of September 30, 2025, cash and cash equivalents increased to $717.155 million from $449.667 million as of December 31, 2024, representing a growth of approximately 59.7%[34] - Total assets decreased to $1.159 billion as of September 30, 2025, from $1.186 billion as of December 31, 2024, a decline of about 2.3%[34] - Current liabilities increased to $359.769 million as of September 30, 2025, compared to $299.385 million as of December 31, 2024, reflecting an increase of approximately 20.2%[34] - The company reported a total of $85.377 million in accounts receivable as of September 30, 2025, slightly up from $85.178 million as of December 31, 2024[34] - Inventory net increased to $67.135 million as of September 30, 2025, from $39.875 million as of December 31, 2024, indicating a rise of approximately 68.5%[34] - The company has a non-current restricted cash of $1.115 million as of September 30, 2025, consistent with $1.114 million as of December 31, 2024[34] - Total liabilities rose to $398.995 million as of September 30, 2025, compared to $344.855 million as of December 31, 2024, marking an increase of about 15.7%[34] - The total equity as of September 30, 2025, was $759,945,000, a decrease from $840,898,000 as of December 31, 2024[35] - The total liabilities and equity as of September 30, 2025, was $1,158,940,000, compared to $1,185,753,000 as of December 31, 2024[35] - The company reported a foreign currency translation adjustment loss of $(6,703,000) for the three months ended September 30, 2025[37] Operational Focus - The company emphasizes the importance of non-GAAP financial metrics for understanding operational performance and financial results[30] - The company is focused on addressing unmet medical needs in oncology, immunology, neuroscience, and infectious diseases through innovative product development[27]

Financial Data and Key Metrics Changes - Total revenues for the third quarter were $116 million, representing a 14% year-over-year growth [14][19] - Adjusted loss from operations improved by 42% year-over-year to $28 million [20] - The company ended the quarter with $817 million in cash, providing flexibility for investments [21] Business Line Data and Key Metrics Changes - Vyvgart and Vyvgart Hytrulo contributed $27.7 million, with a $2.4 million reduction due to a voluntary price adjustment [14] - Demand for Nuzyra increased, supported by higher market coverage and penetration [19] - Zejula experienced a year-over-year decline amid competitive dynamics but grew sequentially [19] Market Data and Key Metrics Changes - Vyvgart remains the number one innovative drug by sales among all new launches in the past two years in China [15] - The average vials per patient for Vyvgart increased over 30% year-to-date versus last year [16] - The company expects continued growth in the China business, which is already commercially profitable [21] Company Strategy and Development Direction - The company aims to bring global innovations to patients in China and develop new innovations for global competition [4] - The focus is on advancing the global pipeline, particularly with ZL1310, which is expected to enter pivotal trials [4][12] - The company is strategically investing in R&D while maintaining financial discipline [21] Management's Comments on Operating Environment and Future Outlook - The management noted a complex and dynamic environment affecting growth pace but remains confident in long-term potential [5] - Regulatory reviews are becoming faster, and negotiations are more transparent, which is encouraging [5] - The company plans to provide updated financial guidance for 2026 in the next earnings report [21] Other Important Information - The company is expanding its global R&D organization to enhance speed and quality [5] - New Chief Business Officer, Dr. Shan He, is expected to play a central role in expanding the portfolio [14] - The company is on track for several important milestones across its global portfolio in the next 12 months [12] Q&A Session Summary Question: Revised revenue guidance and key growth drivers - Management highlighted that growth will be driven by Vyvgart, with expectations for continued patient additions and treatment duration [24][26] Question: Expectations for ZL1503 in atopic dermatitis - Initial data readout is expected in 2026, with a focus on efficacy endpoints and potential expansion into other TH2 diseases [28] Question: Shift in resource allocation towards internal pipeline - Management confirmed a strong focus on the internal pipeline while remaining open to external opportunities [30][32] Question: Opportunities in internal global pipeline - The most immediate opportunity is ZL1310, with strong activity and tolerability observed [35] Question: Strategy for KarXT launch in schizophrenia - The company plans a targeted sales force approach, anticipating significant market opportunity due to the lack of new mechanisms in over 70 years [40][41] Question: Challenges in achieving $2 billion revenue target by 2028 - Management acknowledged slower-than-expected growth in Vyvgart and Zejula but remains optimistic about the overall portfolio [43][45] Question: Pathway to approval for ZL1310 in neuroendocrine tumors - The company plans to conduct a single-arm trial with a focus on response rates, aiming for accelerated approval [47][48]

公司名稱: 再鼎醫藥有限公司 股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | 截至月份: | | --- | | 2025年10月31日 | | 狀態: | | 新提交 | 致：香港交易及結算所有限公司 呈交日期: 2025年11月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | | 於香港聯交所上市 (註1) | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09688 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.000006 | USD | | 30,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.000006 | ...

