Group 1 - The joint statement from the China-US Geneva trade talks led to a significant rise in global risk assets, with the Hang Seng Index gaining nearly 700 points [1] - The Hang Seng Technology Index increased by 5.16%, while the Hang Seng Index and the National Enterprises Index rose by 2.98% and 3.01%, respectively [2] - Major technology stocks surged, with JD.com and Alibaba both rising over 6%, and financial stocks also performed well [2][4] Group 2 - The technology sector saw substantial gains, with stocks like Bilibili, JD.com, Kuaishou, and Alibaba all increasing by over 6% [4] - Apple-related stocks experienced a significant boost, with companies like GoerTek and AAC Technologies rising by over 18% and 15%, respectively, following price adjustments for iPhone models [5][6] - Financial stocks, particularly Chinese brokerage firms, showed strong performance, with China International Capital Corporation rising over 7% [7] Group 3 - Shipping stocks also saw notable increases, with China COSCO Shipping Holdings rising over 8% [8] - Conversely, gold stocks faced sharp declines, with Lingbao Gold and Chifeng Jilong Gold dropping over 11% due to reduced safe-haven demand following the easing of US-China trade tensions [9] - Biopharmaceutical stocks fell, with companies like BeiGene and CanSino Biologics experiencing declines of over 8% and 5%, respectively, due to announcements regarding drug price reductions in the US [10] Group 4 - Southbound capital saw a net sell-off of HKD 18.528 billion, indicating a cautious sentiment among investors [11] - Morgan Stanley expressed optimism about the progress in trade negotiations, leading hedge funds to increase their long positions in Chinese stocks [12]

Investment Rating - The investment rating for the biopharmaceutical industry is "Positive" (maintained) [2] Core Insights - The report highlights the aggressive nature of small cell lung cancer (SCLC), with extensive stage SCLC accounting for approximately 75% of cases, which often rely on systemic treatment and have a poor prognosis [6][21] - The first-line treatment for extensive stage SCLC primarily involves PD-1/PD-L1 immunotherapy combined with doublet chemotherapy, while there are limited approved drugs for later-line treatments, indicating a significant unmet clinical need [24][30] - The report identifies three key areas of focus for research and development in the SCLC field: Antibody-Drug Conjugates (ADC), DLL3 T-cell engagers (TCE), and next-generation immune-oncology (IO) therapies [30][34] Summary by Sections 1. SCLC Overview - SCLC accounts for about 15%-20% of all lung cancer cases, with a high incidence of early metastasis [18][19] - The majority of SCLC cases are extensive stage, which has a poor prognosis and relies heavily on systemic therapies [21][22] 2. Treatment Landscape - The standard treatment for extensive stage SCLC has been established as a combination of chemotherapy and PD-1/PD-L1 immunotherapy, but the overall prognosis remains poor [24][25] - The NCCN and CSCO guidelines recommend various treatment options, including the recent inclusion of Tarlatamab as a preferred second-line treatment [28][29] 3. Research and Development Focus - ADCs are rapidly advancing in the SCLC field, targeting multiple hot spots such as B7-H3, DLL3, and TROP-2, with no ADC products currently approved for SCLC [37][38] - DLL3 TCEs, particularly Tarlatamab, have shown promising early data and are expected to reshape the treatment landscape for SCLC [30][31] - Next-generation IO therapies are being developed to challenge the current PD-L1 standard in first-line SCLC treatment [8][36] 4. Investment Recommendations - The report suggests that companies with strong pipelines in the SCLC space, such as Zai Lab, Zai Lab-U, Innovent Biologics, and others, are likely to benefit from the anticipated growth in the market as new data emerges [9]

