Financial Performance & Profitability - Total revenues for 2Q'25 reached $110.0 million, a 9% increase year-over-year[56] - Adjusted loss from operations improved by 37% year-over-year, from $(54.485) million in 2Q'24 to $(34.187) million in 2Q'25[10, 86] - The company is on track to achieve profitability in 4Q'25, referring to adjusted income from operations[10, 18] - Cash position remains strong at $832.3 million as of June 30, 2025[10] Key Products & Pipeline Updates - VYVGART/VYVGART Hytrulo sales grew 14% year-over-year, reaching $26.5 million in 2Q'25, driven by increased market penetration and extension of DoT[56, 59] - ZL-1310 (DLL3 ADC) showed a 67% ORR in 2L SCLC across all doses and 79% ORR with 1.6 mg/kg (n=14)[42] - Bemarituzumab met the primary endpoint of overall survival in the global Ph3 FORTITUDE-101 study[10, 32] - KarXT's China NDA was accepted in January 2025, showing early and sustained reduction of positive and negative symptoms[26] Strategic Focus & Future Outlook - The company aims to unlock the blockbuster potential of VYVGART and VYVGART Hytrulo through execution excellence, targeting increased HCP coverage and supplemental insurance coverage[19, 20] - Multiple revenue inflections are expected through 2030, with an expected $2 billion revenue in 2028[18] - Zai Lab plans to initiate a global pivotal study of ZL-1310 in 2L ES-SCLC in 2H'25[15, 40]

Core Viewpoint - Zai Ding Pharma reported a total revenue of $110 million for Q2 2025, representing a year-on-year growth of 9.43%, and reaffirmed its full-year revenue guidance of $560 million to $590 million [1] Financial Performance - The operating loss for Q2 2025 was $54.9 million, a reduction of 28% year-on-year, while the adjusted operating loss narrowed by 37% to $34.2 million [1] - The net loss was $40.73 million, down 49.27% compared to the previous year [1] - As of June 30, 2025, the total cash and cash equivalents, short-term investments, and restricted cash amounted to $832.3 million [1] Revenue Drivers - Revenue growth in Q2 was primarily driven by increased sales of Efgartigimod, DaxibotulinumtoxinA, and Nuvaxovid, partially offset by a slowdown in sales of Zolbetuximab [1] - The product revenue for Efgartigimod in Q2 2025 was $26.5 million, up 46% from $18.1 million in Q1 2025, attributed to extended treatment duration and improved market penetration [1] - Zolbetuximab generated $41 million in product revenue for Q2 2025, down from $45 million in the same period of 2024, due to changes in competitive dynamics for PARPi products [1] - DaxibotulinumtoxinA, launched in Q4 2024, generated $4.6 million in product revenue for Q2 2025 [1] Research and Development Expenditure - R&D expenses for Q2 2025 were $50.6 million, down from $61.6 million in Q2 2024, mainly due to cost reductions from resource prioritization and efficiency measures [2] - Selling, general, and administrative expenses for Q2 2025 were $71 million, a decrease from $79.7 million in the same period of 2024, also attributed to cost-saving initiatives [2] Strategic Outlook - The company is entering a critical development phase focused on innovation, scalability, and efficient execution, with significant progress across various business areas [3] - The CEO highlighted the potential of ZL-1310 in treating second-line small cell lung cancer and the positive data for Bemarituzumab in first-line gastric cancer, reinforcing recent commercialization opportunities [3] - The company anticipates continued growth momentum for Efgartigimod, supported by updated treatment guidelines in China, and is preparing for the launch of several key products [3] - With a robust cash reserve and ongoing growth in commercial operations, the company is positioned to create long-term value for shareholders [3]

