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以岭药业:关于中药新药连花御屏颗粒药物临床试验注册申请获得批准的公告
2024-12-13 09:13
证券代码:002603 证券简称:以岭药业 公告编号:2024-039 剂 型:颗粒剂 申请事项:新药临床试验 石家庄以岭药业股份有限公司 关于中药新药"连花御屏颗粒"药物临床试验注册申请 获得批准的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 石家庄以岭药业股份有限公司(以下简称"公司")全资子公司北京以岭药 业有限公司(以下简称"北京以岭")于 2024 年 12 月 12 日收到国家药品监督 管理局核准签发的《药物临床试验批准通知书》,现将相关情况公告如下: 一、临床试验申请及批准通知书主要内容 药物名称:连花御屏颗粒 注册分类:中药新药 1.1 类 适 应 症:普通感冒气虚证 三、风险提示 公司后续将根据国家药品监督管理局临床试验的相关要求和指导原则,开展 临床试验。 由于药物研发的特殊性,从临床试验的申请到药物成功获批上市,周期长、 环节多,易受到诸多不可预测的因素影响,临床试验的申请与开展、进度以及结 果、未来产品市场竞争形势均存在诸多不确定性,公司将根据研发进展情况及时 履行信息披露义务,敬请广大投资者注意投资风险。 特此公告。 受 理 ...
以岭药业:关于全资子公司制剂产品获得美国FDA批准文号的公告
2024-11-29 10:56
证券代码:002603 证券简称:以岭药业 公告编号:2024-038 石家庄以岭药业股份有限公司 关于全资子公司制剂产品获得美国 FDA 批准文号的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 近日,石家庄以岭药业股份有限公司(以下简称"公司")收到美国食品药 品监督管理局(以下简称美国 FDA)的通知,公司全资子公司以岭万洲国际制药 有限公司向美国 FDA 注册申报的 ANDA 产品辛伐他汀片(ANDA,即美国新药 简略申请)已获得批准(申请获得美国 FDA 审评批准意味着申请者可以生产并 在美国市场销售该产品)。现将相关情况公告如下: 一、药品的基本情况 1、药品名称:辛伐他汀片 2、ANDA 号:211394 3、剂型:口服固体制剂 片剂 二、药品的其他相关情况 辛伐他汀片是一种降脂药,适应症主要包括:1.通过减少冠心病死亡来降低 总死亡率,降低高危冠状动脉疾病患者发生非致命心肌梗死、中风和需要进行血 管重建手术的风险。2.降低原发性高脂血症(杂合子家族性和非家族性)和混合 性高脂血症患者的总胆固醇、低密度脂蛋白胆固醇、载脂蛋白 B 和甘油三酯 ...
以岭药业:关于公司药品通过谈判纳入《国家医保目录》的公告
2024-11-28 10:12
石家庄以岭药业股份有限公司 证券代码:002603 证券简称:以岭药业 公告编号:2024-037 关于公司药品通过谈判纳入《国家医保目录》的公告 本公司及董事会全体成员保证信息披露内容的真实、准确和完整,没有虚 假记载、误导性陈述或重大遗漏。 根据国家医疗保障局网站于 2024 年 11 月 28 日发布的《关于印发<国家基本 医疗保险、工伤保险和生育保险药品目录(2024 年)>的通知》(医保发【2024】 33 号),石家庄以岭药业股份有限公司(以下简称"公司")独家产品通络明 目胶囊通过了医保谈判,首次被纳入《国家基本医疗保险、工伤保险和生育保险 药品目录(2024 年)》(以下简称"《国家医保目录》")。具体情况如下: 生产厂家:石家庄以岭药业股份有限公司 剂型:胶囊剂 药品注册分类:中药 1.1 类 功能主治:化瘀通络,益气养阴,止血明目。用于 2 型糖尿病引起的中度非 增殖性糖尿病视网膜病变血瘀络阻、气阴两虚证所致的眼底点片状出血、目睛干 涩、面色晦暗、倦怠乏力,舌质淡,或舌暗红少津,或有瘀斑瘀点,脉细,或脉 细数,或脉涩。 是否独家品种:是 药品分类及代码:扶正剂 ZE02 医保支付标准:2. ...
