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奥赛康:子公司ASKC202注册性临床III期研究完成首例患者给药
Xin Lang Cai Jing· 2025-09-02 09:18
奥赛康公告,子公司江苏奥赛康药业有限公司开发的1类创新药ASKC202联合利厄替尼用于经表皮生长 因子酪氨酸激酶抑制剂(EGFR-TKI)治疗失败伴MET扩增/过表达的局部晚期或转移性非小细胞肺癌的 注册性临床III期研究已完成首例患者给药。ASKC202是江苏奥赛康药业有限公司开发的具有自主知识 产权、全新分子实体、活性显著的口服的cMET抑制剂,用于EGFR TKI治疗后进展的EGFR突变伴MET 扩增/过表达的晚期NSCLC患者治疗。 ...
奥赛康(002755.SZ):子公司创新药ASKC202注册性临床III期研究完成首例患者给药
Ge Long Hui A P P· 2025-09-02 09:18
截至公告披露之日,ASKC202已开展包括单药、联合子公司已上市第三代EGFRTKI利厄替尼的I/II期临 床研究、以及ASKC202的食物影响研究。在ASKC202联合利厄替尼用于EGFRTKI治疗后进展的EGFR 突变伴MET扩增/过表达的晚期NSCLC的I/II期研究中,展现出突出的疗效,同时具有良好的耐受性和安 全性。子公司将在2025年ESMO大会上发表ASKC202联合利厄替尼的I/II期最新临床研究数据。 格隆汇9月2日丨奥赛康(002755.SZ)公布,公司的全资子公司江苏奥赛康药业有限公司(简称"子公司")开 发的1类创新药ASKC202联合利厄替尼用于经表皮生长因子酪氨酸激酶抑制剂(EGFR-TKI)治疗失败伴 MET扩增/过表达的局部晚期或转移性非小细胞肺癌的注册性临床III期研究已完成首例患者给药。 ...
奥赛康:创新药ASKC202注册性临床III期研究完成首例患者给药
人民财讯9月2日电,奥赛康(002755)9月2日晚间公告,公司全资子公司江苏奥赛康药业有限公司开发 的1类创新药ASKC202联合利厄替尼用于经表皮生长因子酪氨酸激酶抑制剂(EGFR-TKI)治疗失败伴MET 扩增/过表达的局部晚期或转移性非小细胞肺癌的注册性临床III期研究已完成首例患者给药。 ...
今年上半年全球9款肺癌新药获批
Bei Ke Cai Jing· 2025-07-01 08:17
Core Insights - Lung cancer remains the leading cause of cancer-related deaths globally, with ongoing research and development of innovative drugs targeting this disease [1][2] - A total of 2813 drugs are currently in development for lung cancer indications, with a significant focus on non-small cell lung cancer (NSCLC) [2] - In the first half of this year, 9 innovative drugs for lung cancer have been approved, providing new treatment options for patients [3] Group 1: Drug Development Trends - The number of drugs in development for lung cancer has increased from 1655 in November 2022 to 2813 by July 2023, with the majority targeting NSCLC [2] - Among the 2813 drugs, small molecule drugs are the most prevalent, totaling 1028, followed by monoclonal antibodies (264), antibody-drug conjugates (ADC) (226), and bispecific antibodies (110) [2] - The most common drug targets include EGFR (66 drugs), PD-1 (42 drugs), and PD-L1 (27 drugs) [2] Group 2: Recent Drug Approvals - The 9 newly approved lung cancer drugs include products from major companies such as Johnson & Johnson, Bristol-Myers Squibb, and domestic firms like Hengrui Medicine and Hansoh Pharma [3][5] - Johnson & Johnson's Evotazumab is the first bispecific antibody approved for lung cancer, initially for second-line treatment of EGFR exon 20 insertion mutations [4] - The domestic drug Luconisumab, developed by Kelun-Biotech, is the second globally and the first in China ADC targeting TROP2, approved for treating advanced NSCLC [5] Group 3: Emerging Treatment Strategies - The approval of new drugs is addressing rare mutations such as EGFR exon 20 insertion, which accounts for 4%-10% of EGFR mutations and has poor prognosis with existing treatments [3] - The PD-1/VEGF bispecific antibody Ivosidenib has been approved for first-line treatment of PD-L1 positive NSCLC, marking a significant advancement in immunotherapy [7] - The introduction of drugs targeting KRAS mutations, previously considered "undruggable," indicates a shift in treatment possibilities for advanced NSCLC [6]
奥赛康:创新转型成果初现,前药平台市场潜力可观-20250513
Tianfeng Securities· 2025-05-13 00:35
Investment Rating - The investment rating for the company is "Buy" with a target price of 29.35 CNY per share, based on the current price of 17.21 CNY [5]. Core Insights - The company focuses on four therapeutic areas: digestion, oncology, resistant infections, and chronic diseases. As of September 2024, it has 32 products that have passed consistency evaluation, with 13 products winning national procurement bids. Future growth is expected from innovative products such as cell factor therapies and CLDN18.2 and EGFR targeting drugs [1][14]. - The SmartKine platform, developed by the company, aims to address the poor druggability of cytokine-based therapies through engineering modifications, allowing selective activation of the immune system to target tumor cells while minimizing systemic toxicity [2][31]. - ASKB589 is positioned to be the first domestically marketed CLDN18.2 monoclonal antibody, showing significant tumor response rates in clinical trials. The company has a strong pipeline with over 20 CLDN18.2-targeting drugs in development [3][30]. - The company has successfully launched its innovative drug, Liratinib, for both first-line and second-line treatment of EGFR-mutant NSCLC, marking a significant milestone in its transformation [3][4]. Summary by Sections Strategic Transformation - The company has a strong foundation and is a leader in the digestive drug sector. It has