Core Viewpoint - Zai Ding Pharma reported a total revenue of $110 million for Q2 2025, reflecting a 9% year-over-year increase, and reaffirmed its full-year revenue guidance of $560 million to $590 million [1] Financial Performance - The operating loss for Q2 2025 was $54.9 million, a 28% year-over-year reduction, while the adjusted operating loss narrowed by 37% to $34.2 million [1] - The company is on track to achieve profitability by Q4 2025, supported by a solid cash reserve and growing commercialization efforts [3] Product Development and Pipeline - The usage of Efgartigimod reached record levels, bolstered by updated treatment guidelines for myasthenia gravis in China [1][3] - ZL-1310 (DLL3 ADC) demonstrated an objective response rate (ORR) of 67% across all dosage groups in a study for second-line extensive-stage small cell lung cancer, with a 79% ORR in the 1.6 mg/kg group [1] - The company plans to initiate a registrational clinical study for ZL-1310 in H2 2025 and is preparing for the global Phase 3 FORTITUDE-101 study of Bemarituzumab for FGFR2b overexpressing gastric cancer [1][2] Strategic Vision - The CEO emphasized that Zai Ding Pharma is entering a critical development phase focused on innovation, scalability, and efficient execution, with substantial progress across all business areas [2] - The company is preparing for the launch of multiple key products, including KarXT and Bemarituzumab, which are expected to drive the next growth phase alongside Efgartigimod and other multi-indication products [3]

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。 Zai Lab Limited 再鼎醫藥有限公司* （於開曼群島註冊成立的有限公司） （股份代號: 9688） 截至2025年6月30日止三個月及六個月的未經審計業績 以及公司進展 再鼎醫藥有限公司（「本公司」）謹此公佈根據美國證券交易委員會的適用規則刊發的本公 司及其附屬公司截至2025年6月30日止三個月及六個月的未經審計簡明合併業績（「2025年第 二季度業績」）以及近期產品亮點和公司進展與2025年和2026年上半年的預期重要里程碑事 件。 2025年第二季度業績乃根據有別於國際財務報告準則（「國際財務報告準則」）的美國公認 會計準則（「美國公認會計準則」）編製。 本公司預期於2025年8月31日或之前根據香港聯合交易所有限公司證券上市規則發佈截至2025 年6月30日止六個月的中期業績，其中將載有聲明，顯示根據美國公認會計準則及國際財務報 告準則報告的財務報表之間的任何重大差異的財務影響。 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 Commission File Number: 001-38205 FORM 10-Q ____________________ ____________________ (Mark One) ZAI LAB LIMITED x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ACT OF 1934 (Exact Name of Registrant as Specified in its Charter) ____________________ For the quarterly period ended June 30, 2025 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ACT OF 1934 For the transition period fr ...

[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) Zai Lab's leadership emphasized innovation, strong execution, and financial discipline, marked by Q2 2025 revenue growth and pipeline progress [CEO & COO Commentary](index=1&type=section&id=CEO%20%26%20COO%20Commentary) Dr. Samantha Du and Josh Smiley highlighted Zai Lab's pivotal period of innovation, scale, and strong execution, emphasizing patient impact, global innovation, and financial discipline - CEO emphasizes Zai Lab's pivotal period, marked by **innovation, scale, and strong execution**, with progress in patient impact, global innovation, and financial discipline[3](index=3&type=chunk) - COO highlights **VYVGART's record patient utilization** and strengthened role in MG treatment due to updated national guidelines, expecting momentum to accelerate in H2 2025[3](index=3&type=chunk) - COO projects **profitability by Q4 2025**, supported by a **28% YoY reduction in operating loss** (**37% adjusted**)[3](index=3&type=chunk) [Second Quarter 2025 Key Highlights](index=1&type=section&id=Second%20Quarter%202025%20Key%20Highlights) Zai Lab reported a 9% YoY total revenue growth to $110.0 million for Q2 2025, reaffirming full-year guidance, with VYVGART achieving record patient utilization and operating loss improving by 28% YoY Key Financial Highlights | Metric | Q2 2025 | YoY Growth | Full-Year 2025 Guidance | | :----- | :------ | :--------- | :---------------------- | | Total Revenues | $110.0 million | 9% | $560M - $590M | | Operating Loss | $54.9 million | (28)% | On track for profitability in Q4 2025 | | Adjusted Operating Loss | $34.2 million | (37)% | | - **VYVGART** reached **record patient utilization** in Q2 2025; updated national guidelines elevate its role as a treatment for both acute and maintenance gMG[4](index=4&type=chunk) - **ZL-1310 (DLL3 ADC)** data presented at ASCO 2025 showed a **67% ORR across all doses** (n=33) and **79% at 1.6mg/kg** (n=14) in 2L ES-SCLC, with a differentiated safety profile; registrational study to be initiated in H2 2025[4](index=4&type=chunk) - The global Phase 3 FORTITUDE-101 study of **bemarituzumab** met its primary endpoint of **overall survival** in first-line gastric cancer, with China regulatory submission expected in H2 2025[4](index=4&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Zai Lab's Q2 2025 revenues grew 9% to $110.0 million, significantly reducing operating and net