Crescent Biopharma FY Conference Summary Company Overview - **Company**: Crescent Biopharma - **Industry**: Biopharmaceuticals, specifically in the immuno-oncology and antibody-drug conjugate (ADC) sectors - **Recent Development**: Entered public markets through a reverse merger in June 2025 [1][2] Core Points and Arguments - **Market Opportunity**: Crescent Biopharma is positioned in a $100 billion market opportunity within the immuno-oncology space, focusing on bi-specific antibodies and ADCs [5] - **Product Pipeline**: - **CR-001**: A bi-specific antibody expected to begin patient dosing in early 2026, with a strong focus on first-in-class opportunities outside of lung cancer [4][5] - **CR-002**: The first ADC, anticipated to enter clinical trials in mid-2026 [4] - **Clinical Strategy**: The company aims to generate robust clinical data over the next 12 to 18 months, focusing on dose finding, safety, and preliminary anti-tumor activity [24][25] - **Leadership and Experience**: The team includes experienced professionals with a history of successful drug development, including the Chief Medical Officer who has worked on approved PD-1 inhibitors [7][9] Key Data and Insights - **Clinical Data Monitoring**: The company is closely monitoring recent data from competitors, particularly in the PD-1/VEGF space, to inform their strategy [40][41] - **Regulatory Focus**: Emphasis on understanding regulatory requirements from bodies like the FDA and EMA to ensure successful drug approval [61] - **Cash Position**: Crescent Biopharma has $153 million in cash, sufficient to fund operations through 2027 and support their clinical development plans [52] Additional Important Content - **Partnership Strategy**: The company is considering partnerships for CR-001 but aims to generate clinical data first to enhance its value proposition [36] - **ADC Development**: There is significant interest in combining ADCs with PD-1/VEGF bi-specifics, and the company is evaluating potential deals to accelerate this aspect of their pipeline [36][48] - **Long-term Vision**: The leadership envisions building a $30-40 billion company, drawing comparisons to successful peers in the industry [64] Conclusion Crescent Biopharma is strategically positioned in the biopharmaceutical industry with a focus on innovative immuno-oncology therapies. The company is preparing for significant clinical developments and is well-capitalized to execute its plans, aiming for a strong market presence in the coming years.

Core Viewpoint - Changchun High-tech Industry (Group) Co., Ltd. announced that its subsidiary, Changchun Jinsai Pharmaceutical Co., Ltd., received the acceptance notice for the clinical trial application of GenSci140 from the National Medical Products Administration, indicating progress in the development of a new targeted therapy for cancer [1][2]. Group 1 - GenSci140 is a novel dual-target antibody-drug conjugate that targets the folate receptor alpha (FRα), designed to enhance binding and internalization in tumor cells [1]. - The drug combines Fab fragments targeting different epitopes of FRα with a single-domain heavy chain antibody (VHH), utilizing a cleavable linker and a topoisomerase I (TOPOI) inhibitor payload [1]. - GenSci140 has shown significant anti-tumor effects in various models, including ovarian cancer, regardless of FRα expression levels [2]. Group 2 - Preclinical studies indicate that GenSci140 possesses strong tumor cell binding and internalization activity, along with high plasma stability of the linker technology developed in-house [2]. - The innovative dual-epitope design and effective cytotoxic mechanism suggest that GenSci140 could become a potential best treatment option for FRα-positive cancer patients, particularly those with low to medium FRα expression [2].