Core Insights - Zai Lab's partner Amgen has halted the evaluation of bemarituzumab in combination with chemotherapy and nivolumab for first-line gastric cancer in the FORTITUDE-102 clinical trial due to insufficient efficacy observed in interim analysis by an independent data monitoring committee [2][3] - The FORTITUDE-102 trial was intended to assess the treatment effects of bemarituzumab, a monoclonal antibody targeting FGFR2b, in combination with chemotherapy and nivolumab [2] - The termination of FORTITUDE-102 affects Zai Lab's strategic plans in the gastric cancer space, especially following the disappointing results from the FORTITUDE-101 trial [3] Summary by Sections Clinical Trial Results - The independent data monitoring committee concluded that the therapy did not demonstrate sufficient efficacy, leading to Amgen's decision to stop the trial [2] - The FORTITUDE-101 trial had previously shown significant statistical and clinical improvement in overall survival compared to chemotherapy alone during interim analysis, but this benefit diminished in the final analysis [2] Future Implications - With the termination of FORTITUDE-102, Zai Lab's strategy for gastric cancer treatment is now uncertain, as the data from this trial was expected to be released by the end of 2025 or early 2026 [3] - Zai Lab has stated it will continue to collaborate closely with Amgen and provide further updates as appropriate [3]

Core Insights - Zai Ding Pharma reported a 13% year-over-year increase in product revenue for Q3 2025, reaching $115.4 million, compared to $101.8 million in Q3 2024, with a 14% increase when adjusted for constant exchange rates [1][1][1] Financial Performance - The operating loss for Q3 2025 was $48.8 million, while the adjusted loss, excluding specific non-cash expenses such as depreciation, amortization, and stock-based compensation, was $28 million [1][1] - The net loss for Q3 2025 was $36 million, with a loss per common share of $0.03 (or $0.33 per American Depositary Share), compared to a net loss of $41.7 million in Q3 2024, where the loss per common share was $0.04 (or $0.42 per ADS) [1][1][1] - The reduction in net loss was primarily attributed to increased product revenue and decreased operating expenses [1] Research and Development Expenditure - R&D expenses for Q3 2025 amounted to $47.9 million, down from $66 million in Q3 2024, mainly due to a decrease in licensing fees related to upfront and milestone payments [1][1][1]

Pipeline Development - Zocilurtatug pelitecan (DLL3 ADC) shows promising data in a difficult-to-treat SCLC population, with an Objective Response Rate (ORR) of 68% at 1.6 mg/kg in 2L SCLC (n=19)[18] - Zai Lab is advancing Zoci into 1L SCLC, with Phase 3 initiated for 2L+ SCLC zoci monotherapy versus investigator's choice and Phase 1 dose escalation ongoing for 1L SCLC zoci + PD-L1 ±chemo[20] - ZL-1503 (IL13/IL31R) demonstrates potent and sustained reduction in IL-31-induced scratching and pSTAT6 in Non-Human Primates (NHP), with clinical data readout expected in 2026[28, 32] - ZL-6201 (LRRC15 ADC) is progressing with a U S IND submission planned by year end 2025 and global phase 1 initiation expected in 1H 2026[34, 39] - ZL-1222 (PD-1/IL-12) is advancing with potential preclinical data update in 2026 and completion of IND enabling studies expected in 2026[38, 40] Commercial Performance - Total revenues for 3Q'25 reached $116 1 million, a 14% year-over-year increase[71] - VYVGART/VYVGART Hytrulo sales were $27 7 million in 3Q'25, a 2% year-over-year increase, driven by an extension of Duration of Treatment (DoT) and increasing market penetration[71, 73] - NUZYRA experienced strong growth, with sales of $15 4 million in 3Q'25, a 54% year-over-year increase, supported by increased market coverage and penetration[71, 73] - Approximately 12% penetration in gMG prevalent patients, with ~21,000 patients treated by VYVGART as of September 30, 2025[63, 64] Financials and Operational Efficiency - Adjusted loss from operations improved from $(48 2) million in 3Q'24 to $(28 0) million in 3Q'25[79, 89] - R&D expenses decreased from 66% of total revenue in 3Q'24 to 41% in 3Q'25[76] - The company's cash position is $817 2 million as of September 30, 2025[85]