losses, supported by product sales and expense efficiencies [Financial Results Overview](index=2&type=section&id=Financial%20Results%20Overview) Zai Lab's total revenues for Q2 2025 reached $109.977 million, a 9% increase from Q2 2024, primarily driven by product revenue, significantly reducing its loss from operations and net loss Consolidated Financial Summary | Metric | Q2 2025 (USD thousands) | Q2 2024 (USD thousands) | YoY Change (%) | | :---------------------- | :---------------------- | :---------------------- | :------------- | | Total Revenues | 109,977 | 100,504 | 9% | | Product Revenue, net | 109,085 | 100,106 | 9% (10% at CER) | | Collaboration Revenue | 892 | 398 | 124% | | Loss from Operations | (54,895) | (76,064) | (28)% | | Net Loss | (40,727) | (80,277) | (49.3%) | | Loss per share (basic & diluted) | (0.04) | (0.08) | (50%) | [Product Revenue Analysis](index=2&type=section&id=Product%20Revenue%20Analysis) Product revenue, net, grew 9% YoY to $109.1 million in Q2 2025, primarily driven by strong sales of VYVGART, XACDURO, and NUZYRA, while ZEJULA sales softened due to competitive dynamics Product Sales Performance | Product | Q2 2025 Sales (USD millions) | Q1 2025 Sales (USD millions) | Q2 2024 Sales (USD millions) | QoQ Growth (%) | YoY Growth (%) | | :------ | :--------------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | VYVGART & Hytrulo | $26.5 | $18.1 | N/A | 46% | N/A | | ZEJULA | $41.0 | N/A | $45.0 | N/A | (8.9)% | | XACDURO | $4.6 | N/A | N/A | N/A | N/A | | NUZYRA | $14.3 | N/A | $12.3 | N/A | 16.3% | - **VYVGART sales growth** was driven by extension of duration of therapy and increasing market penetration[7](index=7&type=chunk) - **ZEJULA sales were softer** due to evolving competitive dynamics within the PARPi class[7](index=7&type=chunk) [Operating Expenses and Profitability](index=2&type=section&id=Operating%20Expenses%20and%20Profitability) Operating expenses saw significant reductions in Q2 2025, with R&D decreasing by 17.9% YoY to $50.6 million and SG&A falling by 10.9% YoY to $71.0 million, leading to a 28% YoY improvement in GAAP loss from operations Operating Expenses Summary | Expense Category | Q2 2025 (USD thousands) | Q2 2024 (USD thousands) | YoY Change (%) | | :--------------- | :---------------------- | :---------------------- | :------------- | | R&D Expenses | (50,614) | (61,625) | (17.9)% | | SG&A Expenses | (71,038) | (79,710) | (10.9)% | | Loss from Operations (GAAP) | (54,895) | (76,064) | (28)% | | Adjusted Loss from Operations (Non-GAAP) | (34,187) | (54,485) | (37.2)% | - Decreases in R&D and SG&A expenses reflect reduced personnel and clinical trial costs, driven by ongoing resource prioritization and efficiency efforts[7](index=7&type=chunk) [Net Loss and Cash Position](index=2&type=section&id=Net%20Loss%20and%20Cash%20Position) Zai Lab's net loss for Q2 2025 significantly narrowed to $40.7 million, down from $80.3 million in Q2 2024, primarily due to product revenue growth outpacing net operating expenses, while maintaining a strong cash position Net Loss Performance | Metric | Q2 2025 (USD) | Q2 2024 (USD) | YoY Change | | :----- | :------ | :------ | :--------- | | Net Loss | $(40.7) million | $(80.3) million | (49.3)% | | Loss per Ordinary Share | $(0.04) | $(0.08) | (50)% | | Loss per ADS | $(0.37) | $(0.82) | (54.9)% | Cash Position | Cash Position (USD millions) | June 30, 2025 | March 31, 2025 | | :--------------------------- | :------------ | :------------- | | Cash & Cash Equivalents, Short-term Investments, Current Restricted Cash | $832.3 | $857.3 | [Non-GAAP Financial Measures](index=6&type=section&id=Non-GAAP%20Financial%20Measures) Zai Lab provides non-GAAP financial measures, including growth rates adjusted for constant exchange rates (CER) and adjusted loss from operations, to offer additional perspective on operational trends and greater transparency - Non-GAAP financial measures are used to provide an additional perspective on operational trends and greater transparency into historical and projected operating performance[26](index=26&type=chunk) Product Revenue and Loss from Operations (Non-GAAP) | Metric | Q2 2025 (USD thousands) | Q2 2024 (USD thousands) | As reported YoY Growth | At CER YoY Growth | | :---------------------- | :------ | :------ | :--------------------- | :---------------- | | Product