智通财经APP讯， 安科生物(300009.SZ)发布公告，公司于2025年 10 月17日至21日在德国柏林召开的欧 洲肿瘤内科学会(ESMO)年会上，以壁报形式公布自主研发的生物创新药重组抗HER2人源化HuA21单克 隆抗体注射液(以下简称"HuA21")联合曲妥珠单抗和化疗治疗HER2阳性晚期胃/胃食管交界处腺癌Ib/II 期剂量递增和扩展研究的最新研究成果。 本次在ESMO年会上披露的HuA21联合曲妥珠单抗联合化疗治疗HER2阳性晚期胃/胃食管交界处腺癌的 临床研究数据进一步证实了其良好的抗肿瘤活性和可耐受的安全性，为III期临床试验提供了支持，加速 药物研发进程。此外，积极的临床数据将为产品市场前景提供有力支持，有助于增强公司产品的未来市 场竞争力。 ...

Company Updates - The company presented significant data at the ESMO conference on October 17, including the approval of sac-TMT for lung cancer in China on October 12, and the approval of trastuzumab deruxtecan on October 17 [1][2] - Sac-TMT demonstrated strong positive overall survival (OS) benefits in the second-line EGFRm non-small cell lung cancer (NSCLC) compared to chemotherapy, marking it as the first successful ADC drug in this indication globally [1] - In the domestic Phase III trial OptiTROP-Lung04, sac-TMT showed statistically and clinically significant improvements in progression-free survival (PFS) and OS, with a median follow-up of 18.9 months, PFS of 8.3 months vs. 4.3 months (HR=0.49), and OS not reached vs. 17.4 months (HR=0.6, p=0.0006) [1] Breast Cancer Insights - In the domestic Phase III trial OptiTROP-Breast02, sac-TMT also showed strong positive OS benefits in HR+ HER2- breast cancer, with PFS of 8.3 months vs. 4.1 months (HR=0.35), and OS not reached but with HR=0.33, indicating significant dual benefits [2] - The HER2 ADC trastuzumab deruxtecan showed clear benefits in a head-to-head trial against Roche's T-DM1, with PFS of 11.1 months vs. 4.4 months (HR=0.39) and OS HR=0.62, leading to its approval in China on October 17 [2] Financial Forecast and Valuation - The company maintains its net profit forecasts for 2025 and 2026 at losses of 672 million yuan and 174 million yuan, respectively [2] - Based on a DCF model, the company maintains an outperform rating and a target price of 550 HKD, indicating a 20.0% upside potential from the current stock price [2]

Summary of Key Points from the Conference Call Company and Industry Overview - **Company**: 科济药业 (Kojin Pharmaceutical) - **Industry**: Biotechnology, specifically focusing on CAR-T cell therapy and cancer treatment Core Insights and Arguments - **Clinical Trials and Efficacy**: - The Phase I clinical trial of Shurijiaolun's adjuvant therapy for pancreatic cancer showed preliminary efficacy, with 83.3% of patients experiencing a significant decrease in CA199 levels, although longer follow-up is needed to assess long-term disease-free survival (DFS) and overall survival (OS) [2][3] - CT0,596, a universal CAR-T therapy, demonstrated rapid tumor clearance in relapsed/refractory multiple myeloma, with two patients achieving stringent complete response (SCR) and negative minimal residual disease (MRD) detection [2][4] - The CD041 project for pancreatic cancer indicated that CAR-T therapy may extend DFS for high-risk patients, but final data requires further clinical validation [2][3] - **Technological Developments**: - The Enma LNP technology showed excellent performance in B-cell clearance but faces challenges in T CAR-T expansion time and antibody level recovery [2][9] - The company is exploring CT0,596 for other plasma cell tumor indications, such as amyloidosis affecting organs like the heart, to expand its clinical application and market potential [2][5] - **Market Position and Future Plans**: - The company is optimistic about returning to the Hong Kong Stock Connect, with a significant market cap recovery providing a safety cushion for this transition [2][24] - Plans to submit IND applications for multiple myeloma by the end of the year and to continue expanding the clinical application of its CAR-T therapies [2][4][19] Additional Important Insights - **Patient Data and Safety**: - In the CD041 project, 6 patients were enrolled, with a median follow-up of 6.05 months; only one patient experienced disease recurrence, indicating a positive trend in DFS [3][20] - All patients in the trials experienced mild to moderate cytokine release syndrome (CRS), with one case of grade 3 CRS managed effectively [3] - **Competitive Landscape**: - The pancreatic cancer treatment landscape is becoming competitive with various emerging drugs, including small molecule inhibitors and ADCs, necessitating exploration of combination therapies for improved efficacy [2][15][17] - **Intellectual Property**: - The company has a strong patent portfolio, including European patent grants for GP10 CAR-T and broad coverage for NK cell technology, ensuring comprehensive protection for its technology platforms [2][21] - **Financial and R&D Progress**: - The company has made progress in its funding chain and plans to disclose more data on universal products by the end of the year [2][25] - Focus remains on challenging projects in solid tumors, leveraging a less competitive environment to concentrate resources [2][26] - **Viral Vector Technology**: - Viral vectors are a core technology for the company, enabling self-production and modification for potential future relapses, with ongoing efforts to innovate in this area [2][27]

