CSTONE PHARMA(02616)
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天风证券:维持基石药业-B“买入”评级 三抗在ESMO展示出良好的疗效及安全性信号
Zhi Tong Cai Jing· 2025-10-22 08:59
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]
中国药企集体亮相欧洲肿瘤内科学会年会 行业看好“出海”持续发生
Zheng Quan Ri Bao Wang· 2025-10-22 02:49
Group 1 - The 2025 European Society for Medical Oncology (ESMO) annual meeting held in Berlin is recognized as one of the most influential oncology conferences globally, showcasing significant breakthroughs in research data from Chinese pharmaceutical companies [1] - The event is seen as a key catalyst for the international expansion of Chinese innovative drugs, with high-quality data disclosure being crucial for international collaboration [1][3] - A total of 2,929 abstracts were presented at the conference, with 448 from Chinese companies, indicating a strong presence and recognition of China's innovation capabilities [2] Group 2 - Chinese pharmaceutical companies showcased their innovative capabilities through clinical data presentations, with 23 studies selected for the latest breakthrough abstracts (LBA), a significant increase from 7 in 2024 [2] - Notable companies like Jiangsu Hengrui Medicine Co., Ltd. presented multiple LBA studies, highlighting their commitment to international research and development strategies [2] - The conference served as a foundation for further international market expansion, with positive clinical data acting as a catalyst for business development (BD) collaborations with major international pharmaceutical companies [3] Group 3 - The total value of overseas BD transactions for Chinese innovative drugs reached $387 billion in the first nine months of the year, nearing the total for the entire previous year [3] - Recent BD agreements, such as the one between Hansoh Pharmaceutical Group and Roche, indicate ongoing interest and activity in the sector [4] - Industry experts predict that while the total transaction value may not reach new highs, the overall number of BD transactions will remain substantial, driven by ongoing innovation and supportive policies [4][5]
基石药业-B(02616):三抗在ESMO展示出良好的疗效及安全性信号
Tianfeng Securities· 2025-10-22 02:30
Investment Rating - The report maintains a "Buy" rating for the company, expecting a relative return of over 20% within the next six months [6]. Core Insights - The preliminary data presented at the ESMO conference for CS2009 (a PD-1/VEGF/CTLA-4 trispecific antibody) shows promising efficacy and safety signals, with 72.2% of 72 advanced solid tumor patients still undergoing treatment as of October 19 [1][3]. - The design of the trispecific antibody demonstrates excellent synergistic effects, enhancing anti-tumor activity in the tumor microenvironment (TME) while minimizing interference with peripheral CTLA-4 single-positive T cells, thus broadening the therapeutic window [2]. - Safety data from the ESMO conference indicates a low incidence of grade 3 or higher treatment-related adverse events (TRAEs) at 13.9%, and immune-related adverse events (irAEs) at 4.2%, with no grade 4 or 5 TRAEs reported [3]. - Initial anti-tumor activity is observed across all dosage groups, with an overall response rate (ORR) of 12.2% and a disease control rate (DCR) of 71.4%, showing a dose-dependent increase in efficacy [4]. - A global multi-center Phase I/II clinical trial for CS2009 has commenced, with plans to initiate Phase III studies in 2026, targeting various indications including first-line non-small cell lung cancer (NSCLC) [5]. Financial Projections - The company is projected to generate total revenues of 123 million, 829 million, and 1.125 billion yuan for the years 2025, 2026, and 2027, respectively, with year-on-year growth rates of -68.25%, 575.37%, and 35.81% [6]. - Net profit attributable to shareholders is expected to be -213 million, 93 million, and 307 million yuan for the same years [6].
基石药业-B(02616):CS2009Ⅰ期数据扎实靓眼,已启动Ⅱ期剂量拓展研究
Southwest Securities· 2025-10-21 15:26
Investment Rating - The report assigns a "Buy" rating for the company, indicating a potential increase in stock price relative to the market index over the next six months [12][13]. Core Insights - The company is advancing its research pipeline into the 2.0 era, with key products expected to catalyze growth soon [7]. - CS2009 has shown good safety and tolerability in Phase I clinical trials, with promising anti-tumor activity and a high disease control rate (DCR) [7]. - The company has initiated Phase II dose expansion studies for CS2009 in specific tumor types, aiming to optimize dosing regimens and gather more data for regulatory submissions [7]. - CS5001 is under investigation for both monotherapy and combination therapy in hematological and solid tumors, with ongoing global multi-center clinical trials [7]. - Strategic collaborations are expanding the international reach of the company's products, particularly for Shugli monoclonal antibody, which is expected to cover multiple indications [7]. Financial Projections - The company forecasts revenues of RMB 2.2 billion, RMB 5.1 billion, and RMB 8.6 billion for the years 2025, 2026, and 2027 respectively [9]. - The projected revenue breakdown includes contributions from various products, with significant growth anticipated for Shugli monoclonal antibody starting in 2026 [8][9]. - The company expects to achieve a positive net profit of RMB 165.95 million by 2027, following substantial losses in the preceding years [2][10]. Revenue and Profitability Metrics - The report outlines a projected revenue decline of 12.21% in 2024, followed by a significant recovery with growth rates of 131.82% and 68.63% in 2026 and 2027 respectively [2][9]. - The earnings per share (EPS) is expected to turn positive by 2027, indicating a turnaround in profitability [2][9]. - The net asset return rate (ROE) is projected to improve significantly, reaching 304.32% by 2027 after a period of negative returns [2][10].