revenue, net | $109,085 | $100,106 | 9% | 10% | | Loss from operations | $(54,895) | $(76,064) | (28)% | (28)% | Reconciliation of GAAP to Non-GAAP Loss from Operations | Metric | Q2 2025 (USD thousands) | Q2 2024 (USD thousands) | | :---------------------------------- | :---------------------- | :---------------------- | | GAAP loss from operations | (54,895) | (76,064) | | Plus: Depreciation and amortization expenses | 3,735 | 2,941 | | Plus: Share-based compensation | 16,973 | 18,638 | | Adjusted loss from operations (Non-GAAP) | (34,187) | (54,485) | [Condensed Consolidated Financial Statements](index=8&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Zai Lab Limited, including the Balance Sheets, Statements of Operations, and Statements of Comprehensive Loss for the specified periods - The unaudited condensed consolidated balance sheets provide a snapshot of assets, liabilities, and shareholders' equity as of June 30, 2025, and December 31, 2024[32](index=32&type=chunk) - The unaudited condensed consolidated statements of operations detail revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024[33](index=33&type=chunk) - The unaudited condensed consolidated statements of comprehensive loss present the net loss and other comprehensive income/loss, primarily foreign currency translation adjustments, for the three and six months ended June 30, 2025, and 2024[34](index=34&type=chunk) [Unaudited Condensed Consolidated Balance Sheets](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) This section presents Zai Lab's unaudited balance sheets, detailing assets, liabilities, and equity for June 30, 2025, and December 31, 2024 Balance Sheet Highlights | Metric (USD thousands) | June 30, 2025 | December 31, 2024 | Change | | :--------------------- | :------------ | :---------------- | :----- | | Total Assets | 1,164,101 | 1,185,753 | (21,652) | | Total Liabilities | 372,366 | 344,855 | 27,511 | | Total Shareholders' Equity | 791,735 | 840,898 | (49,163) | | Cash and cash equivalents | 732,159 | 449,667 | 282,492 | | Short-term investments | — | 330,000 | (330,000) | | Short-term debt | 174,509 | 131,711 | 42,798 | [Unaudited Condensed Consolidated Statements of Operations](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) This section outlines Zai Lab's unaudited statements of operations, detailing revenues, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Statements of Operations Summary | Metric (USD thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------- | :------ | :------ | :------ | :------ | | Total Revenues | 109,977 | 100,504 | 216,464 | 187,653 | | Loss from operations | (54,895) | (76,064) | (111,206) | (146,373) | | Net loss | (40,727) | (80,277) | (89,165) | (133,748) | | Loss per share - basic and diluted | (0.04) | (0.08) | (0.08) | (0.14) | [Unaudited Condensed Consolidated Statements of Comprehensive Loss](index=10&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) This section details Zai Lab's unaudited statements of comprehensive loss, presenting net loss and other comprehensive income/loss, including foreign currency adjustments, for the specified periods Statements of Comprehensive Loss Summary | Metric (USD thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------- | :------ | :------ | :------ | :------ | | Net loss | (40,727) | (80,277) | (89,165) | (133,748) | | Foreign currency translation adjustments | (2,955) | 3,605 | (4,167) | 5,147 | | Comprehensive loss | (43,682) | (76,672) | (93,332) | (128,601) | [Recent Pipeline Updates](index=2&type=section&id=Recent%20Pipeline%20Updates) Zai Lab reported significant advancements across its oncology, immunology, and neuroscience pipelines, with positive clinical data and new registrational study plans [Oncology Pipeline](index=2&type=section&id=Oncology%20Pipeline) Zai Lab reported significant advancements in its oncology pipeline, with ZL-1310 showing strong efficacy in SCLC, bemarituzumab meeting its primary OS endpoint in gastric cancer, and TTFields demonstrating OS benefit in pancreatic cancer [ZL-1310 (DLL3 ADC)](index=2&type=section&id=ZL-1310%20%28DLL3%20ADC%29) ZL-1310 (DLL3 ADC) showed strong efficacy (67% ORR) and a well-tolerated safety profile in 2L ES-SCLC, receiving U.S. FDA Fast Track designation - **ZL-1310** demonstrated an objective