Summary of the Conference Call for Zai Lab Company Overview - **Company**: Zai Lab - **Date**: May 9, 2025 Key Points Industry and Market Performance - Zai Lab's core product, Efgartigimod, experienced strong sales growth in its first year after entering the medical insurance system, despite seasonal impacts in Q1 2025. Patient numbers rebounded significantly in March and April, leading to confidence in annual sales projections [2][4][16] - The company anticipates total revenue for 2025 to reach between $560 million and $590 million, with profitability expected in Q4 2025. By 2028, revenue is projected to exceed $2 billion, continuing to grow into 2030 [2][5] Product Pipeline and Development - The core product GL1,310 (DLD-ADC) is expected to accelerate approval in the U.S. by 2027, with a key clinical study for small cell lung cancer set to launch soon, and data to be presented at the ASCO conference [2][6] - Efgartigimod's market penetration is increasing, with new guidelines recommending its use for patients with myasthenia gravis. The Chinese guidelines for myasthenia gravis are expected to be updated mid-year, indicating significant market potential [2][7] - The launch of Dovato will address the treatment gap for approximately 300,000 cases of Acinetobacter baumannii infections in China, and the company plans to expand Efgartigimod's applications in other conditions [2][9] Financial Performance - In Q1 2025, Zai Lab reported a total revenue increase of 22% year-over-year, reaching $106.5 million. The number of products launched in Greater China increased to 8, up from 5 in the previous year [4] - The company reduced its operational loss by 20% year-over-year in Q1, with adjusted operational loss improving by 25%, setting a solid foundation for achieving profitability in Q4 [11][15] Research and Development - Zai Lab is advancing multiple global R&D projects, including GL1,310, which has shown promising preliminary data in previous conferences. The company plans to initiate a global pivotal clinical study for small cell lung cancer later this year [6][12] - Other important products, such as Zejula and Nuzyra, have also shown strong performance, with Dovato receiving positive feedback from doctors and patients [8] Strategic Initiatives - The company is focused on maintaining prudent financial expenditures, with R&D and SGA expenses significantly decreasing as operational efficiency improves [10] - Zai Lab is actively pursuing insurance negotiations to expand market coverage and enhance patient access to Efgartigimod, aiming to cover 85% of the GMS market potential hospitals [16][22] Competitive Landscape - The introduction of more biologics in the market is seen as beneficial for patients, providing more treatment options and enhancing the long-term use of biologics. Zai Lab is confident in Efgartigimod's market share due to its efficacy and safety profile [21] Future Outlook - Key upcoming catalysts include data updates at ASCO, pivotal clinical data for bemarituzumab in gastric cancer, and ongoing preparations for insurance negotiations [17] - The company is optimistic about the impact of geopolitical factors on its business, believing that current tariff policies will not significantly affect operations [18][19] Conclusion - Zai Lab is positioned for significant growth with a robust product pipeline, strong financial management, and strategic initiatives aimed at expanding market presence and enhancing patient access to innovative therapies [35][36]

Policy Developments - The National Health Commission released the "Guidelines for the Construction and Management of Geriatric Medicine Departments (2025 Edition)", requiring that secondary and higher-level hospitals establish geriatric medicine departments with specific standards for bed allocation and service models [2] Drug and Device Approvals - Roche announced that its innovative bispecific antibody Glofitamab has received approval from the National Medical Products Administration for a new indication to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma [4] - Heng Rui Pharma's application for the CDK4/6 inhibitor Darsylis has been accepted by the National Medical Products Administration for use in early or locally advanced breast cancer [5] - Boehringer Ingelheim's drug Niramolast is proposed for priority review for the treatment of progressive pulmonary fibrosis, showcasing its dual anti-fibrotic and anti-inflammatory effects [6] Financial Data - Zai Lab reported a total revenue of $106.5 million for Q1 2025, a 22% year-over-year increase, and reaffirmed its full-year revenue guidance of $560 million to $590 million [8] - BeiGene achieved a revenue of 8.048 billion yuan in Q1 2025, marking a 50.2% year-over-year growth, driven by strong sales of its core self-developed products [9] Industry Developments - Roche is investing 2.04 billion yuan in a new biopharmaceutical production base in Shanghai, which will focus on the localized production of innovative drugs and is expected to be completed by 2029 [11] - AstraZeneca and Daiichi Sankyo announced positive results from the DESTINY-Breast11 Phase 3 trial for their antibody-drug conjugate Enhertu, demonstrating significant clinical benefits in early breast cancer treatment [12]