异动盘点1021|比亚迪电子涨超4%,地平线机器人-W涨超6%;爱奇艺美股涨超8%,苹果涨近4%
贝塔投资智库· 2025-10-21 04:00
Market Performance Summary - Sinopec Oilfield Service (01033) rose over 12% as the company continues to advance its overseas strategy, with new contract signings increasing by over 70% in the first half of the year [1] - China Hongqiao Group (00931) fell over 13% after a significant 55% surge the previous day, with ongoing discussions regarding potential investments [1] - BYD Electronic (00285) increased over 4% as the company is set to supply power components for NVIDIA's new 800VDC AI server architecture [1] - Horizon Robotics-W (09660) rose over 6% as its HSD technology was first adopted by the ET5 model, with multiple automakers already confirming orders [1] - Bilibili-W (09626) increased over 10% due to strong performance of new games, indicating a gradual release of its commercial value [1] - CRRC Corporation (01766) rose nearly 4% ahead of its third-quarter earnings report, with expectations for continued growth in new train procurement and maintenance [1] - Genscript Biotech (01952) rose over 5% as its EVM14 treatment for squamous cell carcinoma addresses critical clinical needs, leading in clinical development progress [1] - Bosideng (03998) increased nearly 6% following the appointment of renowned British designer Kim Jones as the creative director for its new AREAL high-end urban line [1] - Derin Holdings (01709) fell over 11% after announcing a discounted placement of shares to raise funds for expanding Bitcoin mining operations [1] US Market Highlights - TSMC (TSM.US) rose 0.89% as the first NVIDIA Blackwell wafers were recently produced in the US [3] - Pony.ai (PONY.US) increased 1.76% after partnering with Stellantis for autonomous vehicle solutions [3] - WeRide (WRD.US) rose 2.67% after successfully passing the Hong Kong Stock Exchange hearing, positioning itself to become the first "Robotaxi" stock in Hong Kong [3] - Zeekr (ZK.US) increased 4.48% as pre-sales for the refreshed Zeekr 7X officially began, offering significant pre-sale benefits [3] - iQIYI (IQ.US) rose 8.37% as Morgan Stanley upgraded its target price, citing the long-term growth potential of the domestic IP merchandise market [3] - Taoping (TAOP.US) increased 4.27% after announcing a non-binding letter of intent to acquire 100% of Alphalion Holding Limited [3] - Micron Technology (MU.US) rose 2.17% as several major firms raised their target prices for the company [4] - U.S. Antimony Corporation (UAMY.US) surged 20.02% following its proposal to acquire Larvotto Resources to enhance its critical mineral asset portfolio [4] - Apple (AAPL.US) rose 3.94% as a report indicated strong early sales of the iPhone 17 series in China and the U.S. [4] - Moderna (MRNA.US) increased 4.73% after presenting positive data on its mRNA vaccine pipeline at the IDWeek 2025 conference [4]
高盛:点评基石药业-B(02616)三抗ESMO数据 予“买入”评级 升目标价至7.05港元
智通财经网· 2025-10-21 02:58
Core Viewpoint - Goldman Sachs released a report on the preliminary Phase 1 study data of CS2009 (a PD-1/VEGF/CTLA-4 tri-specific antibody) presented at the ESMO 2025 conference, indicating good safety and early tumor response signals across various cancer types, supporting further research on this asset [1] Group 1: Safety and Tolerability - CS2009 demonstrated good tolerability during the dose escalation study involving 72 patients across six dosage levels (1/3/10/20/30/45 mg/kg) [2] - In comparison, the HARMONi-2 trial showed that ivonescimab (PD-1/VEGF dual antibody) had a 29% incidence of grade 3 or higher treatment-related adverse events (TRAE) and 7% for immune-related adverse events (irAE) [2] - Higher dose groups experienced fewer adverse reactions, potentially due to shorter observation times, as some adverse reactions may take 4-8 weeks to manifest [2] Group 2: Competitive Potential in NSCLC - Among 49 patients who underwent at least one tumor assessment, partial responses were observed in seven patients across five cancer types, indicating preliminary pan-cancer potential for CS2009 [3] - Notably, in 12 IO-treated NSCLC patients without prior anti-angiogenic therapy, CS2009 showed a 25% objective response rate (ORR) and an 83% disease control rate (DCR), suggesting positive evidence for further research in NSCLC [3] - For context, other treatments like cadonilimab and BNT327 showed ORR/DCR of 13%/96% and 12.5%/62.5% respectively in similar patient populations [3] Group 3: Future Development Plans - The management plans to select the recommended Phase 3 dose from 20 mg/kg and 30 mg/kg based on Phase 1 data, aiming to initiate a global Phase 3 trial by the end of 2026 for NSCLC treatment [4] - A recently launched Phase 2 trial in Australia and China has over 30 clinical centers initiated, with patient enrollment expected to start soon [4] - Goldman Sachs adjusted the earnings per share forecast for the company from RMB -0.21/-0.7/0.09 to RMB -0.22/1.07/0.01, reflecting an increased view on CS2009's success probability from 30% to 49% [4]
