Core Viewpoint - Sichuan Kelun Pharmaceutical Co., Ltd. announced that its subsidiary, Sichuan Kelun Botai Biopharmaceutical Co., Ltd., received breakthrough therapy designation from the National Medical Products Administration (NMPA) for its TROP2 ADC product, sac-TMT, in combination with PD-L1 monoclonal antibody, Tagolizumab, for the first-line treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) without driver gene mutations [2][3]. Group 1: Product and Clinical Development - Sac-TMT is a novel TROP2 ADC developed by Kelun Botai, targeting advanced solid tumors such as NSCLC, breast cancer (BC), gastric cancer (GC), and gynecological tumors [3][5]. - The drug utilizes a new linker and has a drug-antibody ratio (DAR) of 7.4, employing a topoisomerase I inhibitor as an effective payload to induce DNA damage in tumor cells [3][5]. - Sac-TMT has previously received four other breakthrough therapy designations for various indications, including triple-negative breast cancer (TNBC) and EGFR mutation-positive NSCLC [3][4]. Group 2: Regulatory and Market Position - Sac-TMT is the first domestically developed ADC with global intellectual property rights and the first TROP2 ADC approved for lung cancer indications globally [5]. - The drug has already been approved for two indications in China, including treatment for advanced TNBC and EGFR mutation-positive NSCLC after prior treatment [4][5]. - Kelun Botai has initiated eight registration clinical studies in China, while Merck has started 14 ongoing global Phase III clinical studies for sac-TMT in various cancer types [5]. Group 3: Collaborations and Partnerships - In May 2022, Kelun Botai granted Merck exclusive rights to develop, use, manufacture, and commercialize sac-TMT outside Greater China [4]. - Tagolizumab, the PD-L1 monoclonal antibody used in combination with sac-TMT, is the first approved PD-L1 antibody for first-line treatment of nasopharyngeal carcinoma in China [6].

这是芦康沙妥珠单抗(sac-TMT)获NMPA授予的第五项突破性疗法认定。此前，芦康沙妥珠单抗(sac- TMT)于2022年7月就治疗局部晚期或转移性三阴性乳腺癌(TNBC)，于2023年1月就治疗表皮生长因子受 体酪氨酸激酶抑制剂(EGFR-TKI)治疗后疾病进展的局部晚期或转移性EGFR突变NSCLC，于2023年6月 就治疗既往接受过至少二线系统化疗的局部晚期或转移性激素受体阳性(HR+)及人类表皮生长因子受体 2阴性(HER2-)乳腺癌(BC)患者，以及于2024年3月就一线治疗不可手术切除的局部晚期、复发或转移性 PD-L1阴性TNBC，获得突破性疗法认定。 芦康沙妥珠单抗(sac-TMT)联合塔戈利单抗一线治疗晚期或转移性非鳞状NSCLC患者的2期OptiTROP- Lung01临床研究结果于2025年美国临床肿瘤学会(ASCO)年会上的壁报环节公布。 格隆汇6月11日丨科伦博泰生物-B(06990.HK)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)(佳泰莱®)联合抗程序性细胞死亡配体1(PD-L1)单克隆抗体 ("单抗")塔戈利 ...

Summary of IDEA Biosciences Conference Call Company Overview - **Company**: IDEA Biosciences - **Focus**: Development of innovative therapies for cancer treatment, with six clinical programs currently and a target of nine by year-end [2][1]. Key Value Drivers - **Lead Program**: Derobicertib, targeting metastatic human melanoma, currently in a registrational trial [2][1]. - **Enrollment Status**: Completed enrollment for the trial, with over 320 patients enrolled, exceeding the target of 250 [12][13]. - **Primary Endpoint**: Median progression-free survival (PFS) is crucial for potential accelerated approval, with historical PFS around 2-3 months and a target of over 5.5 months for the current study [3][8]. Clinical Data and Updates - **PFS Results**: Previous studies showed a PFS of approximately 7 months, with a specific setting achieving nearly 11 months [10][11]. - **Overall Survival (OS)**: Anticipated update on OS data from the phase two study, with historical OS in treatment-naive settings around 12-13 months [17][18]. - **Market Opportunity**: Targeting the HLA A2 negative population, with an estimated annual incidence of 4,000 to 5,000 patients in the US and Europe [20][19]. Commercial Strategy - **Commercial Organization**: Building a commercial team with key hires, including a Chief Commercial Officer and heads of various departments [24][25]. - **Regulatory Strategy**: Fast track designation from the FDA for expedited review, with ongoing discussions regarding NDA submission [14][16]. Pipeline and Future Developments - **Additional Programs**: Focus on MTAP deletion space and DLL3, with several data catalysts expected [5][6][51]. - **Combination Therapies**: Emphasis on rational combinations, particularly with PRMT5 inhibitors in lung cancer [70][71]. - **IND Filings**: Targeting multiple INDs, with a goal of one IND per year, and a record of four INDs planned for the current year [86][87]. Financial Position - **Cash Reserves**: Reported over $1 billion in cash, providing a strong financial position for ongoing and future clinical activities [88][87]. Conclusion - IDEA Biosciences is positioned for significant growth with multiple clinical programs, a robust commercial strategy, and a strong financial foundation, aiming to address unmet needs in cancer treatment through innovative therapies and strategic partnerships.

证券研究报告 2025年06月09日 行业报告： 行业专题研究 买全球最好的中国创新药：突破性疗法（BTD）品种梳理 作者： 分析师 杨松 SAC执业证书编号：S1110521020001 分析师 曹文清 SAC执业证书编号：S1110523120003 联系人 刘一伯 1 行业评级： 上次评级： 强于大市 强于大市 维持 （ 评级） 请务必阅读正文之后的信息披露和免责申明 医药生物 突破性疗法梳理：从热门靶点到全球新靶点、从老牌药企到新兴药企 ◆ 突破性疗法梳理： （1）突破性疗法意味着显著且可靠临床的意义。突破性疗法最初于2020年被CDE引入国内，允许创新药物与改良型新药研发企业在三期 临床开展前申请突破性治疗药物程序，其要旨集中于两点：（1）用于加快治疗严重危及生命或严重影响生存质量的疾病新药落地，从而 尽早满足患者的治疗需求；（2）针对适应症尚无有效治疗手段或药物，新药较现阶段治疗手段具有足够证明其临床优势。 （2）突破性疗法的动态变化，从热门靶点到新靶点、从老牌Pharma&biotech逐步扩散：Insight数据库显示，截至2025年6月4日，仅考 虑国产创新药（自研），目前CDE共批准126 ...