Aidea Pharma(688488)
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艾迪药业公布2025年三季度业绩:HIV新药收入快速增长 创新管线接连突破
Zhong Zheng Wang· 2025-11-03 09:21
中证报中证网讯(王珞)10月30日晚间,国内抗HIV领域龙头药企江苏艾迪药业(688488.SH)公布三季度业 绩报告,前三季度公司实现营收5.52亿元,同比增长84.83%,其中HIV新药实现销售收入2.11亿元,同 比增长57.12%,连续三年实现高位快速增长。 报告期内,艾迪药业创新管线接连突破,HIV、人源蛋白双领域取得突破性创新。报告显示,第三季 度,艾迪药业整合酶抑制剂研发快速推进,有望突破现有治疗格局;人源蛋白领域又一款改良型新药获 批临床,并购南大药业带来的优质资产协同效应,推动该领域研发收获实质性进展。 HIV新药销售增长"稳、高、快"商业化运营成效卓著 作为HIV领域创新龙头,艾迪药业在该领域已连续三年保持领先性高速增长。艾迪药业董事长傅和亮表 示,最近三年,公司着力构建起了更加高效的HIV新药商业化运营体系与专业化的营销团队。在营销思 路方面,深度践行"医学引领、市场拉动、销售落地"的协同模式,实现HIV新药销售增长的"稳、高、 快"。 近些年,艾迪药业始终以抗艾滋病药物为核心发展领域,不断推动民族创新在抗艾滋病领域从"跟 跑"向"并跑与领跑"跃迁。目前,公司已上市国家1类新药2项,分别 ...
CAR-T药物有望进入商保;绿谷医药违规推广被罚|医药早参
Mei Ri Jing Ji Xin Wen· 2025-11-02 23:24
NO.1 药明巨诺CAR-T药物有望进入商保目录 据媒体报道,药明巨诺的CAR-T细胞药物瑞基奥仑赛注射液在协商进入商保(商业健康保险)创新药目 录方面进展顺利,有望纳入该目录。这是国内获批上市的第一个国产1类CAR-T,上市后的定价是129万 元/针。 点评:商保目录的突破,标志着我国多层次医疗保障体系正加速构建,通过"商保+创新药"模式缓解基 本医保压力,为更多高价疗法打通可及性路径。这不仅助力前沿技术价值实现,更推动生物医药产业从 研发到商业化的完整闭环形成。 NO.2 绿谷医药违规推广九期一(甘露特纳胶囊)被罚款40万元 据信用中国,上海市浦东新区市场监督管理局对绿谷(上海)医药科技有限公司在药品甘露特钠胶囊 (商品名:九期一)推广中的违规行为作出行政处罚决定,处以人民币40万元罚款。 点评:该药自获批起就深陷疗效争议,此次推广违规无疑进一步削弱公众信任。40万元罚款警示意义重 大——尤其是涉及认知度低的重磅新药时,药企必须坚守营销合规底线。 点评:作为国内少数在该领域实现垂直一体化的生物制药公司,其全面的创新产品组合构筑了核心壁 垒。全球约8.5亿名肾病患者催生巨大市场,而当前创新疗法供给不足。 N ...
CAR-T药物有望进入商保;绿谷医药违规推广被罚
Mei Ri Jing Ji Xin Wen· 2025-11-02 23:20
| 2025年11月3日星期一| NO.1药明巨诺CAR-T药物有望进入商保目录 据媒体报道,药明巨诺的CAR-T细胞药物瑞基奥仑赛注射液在协商进入商保(商业健康保险)创新药目录 方面进展顺利,有望纳入该目录。这是国内获批上市的第一个国产1类CAR-T,上市后的定价是129万 元/针。 点评:商保目录的突破,标志着我国多层次医疗保障体系正加速构建,通过"商保+创新药"模式缓解基 本医保压力,为更多高价疗法打通可及性路径。这不仅助力前沿技术价值实现,更推动生物医药产业从 研发到商业化的完整闭环形成。 NO.2绿谷医药违规推广九期一(甘露特纳胶囊)被罚款40万元 据信用中国,上海市浦东新区市场监督管理局对绿谷(上海)医药科技有限公司在药品甘露特钠胶囊(商品 名:九期一)推广中的违规行为作出行政处罚决定,处以人民币40万元罚款。 礼邦医药(江苏)股份有限公司递交招股书,拟在港交所主板上市。据招股书介绍,礼邦医药是一家专注 于肾脏病领域的全球领先生物制药公司,已打造一个垂直一体化平台,涵盖研发、生产及商业化。 点评:作为国内少数在该领域实现垂直一体化的生物制药公司,其全面的创新产品组合构筑了核心壁 垒。全球约8.5亿 ...
