撰文丨王聪 编辑丨王多鱼 排版丨水成文 食管癌 是癌症相关死亡的第七大常见原因，其中， 食管鳞状细胞癌 （ESCC） 是全球最常见的食管癌类型。免疫检查点抑制剂 （例如抗 PD-1、PD-L1 和 CTLA-4 单抗） 与基于铂类药物的化疗相结合，已成为晚期食管鳞状细胞癌的标准治疗方法，并带来了显著的生存获益。然而，仅有 10%-20% 的食管鳞状细 胞癌患者能长期存活，因为大多数患者会对这些药物产生耐药性。 晚期食管鳞状细胞癌的二线治疗采用 伊立替康 （Irinotecan） ，但其疗效也有限，客观缓解率 （ORR） 不超过 10%。 因此，迫切需要开发新的有效治疗策略，以克服当前疗法的局限性，提高食管鳞状细胞癌患者的生存率。 2025 年 7 月 10 日， 北京大学肿瘤医院 鲁智豪 、 沈琳 、 龚继芳 等人在国际顶尖医学期刊 Nature Medicine 上发 表了题为： A bispecific antibody–drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a ph ...

撰文丨王聪 编辑丨王多鱼 排版丨水成文 胃肠道 （GI） 癌症，包括肝癌、胃癌、胰腺癌、神经内分泌肿瘤以及最为常见的结直肠癌，是全球癌症相关死亡的主要原因。根据国际癌症研究机构 （IARC） 的最新统计数据，这些癌症约占所有癌症诊断病例的 24.6%，占癌症死亡病例的 34.2%。 在这项最新研究中，研究团队证明了 CDH17 在胃肠道癌症中高度表达，在结直肠癌的临床样本中几乎 100% 表达， 在其他胃肠道癌症中表达率也高达 23%-88%， 高表达与肿瘤进展、转移及临床预后不良密切相关，且 在正常组织中低表达， 因此成为胃肠道癌症治疗干预的理想靶点。 研究团队开发了一种抗 CDH17 的 抗体药物偶联物 （ADC） ，命名为—— 7MW4911 ，其采用了迈威生物专有的拓扑异构酶抑制剂 MF-6 （Topi MF-6） 有 效载荷，通过可裂解 Linker 的连接， 7MW4911 实现了 4 个 MF-6 与一个抗体偶联的均一偶联比，旨在解决胃肠道癌症中的多药耐药性 。 在全球范围内，结直肠癌 （CRC） 在所有癌症的发病率中排名第三，在癌症相关死亡率中排名第二，而胰腺癌尽管发病率较低，但死亡率却是最高 ...

Summary of Innovent Biologics Update / Briefing Company Overview - **Company**: Innovent Biologics (01801) - **Event**: Healthy China 2030 Oncology Innovation Summit and R&D Day - **Date**: June 27, 2025 Key Points Industry Context - The oncology sector is a major health threat globally, affecting individuals regardless of socioeconomic status [10][14] - The biomedicine industry in China has evolved significantly over the past decade, transitioning from generics to innovative biologics [15][20] Company Achievements - Innovent was established in 2011 and has launched 16 products, with over 20 in R&D [21][22] - The company has invested over ¥8 billion (approximately $1.2 billion) and holds 20% of China's total biologics production capacity [21][22] - In 2024, Innovent's total revenue exceeded ¥9.4 billion (approximately $1.4 billion) [24] Market Position - Innovent is a leader in several oncology segments, including PD-1, VEGF, and CD20, with three of the top ten oncology drugs in China coming from Innovent [24] - The company has made significant strides in drug accessibility and affordability, with prices for monoclonal antibodies now a fraction of those in the U.S. [17][18] Future Outlook - By 2027, Innovent aims to achieve product revenue of ¥20 billion (approximately $3 billion) and to be among the top five in sales revenue in China's biopharma sector [26][40] - The company plans to have five assets in global MRCT Phase III trials by 2030 [30][41] R&D Innovations - Innovent is focusing on next-generation technologies, including new generation immuno-oncology (IO) and antibody-drug conjugates (ADC) [32][37] - The company is developing IBI-363, a PD-1 IL-2 fusion protein, which shows promise in enhancing anti-tumor immunity [36] - Collaborations with multinational firms like Roche, Eli Lilly, and Sanofi are ongoing to enhance R&D capabilities [21][22] Challenges and Opportunities - Despite progress, there are still unmet clinical needs in oncology, and Innovent aims to address these through innovative therapies [47][49] - The company is optimistic about the potential of ADCs combined with IO therapies to improve treatment outcomes for lung cancer and other malignancies [93][94] Conclusion - Innovent Biologics is positioned as a key player in the Chinese biopharma landscape, with a strong focus on innovation and collaboration to drive future growth in oncology treatments [49][50]

