Core Viewpoint - The successful FDA approval of ZEGFROVY (舒沃替尼片) marks a significant milestone for the company as it becomes the first independently developed innovative drug from China to enter the global market, with expectations of reaching over 10 billion yuan in global sales peak [4][6]. Group 1: Product Approval and Market Potential - ZEGFROVY has received accelerated approval from the FDA for treating adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations [4]. - The drug is expected to achieve a global market sales peak of approximately 12.954 billion yuan, with the U.S. market presenting a higher pricing potential compared to China [6]. - The incidence of EGFR exon 20 insertion mutations in NSCLC patients is estimated to be around 4.8% to 5.1% in China, while in the U.S., it ranges from 9% to 12% [5][6]. Group 2: Commercial Strategy and Market Expansion - The company aims to maximize its long-term interests and shareholder returns by actively evaluating various overseas market expansion models, with a focus on the U.S. and European markets due to their stronger payment capabilities [6][11]. - The domestic market remains crucial, but the overseas market is anticipated to become a second growth curve for the company [6][11]. - The company has a commercial team nearing 500 members to enhance market coverage for its products [6]. Group 3: Research and Development Pipeline - The company has a robust pipeline with seven products in international multi-center clinical stages, including ZEGFROVY and three other drugs [7][9]. - ZEGFROVY has shown a confirmed objective response rate (ORR) of 78.6% in treating EGFR exon 20 insertion NSCLC, with a median progression-free survival (mPFS) of 12.4 months [9]. - The company is also developing DZD6008, a selective EGFR TKI, which aims to address unmet clinical needs in NSCLC [9][10]. Group 4: Financial Performance and Funding - The company reported a net loss of approximately 850 million yuan in 2024, a 24% reduction year-on-year, and a net loss of about 190 million yuan in Q1 2025, a 14% decrease [14]. - The company successfully completed a nearly 1.8 billion yuan private placement to support its R&D projects, particularly for ZEGFROVY, Golixty (高瑞哲), and DZD8586 [14][15]. - The annual R&D investment from 2020 to 2024 has shown a consistent increase, indicating a commitment to sustaining product pipeline development [13].

公司代码：688192 公司简称：迪哲医药 迪哲（江苏）医药股份有限公司 目 录 十一、 关于变更注册资本、修订公司章程及议事规则并办理工商变更登记 迪哲（江苏）医药股份有限公司 为维护全体股东的合法权利，确保股东大会的正常秩序和议事效率，保证 大会的顺利进行，根据《中华人民共和国公司法》《中华人民共和国证券法》 《上市公司股东会规则》以及《迪哲（江苏）医药股份有限公司章程》《迪哲 （江苏）医药股份有限公司股东大会议事规则》等相关规定，迪哲（江苏）医 药股份有限公司（以下简称"公司"）特制定 2024 年年度股东大会会议须知： 一、为确认出席大会的股东或其代理人或其他出席者的出席资格，会议工 作人员将对出席会议者的身份进行必要的核对工作，请被核对者予以配合。 二、为保证本次大会的严肃性和正常秩序，切实维护股东的合法权益，请 出席大会的股东或其代理人或其他出席者准时到达会场签到确认参会资格，在 会议主持人宣布现场出席会议的股东和代理人人数及所持有的表决权数量之前， 会议登记应当终止。 三、会议按照会议通知上所列顺序审议、表决议案。 四、股东及股东代理人参加股东大会依法享有发言权、质询权、表决权等 权利。股东及股 ...

2025ASCO 大会国内重点研究总结报告 | [Tabl 分析师： | 罗佳荣 | 分析师： | 李安飞 | | --- | --- | --- | --- | | e_Author] | SAC 执证号：S0260516090004 | | SAC 执证号：S0260520100005 | | | SFC CE.no: BOR756 | | | | | 021-38003671 | | 021-38003669 | | | luojiarong@gf.com.cn | | lianfei@gf.com.cn | | | 请注意，李安飞并非香港证券及期货事务监察委员会的注册持牌人，不可在香港从事受监管活动。 | | | [Table_Summary] 核心观点： 相关研究 [Table_Report ： ] 医药生物非药行业 2024 年报及 2025 年 1 季报总结:蓄势待发，看好国内创新优势与制造优势 2025-05-05 识别风险，发现价值 请务必阅读末页的免责声明 [本报告联系人： Table_C ontacter] 龙雪芳 021-38003558 longxuefang@gf.com.cn 王 ...