| 成交量 | 成交金额 | 成交价格 | 相对当日收盘折溢 | 买方营业部 | 卖方营 | | --- | --- | --- | --- | --- | --- | | （万股） | （万元） | （元） | 价（%） | | 业部 | | 6.93 | 435.32 | 62.78 | 0.00 | 中信证券股份有限公司总部 | 机构专 | | | | | | (非营业场所) | 用 | （文章来源：证券时报网） 证券时报·数据宝统计显示，迪哲医药-U今日收盘价为62.78元，下跌4.08%，日换手率为2.03%，成交额 为5.79亿元，全天主力资金净流入2525.36万元，近5日该股累计下跌5.88%，近5日资金合计净流出 1397.72万元。 两融数据显示，该股最新融资余额为1.43亿元，近5日增加100.62万元，增幅为0.71%。（数据宝） 10月20日迪哲医药-U大宗交易一览 迪哲医药-U10月20日大宗交易平台出现一笔成交，成交量6.93万股，成交金额435.32万元，大宗交易成 交价为62.78元。该笔交易的买方营业部为中信证券股份有限公司总部(非营业场所)，卖方营业部为机构 专用。 ...

Core Viewpoint - The article discusses the recent developments and future prospects of Ying'en Biotech, highlighting its position in the ADC (Antibody-Drug Conjugate) market and the broader trends in the Chinese biotech industry, emphasizing the importance of business development (BD) and the potential for global competitiveness in the sector [1][8]. Company Overview - Ying'en Biotech was listed on the Hong Kong Stock Exchange and achieved a significant market capitalization of HKD 29.932 billion, with its stock price reaching a historical high of HKD 563.500 per share [1]. - The company has a strong focus on ADCs, with 10 clinical-stage pipelines, and is recognized as a "dark horse" in the ADC sector [2][4]. Clinical Development - The company's lead product, DB-1303, has shown significant advantages over the established drug T-DM1 in its Phase III clinical trials, indicating a promising path toward market approval [2][3]. - DB-1303 has received breakthrough therapy designation from both the FDA and CDE, showcasing its potential in treating endometrial cancer, a less competitive indication [3]. Business Development Strategy - Ying'en Biotech has successfully engaged in multiple BD transactions, partnering with notable companies such as BioNTech and GSK, which has positioned it favorably within the industry [7][8]. - The company has a strategic focus on global markets, leveraging its international team and experience to enhance its product development and commercialization efforts [6][7]. Market Trends - The ADC market is projected to grow at a compound annual growth rate (CAGR) of 34% from 2020 to 2024, with the market size expected to exceed USD 13 billion by 2024 [6]. - The article notes a shift in investor sentiment towards Chinese biotech, with a significant increase in BD transactions involving multinational corporations [8][9]. Financial Performance - Despite substantial R&D investments, Ying'en Biotech reported net losses of CNY 387 million, CNY 358 million, and CNY 1.05 billion for the years 2022 to 2024, with a loss of CNY 2.074 billion in the first half of 2025 [12]. - The company maintains confidence in its financial strategy, anticipating that its BD activities will generate significant milestone payments in the coming years [10][12]. Future Outlook - The CEO envisions a future where Chinese ADC companies will be globally recognized for their contributions to patient care, emphasizing the importance of innovation and effective clinical execution [11][12]. - Ying'en Biotech aims to transition from a biotech firm to a pharmaceutical company, focusing on maintaining its R&D integrity while expanding its global presence [10][11].

