Sutro Biopharma (STRO) 2025 Conference Summary Company Overview - Sutro Biopharma is focused on advancing its next-generation antibody-drug conjugates (ADCs) technology, aiming to differentiate from conventional ADCs and enhance commercial viability [3][4][5] Key Points and Arguments 1. **Strategic Reprioritization**: The company has deprioritized its late-stage program for loveltomab tazavibulin, focusing instead on a new pipeline strategy that emphasizes innovative ADCs [3][4] 2. **Next-Generation ADCs**: Sutro is developing ADCs targeting hard-to-reach targets, which are more complex and widely expressed across solid tumors, ensuring better commercial viability [4][5] 3. **Clinical Development Plans**: Sutro aims to deliver three Investigational New Drug (IND) applications over the next three years, starting with STRO-four in the second half of 2025, followed by STRO-six in 2026 and a dual payload ADC in 2027 [4][6] 4. **Innovative Technology**: The company claims to have one of the most powerful ADC technologies, optimizing every component of the ADC to achieve a wider therapeutic index [3][9] 5. **Dual Payload ADCs**: Sutro is focusing on dual payload ADCs, which have the potential to overcome resistance seen in single payload ADCs, providing a competitive edge in the market [6][24][25] 6. **Clinical Efficacy**: Preliminary data suggests that STRO-four has significantly higher exposure and antitumor activity compared to conventional ADCs, with a 17-fold increase in Cmax and a 50-fold increase in exposure at HNSCD [14][20] 7. **Target Selection**: The company emphasizes the importance of selecting patients based on target antigen expression, which enhances the likelihood of positive clinical outcomes [21] Additional Important Content 1. **Collaboration and Partnerships**: Sutro is collaborating with Astellas on dual payload ADCs, which is advancing rapidly and is seen as a significant opportunity for the company [26][29] 2. **Manufacturing Capabilities**: Sutro has developed a robust external CDMO network to improve cost efficiency and speed in ADC manufacturing, which supports its early pipeline [4][7] 3. **Competitive Landscape**: The ADC market is becoming congested, particularly with common targets like FR alpha, which may affect commercial viability; Sutro's focus on unique targets aims to mitigate this risk [5][6] 4. **Regulatory Simplicity**: The development of dual payload ADCs is seen as advantageous due to regulatory simplicity compared to combining multiple compounds [25][30] 5. **Pipeline Execution**: Sutro's leadership team, with extensive ADC oncology experience, is focused on executing the innovative pipeline and achieving key deliverables [31][32]

麦维生物的推荐逻辑是什么？ 迈威生物 20250513 摘要 • 迈威生物聚焦 ADC 和免疫领域，Nectin-4 ADC 肿瘤药物已进入临床三期， 并建立了 ADC 平台，衍生出 CDH17 和 B7H3 等潜力新药，同时布局 T 细 胞接合器，显示出其在肿瘤治疗领域的创新能力和发展潜力。 • 在商业化方面，迈威生物已实现国内市场覆盖，拥有地舒单抗和阿达木单 抗等生物类似药产品，并预计 2025 年获批升白药物，同时积极推进眼科 药物 VEGF 抗体（阿柏西普生物类似药）的上市申请，加速市场扩张。 • 迈威生物通过收购并购实现上市，高管团队实力雄厚，拥有桂勋博士和周 伟等研发领军人物，已发展成为集研发、生产和商业化于一体的综合性生 物制药公司，具备全产业链优势。 • 迈威生物的核心竞争力在于其 ADC 平台，拥有定点偶联和稳定桥联等先进 技术，并采用赖氨酸酶裂解连接子及升级毒素（MMAE 和 DXd），提升药 物杀伤效果，引领国内 ADC 研发升级方向。 • 迈威生物的 Nectin-4 ADC 在尿路上皮癌、三阴性乳腺癌、食管癌及宫颈 癌等适应症上展现出优于 Padcev 的数据，尤其在尿路上皮癌适应症 ...

