申万宏源主要观点如下： 再鼎医药为一家处于商业化阶段的创新型全球生物制药公司。凭借授权引进(license-in)与自主研发，目 前公司共有七款产品于国内获批上市，包括四款肿瘤产品(则乐、爱普盾、擎乐、奥凯乐)、一款免疫产 品(艾加莫德)，以及两款感染性疾病产品(纽再乐、鼎优乐)。此外，公司拥有涵盖肿瘤、免疫、神经科 学和感染性疾病的广泛产品管线。 核心产品持续销售放量，新产品有望进一步丰富产品组合 2019年以来，随着首款商业化产品尼拉帕利于国内获批上市，目前公司已有七款商业化产品。2024年公 司总收入达到3.99亿美元，同比增长50%，主要由于卫伟迦/卫力迦、纽再乐等产品销售放量。新产品方 面，公司已于今年上半年向NMPA递交了KarXT和维替索妥尤单抗(TF ADC)的上市申请。此外，公司预 计将于今年下半年向NMPA递交贝玛妥珠单抗针对1L胃癌的上市申请。随着现有商业化产品的销售放 量，以及Kar-XT、贝玛妥珠单抗、ZL-1310(DLL3ADC)、povetacicept等新产品未来获批上市，公司预计 2028年营收有望达到20亿美元。 申万宏源发布研报称，随着商业化产品的销售放量，以及本地化生 ...

智通财经APP获悉，申万宏源发布研报称，随着商业化产品的销售放量，以及本地化生产布局，再鼎医 药(09688)预计将于2025年四季度实现non-GAAP经营利润。此外，该行预计2025-2027年公司收入分别 为5.53亿美元，8.02亿美元和12.03亿美元，2025-2027年公司归母净利润分别为-1.34亿美元、0.15亿美元 和1.73亿美元。基于DCF模型，给予目标价35.2港元。目标价对应39%的上涨空间，看好公司的创新管 线布局，首次覆盖给予买入评级。 申万宏源主要观点如下： 再鼎医药为一家处于商业化阶段的创新型全球生物制药公司。凭借授权引进（license-in）与自主研发， 目前公司共有七款产品于国内获批上市，包括四款肿瘤产品（则乐、爱普盾、擎乐、奥凯乐）、一款免 疫产品（艾加莫德），以及两款感染性疾病产品（纽再乐、鼎优乐）。此外，公司拥有涵盖肿瘤、免 疫、神经科学和感染性疾病的广泛产品管线。 核心产品持续销售放量，新产品有望进一步丰富产品组合 2019年以来，随着首款商业化产品尼拉帕利于国内获批上市，目前公司已有七款商业化产品。2024年公 司总收入达到3.99亿美元，同比增长50%，主 ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [5][11]. Core Insights - The company is positioned to reach a profitability inflection point due to its differentiated innovative pipeline and ongoing commercialization of its products [2][13]. - The company expects significant revenue growth, projecting revenues of $3.99 billion in 2024, $5.53 billion in 2025, $8.02 billion in 2026, and $12.03 billion in 2027, with a potential revenue of $2 billion by 2028 [2][5][11]. Summary by Sections Product Pipeline and Commercialization - The company has seven products approved for sale in China, including four oncology products, one immunology product, and two infectious disease products [2][27]. - The core products are experiencing strong sales growth, with a projected revenue increase of 50% year-over-year in 2024, driven by products like Weiwei Jia and Niu Zai Le [2][30]. - The company has submitted applications for new products, including KarXT and TF ADC, and anticipates further submissions for other products [2][12]. Financial Projections - The company forecasts revenues of $5.53 billion, $8.02 billion, and $12.03 billion for 2025, 2026, and 2027, respectively, with net profits expected to turn positive by 2027 [5][11]. - The report indicates that the company will achieve non-GAAP operating profit by Q4 2025, supported by local production and increasing product sales [41]. Market Position and Valuation - The company's current stock price reflects a valuation of 7 times the 2025 price-to-sales ratio, compared to an average of 18 times for comparable companies, indicating attractive valuation [11]. - The target price is set at HKD 35.2, representing a 39% upside potential from the current price [5][11]. Key Product Highlights - Efgartigimod (艾加莫德) is expected to become a leading product in the autoimmune field, with significant sales growth projected due to new indications and formulations [3][12]. - ZL-1310 (DLL3 ADC) has shown promising clinical data and is expected to enter critical global studies [4][38]. - The company is actively expanding its global pipeline, focusing on ADCs and bispecific antibodies, with multiple products in various stages of clinical development [4][38].