Financial Data and Key Metrics Changes - Total revenue grew 22% year over year to $106.5 million in Q1 2025, driven by increased sales for VivGuard, Zejula, and NUZYRA [29][30] - Operating loss improved by 20% to $56.3 million, and adjusted loss from operations decreased by 25% to $37.1 million [16][30] - The company reaffirmed its full-year revenue guidance of $560 million to $590 million, anticipating significant sales growth in the latter part of the year [8][30] Business Line Data and Key Metrics Changes - VivGuard sales are expected to grow faster than total revenue growth, with a rebound in patient volumes observed in March and April after a seasonal decline [12][36] - Other products, including Zejula and NUZYRA, delivered sequential growth supported by NRDL access, with early contributions from OGTYRO and ZACDURO [15] - The company is preparing for upcoming NRDL cycles targeting IV renewal for gMG and initial listing of the SC formulation [14] Market Data and Key Metrics Changes - The company noted a significant opportunity in the gMG market in China, with approximately 70,000 patients, and less than 10% currently receiving newer biologic therapies [63] - The competitive landscape for gMG is expected to benefit from the introduction of new therapies, which will enhance overall market education and treatment options [63] Company Strategy and Development Direction - The company aims to expand its global R&D pipeline, with a focus on differentiated and high-potential assets, including GL1310 and other novel therapies [9][10] - Investments are being made to accelerate the global R&D pipeline, with plans to present updated Phase I data at ASCO [10][20] - The company is committed to achieving profitability by Q4 2025, leveraging operational efficiencies and a robust late-stage opportunity pipeline [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets and surpassing $2 billion by 2028, with strong momentum expected to carry into the 2030s [9] - The management team highlighted the importance of strategic initiatives to extend treatment duration and improve patient access [12][14] - The company remains optimistic about its financial position, ending Q1 with a cash position of $857.3 million [31] Other Important Information - The company is advancing its internal pipeline while also considering external opportunities for in-licensing [102][103] - Regulatory discussions with the FDA are ongoing, with no significant changes noted in the approval process despite recent leadership changes at the FDA [53][105] Q&A Session Summary Question: Can you provide more color on VIBGART's sequential change? - Management indicated that the sequential decline was influenced by seasonality and inventory dynamics, with confidence in recovery based on strong patient volumes in April [33][36] Question: Are you comfortable with consensus estimates for VIBGART and fiscal year revenues? - Management reaffirmed their revenue guidance and expressed confidence that VIBGART sales would grow faster than overall business rates [42][44] Question: How do recent FDA changes impact Zai Lab? - Management noted no anticipated impact from tariffs and indicated that FDA interactions have remained productive [50][53] Question: What is the competitive landscape for gMG in China? - Management believes that new approvals will benefit the market and enhance treatment options for patients [63] Question: What is the strategy regarding in-house developed assets? - The company plans to maintain a balanced approach between in-house development and external licensing opportunities [102][103]

