迪哲医药 20250824 摘要 迪哲医药舒尔哲（舒沃替尼）获 FDA 加速批准上市，成为全球首个用于 易介发 20 插入的小细胞肺癌口服 EGFR TKI，并迅速被纳入美国 NCCN 指南，且在中国主要指南中获得最高级别推荐，为公司带来显著的市场 先发优势。 迪哲医药 8,586 项目作为全球首个宁和 BTK 双通道抑制剂，在 ASCO 大会上首次亮相并被选为大会口头报告，展示了其在 CLL 和 SLL 治疗中 的研发成果，并获得 FDA 快速通道认证，预示着其潜在的临床价值和市 场前景。 迪哲医药 2025 年上半年营业收入同比增长 74%至 3.55 亿元，销售费 用率降低约 24%，显示出舒尔哲和高瑞哲通过医保赋能实现快速放量， 商业化增长势头强劲，盈利能力显著提升。 迪哲医药成功完成科创板八条后首家再融资发行，募集资金近 18 亿元， 现金储备增至 22.51 亿元，为核心在研产品的高效开发提供了坚实的资 金保障，缓解了投资人对公司现金流的担忧。 Q&A 2025 年上半年迪哲医药有哪些重要的里程碑事件？ 2025 年上半年，迪哲医药取得了一系列重要的里程碑事件。首先，今年 1 月， 舒尔哲（Shu ...

财务报表中对有大幅变动的财务项目的原因说明如下： 货币资金变动幅度为397.5%,原因:向特定对象发行股票，募集资金到位。 在建工程变动幅度为66.92%,原因:公司研发及生产基地一期建设项目投入增长。 交易性金融资产变动幅度为70.58%,原因:公司利用闲置募集资金购买结构性存款。 据证券之星公开数据整理，近期迪哲医药（688192）发布2025年中报。根据财报显示，迪哲医药增收不 增利。截至本报告期末，公司营业总收入3.55亿元，同比上升74.4%，归母净利润-3.77亿元，同比下降 9.46%。按单季度数据看，第二季度营业总收入1.95亿元，同比上升59.83%，第二季度归母净利润-1.85 亿元，同比下降53.38%。 本次财报公布的各项数据指标表现一般。其中，毛利率95.6%，同比减2.11%，净利率-106.77%，同比 增49.73%，销售费用、管理费用、财务费用总计3.55亿元，三费占营收比99.87%，同比减28.75%，每股 净资产3.54元，同比增141.27%，每股经营性现金流-0.58元，同比增20.43%，每股收益-0.87元，同比减 4.82% | 项目 | 2024年中报 | ...

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 [1][2]. 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 [1]. - The drug is the only approved small molecule targeted therapy for EGFR exon 20 insertion NSCLC in China, with a projected peak sales in the Chinese market of approximately 3.076 billion yuan [2]. - The approval in the U.S. opens up new market opportunities, with a potential global sales peak estimated at 12.954 billion yuan [2]. Group 2: Commercialization Strategy - The company is currently evaluating various overseas market expansion models, aiming to maximize long-term benefits and shareholder returns [3]. - The CEO indicated that the overseas market could become a significant growth driver, while the domestic market remains crucial [3]. - The company has a commercial team nearing 500 members to enhance market coverage for its products [3]. Group 3: Research and Development Pipeline - The company has a robust pipeline with seven drug candidates in international multi-center clinical stages, focusing on unmet medical needs in lung cancer and hematological malignancies [3][4]. - DZD6008, a selective EGFR TKI, shows promise in treating NSCLC patients who have failed multiple lines of therapy [5]. - DZD8586 is a novel dual-target inhibitor that addresses resistance mechanisms in B-cell non-Hodgkin lymphoma, demonstrating good anti-tumor activity [6]. Group 4: Financial Performance and Investment - The company has seen a reduction in net losses, with a reported loss of approximately 850 million yuan in 2024, down 24% year-on-year [7]. - The company successfully raised nearly 1.8 billion yuan through a private placement, with plans to invest over 1 billion yuan in new drug research and development [8]. - The company is actively assessing potential partners for business development (BD) to enhance its global strategy without compromising long-term value [9].

Core Viewpoint - The company, Dize Pharmaceutical, emphasizes its commitment to "source innovation" and "global competition," successfully validating its capability in international multi-center clinical research and overseas approval for innovative drugs [1][3]. Group 1: Company Overview - Dize Pharmaceutical focuses on innovative therapies for malignant tumors and immune diseases, aiming to address unmet clinical needs globally [1][2]. - The company has established seven globally competitive product pipelines, with two leading products, Shuwozhe and Huiruozhe, having reached key clinical trial endpoints and received approvals in China and the U.S. [1][3]. Group 2: Product Development and Clinical Trials - Shuwozhe was included in the NCCN guidelines for treating EGFR exon20ins non-small cell lung cancer (NSCLC) and received FDA approval, filling a significant treatment gap [2][3]. - The company has conducted over 200 clinical trials across more than 20 countries, with ongoing global Phase III clinical studies for Shuwozhe and DZD8586 [4][5]. Group 3: Financial Performance - In 2024, Dize Pharmaceutical reported a revenue of 360 million yuan, a 294% increase year-on-year, and for Q1 2025, revenue reached 160 million yuan, reflecting a 96% growth [6]. Group 4: Strategic Insights - The company advocates for early international multi-center clinical trials to validate drugs and gain international recognition, suggesting that this approach is crucial for domestic pharmaceutical companies aiming for global markets [4][5]. - Dize Pharmaceutical's core strategy involves developing drugs for global competition while establishing technological barriers in familiar and advantageous fields [5][6].

