证券代码：688192 证券简称：迪哲医药 公告编号：2025-49 1 一、关于 DZD8586 CLL/SLL 患者在接受共价和/或非共价 BTK 抑制剂和 BCL-2 抑制剂治疗后， 极易复发。复发难治性 CLL/SLL 通常由两种耐药机制引发：C481X BTK 突变和 非 BTK 依赖性 BCR 信号通路激活，目前尚无能同时解决这两种耐药机制的治疗 方案。 DZD8586 是公司自主研发的全球首创 LYN/BTK 双靶点抑制剂，可同时阻 断 BTK 依赖性和非依赖性 BCR 信号通路，抑制降解剂的耐药突变，对 TEC 家 族其他成员具有高选择性，且可完全穿透血脑屏障。此次被 FDA 授予"快速通 道认定"，是基于 DZD8586 针对既往接受过共价或非共价 BTK 抑制剂及 BTK 降解剂治疗的 CLL/SLL 患者的 I/II 期临床研究汇总分析，该研究结果在今年 2025 美国临床肿瘤学会（ASCO）和第 18 届国际恶性淋巴瘤会议（ICML）上以口头 报告的形式报告，并在 2025 欧洲血液学协会（EHA）年会上发布。 研究数据显示，DZD8586 治疗既往接受过多种治疗的 CLL/SLL 患 ...

格隆汇8月6日丨迪哲医药(688192.SH)公布，公司在研产品DZD8586获美国食品药品监督管理局（以下 简称"FDA"）授予"快速通道认定"（"FastTrack Designation"）用于既往接受过至少两线治疗（包括布鲁 顿氏酪氨酸激酶（BTK）抑制剂和 BCL-2 抑制剂）的复发难治性慢性淋巴细胞白血病/小淋巴细胞淋巴 瘤（CLL/SLL）。 DZD8586 是公司自主研发的全球首创 LYN/BTK 双靶点抑制剂，可同时阻断 BTK 依赖性和非依赖性 BCR 信号通路，抑制降解剂的耐药突变，对TEC家族其他成员具有高选择性，且可完全穿透血脑屏 障。此次被FDA 授予"快速通道认定"，是基于 DZD8586 针对既往接受过共价或非共价BTK 抑制剂及 BTK降解剂治疗的 CLL/SLL 患者的 I/II 期临床研究汇总分析，该研究结果在今年2025美国临床肿瘤学 会（ASCO）和第 18 届国际恶性淋巴瘤会议（ICML）上以口头报告的形式报告，并在 2025 欧洲血液 学协会（EHA）年会上发布。 ...

每经AI快讯，8月6日，迪哲医药(688192.SH)公告称，公司在研产品DZD8586获美国FDA授予"快速通道 认定"，用于既往接受过至少两线治疗的复发难治性慢性淋巴细胞白血病/小淋巴细胞淋巴瘤。DZD8586 是公司自主研发的全球首创LYN/BTK双靶点抑制剂，可同时阻断BTK依赖性和非依赖性BCR信号通 路。 ...

Group 1 - The chemical pharmaceutical sector increased by 0.48% on August 4, with Hai Chen Pharmaceutical leading the gains [1] - The Shanghai Composite Index closed at 3583.31, up 0.66%, while the Shenzhen Component Index closed at 11041.56, up 0.46% [1] - Hai Chen Pharmaceutical's stock price rose by 20.01% to 41.27, with a trading volume of 285,300 shares and a transaction value of 1.101 billion [1] Group 2 - The top gainers in the chemical pharmaceutical sector included Han Yu Pharmaceutical, which rose by 19.98% to 24.32, and Guangsheng Tang, which increased by 18.18% to 120.90 [1] - The sector saw a net inflow of 97.0043 million in main funds, while retail investors contributed a net inflow of 1.279 billion [2] - The main funds showed significant net outflows in several companies, including Hai Chen Pharmaceutical, which had a net inflow of 182 million, but retail investors had a net outflow of 579.696 million [3]

Group 1 - On August 1, Dize Pharmaceutical had a financing buy-in amount of 0.16 billion, ranking 870th in the two markets [1] - The financing repayment amount on the same day was 0.23 billion, resulting in a net sell of 6.50 million [1] - Over the last three trading days, Dize Pharmaceutical received financing buy-ins of 0.14 billion, 0.19 billion, and 0.16 billion respectively [1] Group 2 - On the same day, the securities lending saw a sell of 0.00 thousand shares, with a net buy of 0.02 thousand shares [1]