综上，GenSci140凭借其创新的双表位设计、稳定的链接子技术和高效的细胞杀伤机制，有望成为FRα 阳性的肿瘤患者的潜在最佳治疗选择，尤其在FRα中低表达人群。 格隆汇9月5日丨长春高新(000661.SZ)公布，近日，长春高新技术产业(集团)股份有限公司子公司——长 春金赛药业有限责任公司(简称"金赛药业")收到国家药品监督管理局核准签发的《受理通知书》，金赛 药业注射用GenSci140注册临床试验申请获得受理。 临床前体外和体内研究表明，GenSci140具有良好的肿瘤细胞结合和内化活性，在卵巢癌等多种CDX(细 胞系来源的异体移植肿瘤)和PDX(患者来源肿瘤异种移植)模型中，无论FRα表达水平，均展现了显著的 抗肿瘤效果。另外，GenSci140采用自主研发的接头技术，具备有效载荷活性强和连接子血浆稳定性高 等特性，在产生更强肿瘤杀伤作用的同时，还具备更优的潜在安全性。 GenSci140是金赛药业自主研发的一款新型靶向叶酸受体α亚型(Folate Receptor Alpha,FR α/FOLR1)双表 位抗体药物偶联物，由结合FRα不同表位的Fab和单域重链抗体(VHH)构成双表位抗体，采用可裂 ...

长春高新9月5日公告，公司子公司长春金赛药业有限责任公司注射用GenSci140注册上市许可申请获得 国家药品监督管理局出具的《受理通知书》。注射用GenSci140是金赛药业自主研发的一款新型靶向叶 酸受体α亚型（Folate Receptor Alpha, FRα/FOLR1）双表位抗体药物偶联物，由结合FRα不同表位的Fab 和单域重链抗体（VHH）构成双表位抗体，采用可裂解的连接子并搭载拓扑异构酶I（TOPO I）抑制剂 载荷。GenSci140可同时结合肿瘤细胞上表达的FRα抗原的两个不同表位，增加抗体的结合和内化，促 进TOPO I抑制剂细胞毒性载荷进入细胞，从而直接杀伤肿瘤细胞，同时可通过旁观者杀伤效应进一步 增强抑瘤效果。适应症：晚期实体瘤。 ...

长春高新（000661）(000661.SZ)公告，公司子公司长春金赛药业有限责任公司(简称"金赛药业")收到国 家药品监督管理局核准签发的《受理通知书》，金赛药业注射用GenSci140注册临床试验申请获得受 理。GenSci140是金赛药业自主研发的一款新型靶向叶酸受体α亚型双表位抗体药物偶联物，由结合FRα 不同表位的Fab和单域重链抗体(VHH)构成双表位抗体，采用可裂解的连接子并搭载拓扑异构酶 I(TOPOI)抑制剂载荷。GenSci140可同时结合肿瘤细胞上表达的FRα抗原的两个不同表位，增加抗体的 结合和内化，促进TOPOI抑制剂细胞毒性载荷进入细胞，从而直接杀伤肿瘤细胞，同时可通过旁观者杀 伤效应进一步增强抑瘤效果。 ...

Core Viewpoint - The approval of the clinical trial application for GenSci140 by the National Medical Products Administration is a significant milestone for the company, enhancing its business scope and product structure [1] Company Summary - The subsidiary, Jinsai Pharmaceutical, has received the acceptance notice for the clinical trial application of GenSci140, a novel targeted antibody-drug conjugate for the treatment of advanced solid tumors [1] - GenSci140 is independently developed by Jinsai Pharmaceutical and targets the folate receptor alpha subtype [1] - The successful acceptance of this application is expected to enrich and improve the strategic product line layout, thereby enhancing the company's core competitiveness [1] Industry Summary - The development and commercialization of new drugs involve lengthy and complex processes, which are subject to various uncertainties [1] - The clinical trial process for GenSci140 may face uncertainties that could impact its timeline and outcomes [1]

