Investment Rating - The investment rating for the company is "Buy" (maintained) [1] Core Views - The company has reported a significant increase in revenue, achieving 204 million yuan in the first half of 2024, compared to no revenue in the same period of 2023. The net profit attributable to shareholders was -345 million yuan, showing a reduction in losses year-on-year [2] - The company is expected to see accelerated revenue growth as its product pipeline continues to expand and adapt to new indications, with projected revenues for 2024, 2025, and 2026 being 471 million yuan, 1.049 billion yuan, and 1.646 billion yuan respectively [6][7] - The company’s drug, Shuwotini, has been included in the CSCO guidelines and is expected to continue its growth in sales due to its unique position as the only approved targeted therapy for EGFR Exon20ins NSCLC [4] Summary by Sections Financial Performance - In the first half of 2024, the company achieved revenue of 204 million yuan, with a net profit of -345 million yuan, indicating a year-on-year reduction in losses [2] - The projected revenues for the next three years are 471 million yuan in 2024, 1.049 billion yuan in 2025, and 1.646 billion yuan in 2026, reflecting a growth rate of 416% in 2024 [6][7] Product Pipeline - The company’s drug, Shuwotini, received approval in August 2023 and has been recommended as a first-line treatment in the CSCO guidelines, which is expected to drive sales growth [4] - The company is advancing its other drug candidates, including DZD8586 and DZD6008, which are in various stages of clinical trials and have shown promising results [3][4] Market Performance - The company has outperformed the CSI 300 index with a 12-month performance of 14.0%, while the index itself has declined by 12.3% [3] - As of August 30, 2024, the company's stock price is 37.65 yuan, with a market capitalization of approximately 15.65 billion yuan [3]

Financial Performance - The company's operating revenue for the first half of 2024 was CNY 203,550,120, showing a significant decrease compared to the previous year[14]. - The net profit attributable to shareholders for the same period was a loss of CNY 344,750,887.77, an improvement from a loss of CNY 514,252,601.51 in the previous year[14]. - The net cash flow from operating activities was a negative CNY 300,946,766.51, compared to a negative CNY 440,326,121.29 in the same period last year[14]. - The total assets increased by 9.93% to CNY 1,644,969,645.45 compared to the end of the previous year[14]. - The net assets attributable to shareholders decreased by 28.23% to CNY 609,058,359.39 compared to the end of the previous year[14]. - The basic earnings per share for the first half of 2024 was -CNY 0.83, an improvement from -CNY 1.26 in the same period last year[15]. - The company reported a net loss of CNY 2,210,149,621.38 for the first half of 2024, an improvement from a loss of CNY 2,491,375,362.62 in the previous period[110]. - The total comprehensive loss for the first half of 2024 was CNY 432,298,176.68, compared to a loss of CNY 514,252,601.51 in the same period of 2023[113]. Research and Development - The R&D investment accounted for 188.05% of the operating revenue, indicating a strong focus on research and development[15]. - The company achieved a sales revenue of CNY 203.55 million in the first half of 2024, with the product GaoRuizhe® receiving its registration certificate and issuing the first prescriptions within two days[26]. - The company has established a strong clinical development pipeline, addressing unmet clinical needs in oncology[20]. - The company is committed to source innovation and has a team with over 20 years of experience in drug development and clinical research[25]. - The company has six innovative drugs in global clinical research, with two already approved for market[43]. - The total R&D investment reached approximately ¥382.77 million, an increase of 11.45% compared to the previous year[38]. - The company is transitioning from Me-too drugs to First-in-class and Best-in-class innovations, aligning with new national guidelines for drug development[34]. Corporate Governance - The board of directors confirmed the authenticity, accuracy, and completeness of the semi-annual report[2]. - There are no special arrangements for corporate governance[4]. - The company has not violated decision-making procedures for external guarantees[4]. - The company has not reported any non-recurring gains or losses for the current period[16]. - The company has no major litigation or arbitration matters pending during the reporting period[80]. - The company has no significant related transactions involving asset acquisitions or share purchases that have not been disclosed[82]. Market and Competition - The global oncology drug market is projected to reach USD 419.8 billion by 2030, with China's market expected to reach CNY 548.4 billion[30]. - The company faces competition from major pharmaceutical and biotech firms, which may develop superior drugs, posing a risk to the market value of its existing and pipeline products[48]. - The company is actively pursuing inclusion of its products in the national medical insurance directory to improve patient accessibility[26]. Financial Management - The company relies on external financing for operational funding, and any shortfall in securing sufficient funds could pressure its financial situation[50]. - The company’s long-term borrowings increased by 206.31% to CNY 424 million, primarily due to mid-term working capital loans and project financing[58]. - The average price reduction for drugs successfully negotiated in 2023 was 61.7%, which may impact future product revenues[52]. - The company’s cash and cash equivalents increased by 38.60% to CNY 103 million, reflecting improved operational cash flow[58]. Environmental and Social Responsibility - The company invested 19.84 million yuan in environmental protection during the reporting period[70]. - The company has committed to carbon neutrality by reducing greenhouse gas emissions through various energy-saving technologies and clean energy procurement[70]. - The company promotes water conservation and has implemented water reuse systems, reducing the demand for fresh water resources[72]. Shareholder Information - The company has extended the lock-up period for major shareholders by 6 months following its initial public offering[74]. - The company has a commitment that shareholders cannot reduce their holdings of pre-IPO shares for three full accounting years unless the company becomes profitable[100]. - The company has a total of 288,616,387 shares under equity incentives, with various exercise periods scheduled until 2027[94]. Risk Factors - Risks include potential further losses due to increased investments in clinical trials, drug registration, and market promotion, which may adversely affect financial conditions[47]. - There is a risk of losing core technical personnel, which could negatively impact R&D capabilities and financial performance due to the need for higher compensation to retain talent[48]. - Clinical trial progress may be hindered by various factors, potentially delaying regulatory approvals and adversely affecting business operations[49]. Accounting Policies - The financial statements are prepared in accordance with the Chinese Accounting Standards and reflect the company's financial position accurately[136]. - The company’s accounting policies are tailored to its operational characteristics, including the measurement of expected credit losses and depreciation of fixed assets[135]. - The group recognizes expected credit losses based on historical experience and current conditions, with a focus on the probability-weighted present value of cash flows[146].