Core Insights - The report highlights the significant role of company secretaries (董秘) in connecting investors and listed companies, with a total salary of 4.086 billion yuan for A-share company secretaries in 2024, averaging 754,300 yuan per year [1] Salary Distribution - The salary distribution for company secretaries in the A-share biopharmaceutical sector shows that 32% earn below 500,000 yuan, 41% earn between 500,000 and 1 million yuan, 23% earn between 1 million and 2 million yuan, 3% earn between 2 million and 3 million yuan, and 1% earn above 3 million yuan [5] Age Distribution - The age distribution of company secretaries indicates that 47% are between 40-50 years old, 23% are over 50, 29% are between 30-40, and only 1% are under 30, with the youngest being 28 years old [1] Educational Background - The educational background of company secretaries shows that 4% have an associate degree, 42% hold a bachelor's degree, 50% have a master's degree, and 4% possess a doctoral degree, with over half holding a master's degree or higher [3] Investor Engagement - There is a significant variance in the number of investor meetings held by companies, with 32% of companies hosting fewer than 10 meetings per year, while only 1% have more than 1,000 meetings [9] Top Earning Company Secretaries - The top five highest-paid company secretaries have salaries ranging from 325.65 million yuan to 738.76 million yuan, with the youngest among them being 32 years old and having just started in the role [7]

Core Insights - The report highlights that the total salary of A-share listed company secretaries reached 4.086 billion yuan in 2024, with an average annual salary of 754,300 yuan [1] - Over 21% of the secretaries earn more than 1 million yuan annually, indicating a significant compensation level in the industry [1] Salary Distribution - The salary distribution among secretaries in the biopharmaceutical sector shows that 32% earn below 500,000 yuan, 41% earn between 500,000 and 1 million yuan, 23% earn between 1 million and 2 million yuan, 3% earn between 2 million and 3 million yuan, and 1% earn above 3 million yuan [5] - Five secretaries with salaries exceeding 3 million yuan include Li Wenmei from Mindray Medical (7.3876 million yuan), Jiang Yueheng from Yifang Bio (5.2065 million yuan), and others, with the youngest being 32 years old [7] Age and Educational Background - The age distribution of secretaries shows that those aged 40-50 constitute 47%, while those over 50 account for 23%, and those aged 30-40 make up 29%. Secretaries under 30 represent 1% [1] - In terms of educational qualifications, 4% have an associate degree, 42% hold a bachelor's degree, 50% possess a master's degree, and 4% have a doctoral degree, with over half holding a master's degree or higher [3] Investor Engagement - There is a significant variance in the number of investor meetings held by companies, with 32% of companies hosting fewer than 10 meetings annually, while only 1% have more than 1,000 meetings [9] - The top five companies with the most investor meetings include Sanofi Biologics and others, with meeting counts ranging from 1,107 to 2,661 [10]

Group 1 - The article highlights the approval of ZEGFROVY® (Shuwotini Tablets) by the FDA, marking it as the first independently developed innovative drug from China approved in the U.S. for treating advanced non-small cell lung cancer with EGFR exon20 insertion mutations [3][4] - The drug received priority review and represents a significant breakthrough in targeting difficult-to-treat mutations, showcasing China's capabilities in drug innovation [3] - The article also discusses the approval of a combination drug by Lipin Pharmaceutical for treating moderate to severe Alzheimer's disease, which is the first to successfully challenge original patents under the Paragraph IV process in the U.S. [4][5] Group 2 - A study on the domestic robotic telesurgery system, Jingfeng®, was published in a prestigious international journal, demonstrating a 100% success rate in remote surgeries conducted between hospitals located 450 to 2200 kilometers apart [6][8] - The research indicates significant advancements in China's high-end medical equipment and smart healthcare, marking a milestone in the clinical application of remote surgery technology [8] Group 3 - The article mentions the inclusion of North Chip Medical's LotosPFA™ system in the Late-Breaking Clinical Trials at the ESC Congress 2025, highlighting its innovative approach to non-thermal ablation technology [11][12] - The system's design allows for safer procedures with minimal muscle contraction and reduced bubble formation during ablation, enhancing operational efficiency [11][12] Group 4 - The launch of multiple AI models in healthcare by Shenzhou Medical, including a pediatric rare disease AI model and a brain hemorrhage AI model, aims to address significant challenges in diagnosing and treating rare diseases [18][20] - The "Nezha·Lingtong" model focuses on connecting various stakeholders in pediatric healthcare, while the "Brain Ruikang" model utilizes extensive clinical data to provide personalized treatment pathways [20][22] Group 5 - Sequoia China has invested in over 200 healthcare companies with distinctive technological features and high growth potential, covering various sectors including innovative drugs and digital healthcare [24]