Group 1 - Hansoh Pharmaceutical granted Regeneron Pharmaceuticals exclusive overseas licensing for its GLP-1/GIP dual receptor agonist HS-20094, which has completed multiple Phase II clinical trials and is currently in Phase III trials in China [1][2] - The licensing agreement includes an upfront payment of $80 million, potential milestone payments of up to $1.93 billion, and double-digit royalties on future sales [2][3] - Recent licensing deals by Chinese pharmaceutical companies indicate a growing trend, with 33 license-out transactions completed in Q1 2025, totaling $36.633 billion, a year-on-year increase of approximately 258% [1][6] Group 2 - The licensing deal with Pfizer for the PD-1/VEGF dual antibody SSGJ-707 includes a record upfront payment of $1.25 billion, with potential milestone payments reaching $4.8 billion [3] - Other companies, such as Sinovant and Ansai, have also announced licensing agreements, indicating a robust market for Chinese pharmaceutical innovations [3][4] - The 2025 ASCO annual meeting showcased over 70 original research results from China, highlighting the international competitiveness of Chinese innovative drugs [4][5] Group 3 - The overall trend shows that Chinese innovative drugs are gaining global value, with a significant increase in licensing transactions and amounts [6][7] - The pharmaceutical industry is expected to see steady recovery, driven by the growing demand for innovative therapies and the improvement in the quality and quantity of domestic innovative drugs [7]

当地时间5月30日-6月3日，2025年美国临床肿瘤学会（ASCO）年会将在美国芝加哥举行。这也是全球 规模最大、最具权威性的临床肿瘤会议，其间将展示国际最前沿的临床肿瘤学科研进展和治疗成效。今 年的ASCO年会中，迪哲医药、科伦药业、中国生物制药等多家本土企业最新在研成果入选，涉及PD-1 单抗、ADC（抗体偶联药物）等领域。入选口头报告的中国研究者原创研究数量也超过去年，达70多 项。 多项研究将公布最新进展 每年的美国临床肿瘤学会，都被视为全球肿瘤领域权威的学术交流盛会，会议期间将展示国际最前沿的 临床肿瘤学科研进展和治疗成效。ASCO年会近日公布的常规摘要显示，中国研究者共计70余项原创研 究入选口头报告，数量超越去年（55项）。从目前公布的具体情况来看，部分研究有望为肿瘤患者带来 全新的治疗选择。 迪哲医药近日公告，公司自主研发的两款源头创新产品DZD8586、DZD6008将亮相ASCO年会，分别展 示在B细胞非霍奇金淋巴瘤（B-NHL）和非小细胞肺癌（NSCLC）领域的3项最新研究进展。其中，治 疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）的汇总分析成果将以口头报告形式公布，即 DZ ...

Core Insights - The 2025 ASCO Annual Meeting will take place from May 30 to June 3 in Chicago, showcasing significant advancements in innovative drug development from Chinese pharmaceutical companies [1][5] - Multiple drugs with "first-in-class" or "best-in-class" potential have been selected for oral presentations, highlighting the R&D capabilities of Chinese biotech firms [1] Group 1: Company Highlights - Innovent Biologics has seven studies selected for oral presentations, including IBI363 (PD1xIL2 bispecific antibody) with clinical data on non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and malignant pleural mesothelioma (MLN) [1] - China Biologic Products has twelve studies selected, with four classified as "latest breakthrough abstracts" (LBA), notably the combination of bemarituzumab and anlotinib for first-line treatment of NSCLC [1] - Kelun-Biotech will present six research outcomes, focusing on SKB264 (TROP2 ADC), A167 (PD-L1 monoclonal antibody), and A400 (RET inhibitor) [2] Group 2: Drug Development Focus - Antibody-drug conjugates (ADCs) are a major focus for domestic pharmaceutical companies at this year's meeting, with several companies showcasing their ADC products [2] - Baiyuntianheng's bispecific ADC BL-B01D1 (EGFRxHER3) will present Phase I clinical data for small cell lung cancer (SCLC) and NSCLC [3] - Zai Lab's ZG006 (DLL3xCD3 tri-antibody) will release Phase II dose expansion data for SCLC patients, along with updates on other dual-target antibodies [3] Group 3: Key Clinical Data - The combination therapy of vidutolimab and trastuzumab for HER2-positive gastric cancer will be presented in a rapid oral report [4] - The c-MET ADC RC108 will also update its progress during the meeting [4] - The ASCO 2025 meeting is positioned as a crucial platform for Chinese innovative drug companies to showcase their breakthroughs in key indications, further promoting the internationalization of domestic innovations [5]

Core Viewpoint - Dizh Medical (688192) announced that its two innovative products, DZD8586 and DZD6008, will be showcased at the 2025 American Society of Clinical Oncology (ASCO) annual meeting, highlighting the company's competitive advantages in the fields of hematological malignancies and lung cancer [1] Group 1: DZD8586 in B-NHL and CLL/SLL - DZD8586 is expected to provide a new treatment option for patients with B-cell non-Hodgkin lymphoma (B-NHL) and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) [2] - A summary analysis of a Phase I/II clinical study involving 51 patients with relapsed/refractory CLL/SLL showed an objective response rate (ORR) of 84.2% at a recommended dose of 50mg, indicating good anti-tumor efficacy and manageable safety [2] - DZD8586 also demonstrated anti-tumor activity in a Phase II study for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), with promising results to be presented at the 2025 European Hematology Association (EHA) annual meeting [2][3] Group 2: DZD6008 in NSCLC - DZD6008 is anticipated to address unmet clinical needs in non-small cell lung cancer (NSCLC), particularly for patients with EGFR mutations who have undergone multiple lines of treatment [4] - Early clinical data from the TIAN-SHAN2 study showed that 83.3% of 12 patients with advanced NSCLC experienced tumor shrinkage after treatment with DZD6008, demonstrating durable anti-tumor activity and good tolerability [4][5] - DZD6008 exhibits excellent blood-brain barrier penetration, with a concentration ratio in cerebrospinal fluid exceeding 1, indicating its potential effectiveness in patients with brain metastases [4][5] Group 3: Company Strategy and Future Outlook - The founder and CEO of Dizh Medical emphasized the company's commitment to accelerating the global development of DZD8586 and DZD6008, aiming to provide more treatment options for patients with B-NHL and NSCLC [6] - The promising clinical data presented at ASCO reinforces the company's confidence in advancing DZD8586 into Phase III clinical trials [6]