迪哲医药-U(688192.SH)深度报告： 周小刚(证券分析师) 万鹏辉(证券分析师) S0350521090002 S0350524050003 zhouxg@ghzq.com.cn wanph@ghzq.com.cn | --- | --- | |--------------------|-------------| | 市场数据 | 2024/06/19 | | 当前价格（元） | 41.01 | | 52周价格区间（元） | 24.82-54.58 | | 总市值（百万） | 17,045.93 | | 流通市值（百万） | 5,047.72 | | 总股本（万股） | 41,565.31 | | 流通股本（万股） | 12,308.50 | | 日均成交额（百万） | 65.01 | | 近一月换手（%） | 22.86 | 表现 请务必阅读报告附注中的风险提示和免责声明 2 u 盈利预测：考虑到公司产品创新性高，随着在研管线陆续获批上市，我们预计公司2024-2026年收入分别为4.58、10.49、16.46亿元， 对应归母净利润-7.49、-4.27、0.17亿元，公司是创新型生物医药企业， ...

本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 迪哲（江苏）医药股份有限公司（以下简称"公司"）自主研发的 I 类新药高 瑞哲®（通用名：戈利昔替尼胶囊）正式获得国家药品监督管理局（NMPA）批准， 单药适用于既往至少接受过一线系统性治疗的复发或难治的外周 T 细胞淋巴瘤 （r/r PTCL）成人患者。高瑞哲®是全球首个且唯一作用于 JAK/STAT 通路的治疗 外周 T 细胞淋巴瘤的新药物。单药治疗呈现出病症深度缓解、所有亚型全面获 益、显度延长生存的突破性优势。 一、药品相关情况 证券代码：688192 证券简称：迪哲医药 公告编号：2024-27 迪哲（江苏）医药股份有限公司 自愿披露关于高瑞哲®（戈利昔替尼胶囊） 获得国家药监局批准上市的公告 研究结果显示，高瑞哲®单药治疗复发难治外周 T 细胞淋巴瘤： ● 深度缓解：经 IRC 确认的 ORR 达 44.3%，完全缓解（CR）率达 23.9%， 均是既往靶向治疗方案的近 2 倍。 ● 全面获益：在不同亚型 PTCL 中均观察到肿瘤缓解，满足了既往药物无 法覆盖的 P ...

