Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical industry, indicating a positive outlook for the sector compared to the overall market performance [23]. Core Insights - The pharmaceutical sector experienced a decline of 4.4% this week, underperforming the Shanghai Composite Index, which fell by 0.5% [2][3]. - The overall valuation of the pharmaceutical sector stands at 28.7 times PE (2025E), ranking it 5th among 31 sub-industries [5][10]. - Recent policies from the National Medical Products Administration (NMPA) aim to support the development of high-end medical devices and accelerate the clinical review process for innovative drugs [12]. - Shengnuo Biopharma forecasts a significant profit increase for H1 2025, with expected net profit ranging from 77.03 million to 94.14 million yuan, marking a year-on-year growth of 253.54% to 332.10% [13]. Market Performance - The pharmaceutical and biotechnology index ranked 29th out of 31 sub-industries this week, with various segments showing declines, including chemical preparations (-5.7%) and medical devices (-3.7%) [2][5]. - The report highlights the strong growth in product revenue and licensing deals in the innovative drug sector over the past three years, with a focus on companies expected to release major products and those involved in the CXO industry [12]. Key Events - The NMPA has approved measures to encourage the innovation of high-end medical devices, including optimizing special approval processes and enhancing regulatory frameworks [12]. - The NMPA has also proposed a 30-day review process for clinical trial applications of innovative drugs, aimed at improving the efficiency of drug development [12].

Core Viewpoint - The company, Dize Pharmaceutical, is preparing for its 2024 Annual General Meeting (AGM) and has outlined various proposals, including changes to its registered capital, amendments to the company’s articles of association, and the election of new independent directors. The company reported significant growth in sales and ongoing advancements in its drug development pipeline, while also addressing its financial performance and governance structure. Group 1: AGM Preparation and Governance - The company has established guidelines for the 2024 AGM to ensure the orderly conduct of the meeting and the protection of shareholder rights [2][3] - Shareholders and their representatives are entitled to speak, inquire, and vote during the AGM, with specific procedures for raising questions and making statements [3][4] - The AGM will utilize both on-site and online voting methods, with detailed instructions provided for participation [6][8] Group 2: Financial Performance - In 2024, the company achieved a sales revenue of 360 million yuan, representing a year-on-year increase of 294.24% [11][31] - The company reported a net loss of approximately 846 million yuan for the year, leading to a proposal not to distribute dividends or issue new shares [34] - Research and development expenses for 2024 were approximately 724 million yuan, a decrease of 10.17% compared to the previous year [31][32] Group 3: Drug Development and Market Position - The company’s core products, including Shuwozhe® and Gaoruizhe®, received regulatory approvals and are expected to drive future sales growth [11][31] - Significant progress has been made in the development of new drugs, with several candidates receiving breakthrough designations from regulatory authorities [12][13] - The company is actively expanding its market sales system and has established a robust supply chain to enhance operational efficiency [15][17] Group 4: Corporate Governance and Board Structure - The company has undergone changes in its board of directors, including the appointment of a new independent director to ensure compliance with governance standards [16] - The board has held multiple meetings to review and approve key decisions, ensuring adherence to legal and regulatory requirements [18][20] - The company emphasizes the importance of independent directors in safeguarding the interests of minority shareholders [20][27]

Group 1 - Chengjian Development received a dividend of 7.1282 million yuan from Beijing Jingcheng Jiaye Property Co., Ltd., in which it holds a 33.47% stake [1] - Shengnuo Bio expects a net profit attributable to shareholders of 77.0275 million to 94.1448 million yuan for the first half of 2025, representing a year-on-year increase of 253.54% to 332.10% [1] - JKN2301 dry mixed suspension has been approved for clinical trials, targeting children with influenza [5][6] Group 2 - Jindawei obtained a patent for a method of purifying natto kinase, with a validity of twenty years [2] - CITIC Guoan plans to increase its stake in China Broadcasting Hunan Company to approximately 5.29% through a capital increase of 278 million yuan [2] - Ji Electric announced the resignation of its general manager, Niu Guojun, due to work changes [3] Group 3 - Xintian Green Energy successfully issued 1.5 billion yuan in green medium-term notes with a term of 3+N years and an interest rate of 2.05% [7] - Hengrun Co. plans to invest 1.2 billion yuan in a project to produce 2,000 sets of wind turbine gearbox components [9] - Pulaide received a government subsidy of 10 million yuan, accounting for 15.87% of its audited net profit for the last fiscal year [10] Group 4 - Boteng Co. passed the EU QP audit, receiving a compliance statement for its CDMO services [12] - Zhou Dasheng added 7 self-operated stores in May, with total investments ranging from 900,000 to 6.5 million yuan [13] - Wantai Bio initiated a Phase III clinical trial for its live attenuated varicella vaccine [15] Group 5 - Shanghai Pharmaceuticals received a drug registration certificate for Pregabalin capsules in Thailand [19] - Sanxing Medical's subsidiary is expected to win contracts worth approximately 143 million yuan from State Grid projects [21] - Jiangsu Huachen plans to issue 460 million yuan in convertible bonds [24] Group 6 - Jian Gong Repair won a soil pollution remediation project worth 32.76 million yuan [25] - Dize Pharmaceutical completed patient enrollment for a global Phase III clinical trial of its drug [26] - Del Co. received acceptance for its application to issue shares for asset acquisition and raise matching funds [27] Group 7 - Beijing Kerui won multiple power grid projects with a total value of approximately 154 million yuan [27] - Xie Chuang Data signed financing lease contracts totaling 498 million yuan with Su Yin Financial Leasing [28] - Meige Intelligent submitted an application for H-share listing on the Hong Kong Stock Exchange [29][31] Group 8 - Aikodi plans to repurchase shares worth 100 million to 200 million yuan for employee stock ownership plans [54] - Kong Kong Industrial intends to sell 80% of Tianyuan Construction to its controlling shareholder [55] - Youyou Green Energy proposed a cash dividend of 12 yuan per 10 shares, totaling 50.4 million yuan [55]

