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双鹭药业:北京双鹭药业股份有限公司关于高级管理人员减持计划期限届满暨实施结果的公告
2024-10-16 12:07
证券代码:002038 证券简称:双鹭药业 公告编号:2024-033 北京双鹭药业股份有限公司 关于高级管理人员减持计划期限届满暨实施结果的公告 公司董事、董事会秘书梁淑洁女士保证向本公司提供的信息内容真实、准确、完整, 没有虚假记载、误导性陈述或重大遗漏。 本公司及董事会全体成员保证公告内容与信息披露义务人提供的信息一致。 北京双鹭药业股份有限公司(以下简称"公司")于 2024 年 6 月 25 日披露了《北京双 鹭药业股份有限公司关于高级管理人员减持股份预披露公告》(公告编号:2024-024),公司 董事兼董事会秘书梁淑洁女士持有本公司 2,000,759 股(占本公司总股本比例 0.1947%),计 划在预披露公告之日起十五个交易日后的三个月内(即 2024 年 7 月 16 日至 2024 年 10 月 15 日,窗口期不减持),以集中竞价交易方式减持所持公司股份合计不超过 500,190 股(占 本公司总股本比例不超过 0.0487%)。 公司近日收到梁淑洁女士出具的《股份减持计划实施完成的告知函》,现将有关情况公 告如下: 一、股东减持情况 | 股东名称 | 减持方式 | | | 减持时间 ...
双鹭药业:北京双鹭药业股份有限公司关于获得依替巴肽注射液药品注册证书的公告
2024-10-15 10:21
证券代码:002038 证券简称:双鹭药业 公告编号:2024-032 北京双鹭药业股份有限公司 关于获得依替巴肽注射液药品注册证书的公告 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。 北京双鹭药业股份有限公司(以下简称"公司")于近日收到国家药品监督管理局 ( 以 下 简 称 " 国 家 药 监 局 " ) 核 准 签 发 的 依 替 巴 肽 注 射 液 ( 商 品 名 : 依 文 ® ) (10ml:20mg)《药品注册证书》,现将药品相关情况介绍如下: 一、药品基本信息 药品名称:依替巴肽注射液 剂 型:注射剂 规 格:10ml:20mg 注册分类:化学药品 3 类 生产企业:北京双鹭药业股份有限公司 该产品为国家医保目录乙类品种,2022 年 7 月入选第七批国家集中招标采购产品目 录。截止到目前该产品同规格通过一致性评价的企业已达八家,本次公司产品获批视同通 过一致性评价。 三、对上市公司的影响及风险提示 该药品的获批将丰富公司心脑血管治疗领域的产品储备,增加公司抗血小板聚集和抗 血栓药物的储备。与公司已经通过一致性评价的依诺肝素钠注射液(依理®) ...
双鹭药业:半年度非经营性资金占用及其他关联资金往来情况汇总表
2024-08-25 07:36
情况汇总表 | | 上海信忠医 药科技有限 | 联营企业 | 其他非流动资 产 | 400.00 | | 400.00 服务费 | 经营性 往来 | | --- | --- | --- | --- | --- | --- | --- | --- | | | 公司 | | | | | | | | | PNUVAX INCORPO RATED | 前控股子公 司 PNUVAX SL | 其他应收款 | 1,610.19 | 41.97 | 1,568.22 股权转让款 | 非经营 性往来 | | | | BIOPHAR | | | | | | | | | MACEUTIC | | | | | | | | | ALS INC 的 | | | | | | | | | 少数股东 | | | | | | | 总计 | — | — | — | 25,201.41 | 41.97 | 25,159.44 | — | 单位:万元 北京双鹭药业股份有限公司 | | | 占用方与上 | | 2024 年期 | 2024 年度占用 | 2024 年度 | 2024 年度 | 2024 年期 | | | | --- | --- | - ...