一个催化剂的所以说整体还是比较看好这个迪哲的然后在我们这个发布报告之后呢整个公司的股价表现也是比较不错的那么接下来呢就给各位领导来展开一下我们的这个报告首先呢迪哲呢他这个公司的这个还是比较坚持这个源头的创新的然后整个公司这个研发的理念就是希望所研发的药物呢能够比较好的来满足 目前全球的这样一个未满足的临床需求同时呢公司的这个转化医学的平台是比较领先的也是依托着这样一个平台呢建立了比较具有创新性和市场潜力的这样一个小分子的研发管线目前呢是有5款产品是处于这个临床阶段的那么公司的管理团队呢也是这种比较豪华吧然后多名的核心人员呢是来自阿斯利康的这个中国创新中心的 那么在研发投入方面的公司也是持续的加大了他们的研发投入然后推动着公司整个高质量的一个创新吧同时呢公司也是实施了这个股权激烈计划也是彰显了公司的一个长期发展的信心那么这个是关于公司一个整体的情况公司它的这个核心的价值呢还是在于它的这三个核心的药物方面舒沃提尼 戈利奇提尼以及8586这三个产品那么接下来呢就给各位领导来展开一下这三个产品 首先是舒沃蒂尼 舒沃蒂尼是这个把像EGFR20万强子的这样一个小分子的TKR药物然后整个目前在全球范围内的研发进度是比较领先 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-26 一、ASCO 大会口头报告 舒沃哲®是一款针对多种 EGFR 突变亚型的高选择性 EGFR 靶向药物，是肺 癌领域首个获中美双"突破性疗法认定"的国创新药。基于中国注册临床研究"悟 空 6"（WU-KONG6）的积极结果，舒沃哲®于 2023 年 8 月在国内获批上市，是 目前全球唯一获批且可及的靶向 EGFR Exon20ins NSCLC 的小分子酪氨酸激酶 抑制剂（TKI）。 "悟空 1B"（WU-KONG1B）是一项在欧美、澳洲、亚洲等全球 10 个国家 及地区开展的 II 期、开放标签、国际多中心注册临床研究，旨在评估舒沃哲®治 疗含铂化疗失败或不耐受的 EGFR Exon20ins NSCLC 的疗效和安全性，主要研 究终点为独立影像评估委员会（IRC）评估的客观缓解率（ORR），关键次要研 究终点为中位缓解持续时间（mDoR）。 截至 2024 年 3 月 22 日，II 期推荐剂量（RP2D）300 mg 剂量组共纳入 111 1 例经治 EGFR Exon20ins NSCLC 患者，其中 107 例纳入疗效分析集，亚裔/ ...

证券代码：688192 证券简称：迪哲医药 迪哲（江苏）医药股份有限公司 投资者关系活动记录表 （2024年4月-5月） 投资者关系 □特定对象调研 分析师会议 □媒体采访 业绩说明会 活动类别 □新闻发布会 路演活动 □现场参观 一对一沟通 其他（电话会议） 出席单位 浙商证券，中金公司，天风证券，中信证券，兴业证券，申万宏 及人员 源，东吴证券，长江证券，海通证券，信达证券，华西证券，广 发证券，保宁资产等 ...

