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]

Group 1 - The article provides a list of companies scheduled for various corporate events on November 6, 2025, including shareholder meetings and earnings announcements [1][4]. - Companies mentioned include major players such as Jiesheng Electronics, Xiaoma Zhixing-W, and Wenyuan Zhixing-W, indicating a busy day for the Hong Kong stock market [5]. - The article highlights the significance of these events for investors, as they may impact stock performance and market sentiment [5]. Group 2 - Specific events listed include earnings announcements, dividend distributions, and stock rights issues for companies like Meilan Airport and Huasheng Holdings [5]. - The presence of multiple companies from various sectors suggests a diverse range of investment opportunities on that date [5]. - The article emphasizes the importance of monitoring these events for potential investment strategies and market movements [5].

Core Viewpoint - Zai Ding Pharmaceutical (09688) announced that its partner Amgen will stop the FORTITUDE-102 clinical trial due to insufficient efficacy based on interim analysis requested by the data monitoring committee [1] Group 1 - The FORTITUDE-102 trial was evaluating the combination of bemarituzumab with chemotherapy and nivolumab for first-line gastric cancer [1] - The announcement was made during Amgen's Q3 2025 earnings call on November 4, 2025 [1]

Core Viewpoint - The company Zai Lab (09688) announced that its partner Amgen will halt the FORTITUDE-102 clinical trial due to insufficient efficacy observed in a preliminary analysis mandated by the data monitoring committee [1] Group 1 - The FORTITUDE-102 trial was assessing the combination of bemarituzumab with chemotherapy and nivolumab for first-line gastric cancer treatment [1] - The announcement was made during Amgen's Q3 2025 earnings call scheduled for November 4, 2025 [1]

Zai Lab Limited 再鼎醫藥有限公司* 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。 本公司將繼續與安進公司密切合作，並在適當時提供進一步的更新。 承董事會命 再鼎醫藥有限公司 董事、董事長兼首席執行官 杜瑩 （於開曼群島註冊成立的有限公司） （股份代號：9688） 內幕消息 關於安進公司貝瑪妥珠單抗 1b/3 期臨床研究 FORTITUDE-102 的更新 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（「上市規則」）第 13.09(2)(a)條及香港法例第 571 章證券及期貨條例第 XIVA 部 項下內幕消息條文（定義見上市規則）而作出。 本公司的合作夥伴及該研究申辦方安進公司，於 2025 年 11 月 4 日在其 2025 年第三季 度財報發佈會期間宣佈，評估貝瑪妥珠單抗聯合化療及納武利尤單抗用於一線胃癌的 1b/3 期臨床研究 FORTITUDE-102，由於根據資料監查委員會的要求所做的 ...