Financial Data and Key Metrics Changes - The company ended Q3 2025 with a cash position of approximately $238.56 million [38] - Total GAAP operating expenses for Q3 2025 were $234.2 million, a decrease from $568.4 million in Q2 2025, primarily due to a higher stock-based compensation expense recorded in the previous quarter [39] - Non-GAAP operating expenses for Q3 2025 were $103.4 million, an increase from $89.6 million in the previous quarter, mainly due to increased R&D expenses related to ongoing trials [39] Business Line Data and Key Metrics Changes - The HARMONi-3 study is enrolling ahead of goals, with over 80% of the planned 600 squamous patients cohort already enrolled, expected to complete enrollment in Q1 2026 [37] - The non-squamous cohort in HARMONi-3 is also enrolling ahead of plan, with an expected completion for 1,000 patients in the second half of 2026 [37] Market Data and Key Metrics Changes - The company announced the expansion of its clinical development program with the addition of the global phase III HARMONi-GI3 trial, evaluating ivonescimab as first-line therapy in unresectable metastatic colorectal cancer [24] - The HARMONi-6 study demonstrated a significant progression-free survival benefit for ivonescimab in advanced squamous non-small cell lung cancer, with a hazard ratio of 0.60 [18] Company Strategy and Development Direction - The company aims to establish ivonescimab as a new standard of care for advanced squamous non-small cell lung cancer, with ongoing studies to support this goal [20] - The strategic focus includes expanding ivonescimab's application beyond lung cancer to other solid tumors, with a total of 14 planned or ongoing phase III clinical trials [24] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the results of the HARMONi-6 study and its implications for future studies, highlighting the potential for ivonescimab to address unmet needs in oncology [23] - The company is preparing to submit a Biologics License Application (BLA) for ivonescimab based on the HARMONi study results, with expectations for FDA approval [27][28] Other Important Information - The company has had continuous interactions with the FDA regarding the BLA submission and is confident in the safety and efficacy data generated from the HARMONi studies [54] - The HARMONi-3 study has undergone protocol amendments to separate statistical analyses by histology, which is expected to reduce regulatory risks [74] Q&A Session Summary Question: When could we expect to see the first OS cut from HARMONi-6? - Management indicated that specific timelines are difficult to disclose, but a review in 2026 is a fair estimate [44] Question: What options are being evaluated to extend the runway for funding? - The company has an ATM with approximately $350 million and has received inbound interest for additional capital [48] Question: Can you provide any color on the BLA submission and interactions with the FDA? - Continuous interactions with the FDA have been positive, and the company is moving forward with the BLA submission based on the data from HARMONi [54] Question: What prompted the protocol amendments to HARMONi-3? - The amendments were made to accelerate the front-line lung cancer opportunity and reduce regulatory risks by separating analyses by histology [74]

Summary of Sensei Biotherapeutics Conference Call Company Overview - **Company**: Sensei Biotherapeutics (NasdaqGM:SNSE) - **Event Date**: October 20, 2025 - **Focus**: Update on Solnestretug, a VISTA-targeting antibody in immuno-oncology Key Points Industry Context - **Immuno-Oncology**: The call marks a significant milestone for the field, particularly regarding VISTA-targeting therapies, which have not previously demonstrated progression-free survival data in PD1-resistant tumors [2][56] Clinical Data and Findings - **Solnestretug**: - Represents the first progression-free survival data for any VISTA-targeting antibody [2] - Demonstrated clinical activity, durability, and tolerability, suggesting a differentiated mechanism of action [2] - Designed to selectively reverse immunosuppression in the tumor microenvironment, avoiding systemic toxicity [4][6] - **Clinical Trials**: - Phase one dose escalation showed no dose-limiting toxicity, reaching a top dose of 15 mg/kg [7][8] - Combination therapy with cemiplimab was well tolerated, with a six-month progression-free survival rate of 37% for patients previously treated with immunotherapy [15][21] - Notably, 50% of patients receiving the 15 mg/kg dose had a six-month progression-free survival [16][21] Safety Profile - **Adverse Events**: - Low-grade cytokine release syndrome was the only notable class-related adverse event, with no grade 3 or 4 adverse events attributed to Solnestretug [12][48] - The safety profile was consistent with that of single-agent cemiplimab, indicating a well-tolerated regimen [48][56] Market Opportunity - **Commercial Potential**: - PD1-targeted therapies generate over $45 billion annually, with significant unmet needs in secondary resistance cases [4][5] - VISTA's expression across various cancer types presents a broad therapeutic potential [5] Future Plans - **Phase Two Studies**: - Planned initiation in early 2026, focusing on hot tumor settings and potentially leading to accelerated approval in the PD1-resistant population [25][29] - Two-study approach: one randomized study in non-small cell lung cancer and a single-arm study in Merkel cell carcinoma [26][27] Regulatory Considerations - **FDA Engagement**: - Ongoing discussions with the FDA regarding phase two study design and potential for breakthrough therapy designation [54] Conclusion - **Overall Impact**: - Solnestretug represents a significant advancement in immuno-oncology, offering a new therapeutic path for patients with secondary resistance to existing therapies [56][57] - **Future Outlook**: - The company is optimistic about the potential of Solnestretug to redefine treatment options in the immuno-oncology landscape [57]