Summary of ADC Therapeutics Conference Call Company Overview - **Company**: ADC Therapeutics - **Industry**: Biotechnology, specifically focused on antibody-drug conjugates (ADCs) - **Lead Product**: ZYNLONTA (anti-CD19 ADC) approved for third-line treatment of diffuse large B-cell lymphoma (DLBCL) as a monotherapy [2][3] Core Points and Arguments - **Market Opportunity**: ADC Therapeutics estimates a peak sales opportunity for ZYNLONTA between $600 million to $1 billion, driven by ongoing clinical trials and a favorable competitive landscape [4][3] - **Clinical Trials**: - LOTIS-5: Phase 3 study combining ZYNLONTA with rituximab in second-line DLBCL, with data expected by the end of the year [5][15] - LOTIS-7: Phase 2 study combining ZYNLONTA with Roche's glofitamab, showing promising early results with a 93% overall response rate and 87% complete response rate in initial patients [25][27] - **Competitive Landscape**: The company believes that the DLBCL market is less competitive than perceived, with only 20% of patients receiving CAR-T therapy due to accessibility issues, leaving a significant opportunity for ZYNLONTA [7][9] Important Data Points - **LOTIS-5 Expectations**: Aiming for a progression-free survival (PFS) benefit of approximately 6 months over the current standard of care, with a complete response (CR) rate target of 40-50% [16][19] - **LOTIS-7 Results**: The combination therapy has shown a favorable safety profile with no new safety signals and a lower incidence of neutropenia compared to historical data [28][30] - **Indolent Lymphomas**: Ongoing studies in high-grade follicular and marginal zone lymphoma show promising early results, with a 97% overall response rate and 77% complete response rate in follicular lymphoma [42][43] Financial Position - **Cash Position**: ADC Therapeutics ended Q2 with $265 million in cash, providing a runway into 2028 [54] - **Upcoming Catalysts**: Expected revenue opportunities from potential approvals and guideline inclusions for LOTIS-5 and LOTIS-7 by the first half of 2027 [54] Additional Insights - **Regulatory Engagement**: The company is actively engaging with the FDA and plans to submit data for LOTIS-5, aiming for a swift transition from data readout to submission [24][36] - **Partnership with Roche**: Roche is a key partner in the LOTIS-7 study, providing clinical drug supply and regulatory insights [37][38] - **Market Dynamics**: The company highlights that the DLBCL market is evolving, with a significant portion of patients still lacking effective treatment options, positioning ZYNLONTA as a potential new standard of care [10][12] This summary encapsulates the key points discussed during the conference call, focusing on ADC Therapeutics' strategic direction, clinical trial progress, market opportunities, and financial health.

Core Viewpoint - Heng Rui Medicine has shown strong performance in the stock market, with significant price increases and new clinical trial approvals for innovative drugs [1] Group 1: Stock Performance - Heng Rui Medicine (600276.SH) saw a peak increase of 6.61% to 73.42 CNY, marking a new high since June 16, 2021, with a year-to-date increase of approximately 60% [1] - Heng Rui Medicine (1276.HK) rose by 8.14% to 87.05 HKD, approaching a historical closing high, with a trading volume of 1 billion HKD and a market capitalization of 577.8 billion HKD [1] - Since its listing on the Hong Kong Stock Exchange on May 23, the stock price has increased by 97.62% from the issue price of 44.05 HKD [1] Group 2: Drug Approvals - The company announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., received approval from the National Medical Products Administration for clinical trials of SHR-A2009, an antibody-drug conjugate targeting HER3, which has no similar drugs approved globally [1] - Additionally, the company received approval for clinical trials of HRS-7172 tablets, a new type of small molecule inhibitor for cancer treatment, with no similar drugs approved domestically or internationally [1]

Core Viewpoint - Heng Rui Medicine (600276)(01276) announced that its subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-A2009, which will commence shortly [1] Group 1: Product Development - SHR-A2009 is an antibody-drug conjugate targeting HER3, specifically binding to HER3 on the surface of tumor cells [1] - The drug is designed to be internalized by the tumor cells and transported to lysosomes, where it releases free toxins to kill the cancer cells [1] - No similar drugs have been approved for market globally, indicating a potential first-mover advantage for the company [1]

Core Viewpoint - Heng Rui Medicine's subsidiary, Suzhou Shengdiya Biopharmaceutical Co., Ltd., has received approval from the National Medical Products Administration for the clinical trial of SHR-A2009, a novel antibody-drug conjugate targeting HER3 [1] Company Summary - SHR-A2009 is designed to specifically bind to HER3 on the surface of tumor cells, leading to internalization and subsequent release of cytotoxic agents within lysosomes to kill cancer cells [1] - This drug is notable as there are currently no similar drugs approved for market globally [1]