利厄替尼

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奥赛康(002755.SZ):创新药ASKC202在2025年ESMO年会公布临床研究数据
智通财经网· 2025-10-19 08:55
奥赛康(002755.SZ)公告,公司子公司江苏奥赛康药业有限公司于2025年10月18日在德国柏林召开的欧 洲肿瘤内科学会(ESMO)年会上,以壁报形式首次公布新型cMET抑制剂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 肺癌的剂量递增及扩展临床试验研究数据。 ASKC202联合利厄替尼用于经EGFR-TKI治疗失败伴MET扩增/过表达的非小细胞肺癌显示出良好的耐 受性和安全性,疗效上显示出肿瘤缓解率高、缓解持续时间长的获益信号。ASKC202联合利厄替尼的 III期确证性临床研究正在开展中。 ...
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
Core Viewpoint - The announcement highlights the completion of the first patient dosing in a Phase III clinical trial for ASK202, a novel oral cMET inhibitor developed by Jiangsu Aosaikang Pharmaceutical Co., Ltd, targeting advanced non-small cell lung cancer (NSCLC) patients with EGFR mutations and MET amplification/overexpression after failure of EGFR-TKI treatment [1] Group 1 - The clinical trial is a registration study for ASK202 in combination with Lapatinib for patients with locally advanced or metastatic NSCLC [1] - ASK202 is characterized as a first-class innovative drug with independent intellectual property rights and significant activity [1] - The target patient population includes those who have progressed after EGFR-TKI therapy and exhibit MET amplification or overexpression [1]
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
Core Viewpoint - The company announced that its wholly-owned subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., has completed the first patient dosing in a Phase III clinical trial for the innovative drug ASKC202 in combination with Lapatinib for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with MET amplification/overexpression after failure of epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) [1] Group 1 - The Phase III clinical study for ASKC202 in combination with Lapatinib targets patients who have experienced treatment failure with EGFR-TKIs and have MET amplification/overexpression [1] - The company has also conducted Phase I/II clinical studies for ASKC202 as a monotherapy and in combination with the third-generation EGFR-TKI Lapatinib, as well as a food effect study for ASKC202 [1] - Preliminary results from the Phase I/II study of ASKC202 in combination with Lapatinib show significant efficacy, along with good tolerability and safety [1] Group 2 - The company plans to present the latest clinical research data for ASKC202 in combination with Lapatinib at the 2025 ESMO conference [1]
奥赛康:创新药ASKC202注册性临床III期研究完成首例患者给药
Zheng Quan Shi Bao Wang· 2025-09-02 09:16
Core Viewpoint - The announcement indicates that the clinical trial for the innovative drug ASK202, developed by the company's wholly-owned subsidiary, has commenced with the first patient dosed, targeting a specific type of lung cancer [1] Group 1: Company Developments - The company’s subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., is responsible for the development of the innovative drug ASK202 [1] - The drug is intended for use in patients with locally advanced or metastatic non-small cell lung cancer who have failed treatment with epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) and have MET amplification or overexpression [1] Group 2: Clinical Research - The registration clinical phase III study for ASK202 has successfully completed the first patient dosing [1] - This study represents a significant step in the development of new treatment options for a challenging patient population in oncology [1]
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]
翰森制药的肺癌靶向药首入海外市场
Xin Lang Cai Jing· 2025-06-04 13:03
Core Viewpoint - Hansoh Pharmaceutical's innovative drug, Amivantamab (Aumseqa®), has been approved for marketing in the UK, marking it as the first innovative drug from the company to enter the overseas market and the first Chinese-origin EGFR-TKI to be launched internationally [1][2]. Group 1: Drug Approval and Market Entry - Amivantamab is approved for use as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activated EGFR mutations, as well as for patients with T790M mutation-positive NSCLC [1]. - The drug has already been approved for four indications in China, making it the most approved indication for a Chinese-origin third-generation EGFR-TKI [2]. Group 2: Market Context and Competitors - As of March 2025, there are seven third-generation EGFR-TKI products available in China, including Amivantamab and others like Osimertinib and Furmonertinib [3]. - The market for NSCLC treatments is significant, with lung cancer accounting for 18.7% of global cancer deaths in 2022, and NSCLC being the most common type, representing approximately 85% of all lung cancer cases [4]. Group 3: Historical Context and Future Prospects - The first-generation EGFR-TKI, Gefitinib, was launched in the early 2000s, followed by second-generation drugs that also faced resistance issues, leading to the development of third-generation EGFR-TKIs like Osimertinib [5]. - Current research is focused on addressing resistance issues associated with third-generation EGFR-TKIs, with innovations such as EGFR/C-MET dual antibodies and ADC drugs being explored [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
Core Viewpoint - CICC maintains the profit forecast for Innovent Biologics (01801) at RMB 472 million for 2025 and RMB 1.298 billion for 2026, with an outperform rating for the industry [1] - The target price is raised by 12.2% to HKD 66, indicating a potential upside of 20.2% from the current stock price [1] Group 1: Revenue Growth and Product Launches - The company reported product revenue exceeding RMB 2.4 billion in Q1 2025, achieving over 40% year-on-year growth, aligning with CICC's expectations [1] - Core product Sintilimab generated sales of USD 137.5 million (approximately RMB 1 billion) in Q1 2025, reflecting a 19% year-on-year growth after excluding exchange rate effects [2] - Four new drugs were launched in the quarter, contributing to revenue growth, with a total of 15 products approved and 3 under review as of April 2025 [2] Group 2: Upcoming Data and Product Pipeline - IBI363 is set to present pivotal data at the 2025 ASCO, with three major indications (melanoma, colorectal cancer, and non-small cell lung cancer) accepted for oral presentation [3] - The early data for IBI363 shows promise, and the maturity of the PoC data may unlock significant global commercialization potential [3] Group 3: ADC Platform Development - The ADC platform continues to gain recognition, with IBI343 (CLDN18.2 ADC) data presented at ASCO, following its previous oral report at ESMO Asia [4] - Other ADC candidates, including HER2 ADC IBI354 and TROP2 ADC IBI130, were also selected for poster presentations [4] - The company announced the completion of the first patient dosing in the Phase I trial of the globally first CEACAM5 dual payload ADC (IBI3020), enhancing its "IO+ADC" technology platform [4]