医药生物行业:艾迪药业核心原料药获批,国产抗艾产业链竞争力提升
Jianghai Securities· 2025-10-31 08:29
Investment Rating - The industry investment rating is "Overweight" (maintained) [5] Core Insights - The approval of Aidi Pharmaceutical's core product, Dolutegravir Sodium, marks a significant breakthrough in the vertical integration of the anti-HIV drug supply chain, enhancing the company's competitiveness and cost control in the domestic market [5][7] - The approval aligns with national policies encouraging innovation in the pharmaceutical industry and supports the high-quality development of the biopharmaceutical sector, showcasing the increasing R&D capabilities of domestic pharmaceutical companies [7] Summary by Sections Recent Industry Performance - Over the past 12 months, the industry has shown a relative return of -7.19% compared to the CSI 300 index, with absolute returns of 13.9% [3] Key Events - Aidi Pharmaceutical announced the approval of its core product, Dolutegravir Sodium, by the National Medical Products Administration (NMPA), which is a key drug in the WHO's first-line treatment for HIV [5][6] Investment Recommendations - The report suggests focusing on other antiviral companies, particularly those with existing products or strong R&D capabilities in chronic viral diseases like HIV and hepatitis B [7] - It also recommends investing in specialty raw material and CDMO companies, highlighting the value of firms with high-quality standards and technological barriers [7]
机构风向标 | 艾迪药业(688488)2025年三季度已披露前十大机构持股比例合计下跌1.26个百分点
Xin Lang Cai Jing· 2025-10-31 02:54
Group 1 - Eddie Pharmaceuticals (688488.SH) reported its Q3 2025 results on October 31, 2025, with 13 institutional investors holding a total of 216 million shares, representing 51.44% of the company's total equity [1] - The top ten institutional investors include Guangzhou Weimei Investment Co., Ltd., Weimei Investment (Hong Kong) Co., Ltd., AEGLE TECH LIMITED, and others, collectively holding 51.23% of the shares, which is a decrease of 1.26 percentage points from the previous quarter [1] Group 2 - In the public fund sector, one fund, the Xingquan Business Model Mixed (LOF) A, increased its holdings by 0.64% compared to the previous period [2] - Three public funds reduced their holdings, including Penghua Medical Technology Stock A, with a total decrease of 0.65% [2] - Three new public funds disclosed their holdings this period, including Huatai-PineBridge Medical Care Mixed, Yongying Medical Health A, and Hongtu Innovation Medical Care Stock [2]
艾迪药业的前世今生:2025年三季度营收5.52亿元低于行业平均,净利润1611.19万元低于中位数
Xin Lang Cai Jing· 2025-10-30 12:50
Core Viewpoint - Eddie Pharmaceutical is an innovative company in the domestic anti-HIV drug sector, focusing on the exploration, research, and sales of innovative chemical drugs and human-derived protein products [1] Group 1: Business Performance - For Q3 2025, Eddie Pharmaceutical reported revenue of 552 million yuan, ranking 21st among 34 companies in the industry, with the industry leader, Changchun High-tech, generating 9.807 billion yuan [2] - The company's net profit for the same period was 16.11 million yuan, ranking 22nd in the industry, with the top performer, Tonghua Dongbao, achieving a net profit of 1.188 billion yuan [2] - The main business composition includes human-derived proteins at 149 million yuan (41.11%), new drugs at 129 million yuan (35.69%), diagnostic equipment and reagents at 49.35 million yuan (13.62%), and generic drugs at 34.31 million yuan (9.47%) [2] Group 2: Financial Ratios - As of Q3 2025, Eddie Pharmaceutical's debt-to-asset ratio was 41.35%, higher than the previous year's 40.23% and above the industry average of 26.88% [3] - The gross profit margin for the same period was 65.72%, an increase from 52.81% year-on-year, but still below the industry average of 70.17% [3] Group 3: Executive Compensation - The chairman, Fu Helian, received a salary of 1.1336 million yuan in 2024, an increase of 13,900 yuan from 2023 [4] - The president, Zhang Jie, earned 3.7593 million yuan in 2024, up by 745,800 yuan from 2023 [4] Group 4: Shareholder Information - As of September 30, 2025, the number of A-share shareholders increased by 1.55% to 12,100, with an average holding of 34,700 circulating A-shares, a decrease of 1.53% [5] - New significant shareholders include Xingquan Commercial Model Mixed A and Huatai-PineBridge Healthcare Mixed, while some previous top shareholders have exited [5] Group 5: Growth Prospects - In the first half of 2025, Eddie Pharmaceutical's revenue grew by 100.19% year-on-year to 362 million yuan, with a net profit of 9.19 million yuan, marking a turnaround from losses [6][7] - Key growth drivers include the recovery of sales from the already launched product, Ainomi, and the expansion of the HIV drug business [6] - The company is advancing its research on the ACC017 enzyme inhibitor and plans to submit IND applications for long-acting HIV prevention drugs by the end of 2025 [6][7]
艾迪药业(688488) - 艾迪药业关于召开2025年第三季度业绩说明会的公告
2025-10-30 09:22
会议召开时间:2025 年 11 月 10 日 (星期一)13:00-14:00 会 议 召 开 地 点 : 上 海 证 券 交 易 所 上 证 路 演 中 心 ( 网 址 : https://roadshow.sseinfo.com) 会议召开方式:上证路演中心网络文字互动 证券代码:688488 证券简称:艾迪药业 公告编号:2025-065 江苏艾迪药业集团股份有限公司 关于召开 2025 年第三季度业绩说明会的公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性承担法律责任。 重要内容提示: 投资者可于 2025 年 11 月 3 日(星期一)至 11 月 7 日(星期五)16:00 前登录上证路演中心网站首页点击"提问预征集"栏目或通过公司邮箱 ad@aidea.com.cn 进行提问。公司将在说明会上对投资者普遍关注的问题进行回 答。 江苏艾迪药业集团股份有限公司(以下简称"公司")已于 2025 年 10 月 31 日发布公司 2025 年第三季度报告,为便于广大投资者更全面深入地了解公司 2025 年第三季度经营成果、财务状 ...