adapted to national procurement policies, optimizing its revenue structure and achieving profitability after two years of losses. In 2024, total revenue reached 1.778 billion CNY, a 23.15% increase, with a net profit of 160.29 million CNY, up 207.92% [14][20]. - The revenue from oncology products grew to 631 million CNY, accounting for 35.51% of total revenue, while the digestive segment's contribution decreased significantly from 67.84% in 2020 to 15.18% in 2024 [24][20]. Innovation and R&D - The company has a robust R&D pipeline with 42 projects, including 9 key innovative drugs. It has maintained leading industry investment levels in R&D, with expenditures of 4.14 billion CNY in 2021, 7.23 billion CNY in 2022, and 5.94 billion CNY in 2023 [28][29]. - The SmartKine platform is a significant innovation, with two lead candidates, ASKG315 and ASKG915, currently in clinical trials, aiming to enhance the safety and efficacy of cytokine therapies [2][31]. Financial Forecast and Market Valuation - The company forecasts revenues of 1.918 billion CNY, 2.169 billion CNY, and 2.935 billion CNY for 2025, 2026, and 2027, respectively, with growth rates of 7.92%, 13.07%, and 35.30% [4][5]. - The estimated net profit for the same years is projected to be 190 million CNY, 289 million CNY, and 530 million CNY, indicating a strong upward trend in profitability [4][5].
天风证券晨会集萃-20250513
Tianfeng Securities· 2025-05-12 23:43
Group 1 - The report highlights the core viewpoint that the company, Qii 712 (603712), is a key supplier in military wireless communication, with a focus on independent research and innovation in military communication technology [2] - The company reported a revenue of 216 million yuan in Q1 2025, a decrease of 55.88% year-on-year, and a net profit of -54.02 million yuan, down 440.23% year-on-year [2] - The report anticipates that the company will benefit from the increasing defense spending and the expanding market for military private network wireless communication [2] Group 2 - The report on the pet economy indicates a strong growth momentum, with the fifth TOPS Pet Expo showcasing over 1,200 exhibitors and a 43% increase in visitor numbers compared to the previous year [3] - Exports of pet food from China reached 82,400 tons in the first quarter of 2025, reflecting a year-on-year growth of 19.68% [3] - The report suggests that the pet economy is transitioning from "scale expansion" to "value creation," with leading companies focusing on innovation and brand development [3] Group 3 - The report on Aosaikang (002755) indicates a total revenue of 509 million yuan in Q1 2025, a year-on-year increase of 13.39%, and a net profit of 54.73 million yuan, up 73.50% year-on-year [4] - Aosaikang's SmartKine platform is highlighted as a promising innovation in the field of immunotherapy, aiming to selectively activate the immune system to target tumor cells [4] - The report projects significant revenue growth for Aosaikang, with expected revenues of 1.90 billion, 2.89 billion, and 5.30 billion yuan for 2025, 2026, and 2027 respectively [30] Group 4 - The report on Zhongji Xuchuang (300308) shows a revenue of 6.67 billion yuan in Q1 2025, a year-on-year increase of 37.82%, and a net profit of 1.58 billion yuan, up 56.83% year-on-year [33] - The company is focusing on the development of 800G and 1.6T optical modules, with expectations for increased demand in the second half of 2025 [33] - The report emphasizes the strategic partnership with CarLink to develop vehicle-mounted optical communication modules, aiming to enhance smart vehicle capabilities [33]
奥赛康(002755):创新转型成果初现,前药平台市场潜力可观
Tianfeng Securities· 2025-05-12 13:30
Investment Rating - The investment rating for the company is "Buy" with a target price of 29.35 CNY per share, based on a current price of 17.21 CNY [5]. Core Insights - The company, Aosaikang, focuses on four therapeutic areas: digestion, oncology, resistant infections, and chronic diseases. As of September 2024, it has 32 products passing consistency evaluations, with 13 products winning national procurement bids. Future growth is expected from innovative products such as cell factor therapies and CLDN18.2 and EGFR targeting drugs [1][14]. - The SmartKine platform, developed by the company, aims to address the poor druggability of cytokine-based therapies through engineering modifications, allowing selective activation of the immune system to target tumor cells while minimizing systemic toxicity [2][31]. - The clinical progress of ASKB589, a monoclonal antibody targeting CLDN18.2, shows