Group 1 - The company is actively expanding its international market presence, particularly in the U.S. insulin market through strategic partnerships and ongoing clinical trials for three types of insulin [1] - The company has achieved sales of approximately 200,000 units of liraglutide injection in Q1 2025, with a strong foundation for annual sales growth due to successful procurement results [2] - The company is focusing on the sales of insulin analog products and expanding its market presence for GLP-1 receptor agonists and SGLT-2 inhibitors to meet diverse patient needs [2] Group 2 - The company has received approvals for insulin products in several developing countries, including Nicaragua and Uzbekistan, and is working on expanding registrations for insulin products in these markets [1] - The company is advancing its clinical trials for new products, including THDBH120 for weight loss, which has completed its Phase II clinical trial [2][3] - The company is not currently developing oral insulin products due to technical challenges but will monitor industry advancements for potential future adjustments in R&D strategy [3] Group 3 - The company’s parent group, Dongbao Group, is working to reduce its share pledge ratio, which is currently high due to long project cycles and financial pressures [3] - The long-term outlook for Dongbao Group is positive, with ongoing projects and products expected to enter a recovery phase, improving operational capabilities [4]

Group 1 - The core finding of the ASCO annual meeting is the announcement of the phase III clinical trial data for the "Defu Combination" (Bemarituzumab + Anlotinib) as a first-line treatment for locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC), showing a median progression-free survival (PFS) of 10.12 months, outperforming the comparative drug [1] - This study represents the first positive phase III clinical research result comparing immune checkpoint (PD-1) inhibitors combined with chemotherapy for the first-line treatment of squamous non-small cell lung cancer [1] - The innovative clinical trial design involved sequential treatment with Bemarituzumab combined with chemotherapy followed by Bemarituzumab combined with Anlotinib, breaking through traditional treatment standards [1] Group 2 - Based on the clinical research results, the company has submitted a new indication application for the "Defu Combination," which was accepted by the National Medical Products Administration (NMPA) on April 22 [2] - Anlotinib has already been approved for 8 indications, with 5 more in the NDA stage, while the "Defu Combination" has received approval for 3 indications and has 3 more in the new drug application stage [2] - The ASCO annual meeting is a highly regarded event in the clinical oncology field, serving as an industry benchmark, with over 70 original research projects from Chinese researchers selected for oral presentations this year, including many "First in Class" and "Best in Class" studies [2]

唯一实现每日单次口服给药的KRAS G12C抑制剂。 结果显示，戈来雷塞具有良好的疗效及安全性。截至 2024 年 9 月 28 日，共有 119 例非小细胞 肺癌受试者纳入分析。独立影像学评审委员会（ IRC ）评估的确认的客观缓解率（ cORR ）达到 49.6% （ 40.2%-59.0% ） ，疾病控制率（ DCR ）达到 86.3% （ 78.7%-92.0% ） ，中位 缓解持续时间（ DOR ） 14.5 个月 （ 9.6-NE ） ，中位无进展生存期（ PFS ） 8.2 个月（ 5.2-11.1 ），中位生存期（ OS ） 17.5 个月（ 13.6-NE ）。 得益于创新的药物共晶设计和稳定的构型 ， 戈来雷塞有良好的安全性特征， ≥3 级治疗相关不良事 件发生率更低，且具有良好的消化道安全性特征。戈来雷塞是目前国内已获批的 KRAS G12C 抑制 剂中，唯一实现每日单次口服给药的 KRAS G12C 抑制剂，患者服用更加方便。 随着此次获批，戈来雷塞商业化也将正式开始。 艾力斯表示， 除了此次获批的适应症，戈来雷塞联 合 SHP2 抑制剂用于在非小细胞肺癌一线治疗，以及戈来雷塞单药用于 ...

证券代码：002099 证券简称：海翔药业 浙江海翔药业股份有限公司投资者关系活动记录表 编号：2025-002 | | 媒体采访 □业绩说明会 | | 特定对象调研 | □分析师会议 | | | --- | --- | --- | --- | --- | --- | | 投资者关系 | | | | | | | | □新闻发布会 □路演活动 | | | | | | 活动类别 | □现场参观 □投资者接待日活动 | | | | | | | □其他 | | | | | | | 2025 年 5 月 21 日上午：东方财富证券、中财保理、朴润资 | | | | | | 参与单位名称 | 产； | | | | | | 及人员姓名 | 2025 年 5 月 21 日下午：中泰证券； | | | | | | | 2025 年 5 月 22 日上午：华创证券、建信养老、人保养老。 | | | | | | 时间 | 2025 年 5 月 21 日-2025 年 5 月 22 日 | | | | | | 地点 | 浙江省台州市椒江区岩头工业区海虹路 71 号公司会议室 | | | | | | | 董事会秘书：颜康； | | ...

