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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 10:29
9月2日晚间,奥赛康(002755)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。 公告显示,ASKC202片拟开发适应症为,联合利厄替尼治疗伴有MET扩增/过表达的接受EGFR-TKI治 疗后疾病进展的EGFR突变阳性局部晚期或转移性非小细胞肺癌(NSCLC)患者。 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EGFRTKI治疗后进展的EGFR突变伴MET扩增/过表达的晚期NSCLC患者治疗。 谈及业绩增长,奥赛康表示,公司近两年有多款新品开展商业化销售,为公司业务带来新的增长点,公 司营业收入实现同比增长,盈利能力进一步提升。公司为实现可持续发展,提升核心竞争力,继续维持 高比例研发投入。随着公司研发管线的不断推进,部分药品已进入三期临床研发阶段,按照会计政策对 相关研发投入进行资本化,导致本期研发费用有所下降等。 公司于2024年4月在美国 ...
奥赛康(002755):盈利能力持续改善,创仿结合成果初显
NORTHEAST SECURITIES· 2025-09-01 07:06
[Table_Info1] 奥赛康(002755) 化学制药/医药生物 [Table_Date] 发布时间:2025-09-01 [Table_Title] 证券研究报告 / 公司点评报告 盈利能力持续改善,创仿结合成果初显 --- 奥赛康 2025 年中期业绩点评 事件: [Table_Summary] 公司发布 2025 年中期业绩报告,实现收入 10.07 亿元(+9.2%),实现归 属于上市公司股东的净利润 1.60 亿元(+111.6%)。 点评: 财务端:盈利能力修复明显,费用结构持续优化,现金流大幅改善。1) 25H1 实现扣非归母净利润 1.41 亿元(+155.7%),自 2024 年扭亏为盈 始,公司盈利能力呈现加速修复态势;2)25H1 公司实现毛利率 81.7% (同比持平),实现净利率 14.6%(+7.6pct);3)25H1 实现期间费用率 66.9%(-8.3pct),成本费用控制成效显著。25H1 公司销售/管理/研发/财 务费用率分别同比-3.5/-0.7/-4.5/+0.3pct;3)24 年公司经营性现金流净额 为 4.23 亿元(+42.5%),超 24 全年水平,现 ...
奥赛康(002755):业绩符合预期 利厄替尼顺利商业化
Xin Lang Cai Jing· 2025-05-23 10:39
Core Insights - The company achieved operating revenue of 1.778 billion yuan in 2024, representing a year-on-year growth of 23.15%, and a net profit attributable to shareholders of 160 million yuan, marking a turnaround from losses [1] - In Q1 2025, the operating revenue reached 509 million yuan, with a year-on-year increase of 13.39%, and a net profit attributable to shareholders of 55 million yuan, up 73.50% year-on-year [1] - The growth in revenue is driven by the expansion of anti-infection and chronic disease products, with the generics business showing positive growth [1] Revenue Breakdown - The anti-infection and chronic disease segments generated revenues of 494 million yuan and 323 million yuan in 2024, with year-on-year growth rates of 74.94% and 57.65% respectively [1] - The oncology and digestive segments faced pressure from centralized procurement, with revenues of 631 million yuan and 270 million yuan in 2024, showing year-on-year changes of 2.31% and -9.74% respectively [1] Profitability and R&D - The company's gross margin improved to 81.34% in 2024, an increase of 0.53 percentage points year-on-year, while the net profit margin turned positive at 7.23% [1] - R&D expenses were significantly reduced, primarily due to the capitalization of expenses related to the ASKB589 project, which entered Phase 3 clinical trials in early 2024 [1] Product Development and Commercialization - The company successfully advanced the commercialization of Liratinib, which received approvals for two indications in 2025, targeting specific types of non-small cell lung cancer (NSCLC) [2] - A collaboration with Innovent Biologics was established to accelerate the reach of Liratinib to more patients [2] Innovation Pipeline - The company is focused on source innovation with multiple early-stage research pipelines, including ASKB589, ASKG712, and ASKG915, which are under various stages of clinical trials [3] - ASKB589 targets CLDN18.2 and is in Phase 3 clinical trials for gastric cancer, showing promising early results [3] - ASKG712 is in Phase 2a clinical trials for neovascular age-related macular degeneration (nAMD), while ASKG915 is in Phase 1 clinical trials [3] Investment Outlook - The company is positioned as a leading player in the digestive field and is actively seeking to expand its drug matrix and strengthen its R&D capabilities [4] - The company is expected to achieve net profits of 184 million yuan, 229 million yuan, and 287 million yuan from 2025 to 2027, with corresponding forecasted P/E ratios of 89, 72, and 57 times [4]
奥赛康24年报及25年一季报点评:创新转型快速推进,25年迎来商业化元年
Orient Securities· 2025-05-07 12:23
Investment Rating - The investment rating for the company is "Buy" (maintained) with a target price of 22.36 CNY [1]. Core Views - The company has achieved significant revenue growth, with a reported revenue of 1.778 billion CNY in 2024, representing a year-on-year increase of 23.15%. The net profit attributable to the parent company for the same year was 160 million CNY, a substantial increase of 207.92% [9]. - The first innovative product has been approved for market launch, marking 2025 as a year of commercialization for the company. The innovative transformation has been successful, with the drug Lapatinib (a third-generation EGFR inhibitor) approved for treating non-small cell lung cancer [9]. - The company has a promising pipeline with early-stage research products like IL-15 and ASKG712, which are expected to contribute to future growth [9]. Financial Performance Summary - The company's revenue is projected to grow from 1.443 billion CNY in 2023 to 3.217 billion CNY in 2027, with a compound annual growth rate (CAGR) of