Summary of Key Takeaways from the Conference Call Industry Overview - **Industry**: China Biotech and Healthcare - **Date**: September 10, 2025 - **Source**: Morgan Stanley Research Core Insights 1. **Emerging Business Development Options**: The robust out-licensing activity in the Chinese biopharma sector presents unique opportunities for overseas investors, particularly in transactions involving royalties from out-licensed innovations, exemplified by the BeOne/Imdelltra deal [3] 2. **Immunology Targets Enthusiasm**: A major biopharma company expressed confidence in its assets targeting OX40L, IL-13/TSLP, and IL-33, with a particular focus on OX40L's differentiated therapeutic positioning. This includes assets from Innovent, Keymed, and Akeso [4][7] 3. **Investor Focus on Specific Products**: Investor inquiries were concentrated on the commercial outlooks for Vyvgart and KarXT, as well as the R&D progress for ZL-1310 [4][8] Product-Specific Developments 1. **Vyvgart**: Key near-term drivers include guideline inclusion, lengthening of the duration of treatment (DoT), and inclusion in the National Reimbursement Drug List (NRDL) for subcutaneous formulations [8] 2. **KarXT**: Anticipated post-NRDL pricing is projected to be 10-15% of the US price, with a favorable inpatient landscape in China aiding commercial adoption [8] 3. **ZL-1310**: An update on second-line small cell lung cancer (SCLC) data is expected in October 2025, with a target of over 60% overall response rate (ORR) and a median progression-free survival (mPFS) of approximately 6 months [8] Additional Considerations - **Market Sentiment**: The overall sentiment towards the China biotech sector remains attractive, with positive commentary on immunology assets indicating potential growth and resilience against funding uncertainties [7] - **Investment Risks**: Investors are advised to consider potential conflicts of interest when interpreting research from Morgan Stanley, as the firm may have business relationships with the companies discussed [5][10] This summary encapsulates the key points from the conference call, highlighting the current landscape and future outlook for the China biotech and healthcare industry.

Summary of Zai Lab (ZLAB) Earnings Review Company Overview - **Company**: Zai Lab (ZLAB) - **Industry**: Biotechnology Key Financial Highlights - **2Q25 Product Revenue**: US$109.1 million, a 9% year-over-year increase, but below expectations (Goldman Sachs estimate: US$125.6 million) [1] - **Zejula Revenue**: US$41 million, down 17% quarter-over-quarter and 9% year-over-year, compared to Goldman Sachs estimate of US$50.1 million [1] - **Augtyro Revenue**: US$1.4 million, down 14% quarter-over-quarter, significantly below Goldman Sachs estimate of US$5.9 million [1] - **Efgartigimod Revenue**: US$26.5 million, a 46% quarter-over-quarter increase, slightly below Goldman Sachs estimate of US$29.5 million [1] Management Guidance - **FY25 Revenue Guidance**: Reiterated at US$560-$590 million, with non-GAAP profitability expected in 4Q25 [1] - **Sales Growth Expectations**: Management anticipates accelerated sales growth in 2H25 despite a lower-than-expected performance in 1H25 [2] Operational Efficiency - **Operating Loss**: Non-GAAP operating loss narrowed to US$34 million, down 8% quarter-over-quarter and 37% year-over-year [2] - **SG&A Costs**: US$71 million, down 11% year-over-year, indicating disciplined spending [2] - **R&D Expenses**: US$51 million, down 18% year-over-year, with expectations for modest growth in R&D investment towards 2H25 [2] Key Catalysts and Upcoming Events - **NMPA Approvals**: Key products to watch include KarXT for schizophrenia and TIVDAK for r/m CC post-chemotherapy [7] - **BLA Submissions**: Planned submissions for bemarituzumab in 1L gastric cancer and Optune in 1L pancreatic cancer [7] - **Data Readouts**: Expected updates from pivotal studies and clinical trials in 2H25 and early 2026 [7] Valuation and Price Target - **Price Target**: Adjusted to US$56.30 (previously US$56.94) for ZLAB and HK$43.88 (previously HK$44.38) for Zai Lab (H) [8] - **EPS Estimates**: Adjusted for FY25E-FY27E from -US$1.7/-US$1.4/-US$1.2 to -US$1.7/-US$1.2/-US$1.1 [8] Investment Thesis - **Transition Strategy**: Zai Lab is shifting from a licensing-in based model to a dual engine focusing on in-house and licensing opportunities globally [9] - **Market Potential**: The company has a strong pipeline with 10+ high-quality assets expected to generate significant revenue by 2028 [9] - **Risks**: Key risks include fluctuations in licensing deals, supply chain disruptions, uncertainties in drug pricing, and potential delays in clinical or regulatory progress [10] Conclusion - **Investment Rating**: Buy rated, with a favorable risk/reward profile due to the company's strategic transition and growth potential in the biotechnology sector [9][10]