Financial Data and Key Metrics Changes - Total revenue grew 22% year over year to $106.5 million in Q1 2025, driven by increased sales for VivGuard, Zejula, and NUZYRA [27] - Operating loss improved by 20% to $56.3 million, and adjusted loss from operations decreased by 25% to $37.1 million, reflecting operational efficiency [15][27] - The company reaffirmed its full-year revenue guidance of $560 million to $590 million, anticipating significant sales growth in the latter part of the year [6][28] Business Line Data and Key Metrics Changes - VivGuard sales are expected to grow faster than total revenue growth, with a rebound in patient volumes observed in March and April after a seasonal decline [11][12] - Other products, including Zejula and NUZYRA, showed sequential growth supported by NRDL access, with early contributions from newly launched products like OGTYRO and ZACDURO [14] - The company is preparing for the upcoming NRDL cycle targeting IV renewal for gMG and initial listing of the SC formulation, effective January 1, 2026 [12] Market Data and Key Metrics Changes - The company noted a significant opportunity in the gMG market in China, with approximately 70,000 patients, and less than 10% currently receiving newer biologic therapies [60] - The competitive landscape for gMG is expected to benefit from the introduction of new therapies, which will enhance overall market education and treatment options [60] Company Strategy and Development Direction - The company aims to expand its global R&D pipeline, with a focus on innovative therapies and maintaining a balanced approach between in-house development and business development opportunities [8][100] - Investments are being made to accelerate the global R&D pipeline, with a commitment to advancing at least one global product to IND submission stage every year [23] - The company is focused on achieving profitability by Q4 2025, leveraging operational efficiencies and a robust late-stage pipeline [15][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability by Q4 2025, citing strong business fundamentals and strategic direction [6][27] - The company anticipates accelerating sales growth in the next three quarters, which will translate into significant operating leverage [6] - Management highlighted the importance of new product launches and regulatory approvals in driving future growth [15][28] Other Important Information - The company ended the quarter with a strong cash position of $857.3 million, providing a solid foundation for future investments and growth initiatives [29] - The company is actively pursuing regulatory reviews for multiple products, including CAR XT for schizophrenia and TIVDAC for cervical cancer [15] Q&A Session Summary Question: Can you describe the sequential change in VIBGART sales? - Management indicated that the sequential decline was influenced by seasonal trends and inventory dynamics, with a strong recovery in patient volumes observed in March and April [31][32] Question: Are you comfortable with the current consensus for VIBGART and fiscal year revenues? - Management reaffirmed confidence in the revenue guidance range of $560 million to $590 million, indicating that VIBGART sales are expected to grow faster than overall sales growth [41] Question: How do recent FDA changes and tariffs impact Zai Lab? - Management noted no anticipated impact from tariffs, as local manufacturing is in place for many products, and FDA interactions have remained productive [46][50] Question: What is the competitive landscape for gMG in China? - Management expressed optimism about the competitive dynamics, stating that new approvals will benefit the overall market and enhance treatment options for patients [60] Question: What is the strategy regarding in-house developed assets versus in-licensing? - Management indicated a balanced approach, continuing to pursue both in-house development and high-quality external opportunities [100]

Financial Performance & Targets - Zai Lab reported a 22% year-over-year increase in total revenues for 1Q'25, reaching $106.5 million[8][44] - The company is targeting profitability in 4Q'25[13][41][48][53][54][75] - Zai Lab anticipates total revenue between $560 million and $590 million[41] - As of March 31, 2025, Zai Lab's cash position was strong at $857.3 million, compared to $879.7 million as of December 31, 2024[9][10][42][76] Key Product Performance & Pipeline Updates - VYVGART/VYVGART Hytrulo sales increased by 38% year-over-year in 1Q'25, reaching $18.1 million[44] - NUZYRA sales increased by 53% year-over-year in 1Q'25, reaching $15.1 million[44] - ZEJULA maintained its position as the leading PARP inhibitor in hospital sales for ovarian cancer[47] - Two NDAs, KarXT for schizophrenia and TIVDAK for cervical cancer, are under NMPA review[7] - ZL-1310 (DLL3 ADC) is progressing rapidly, with updated data to be presented at ASCO and a pivotal trial to be initiated in 2H'25[7][35][56][70] Strategic Focus & Pipeline Expansion - The company aims to generate at least 1-2 INDs per year[40] - Zai Lab is expanding its immunology franchise with Povetacicept (APRIL/BAFF) and VRDN-003 (IGF-1R)[7] - The company is preparing for potential launches of KarXT and bemarituzumab[19][67][72] - Zai Lab is planning local manufacturing for key products like KarXT and bemarituzumab[19][28]

Core Insights - The company reported total revenue of $106 million for Q1 2025, representing a year-over-year increase of 22% [1] - Product revenue netted $106 million, showing a year-over-year growth of 21% [1] - Operating loss was $56.3 million, a decrease of 20% compared to the previous year, while adjusted operating loss was $37.1 million, down 25% year-over-year [1] - As of March 31, 2025, the company had cash reserves of $857 million [1] - The company projects full-year revenue guidance for 2025 to be between $560 million and $590 million [1]

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3月31日止三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3月31日止三個月的未經審計簡明合併業績 （「2025年第一季度業績」）以及近期產品亮點和公司進展與2025年的預期重要里 程碑事件。2025年第一季度業績乃根據有別於國際財務報告準則的美國公認會計準 則編製。 承董事會命 再鼎醫藥有限公司 董事長兼首席執行官 杜瑩 香港，2025年5月8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. Morrison 先生、 Leon O. ...