Core Insights - The establishment of the Sci-Tech Innovation Board (STAR Market) has enabled 20 innovative biopharmaceutical companies to list under the fifth set of listing standards, reshaping China's biopharmaceutical landscape [1] - The China Securities Regulatory Commission (CSRC) has introduced measures to enhance the STAR Market's support for high-growth, unprofitable tech companies, emphasizing the importance of "hard technology" [1][3] - The fifth set of listing standards allows unprofitable innovative companies to raise funds, breaking traditional capital market constraints and facilitating financing for R&D-focused firms [1][2] Industry Developments - Since its inception, the STAR Market has seen 20 innovative biopharmaceutical companies adopt the fifth set of listing standards, with significant fundraising efforts directed towards advanced technologies such as antibody drugs and ADCs [1] - In 2024, these 20 companies collectively achieved revenue of 14.21 billion yuan, a year-on-year increase of 44.17%, with several companies projected to exceed 1 billion yuan in revenue soon [1] - Companies like Dizhe Pharmaceutical have reported substantial revenue growth, with a 294.24% increase to 360 million yuan, driven by innovative drug development [2] Company Performance - Companies such as Junshi Biosciences have successfully raised over 8 billion yuan through the STAR Market, significantly advancing their clinical projects and R&D initiatives [2][3] - Ailis, which listed under the fifth set of standards, achieved commercialization of its core product within 2 years and 5 months, demonstrating the effectiveness of the STAR Market in supporting innovative firms [3] - ShenZhou Cell has transitioned from having no products or revenue at the time of listing to achieving 2.51 billion yuan in revenue, marking a successful turnaround [5] Innovation Ecosystem - The STAR Market has fostered an innovation-driven ecosystem, enhancing the flow of resources and increasing recognition of innovative technologies within the capital market [3][4] - Companies are increasingly focusing their resources on R&D, maintaining high levels of investment intensity, and establishing a virtuous cycle of research and development [6] - The introduction of the STAR Market has led to a fundamental shift in the development logic of listed companies, prioritizing quality over scale and fostering collaborative ecosystems [6]

Group 1 - The establishment of the Sci-Tech Innovation Board (STAR Market) has enabled 20 innovative biopharmaceutical companies to list under the fifth set of listing standards, shaping the landscape of China's biopharmaceutical industry [1][2] - The fifth set of listing standards is designed for unprofitable but high-growth technology companies, allowing them to raise funds during the research and development phase [1][2] - The China Securities Regulatory Commission (CSRC) has emphasized the importance of supporting high-quality unprofitable technology companies to list on the STAR Market, enhancing the inclusiveness of the listing system [1][2] Group 2 - Since the launch of the STAR Market, 20 innovative biopharmaceutical companies have utilized the fifth set of listing standards, with significant fundraising efforts directed towards advanced technologies such as antibody drugs and ADCs [2][3] - In 2024, these 20 companies collectively achieved revenue of 14.21 billion yuan, a year-on-year increase of 44.17%, with several companies expected to surpass 1 billion yuan in revenue in the coming years [2][3] - Companies like Elysium and Zhenzhong Cell have demonstrated remarkable growth, with revenues reaching 3.5 billion yuan and 2.5 billion yuan respectively, showcasing the potential of unprofitable companies to achieve significant revenue post-listing [2][3] Group 3 - The STAR Market has provided a diversified financing channel for innovative drug companies, enabling them to secure substantial funding for their R&D projects [3][4] - Companies like Junshi Biosciences have raised over 8 billion yuan through the STAR Market, facilitating the advancement of clinical projects and the development of new research initiatives [3][4] - The innovative listing standards have proven beneficial for companies like Elysium, which transitioned from unprofitable to profitable status within a short period, validating the effectiveness of the STAR Market's framework [4] Group 4 - The STAR Market has activated an innovation ecosystem by enhancing the flow of capital and increasing recognition of innovative technologies, thereby encouraging investment in R&D and talent cultivation [5][6] - Companies have leveraged their STAR Market listings to enhance their visibility and credibility in both domestic and international markets, leading to increased investment in R&D [5][6] - The collaborative efforts between companies and academic institutions have fostered technology transfer and improved innovation capabilities, contributing to the overall growth of the industry [5][6] Group 5 - The STAR Market has facilitated the transition of companies from having no products or revenue to successfully launching multiple products and achieving significant sales [6][7] - Companies like Mankang Pharmaceutical have effectively resolved financing bottlenecks through STAR Market fundraising, allowing for increased investment in innovative drug development [6][7] - The STAR Market is fostering a closed-loop ecosystem driven by innovation, with companies focusing on R&D and creating a virtuous cycle of development [7][8]