双鹭药业:半年报董事会决议公告
2024-08-25 07:36
证券代码:002038 证券简称:双鹭药业 公告编号:2024-030 北京双鹭药业股份有限公司 第九届董事会第三次会议决议公告 本公司及董事会全体成员保证信息披露的内容真实、准确和完整,没有虚假记载、误导性 陈述或重大遗漏。 会议以投票表决方式,审议通过了《关于 2024 年半年度报告及摘要的议案》 北京双鹭药业股份有限公司董事会 议案内容详见公司于 2024 年 8 月 26 日披露在《中国证券报》、巨潮资讯网的《北京双鹭药业 股份有限公司 2024 年半年度报告摘要》(公告编号:2024-029),以及披露在指定信息披露网站巨潮 资讯网(www.cninfo.com.cn)的《北京双鹭药业股份有限公司 2024 年半年度报告》。 二〇二四年八月二十六日 经与会董事签字并加盖公司公章的董事会决议。 特此公告。 该议案已经公司董事会审计委员会 2024 年第六次会议全体委员一致同意审议通过。 议案表决情况:本议案有效表决票 6 票,同意 6 票,反对 0 票,弃权 0 票。 三、备查文件 二、董事会会议审议情况 一、 董事会会议召开情况 北京双鹭药业股份有限公司(以下简称"公司")第九届董事会第三次会议于 ...
双鹭药业(002038) - 2024 Q2 - 季度财报
2024-08-25 07:36
Financial Performance - Revenue for the reporting period was RMB 392.06 million, a decrease of 32.81% compared to the same period last year[12] - Net profit attributable to shareholders of the listed company was RMB 29.59 million, a significant decrease of 90.67% year-on-year[12] - Net cash flow from operating activities was RMB 135.81 million, down 28.62% compared to the previous year[12] - Basic earnings per share (EPS) were RMB 0.03, a decrease of 90.32% compared to the same period last year[12] - Total assets at the end of the reporting period were RMB 6.09 billion, a decrease of 2.97% compared to the end of the previous year[12] - The weighted average return on equity (ROE) was 0.51%, down 5.13 percentage points from the same period last year[12] - Revenue for the reporting period was RMB 392.06 million, a decrease of 32.81% year-over-year[31] - Net profit attributable to shareholders was RMB 29.59 million, a significant decline of 90.67% year-over-year[31] - R&D investment totaled RMB 117.12 million, down 35.98% year-over-year, with R&D expenses at RMB 57.42 million, a decrease of 6.03%[31] - Sales revenue of key products such as Temozolomide and Recombinant Human Basic Fibroblast Growth Factor decreased by 24.61% and 27.45% respectively[31] - Revenue from the pharmaceutical industry accounted for 99.29% of total revenue, with a year-over-year decrease of 32.57%[33] - Revenue from biological and biochemical drugs was RMB 147.82 million, a decrease of 30.21% year-over-year[33] - Revenue from chemical drugs was RMB 239.04 million, a decrease of 33.75% year-over-year[33] - Revenue from the Northeast region decreased by 48.52% year-over-year, while revenue from the total distribution channel (non-regional and export business) increased by 235.10%[34] - Gross margin for the pharmaceutical industry was 77.05%, a decrease of 6.44% year-over-year[34] - The company's cash and cash equivalents increased by 182.63% year-over-year, primarily due to the absence of dividend distribution during the reporting period[32] - The company's monetary funds at the end of the reporting period amounted to 670,983,014.82 yuan, accounting for 11.02% of total assets, an increase of 0.13% compared to the previous year[35] - Accounts receivable decreased by 0.66% to 154,045,649.68 yuan, representing 2.53% of total assets[35] - Inventory increased by 0.62% to 178,060,203.85 yuan, accounting for 2.92% of total assets[35] - Long-term equity investments increased by 0.57% to 913,622,554.54 yuan, representing 15.00% of total assets[36] - The company's financial assets decreased by 118,495,945.17 yuan due to fair value changes, with a total financial asset value of 766,480,823.70 yuan at the end of the period[37] - The company's monetary funds of 15.78 million yuan were judicially frozen due to a contract dispute involving its partners[38] - The company invested 22,000,000.00 yuan during the reporting period, a 100.00% increase compared to the same period last year[39] - The company invested 40,000,000.00 yuan in Suzhou Pulekang Pharmaceutical Technology Co., Ltd., holding an 11.77% stake[40] - The company's investment in Fosun Pharma decreased to 28,213,002.00 yuan from an initial investment cost of 36,080,160.76 yuan[41] - The company's investment in Shouyao Holdings decreased to 277,864,421.14 yuan from an initial investment cost of 90,000,000.00 yuan[41] - The company's total assets as of June 30, 2024, amounted to 6,091,213,644.22 yuan, a decrease from 6,277,761,845.44 yuan at the beginning of the period[91] - The company's monetary funds decreased