approximately 29.3% [7]. - The net profit attributable to the parent company is expected to increase from a loss of 149 million CNY in 2023 to a profit of 473 million CNY in 2027, reflecting a significant turnaround [7]. - The gross margin is expected to remain stable around 80.5% to 81.0% over the forecast period, indicating strong pricing power and cost control [7]. Valuation Summary - The absolute valuation of the company suggests a reasonable market value of 20.755 billion CNY, corresponding to a target price of 22.36 CNY per share [11]. - The forecasted price-to-earnings (P/E) ratio is expected to decrease from -110.6 in 2023 to 34.8 in 2027, indicating improving profitability [7]. - The price-to-book (P/B) ratio is projected to decline from 5.7 in 2023 to 4.0 in 2027, reflecting a more attractive valuation as the company becomes profitable [7].
奥赛康创新药战略再添核心拼图 利厄替尼片一线适应症获批上市
Quan Jing Wang· 2025-04-30 23:49
Core Viewpoint - The approval of Liratinib tablets for first-line treatment marks a significant breakthrough for the company in the field of targeted therapy for lung cancer, expanding its innovative drug strategy [1][2][8] Company Developments - The company’s subsidiary, Jiangsu Aosaikang Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration for Liratinib tablets, which are indicated for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with specific EGFR mutations [1][2] - Liratinib is a third-generation EGFR TKI developed collaboratively with the Chinese Academy of Sciences, featuring independent intellectual property rights and significant efficacy [1][2] Clinical Data and Efficacy - Clinical trials for Liratinib showed an objective response rate (ORR) of 68.8% and a disease control rate (DCR) of 92.4%, with a median duration of response (DoR) of 11.1 months and a median progression-free survival (PFS) of 11.0 months [4] - The drug demonstrated good efficacy in patients with central nervous system (CNS) metastases, with an ORR of 65.9% and a median PFS of 10.6 months [4] Market Potential and Commercialization - The domestic EGFR TKI market exceeds 20 billion yuan, and with the exclusive commercialization partnership with Innovent Biologics, Liratinib is expected to accelerate market penetration due to its efficacy and pricing advantages [5] - The company reported a net profit of 160 million yuan in 2024, indicating a turnaround and potential for stock price recovery and value reassessment [5] Research and Development Focus - The company has a robust pipeline with 42 ongoing projects, including 10 key innovative drugs in clinical research, and continues to invest heavily in R&D, with 354 million yuan allocated in 2024 [6][7] - The company aims to enhance its competitive edge by focusing on the development of small molecule targeted innovative drugs and tumor immunobiological innovative drugs [7][8]
医药生物行业周报(4月第4周):国产创新药闪耀ASCO
Century Securities· 2025-04-28 02:23
Investment Rating - The report does not explicitly state an investment rating for the industry, but it suggests a long-term focus on domestic innovative drugs in the oncology field and AI medical investment opportunities [3][4]. Core Insights - The pharmaceutical and biotechnology sector saw a weekly increase of 1.16%, outperforming the Wind All A index (1.15%) and the CSI 300 index (0.38%) [3][8]. - The upcoming ASCO conference is highlighted as a significant event for domestic innovative drug companies, with over 70 oral presentations and more than 10 major studies expected [3][4]. - The Ministry of Industry and Information Technology and six other departments issued a plan for the digital transformation of the pharmaceutical industry, aiming for significant advancements by 2027 and full coverage by 2030 [3][4]. Market Weekly Review - The pharmaceutical and biotechnology sector increased by 1.16% from April 21 to April 25, outperforming the Wind All A index and the CSI 300 index [3][8]. - Notable performers included medical research outsourcing (6.34%) and raw materials (4.72%), while blood products (-3.26%) and vaccines (-6.38%) continued to decline [3][9]. - Individual stock performances showed significant gains for Yong'an Pharmaceutical (31.4%), Shuyou Shen (28.4%), and Erkang Pharmaceutical (27.7%), while *ST Jiyuan (-43.2%), Nanhua Biological (-35.3%), and Shuangcheng Pharmaceutical (-27.7%) faced substantial losses [3][11]. Industry News and Key Company Announcements - On April 25, Kangfang Bio announced FDA approval for its drug Anike for the treatment of recurrent or metastatic nasopharyngeal carcinoma [12]. - The same day, Kangfang Bio also reported the approval of its PD-1/VEGF bispecific antibody for first-line treatment of specific lung cancer types [13]. - The digital transformation plan for the pharmaceutical industry aims to enhance competitiveness and quality management through AI and data integration by 2030 [3][4].