Financial Data and Key Metrics Changes - For Q1 2025, total revenue was $2.7 million, a significant decrease from $25.4 million in Q1 2024 [27] - Total operating costs and expenses for Q1 2025 were $17.7 million, down 76% year-over-year from $74.5 million in Q1 2024 [28] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49 million, or $0.49 per share, in Q1 2024 [28] Business Line Data and Key Metrics Changes - The company is focused on advancing FG3246 and FG3180 in metastatic castration-resistant prostate cancer (mCRPC) [6] - Roxadustat is being developed for anemia associated with lower-risk myelodysplastic syndromes (MDS), with a Type C meeting request filed with the FDA [8][23] Market Data and Key Metrics Changes - There are approximately 290,000 men diagnosed with prostate cancer annually in the U.S., with 65,000 being drug-treatable patients in the mCRPC stage [9] - The total addressable market for FG3246 in mCRPC is estimated to exceed $5 billion in annual sales [10] Company Strategy and Development Direction - The company is divesting FibroGen China to AstraZeneca, with total consideration expected to increase to approximately $185 million, extending the cash runway into the second half of 2027 [5][26] - The strategic focus is on U.S. pipeline opportunities, particularly FG3246 and FG3180, and advancing clinical trials [4][6] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the refined focus and multiple near-term catalysts across clinical programs to create shareholder value [9] - The company anticipates important feedback from the FDA regarding roxadustat and plans to initiate the Phase II monotherapy study for FG3246 and FG3180 in mCRPC [31] Other Important Information - The company recorded cash flow positive results in Q1 2025, generating $7.3 million in cash flow on a consolidated basis [29] - The IND for FG3180 was cleared, allowing it to be used alongside FG3246 in upcoming trials [7][12] Q&A Session Summary Question: Regarding clinical development on FG3246 and market dynamics after Pluvicto approval - Management confirmed that Pluvicto experienced patients will be allowed in the Phase II monotherapy trial to mitigate enrollment challenges [38][39] Question: Comments on recent FDA communications regarding roxadustat - Management reported favorable interactions with the FDA, including timely responses to IND filings and Type C meeting requests [40][42] Question: Feasibility studies in colorectal cancer due to cash infusion from AstraZeneca - Management indicated that while colorectal cancer is a potential opportunity, the immediate focus is on starting the Phase II monotherapy trial [44][45]

Core Insights - FibroGen reported financial results for Q1 2025, highlighting a significant decrease in total revenue compared to the same period in 2024, with total revenue of $2.7 million versus $25.4 million [14] - The company is focused on advancing its lead asset, FG-3246, with a Phase 2 monotherapy dose optimization study expected to start in Q3 2025 [2][5] - FibroGen is in the process of selling its China operations to AstraZeneca for approximately $185 million, which is expected to close in Q3 2025 [5][6] Financial Performance - Total revenue for Q1 2025 was $2.7 million, a decrease from $25.4 million in Q1 2024 [14] - The net loss from continuing operations for Q1 2025 was $16.8 million, or $0.16 per share, compared to a net loss of $49.0 million, or $0.49 per share, in the previous year [14][19] - As of March 31, 2025, FibroGen reported $33.8 million in cash and cash equivalents in the U.S. and $128.4 million in total consolidated cash [14] Strategic Developments - The company has filed a Type C meeting request with the FDA to discuss the potential Phase 3 development program for roxadustat in treating anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) [2][7] - The anticipated initiation of the Phase 2 monotherapy trial of FG-3246 in metastatic castration-resistant prostate cancer (mCRPC) is set for Q3 2025 [5][11] - Topline results from the Phase 2 portion of the investigator-sponsored study of FG-3246 in combination with enzalutamide are expected in Q4 2025 [5][6] Transaction Details - The sale of FibroGen China to AstraZeneca is expected to provide a total consideration of approximately $185 million, which includes an enterprise value of $85 million plus estimated net cash of $100 million [5][6] - Upon closing, the transaction will extend FibroGen's cash runway into the second half of 2027 [5][14] Upcoming Milestones - The company anticipates feedback from the FDA regarding the development plan for roxadustat in Q3 2025 [7] - The Phase 2 trial of FG-3246 will also include FG-3180 to assess its diagnostic performance and correlation with CD46 expression [6][11]