to 670,983,014.82 yuan from 683,831,097.67 yuan at the beginning of the period[91] - Accounts receivable decreased to 154,045,649.68 yuan from 200,470,744.96 yuan at the beginning of the period[91] - Inventory increased to 178,060,203.85 yuan from 144,456,874.27 yuan at the beginning of the period[91] - Long-term equity investments increased to 913,622,554.54 yuan from 905,919,506.61 yuan at the beginning of the period[92] - Total liabilities decreased from 467,724,343.08 yuan to 252,391,989.87 yuan, a significant reduction of 46%[93] - Total assets decreased from 6,131,717,222.05 yuan to 5,922,705,692.02 yuan, a reduction of 3.4%[95] - Current liabilities decreased from 391,826,154.69 yuan to 195,247,243.62 yuan, a reduction of 50.2%[96] - Non-current liabilities decreased from 94,398,070.79 yuan to 73,918,687.65 yuan, a reduction of 21.7%[93] - Total owner's equity decreased slightly from 5,810,037,502.36 yuan to 5,838,821,654.35 yuan, a reduction of 0.5%[93] - Cash and cash equivalents decreased from 649,744,930.38 yuan to 625,674,038.65 yuan, a reduction of 3.7%[94] - Trade receivables decreased from 199,604,359.53 yuan to 153,568,359.68 yuan, a reduction of 23.1%[95] - Inventory increased from 203,329,809.58 yuan to 222,869,256.51 yuan, an increase of 9.6%[95] - Development expenditure increased from 474,733,109.74 yuan to 510,682,796.54 yuan, an increase of 7.6%[95] - Long-term equity investments increased slightly from 1,157,401,580.12 yuan to 1,165,427,296.15 yuan, an increase of 0.7%[95] - Total operating revenue for the first half of 2024 was RMB 392.06 million, a decrease from RMB 583.51 million in the same period last year[98] - Net profit attributable to the parent company's shareholders was RMB 29.59 million, down significantly from RMB 317.16 million in the first half of 2023[99] - R&D expenses for the first half of 2024 were RMB 57.42 million, slightly lower than the RMB 61.10 million in the same period last year[98] - Sales expenses decreased to RMB 48.80 million in the first half of 2024, compared to RMB 141.16 million in the first half of 2023[98] - Basic earnings per share for the first half of 2024 were RMB 0.03, a significant drop from RMB 0.31 in the same period last year[99] - Total comprehensive income for the first half of 2024 was RMB 28.78 million, compared to RMB 316.18 million in the first half of 2023[99] - Operating profit for the first half of 2024 was RMB 18.48 million, a sharp decline from RMB 350.36 million in the same period last year[98] - The company's financial income was RMB 4.84 million in the first half of 2024, down from RMB 7.41 million in the same period last year[98] - Total assets impairment loss for the first half of 2024 was RMB 13.38 million, compared to RMB 28.04 million in the same period last year[98] - The company's investment income for the first half of 2024 was RMB 14.68 million, down from RMB 37.43 million in the same period last year[98] - Sales revenue from goods and services in H1 2024 decreased to 452.51 million yuan from 582.50 million yuan in H1 2023, a decline of 22.3%[103] - Net cash flow from operating activities in H1 2024 was 135.81 million yuan, down 28.6% compared to 190.25 million yuan in H1 2023[103] - Tax refunds received in H1 2024 increased significantly to 17.41 million yuan, up 167.8% from 6.50 million yuan in H1 2023[103] - Cash outflow for purchasing goods and services in H1 2024 rose to 190.36 million yuan, a 46.0% increase from 130.38 million yuan in H1 2023[103] - Net cash flow from investing activities in H1 2024 improved to -26.97 million yuan, compared to -49.01 million yuan in H1 2023[105] - Cash and cash equivalents at the end of H1 2024 increased to 648.88 million yuan, up 14.7% from 565.71 million yuan at the end of H1 2023[105] - Parent company's operating cash flow in H1 2024 was 101.72 million yuan, a 48.5% decrease from 197.55 million yuan in H1 2023[106] - Parent company's investment cash flow in H1 2024 improved to -4.11 million yuan, compared to -61.96 million yuan in H1 2023[107] - Total owner's equity at the end of H1 2024 stood at 5.81 billion yuan, with minority interests of 9.42 million yuan[108] - The