Core Insights - DualityBio has a strong pipeline of antibody-drug conjugate (ADC) candidates, showcasing its innovation capabilities in the ADC space [1][2] - The company has established multiple strategic partnerships with global biopharmaceutical firms, enhancing its development efforts and validating its platform [3] - Revenue projections indicate significant growth, with expectations of reaching RMB2.0 billion by FY25E, primarily from licensing and collaborations [4] Group 1: ADC Product Pipeline - DB-1303/BNT323 (HER2 ADC) is expected to file for FDA accelerated approval by 2025 for HER2-expressing endometrial cancer [1] - DB-1311/BNT324 (B7-H3 ADC) shows promising early results with a 70.4% response rate in 3L+ SCLC patients [1][2] - DB-1310 (HER3 ADC) has demonstrated a median progression-free survival (mPFS) of 8.3 months in heavily pre-treated 4L+ EGFR-TKI resistant NSCLC [2] Group 2: Strategic Partnerships - DualityBio has formed partnerships with major companies like BioNTech, BeiGene, and GSK, resulting in a total deal value exceeding US$6.0 billion [3] - The partnerships focus on various ADC programs, including B7-H3, HER2, and TROP2 ADCs, which enhances the company's market position [3] - The replicable partnership model is seen as a sustainable path for future innovation and growth in the ADC sector [3] Group 3: Financial Projections - Total revenue is projected to reach RMB2.0 billion in FY25E, with expectations of product sales revenue starting in 2027E [4] - The target price for DualityBio is set at HK$270.34 based on a discounted cash flow (DCF) valuation [4]

目前，映恩生物已披露了27条ADC研发管线，本次在ASCO大会上公布数据的DB-1310和DB- 1311/BNT324，目前均处于临床Ⅰ/Ⅱa期。 近日，2025年美国临床肿瘤学会（ASCO）年会在美国芝加哥拉开帷幕。中国ADC（抗体药物偶联物） 企业映恩生物（HK09606）以口头报告的形式，首次公布了DB-1310用于治疗晚期实体瘤患者的Ⅰ/Ⅱa 期试验的初步结果，以及DB-1311用于经多线治疗的去势抵抗性前列腺癌患者的数据。 《每日经济新闻》记者注意到，5月底，全球头部ADC药企"第一三共"撤回了类似药物的适应证在美国 寻求加速批准的BLA（生物制品许可申请）。 6月3日，映恩生物首席科学官邱杨在公司召开的2025年ASCO数据说明会上表示，团队对HER3（一种 表皮生长因子受体）靶点和DB-1310充满信心，未来，公司可能公布DB-1310在EGFR（也是一种表皮生 长因子受体，此处意在标明癌症基因分型）野生型肺癌和乳腺癌领域的更多数据。 研究结果：近三分之一患者首次评估时肿瘤缩小 DB-1310是一款HER3 ADC药物，对应的临床试验是一项多中心、开放性、非随机的首次人体研究，旨 在评估晚期/ ...

