证券代码：688192 证券简称：迪哲医药 公告编号：2025-44 迪哲（江苏）医药股份有限公司 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"）首次公开发行股票 及向特定对象发行A股股票募集资金按照相关法律、法规、规范性文件的规定 在银行开立了募集资金专项账户。公司于近日办理完成了部分首次公开发行股 票及向特定对象发行A股股票募集资金专户的注销手续，具体情况如下： 一、募集资金基本情况 （一）首次公开发行股票 经中国证券监督管理委员会《关于同意迪哲（江苏）医药股份有限公司首 次公开发行股票注册的批复》（证监许可[2021]3494号）同意注册，公司向社 会公众首次公开发行人民币普通股（A股）40,000,100股，募集资金总额为人民 币2,103,205,258.00元，扣除发行费用后，募集资金净额为人民币1,986,567,781.57 元。上述募集资金已经普华永道中天会计师事务所（特殊普通合伙）验证，并 出具了《验资报告》（普华永道中天验字（2021）第1192号）。 ...

Group 1: Drug Approvals and Innovations - Eli Lilly's drug Tirzepatide has received approval for a third indication in China, becoming the first and only prescription drug for treating moderate to severe obstructive sleep apnea in obese adults [1] - Diligent Pharma's innovative lung cancer drug, Shuwotai, has been granted accelerated approval by the FDA for adult patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations [2] - Xiansheng Pharmaceutical's drug Enzashu has been approved in China as the first targeted therapy for all populations of platinum-resistant ovarian cancer, addressing a significant treatment gap in this area [3] Group 2: Financial Performance and Market Trends - Nuotai Bio expects a net profit of 300 to 330 million yuan for the first half of 2025, representing a year-on-year increase of 32.06% to 45.27%, driven by significant sales growth in peptide raw materials [4] - The recent surge in net profit forecasts from several companies, including Nuotai Bio, reflects the ongoing strong market demand for GLP-1 weight loss drugs [4] - Kangyuan Pharmaceutical's KYS2301 gel has received clinical trial approval for atopic dermatitis, marking a significant advancement in the treatment options available for this condition [5][6]

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 [4][6]. 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 [4]. - The drug is expected to achieve a global market sales peak of approximately 12.954 billion yuan, with the U.S. market presenting a higher pricing potential compared to China [6]. - The incidence of EGFR exon 20 insertion mutations in NSCLC patients is estimated to be around 4.8% to 5.1% in China, while in the U.S., it ranges from 9% to 12% [5][6]. Group 2: Commercial Strategy and Market Expansion - The company aims to maximize its long-term interests and shareholder returns by actively evaluating various overseas market expansion models, with a focus on the U.S. and European markets due to their stronger payment capabilities [6][11]. - The domestic market remains crucial, but the overseas market is anticipated to become a second growth curve for the company [6][11]. - The company has a commercial team nearing 500 members to enhance market coverage for its products [6]. Group 3: Research and Development Pipeline - The company has a robust pipeline with seven products in international multi-center clinical stages, including ZEGFROVY and three other drugs [7][9]. - ZEGFROVY has shown a confirmed objective response rate (ORR) of 78.6% in treating EGFR exon 20 insertion NSCLC, with a median progression-free survival (mPFS) of 12.4 months [9]. - The company is also developing DZD6008, a selective EGFR TKI, which aims to address unmet clinical needs in NSCLC [9][10]. Group 4: Financial Performance and Funding - The company reported a net loss of approximately 850 million yuan in 2024, a 24% reduction year-on-year, and a net loss of about 190 million yuan in Q1 2025, a 14% decrease [14]. - The company successfully completed a nearly 1.8 billion yuan private placement to support its R&D projects, particularly for ZEGFROVY, Golixty (高瑞哲), and DZD8586 [14][15]. - The annual R&D investment from 2020 to 2024 has shown a consistent increase, indicating a commitment to sustaining product pipeline development [13].

新华财经上海7月3日电（记者杜康）7月3日，百利天恒、迪哲医药两家科创板创新药企业的新药管线又 传来重大突破，研发创新次第开花。 舒沃替尼先后获得中、美四项突破性疗法（BTD）的认定。本次FDA申报中，舒沃替尼亦获得了"优先 审评"资格。FDA的"优先审评资格"主要授予在治疗、诊断或预防某些严重疾病方面取得重大安全性或 有效性突破的药物。对于获得优先审评资格的药物，FDA将加快完成审评，让药物更快地进入市场，更 早惠及患者。 记者获悉，截至目前，已有10款国产创新药获批在美国上市，科创板创新药企业推出其中4款。 百利天恒与迪哲医药在这两款新药上取得的突破，是中国生物医药产业实力崛起的缩影，生动展现了中 国创新药从"跟跑者"到"引领者"的身份转变，从"跟随仿制"向"自主创新"的发展模式转变，日益成为全 球创新药研发的核心阵地。 （文章来源：新华财经） 此前，百利天恒以8亿美元首付款、最高可达到84亿美元潜在交易总额的价格将该款产品授权跨国制药 巨头百时美施贵宝（BMS），这也是全球ADC领域单个资产的最高额交易。公告显示，目前伦康依隆 妥单抗还在中美进行40余项针对多种肿瘤类型的临床试验。 迪哲医药旗下舒沃替尼 ...

