Core Viewpoint - The approval of the antibody-drug conjugate (ADC) sac-TMT for a third indication marks a significant advancement in the treatment of EGFR mutation-positive locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) after progression on EGFR tyrosine kinase inhibitors (TKIs) [1][2] Group 1: Product Approval and Clinical Significance - The National Medical Products Administration (NMPA) has approved sac-TMT for treating adult patients with locally advanced or metastatic NSCLC who have progressed after TKI treatment [1] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to platinum-based doublet chemotherapy in this patient population [1] - The treatment has demonstrated statistically and clinically significant improvements in progression-free survival (PFS) and OS compared to standard platinum-based chemotherapy [1] Group 2: Clinical Research and Future Developments - The approval is based on the results of a randomized, open-label, multicenter Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study evaluates the efficacy and safety of sac-TMT administered every two weeks at a dose of 5 mg/kg compared to pemetrexed plus platinum-based therapy in patients with EGFR mutation-positive NSCLC who have failed EGFR-TKI treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic NSCLC has completed patient enrollment in China [2]

智通财经APP讯，科伦博泰生物-B(06990)发布公告，公司靶向人滋养细胞表面抗原2(TROP2)的抗体偶 联药物(ADC)芦康沙妥珠单抗(sac-TMT，亦称SKB264/MK-2870)(佳泰莱)获国家药品监督管理局(NMPA) 批准第三项适应症，用于治疗经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR 基因突变阳性的局部晚期或转移性非鳞状非小细胞肺癌(NSCLC)成人患者。 本次批准是基于一项随机、开放标签、多中心III期临床研究(OptiTROPLung04)，该研究已入选2025年 欧洲肿瘤内科学会(ESMO)大会最新突破性摘要(LBA)，并将以主席论坛(PresidentialSymposium)口头报 告(报告编号：LBA5)的形式发布。OptiTROP-Lung04研究旨在评估芦康沙妥珠单抗(sacTMT)单一疗法每 两周(Q2W)5mg/kg静脉注射对比培美曲塞联合铂类治疗经EGFR-TKI治疗失败的EGFR突变的局部晚期或 转移性非鳞状NSCLC患者的有效性和安全性。 芦康沙妥珠单抗(sac-TMT)是迄今为止全球首个且唯一对比含铂双药化疗显示出显著的总生存期 ...

Core Insights - The company Keren Biotechnology (06990.HK) has received approval from the National Medical Products Administration (NMPA) for its antibody-drug conjugate (ADC) sac-TMT, targeting TROP2, for a third indication in treating adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) who have progressed after treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) [1][2] Group 1 - The approval is based on a randomized, open-label, multi-center Phase III clinical study (OptiTROP-Lung04), which will be presented at the 2025 European Society for Medical Oncology (ESMO) conference [2] - The study evaluates the efficacy and safety of sac-TMT administered every two weeks at a dose of 5 mg/kg compared to pemetrexed combined with platinum-based therapy in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have failed EGFR-TKI treatment [2] - Sac-TMT is the first and only ADC to show significant overall survival (OS) benefits compared to standard platinum-based doublet chemotherapy in this patient population [1][2] Group 2 - In March 2025, sac-TMT was approved by NMPA for use in patients with EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC who have progressed after EGFR-TKI and platinum-based chemotherapy [2] - The single-agent therapy with sac-TMT significantly extends the overall survival of these patients compared to standard treatment [2] - Another Phase III registration study of sac-TMT combined with osimertinib as first-line treatment for EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC has completed patient enrollment in China [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內 容 概 不 負 責，對 其 準 確 性 或 完 整 性 亦 不 發 表 任 何 聲 明，並 明 確 表 示，概 不對因本公告全部或任何部份內容而產生或因倚賴該等內容而引致的 任 何 損 失 承 擔 任 何 責 任。 於2025年3月，蘆 康 沙 妥 珠 單 抗(sac-TMT)已 獲NMPA批准用於EGFR-TKI和 含鉑化療治療後進展 的EGFR基 因 突 變 陽性的局部晚期或轉移性非鱗狀 NSCLC。與 標 準 治 療 相 比，蘆 康 沙 妥 珠 單 抗(sac-TMT)單一療法顯著延長 此 類 患 者 的 總 生 存 期。另外一項 蘆康沙妥珠單抗(sac-TMT)聯合奧希替尼 一線治療EGFR突變的局部晚期或轉移性非鱗狀NSCLC的III期註冊性研究 已 在中國 完成全部患者入組。 關於蘆康沙妥珠單抗(sac-TMT)（佳泰萊®） Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 四川科倫博泰生物醫藥股份有限公司 （於 中 華 人 民 共 和 國 註 冊 成 立 的 股 份 有 限 公 司） ...