Core Viewpoint - DIZHE Pharmaceutical is set to present significant research advancements for its innovative drugs, Golixty and DZD8586, at the upcoming 2025 European Hematology Association (EHA) annual meeting and the 18th International Conference on Malignant Lymphoma (ICML) [2] Group 1: Golixty for PTCL - Golixty offers new hope for patients with Peripheral T-cell Lymphoma (PTCL) who experience relapse after first-line treatment, with approximately 40% of patients achieving complete remission (CR) and 80% achieving partial remission (PR) relapsing within two years [3] - A Phase II prospective multicenter clinical study shows that Golixty maintenance therapy after first-line systemic treatment results in a 24-month disease-free survival rate of 74.2% for CR1 patients, and a 50.0% complete remission rate with a median duration of response of 23.9 months for PR patients [3] - Golixty is a new generation, oral, highly selective JAK1 inhibitor that may address the lack of effective maintenance treatment options for PTCL, demonstrating significant anti-tumor activity and safety [4] Group 2: DZD8586 for B-NHL - DZD8586 shows promise as a new treatment strategy for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL), with an objective response rate of 84.2% in patients previously treated with various therapies [5] - The drug exhibits significant anti-tumor efficacy and good safety profile, with no observed drug-related bleeding, atrial fibrillation, or major cardiac risks [6] - DZD8586's potential to overcome limitations of traditional small molecule drugs in treating Diffuse Large B-cell Lymphoma (DLBCL) is highlighted, as it blocks BTK and LYN signaling pathways, improving clinical outcomes [6] Group 3: Company Commitment - DIZHE Pharmaceutical's founder and CEO expresses excitement over the clinical potential of Golixty and DZD8586 in addressing significant unmet needs in PTCL and B-NHL, emphasizing the recognition of their innovative capabilities [6]

Core Insights - The "Innovation Drug Industry Special Session" showcased 18 leading biopharmaceutical companies from the Sci-Tech Innovation Board, highlighting their technological breakthroughs and international collaboration strategies [1] - The innovation-driven growth of these companies is evident through significant R&D investments and the successful transition of laboratory results to clinical applications, with 6 new first-class innovative drugs launched in 2024 [2] - The commercialization process is accelerating, with companies experiencing explosive sales growth and improved profitability due to optimized production costs and mature sales systems [3] R&D Investment and Strategies - In 2024, BaiLi Tianheng's R&D investment reached 1.443 billion yuan, a year-on-year increase of over 90%, with 15 candidate drugs in clinical stages and over 80 clinical trials globally [2] - Junshi Bioscience is focusing resources on high-potential projects and exploring next-generation innovative therapies for cancer and autoimmune diseases, with multiple products expected to enter critical registration clinical trials by 2025 [2] - Frontier Biotech is optimizing its pipeline layout based on market needs, focusing on long-acting HIV drugs and new technology RNA drugs, ensuring sustainable development through differentiated competitive advantages [2] Commercialization and Financial Performance - In 2024, Dize Pharmaceutical achieved sales revenue of 360 million yuan, a year-on-year increase of 294.24%, with two products included in the national medical insurance directory [3] - Junshi Bioscience reported a revenue of 1.948 billion yuan in 2024, a 30% increase, with a 44% reduction in net losses, attributed to cost control and resource allocation towards promising R&D projects [4] - Companies are enhancing their global market strategies, with BaiLi Tianheng aiming to become a multinational pharmaceutical company with leading capabilities in tumor treatment by 2028 [4][5]

迪哲医药是"科八条"发布以来，再融资获得证监会注册的首家上交所未盈利企业。 迪哲医药本次再融资的目的，是计划投资新药研发以及国际标准创新药产业化项目，同时补充流动资 金。公司目前对于临床试验产品及商业化产品是以生产外包服务（CMO）的形式对其进行委托生产。 生物医药资本市场是否有逐渐回暖趋势，受到市场关注。根据东方财富Choice金融终端数据，今年以 来，截至4月16日，科创板生物产业板块中的110只个股，有一半以上的个股累计涨幅为正数，其中累计 涨幅超过30%的共有17只。 迪哲医药已有两款产品舒沃哲和高瑞哲在国内上市并进入新版国家医保目录，并且舒沃哲向美国食品药 品监督管理局（FDA）递交的上市申请已经获得受理并纳入优先审评。 近期有部分券商唱多创新药行业，认为受到的"对等关税"影响很低。如国金证券认为，中国创新药出海 多数采用BD（Business Development，商务合作，即将药物的海外开发权益授权给国外药企）、NewCo （设立海外新公司，授权管线并获得股权）等方式，其本质是IP（Intellectual Property）的交易，并不 涉及具体药品的制造出口，关税波动风险小。 根据公司前期 ...