● 本报记者 傅苏颖 "依托过往科学领域的传承与积累，公司自成立之初便确立了'源头创新'的理念与'全球竞争'的定位。目 前，迪哲已成功验证独立支撑一款创新药物从0到1全生命周期的国际多中心临床研发及海外申报获批能 力，这种可复制的差异化创新优势，正是企业最坚实的护城河。"迪哲医药创始人、董事长、首席执行 官张小林日前在接受中国证券报记者专访时表示，未来，迪哲医药将围绕全球未满足临床需求，深化具 有差异化竞争力的管线布局，助力中国医药产业实现创新跃迁，让更多中国"源创"新药造福全球患者。 突破难治靶点 "目前来看，国内真正在国际上获认可的国产创新药案例虽有但尚不多，因此，建议国内药企，尤其是 将市场定位在全球的企业，应尽早开展国际多中心临床试验，以便更好地验证药物、获取国际多中心数 据，进而得到国际认可。基于此，公司在药物研发方面的基本理念是，开展国际多中心临床试验越早越 好，且大部分在研产品的临床试验都会采用国际多中心模式。"张小林表示。 "舒沃哲在美获批上市对迪哲具有重大意义，实现从0到1的突破实属不易，对公司发展影响深远。"张小 林表示，对于其他公司而言，迪哲的这一成果可作为成功案例参考。当前，小型生物科 ...

投资者参与新注册科创成长层股票的申购、交易，需签署《科创成长层风险揭示书》。 据东方财富Choice数据显示，具体来看，32家尚未摘"U"的存量公司包括： 泽璟制药、君实 生物、前沿生物、青云科技、和辉光电、精进电动、百济神州、迪哲医药、迈威生物、翱捷科 技、亚虹医药、首药控股、海创药业、云从科技、益方生物、奥比中光、盟科药业、诺诚健 华、信科移动、星环科技、裕太微、云天励飞、天智航、奇安信、寒武纪、亿华通、埃夫特、 慧智微、芯联集成、智翔金泰、盛科通信、中巨芯。 上交所发布《科创板上市公司自律监管指引第5号——科创成长层》（简称《科创成长层指引》。 上交所相关负责人在答记者问中表示，这次改革没有针对未盈利企业纳入科创成长层设置额外的上 市门槛， 存量32家未盈利企业将自指引发布实施之日起进入科创成长层，新注册的未盈利企业将自 上市之日起进入。 ...

北京商报讯（记者 丁宁）7月10日，迪哲医药（688192）舒沃哲（舒沃替尼片）被纳入美国国立综合癌 症网络（NCCN）非小细胞肺癌指南推荐，用于治疗经治表皮生长因子受体20号外显子插入突变非小细 胞肺癌。舒沃哲成为全球唯一纳入国际权威肺癌指南的EGFR exon20ins NSCLC小分子靶向药。早前， 舒沃哲已通过优先审评获美国食品药品监督管理局批准上市。 7月12日，迪哲医药举办舒沃哲美国获批新闻发布会。会上，舒沃哲中国注册临床研究主要研究者、"悟 空1B"主要研究者、北京协和医院教授王孟昭表示，舒沃替尼从源头突破成药难点，为全球EGFR exon20ins NSCLC患者提供了安全有效的靶向治疗手段。从中国注册研究"悟空6"到国际多中心注册研 究"悟空1B"，标志着中国自主研发的源头创新药物首次在EGFR exon20ins NSCLC领域完成从中国到全 球的全链条验证。 迪哲医药创始人、董事长兼首席执行官张小林表示，基于过去科学的传承和积累，使得迪哲医药从成立 伊始就奠定了"源头创新"的理念和"全球竞争"的定位。迪哲医药独立支撑起一款全球首创药物从0到1的 全生命周期研发与申报，这种能力已被成功验证 ...

7月10日，迪哲医药(688192.SH)舒沃哲(ZEGFROVY，通用名：舒沃替尼片)被纳入美国国立综合癌症网 络(NCCN)非小细胞肺癌指南推荐，用于治疗经治表皮生长因子受体(EGFR)20号外显子插入突变 (exon20ins)非小细胞肺癌(NSCLC)。舒沃哲成为全球唯一纳入国际权威肺癌指南的EGFR exon20ins NSCLC小分子靶向药。 早前，舒沃哲已于7月3日通过优先审评获美国食品药品监督管理局(FDA)批准上市，成为全球首个且唯 一在美国获批的EGFR exon20ins NSCLC国创新药，也是中国首个独立研发在美获批的全球首创新药。 在7月12日于北京举办的舒沃哲美国获批新闻发布会上，"悟空1B"(WU-KONG1B)一位主要研究者、台 湾大学癌医中心分院杨志新教授表示："舒沃替尼'强效缩瘤、安全可控'的特性，让我们看到了其全球 同类最佳的潜力。从研究者的角度来看，舒沃替尼的创新意义远超过这一个药品的本身，它打破了长期 以来EGFR exon20ins缺乏兼具'疗效、安全性、便利性'小分子口服靶向药物治疗的僵局，为患者带来更 优治疗选择。" 舒沃哲中国注册临床研究(悟空6，WU-KO ...