company's comprehensive income for the period increased by RMB 29,590,001.31[109] - The total comprehensive income for the period attributable to the parent company's owners was RMB 317,164,126.27[111] - The company allocated RMB 102,735,000.00 for profit distribution to owners (or shareholders)[112] - The company's total owner's equity at the end of the period was RMB 5,692,682,541.11[113] - The company's capital reserve at the beginning of the period was RMB 43,846,655.86[111] - The company's undistributed profit at the end of the period was RMB 10,171,087.18[113] - The company's general risk reserve at the beginning of the period was RMB 3,763,808.24[111] - The company's total owner's equity at the beginning of the period was RMB 5,479,238,208.27[111] - The company's total comprehensive income for the period decreased by RMB 984,793.43 due to minority interests[111] - The company's total owner's equity at the end of the period increased by RMB 213,444,332.84 compared to the beginning of the period[111] - The company's total owner's equity at the end of the period was 5,679,253,677.35 yuan, an increase of 11,006,215.86 yuan compared to the beginning of the period[114][115] - The company's comprehensive income for the period was 11,006,215.86 yuan[114] - The company's undistributed profit at the end of the period was 3,953,643,608.31 yuan, an increase of 11,006,215.86 yuan compared to the beginning of the period[115] - The company's capital reserve at the end of the period was 49,185,236.14 yuan, unchanged from the beginning of the period[114][115] - The company's total owner's equity at the beginning of the period was 5,668,247,461.49 yuan[114] - The company's undistributed profit at the beginning of the period was 3,942,637,392.45 yuan[114] - The company's total owner's equity at the end of the previous year was 5,400,453,691.35 yuan[116] - The company's undistributed profit at the end of the previous year was 3,693,420,451.92 yuan[116] - The company's capital reserve at the end of the previous year was 43,416,236.13 yuan[116] - The company's total owner's equity at the beginning of the previous year was 5,400,453,691.35 yuan[116] Dividend Policy - The company plans not to distribute cash dividends, issue bonus shares, or convert capital reserve into share capital[2] Company Information - The company's registered address, office address, website, and email remained unchanged during the reporting period[9] - The company's stock code is 002038, and it is listed on the Shenzhen Stock Exchange[7] - The company's legal representative is Xu Mingbo[7] Accounting Standards - The company reported no differences in net profit and net assets between International Financial Reporting Standards (IFRS) and Chinese Accounting Standards (CAS) for the reporting period[13] Non-Recurring Gains and Losses - Non-recurring gains and losses for the period totaled a net loss of -90,921,265.42 yuan, with significant items including government subsidies of 5,307,446.48 yuan and losses from financial asset transactions of -118,495,945.17 yuan[14] Industry and Products - The company operates in the pharmaceutical manufacturing industry (C27) and focuses on gene engineering and related drug R&D and production[16] - Over 30 years, the company has developed 80+ products, including 3 Class 1 new drugs, and has received multiple national and municipal awards for scientific progress[17] - Core products include biological preparations for wound repair and oncology treatments, with key products like Lifegen (human granulocyte colony-stimulating factor) and Megal (interleukin-11) being major profit drivers[17] - The company has 8 major production bases across Beijing, Hebei, and Henan, producing various dosage forms including tablets, capsules, injections, and biological products[19] - Main product lines include 15 oncology and immunomodulatory drugs, 8 cardiovascular drugs, 13 anti-infective drugs, and 5 diabetes drugs[20] - The company's product "立生素 ® 重组人粒细胞刺激因子注射液" has been recognized as a National Key New Product and has won multiple awards including the Beijing Science and Technology Progress Second Prize[21] - "久立 ® 聚乙二醇化人粒细胞刺激因子注射液" is