格隆汇10月20日丨信立泰(002294.SZ)公布，收到子公司美国SalubrisBiotherapeutics,Inc.（下 称"SalubrisBio"）的通知，其在2025年欧洲肿瘤内科学会年会（ESMO）展示了JK06在I/II期临床试验中 的部分剂量递增数据。初步的数据显示，JK06在包括非小细胞肺癌（NSCLC）和乳腺癌在内的不可切 除的局部晚期或转移性肿瘤患者中，展现出良好的安全性和疗效。 ESMO会议上报告的数据，涵盖了JK06在欧洲（部分国家）入组的34例晚期复发性/难治性实体瘤患 者。所有患者均为接受肿瘤标准治疗方案失败后入组，其中83%曾接受过三线或以上治疗，59%曾接受 过四线或以上治疗。在剂量递增阶段入组的患者按每三周（Q3W）一次的频率接受JK06治疗，覆盖五 个剂量水平（1.5-8.0mg/kg）。其中，29例患者经过肿瘤临床疗效评估，并获得关键疗效性数据。 ...

Core Viewpoint - The company Baillie Gifford has announced the completion of the first patient enrollment in a Phase III clinical trial for its innovative biopharmaceutical T-Bren (HER2ADC), which is being compared to pembrolizumab combined with platinum-based chemotherapy for first-line treatment of advanced or metastatic non-squamous non-small cell lung cancer with HER2 mutations [1] Group 1 - T-Bren (BL-M07D1) is a targeted HER2 innovative ADC with best-in-class potential, demonstrating significant anti-tumor efficacy in clinical trials [1] - The Phase III clinical study comparing T-Bren to pembrolizumab combined with platinum-based chemotherapy has recently entered its third phase and completed the first patient enrollment [1] Group 2 - Currently, T-Bren is involved in 14 clinical trials domestically and internationally, including 5 Phase III, 1 Phase II/III, 2 Phase II, 3 Phase I/II, and 3 Phase I trials [1] - The trials cover various indications, including first-line and second-line HER2-positive breast cancer, post-operative adjuvant therapy for HER2-positive breast cancer, neoadjuvant therapy for HER2-positive breast cancer, HER2 low-expressing breast cancer, HER2-positive gastric or gastroesophageal junction adenocarcinoma, and HER2-mutated non-squamous non-small cell lung cancer, as well as other cancers such as lung, gastrointestinal, urological, and gynecological tumors [1]

Bren(HER2ADC)对比帕博利珠单抗联合含铂化疗用于在一线HER2突变的晚期或转移性非鳞状非小细胞 肺癌III期临床试验已于近日完成首例受试者入组。 T-Bren(BL-M07D1)是一种靶向HER2的创新型ADC，具有同类最佳(Best-in-class)潜力，已在临床试验中 展示出显著的抗肿瘤功效。近日，T-Bren对比帕博利珠单抗联合含铂化疗用于在一线HER2突变的晚期 或转移性非鳞状非小细胞肺癌的临床研究已进入III期临床试验阶段并完成首例受试者入组。 截至目前，T-Bren正在国内外开展14项临床试验，包括5个III期、1个II/III期、2个II期、3个I/II期及3个I 期临床试验，覆盖一线和二线及以上HER2阳性乳腺癌、HER2阳性乳腺癌术后辅助、HER2阳性乳腺癌 新辅助治疗、HER2低表达乳腺癌、HER2阳性胃或胃食管结合部腺癌和HER2突变的非鳞状非小细胞肺 癌，以及肺癌、消化道肿瘤、泌尿系统肿瘤和妇科肿瘤等多项适应症。 智通财经APP讯，百利天恒(688506.SH)发布公告，公司自主研发的创新生物药注射用T- ...