Investment Rating - The industry investment rating is "Positive" (maintained) [1] Core Views - The in vivo CAR-T technology is emerging as a new hotspot in cell therapy, with significant investment opportunities in the domestic market. Major pharmaceutical companies are actively entering this field, with multiple high-value transactions occurring in 2025 [5][14] - Compared to traditional CAR-T, in vivo CAR-T offers advantages such as reduced manufacturing costs, shortened processing times, and improved accessibility for patients, making it applicable in various diseases including B-cell malignancies and autoimmune diseases [6][15] - The report highlights the performance of various sub-sectors within the pharmaceutical industry, noting that the hospital sector showed the highest increase, while the medical R&D outsourcing sector experienced the largest decline [7][24] Summary by Sections Section 1: In Vivo CAR-T Transactions - Numerous significant transactions in the in vivo CAR-T space have occurred in 2025, indicating strong interest and investment potential. Notable deals include AstraZeneca's acquisition of EsoBiotech for $1 billion and BMS's agreement to acquire Orbital Therapeutics for $1.5 billion [5][14] Section 2: Market Performance - In the second week of October 2025, the pharmaceutical sector declined by 1.20%, underperforming the CSI 300 index by 0.69 percentage points, ranking 25th among 31 sub-industries. The hospital sector saw the largest increase at 1.79% [7][18] - The report provides a detailed analysis of sub-sector performance, with the hospital sector leading gains and the medical R&D outsourcing sector facing the most significant losses [24][28] Section 3: Recommended Stocks - The report recommends several stocks for investment, including Shiyao Group, Sunshine Nuohuo, and Yuekang Pharmaceutical, among others [8][16]

百利天恒公告，全资子公司SystImmune与百时美施贵宝就BL-B01D1（EGFR×HER3双抗ADC）项目达 成的合作协议已触发里程碑事件，正式触发合作协议项下第一笔2.5亿美元的近期或有付款条件。 SystImmune将于近期收到款项，实际到账金额需扣除银行手续费。根据合作协议，公司后续还有资格 获得最高可达2.5亿美元的近期或有付款，以及在达到特定的开发、注册和销售里程碑后最高可达71亿 美元的额外付款。 ...

科伦药业（002422）(002422.SZ)发布公告，公司近日获悉，公司控股子公司四川科伦博泰生物医药股 份有限公司(简称"科伦博泰")靶向人滋养细胞表面抗原2(TROP2)的抗体偶联药物(ADC)芦康沙妥珠单抗 (sac-TMT，亦称SKB264/MK-2870)(佳泰莱)获国家药品监督管理局(NMPA)批准第三项适应症，用于治 疗经表皮生长因子受体(EGFR)酪氨酸激酶抑制剂(TKI)治疗后进展的EGFR基因突变阳性的局部晚期或 转移性非鳞状非小细胞肺癌(NSCLC)成人患者。 芦康沙妥珠单抗(sac-TMT)是迄今为止全球首个且唯一对比含铂双药化疗显示出显著的总生存期(OS)获 益，并且已获批用于仅接受过TKI治疗后进展(2L)的晚期NSCLC的ADC。在预设的OS期中分析中，与 目前含铂双药化疗标准治疗相比，芦康沙妥珠单抗(sac-TMT)单一疗法在无进展生存期和总生存期均具 有显著统计学意义和临床意义的改善，显著延长此类患者的无进展生存期和总生存期。 ...

Core Viewpoint - Shenzhen Wego Biological Products Co., Ltd. has received notification from the Shenzhen Stock Exchange regarding the acceptance of its application for a specific object issuance of A-shares, indicating a step forward in its capital raising efforts [1] Group 1: Company Announcement - The company announced that it received a notice from the Shenzhen Stock Exchange on October 10, 2025, regarding the acceptance of its application for issuing shares to specific investors [1] - The application documents submitted by the company were deemed complete by the Shenzhen Stock Exchange, leading to the decision to accept the application [1] - The issuance of A-shares is subject to approval from the Shenzhen Stock Exchange and registration consent from the China Securities Regulatory Commission, indicating that the process is not yet finalized [1] Group 2: Regulatory Process - The final approval from the Shenzhen Stock Exchange and the China Securities Regulatory Commission remains uncertain, highlighting the regulatory hurdles that the company must navigate [1] - The company commits to timely information disclosure based on the progress of this matter, emphasizing transparency in its operations [1]

每经头条（nbdtoutiao）——万亿美元"世纪豪赌"！英伟达、OpenAI等巨头集体出手！循环融资靠谱 吗？专家：AI泡沫规模已是2008年全球房地产泡沫的4倍 （记者 王晓波） 每经AI快讯，华大智造10月12日晚间发布公告称，公司第二届第十七次董事会会议于2025年10月12日 以现场结合通讯方式召开。会议审议了《关于就CoolMPS测序技术签署授权许可协议暨受让与关联方相 关共有专利并进行授权收入分成的议案》等文件。 ...

派格宾是公司目前的核心产品，是公司自主研发的全球首个40kD聚乙二醇长效干扰素α-2b注射液，是 治疗用生物制品国家1类新药，是我国第一个国产上市的聚乙二醇(PEG)修饰干扰素品种。派格宾于 2016年10月获批上市，获批适应症为治疗成人慢性丙型肝炎;2017年9月获批成人慢性乙型肝炎适应症。 特宝生物(688278.SH)发布公告，近日，公司收到国家药品监督管理局核准签发的《药品注册证书》， 公司产品派格宾联合核苷(酸)类似物用于成人慢性乙型肝炎患者的HBsAg持续清除的增加适应症(简 称"增加适应症")上市许可申请获得批准。 ...