a long-acting formulation included in the National High-end Formulation Competitiveness Enhancement Project[21] - "迈格尔 ® 注射用人白介素 -11" is part of the National "863" Plan and has been granted a national invention patent[21] - "欣吉尔 ® 注射用人白介素 -2" is the only alanine-mutated interleukin-2 internationally and has been listed as a National Key New Product[21] - "交宁 ® 替莫唑胺胶囊" has passed consistency evaluation and won the Beijing Science and Technology Progress Third Prize[21] - "立生 ® 来那度胺胶囊" has received national major project funding and passed consistency evaluation[21] - "立生宁 ® 注射用三氧化二砷" is a National Essential Medicine and a Beijing Independent Innovation Product[21] - "欧宁 ® 注射用胸腺五肽" has a formulation patent and has been granted a national invention patent[21] - Xinerjin® Paclitaxel Injection has passed consistency evaluation and won bids in centralized procurement renewals, used for ovarian cancer, breast cancer, and non-small cell lung cancer[23] - Lixinwei® Voriconazole Tablets/Injection passed consistency evaluation and won bids in centralized procurement renewals, used for fungal infections in adults and children over 2 years old[23] - Xinfutai® Voglibose Tablets, a 2023 new product, passed consistency evaluation and won bids in centralized procurement renewals, used for improving postprandial hyperglycemia in diabetic patients[23] - Dapagliflozin Tablets, approved in 2023, passed consistency evaluation, used for adult patients with type 2 diabetes[23] - Lixin® Arginine Injection, a 2023 new product, passed consistency evaluation and won bids in centralized procurement renewals, used for improving neurological symptoms in acute ischemic stroke patients[23] - Lixin® Rivaroxaban Tablets passed consistency evaluation, used for preventing postoperative thrombosis, with small-dose formulations under application[23] - Lixin® Cyclosporine Injection/Soft Capsules, used for preventing rejection in organ and bone marrow transplants, has applied for consistency evaluation[23] - Xinfutai® Mycophenolate Mofetil Dispersible Tablets, used for preventing rejection in kidney, heart, or liver transplants, listed as a Beijing independent innovation product[23] - Beikene®/Xinbeike® Compound Coenzyme for Injection, used for acute and chronic hepatitis, is a national exclusive product and won the Beijing Science and Technology Award[23] - Yili® Enoxaparin Sodium Injection passed consistency evaluation, used for preventing venous thromboembolism, and won the Shandong Science and Technology Progress Award[23] Strategic Development - The company plans to increase the proportion of innovative drug development and services, leveraging its financial strength to invest in high-quality targets in the pharmaceutical and health sectors[25] - The company aims to expand its product portfolio to over 20 products within two years, focusing on common and seasonal diseases[26] - The company employs a "VIC model" (VC + IP + CRO) for innovative drug development to mitigate risks and accelerate the process[26] - The company has achieved breakthroughs in oral and injectable production capacity and quality, aiming to double current levels within two years[26] - The company's sales strategy includes a mix of direct sales and distribution, with a focus on expanding into grassroots medical institutions and private hospitals[26] - The company is actively exploring new sales channels, including e-commerce, to diversify its sales model and reduce reliance on a single channel[26] - The company has successfully launched several new products in 2023 and 2024, including Gabapentin Capsules, Pregabalin Oral
双鹭药业:第九届董事会独立董事专门会议第三次会议审核意见
2024-08-25 07:36
北京双鹭药业股份有限公司 根据中国证监会《上市公司独立董事管理办法》、《深圳证券交易所上市公司规范运作 指引》、《公司章程》等有关规定,作为公司的独立董事,本着对公司、全体股东及投资者 负责的态度,按照实事求是的原则对公司截止 2024 年 6 月 30 日对外担保情况和控股股东 及其他关联方占用资金情况进行了认真负责的核查事项进行认真核查后,发表如下意见: 1、公司能严格遵循《公司法》、《证券法》、《上市公司监管指引第 8 号——上市公司资 金往来、对外担保的监管要求》等法律法规和《公司章程》、《对外担保管理办法》、《规范 与关联方资金往来管理制度》、《关联交易管理制度》的有关规定。 2、至本报告期末,公司累积和当期无任何形式的对外担保,也无以前期间发生但延续 到报告期的对外担保事项。 3、报告期内,公司不存在控股股东及其他关联方非经营性占用上市公司资金的情况, 也不存在以前年度发生并累计至报告期末的违规关联方占用资金情况。报告期内,公司与 关联方发生的关联交易均履行了相关的程序,确保了交易的公平合理,未发生损害公司利 益的行为。 议案表决情况:本议案有效表决票 2 票,同意 2 票,反对 0 票,弃权 0 ...