证券代码：688192 证券简称：迪哲医药 公告编号：2025-38 迪哲（江苏）医药股份有限公司 自愿披露关于舒沃哲®对比含铂化疗完成一线治疗 EGFR 20 号 外显子插入突变的晚期非小细胞肺癌全球多中心 III 期临床试验 患者入组的公告 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"）近日完成了舒沃哲® （通用名：舒沃替尼片）对比含铂化疗一线治疗携带表皮生长因子受体（EGFR） 20 号外显子插入突变（Exon20ins）的晚期非小细胞肺癌（NSCLC）的全球多中 心 III 期临床试验（悟空 28，WU-KONG28）的患者入组。 舒沃哲®是公司自主研发的一款口服、不可逆、针对多种 EGFR 突变亚型的 高选择性 EGFR 酪氨酸激酶抑制剂（TKI），是目前全球唯一获批治疗 EGFR Exon20ins NSCLC 的口服小分子靶向药，也是全线治疗该适应症目前首个且唯一 获中、美双"突破性疗法认定"（BTD）的创新药物。 一、关于舒沃哲® 由于研发药品具有高科技、高风 ...

Investment Rating - The report maintains a "Buy" rating for multiple companies in the pharmaceutical and biotech industry, indicating a positive outlook on their growth potential and market performance [6]. Core Insights - The ASCO conference showcased significant advancements in domestic innovative drugs, highlighting the competitive edge of Chinese pharmaceutical companies in the global market [4][12]. - The report emphasizes the clinical value and market potential of several key drugs presented at ASCO, including promising results from various companies [4][12]. Summary by Relevant Sections Domestic Key Research Overview - BaiLi Tianheng's BL-B01D1 demonstrated a 35.3% confirmed overall response rate (cORR) in patients with non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) [18]. - DiZhe Pharmaceutical's DZD6008 achieved over 80% overall response rate (ORR) in heavily treated chronic lymphocytic leukemia (CLL) patients, indicating its potential as a new treatment option [4][12]. - FuHong HanLin's PD-L1 ADC showed excellent performance in immune-resistant squamous NSCLC patients, while HLX22 is expected to redefine first-line treatment for advanced gastric cancer [4][12]. - KeLun BoTai's sac-TMT data confirmed long-term survival benefits in third-line EGFR-mutant NSCLC and first-line triple-negative breast cancer (TNBC) [4][12]. - KangNing JieRui's HER2 bispecific ADC demonstrated comparable efficacy and better safety than existing treatments [4][12]. - MaiWei Biotech's 9MW2821 combined with toripalimab is anticipated to be a strong contender in first-line urothelial carcinoma treatment [4][12]. - SanSheng Pharmaceutical updated data on SSGJ-707 for first-line treatment of wild-type NSCLC, with a significant partnership with Pfizer [4][12]. - XinDa Biotech's IBI363 showed potential in activating "cold" tumors, aiming to become a cornerstone drug in immunotherapy [4][12]. - YaSheng Pharmaceutical's Lisaftoclax achieved positive results in patients resistant to venetoclax, filling a treatment gap in myeloid malignancies [4][12]. - ZhengDa TianQing's "DeFu combination" was selected for LBA, potentially offering a new first-line treatment for PD-L1 positive NSCLC [4][12]. - ZeJing Pharmaceutical and ZaiDing Pharmaceutical presented excellent data on ZG006 and ZL-1310 for late-line SCLC treatment, showcasing the global competitiveness of domestic drugs [4][12].