response rate (**ORR**) of **67% across all dose levels** (n=33) and **79% at 1.6 mg/kg** (n=14) in second-line extensive-stage small cell lung cancer (ES-SCLC)[8](index=8&type=chunk) - **ZL-1310** exhibited a **well-tolerated safety profile** with **6% Grade ≥3 treatment-related adverse events (TRAEs)** and no drug discontinuations[8](index=8&type=chunk) - The U.S. FDA granted **Fast Track designation** to ZL-1310 for treatment of ES-SCLC in May 2025[8](index=8&type=chunk) [Bemarituzumab (FGFR2b)](index=3&type=section&id=Bemarituzumab%20%28FGFR2b%29) Bemarituzumab (FGFR2b) plus chemotherapy met its primary OS endpoint in Phase 3 FORTITUDE-101 for first-line gastric cancer, with China submission planned for H2 2025 - The Phase 3 FORTITUDE-101 clinical trial evaluating first-line **bemarituzumab plus chemotherapy** met its primary endpoint of **overall survival (OS)** at a pre-specified interim analysis[11](index=11&type=chunk) - **Bemarituzumab plus chemotherapy significantly improved OS** in patients with FGFR2b overexpression compared to chemotherapy alone[11](index=11&type=chunk) - Zai Lab plans to move rapidly toward **regulatory submission in China in the second half of 2025** for bemarituzumab[11](index=11&type=chunk) [Tumor Treating Fields (TTFields)](index=3&type=section&id=Tumor%20Treating%20Fields%20%28TTFields%29) Tumor Treating Fields (TTFields) therapy showed OS benefit and improved quality of life in pancreatic cancer, with China regulatory filing planned for H2 2025 - Phase 3 PANOVA-3 trial data demonstrated that **TTFields therapy**, when added to standard of care, achieved an **OS benefit** supported by significantly improved quality of life and extended pain-free survival in pancreatic cancer[11](index=11&type=chunk) - Zai Lab plans to file for **regulatory approval in China in the second half of 2025** for TTFields in first-line pancreatic cancer[11](index=11&type=chunk) [ZL-6201 (LRRC15 ADC)](index=4&type=section&id=ZL-6201%20%28LRRC15%20ADC%29) ZL-6201 (LRRC15 ADC) is advancing into global Phase 1 development, targeting sarcoma and other LRRC15-positive solid tumors - Zai Lab is advancing **ZL-6201 (LRRC15 ADC)** into **global Phase 1 development**[13](index=13&type=chunk) - **ZL-6201** targets patients with sarcoma and potentially other LRRC15-positive solid tumors, such as breast cancer and other malignancies[13](index=13&type=chunk) [Immunology Pipeline](index=3&type=section&id=Immunology%20Pipeline) The immunology pipeline saw updates for Efgartigimod, with new China MG guidelines emphasizing its role, ZL-1503 showing promising preclinical data, and Povetacicept and VRDN-003 advancing to pivotal/registrational studies [Efgartigimod (FcRn)](index=3&type=section&id=Efgartigimod%20%28FcRn%29) China MG guidelines (2025) recommend VYVGART (efgartigimod) for early and sustained long-term treatment in myasthenia gravis, targeting Minimal Symptom Expression - The China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (MG) (2025) were published in July 2025, emphasizing **Minimal Symptom Expression (MSE)** as the primary treatment goal[11](index=11&type=chunk) - **VYVGART (efgartigimod)** is now recommended for **early use in mild-to-moderate and highly active MG patients** and for sustained long-term treatment[11](index=11&type=chunk) [ZL-1503 (IL-13/IL-31R)](index=3&type=section&id=ZL-1503%20%28IL-13%2FIL-31R%29) ZL-1503 showed promising preclinical data for moderate-to-severe atopic dermatitis, supporting global Phase 1 advancement in H2 2025 with favorable safety - New preclinical data for **ZL-1503** highlights its potential as a promising treatment for **moderate-to-severe atopic dermatitis** and other IL-13 and IL-31-driven diseases[11](index=11&type=chunk) - **ZL-1503's favorable preclinical safety profile**, prolonged half-life, and durable suppression of inflammatory and pruritogenic pathways support its continued advancement[11](index=11&type=chunk) - Zai Lab plans to advance **ZL-1503 into a global Phase 1 study** in moderate-to-severe atopic dermatitis in the second half of 2025[12](index=12&type=chunk) [Povetacicept (APRIL/BAFF)](index=4&type=section&id=Povetacicept%20%28APRIL%2FBAFF%29) Zai Lab will partner with Vertex to initiate a global pivotal Phase 2/3 study of povetacicept in pMN in Greater China in H2 2025 - Zai Lab plans to