（原标题：谢方敏辞任董事会主席兼CEO；百洋医药与多家医疗机构展开合作） 这里是《21健讯Daily》，欢迎与21世纪经济报道新健康团队共同关注医药健康行业最新事件！ 政策动向 徐景和在受理和举报中心调研并开展接访下访 12月9日，国家药监局官微发文显示，国家药监局党组成员、副局长徐景和在受理和举报中心调研受理 和举报工作并开展接访下访，听取两家医疗器械、化妆品企业相关诉求，进行了现场沟通和答复。徐景 和指出，要科学把握安全与发展、监管与服务的关系，坚持依法行政、科学监管，有效保障企业合法权 益，助力产业高质量发展。要深刻认识当前投诉举报工作面临的新形势、新任务，坚持法治思维，依法 依规解决投诉举报事项，推进社会共治取得新成效。 药械审批 苑东生物：布瑞哌唑片获得药品注册证书 欧莱雅将增持高德美10%股份 高德美（瑞士证券交易所：股票代码为"GALD"）宣布：欧莱雅集团拟增加对该公司的股权投资，将从 Sunshine SwissCo GmbH处额外收购 10% 的股份。Sunshine SwissCo GmbH是由殷拓集团（EQT）、阿 布扎比投资局（ADIA）及Auba Investment Pte. Lt ...

Core Insights - Dize Pharmaceutical (Jiangsu) Co., Ltd. reported a revenue of 586 million yuan for the first three quarters of 2025, marking a 73% year-on-year increase [2] - The company achieved quarterly revenues of 160 million yuan, 195 million yuan, and 231 million yuan in Q1, Q2, and Q3 respectively, with a compound growth rate of 20% [2] Commercialization and Operational Efficiency - The core products, Shuwozhe® (Shuwotini tablets) and Gao Ruizhe® (Golisitinib capsules), have shown significant growth in market penetration and sales revenue, driving robust revenue growth [3] - Dize Pharmaceutical achieved commercial profitability for the first time in H1 2025, with revenues covering costs beyond R&D expenses, indicating a developing financial sustainability model [3] R&D and Product Pipeline - The company is actively expanding clinical research for its two marketed products and has entered Phase III clinical trials for its globally innovative LYN/BTK dual-target inhibitor, birelentinib, which has received Fast Track designation from the FDA [3] - Dize Pharmaceutical is focusing on non-small cell lung cancer (NSCLC), covering approximately 70% of NSCLC patients, and has made significant progress in 11 recent studies presented at the 2025 World Lung Cancer Conference [4][5] Market Potential and Future Plans - The company is targeting a potential market worth billions in the hematological malignancies sector with its core pipelines, Gao Ruizhe® and birelentinib, aimed at T-cell and B-cell lymphomas [5] - Dize Pharmaceutical's CEO highlighted the historical revenue peak driven by the commercialization of core products and emphasized the commitment to addressing unmet clinical needs while enhancing value creation capabilities [6]

Core Insights - The company reported a significant revenue increase of 73.23% year-on-year, reaching 586 million yuan in the first three quarters of 2025, driven by the commercialization of its core products, Shuwozhe® and Gaoruizhe® [1][2] - The company achieved commercial profitability for the first time in the first half of 2025, marking a milestone in its financial sustainability [2][3] - The company is advancing its innovative pipeline, with the dual-target inhibitor Birelentinib entering Phase III clinical trials and receiving Fast Track designation from the FDA [1][6] Commercialization and Financial Performance - Revenue growth showed a quarterly upward trend, with Q1, Q2, and Q3 sales of 160 million yuan, 195 million yuan, and 231 million yuan respectively, indicating a compound growth rate of 20% [2][3] - The sales expense ratio decreased to 72% in the first three quarters, down from 124% in the previous year, reflecting improved cost control and operational efficiency [3] Research and Development Progress - The company is actively expanding the indications for its two marketed products and has a robust pipeline with seven globally competitive products, each with first-in-class or best-in-class potential [5][6] - Recent research presented at the World Lung Cancer Conference highlighted positive results for Shuwozhe® in treating various NSCLC mutations, showcasing its efficacy and safety [4][5] Strategic Focus and Market Position - The company is committed to addressing unmet clinical needs globally, enhancing its core competitiveness, and creating value for shareholders [2] - The strategic focus on source innovation and global development has led to significant milestones, including the FDA's accelerated approval of Shuwozhe® [6]

Core Insights - The company reported a significant revenue increase of 73% year-on-year, reaching 586 million yuan in the first three quarters of 2025 [1] - The core products have shown substantial market penetration and sales growth, with ongoing clinical research for two already launched products [1] - The company’s innovative drug birelentinib has entered Phase III clinical trials and received Fast Track designation from the FDA [1] - Another key product, DZD6008, is advancing in dosage expansion studies targeting EGFR mutation non-small cell lung cancer [1] - The CEO highlighted that the revenue growth is attributed to the commercialization of core products and the establishment of a global innovation strategy [1] Financial Performance - Revenue for the first three quarters reached 586 million yuan, marking a 73% increase compared to the previous year [1] - The company achieved a historical high in revenue during this period [1] Product Development - Birelentinib, a dual-target inhibitor, is in Phase III clinical trials [1] - DZD6008, an EGFR TKI, is progressing in clinical studies for EGFR mutation non-small cell lung cancer [1] Strategic Vision - The company is focusing on unmet clinical needs globally and aims to expand treatment boundaries [1] - Milestones in the company’s global innovation blueprint have been reached [1]