Core Viewpoint - Suzhou Zelgen Biopharmaceutical Co., Ltd. has received approval from the National Medical Products Administration for clinical trials of injectable ZG006 in combination with etoposide and cisplatin for advanced neuroendocrine cancer [2][5] Group 1: Drug Information - ZG006 (INN name: alveltamig) is a trispecific antibody drug developed through the company's dual/multi-specific antibody research platform [3] - ZG006 has received clinical trial permits from both the FDA in the United States and the NMPA in China, and has been designated as a breakthrough therapy by the NMPA and an orphan drug by the FDA [3] - ZG006 targets two different DLL3 epitopes and CD3, acting as a T-cell engager that connects T-cells to tumor cells, showing significant tumor suppression in preclinical studies [3] Group 2: Clinical Trial Approval - The clinical trial approval for ZG006 in combination with etoposide and cisplatin is specifically for advanced neuroendocrine cancer [2] - The approval is not expected to have a significant impact on the company's recent performance due to the lengthy and uncertain nature of drug development [2][5] Group 3: Recent Developments - The company presented clinical research data and updates on ZG006 and ZG005 at the 2025 European Society for Medical Oncology (ESMO) annual meeting [4]

Core Insights - CS2009, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, demonstrated promising initial data at the 2025 ESMO conference, with 72.2% of 72 advanced solid tumor patients still undergoing treatment as of October 19 [1][2] - The design of the tri-antibody shows excellent synergistic effects, enhancing anti-tumor activity in the tumor microenvironment (TME) while avoiding interference with peripheral CTLA-4 positive T cells, thus broadening the therapeutic window [1] - CS2009 exhibited good safety profiles, with grade 3 or higher treatment-related adverse events (TRAE) occurring in only 13.9% of patients, and no grade 4 or 5 TRAE reported [2] Efficacy and Safety - Initial results indicate a good and improving anti-tumor activity, with an overall response rate (ORR) of 12.2% and a disease control rate (DCR) of 71.4% across all dose groups, showing a dose-dependent increase [3] - The safety profile of CS2009 is favorable compared to other immune-oncology (IO) dual antibodies and combination therapies, with lower rates of adverse events [2][3] Clinical Development - A global multi-center phase I/II clinical trial for CS2009 has been initiated, with plans for a phase III trial expected to start in 2026 [4] - The phase II study has already commenced in Australia, with more data anticipated to be presented at the 2026 ASCO conference [4] Financial Projections - The company forecasts total revenues of 123 million, 829 million, and 1.125 billion yuan for 2025, 2026, and 2027, respectively, with year-on-year growth rates of -68.25%, 575.37%, and 35.81% [4] - Net profits attributable to shareholders are projected to be -213 million, 93 million, and 307 million yuan for the same years [4] Investment Outlook - The company maintains a "buy" rating for CS2009, citing its initial efficacy and safety data, as well as the potential for further positive signals with extended follow-up [5]

Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for Basilea Pharmaceutica-B (02616), highlighting the promising efficacy and safety data of CS2009 (PD-1/VEGF/CTLA-4 tri-specific antibody) presented at ESMO, with expectations for its clinical and commercial potential in the future [1] Group 1: Clinical Data and Efficacy - CS2009 showed preliminary efficacy data at the 2025 ESMO conference, with 72.2% of 72 advanced solid tumor patients still undergoing treatment as of October 19, and over 51% of patients having previously received immunotherapy, with a median follow-up of only 1.9 months [1] - All dosage groups exhibited anti-tumor activity with a dose-dependent increase trend; the overall response rate (ORR) was 12.2% (6/49) and the disease control rate (DCR) was 71.4% (35/49) despite a short median follow-up time of approximately 2 months [4] - CS2009 demonstrated a favorable ORR and high DCR (71%) compared to other dual antibodies, even with a significantly shorter follow-up time and a higher rate of previously treated patients [4] Group 2: Safety Profile - CS2009 exhibited a good safety profile, with a grade 3 or higher treatment-related adverse event (TRAE) rate of only 13.9% and a grade 3 or higher immune-related adverse event (irAE) rate of 4.2%, with no grade 4 or 5 TRAEs reported [3] - The incidence of grade 3 or higher TRAEs and those leading to treatment discontinuation was significantly lower than other immuno-oncology dual antibodies and combination therapies, indicating a safety advantage for CS2009 [3] Group 3: Future Development Plans - The global multi-center phase I/II clinical trial for CS2009 has been initiated, with the first patient enrolled in Australia; more data is expected to be presented at the 2026 Q2 ASCO conference [5] - The phase III registration clinical plan is set to include first-line NSCLC (AGA negative, PD-L1 TPS >= 1%), first-line squamous and non-squamous NSCLC (AGA negative, combined with platinum-based chemotherapy), and other first-line solid tumor indications, with an expected launch in 2026 [5]