Financial Data and Key Metrics Changes - The company has achieved significant growth, reaching over 3.4 million patients treated globally with its oncology medicines, supported by strong commercial execution [56] - Keytruda is approved in 56 indications in the US, 44 in the EU, and 41 in Japan, showcasing its leadership in immuno-oncology [56][59] Business Line Data and Key Metrics Changes - The oncology portfolio has yielded 35 phase three trials with statistically significant overall survival and 56 FDA approved indications [7] - The development of subcutaneous pembrolizumab with barahyaluronidase alfa has shown comparability to IV Keytruda, with a median injection time of two minutes [17][19] Market Data and Key Metrics Changes - The company is focusing on expanding its presence in earlier stage diseases, particularly in head and neck cancer, where there is a significant unmet medical need [60] - The anticipated peak uptake of subcutaneous pembrolizumab in the US is expected to reach between 30-40% within 18 to 24 months [62] Company Strategy and Development Direction - The company aims to diversify its oncology portfolio beyond Keytruda, focusing on additional therapeutic areas such as HIV vaccines, immunology, cardiovascular, and ophthalmology [6] - The strategy includes leveraging the proven track record of Keytruda to sustain leadership in oncology beyond its loss of exclusivity in 2028 [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing development of innovative therapies and the potential for significant impact on cancer care through a diversified pipeline [55] - The company is committed to maximizing patient access and improving outcomes through its robust commercial engine and innovative product offerings [63] Other Important Information - The company has a strong focus on biomarker development, which is crucial for patient selection and optimizing treatment outcomes [36] - There are ongoing phase III studies for various agents, including MK1084 and Sac TMT, which are expected to read out in the near future [53][64] Q&A Session Summary Question: What is the company's perspective on the evolving market for PD-1, PD-L1, and VEGF bispecifics? - Management highlighted the consistent improvements in progression-free survival across multiple indications and expressed optimism about the ongoing trials in China, with plans to expand to the US [75][78] Question: How does the company view the market opportunity for head and neck cancer treatments? - Management clarified that patients receiving preoperative Keytruda did not lose the opportunity for surgery, and emphasized the safety and efficacy of the treatment [79]

Financial Data and Key Metrics Changes - The company reported a confirmed overall response rate (ORR) of 68% and a disease control rate of 93% across all dose levels in the ongoing clinical trial for ZL1310 [12][21] - The median follow-up for the efficacy evaluable patients was 3.4 months, with some patients remaining in response for over 9 months [22][43] Business Line Data and Key Metrics Changes - ZL1310, the investigational DLL3 targeted antibody-drug conjugate, demonstrated promising clinical activity in patients with relapsed or refractory extensive stage small cell lung cancer [6][19] - The safety profile of ZL1310 was reported as manageable, with only 16% of patients in the low-dose group requiring dose interruptions [10][19] Market Data and Key Metrics Changes - Small cell lung cancer accounts for approximately 15% of all lung cancers, affecting around 372,000 patients worldwide, with a poor prognosis and a median overall survival of about 13 months [6][19] - The estimated global prevalence of DLL3 expressing neuroendocrine carcinomas is roughly 350,000 to 400,000 patients, indicating a significant market opportunity for ZL1310 [26] Company Strategy and Development Direction - The company plans to initiate a registrational study in second-line small cell lung cancer later this year, with overall survival as the primary endpoint [22][23] - There is a strategy to expand ZL1310 into first-line small cell lung cancer and other DLL3 expressing solid tumors, aiming to reduce treatment burden for patients [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for accelerated approval based on the promising data and ongoing discussions with the FDA [56][57] - The company is optimistic about the efficacy of ZL1310 in the competitive landscape, particularly in comparison to existing therapies [48][49] Other Important Information - The company is exploring combination therapies with ZL1310, including carboplatin and atezolizumab, to enhance treatment efficacy [38][39] - The company has received fast track designation from the FDA, which may facilitate the development process [32] Q&A Session Summary Question: Can you comment on the therapeutic window and confidence in the selected dose for pivotal studies? - Management indicated that the 1.6 mg/kg dose shows a good balance of efficacy and safety, with a slight attrition in response at higher doses [29][30] Question: What is the dosing strategy and safety consideration for the combination trial? - The company is methodically exploring combinations with existing chemotherapy regimens and is confident in the competitive activity of ZL1310 [37][38] Question: How does the durability of ZL1310 compare to competitors in refractory small cell lung cancer? - Management noted that the durability of response is clinically meaningful, with a median follow-up of 6.9 months for the most mature data set [42][43] Question: What gives confidence in potential accelerated approval for ZL1310? - Ongoing discussions with the FDA suggest that accelerated approval is a viable option, contingent on the results of the randomized trial [56][57] Question: What are the remaining items to align with the FDA before initiating the pivotal study? - The main focus is to finalize the dosing strategy and ensure alignment on study design with the FDA [65][66]