艾迪药业(688488) - 2025 Q3 - 季度财报
2025-10-30 09:20
Financial Performance - The company's revenue for the third quarter reached ¥189,915,553.50, representing a year-on-year increase of 61.21%[4] - The total profit for the quarter was a loss of ¥5,944,294.57, with a net loss attributable to shareholders of ¥16,031,453.91[4] - The company reported a net cash flow from operating activities of ¥27,488,827.13 for the year-to-date period[4] - The net profit attributable to shareholders increased due to the total profit growth from the beginning of the year to the end of the reporting period[9] - Cash flow from operating activities increased due to higher sales revenue and improved collection compared to the same period last year[9] - The net profit for the first three quarters of 2025 was ¥16.1 million, a turnaround from a net loss of ¥61.7 million in the same period of 2024[30] - The operating profit for the first three quarters of 2025 was ¥28.5 million, compared to an operating loss of ¥77.3 million in 2024[30] Research and Development - Research and development expenses amounted to ¥24,027,176.88, accounting for 12.65% of total revenue, a decrease of 6.44 percentage points compared to the previous year[4] - The company plans to continue increasing investment in new drug promotion and research and development efforts[4] - Research and development expenses for the first three quarters of 2025 were ¥65.0 million, slightly up from ¥64.0 million in 2024, indicating continued investment in innovation[30] - The Phase III clinical trial for the integrase inhibitor ACC017 has officially commenced, with ethical approvals obtained from multiple hospitals, indicating strong progress in HIV treatment development[15] - The compound ADC118, a new drug for HIV treatment, has received clinical trial approval, potentially offering differentiated advantages in patient care if successfully launched[16] - The raw material for the drug Dolutegravir has been approved for market application, which will enhance supply security and reduce production costs for the company[17] - The company is advancing its research on long-acting HIV prevention drugs, with promising preliminary results indicating good antiviral activity and safety[18] - The product pipeline includes a diverse range of HIV treatments, showcasing the company's commitment to innovation and long-term growth in the sector[19] - The injection drug ADB116 has received approval to start clinical trials for treating acute ischemic stroke, marking significant progress in the company's human protein drug development[20] Market and Sales Strategy - The increase in revenue was primarily driven by a ¥28,864,200 increase in HIV drug business income and the consolidation of Nanda Pharmaceutical's data for three months compared to one month in the previous year[4] - The company has established a commercial operation system for HIV new drugs, focusing on "medical guidance, market pull, and sales implementation" as its core marketing strategy[14] - The company has optimized market promotion strategies based on clinical research data and real-world study results to support the commercialization process[14] - The company conducted diverse activities in key provinces to enhance awareness of the metabolic advantages of its HIV drug, particularly focusing on weight and blood lipid issues[14] - The company is committed to a differentiated sales model to ensure effective release of commercial value[14] Financial Position - Total assets at the end of the reporting period were ¥1,844,943,110.70, a decrease of 1.32% from the previous year[5] - The company's total assets decreased from ¥1,869.6 million in 2024 to ¥1,844.9 million in 2025, a decline of 1.3%[27] - Total liabilities decreased from ¥802.5 million in 2024 to ¥763.0 million in 2025, a reduction of 4.9%[27] - The company's total current assets amounted to approximately RMB 895.79 million, showing a slight increase from RMB 894.93 million at the end of 2024[25] - The company's cash and cash equivalents stood at approximately RMB 341.02 million, reflecting a stable liquidity position compared to RMB 335.34 million at the end of 2024[25] - The company's cash and cash equivalents increased, contributing to improved liquidity and financial stability[30] - The total equity attributable to shareholders decreased slightly from ¥980.9 