Group 1 - The core viewpoint of the news is that Dizhihua's drug, Shuwotini (舒沃替尼片), has been included in the National Comprehensive Cancer Network (NCCN) guidelines for the treatment of non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, marking it as the only small molecule targeted therapy recognized globally for this specific mutation [1] - Shuwotini is an oral, irreversible, highly selective EGFR tyrosine kinase inhibitor designed for patients with locally advanced or metastatic NSCLC who have progressed after platinum-based chemotherapy or are intolerant to it, and have confirmed EGFR exon 20 insertion mutations [1] - The successful approval of Shuwotini by the FDA was highlighted during a press conference, where a leading researcher emphasized its potential to reshape treatment paradigms in the field of lung cancer [1] Group 2 - The founder and CEO of Dizhihua, Dr. Zhang Xiaolin, articulated the company's commitment to "source innovation" and "global competition," emphasizing the successful development and approval of a globally innovative drug from inception to market [2] - Dr. Zhang outlined the "Dizhihua Path," which includes a solid scientific foundation, early collaboration with top international research centers, and a strategic focus on product investment [2] - The company aims to integrate Chinese cultural elements into its projects to facilitate global recognition of Chinese innovation, with Shuwotini's approval in the U.S. exemplifying the "Wukong Spirit" of breaking boundaries through scientific strength [2]

Core Viewpoint - The Shanghai Stock Exchange Science and Technology Innovation Board Biopharmaceutical Index has shown strong performance, with significant increases in constituent stocks, indicating a positive trend in the biopharmaceutical sector [1][3]. Market Performance - As of July 11, 2025, the Biopharmaceutical Index rose by 1.23%, with notable gains from stocks such as Yifang Biotech (+10.31%), Shouyao Holdings (+8.34%), and Te Bao Biotech (+7.18%) [1]. - The Jiashi Science and Technology Medicine ETF (588700) also increased by 1.14%, marking its third consecutive rise [1]. Liquidity and Trading Volume - The Jiashi Science and Technology Medicine ETF recorded a turnover rate of 9.54% and a trading volume of 21.11 million yuan [3]. - Over the past month, the ETF has maintained an average daily trading volume of 33.32 million yuan, ranking first among comparable funds [3]. Fund Growth and Performance - In the last two weeks, the Jiashi Science and Technology Medicine ETF's scale increased by 17.56 million yuan, leading among comparable funds [3]. - The ETF's net value has risen by 37.70% over the past year, with a maximum single-month return of 23.29% since its inception [3]. Top Holdings - As of June 30, 2025, the top ten weighted stocks in the Biopharmaceutical Index accounted for 50.3% of the index, including companies like United Imaging Healthcare, BeiGene, and Huatai Medical [3][5]. Policy Support and Market Outlook - Recent policy documents have been released to support the high-quality development of innovative drugs, highlighting government backing for the sector [6]. - The number of innovative drugs in development in China has reached over 4,000, representing approximately 30% of the global total [5][6].

Group 1 - The core viewpoint of the articles highlights the renewed activity in the innovative drug sector, driven by supportive government policies and recent approvals of innovative drugs in the domestic market [1][2] - The National Healthcare Security Administration and the National Health Commission have issued measures to support the high-quality development of innovative drugs, including 16 specific measures across five areas [1] - The introduction of a commercial health insurance directory for innovative drugs aims to include high-value, clinically significant drugs that are not yet part of the basic medical insurance list, indicating a shift towards multi-layered medical insurance systems [1] Group 2 - East China Securities emphasizes the strong policy support for innovative drug development, which is expected to lead to significant growth in the market as new drugs are approved and commercial insurance directories are established [2] - The successful international approval of domestic innovative drugs, such as the approval of Shuwotini by Dize Pharmaceutical in the U.S., showcases the international competitiveness of local innovative drugs [2] - The innovative drug sector is identified as a core investment theme within the biopharmaceutical industry, with recommendations to explore investment opportunities in related segments such as medical devices, traditional Chinese medicine, chain pharmacies, and medical services [2]