Group 1 - Baili Tianheng announced that its drug Iza-bren (BL-B01D1) for nasopharyngeal carcinoma achieved its primary endpoint in a Phase III clinical trial, marking it as the first dual antibody ADC to complete such a study globally [2][3] - The drug was licensed to Bristol-Myers Squibb for an upfront payment of $800 million, with a potential total deal value of up to $8.4 billion, representing the highest transaction for a single asset in the ADC field [2] Group 2 - Dize Pharma received FDA approval for its drug ZEGFROVY® (Shuwotini), which is indicated for adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, following disease progression after platinum-based chemotherapy [3][4] - Shuwotini has been recognized with four breakthrough therapy designations in China and the U.S., making it the only drug to achieve "BTD Grand Slam" for treating EGFR exon 20 insertion NSCLC [4] Group 3 - The breakthroughs by Baili Tianheng and Dize Pharma reflect the rising strength of China's biopharmaceutical industry, showcasing a shift from being "followers" to "leaders" in innovative drug development [5] - As of now, 10 domestic innovative drugs have been approved for marketing in the U.S., with four of them coming from companies listed on the STAR Market [5] - Recent policies from the National Healthcare Security Administration and the National Health Commission aim to support the high-quality development of innovative drugs through various measures, injecting vitality into China's innovative drug sector [5]

Core Viewpoint - Dize Pharmaceutical's drug, Shuwotini (generic name: Shuwotini tablets), has received FDA approval for its New Drug Application (NDA), marking it as the first and only EGFR exon20ins NSCLC drug approved by the FDA globally [1][2]. Group 1: Drug Approval and Significance - Shuwotini is approved for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression after platinum-based chemotherapy and have confirmed EGFR exon20ins mutations [1]. - The drug was granted priority review and is recognized as a breakthrough in treating a challenging target that has seen limited treatment options for nearly 20 years [1][3]. - Shuwotini is an oral, irreversible, and highly selective EGFR tyrosine kinase inhibitor (TKI) that targets multiple EGFR mutation subtypes [1]. Group 2: Clinical Research and Efficacy - The FDA approval is based on the efficacy and safety data from the international multicenter clinical study "WU-KONG1B," which will be presented at the 2024 ASCO annual meeting and has been accepted for publication in a top-tier journal [2]. - The study demonstrated significant efficacy advantages of Shuwotini, validated in both Asian and non-Asian patient populations, enhancing treatment convenience and patient compliance with its once-daily oral administration [2]. Group 3: Market Impact and Stock Performance - Following the announcement of FDA approval, Dize Pharmaceutical's stock price rose by 9.54%, reaching 64.56 yuan per share [4].

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 Hang Seng Index Company will announce the second quarter review results on August 22 [1] - The Guangdong vehicle policy aims to launch by November with a daily quota of 100 vehicles [1] Group 2 - 康视云 is listed today, with 蓝思科技 and five other stocks available for subscription [1] - Luxshare Precision is planning to issue shares overseas and list on the Hong Kong Stock Exchange [1] - Ganfeng Lithium has completed the acquisition of the remaining 40% stake in Mali Lithium [1] - Xiaopeng Motors issued 293,600 Class A ordinary shares under its equity incentive plan [1] - Lei Jun stated that the subscription rate for Xiaomi Group's SU7 and SU7 Ultra is less than 15% [1] - Honghua Group signed drilling rig sales agreements totaling over 100 million USD [1] - Diligent Pharma received accelerated approval from the US FDA for its product Shuwozhe [1]

Core Points - Diger Pharma announced that its new drug application for ZEGFROVY® (generic name: suvoritinib tablets) has been officially approved by the U.S. Food and Drug Administration (FDA) [1] - The drug is indicated for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have disease progression after platinum-based chemotherapy and have confirmed epidermal growth factor receptor (EGFR) exon 20 insertion mutations [1] Company Summary - Diger Pharma's ZEGFROVY® is now FDA-approved, marking a significant milestone for the company in the oncology market [1] - The approval targets a specific patient population, enhancing the company's portfolio in precision medicine [1] Industry Summary - The approval of ZEGFROVY® reflects ongoing advancements in targeted therapies for NSCLC, particularly for patients with specific genetic mutations [1] - This development may influence competitive dynamics within the oncology sector, as companies focus on personalized treatment options [1]

迪哲（江苏）医药股份有限公司（以下简称"公司"）自主研发的舒沃哲® （英文商品名：ZEGFROVY®，通用名：舒沃替尼片）的新药上市申请（New Drug Application，NDA），正式获得美国食品药品监督管理局（FDA）批准，用于既 往经含铂化疗治疗时或治疗后出现疾病进展，并且经 FDA 批准的试剂盒检测确 认，存在表皮生长因子受体（EGFR）20 号外显子插入突变（Exon20ins）的局部 晚期或转移性非小细胞肺癌（NSCLC）的成人患者。 舒沃哲®通过通过优先审评（Priority Review）程序获得批准上市，成为目前 全球首个且唯一在美获批的 EGFR Exon20ins NSCLC 国创新药。其在分子设计的 源头进行了重大创新，突破难治靶点，是中国首个独立研发在美获批的全球首创 新药。 一、药品相关情况 舒沃哲®是一款口服、不可逆且针对多种 EGFR 突变亚型的高选择性 EGFR 酪氨酸激酶抑制剂（TKI），于 2023 年 8 月在中国获批上市，是目前 EGFR Exon20ins NSCLC 二/后线唯一标准治疗方案，填补了该领域近 20 年临床空白。 基于优异的疗效和安全性，舒沃 ...