Financial Performance - Net product revenue for Q3 2025 was $115.4 million, a 13% increase year-over-year, driven by higher sales of NUZYRA and XACDURO[85]. - Total revenues for the three months ended September 30, 2025, increased by $13.8 million (14%) to $116.1 million compared to $102.3 million in the same period of 2024[100]. - Product revenue, net, rose by $13.5 million (13%) to $115.4 million for the three months ended September 30, 2025, driven by increased sales of NUZYRA and VYVGART[101]. - Collaboration revenue surged by $0.3 million (76%) to $734,000 for the three months ended September 30, 2025, reflecting promotional activities in mainland China[105]. - Net loss for the three months ended September 30, 2025, was $36.0 million, a reduction of $5.7 million (14%) compared to a net loss of $41.7 million in the same period of 2024[120]. - Net product revenue for the nine months ended September 30, 2025, increased by $41.0 million (14%) to $330.1 million compared to $289.1 million in the same period of 2024[100]. - Interest income decreased by $0.7 million (8%) to $8.3 million for the three months ended September 30, 2025, primarily due to lower interest rates[115]. - Foreign currency gains were $6.4 million for the three months ended September 30, 2025, down from $14.5 million in the same period of 2024, driven by RMB appreciation against the U.S. dollar[117]. - The company reported a loss per ordinary share of $0.03 for the three months ended September 30, 2025, compared to a loss per ordinary share of $0.04 in the same period of 2024[120]. Research and Development - The company expects to continue incurring substantial costs related to research and development and commercialization activities[83]. - The global Phase I clinical trial of Zocilurtatug Pelitecan (Zoci) showed a 68% overall response rate in 2L patients with ES-SCLC[86]. - The FDA granted Breakthrough Therapy Designation to Povetacicept for IgA nephropathy, with full enrollment of the Phase III study completed[91]. - The NMPA granted Innovative Medical Device Designation for TTFields therapy for pancreatic cancer, with plans to file for regulatory approval in Q4 2025[90]. - As of September 30, 2025, the company may be required to pay up to $211.0 million in development and regulatory milestone payments for current clinical programs[98]. Expenses and Cash Flow - Research and development expenses decreased by $18.1 million (27%) to $47.9 million for the three months ended September 30, 2025, primarily due to reduced licensing fees and personnel costs[106]. - Selling, general, and administrative expenses increased by $2.9 million (4%) to $70.1 million for the three months ended September 30, 2025, mainly due to higher selling expenses for NUZYRA and VYVGART[114]. - Net cash used in operating activities decreased by $34.3 million to $124.8 million for the nine months ended September 30, 2025, compared to $159.1 million in 2024[140]. - Net cash provided by investing activities increased by $346.6 million, primarily due to a $313.7 million increase in proceeds from the maturity of short-term investments[141]. - As of September 30, 2025, the company had cash and cash equivalents of $717.2 million, restricted cash of $101.1 million, and short-term investments of nil[152]. - The net increase in cash, cash equivalents, and restricted cash was $267.5 million for the nine months ended September 30, 2025[139]. Debt and Financial Commitments - The company had short-term debt of $203.0 million as of September 30, 2025, compared to $131.7 million as of December 31, 2024[156]. - The two largest customers accounted for approximately 19% of total accounts receivable as of September 30, 2025[153]. - The company had commitments of $0.7 million related to commercial manufacturing development activities and capital expenditures as of September 30, 2025[136]. - The company has identified opportunities to access capital through debt arrangements totaling approximately $275.4 million to support working capital needs in mainland China[137]. - A 100-basis point increase in interest rates would not materially increase the company's interest expense on short-term debt[156]. Leadership and Strategy - The company appointed Dr. Shan He as Senior Vice President, Chief Business Officer, to lead strategy for business development and partnerships[92]. - The company plans to increase patient access to existing commercial products through NRDL listing and supplemental insurance coverage[93]. - The company anticipates fluctuations in financial results based on the success of commercial products and research and development expenses[84].

