迪哲医药 中国首个独立研发在美获批的全球首创新药诞生 7月3日，迪哲医药宣布舒沃哲® （ZEGFROVY®，通用名：舒沃替尼片） 的新药上市申请，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®通过优先审评程序获得批准上市， 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 。 力品药业 挑战原研专利成功！力品药业阿尔茨海默高端制剂获FDA批准 7月15日，由力品药业自主研发的盐酸美金刚多奈哌齐缓释胶囊获得美国FDA批准，用于治疗中重度阿尔茨 海默病。 这是国内首个通过Paragraph IV专利挑战成功上市的阿尔茨海默病复方缓释制剂。 阿尔茨海默病 （AD） 是一种中枢神经系统退行性疾病，主要发生于老年及老年前期人群。随着老龄化进程 加速，目前 ...

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, Dige Medical, will present its newly developed targeted lung cancer drugs, ZEGFROVY (generic name: Shuwotini tablets) and a highly selective JAK1 inhibitor, Goliqitini capsules, at the 2025 World Lung Cancer Conference (WCLC) in Barcelona, Spain, from September 6 to 9, 2025 [1] Summary by Relevant Categories - **Product Development** - Dige Medical is set to showcase multiple latest research results on its innovative lung cancer therapies at an upcoming international conference [1] - The international multicenter registration clinical study "Wu-Kong1B" for ZEGFROVY has had its latest data selected for an oral presentation [1]

Core Insights - The approval of ZEGFROVY (suwotrectin) by the FDA and its inclusion in the NCCN guidelines marks a significant milestone for the company and the industry, establishing it as the first and only targeted therapy for EGFR exon20ins NSCLC globally [1][2] - The successful development of ZEGFROVY demonstrates the potential for Chinese biotech firms to innovate and compete on a global scale, shifting from technology output to value output [2] Company Developments - ZEGFROVY is recognized as the first innovative drug developed independently in China to receive approval in the U.S., highlighting the company's capability in full lifecycle drug development [1] - The company emphasizes its commitment to "source innovation" and global competition, which has been validated through the successful launch of ZEGFROVY [1][2] Industry Implications - The success of ZEGFROVY encourages other companies to plan international clinical trials and global registration strategies from the early stages of drug development [2] - There is a call for a clear tiered evaluation system for innovative drugs at the national level, which would provide institutional incentives for source innovation and guide the industry towards high-quality development [2]

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]