Group 1 - The core point of the article is that Diligent Pharma's lung cancer targeted drug, Shuwotai (Shuwotai tablets), has been included in the NCCN guidelines, making it the only small molecule targeted drug for EGFR Exon20ins non-small cell lung cancer globally [1][3][4] - Shuwotai has received FDA approval for use in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression after platinum-based chemotherapy [3][4] - The market for EGFR exon20ins patients is estimated to be no less than $2 billion, as they account for approximately 10% of non-small cell lung cancer cases [2][6] Group 2 - Following the withdrawal of Takeda's Mobocertinib from the market, Diligent Pharma will compete directly with Johnson & Johnson in the EGFR exon20ins market [5][6] - Diligent Pharma's stock price has increased significantly, rising from 58.94 yuan per share on July 2 to 76.41 yuan per share on July 30, following the approval of Shuwotai [4] - The company is currently conducting a global multi-center Phase III confirmatory trial (WU-KONG28) to push Shuwotai towards first-line treatment, with breakthrough therapy designation obtained in both China and the U.S. for first-line indications [7]

Summary of the Conference Call for Dize Pharmaceutical Company Overview - Dize Pharmaceutical was established in 2017 by Guotou Innovation and a subsidiary of AstraZeneca, and it went public on the STAR Market in 2021. The company focuses on the research and development of small molecule drugs, with a core team that has extensive international experience from AstraZeneca China [9][3]. Key Products and Market Performance Shuwotini - Shuwotini is the world's first small molecule drug targeting EGFR exon 20 insertion mutations in non-small cell lung cancer (NSCLC), already launched in China and included in medical insurance. Expected sales in China are close to 400 million RMB in 2024, projected to reach 700-800 million RMB in 2025. In the US, it is expected to be priced around $200,000 [2][4]. - The drug has rapidly become the top recommended product in treatment guidelines for second-line therapy, with an anticipated penetration rate of over 30% in second-line and around 30% in first-line treatments in China. The US market penetration is expected to reach 40% [16][17]. - The peak sales potential for Shuwotini in China is estimated at 2 billion RMB, while in the overseas market, it could reach $900 million, contributing approximately $500 million from the US market [17][22]. Gresitini - Gresitini is approved for the treatment of relapsed/refractory peripheral T-cell lymphoma (PTCL) and has entered the Chinese medical insurance system. The phase III clinical trial for first-line PTCL is expected to complete enrollment in 2025, with a potential US launch in the first half of 2026 [6][18]. - The peak sales potential for Gresitini in China is estimated at 1 billion RMB, with overseas sales potential reaching $600 million [22]. 8,586 - 8,586 is a dual-target BTK inhibitor with strong blood-brain barrier penetration, currently undergoing registration clinical trials for relapsed/refractory mantle cell lymphoma (MCL) and has potential applications in DLBCL. It aims to address resistance issues associated with BTK inhibitors [7][19]. - The domestic peak sales potential for 8,586 is estimated at 2 billion RMB, while overseas it could reach $1.5 billion [20][22]. 6,008 - 6,008 is a next-generation EGFR TKI effective against C797S mutations and has blood-brain barrier penetration capabilities. It is expected to be presented at the 2025 ASCO conference, with preliminary data anticipated by the end of the year [7][21]. - The domestic peak sales potential for 6,008 is estimated at 2 billion RMB, with overseas potential reaching $1.5 billion [21][22]. Financial Projections - The total peak sales potential for the four main products in the domestic market is projected to reach 6 billion RMB, corresponding to a market valuation of 180 billion to 200 billion RMB. In the overseas market, the combined sales potential is estimated at $3.5 billion, leading to a total target market valuation of approximately 40 billion RMB [8][22]. Competitive Landscape - Shuwotini's competitive advantages include its high safety profile and significant efficacy compared to traditional therapies, which have lower objective response rates (ORR) and progression-free survival (PFS) [13][15]. - Current competitors include companies like Ailis and Ravent, with their respective drugs showing varying efficacy and safety profiles [14]. Additional Insights - The core team of Dize Pharmaceutical has established a robust small molecule drug development platform, particularly excelling in central nervous system research, which accelerates drug development processes [9][4]. - The company aims to achieve profitability by 2027 following a recent financing round of 1.85 billion RMB, which has alleviated some negative impacts from previous share reductions [3].