Core Viewpoint - The National Medical Products Administration has conditionally approved the innovative drug Glecirasib (brand name: Airikai) developed by Elysium, which is indicated for adult patients with advanced non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations who have received at least one prior systemic therapy [1] Group 1 - The drug Glecirasib is classified as a first-class innovative drug [1] - The approval was granted through a priority review and approval process [1] - The target patient population includes adults with advanced NSCLC and specific genetic mutations [1]

Financial Data and Key Metrics Changes - Total revenues for the quarter were $60.6 million, down from $84 million in the same period last year, primarily due to the absence of a significant accrual from Syngenta's initial down payment [9][10] - Gross profit decreased to $24 million from $42.6 million year-over-year, with gross margin declining from 51% to 39% due to the previous year's accrual effect [14][15] - Adjusted EBITDA for the quarter was $9 million, down from $21.1 million last year, reflecting the impact of the Syngenta down payment accrual [17][18] - Cash from operating activities improved significantly to $23.3 million, a $40.7 million increase compared to the prior year's cash requirement of $17 million [20][21] - Total debt decreased by $13 million, leading to a leverage ratio of 4.1 at the end of the quarter [23] Business Line Data and Key Metrics Changes - Crop Protection revenues decreased due to lower sales of non-core products in Argentina, partially offset by higher sales of bioprotection solutions [14] - Integrated Products revenues increased by 26%, driven by accelerated sales of HB4 grain from existing inventory [14] - Inoculant sales showed underlying operational growth, slightly offset by seasonal effects on fertilizers [14] Market Data and Key Metrics Changes - The Argentine market experienced reduced commercial activity, with purchasing behavior becoming more aligned with the agronomic calendar rather than speculative patterns [10][11] - The U.S. and Mexico markets showed good growth, indicating early signs of recovery, while Brazil remained in a low season with positive sentiment due to improved soybean prices [12][13] - Overall, the performance in Argentina was not indicative of market status, with expectations for better conditions in the upcoming summer crop season [12][13] Company Strategy and Development Direction - The company is transitioning to a more sustainable agricultural model, focusing on cash flow performance and working capital efficiency [6][20] - The long-awaited EPA approval of Rhinotech allows the company to offer a full suite of biological solutions for pest control and plant health [6] - The company aims to reduce reliance on the Argentine market, targeting growth in Brazil, the U.S., and Europe [70] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism about the Argentine market, noting improved macroeconomic conditions and stable farmer sentiment [51][52] - The company anticipates a healthy winter crop season in Argentina, with expectations for a stronger summer crop season [52][53] - Management highlighted the importance of maintaining operational excellence and leveraging technology platforms for future growth [60][70] Other Important Information - The company has implemented a significant reduction in payroll and structural costs, resulting in annualized savings of approximately $5 million [28] - The Rhinotech platform is positioned for a prelaunch year in 2025, with registrations ongoing in key markets [30][31] Q&A Session Summary Question: Inquiry about cash advancement and working capital unwind - Management indicated an expected additional $10 million from the transition to a lighter model with HB4, aiming for a return to historical net working capital levels of four to four and a half months of sales [44][45] Question: Sentiment in Argentina and macroeconomic conditions - Management noted that sentiment in Argentina is slowly building up, with stable macroeconomic conditions leading to normalized purchasing behavior [50][51] Question: Non-operating income payment details - The $7.5 million non-operating income payment was primarily non-cash, involving an exchange of IP and intangible assets [65] Question: Field trial results for Neovil product - Management confirmed ongoing replicated third-party field trials for Neovil, with positive feedback from strategic and channel partners [94] Question: Interest in HB4 traits from seed companies - Management confirmed ongoing collaboration with public and private institutions for HB4 wheat in the U.S., with a focus on Latin America for HB4 soybeans [97][98]

证券研究报告 医药生物 | 化学制药 非金融|首次覆盖报告 hyzqdatemark 2025 年 05 月 21 日 | 2025 | | 年 | 05 | 月 20 | 日 | | | | | | | | | | | | 基本数据 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 收盘价（元） | | | | | 44.75 | | | | | | | | | | | | | | | 低 | | | | | | 年 | | | 高 | / | 最 | | 一 | | 最 | 内 | | | | 总市值（百万元） 4,197.55 | 流通市值（百万元） 4,197.55 | | | | 93.80 24.13 19.58 | （元） | 资产负债率（%） | 资料来源：聚源数据 | | | | 56.00/32.88 | | 总股本（百万股） | | | | 每股净资产（元/股） | 华纳药厂(688799.SH) ...