Core Viewpoint - Chinese innovative pharmaceuticals are accelerating their international expansion, with significant licensing deals and supportive policies facilitating this trend [2][6][7]. Group 1: Market Activity - In the first half of the year, the upfront payments for innovative drug licensing exceeded $2.5 billion, with total transaction amounts nearing $50 billion, almost matching the total for the previous year [2]. - A notable licensing agreement was signed between 3SBio and Pfizer, valued at up to $60.5 billion, involving the exclusive rights for the PD-1/VEGF bispecific antibody SSGJ-707 outside of mainland China [3]. - Rongchang Bio announced a licensing deal with Vor Biopharma Inc. with a total transaction value of $4.23 billion, including an upfront payment of $45 million [3]. Group 2: Policy Support - The rapid development of the innovative drug industry is supported by policy reforms, including expedited drug review processes and dynamic adjustments to the medical insurance catalog [6][7]. - In the first half of the year, 43 innovative drugs and 45 innovative medical devices were approved, representing year-on-year increases of 59% and 87%, respectively [6]. - Recent measures have been introduced to support the internationalization of innovative drugs, encouraging companies to explore markets in Southeast Asia and Central Asia [7]. Group 3: Industry Trends - The internationalization strategies of Chinese pharmaceutical companies are diversifying, with four main models identified: independent internationalization, licensing, NewCo model, and mergers and acquisitions [5]. - The collaboration landscape is broadening, with partnerships not only with traditional pharmaceutical companies but also with emerging biotech firms [4]. - Despite the progress, challenges remain, including weaknesses in basic research, target homogeneity, regulatory alignment, and commercialization capabilities [7].

证券代码：688192 证券简称：迪哲医药 公告编号：2025-46 迪哲（江苏）医药股份有限公司 关于高级管理人员减持股份结果公告 本公司董事会、全体董事及相关股东保证本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。 重要内容提示： 高级管理人员持股的基本情况 | 股东名称 | 吴清漪 | | | | --- | --- | --- | --- | | 股东身份 | 控股股东、实控人及一致行动人 | □是 | √否 | | | 直接持股 5%以上股东 | □是 | √否 | 一、减持主体减持前基本情况 1 | | 董事、监事和高级管理人员 | √是 □否 | | --- | --- | --- | | | 其他：无 | | | 持股数量 | 1,208,217股 | | | 持股比例 | 0.2630% | | | 当前持股股份来源 | 股权激励取得：1,196,417股 | | | | 集中竞价交易取得：11,800股 | | 上述减持主体无一致行动人。 二、减持计划的实施结果 本次股份减持计划实施前，迪哲（江苏）医药股份有限公司（以下简称"公 ...