一品红参股企业畅溪制药与以岭药业达成战略合作 共同开发创新型吸入药物
证券时报网· 2024-11-12 01:50
Core Viewpoint - The strategic collaboration between Hangzhou Changxi Pharmaceutical Co., Ltd. and Shijiazhuang Yiling Pharmaceutical Co., Ltd. focuses on the development of innovative drugs for lung and related diseases, leveraging Changxi's expertise in inhalation powder technology [1] Company Summary - Hangzhou Changxi Pharmaceutical Co., Ltd. is a subsidiary of Yipinhong and specializes in the development of inhalation powder formulations [1] - Shijiazhuang Yiling Pharmaceutical Co., Ltd. is engaged in the research and development of innovative drug molecules targeting lung diseases [1] Industry Summary - The collaboration aims to combine the strengths of both companies to ensure the market success of the developed products in the therapeutic area of lung diseases [1]
以岭药业:Q3收入端降幅收窄,强研发创新推动新药进展不断
湘财证券· 2024-11-08 06:25
Investment Rating - The report maintains a "Buy" rating for Yiling Pharmaceutical (002603 SZ) [2] Core Views - Yiling Pharmaceutical's Q3 revenue decline narrowed, with respiratory drug demand expected to recover in Q4, potentially stabilizing revenue [2] - The company reported a 25 76% YoY decline in revenue to 6 365 billion yuan and a 68 46% YoY drop in net profit to 555 million yuan for the first three quarters of 2024 [2] - Q3 revenue was 1 761 billion yuan, down 1 3% YoY, with net profit falling 84 07% to 24 32 million yuan [2] - Gross margin decreased by 7 62 percentage points to 53 39%, while net margin dropped by 11 82 percentage points to 8 63% [2] - High prices of traditional Chinese medicine raw materials, such as Coptis, contributed to the margin decline [2] R&D and Innovation - Yiling Pharmaceutical's core competitiveness lies in its strong R&D capabilities, particularly in the field of collateral disease theory [3] - The company invested 572 million yuan in R&D in the first three quarters of 2024, with an R&D expense ratio of 8 99% [3] - Several new drugs, including Qifang Bitong Tablets and Chaihuang Lidan Capsules, have been accepted for new drug applications [3] - Seven drugs are currently in clinical stages, with two in Phase III clinical trials [3] - The company plans to submit 1-2 new drug applications annually, focusing on respiratory, endocrine, gastrointestinal, and pediatric fields [3] Financial Projections - Revenue for 2024-2026 is projected to be 8 841 billion yuan, 9 928 billion yuan, and 11 436 billion yuan, respectively, with YoY growth rates of -14 3%, 12 3%, and 15 2% [5] - Net profit attributable to shareholders is expected to be 870 million yuan, 1 111 billion yuan, and 1 364 billion yuan for 2024-2026 [5] - EPS is forecasted at 0 52 yuan, 0 67 yuan, and 0 82 yuan for the respective years [5] - The PE ratio is estimated at 32 45x, 25 40x, and 20 70x for 2024-2026 [5] Key Financial Metrics - Gross margin is expected to remain stable at around 55 7%-55 9% from 2024-2026 [6] - ROE is projected to recover from 7 4% in 2024 to 10 5% in 2026 [6] - The company's debt-to-asset ratio is forecasted to decrease from 32 6% in 2023 to 30 8% in 2026 [6]
以岭药业:三季度业绩短期承压,轻装上阵未来可期
国盛证券· 2024-11-08 01:17
Investment Rating - The report maintains a "Buy" rating for Yiling Pharmaceutical (002603 SZ) [1][3] Core Views - Yiling Pharmaceutical's Q3 2024 performance was under pressure, with revenue of 6 365 billion yuan, down 25 8% YoY, and net profit attributable to parent company of 550 million yuan, down 68 5% YoY [1] - The company's respiratory product sales are expected to gradually recover as external factors stabilize, with Lianhua Qingke tablets showing strong growth potential after OTC approval [1] - Yiling Pharmaceutical is deepening academic promotion efforts in the cardiovascular field, aiming to drive stable growth of its Tongcanqi product [1] - The company has a robust innovation pipeline, with 7 products in clinical stages, including Lianhua Qingke Granules for children and Luobitong Tablets for rheumatoid arthritis [1] Financial Performance - For Q3 2024, Yiling Pharmaceutical reported revenue of 1 761 billion yuan, down 1 3% YoY, and net profit attributable to parent company of 24 million yuan, down 84 1% YoY [1] - The company's 2024-2026 net profit forecasts are adjusted to 814 million yuan, 1 078 billion yuan, and 1 248 billion yuan, with growth rates of -39 8%, 32 5%, and 15 8% respectively [1] - Yiling Pharmaceutical's 2024E revenue is projected at 8 7 billion yuan, with a YoY decline of 15 7%, while 2025E