Revenue Performance - Net product revenue for Q1 2025 was $105.7 million, a 21% increase compared to Q1 2024, driven by higher sales of NUZYRA, VYVGART, and ZEJULA[82]. - Total revenues for Q1 2025 were $106.5 million, up 22% from $87.1 million in Q1 2024[93]. - ZEJULA generated $49.5 million in revenue, a 9% increase; VYVGART / VYVGART Hytrulo revenue rose by 38% to $18.1 million; NUZYRA saw a 53% increase to $15.1 million[94]. Expenses - Research and development expenses increased by 11% to $60.7 million in Q1 2025, primarily due to licensing fees of $20.0 million[99]. - Selling, general, and administrative expenses decreased by 8% to $63.4 million in Q1 2025[93]. - Clinical program expenses rose by $9.3 million to $28.1 million, a 50% increase year-over-year, driven by a $20.0 million increase in licensing fees[100]. - Selling, general, and administrative expenses decreased by $5.8 million to $63.4 million, an 8% decline from Q1 2024, primarily due to a $5.3 million reduction in personnel compensation[103]. Net Loss - The net loss for Q1 2025 was $48.4 million, a 9% improvement from a net loss of $53.5 million in Q1 2024[93]. - Net loss for Q1 2025 was $48.4 million, or a loss per ordinary share of $0.04, compared to a net loss of $53.5 million in Q1 2024[109]. Cash Flow and Financial Position - Net cash used in operating activities decreased by $28.4 million to $61.7 million in Q1 2025, reflecting improved operational efficiency[128]. - Net cash provided by investing activities surged by $322.8 million to $326.1 million, mainly due to $313.7 million from the maturity of short-term investments[130]. - As of March 31, 2025, the company had cash and cash equivalents of $857.3 million, expected to meet cash requirements for at least the next 12 months[125]. - Short-term debt outstanding as of March 31, 2025, was $173.4 million, with additional borrowing capacity of approximately $240.2 million available[126]. - As of March 31, 2025, the company had cash and cash equivalents of $757.3 million, an increase from $449.7 million as of December 31, 2024[140]. - The company reported restricted cash of $101.1 million as of both March 31, 2025, and December 31, 2024[140]. - Short-term investments decreased from $330.0 million as of December 31, 2024, to nil as of March 31, 2025[140]. - The company had short-term debt of $173.4 million as of March 31, 2025, up from $131.7 million as of December 31, 2024[145]. Currency and Other Income - Foreign currency gain was $0.7 million in Q1 2025, contrasting with a loss of $2.1 million in Q1 2024, due to RMB appreciation against the U.S. dollar[106]. - Other expense, net was $0.2 million in Q1 2025, a significant decline from other income of $9.4 million in Q1 2024, primarily due to changes in equity investment valuations[107]. Future Outlook - The company expects to continue incurring substantial costs related to research and development and commercialization activities[80]. - The company anticipates fluctuations in financial results based on the success of commercial products and research and development expenses[81]. - Future milestone payments could total up to $247.5 million for current clinical programs and $684.9 million for other programs, contingent on product candidate progress[90]. Credit and Investment Management - The company has historically collected receivables within credit terms with no significant credit losses incurred[141]. - The investment portfolio primarily consists of time deposits aimed at preserving principal and maximizing income without significantly increasing risk[143]. - The company monitors credit risk related to accounts receivable through ongoing balance monitoring and limiting credit based on payment history[141]. - A 100-basis point increase in interest rates would not materially increase the company's interest expense[145]. - A hypothetical 10% relative change in interest rates would not have a material impact on future interest income[144].