Core Insights - CytomX Therapeutics announced positive interim clinical results for CX-2051, an EpCAM-directed antibody-drug conjugate (ADC) for advanced colorectal cancer (CRC), highlighting its strategic importance for the company [3][7] - The company has initiated dose expansions for CX-2051 at 7.2 mg/kg, 8.6 mg/kg, and 10 mg/kg, with a Phase 2 study planned for the first half of 2026 [7][3] - Financial results for Q1 2025 show total revenue of $50.9 million, an increase from $41.5 million in Q1 2024, driven by collaborations with Bristol Myers Squibb and Amgen [9][10] Pipeline Program Updates - CX-2051 is currently in a Phase 1 dose escalation study, with an update on data from at least 70 patients expected by Q1 2026 [7] - CX-801, a PROBODY interferon alpha-2b, is also in development, with initial Phase 1a translational data expected in the second half of 2025 [7][5] - The company is focusing on combination therapy with CX-801 and KEYTRUDA, aiming to initiate this in 2025 [7] Financial Overview - As of March 31, 2025, the company reported cash, cash equivalents, and investments totaling $79.9 million, down from $100.6 million at the end of 2024 [8] - Total operating expenses for Q1 2025 were $28.3 million, a decrease from $29.8 million in Q1 2024, with R&D expenses at $18.9 million, down from $22.1 million [10][11] - The net income for Q1 2025 was $23.5 million, compared to $13.8 million in Q1 2024, reflecting improved operational efficiency [18]

近期，全产业链布局的创新型生物制药企业迈威生物与生成式人工智能驱动的生物医药科技公司英矽智 能正式宣布达成战略合作。此次强强联合，基于双方在 ADC 研发和人工智能领域的独特优势，旨在以 AI 赋能 ADC 创新药研发，标志着生物医药领域开启了协同创新的全新篇章。 迈威生物在 ADC 技术平台构建、单/双抗分子发现等方面具备优异能力，并已打通 ADC 药物从研发到 生产的全产业链。基于全面的平台技术优势和丰富的研发数据积累，迈威生物开发了一系列结构均一、 质量稳定的 ADC 创新药，已在临床取得验证。 英矽智能联合首席执行官兼首席科学官任峰博士表示："我们很高兴与迈威生物达成合作，这与英矽智 能对生物制剂疗法的广泛关注一致。抗体偶联药物是一种具有广阔前景的新型疗法，利用新兴技术解决 具有挑战性的疾病。同样，生成式人工智能为进一步加快这一变革性创新提供了的潜力。通过结合迈威 生物在生物制剂领域的深厚专业知识与英矽智能先进的生成式人工智能平台，我们有望以前所未有的效 率和精准度，开发下一代疗法，满足尚未得到满足的医疗需求。" 双方的携手，不仅是企业间资源与技术的整合，更是对未来生物医药发展趋势的前瞻性布局。此次战 ...

2025 年 05 月 12 日 行业走势图 投资评级：看好（维持） 数据来源：聚源 -36% -24% -12% 0% 12% 24% 2024-05 2024-09 2025-01 生物制品 沪深300 相关研究报告 生物制品 《重症肌无力：生物制剂打开治疗新 格局，AAN2025 泰它西普重磅 III 期 数 据 即 将 读 出 — 行 业 深 度 报 告 》 -2025.4.1 《DLL3：SCLC 高表达明星靶点，多 款国产新药未来可期 —行业深度报 告》-2024.12.30 《双抗&CAR-T：新一代 BCDT 疗法 新星，进军千亿自免蓝海市场—行业 深度报告》-2024.12.7 小细胞肺癌：中国管线全球领先，研发聚焦三大新领域 ——行业深度报告 | 余汝意（分析师） | 余克清（分析师） | 汪晋（联系人） | | --- | --- | --- | | yuruyi@kysec.cn | yukeqing@kysec.cn | wangjin3@kysec.cn | | 证书编号：S0790523070002 | 证书编号：S0790525010002 | 证书编号：S0790123050 ...