Financial Performance - Total revenues grew 14% year-over-year to $116.1 million in Q3 2025, with an operating loss improved by 28% year-over-year to $48.8 million[4] - Product revenue, net was $115.4 million in Q3 2025, representing 13% year-over-year growth, driven by increased sales for NUZYRA and XACDURO[12] - Adjusted loss from operations was $28.0 million in Q3 2025, a 42% improvement year-over-year[4] - Net loss was $36.0 million in Q3 2025, compared to a net loss of $41.7 million for the same period in 2024[10] - Total revenues for Q3 2025 reached $116.1 million, a 13% increase compared to $102.3 million in Q3 2024[33] - Product revenue, net for the nine months ended September 30, 2025, was $330.1 million, reflecting a 14% year-over-year growth[33] - Loss from operations for Q3 2025 was $48.8 million, a 28% improvement from a loss of $67.9 million in Q3 2024[36] - Adjusted loss from operations for Q3 2025 was $28.0 million, compared to $48.2 million in Q3 2024[36] - Comprehensive loss for Q3 2025 was $42.7 million, down from $56.2 million in Q3 2024[34] Cash and Liabilities - Cash and cash equivalents totaled $817.2 million as of September 30, 2025, down from $832.3 million as of June 30, 2025[10] - Cash and cash equivalents increased to $717.2 million as of September 30, 2025, up from $449.7 million at the end of 2024[32] - Total current liabilities rose to $359.8 million as of September 30, 2025, compared to $299.4 million at the end of 2024[32] - The company’s accumulated deficit increased to $2.58 billion as of September 30, 2025, from $2.45 billion at the end of 2024[32] Guidance and Future Outlook - Zai Lab is revising total revenue guidance for the full year 2025 to at least $460 million[21] - The company anticipates continued revenue growth and aims to achieve profitability in the future, although specific timelines were not provided[27] Research and Development - Research and Development (R&D) expenses decreased to $47.9 million in Q3 2025 from $66.0 million in Q3 2024[12] - Zocilurtatug pelitecan (zoci) is entering pivotal development with a global registrational study initiated for second-line extensive-stage small cell lung cancer[4] - KarXT was included in China's national-level treatment guidelines for schizophrenia, with launch preparations underway[4] Product Performance - VYVGART and VYVGART Hytrulo generated $27.7 million in Q3 2025, reflecting a 4.6% quarter-over-quarter growth[12]

Core Insights - The annual adjustment of the National Medical Insurance (NMI) catalog has progressed, with negotiations for the 2025 NMI drug catalog and commercial insurance innovative drug catalog taking place from October 30 to November 3, involving 120 domestic and foreign companies [1] - The introduction of the commercial insurance innovative drug catalog is a significant highlight, marking its first establishment, with 141 submissions and 121 passing the preliminary review [1][2] - The NMI's focus is on "basic protection," which has led to high-value innovative drugs like CAR-T therapies not being included in the basic catalog, while the commercial insurance catalog aims to cover high-innovation drugs that exceed basic insurance limits [2] Group 1 - The NMI negotiations involved 127 drugs for the basic catalog and 24 for the commercial insurance catalog, with the new catalogs expected to be released in early December and implemented on January 1 [1] - The commercial insurance innovative drug catalog respects the market position of commercial insurance companies, differing from the NMI catalog adjustments [2] - Five CAR-T therapies are in the preliminary review for the commercial insurance catalog, indicating a growing acceptance of high-value therapies in the market [2][3] Group 2 - The support from commercial insurance for high-value innovative products like CAR-T therapies is seen as essential for risk-sharing among patients and promoting industry development [3] - There is a need for national involvement to enhance the role of commercial insurance in rare disease coverage, as profitability concerns may limit insurance companies' willingness to cover patients with pre-existing conditions [3] - The potential for innovative drugs included in both NMI and commercial insurance catalogs to experience rapid revenue growth is highlighted, benefiting patients and leading to increased flexibility for related companies [4]