Group 1 - *ST San Sheng (002742.SZ): The controlling shareholder Pan Xianwen's 32.2 million shares have been transferred, accounting for 7.30% of the total share capital, reducing his holding from 17.26% to 16.75, with no change in company control [1] - Aikang Co., Ltd. (300889.SZ): Shareholders Zhang Fengbin and Feng Renrong reduced their holdings by a total of 1.76 million shares, accounting for 1.06% of the total share capital, completing the reduction plan [1] - Allianz Ruishi (301042.SZ): Director Shen Lei reduced his holdings by 98,700 shares, accounting for 0.14% of the total share capital, with the reduction plan period ending [1] Group 2 - Baotong Technology (300031.SZ): Controlling shareholder Bao Zhifang and director Tang Yu plan to reduce their holdings by up to 8.3749 million shares and 1.526988 million shares, accounting for no more than 2% and 0.36% of the total share capital, respectively [2] - Biyiwei (688045.SH): Shareholders Fang Guang Erqi and Yuan Chengjun plan to reduce their holdings by up to 139,680 shares and 69,840 shares, accounting for no more than 2% and 1% of the total share capital, respectively [2] - Chahua Co., Ltd. (603615.SH): Shareholder Shenzhen Hanjinliang reduced 2.397 million shares, accounting for 0.99% of the total share capital, completing the reduction plan [2] Group 3 - Dacai Co., Ltd. (605287.SH): Shareholder Qingdao Dikuang Chanquan Development Co., Ltd. reduced 3.64 million shares, accounting for 2.60% of the total share capital, completing the reduction plan [3] - Dize Pharmaceutical (688192.SH): Vice President Zhang Shiying reduced 161,550 shares, accounting for 0.0035% of the total share capital, completing the reduction plan [3] - Fuhan Micro (300613.SZ): Controlling shareholder's concerted action party plans to reduce up to 6.90208 million shares, accounting for 3% of the total share capital [3] Group 4 - Guanghuan Xinwang (300383.SZ): Directors and vice presidents plan to reduce a total of up to 720,476 shares, accounting for no more than 0.04% of the total share capital [4] - Hanyu Group (300403.SZ): Director and Vice President Wu Geming plans to reduce up to 1 million shares, accounting for 0.1658% of the total share capital [4] - Haosen Intelligent (688529.SH): Shareholders plan to reduce a total of up to 3 million shares, accounting for 1.7838% of the total share capital [4] Group 5 - Huilong New Materials (301057.SZ): Controlling shareholder's concerted action party plans to reduce up to 3.482902 million shares, accounting for 3% of the total share capital excluding repurchased shares [5] - Huitong Co., Ltd. (688219.SH): Shareholder Tong'an Fund reduced 4.667815 million shares, accounting for 0.93% of the total share capital, completing the reduction plan [5] Group 6 - Jiangsu Shentong (002438.SZ): Shareholder Huzhou Fenglin Huoshan Equity Investment Partnership reduced a total of 14.205 million shares, accounting for 2.798808% of the total share capital, completing the reduction plan [6] - Jiangtian Chemical (300927.SZ): Shareholder Jiangshan Co., Ltd. reduced 1.3265 million shares, accounting for 0.92% of the total share capital [6] - Jin Sanjiang (301059.SZ): Shareholder Guangzhou Saina reduced 104,900 shares, accounting for 0.05% of the total share capital, completing the reduction plan [6] Group 7 - Jingxue Energy (301010.SZ): Controlling shareholder's concerted action party reduced 1.08 million shares, accounting for 1% of the total share capital, completing the reduction plan [7] - Jiuwu High-Tech (300631.SZ): Vice President Wang Xiaohu and Cheng Junjun plan to reduce up to 18,900 shares and 5,000 shares, accounting for no more than 0.1511% and 0.04% of the total share capital, respectively [7] - Kanghui Pharmaceutical (603139.SH): Shareholder Shanghai Sailoxian plans to reduce up to 2.9964 million shares, accounting for 3% of the total share capital [7] Group 8 - Meino Biological (301156.SZ): Shareholder's concerted action party reduced 1.297029 million shares, accounting for 0.92% of the total share capital, completing the reduction plan [8] - Minfa Aluminum Industry (002578.SZ): Shareholder Huang Tianhuo reduced 6.6702 million shares, accounting for 0.71% of the total share capital, reducing his holding to 4.9963% [8] - Nuo Puxin (002215.SZ): Directors and senior management plan to reduce a total of up to 1.8607 million shares, accounting for no more than 0.185% of the total share capital [8] Group 9 - Entropy Technology (301330.SZ): Shareholders reduced a total of 4,693,864 shares, accounting for 1.9556% of the total share capital, completing the reduction plan [9] - Shengbang Co., Ltd. (301233.SZ): Supervisor Hu Jilin plans to reduce up to 5,650 shares, accounting for 0.0111% of the total share capital [9] - Shudao Equipment (300540.SZ): Senior management did not reduce their shares, and the reduction plan period has ended [9] Group 10 - Tongyu Communications (002792.SZ): Controlling shareholder and actual controller Shi Guiqing plans to reduce up to 15,653,487 shares, accounting for 2.9963% of the total share capital [10] Group 11 - Wuzhou Xinchun (603667.SH): Senior management plans to reduce a total of up to 22,500 shares, accounting for no more than 0.0061%, 0.0067%, and 0.0037% of the total share capital [11] - New Sharp Co., Ltd. (688257.SH): Senior management plans to reduce up to 750,000 shares, accounting for no more than 0.2971% of the total share capital [11] - New Hope (000876.SZ): Senior management reduced 225,000 shares, accounting for 0.005% of the total share capital, completing the reduction plan [11] Group 12 - Youke De (688158.SH): Shareholder Zhongyi Capital reduced 882,766 shares, accounting for 0.19% of the total share capital, completing the reduction plan [12] - Changqing Technology (001324.SZ): Shareholders reduced a total of 4,165,050 shares, accounting for 3.00% of the total share capital, completing the reduction plan [12] - Changxin Bochuang (300548.SZ): Shareholders plan to reduce up to 8.6 million shares, accounting for 2.95% of the total share capital [12] Group 13 - Zhongfu Industrial (600595.SH): Shareholder Henan Yicheng Chuangtou plans to reduce up to 40 million shares, accounting for 1% of the total share capital [13] - Zhuhai Ming Technology (300232.SZ): Controlling shareholder Lin Mingfeng plans to reduce up to 21,722,009 shares, accounting for 1.99% of the total share capital [13] - Zhuoyi Information (688258.SH): Employee shareholding platform plans to reduce up to 2,271,445 shares, accounting for no more than 1.88% of the total share capital [13]