研 行 行业周报 业 半年报预告密集披露，关注业绩表现 ——医药生物行业周报 究 分析师： 侯雅楠 SAC NO： S1150524120001 2025 年 07 月 11 日 医药生物 投资要点： 证券分析师 行业要闻 侯雅楠 022-23839211 houyn@bhzq.com （1）国家医疗保障局公布《2025 年国家基本医疗保险、生育保险和工伤保 险药品目录及商业健康保险创新药品目录调整工作方案》等相关文件； 研究助理 近三月行业指数走势图 （2）默沙东 100 亿美元收购 Verona，获得慢性阻塞性肺病（COPD）重磅 新药； （3）7.2mg 司美格鲁肽申报上市。 证 公司公告 券 研 （1）亚盛医药-B：自愿公告新型 Bcl-2 抑制剂利沙托克拉（利生妥®）正式 获中国国家药品监督管理局批准，用于治疗成人慢性淋巴细胞白血病/小淋巴 细胞淋巴瘤患者； 究 （2）药明康德：2025 年半年度业绩预增公告； 报 相关研究报告 （3）甘李药业：2025 年半年度业绩预增公告； 告 录有望出台——医药生物行 （4）艾力斯：自愿披露关于甲磺酸伏美替尼片 EGFR 20 外显子插入突变 NSCLC 二线 ...

Major Events - QianShi International (00381) subsidiary FuLao Investment signed a memorandum of understanding with Yanji Municipal Government for potential cooperation in digital economy-related businesses in Hong Kong [1] - Stone Pharmaceutical Group (02005) obtained production registration approval for potassium chloride and sodium chloride injection (500ml and 250ml) [1] - Basilea Pharmaceutica (02616) received approval from the National Medical Products Administration for the domestic production registration application of Prujita® (Pralsetinib capsules) [1] - United BioPharma (03933) received FDA approval for new drug clinical trials for UBT37034 injection [1] - China National Pharmaceutical Group (01177) had the application for the new indication of Kumosil capsules for first-line treatment of breast cancer accepted [1] - Oceanwide Holdings (08476) applied to the Stock Exchange for a transfer listing to the main board [1] Financial Data - Kaison Holdings (00102) reported a loss attributable to shareholders of approximately HKD 740 million for 2023, a shift from profit to loss year-on-year [1] - JiaoGe Friends Holdings (01450) achieved a cumulative GMV of approximately CNY 6.98 billion in the first half of the year, a year-on-year increase of approximately 17.11% [1] - Sunny Optical Technology (02382) reported a smartphone lens shipment of approximately 95.056 million units in June, a month-on-month decrease of 3.1% and a year-on-year decrease of 12.7% [1] - Fast Retailing (06288) announced a profit attributable to the parent company of JPY 339.099 billion for the first three quarters, a year-on-year increase of 8.4% [1] - Jianye Real Estate (00832) reported a total property contract sales of CNY 4.44 billion in the first half of the year, a year-on-year decrease of 1.2% [1] - China Lilang (01234) reported a mid-to-high single-digit year-on-year growth in retail sales of "LILANZ" products in the first half of the year [1]

格隆汇7月10日丨中国生物制药(01177.HK)宣布，集团自主研发的CDK2/4/6抑制剂库莫西利胶 囊"TQB3616"联合氟维司群注射液用于既往未经治疗的HR阳性、HER2阴性(HR+/HER2-)局部晚期或转 移性乳腺癌，已向中国国家药品监督管理局药品审评中心("CDE")提交新适应症上市申请，并获得受 理。 乳腺癌是女性最常见的恶性肿瘤之一。其中，HR+/HER2-乳腺癌约占全部乳腺癌的65%-70%，是乳腺 癌最常见的亚型。约4%-6%的乳腺癌患者初诊即晚期，而早期患者即使接受标准辅助治疗，仍有 30%-40%进展成为晚期。《中国临床肿瘤学会(CSCO)乳腺癌指南(2025版)》等权威指南一致推荐 CDK4/6抑制剂联合内分泌治疗用于HR+/HER2-晚期乳腺癌一线治疗。 集团已于2024年7月递交库莫西利的新药上市申请，并获CDE受理，用于联合氟维司群治疗既往内分泌 经治的HR+/HER2-局部晚期或转移性乳腺癌。此次一线适应症上市申请再获受理，进一步证实了该联 合疗法在晚期乳腺癌不同治疗阶段的广阔潜力。 TQB3616-III-02(NCT04523272)是一项随机、双盲、平行对照、多中心I ...

中国生物制药公告，集团自主研发的CDK2/4/6抑制剂库莫西利胶囊"TQB3616"联合氟维司群注射液用 于既往未治疗的HR阳性、HER2阴性局部晚期或转移性乳腺癌，已向中国国家药品监督管理局药品审评 中心提交新适应症上市申请并获得受理。此前，集团已于2024年7月提交库莫西利的新药上市申请并获 中国国家药品监督管理局药品审评中心受理。此次一线适应症申请的受理进一步证实了该联合疗法在晚 期乳腺癌不同治疗阶段的广阔潜力。该研究已达到主要终点，详细数据将于近期国际权威学术大会公 布。 ...