Core Insights - The 2025 European Hematology Association (EHA) annual meeting showcased nearly 60 clinical research results from four Chinese innovative drug companies, highlighting China's scientific strength in developing innovative therapies for hematological cancers [1] - The collective breakthroughs of these companies at international platforms like ASCO and EHA signify a strategic shift in China's innovative drug industry from "fast following" to "independent innovation" [1] - The EHA annual meeting is a significant academic event in the global hematology field, attracting over 10,000 professionals from more than 100 countries [1] Company Highlights - BeiGene presented four major oral reports at the EHA meeting, demonstrating key breakthroughs in its pipeline for hematological cancer treatments [1] - The next-generation BCL2 inhibitor, Sotorasib, combined with Baiyueze®, achieved total response rates of 96% and 79% for patients with relapsed/refractory chronic lymphocytic leukemia (CLL) and mantle cell lymphoma, respectively [2] - The potential first-in-class BTK degrader BGB-16673 showed promising early data for treating CLL and Waldenström's macroglobulinemia [2] - Innovent Biologics had 25 studies presented as posters at the EHA meeting, focusing on new BTK inhibitors and BCL2 inhibitors for various lymphomas [2] Research Developments - The combination of Mesutoclax and Obinutuzumab for first-line treatment of CLL/SLL showed a total response rate of 97.6% in a cohort of 42 newly diagnosed patients, with a registration phase III clinical trial now underway [3] - Dizhizhi Pharmaceuticals showcased multiple research advancements covering T-cell and B-cell lymphomas, including the JAK1 inhibitor, Gyrizhe®, which demonstrated effective maintenance treatment in peripheral T-cell lymphoma [3] - Micu Biotech presented 19 new research results on its selective HDAC inhibitor, Sitarabin, across various hematological malignancies, indicating significant tumor response and broad application prospects [4]

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 2024 年年度股东大会会议资料 2025 年 6 月 | 年年度股东大会会议须知 1 | 2024 | | | | --- | --- | --- | --- | | 年年度股东大会会议议程 3 | 2024 | | | | 一、 | 关于公司《2024 | 年年度报告及其摘要》的议案 5 | | | 二、 | 关于公司《2024 | 年度董事会工作报告》的议案 6 | | | 附件一：《2024 | 年度董事会工作报告》 7 | | | | 三、 | 关于公司《2024 | 年度监事会工作报告》的议案 16 | | | 附件二：《2024 | 年度监事会工作报告》 17 | | | | 四、 | 关于公司《2024 | 年度财务决算报告》的议案 21 | | | 附件三：《2024 | 年度财务决算报告》 22 | | | | 五、 | 关于公司《2025 | 年度财务预算报告》的议案 24 | | | 附件四：《2025 | 年度财务预算报告》 25 | | | | 六、 | 关于公司《2024 | 年度利润分配预案》的议案 26 ...

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 Viewpoint - The company, DIZH Pharmaceutical (688192.SH), is set to present significant research advancements on its first-in-class drugs, GoliXitini (GoliXitini Capsules) and DZD8586, at the upcoming EHA and ICML conferences, focusing on their efficacy and safety in treating hematological malignancies [1][2]. Group 1: GoliXitini Research Findings - GoliXitini is being studied for maintenance therapy in patients with peripheral T-cell lymphoma (PTCL) who have achieved remission after first-line systemic treatment, showing potential to maintain and enhance anti-tumor efficacy with manageable safety [1] - The drug has demonstrated encouraging anti-tumor efficacy and good safety in various clinical studies, including those involving first-line treatment with the CHOP regimen for PTCL and real-world studies for relapsed/refractory T-cell large granular lymphocyte leukemia (r/rT-LGLL) [1] Group 2: DZD8586 Research Findings - DZD8586 has shown an objective response rate (ORR) of 84.2% in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients who have previously undergone multiple treatments, including those with classic BTK resistance mutations [2] - The safety profile of DZD8586 is controllable, with no observed drug-related bleeding, atrial fibrillation, or major cardiac risks in clinical settings [2] - Latest data from a Phase II clinical study of DZD8586 as a monotherapy for relapsed/refractory diffuse large B-cell lymphoma (r/rDLBCL) will also be presented, indicating good anti-tumor efficacy and safety [2]

证券代码：688192 证券简称：迪哲医药 公告编号：2025-37 迪哲（江苏）医药股份有限公司 自愿披露关于高瑞哲®和 DZD8586 最新研究进展在 2025 欧 洲血液学协会（EHA）年会以及第 18 届国际恶性淋巴瘤会 议（ICML）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"）将于 2025 欧洲血液 学协会（EHA）年会和第 18 届国际恶性淋巴瘤会议（ICML），公布其血液肿瘤 管线中的两大全球首创（First-in-Class）新药高瑞哲®（通用名：戈利昔替尼胶囊） 和 DZD8586 的重要研究进展。其中，高瑞哲®针对经一线系统性治疗后缓解的外 周 T 细胞淋巴瘤（PTCL）维持治疗的长期随访数据，以及 DZD8586 治疗慢性 淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）的汇总分析成果，均将在 ICML 大会进行口头报告。 一、关于高瑞哲®相关研究 PTCL 是一种异质性高且罕见的非霍奇金淋巴瘤，一线标准治疗方案为 CHOP 或 CHO ...