智通财经APP获悉，5月21日，罗氏(RHHBY.US)宣布III期TALENTACE研究达到主要研究终点，该研究 评估了阿替利珠单抗、贝伐珠单抗和按需经动脉化疗栓塞术（TACE）在未接受过既往全身系统治疗的 不可切除肝细胞癌（HCC）患者中的疗效和安全性。 该研究显示，主要终点TACE 无进展生存期（TACE-PFS，从随机分组到研究者评估的TACE不可治疗 进展或TACE失败/抵抗或任何原因死亡的时间）取得了统计学和临床意义上的显著改善，中期分析时总 生存期（OS）尚不成熟。同时，由RECIST v1.1评估的PFS也观察到了有临床意义的改善。 TALENTACE研究开创性地探索了免疫检查点抑制剂阿替利珠单抗联合抗血管生成靶向治疗贝伐珠单抗 与按需TACE同期联合治疗的协同效应。同时，TALENTACE研究创新性地将TACE-PFS作为主要终 点，并在未经系统治疗的中高肿瘤负荷HCC 患者中显示出治疗获益，有望为肝癌局部肿瘤控制与系统 分子干预的联合治疗模式提供高级别循证依据。研究数据分析显示，阿替利珠单抗和贝伐珠单抗的安全 性特征与先前的数据和基础疾病一致。 罗氏制药中国医学事务副总裁李滨博士表示，他们 ...

Financial Data and Key Metrics Changes - Nuvation Bio has four clinical assets, with the lead asset telotrectinib showing an overall response rate of 89% and a median progression-free survival (PFS) of 46 months, which is significantly higher than other oncology agents [11][12] - The discontinuation rate for telotrectinib is reported at 6.5%, indicating a favorable tolerability profile [12] Business Line Data and Key Metrics Changes - The DDC program is in the clinic for five different indications, targeting patients who have failed ADCs, showcasing a novel approach to drug delivery [6][7] - The sacrocitinib program has shown promising results in gliomas, with one patient achieving a complete response for over three years [4][45] Market Data and Key Metrics Changes - The NCCN guidelines have shifted to contraindicate IO chemotherapy for patients with ROS1 mutations, which is expected to significantly influence treatment practices and market dynamics [30][31] - There is an estimated market opportunity of about 3,000 patients per year for telotrectinib, potentially leading to a multibillion-dollar market as more patients are treated with targeted therapies [33] Company Strategy and Development Direction - Nuvation Bio is focused on advancing its clinical assets, particularly telotrectinib, which has received breakthrough designation and priority review from the FDA [19][39] - The company is exploring strategic alternatives for its NUB-868 program, indicating a proactive approach to its pipeline management [7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the timely approval of telotrectinib, citing extensive interactions with the FDA and the unique profile of the drug [39] - The company is optimistic about the changing treatment landscape for ROS1 lung cancer, anticipating increased adoption of their therapies following guideline changes [30][31] Other Important Information - Nuvation Bio secured $150 million in royalty financing, which is expected to provide sufficient capital to avoid future cash raises [35][36] - The company is preparing to present data from its DDC program in the second half of the year, indicating ongoing commitment to innovation [57] Q&A Session Summary Question: What differentiates telotrectinib from other ROS1 inhibitors? - Telotrectinib is the only ROS1 inhibitor with breakthrough designation in both first and second lines, supported by a large safety database of over 400 patients [19][20] Question: How has the NCCN guideline change impacted treatment practices? - The NCCN now recommends switching to ROS1 agents if a mutation is found, which is expected to significantly influence clinical practice [30][31] Question: What is the expected market opportunity for telotrectinib? - The potential market includes about 3,000 patients annually, with a possibility of reaching a multibillion-dollar market as more patients are treated with targeted therapies [33]

圣兆药物 20250520 摘要 • 圣兆药物拥有 26 个在研管线，覆盖恶性肿瘤、精神分裂症等适应症，业 务模式以委托生产加自主生产为主，依托 MAH 制度，与吉林敖东、海正 药业和澳亚生物合作，其中盐酸多柔比星脂质体已获批上市并在集采中中 标。 • 公司核心技术团队由 90 多名研发人员组成，硕博比例高达 75%，包括多 位曾担任 CDE 新药审评专家的核心骨干，具备创新制剂领域丰富的产业化 经验，是国内创新制剂领域技术实力最强的团队之一。 • 复杂注射剂研发难度大，涉及工艺、原料药和质量控制等多个环节，但市 场规模巨大，如布比卡因 V0 等产品国内销售额均超 50 亿人民币，且具有 较高的技术壁垒和较快的临床周期，为企业带来高利润空间。 • 圣兆药物在复杂注射剂领域已申报并获批 8 个产品，其中 2 个已获批，6 个正在审评中，预计 2026 年左右获批，突破国外产业化技术壁垒，实现 线性放大连续化生产工艺，并拥有全球最大单批次产能，已授权 99 项发 明专利。 Q&A 圣兆药物的业务模式和技术平台有哪些特点？ 圣兆药物是一家专注于长效缓释和靶向制剂产品研发与产业化的医药企业。公 司成立于 2011 年 ...