证券代码：688192 证券简称：迪哲医药 公告编号：2024-25 迪哲（江苏）医药股份有限公司 自愿披露关于舒沃哲®最新研究成果获选 2024 年美国临床 肿瘤学会（ASCO）大会报告的公告 本公司董事会及全体董事保证公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏，并对其内容的真实性、准确性和完整性依法承担法律责任。 迪哲（江苏）医药股份有限公司（以下简称"公司"）将在 2024 年 5 月 31 日—6 月 4 日于芝加哥举行的美国临床肿瘤学会（ASCO）年会上，公布其自主 研发的 I 类新型肺癌靶向药舒沃哲®（通用名：舒沃替尼片）针对表皮生长因子 受体（EGFR）20 号外显子插入（Exon20ins）突变型晚期非小细胞肺癌（NSCLC） 的两项最新研究成果。其中舒沃哲®针对经治 EGFR Exon20ins 突变型 NSCLC 的 全球注册临床研究"悟空 1 B 部分"（WU-KONG1 Part B）数据将在本次大会以 口头报告形式首次公布。初步分析结果表明，研究已达到其预设的主要研究终点， 舒沃哲®二/后线治疗 EGFR Exon20ins 突变 NSCLC 展现出积极的抗肿瘤疗效， 且安 ...

Investment Rating - The report assigns a "Buy" rating to the company, with a target price of 51.66 RMB, representing a 24.4% upside from the latest closing price of 41.52 RMB [12][17] Core Views - The company is a global innovative biopharmaceutical enterprise focused on oncology and immunology, with a differentiated pipeline and strong R&D capabilities [17][28] - Its lead product, Sunvozertinib, is a best-in-class EGFR Exon20ins inhibitor for NSCLC, with global competitiveness and rapid commercialization [17][28] - Golvatinib, a highly selective JAK1 inhibitor, is expected to be the second commercialized product, enhancing the company's competitiveness in oncology and immunology [17][39] Financial Projections - The company is expected to achieve revenues of 466 million RMB, 902 million RMB, and 1.512 billion RMB in 2024, 2025, and 2026, respectively, with EPS of -1.95 RMB, -1.22 RMB, and -0.14 RMB [17][20] - The DCF valuation method is used, assuming a perpetual growth rate of 2%, β coefficient of 2.3, risk-free rate of 2.75%, and market return of 7.8%, resulting in a WACC of 11.93% and a valuation of 21.473 billion RMB [12][17] Pipeline Overview - The company has six globally competitive product pipelines, with two leading products in global pivotal clinical trials, one of which has been approved for marketing [17][28] - Sunvozertinib, the first commercialized product, has achieved cumulative sales revenue of approximately 173 million RMB in just over seven months since its launch [17][28] - Golvatinib, a highly selective JAK1 inhibitor, has been accepted for NDA and included in the priority review process in China, with global registration clinical studies showing promising results [17][39] R&D and Commercialization - The company has a strong R&D team with global leading translational science and molecular design capabilities, ensuring efficient R&D and commercialization processes [34][40] - R&D investment continues to increase, with 806 million RMB in 2023, a 21.23% year-on-year increase, and the R&D team has grown to 261 members, with 75.9% holding master's or doctoral degrees [40][41] Market Potential - Sunvozertinib addresses the unmet clinical needs of EGFR Exon20ins NSCLC patients, with a global market potential of 74,000 new patients by 2024 [46][47] - Golvatinib targets the unmet needs of PTCL patients, with a global market potential of 41,000 new patients by 2024 [64][65]

北京市中伦律师事务所 关于迪哲（江苏）医药股份有限公司 2023 年年度股东大会的 法律意见书 二〇二四年五月 北京市朝阳区金和东路 20 号院正大中心 3 号南塔 22-31 层 邮编：100020 22-31/F, South Tower of CP Center, 20 Jin He East Avenue, Chaoyang District, Beijing l00020, P.R. China 电话/Tel : +86 10 5957 2288 传真/Fax : +86 10 6568 1022/1838 www.zhonglun.com 北京市中伦律师事务所 关于迪哲（江苏）医药股份有限公司 2023 年年度股东大会的 法律意见书 致：迪哲（江苏）医药股份有限公司 根据迪哲（江苏）医药股份有限公司（以下简称"公司"）与北京市中伦律 师事务所（以下简称"本所"）签订的《常年法律服务协议》的约定，本所律师 对公司 2023 年年度股东大会（以下简称"本次股东大会"）的合法性进行见证 并出具法律意见。 本法律意见书根据《中华人民共和国公司法》（以下简称"《公司法》"）、 《中华人民共和国证券法》（以下 ...