and 2026E revenues are expected to grow by 15 5% and 14 4% respectively [2] Valuation Metrics - The company's 2024E-2026E P/E ratios are 37X, 28X, and 24X respectively [1] - Yiling Pharmaceutical's 2024E-2026E P/B ratios are 2 5X, 2 4X, and 2 2X respectively [2] - The stock's closing price on November 7, 2024 was 17 92 yuan, with a total market capitalization of 29 939 billion yuan [3] Product Pipeline - Yiling Pharmaceutical plans to submit 1-2 new drug applications annually, with Qifang Bitong Tablets for persistent allergic rhinitis and Chaihuang Lidan Capsules for chronic cholecystitis currently under review [1] - The company's Qiluo Mingmu Capsule for diabetic retinopathy was approved in 2023, adding to its innovative product portfolio [1] Market Position - Yiling Pharmaceutical operates in the traditional Chinese medicine sector, with a strong presence in respiratory and cardiovascular therapeutic areas [1][3] - The company's Lianhua Qingke tablets have demonstrated rapid market penetration since their launch, benefiting from the company's established respiratory product brand and distribution channels [1]
以岭药业:2024年三季报点评:经历调整阵痛,期待修复拐点
华创证券· 2024-11-04 09:15
Investment Rating - The report maintains a "Recommend" rating for Yiling Pharmaceutical with a target price of 22.8 RMB, compared to the current price of 16.90 RMB [1] Core Views - Yiling Pharmaceutical experienced a significant decline in revenue and profits in 1-3Q24, with revenue at 6.36 billion RMB (-26% YoY) and net profit at 550 million RMB (-68% YoY) [1] - The company's respiratory product line is expected to recover in 2025 after inventory adjustments, with Lianhua Qingwen projected to see a significant rebound in shipments by mid-2025 [2] - The cardiovascular and cerebrovascular product line remains relatively stable, with expected gross margin recovery in 2025 as raw material costs decline [2] - Yiling Pharmaceutical continues to advance its innovative traditional Chinese medicine pipeline, with several new drugs either approved or in the approval process [2] Financial Performance - 3Q24 revenue was 1.76 billion RMB (-1.3% YoY), with net profit of 20 million RMB (-84% YoY) [1] - The company's gross margin declined significantly due to changes in product mix and raw material costs [1] - Forecasted net profit for 2024-2026 is 900 million RMB, 1.08 billion RMB, and 1.30 billion RMB, with year-on-year growth rates of -33%, +20%, and +20% respectively [2] Valuation - The report uses a sum-of-the-parts valuation method, estimating a fair value of 38.2 billion RMB [2] - For existing products, a PE multiple of 20x is applied to 2025 estimated profits of 1.08 billion RMB, resulting in a valuation of 21.7 billion RMB [2] - For innovative traditional Chinese medicines, a 3x peak sales multiple is used, contributing 16.5 billion RMB to the valuation [2] Product Analysis - Respiratory products: Lianhua Qingwen is expected to see a shipment recovery in mid-2025, while Lianhua Qingke is expected to grow through marketing strategy adjustments [2] - Cardiovascular and cerebrovascular products: Sales are expected to stabilize in 2025 with improved marketing compliance and academic promotion [2] - Innovative drugs: Several new drugs, including Jieyu Chufan and Yishen Yangxin Anshen, are expected to contribute to growth [2] Financial Projections - Revenue is projected to decline by 12.8% in 2024 but grow by 12% in both 2025 and 2026 [3] - Gross margin is expected to recover from 53.4% in 2024 to 55.4% in 2026 [6] - ROE is forecasted to improve from 7.6% in 2024 to 9.6% in 2026 [6] Market Performance - The stock has underperformed the CSI 300 index over the past 12 months [5] - The 12-month high/low price range is 25.97/14.43 RMB [4]
以岭药业投资成立中药材公司
证券时报网· 2024-11-04 01:38
证券时报e公司讯,企查查APP显示,近日,承德仟药兴中药材有限公司成立,法定代表人为周晓林, 注册资本为200万元,经营范围包含:中草药种植;地产中草药(不含中药饮片)购销;初级农产品收 购;食用农产品初加工等。 企查查股权穿透显示,该公司由以岭药业间接全资持股。 ...
以岭药业(002603) - 2024年10月29日投资者关系活动记录表
2024-10-30 09:35
证券代码: 002603 证券简称:以岭药业 石家庄以岭药业股份有限公司投资者关系活动记录表 编号:20241029 | --- | --- | --- | |----------------|--------------------------------|-----------------------------------------------------------------------------------------------| | 投 资 者 关 | □特定对象调研 | □ 分析师会议 | | 系 活 动 类 别 | □ 媒体采访 | ☑ 业绩说明会(电话会议) | | | □ 新闻发布会 □ | 路演活动 | | | □ 现场参观 | | | | □ 其他 | (请文字说明其他活动内容) | | 参 与 单 位 | | 华创证券、国盛证券、海通证券、中信建投证券、中金公司、兴业证券、华泰 | | 名 称 及 人 | | 证券、华福证券、浙商证券、申万宏源、中泰证券、招商证券、德邦证券、东 | | 员姓名 | | 北证券、中邮证券、开源证券、华西证券、西部证券 以及其他通过华创证券电话会 ...