Core Viewpoint - Tianfeng Securities maintains a "Buy" rating for CStone Pharmaceuticals-B (02616), highlighting the initial efficacy and safety data of CS2009 (PD-1/VEGF/CTLA-4 tri-specific antibody) presented at ESMO, and anticipates further clinical and commercial potential for the tri-specific antibody [1] Group 1: Clinical Data and Efficacy - CStone Pharmaceuticals presented preliminary data from the Phase I clinical study of CS2009 at the 2025 ESMO annual meeting, with 72.2% of 72 advanced solid tumor patients still undergoing treatment as of October 19, and over 51% of patients having previously received immunotherapy, with a median follow-up period of only 1.9 months [1] - The design of the tri-specific antibody shows excellent synergistic effects, enhancing anti-tumor activity in the tumor microenvironment (TME) while avoiding interference with peripheral CTLA-4 single-positive T cells, significantly broadening the therapeutic window [2] - All dose groups observed anti-tumor activity with a dose-dependent increasing trend; with a median follow-up time of approximately 2 months, the overall response rate (ORR) was 12.2% and the disease control rate (DCR) was 71.4% [4] Group 2: Safety Profile - CS2009 demonstrated good safety at the ESMO conference, with a grade 3 or higher treatment-related adverse event (TRAE) incidence of only 13.9% and grade 3 or higher immune-related adverse event (irAE) incidence of 4.2%, with no grade 4 or 5 TRAE reported [3] - The incidence of grade 3 or higher TRAE and TRAE leading to treatment discontinuation was significantly lower than other immuno-oncology (IO) dual antibodies and combination therapies, indicating a safety advantage for CS2009 [3] Group 3: Future Development Plans - The global multi-center Phase I/II clinical trial for CS2009 has been initiated, with the first patient enrolled in Australia, and more data expected to be presented at the ASCO conference in Q2 2026 [4] - The Phase III registration clinical plan is expected to start in 2026, targeting various indications including first-line non-small cell lung cancer (NSCLC) and other solid tumors in combination with standard chemotherapy regimens [4]

Core Insights - The company announced that clinical research data and latest progress for its self-developed drugs Alveltamig (code: ZG006) and Nilvanstomig (code: ZG005) will be presented at the European Society for Medical Oncology (ESMO) annual meeting scheduled from October 17 to 21, 2025 [1] Drug Development - ZG006 is the world's first tri-specific antibody targeting the DLL3 target (DLL3×DLL3×CD3), representing a first-in-class molecular form with the potential to become a best-in-class molecule [1] - ZG005 is one of the first drugs to enter clinical research targeting the same mechanism, with no similar mechanism drugs approved for market globally [1]

Core Viewpoint - 基石药业-B (02616) is preparing to present clinical data for its drug candidates CS2009 and CS5001 at the upcoming ESMO annual meeting in October 2025, highlighting its advancements in cancer treatment [1] Group 1: Clinical Trials and Data - CS2009, a tri-specific antibody targeting PD-1/VEGF/CTLA-4, has preliminary data from a Phase I dose-escalation study involving 9 patients, which will be presented at the ESMO conference [1] - The company will showcase initial data from approximately 70 patients with advanced solid tumors for CS2009, marking the first known clinical data release globally for this tri-specific antibody [1] - CS5001, an antibody-drug conjugate targeting ROR1, has its Phase Ib clinical study design summary published on the ESMO website [1]

Core Viewpoint - The announcement highlights the upcoming presentation of clinical data for two key drug candidates, CS2009 and CS5001, at the 2025 ESMO annual meeting, marking significant milestones for the company in the oncology sector [1] Group 1: Clinical Trials and Data - The company will present preliminary data from the ongoing Phase I dose-escalation study of CS2009, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, involving approximately 70 patients with advanced solid tumors [1] - The abstract for CS2009 includes data from 9 patients as of the submission deadline on May 8, 2025, fulfilling ESMO's submission requirements [1] - The clinical data for CS5001, an antibody-drug conjugate targeting ROR1, will also be summarized in the ongoing Phase Ib study design [1]

Core Insights - The upcoming European Society for Medical Oncology (ESMO) annual meeting will take place from October 17 to 21, 2025, in Berlin, Germany [1] - The company has announced that preliminary data for its core clinical pipeline, CS2009 (a PD-1/VEGF/CTLA-4 tri-specific antibody), will be presented at the ESMO conference [1] - CS2009's abstract includes data from 9 patients as of the submission deadline on May 8, 2025, fulfilling ESMO's submission requirements [1] - The company will showcase initial data from a Phase I dose-escalation study of CS2009 involving approximately 70 patients with advanced solid tumors, marking the first known clinical data on a PD-1/VEGF/CTLA-4 tri-specific antibody globally [1]

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。 ...

Core Viewpoint - The announcement highlights the completion of the first patient enrollment in the global multi-center Phase II clinical trial of CS2009, a novel tri-specific antibody targeting PD-1, VEGFA, and CTLA-4, by the company [1] Group 1: Clinical Trial Progress - The Phase II clinical trial of CS2009 is actively enrolling patients in Australia and China, with plans to expand to the United States in the future [1] - The first patient has been enrolled in Australia, marking a significant milestone in the trial [1] Group 2: Product Overview - CS2009 is a tri-specific antibody developed independently by the company, designed to target PD-1, VEGFA, and CTLA-4, aiming to achieve multi-dimensional anti-tumor effects [1] - The antibody has the potential to be a first-in-class or best-in-class treatment due to its differentiated molecular design [1] Group 3: Mechanism and Disease Coverage - CS2009 can reactivate exhausted tumor-infiltrating T cells and has neutralizing capabilities comparable to existing anti-VEGF antibodies [1] - The product has a broad disease coverage, including but not limited to non-small cell lung cancer, small cell lung cancer, liver cancer, gastric cancer, ovarian cancer, cervical cancer, breast cancer, colorectal cancer, and esophageal cancer [1]