partner with Vertex to execute the **global pivotal Phase 2/3 study of povetacicept in Primary Membranous Nephropathy (pMN)** in Greater China[17](index=17&type=chunk) - The **povetacicept study in pMN** is expected to start in the second half of 2025[17](index=17&type=chunk) [VRDN-003 (IGF-1R, subcutaneous)](index=5&type=section&id=VRDN-003%20%28IGF-1R%2C%20subcutaneous%29) Zai Lab will initiate a registrational study for VRDN-003 in thyroid eye disease in Greater China in H2 2025, with global results expected in H1 2026 - Zai Lab will initiate a **registrational study for VRDN-003 in thyroid eye disease** in Greater China in the second half of 2025[21](index=21&type=chunk) - Partner Viridian is expected to provide **topline results from the global registrational REVEAL-1 and REVEAL-2 studies in the first half of 2026**[21](index=21&type=chunk) [Neuroscience Pipeline](index=4&type=section&id=Neuroscience%20Pipeline) In the neuroscience pipeline, Zai Lab's partner Bristol Myers Squibb is expected to provide data readout from the Phase 3 ADEPT-2 study of Xanomeline-Trospium (KarXT) in Alzheimer's Disease Psychosis in H2 2025 [Xanomeline-Trospium (KarXT)](index=4&type=section&id=Xanomeline-Trospium%20%28KarXT%29) Zai Lab's partner Bristol Myers Squibb expects data readout from the Phase 3 ADEPT-2 study of KarXT in Alzheimer's Disease Psychosis in H2 2025 - Zai Lab partner Bristol Myers Squibb to provide **data readout from the Phase 3 ADEPT-2 study of KarXT in Alzheimer's Disease Psychosis** in the second half of 2025[15](index=15&type=chunk) [Anticipated Major Milestones (2025 & H1 2026)](index=3&type=section&id=Anticipated%20Major%20Milestones%20%282025%20%26%20H1%202026%29) Zai Lab anticipates multiple NMPA submissions and approvals, alongside key clinical developments and data readouts across its pipelines through H1 2026 [Upcoming Potential NMPA Submissions](index=3&type=section&id=Upcoming%20Potential%20NMPA%20Submissions) Zai Lab plans to submit for NMPA approval in H2 2025 for bemarituzumab in first-line gastric cancer, Tumor Treating Fields in first-line pancreatic cancer, and efgartigimod (prefilled syringe) for gMG and CIDP - **NMPA submission for Bemarituzumab (FGFR2b)** in first-line gastric cancer in H2 2025[11](index=11&type=chunk) - **NMPA submission for Tumor Treating Fields (TTFields)** in first-line pancreatic cancer in H2 2025[11](index=11&type=chunk) - **NMPA submission for Efgartigimod (FcRn)** for prefilled syringe in gMG and CIDP in H2 2025[11](index=11&type=chunk) [Upcoming Potential NMPA Approvals](index=3&type=section&id=Upcoming%20Potential%20NMPA%20Approvals) Zai Lab expects potential NMPA approvals for Xanomeline-Trospium (KarXT) in schizophrenia, Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer, and Repotrectinib (ROS1/TRK) in NTRK+ solid tumors - Potential **NMPA approval for Xanomeline-Trospium (KarXT)** in schizophrenia[11](index=11&type=chunk) - Potential **NMPA approval for Tisotumab Vedotin (Tissue Factor ADC)** in recurrent or metastatic cervical cancer following progression on or after chemotherapy[11](index=11&type=chunk) - Potential **NMPA approval for Repotrectinib (ROS1/TRK)** in NTRK+ solid tumors[11](index=11&type=chunk) [Expected Clinical Developments and Data Readouts](index=4&type=section&id=Expected%20Clinical%20Developments%20and%20Data%20Readouts) Key clinical developments include initiating a global registrational study for ZL-1310 in 2L ES-SCLC and a global Phase 1 study for ZL-1503 in atopic dermatitis in H2 2025, with various data readouts expected across the pipeline - **ZL-1310**: Global registrational study of monotherapy in 2L ES-SCLC to be initiated in H2 2025; data readout for dose escalation of doublet in combination with atezolizumab in 1L ES-SCLC[18](index=18&type=chunk) - **ZL-1503**: Global Phase 1 study in moderate-to-severe atopic dermatitis to advance in H2 2025[12](index=12&type=chunk) - **Bemarituzumab**: Detailed results from Phase 3 FORTITUDE-101 study and potential data readout from Phase 1b/3 FORTITUDE-102 study in first-line gastric cancer[19](index=19&type=chunk) - **Efgartigimod**: Topline results from Phase 2 study in Lupus Nephritis (Q4 2025), Phase 3 ADAPT-SERON study in seronegative gMG (H2 2025), and Phase 3 ADAPT-OCULUS study in ocular myasthenia gravis (H1 