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 Viewpoint - AstraZeneca has announced a complete withdrawal from the CNS (Central Nervous System) field, terminating multiple pipeline projects, marking a significant strategic decision following its $80 billion revenue target announcement [1][2]. Group 1: AstraZeneca's Strategic Decision - The decision to exit the CNS field reflects the high difficulty of product development in this area and the pressure to achieve short-term KPIs, leading the company to focus on more certain high-revenue products like weight loss drugs and ADCs [2][4]. - The withdrawal indicates a significant loss of research investment and time, as the CNS field has seen mixed results in recent years, with other major companies like Amgen, Pfizer, and Sanofi also abandoning CNS projects [2][8]. Group 2: CNS Market Overview - The CNS market is considered the third-largest disease market, with a strong necessity for drug control and long medication cycles for conditions such as depression, schizophrenia, Parkinson's, and Alzheimer's [2][3]. - Despite recent setbacks, there have been notable breakthroughs in the CNS field, including advancements in Alzheimer's treatments and new mechanisms for schizophrenia drugs, indicating potential for future growth [7][12]. Group 3: Challenges in CNS Drug Development - CNS drug development faces significant challenges, including limited understanding of brain mechanisms, the blood-brain barrier, and subjective symptom assessment, leading to lower approval rates compared to non-CNS drugs [4][5]. - The slow iteration of drugs in the CNS field means that any successful product can enjoy a longer lifecycle with less competition, which has allowed smaller companies to establish themselves [5][12]. Group 4: Domestic CNS Players - The domestic CNS drug market in China is projected to grow from approximately $16.9 billion in 2022 to $31.1 billion by 2030, with a compound annual growth rate (CAGR) of nearly 8%, outpacing global growth [12][13]. - Local companies are increasingly focusing on innovative CNS drugs, with several firms transitioning from generics to original drug development, leveraging improved research infrastructure and market demand [13][14].