以岭药业(002603) - 2024 Q3 - 季度财报
2024-10-28 10:05
Financial Performance - The company's revenue for Q3 2024 was ¥1,760,955,184.28, a decrease of 1.30% compared to the same period last year[3]. - Net profit attributable to shareholders was ¥24,319,734.26, down 84.07% year-over-year[3]. - The net profit excluding non-recurring gains and losses was ¥2,571,866.06, a decline of 97.41% compared to the previous year[3]. - Total operating revenue for Q3 2024 was CNY 6,365,441,001.17, a decrease of 25.6% compared to CNY 8,574,678,320.29 in the same period last year[15]. - Net profit for Q3 2024 was CNY 549,086,852.74, a decline of 68.7% compared to CNY 1,753,936,733.34 in Q3 2023[16]. - The total comprehensive income for the third quarter was approximately CNY 549.64 million, a decrease from CNY 1.75 billion in the same period last year[17]. - Basic and diluted earnings per share for the quarter were CNY 0.3321, compared to CNY 1.0527 in the previous year[17]. Assets and Liabilities - The total assets at the end of the reporting period were ¥16,614,084,710.98, representing a decrease of 2.15% from the end of the previous year[3]. - The company's total assets decreased to CNY 16,614,084,710.98 from CNY 16,979,326,536.89 year-over-year, reflecting a reduction of 2.1%[14]. - Total liabilities decreased to CNY 5,128,442,387.30 from CNY 5,541,331,336.92, a reduction of 7.4% year-over-year[14]. - Long-term borrowings increased to CNY 667,102,581.96 from CNY 599,100,000.00, representing an increase of 11.4%[14]. Cash Flow - Cash flow from operating activities was ¥322,629,831.08, an increase of 123.08% compared to the same period last year[7]. - Cash inflow from operating activities was CNY 5.6 billion, down from CNY 7.66 billion year-on-year, indicating a decline of approximately 26.9%[18]. - The net cash flow from operating activities was CNY 322.63 million, an increase from CNY 144.62 million in the previous year[19]. - Cash outflow from investing activities totaled CNY 2.15 billion, compared to CNY 4.12 billion in the previous year, reflecting a decrease of approximately 47.9%[19]. - The net cash flow from financing activities was negative CNY 307.89 million, a decline from a positive CNY 147.18 million in the previous year[19]. - The cash and cash equivalents at the end of the period amounted to CNY 861.24 million, down from CNY 991.60 million at the end of the previous year[19]. - The company reported a decrease in cash paid to employees, totaling CNY 1.51 billion, compared to CNY 1.79 billion in the previous year[19]. Shareholder Information - The total number of common shareholders at the end of the reporting period is 189,795[8]. - The largest shareholder, Yiling Pharmaceutical Technology Co., Ltd., holds 31.53% of the shares, totaling 526,775,963 shares[8]. - The second-largest shareholder, Wu Xiangjun, holds 20.81% of the shares, totaling 347,728,119 shares, with 260,796,089 shares pledged[8]. - The total number of preferred shareholders with restored voting rights is not applicable[8]. Other Financial Metrics - The weighted average return on equity was 0.27%, down 1.25% year-over-year[3]. - The company reported a significant decrease in financial expenses, which rose to ¥25,657,133.42, an increase of 171.42% year-over-year[7]. - The company’s contract liabilities decreased by 39.65% to ¥173,514,006.27 due to a reduction in advance payments received[7]. - The company’s other payables increased by 609.11% to ¥306,333,411.48, primarily due to accrued dividends[7]. - The company’s investment income increased by 228.64% to ¥501,146.91, attributed to gains from trading financial assets[7]. - Research and development expenses for Q3 2024 amounted to CNY 571,912,835.78, slightly down from CNY 593,708,782.64 in the previous year[16]. Inventory and Receivables - Accounts receivable increased to ¥2,778,342,773.44 from ¥2,401,186,364.09 at the beginning of the period[12]. - Inventory decreased to ¥1,940,905,922.51 from ¥2,458,692,034.90 at the beginning of the period[12]. - The company has a trading financial asset balance of ¥9,000,000.00, down from ¥205,968,611.11 at the beginning of the period[12]. - The company reported a significant increase in prepayments to ¥148,349,186.50 from ¥109,711,768.30 at the beginning of the period[12]. Audit and Reporting - The company has not undergone an audit for the third quarter report[20]. - The report was released by the board of directors on October 29, 2024[21].