根据披露，CS2009是基石药业从分子设计开始自主研发的一款靶向PD-1、VEGFA和CTLA-4的新型三 特异性抗体，通过协同作用实现多维度的抗肿瘤效应，具备同类首创/同类最佳潜力。CS2009具备差异 化的分子设计，结合了三个经临床验证的靶点，能够重新启动接近耗竭状态的肿瘤浸润T细胞，并具备 与原抗VEGF抗体相当的VEGF中和能力。其疾病覆盖范围广泛，包括但不限于非小细胞肺癌、小细胞 肺癌、肝癌、胃癌、卵巢癌、宫颈癌、乳腺癌、结直肠癌及食管癌等。 格隆汇9月23日丨基石药业-B(02616.HK)发布公告，公司核心管线CS2009(PD-1/VEGF/CTLA-4三特异性 抗体)的全球多中心II期临床试验于澳大利亚完成首例患者入组。该试验目前正在澳大利亚和中国积极入 组，未来将扩展至美国。 ...

智通财经APP讯，基石药业-B(02616)发布公告，公司核心管线CS2009(PD-1/VEGF/CTLA-4三特异性抗 体)的全球多中心II期临床试验于澳大利亚完成首例患者入组。该试验目前正在澳大利亚和中国积极入 组，未来将扩展至美国。 CS2009是基石药业从分子设计开始自主研发的一款靶向PD-1、VEGFA和CTLA-4的新型三特异性抗 体，通过协同作用实现多维度的抗肿瘤效应，具备同类首创/同类最佳潜力。CS2009具备差异化的分子 设计，结合了三个经临床验证的靶点，能够重新启动接近耗竭状态的肿瘤浸润T细胞，并具备与原抗 VEGF抗体相当的VEGF中和能力。其疾病覆盖范围广泛，包括但不限于非小细胞肺癌、小细胞肺癌、 肝癌、胃癌、卵巢癌、宫颈癌、乳腺癌、结直肠癌及食管癌等。 ...

Core Viewpoint - The announcement by the company highlights its participation in the upcoming ESMO conference, where it will present significant clinical research data for its key products CS2009 and CS5001, indicating a strong focus on advancing its oncology pipeline [1] Group 1: Product Development - CS2009 is a potential first-in-class/best-in-class trispecific antibody targeting PD1/VEGF/CTLA-4, with ongoing global multi-center Phase I dose escalation and expansion studies actively recruiting patients in Australia and China, with plans to expand to the US for Phase II enrollment [1] - The company will present the Phase Ia clinical research data for CS2009 at the ESMO conference, marking it as one of the first global reports on clinical data for PD1/VEGF/CTLA-4 trispecific antibodies [1] Group 2: Clinical Trials - CS5001 is the first known ROR1 ADC to demonstrate clinical efficacy in both lymphoma and solid tumors, with its clinical development progress ranking among the top two globally [1] - The global multi-center Phase Ib clinical trial for CS5001 is concurrently advancing in the US, Australia, and China, with the company set to unveil the ongoing Phase Ib study design at the ESMO conference [1]

Summary of Key Points from the Conference Call of 基石药业 Company Overview - **Company**: 基石药业 (Company) - **Focus**: Development of tri-specific antibodies and other therapeutic products in oncology and autoimmune diseases Industry and Product Development - **Clinical Trials**: The tri-specific antibody product (EB2009) has progressed to the fifth dose group (30 mg/kg) in Phase I clinical trials, with safety exceeding expectations and stable pharmacokinetic (PK) data supporting a dosing regimen every three weeks [2][3][4] - **Antitumor Activity**: Initial antitumor activity was observed in the first dose group, with data updates expected at the ESMO conference [2][3] - **Research Pipeline**: The pipeline includes ROW1 ADC, with ongoing patient recruitment across various cohorts, and the company is expanding into autoimmune disease with two new dual-antibody targets [2][5] Upcoming Data and Conferences - **Data Presentation**: The company plans to present safety, PK, pharmacodynamics (PD), and preliminary efficacy data at the ESMO conference, with at least 30 patients' data expected to be disclosed [2][6][7] - **Future Trials**: The company does not plan to conduct single-arm registration trials but will open multiple cohorts in Phase 1B and Phase II, with a focus on lung cancer, particularly first-line lung cancer [2][8][9] Commercialization and Market Strategy - **Product Launches**: The company anticipates starting overseas sales of Shugli monoclonal antibody in the second half of the year, with Platinib's health insurance negotiations progressing steadily [3][19] - **Pricing Strategy**: Platinib's annual treatment cost is expected to decrease from over 600,000 yuan to below 300,000 yuan after entering health insurance, with potential further reductions to below 200,000 yuan [21] Financial Status - **Current Financials**: As of the mid-year report, the company has over 600 million yuan in cash, indicating a tight financial situation. The company is actively working on improving cash flow through various assets and commercialization efforts [23] Key Takeaways - **Innovative Design**: The tri-specific antibody design is notable for its molecular weight being similar to dual antibodies, with a focus on synergistic effects between PD-1 and CTLA-4 [2][11][17] - **Regulatory Milestones**: Important upcoming milestones include data presentations at ASH and ASCO conferences, and the initiation of Phase III registration trials for lung cancer [22] - **Market Positioning**: The company is positioning itself strategically in both oncology and autoimmune disease markets, with a focus on innovative therapies that leverage existing data on PD-1 and CTLA-4 interactions [2][14]