乐普生物科技公告，自主研发的候选药物MRG003(一种表皮生长因子受体靶向创新型抗体药物偶联物 (ADC)候选药物，用于治疗复发性或转移性鼻咽癌(R/M NPC))的关键注册性临床研究结果于2025年美国 临床肿瘤学会(ASCO)年会上以"重磅研究摘要(LBA)"形式公布，并于会上作口头报告。截至2024年6月 30日，MRG003组的客观缓解率(ORR)为30.2%，化疗组为11.5%(95%CI:7.0%,30.5%,P=0.0025)。 MRG003组的无进展生存期(PFS)显著改善(HR=0.63,95%CI:0.43,0.91,P=0.0146)，中位PFS为5.8个月。截 至2024年12月30日的期中分析中，两组患者的中位生存期(OS)分别为17.1个月和12个月 (HR=0.73,95%CI:0.48,1.12)。 ...

AbbVie (ABBV) announced that the FDA has granted accelerated approval to its antibody-drug conjugate (ADC), telisotuzumab vedotin (or Teliso-V), for treating certain patients with non-small cell lung cancer (NSCLC). The drug will be marketed under the brand name Emrelis.Under this approval, Emrelis is approved to treat adult patients with locally advanced or metastatic, non-squamous NSCLC with high c-Met protein overexpression (OE) who have received a prior systemic therapy. This makes it the first FDA-appr ...

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, which is consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][16] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, primarily due to higher license revenues and lower expenses [17] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, mainly due to net loss from operations and timing of cash receipts [17] Business Line Data and Key Metrics Changes - Milestone and royalty payments contributed an additional $5.6 million to total revenue for the quarter [6] - The LOTUS-seven study showed a 95.5% overall response rate and a 90.9% complete response rate in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with ongoing trials showing promising data [5][9] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][10] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant patient reach and commercial opportunity [9][10] - Regulatory discussions are planned based on data from 100 patients, aligning with recent examples of bispecific combination therapies [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash runway extending into the second half of 2026, positioning the company to deliver on upcoming catalysts [20] - The management is encouraged by the promising data from ongoing trials and believes in multiple pathways to achieve peak revenue goals [22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [7][19] - The company is engaged in discussions for potential research collaborations to advance its preclinical assets [8][19] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with encouraging complete response rates serving as strong biomarkers for durability [24][27] Question: Competitive strategy and regulatory engagement - Management plans to engage with regulatory authorities after gathering data from approximately 100 patients, assessing the best path forward [29][47] Question: Expected patient numbers at upcoming conferences - Management confirmed that 40 patients have been enrolled, with additional patients expected to be presented at the EHA conference [33][34] Question: LOTUS-five trial data expectations - Management reiterated that the timing for top-line data from the LOTUS-five trial could be late 2025 or early 2026, depending on the number of PFS events [42][43] Question: Discontinuation of the ADCT-602 program - Management clarified that the discontinuation of the ADCT-602 program has minimal financial impact, allowing focus on other research programs [49][50]