promising results in combination therapies for gastric cancer, with an overall response rate (ORR) of 81.8% and a disease control rate (DCR) of 100% in high-expressing populations [3][30]. - The company has successfully launched its first innovative drug, Liratinib, for EGFR-mutant non-small cell lung cancer (NSCLC), with both first-line and second-line indications approved [3][4]. Summary by Sections Strategic Transformation - Aosaikang has a strong foundation in the pharmaceutical industry, being a leading player in the digestion drug sector. The company has adapted to national procurement policies, optimizing its revenue structure and achieving profitability after two years of losses [14][20]. - The company has accelerated its focus on innovative drug development, with a robust pipeline of 42 projects, including 9 key innovative drugs [28][29]. Financial Forecast and Market Valuation - Revenue projections for 2025-2027 are estimated at 1.918 billion, 2.169 billion, and 2.935 billion CNY, with year-on-year growth rates of 7.92%, 13.07%, and 35.30% respectively. Net profit is expected to reach 190 million, 289 million, and 530 million CNY during the same period [4][5]. - The company’s market valuation is estimated using a discounted cash flow (DCF) method, assuming a weighted average cost of capital (WACC) of 7.47% and a perpetual growth rate of 0.5% [4]. Product Pipeline and Innovation - The company is advancing its innovative drug pipeline, with significant investments in research and development. The SmartKine platform is a key focus, with two innovative molecules, ASKG315 and ASKG915, currently in clinical trials [2][29]. - The company’s diverse product offerings are expected to drive future growth, particularly in oncology and chronic disease treatments, as it continues to expand its market presence [1][28].
中金:维持信达生物(01801)“跑赢行业”评级 升目标价至66港元
智通财经网· 2025-05-06 01:38
智通财经APP获悉,中金发布研报称,维持信达生物(01801)2025年/2026年归母净利润预测4.72亿 元/12.98亿元不变。该行维持跑赢行业评级。考虑到公司下一代重磅产品 IBI363 PoC数据成熟及ADC管 线进展,有望解锁更广阔的全球商业化空间,基于DCF模型,该行上调目标价12.2%至66港币,较当前 股价有20.2%的上行空间。 公司宣布IBI363(PD-1/IL-2α-bias)第一批开发的三大适应症黑色素瘤、肠癌、非小细胞肺癌的成熟概念 验证(PoC)数据均被2025 ASCO接收为口头报告。该行认为IBI363作为公司源头研发的潜力下一代IO分 子,其早期数据亮眼,如今PoC数据成熟可能成为其解锁全球商业化价值的重要转折点,建议积极关注 数据读出。 事件:5月1日,公司公告2025年一季度产品收入超过24亿元,同比保持40%以上增长,符合该行预期。 此外,公司预告将在当地时间5月30日-6月3日举办的2025 ASCO年会读出多个重磅数据,包括七项口头 报告。 ADC平台不断获证,逐渐完善"IO+ADC"技术平台 本次2025 ASCO,公司IBI343(CLDN18.2 ADC) ...
依沃西单抗一线治疗NSCLC获批上市,全球首个对比帕博利珠单抗临床3期获显著阳性结果
Ping An Securities· 2025-04-28 05:34
Investment Rating - The industry investment rating is "stronger than the market" [3][47]. Core Viewpoints - The approval of Ivosidenib for first-line treatment of NSCLC in China is a significant milestone, being the first to show positive results in a clinical trial comparing it to Pembrolizumab [3]. - The HARMONi-2 trial demonstrated that Ivosidenib significantly improved progression-free survival (mPFS of 11.14 months vs. 5.82 months for Pembrolizumab), with a hazard ratio (HR) of 0.51, indicating a 49% reduction in the risk of disease progression or death [3]. - The interim analysis of overall survival (OS) at 39% maturity showed a 22.3% reduction in mortality risk for Ivosidenib compared to Pembrolizumab (HR=0.777) [3]. Summary by Sections Industry News - Ivosidenib has received approval for a new indication in first-line treatment of PD-L1 positive locally advanced or metastatic NSCLC based on the HARMONi-2 trial results [3]. - The trial involved a randomized comparison of Ivosidenib and Pembrolizumab, with primary endpoints focused on progression-free survival (PFS) [3]. - Additional studies have shown Ivosidenib's efficacy in various NSCLC settings, including in combination with chemotherapy [4]. Investment Strategy - The report suggests focusing on "innovation," "overseas expansion," "equipment upgrades," and "consumption recovery" as key investment themes [6]. - Companies to watch include innovative drug developers and those with strong overseas market potential, such as BeiGene, Dongcheng Pharmaceutical, and others [6]. Key Companies to Watch - **Nocera Healthcare**: Expected to achieve over 1 billion yuan in revenue from its core product, with a 49% year-on-year growth in sales [7]. - **Sihuan Pharmaceutical**: Strong fundamentals with a stable growth outlook, particularly in the ADC market [10]. - **China Biopharmaceutical**: Rapid revenue growth with a focus on innovative products, particularly in oncology [11]. - **Aier Eye Hospital**: Benefiting from increasing demand for eye care services and a strong pipeline of new products [20].