million in 2024 to ¥978.0 million in 2025, indicating a stable equity position despite operational challenges[27] Cash Flow - In the first three quarters of 2025, the cash inflow from operating activities reached ¥622,963,170.44, a significant increase of 58% compared to ¥394,442,257.42 in the same period of 2024[32] - The net cash flow from operating activities was ¥27,488,827.13, recovering from a loss of ¥927,675.73 in the previous year[33] - Total cash outflow from operating activities was ¥595,474,343.31, up from ¥395,369,933.15 in the prior year, indicating increased operational expenditures[33] - Cash inflow from investment activities totaled ¥315,741,499.87, down 54% from ¥685,229,113.92 in the same period last year[33] - The net cash flow from investment activities was ¥5,546,049.83, a decrease of 89% compared to ¥51,924,796.07 in 2024[33] - Cash inflow from financing activities was ¥371,924,000.00, an increase of 7% from ¥348,968,000.00 in the previous year[33] - The net cash flow from financing activities showed a decline to -¥20,227,793.53 from a positive ¥55,183,664.22 in the same period last year[33] - The ending balance of cash and cash equivalents was ¥337,018,912.63, slightly up from ¥327,907,012.16 in the previous year[33] - The company reported a significant increase in cash received from other operating activities, which rose to ¥111,673,725.51 from ¥26,250,012.03 in the prior year[32] - The total cash outflow for investment activities was ¥310,195,450.04, down from ¥633,304,317.85 in the same period last year, reflecting a reduction in capital expenditures[33] Non-Operating Income - Non-operating income included government subsidies amounting to ¥4,349,000, contributing positively to the financial results[7] - The company reported a decrease in credit impairment losses and asset impairment losses by approximately 37.36 million yuan compared to the same period last year[9] - Basic and diluted earnings per share increased due to the rise in net profit attributable to shareholders from the beginning of the year to the end of the reporting period[9] International Expansion - The registration certificate for the drug Anomi-T has been granted in Zanzibar, allowing for commercial sales and marking a step forward in international market expansion[23] - The company has actively participated in international academic conferences, enhancing its influence in the global HIV field and showcasing its research capabilities[22]
江苏艾迪药业集团股份有限公司 关于多替拉韦钠原料药获得上市申请批准通知书的自愿性披露公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-10-28 20:22
Core Points - The company has received approval from the National Medical Products Administration for the listing application of the chemical raw material drug Dolutegravir Sodium [1][3] - Dolutegravir Sodium is part of the company's fundraising project focused on the R&D of high-end generic drugs for HIV [2][3] - The approval indicates that the raw material meets national drug review technical standards, allowing for its use in domestic formulations [3] Company Information - The production enterprise is Yangzhou Aidi Pharmaceutical Technology Co., Ltd., located at No. 6 Qiqiao Road, Yangzhou High-tech Industrial Development Zone [2] - The raw material is packaged in various specifications: 20kg, 5kg, 1kg, and 0.5kg [1] Impact on the Company - The approval of Dolutegravir Sodium is expected to enhance the supply and quality of raw materials, potentially lowering production costs [3] - If the generic version of Dolutegravir Sodium is approved for market, it will diversify the company's offerings in anti-HIV medications and complement existing products [3] - The company will continue to advance the registration and listing of the formulation following the approval of the raw material [3]
艾迪药业(688488) - 艾迪药业关于ADC118片获得药物临床试验批准通知书的自愿性披露公告
2025-10-28 09:37
江苏艾迪药业集团股份有限公司(以下简称"公司")及全资子公司成都艾 迪医药技术有限公司、南京艾迪医药科技有限公司收到国家药品监督管理局(以 下简称"国家药监局")于 2025 年 10 月 28 日核准签发的《药物临床试验批准 通知书》(以下简称"通知书"),同意公司抗艾滋病领域在研 1 类新药 ADC118 片开展临床试验。现将相关情况公告如下: 一、通知书基本情况 江苏艾迪药业集团股份有限公司 关于 ADC118 片获得药物临床试验批准通知书的 自愿性披露公告 本公司董事会及全体董事保证本公告内容不存在任何虚假记载、误导性陈述 或者重大遗漏,并对其内容的真实性、准确性和完整性依法承担法律责任。 证券代码:688488 证券简称:艾迪药业 公告编号:2025-064 药品名称:ADC118 片 受理号:CXHL2500787 申请事项:境内生产药品注册临床试验 以 HIV 整合酶抑制剂为核心药物的"鸡尾酒"治疗方案是国内外主流艾滋 病抗病毒治疗指南推荐方案之一。根据 Gilead、GSK 和 MSD 公司历年年度财报, HIV 整合酶抑制剂产品全球销售额持续增长,2024 年含 HIV 整合酶抑制剂的产 品 ...