2026)[19](index=19&type=chunk) - **Povetacicept**: Global pivotal Phase 2/3 study in Primary Membranous Nephropathy (pMN) in Greater China expected to start in H2 2025[17](index=17&type=chunk) - **VRDN-003**: Registrational study in thyroid eye disease in Greater China to be initiated in H2 2025; topline results from global registrational REVEAL-1 and REVEAL-2 studies in H1 2026[21](index=21&type=chunk) - **KarXT**: Data readout from Phase 3 ADEPT-2 study in Alzheimer's Disease Psychosis in H2 2025[15](index=15&type=chunk) - **IgA Nephropathy (IgAN)**: Interim analysis of global Phase 3 RAINIER study following 36 weeks of treatment with potential for U.S. accelerated approval filing in H1 2026[20](index=20&type=chunk) [Additional Company Information](index=6&type=section&id=Additional%20Company%20Information) This section provides details on Zai Lab's conference call, company overview, non-GAAP measures, forward-looking statements, and investor/media contacts [Conference Call and Webcast](index=6&type=section&id=Conference%20Call%20and%20Webcast) Zai Lab hosted a live conference call and webcast on August 7, 2025, to discuss financial results and corporate updates, with a replay available on the company's website - Conference call and webcast held on **August 7, 2025, at 8:00 a.m. ET (8:00 p.m. HKT)**[2](index=2&type=chunk) - Access to live webcast via http://ir.zailaboratory.com; registration required for dial-in[22](index=22&type=chunk)[28](index=28&type=chunk) [About Zai Lab](index=6&type=section&id=About%20Zai%20Lab) Zai Lab Limited is an innovative, research-based, commercial-stage biopharmaceutical company operating in China and the United States, focused on developing and commercializing innovative products for unmet medical needs - Zai Lab is an **innovative, research-based, commercial-stage biopharmaceutical company** based in China and the United States[24](index=24&type=chunk) - Focus areas include **oncology, immunology, neuroscience, and infectious disease**, addressing significant unmet medical needs[24](index=24&type=chunk) [Non-GAAP Measures Definition](index=6&type=section&id=Non-GAAP%20Measures%20Definition) Zai Lab uses non-GAAP financial measures, such as constant exchange rate (CER) adjusted growth rates and adjusted loss from operations, to provide a clearer understanding of business performance and operational trends - Non-GAAP measures include **growth rates adjusted for constant exchange rates (CER)** and **adjusted loss from operations**[26](index=26&type=chunk) - **Adjusted loss from operations excludes depreciation, amortization, and share-based compensation**[26](index=26&type=chunk) - These measures provide additional perspective on operational trends and greater transparency but should not be considered an exclusive alternative to GAAP[26](index=26&type=chunk) [Forward-Looking Statements & Disclaimers](index=6&type=section&id=Forward-Looking%20Statements%20%26%20Disclaimers) The press release contains forward-looking statements regarding Zai Lab's strategy, pipeline potential, commercialization, financial guidance, and future results, which are subject to inherent uncertainties and risks - The press release contains **forward-looking statements** relating to Zai Lab's strategy, plans, potential of its business, commercial products, and pipeline programs, including revenue growth and profitability[27](index=27&type=chunk) - Forward-looking statements are subject to **inherent uncertainties, risks, and changes in circumstances** that may differ materially from those contemplated[27](index=27&type=chunk)[29](index=29&type=chunk) - Investors should not place undue reliance on these statements, and the company undertakes no obligation to update or revise them, except as may be required by law[29](index=29&type=chunk) [Investor & Media Contacts](index=7&type=section&id=Investor%20%26%20Media%20Contacts) Contact information for Zai Lab's Investor Relations and Media teams is provided for further inquiries - Investor Relations contacts: Christine Chiou / Lina Zhang[31](index=31&type=chunk) - Media contacts: Shaun Maccoun / Xiaoyu Chen[31](index=31&type=chunk)

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 | | | 致：香港交易及結算所有限公司 公司名稱: 再鼎醫藥有限公司 呈交日期: 2025年8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 | USD | | 30,000 | 本月底法定/註冊股本總額： USD 30,000 FF ...