Core Viewpoint - 基石药业-B (02616.HK) announced the latest clinical progress of CS2009, a potential first-in-class/traditional best PD-1/VEGF/CTLA-4 trispecific antibody, which aims to enhance efficacy while reducing systemic toxicity [1][2] Group 1: Clinical Development - CS2009 features balanced single-arm PD-1 and CTLA-4 binding arms along with a bivalent VEGFA binding arm, producing a strong multi-target synergistic effect [1] - The global multi-center I/II clinical study is actively recruiting patients in Australia and China, with plans to expand to the U.S. for Phase II enrollment, expecting to exceed 100 patients by the end of the year [1] Group 2: Safety and Efficacy - The Phase Ia dose-escalation study has completed assessments at four dose levels in heavily pre-treated advanced solid tumor patients, with the fourth dose level (20 mg/kg every three weeks) showing no dose-limiting toxicities (DLT) [2] - The study is currently enrolling patients at the fifth dose level (30 mg/kg every three weeks) to observe safety beyond the recommended Phase II dose (RP2D) and to broaden its safety profile [2] - CS2009 has demonstrated good tolerability across all evaluated dose levels, with pharmacokinetic (PK) characteristics supporting a three-week dosing regimen, and pharmacodynamic (PD) data confirming T-cell activation and anti-VEGFA neutralization [2]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The development of trispecific antibodies (TsAbs) is accelerating, with a focus on companies such as Zai Lab and Sanofi [18]. - The report highlights the performance of various sub-sectors within the industry, ranking them as follows: innovative drugs > CXO > traditional Chinese medicine > medical devices > pharmacies > pharmaceutical commerce [12][13]. Summary by Sections Industry Performance - The A-share pharmaceutical index has increased by 1.3% this week and 2.5% year-to-date, outperforming the CSI 300 by 0.2% and 3.6% respectively [11]. - The H-share biotechnology index has shown a 0.3% increase this week and a 27.8% increase year-to-date, outperforming the Hang Seng Technology Index by -1.7% and 9.6% respectively [11]. Specific Company Recommendations - From a growth perspective, the report recommends focusing on innovative drug companies such as Zai Lab, Sanofi, and others [13]. - For undervalued stocks, it suggests looking into traditional Chinese medicine companies like Zai Lab and Dong-E E-Jiao [13]. - High dividend yield stocks are recommended from the traditional Chinese medicine sector, including Jiangzhong Pharmaceutical and Yunnan Baiyao [13]. Trispecific Antibodies Development - TsAbs are engineered antibodies capable of binding to three different antigen targets, offering enhanced therapeutic potential in cancer immunotherapy [18]. - Currently, no TsAbs have been approved for market, but several companies, including Zai Lab and Sanofi, are actively developing these therapies [18][32]. Clinical Progress - The report outlines the clinical stages of various TsAbs, noting that Zai Lab's ZG006 is among the leading candidates in clinical trials [32]. - Other notable candidates include those from companies like Sanofi and IBI3003 from Innovent Biologics, which are also in advanced clinical stages [32].

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The development of trispecific antibodies (TsAbs) is accelerating, with a focus on companies such as Zai Lab and Sanofi [18]. - The report highlights the performance of various sub-sectors within the industry, ranking them as follows: innovative drugs > CXO > traditional Chinese medicine > medical devices > pharmacies > pharmaceutical commerce [12][13]. - Specific stock selection strategies are recommended based on growth potential, valuation, dividend yield, and left-side investment opportunities [13]. Summary by Sections Industry Performance - The A-share pharmaceutical index has increased by 1.3% this week and 2.5% year-to-date, outperforming the CSI 300 by 0.2% and 3.6% respectively [11]. - The H-share biotechnology index has shown a 0.3% increase this week and a 27.8% increase year-to-date, outperforming the Hang Seng Technology Index by -1.7% and 9.6% respectively [11]. Trispecific Antibodies - TsAbs are engineered antibodies capable of binding to three different antigen targets, offering enhanced therapeutic potential in cancer immunotherapy [18]. - Currently, no TsAbs have been approved for market, but several companies, including Zai Lab and Sanofi, are actively developing these therapies [18][32]. Stock Recommendations - Growth-oriented stock picks focus on innovative drug companies such as Zai Lab, Sanofi, and others [13]. - For undervalued stocks, the report recommends traditional Chinese medicine companies like Zai Lab and Dong-E E-Jiao [13]. - High-dividend stocks are primarily found in the traditional Chinese medicine sector, with companies like Jiangzhong Pharmaceutical and Yunnan Baiyao highlighted [13]. Clinical Development - The report outlines the clinical stages of various trispecific antibody drugs, noting that the fastest progress is seen in Merck's Restoret, currently in phase 2b/3 trials [31]. - Domestic companies are also advancing in this area, with Zai Lab's ZG006 and others in clinical stages [32].