高盛:点评基石药业-B三抗ESMO数据 予“买入”评级 升目标价至7.05港元
Zhi Tong Cai Jing· 2025-10-21 02:57
Core Insights - Goldman Sachs highlights the promising preliminary Phase 1 data for CS2009, a tri-specific antibody targeting PD-1, VEGF, and CTLA-4, presented at the ESMO 2025 conference, indicating good safety and early tumor response signals across various cancer types [1][2] Group 1: Safety and Tolerability - CS2009 demonstrated good tolerability during the Phase 1 dose escalation study involving 72 patients across six dosage levels (1/3/10/20/30/45 mg/kg) [2] - In comparison, the HARMONi-2 trial showed that ivonescimab (PD-1/VEGF dual antibody) had a 29% incidence of grade 3 or higher treatment-related adverse events (TRAE) and 7% for immune-related adverse events (irAE) [2] - Higher dose groups of CS2009 reported fewer adverse reactions, potentially due to shorter observation periods, with the median observation time being 1.9 months [2] Group 2: Competitive Potential in NSCLC - Among 49 patients who underwent at least one tumor assessment, partial responses were observed in seven patients across five cancer types, suggesting CS2009's broad potential [3] - Notably, in 12 IO-treated NSCLC patients without prior anti-angiogenic therapy, CS2009 exhibited a 25% objective response rate (ORR) and an 83% disease control rate (DCR) [3] - The initial ORR signals are viewed positively, although further data is needed to assess CS2009's potential differentiated efficacy due to the small sample size and short follow-up [3] Group 3: Future Development Plans - The management plans to select the recommended Phase 3 dose from 20 mg/kg and 30 mg/kg based on Phase 1 data, aiming to initiate a global Phase 3 trial by the end of 2026 [4] - The ongoing Phase 2 trials in Australia and China have commenced with over 30 clinical centers, and patient enrollment is expected to begin soon [4] - Goldman Sachs has upgraded its earnings forecasts for the company, reflecting an increased view on CS2009's success probability from 30% to 49%, and revised the 12-month target price to HKD 7.05 [4]
基石药业-B(02616.HK)早盘涨超7%
Mei Ri Jing Ji Xin Wen· 2025-10-21 02:50
每经AI快讯,基石药业-B(02616.HK)早盘涨超5%,截至发稿,涨7.41%,报7.39港元,成交额5465.48万 港元。 ...
基石药业-B早盘涨超7% 公司在2025 ESMO年会首次发表CS2009的I期临床试验数据
Zhi Tong Cai Jing· 2025-10-21 02:39
Core Viewpoint - 基石药业's stock price increased significantly, with a rise of 7.41% to HKD 7.39, driven by the announcement of clinical trial data and GIC's increased stake in the company [1] Group 1: Clinical Developments - 基石药业 presented preliminary data from the Phase I clinical trial of CS2009, a tri-specific antibody targeting PD1/VEGF/CTLA-4, at the 2025 ESMO conference [1] - The company also disclosed the design of the Phase Ib clinical trial for CS5001, an ADC targeting ROR1 [1] Group 2: Shareholder Activity - GIC disclosed on October 13 that it has increased its stake in 基石药业 to 6% [1] - This marks GIC's second significant purchase in less than two months, having previously acquired 80.4 million shares on August 18 for over HKD 630 million [1]
港股异动 | 基石药业-B(02616)早盘涨超7% 公司在2025 ESMO年会首次发表CS2009的I期临床试验数据
智通财经网· 2025-10-21 02:36
Core Viewpoint - 基石药业-B (02616) shares rose over 5% in early trading, reaching a peak increase of 7.41% at HKD 7.39, with a trading volume of HKD 54.65 million [1] Group 1: Clinical Research Developments - The company presented preliminary data from its Phase I clinical study of CS2009 (a PD1/VEGF/CTLA-4 trispecific antibody) at the 2025 ESMO conference [1] - Additionally, the design of the Phase Ib clinical study for CS5001 (a ROR1 antibody-drug conjugate) was disclosed [1] Group 2: Shareholder Activity - GIC disclosed on October 13 that it has increased its stake in 基石药业 to 6% [1] - This marks GIC's second significant purchase of the company's shares in less than two months, having previously acquired 80.4 million shares on August 18 for over HKD 630 million [1]