医药生物行业跟踪周报:康方生物PD1/VEGF双抗研发成果,点燃全球双抗热情-20250427
Soochow Securities· 2025-04-27 12:17
Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1]. Core Insights - The approval of 康方生物's依沃西单抗 for first-line treatment of PD-L1 positive non-small cell lung cancer (NSCLC) has significantly increased global interest in PD-1/VEGF dual antibodies, indicating a promising investment opportunity in this sector [21][23]. - The report highlights the strong performance of the A-share pharmaceutical index, which has increased by 1.2% this week and decreased by 0.3% year-to-date, outperforming the CSI 300 index by 0.8% and 3.5% respectively [4][9]. - The report suggests a ranking of favored sub-industries as follows: innovative drugs > CXO > traditional Chinese medicine > medical devices > pharmacies > pharmaceutical commerce [10][11]. Summary by Sections Industry Trends - The A-share pharmaceutical index has shown a weekly increase of 1.2% and a year-to-date decrease of 0.3%, while the H-share biotechnology index has increased by 9% this week and 30% year-to-date, outperforming the Hang Seng Technology Index by 7% and 18.5% respectively [4][9]. - Specific sectors such as raw materials (+4.7%), medical services (+3.4%), and chemical drugs (+2.7%) have seen significant price increases, while pharmaceutical commerce (-0.3%), traditional Chinese medicine (-0.5%), and biological products (-0.9%) have experienced declines [4][9]. Research and Development Progress - 康方生物's依沃西单抗 has been approved for use in treating PD-L1 positive NSCLC, marking a significant milestone in the development of PD-1/VEGF dual antibodies [21]. - The report notes that several companies, including 三生制药 and 宜明昂科, are advancing their PD(L)1/VEGF dual antibodies through various clinical stages, indicating a competitive landscape in this therapeutic area [23]. Investment Strategy - The report recommends focusing on growth-oriented stocks primarily in the innovative drug sector, with specific mentions of companies such as 信达生物, 康方生物, and 恒瑞医药 [11]. - For undervalued stocks, the report suggests looking into traditional Chinese medicine companies like 佐力药业 and 东阿阿胶, while high-dividend stocks are recommended from the same sector, including 江中药业 and 云南白药 [11].
信达生物(01801):2024年收入符合预期,“全球新”管线进展丰富
Tianfeng Securities· 2025-03-31 08:06
Investment Rating - The report maintains a "Buy" rating for the company, expecting a relative return of over 20% within the next six months [7]. Core Insights - The company achieved a total revenue of 9.42 billion RMB in 2024, representing a year-on-year growth of 51.8%. Product revenue reached 8.23 billion RMB, up 43.6% year-on-year. The company also reported its first positive Non-IFRS profit of 330 million RMB and an EBITDA of 410 million RMB, with IFRS losses narrowing by 90.8% [1]. - The company has seen a decrease in various expense ratios, with sales expenses at 4.347 billion RMB (46.14% of revenue, down 3.83 percentage points), R&D expenses at 2.681 billion RMB (28.45%, down 7.45 percentage points), and administrative expenses at 738 million RMB (7.83%, down 4.25 percentage points). This reduction in expense ratios is attributed to significant revenue growth [2]. - The company is expected to launch six new drugs in 2025, with one drug entering the medical insurance system. Several products are nearing commercialization, which will serve as a significant growth driver. Recently, five new products were approved for market, including drugs targeting various cancers and conditions [3]. - The company has promising products in the pipeline, particularly in the weight loss sector with the drug Masitide, which is expected to yield data from ongoing studies by the end of 2025. In oncology, early data from several products have shown strong potential, with international clinical trials underway [4]. - Revenue forecasts for 2025-2026 have been revised upwards, with expected revenues of 11.518 billion RMB and 14.721 billion RMB, respectively. Net profit estimates for the same period have also been increased to 515 million RMB and 1.830 billion RMB. The revenue for 2027 is projected to reach 20.020 billion RMB, with net profit expected at 3.109 billion RMB [5].