报告摘要 市场表现： 2025 年5 月23 日，医药板块涨跌幅+0.42%，跑赢沪深300 指数1.23pct，涨跌幅居申万31 个子行业第2 名。各医药子行业中，医疗设备(+1.43%)、医疗研发外包(+0.98%)、线下药店（+0.74%）表现居前，疫 苗（-0.68%)、血液制品(-0.43%)、医院（-0.27%)表现居后。个股方面，日涨幅榜前3 位分别为新天地 (+20.02%)、海辰药业(+20.00%)、多瑞医药(+20.00%)；跌幅榜前3 位为亚虹医药（-5.86%）、百济神州 (-4.15%)、润都股份（-3.94%)。 行业要闻： 近日，GSK 宣布，美国FDA 批准其"first-in-class"抗体疗法Nucala（Mepolizumab）作为辅助维持治疗， 用于伴有嗜酸性粒细胞表型、病情控制不佳的成人慢性阻塞性肺病（COPD）患者。Nucala 是一种靶向 IL-5的单克隆抗体，已开发用于治疗一系列与2 型炎症相关的IL-5 介导疾病。 该药是首个在临床表现多样COPD 人群中开展研究并获批用于嗜酸性粒细胞表型患者的生物制品，该疾 病表型以血液嗜酸性粒细胞计数（BEC）≥150 ...

本报讯(记者李亚男)5月23日晚间，迪哲(江苏)医药股份有限公司(以下简称"迪哲医药")发布公告称，其 自主研发的两款源头创新药物DZD8586和DZD6008将于2025年美国临床肿瘤学会(ASCO)年会上，分别 报告在B细胞非霍奇金淋巴瘤(B-NHL)和非小细胞肺癌(NSCLC)领域的三项最新研究进展。其中， DZD8586治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)的汇总分析结果将以口头报告形式公 布。 迪哲医药创始人、董事长兼首席执行官张小林表示："本次ASCO大会上公布的DZD8586和DZD6008多 项临床数据，进一步彰显了迪哲医药在血液瘤与肺癌难治性肿瘤领域的研发实力与全球差异性竞争优 势。尤其是DZD8586治疗慢性淋巴细胞白血病/小淋巴细胞淋巴瘤(CLL/SLL)患者疗效显著，为我们接下 来推进DZD8586的Ⅲ期临床研究注入了巨大的信心与动力。未来，我们将持续加速这两款核心产品的 全球开发步伐，期待能够给B细胞非霍奇金淋巴瘤(B-NHL)和非小细胞肺癌(NSCLC)患者提供更多治疗 新选择。" 公告显示，DZD8586是一款全球首创、可完全穿透血脑屏障的非共价LYN/BTK ...

Core Viewpoint - The company is experiencing significant revenue growth driven by the inclusion of its key products, Shuwotini and Golixitini, in the new national medical insurance catalog starting January 1, 2025, which is expected to accelerate commercialization and data readouts [1][2][5]. Performance Summary - In 2024, the company achieved sales revenue of 360 million yuan, a year-on-year increase of 294.24%, with approximately 52 million yuan of this revenue impacted by price compensation to distributors [2]. - For Q1 2025, the company reported revenue of 160 million yuan, reflecting a year-on-year growth of 96.32%, primarily due to the official implementation of the new national medical insurance catalog for its core products [2]. Catalysts Summary - Shuwotini received priority review from the FDA for its new drug application in January 2025, targeting advanced NSCLC with EGFR Exon20ins mutations, and is expected to be approved as planned [3]. - Golixitini was approved in June 2024 for the treatment of relapsed or refractory peripheral T-cell lymphoma (PTCL) in adults, showing promising overall response rates and safety [3]. - DZD8586, a dual-target inhibitor for B-NHL, is expected to present clinical data at the 2025 ASCO conference, showcasing its efficacy and safety [4]. - DZD6008, a new selective EGFR TKI, is in clinical research and aims to address unmet clinical needs in NSCLC, with preliminary data also set to be reported at the 2025 ASCO conference [4]. Profit Forecast and Valuation - The company forecasts revenues of 753 million yuan, 1.259 billion yuan, and 2.174 billion yuan for 2025, 2026, and 2027 respectively, driven by the commercialization of Shuwotini and Golixitini [5].