Core Insights - Adidas reported a 7% year-on-year revenue growth for FY2025H1, reaching €12.105 billion, with a net profit increase of 121% to €798 million [4] - The brand's revenue growth was 14% on a currency-neutral basis, with all regional markets achieving double-digit growth [4] - The company maintains its full-year guidance, expecting high single-digit revenue growth on a currency-neutral basis for FY2025, with double-digit growth for the Adidas brand [4] Market Trends - The domestic market indices showed positive performance, with the Shanghai Composite Index closing at 3,617.60, up 0.96% [3] - The textile and apparel sector experienced a decline of 2.14% this week, underperforming the broader market [5] - Retail sales of sports and entertainment products grew significantly, with a 22.2% year-on-year increase in the first half of 2025 [5] Industry Dynamics - The Chinese gold consumption in the first half of 2025 was 505.205 tons, a decrease of 3.54% year-on-year, with jewelry consumption dropping by 26% [5] - The pharmaceutical industry is seeing advancements in innovative drugs, particularly in obesity treatments with GLP-1 and Amylin therapies showing promising results in clinical trials [8][11] - In the biopharmaceutical sector, ADC drugs for lung cancer are demonstrating significant efficacy, with several products showing improved outcomes in clinical trials [10][12]

作者：行情君 资料显示，再鼎医药有限公司是一家以患者为中心的、处于商业化阶段的创新型全球生物制药公司,立 足中国、全球运营,致力于为中国及全球的患者提供针对肿瘤、自身免疫性疾病、感染性疾病和中枢神 经系统疾病的同类最优和同类首创药物。公司的使命是成为全球领先的生物制药公司,为中国和世界各 地的患者提供变革性创新药物。再鼎医药的长期目标是成为全球领先的生物制药公司,以中国为基,为全 球患者提供创新疗法。 本文源自：金融界 8月5日，再鼎医药(ZLAB)开盘上涨2.8%，截至21:30，报39.115美元/股，成交67.58万美元，总市值 43.45亿美元。 大事提醒： 财务数据显示，截至2025年03月31日，再鼎医药收入总额1.06亿美元，同比增长22.19%；归母净利 润-4843.8万美元，同比增长9.41%。 8月7日，再鼎医药将于(美东)盘前披露2025财年中报（数据来源于纳斯达克官网，预计披露日期为美国 当地时间，实际披露日期以公司公告为准）。 ...

Group 1 - The Hong Kong biotechnology stocks collectively rose, with notable increases in several companies' stock prices [1][2] - Beihai Kangcheng-B saw a rise of nearly 19%, while other companies like Gilead Sciences-B and Ascentage Pharma-B also experienced significant gains of over 15% and 9% respectively [1][2] - The overall trend indicates a positive sentiment in the biotechnology sector, with multiple companies achieving gains of over 5% [1][2] Group 2 - Specific stock performance includes: Beihai Kangcheng-B at 18.99% increase, Gilead Sciences-B at 15.30%, and Ascentage Pharma-B at 9.48% [2] - The market capitalization of these companies varies significantly, with Gilead Sciences-B at approximately 11.477 billion and Ascentage Pharma-B at about 29.86 billion [2] - Other notable performers include Jiahua Bio-B and Beikang Medical-B, both showing increases of over 7% [1][2]