Core Viewpoint - The article discusses the implications of the U.S. government's decision to impose tariffs on imported pharmaceuticals, highlighting potential impacts on global pharmaceutical supply chains and the strategies that Chinese innovative drug companies may adopt in response [2][6][10]. Group 1: Impact of Tariffs on Pharmaceutical Industry - The U.S. tariffs on pharmaceuticals aim to encourage multinational companies to establish production facilities in the U.S., thereby reducing reliance on imports [2][5]. - Analysts suggest that the tariff policy may lead to increased instability in the global pharmaceutical supply chain, particularly affecting Chinese innovative drug companies' international strategies [2][6]. - The tariffs could result in higher export costs and reduced profit margins for Chinese companies that depend on the U.S. market [6][10]. Group 2: Responses from Chinese Innovative Drug Companies - Several Chinese innovative drug companies are assessing the potential impacts of the tariffs, with some indicating that they may face valuation pressures in the short term [2][6]. - Companies like Hengrui Medicine and Zai Lab have stated that the tariffs will have limited impact on their operations due to their low reliance on U.S. sales [7][8]. - Analysts recommend that Chinese companies accelerate local production in the U.S. to mitigate tariff risks and explore supply chain diversification in lower-cost regions [10][11]. Group 3: Long-term Strategies and Market Dynamics - The article emphasizes the importance of maintaining strong research and development capabilities and diversifying risk through licensing agreements [3][12]. - The global pharmaceutical landscape may shift, with Indian pharmaceutical companies potentially benefiting from the changes in the supply chain dynamics [6][10]. - The article notes that while geopolitical risks are significant, the ultimate competitive advantage for innovative drug companies lies in their ability to deliver clinical value and innovation [12].

Financial Data and Key Metrics Changes - Total revenue for 2024 grew 50% year-on-year, with a remarkable 66% growth in Q4 [9][16] - Loss from operations improved by 45% in Q4 and 23% for the full year [14][57] - Cash position at the end of the quarter was $879.7 million, supporting future growth [14][58] Business Line Data and Key Metrics Changes - VYVGART generated $93.6 million in sales for 2024, marking a successful launch [9][17] - ZEJULA and NUZYRA also contributed to revenue growth, with ZEJULA being the leading PARP inhibitor for ovarian cancer in China [27][31] - New product launches, including VYVGART Hytrulo, AUGTYRO, and XACDURO, are expected to drive future revenue [30][31] Market Data and Key Metrics Changes - VYVGART's market penetration in China is currently under 10%, indicating significant growth potential [24] - Approximately 170,000 gMG patients in China present a large market opportunity for VYVGART [24] - The upcoming update to national gMG guidelines in mid-2025 is expected to enhance VYVGART's market position [25] Company Strategy and Development Direction - The company aims for a five-year CAGR of 50% through 2028, with a target of reaching $2 billion in revenue by 2028 [8][14] - Focus on advancing a global pipeline with multiple product launches and regulatory submissions planned for 2025 [10][12] - Emphasis on optimizing cost structure while investing in key growth drivers [13][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability by Q4 2025, supported by strong revenue growth and operational efficiency [14][59] - The company is positioned at a major value inflection point, with a commitment to innovation and execution excellence [14][32] - Anticipated strong performance across brands, particularly VYVGART, ZEJULA, and NUZYRA, in 2025 [31] Other Important Information - The company has made significant advancements in its global pipeline, including promising results for ZL-1310 in small cell lung cancer [34][35] - Regulatory discussions for accelerated approval of ZL-1310 are ongoing, with plans to initiate pivotal studies [38][74] - The company is actively exploring additional indications for its products to maximize patient benefit [12][39] Q&A Session Summary Question: Regarding 2025 revenue guidance and potential growth products - Management highlighted ZEJULA and NUZYRA as key growth drivers alongside VYVGART, with expectations for strong performance across all brands [63] Question: Growth trajectory for VYVGART in 2025 - Management expects stronger growth in the second half of 2025, driven by new patient starts and updates to treatment guidelines [70] Question: Regulatory strategy for DLL3 and pivotal study plans - Management confirmed plans to start a pivotal study this year, with confidence in achieving accelerated approval [74] Question: Observations on CIDP and KarXT's commercial potential - Management noted limited impact from CIDP in 2025 due to lack of NRDL listing, focusing on gMG instead [98] - Excitement about KarXT's potential in schizophrenia treatment, with plans for a dedicated sales force [100] Question: Strategy for povetacicept and key catalysts for 2025 - Management indicated participation in global trials for povetacicept, aiming for accelerated approval [121] - Key catalysts include data updates for DLL3 assets and regulatory submissions for bemarituzumab [126]

February 2025 Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Updates NASDAQ:ZLAB | HKEX:9688 © 2025. Zai Lab. All Rights Reserved. Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding o ...