Group 1 - Palin Bio received an administrative regulatory decision from Shanxi Securities Regulatory Commission due to internal control deficiencies and inaccurate information disclosure, leading to warnings for its management [1] - Maiwei Bio's chairman Liu Datao is under investigation for suspected short-term trading, which may affect investor confidence and the company's reputation despite claims of no impact on daily operations [2] - Gilead Sciences reached a settlement of $202 million with the U.S. government over kickback allegations, which could negatively impact investor confidence and the company's reputation if compliance issues are not addressed [3] Group 2 - Rongchang Bio's ADC drug, Vidisicimab, received approval from NMPA for treating HER2-positive advanced breast cancer, marking a significant market opportunity and potential revenue increase for the company [4] - Hansoh Pharma's innovative drug Amivantamab received NMPA approval for a new indication, expanding its market potential and likely boosting sales and investor interest [5]

编号：2025-001 投资者关系活 动类别 √特定对象调研 □分析师会议 □媒体采访 □业绩说明会 □新闻发布会 □路演活动 □现场参观 √其他 （电话会议） 参与单位名称 及人员姓名 招商基金、泓德基金、中融基金、大家资产、东吴证券、招商证券、西部证 券、国盛证券等 75 家机构 93 名参与人员 时间 2025 年 4 月 30 日—2025 年 5 月 8 日 地点 北京 公司会议室 上市公司 接待人员 董事长、总经理 陈宜顶 副总经理、董事会秘书、财务负责人 林涛 证券事务代表 李鹏君 投资者关系活 动主要内容介 绍 问：公司 2024 年度业绩？ 2024 年，公司聚焦生物医药与细胞免疫治疗，集中优势资源推动核心业 务发展，并坚定不移地推进全球化战略。公司秉持"市场导向、客户至上、 创新驱动"的研发理念，持续加强重点与热点产品的研发力度，推出一系列 高质量且契合市场需求的产品，有效满足市场对重组蛋白等生物试剂不断增 长需求。在内部管理方面，公司进行全面优化，建立健全营销网络体系，全 方位提升综合竞争力与盈利能力。得益于全体员工的共同努力，2024 年度， 公司实现营业收入 64,502.19 万元 ...

Core Viewpoint - Lepu Biopharma-B (02157) has regained market attention due to significant progress in its ADC pipeline, leading to a stock price increase of nearly 78% year-to-date, despite a previous decline since its IPO in 2022 [1][18]. Group 1: Company Overview - Lepu Biopharma was established in 2018 and has built its pipeline through acquisitions and partnerships, including PD-1 antibodies and ADC drugs [1]. - The company focuses on integrating PD-1 as a cornerstone for cancer treatment while developing ADCs and other therapies for enhanced clinical outcomes [1][12]. Group 2: Financial Performance - In 2024, Lepu Biopharma is projected to achieve revenue of 368 million RMB, a year-on-year increase of 63.21%, driven by the commercialization of PD-1 [4]. - Despite revenue growth, the company reported a loss of 424 million RMB in the same year, with cash reserves remaining stable at 401 million RMB [4]. Group 3: Pipeline Development - The core drug in Lepu's pipeline is MRG003, an EGFR-targeting ADC, which has shown promising results in clinical trials for nasopharyngeal carcinoma (NPC) and head and neck squamous cell carcinoma (HNSCC) [4][10]. - MRG003 has received breakthrough therapy designation from both the CDE and FDA, indicating its potential in treating difficult-to-manage cancers [10]. Group 4: Competitive Landscape - The global market for EGFR-targeting ADCs is competitive, with several companies, including Rakuten Medical and Systimmune, also developing similar therapies [6][7]. - Lepu's MRG003 has demonstrated superior efficacy compared to existing treatments, with an overall response rate (ORR) of 47.4% in NPC patients, significantly higher than the typical 20-30% ORR for second-line therapies [7][10]. Group 5: Future Prospects - The company is actively exploring combination therapies, such as MRG003 with PD-1, which has shown an ORR of 66.7% in early trials [12]. - Lepu is also advancing its CG0070 oncolytic virus therapy, which has shown promising results in treating non-muscle invasive bladder cancer (NMIBC) and has received breakthrough therapy designation from the FDA [14][15]. Group 6: Challenges Ahead - Despite the positive developments, Lepu Biopharma's reliance on external acquisitions for its pipeline raises questions about its internal R&D capabilities [18]. - The company faces challenges related to ongoing losses and the need for substantial funding to support its numerous clinical trials [18].