双鹭药业:半年报监事会决议公告
2024-08-25 07:36
证券代码:002038 证券简称:双鹭药业 公告编号:2024-031 北京双鹭药业股份有限公司 第九届监事会第三次会议决议公告 三、备查文件 经与会监事签字的监事会决议。 特此公告。 本公司及监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。 (一)审议通过了《关于 2024 年半年度报告及摘要的议案》 经审核,监事会认为董事会编制和审核北京双鹭药业股份有限公司《2024 年半年度报告》及 《2024 年半年度报告摘要》的程序符合法律、行政法规和中国证监会的规定,报告内容真实、准 确、完整地反映了上市公司的实际情况,不存在任何虚假记载、误导性陈述或者重大遗漏。 《北京双鹭药业股份有限公司 2024 年半年度报告摘要》(2024-029)详见 2024 年 8 月 26 日 《中国证券报》、巨潮资讯网公司公告,《北京双鹭药业股份有限公司 2024 年半年度报告》详见 指定信息披露巨潮资讯网(www.cninfo.com.cn)。 议案表决情况:本议案有效表决票 3 票,同意 3 票,反对 0 票,弃权 0 票 一、监事会会议召开情况 北京双鹭药业股份有限公司(以下简称"公 ...
双鹭药业(002038) - 2024 Q2 - 季度业绩预告
2024-07-10 12:17
Financial Performance - Net profit attributable to shareholders of the listed company decreased significantly compared to the same period last year, with a profit of 31,716.41 million yuan in the previous year [4] - The decrease in net profit is mainly due to the fair value changes of held trading financial assets and available-for-sale financial assets, with a fair value change loss of approximately -118 million yuan in the first half of 2024, compared to a gain of 108 million yuan in the same period last year, resulting in a year-on-year decrease of 226 million yuan [5] Earnings Per Share - Basic earnings per share for the same period last year were 0.31 yuan per share [4] - Basic earnings per share after deducting non-recurring gains and losses were 0.19 yuan per share for the same period last year [4] Audit and Communication - The company has communicated with the annual audit accounting firm regarding the performance forecast, and there are no significant disagreements [6]
双鹭药业:北京双鹭药业股份有限公司关于获得硫酸氨基葡萄糖胶囊药品注册证书的公告
2024-07-05 09:14
证券代码:002038 证券简称:双鹭药业 公告编号:2024-027 北京双鹭药业股份有限公司 关于获得硫酸氨基葡萄糖胶囊药品注册证书的公告 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。 北京双鹭药业股份有限公司(以下简称"公司")于近日收到国家药品监督管理局 (以下简称"国家药监局")核准签发的硫酸氨基葡萄糖胶囊(商品名:级宁®)《药品注 册证书》,现将药品相关情况介绍如下: 一、药品基本信息 药品名称:硫酸氨基葡萄糖胶囊 剂 型:胶囊剂 规 格:0.25 克(以硫酸氨基葡萄糖计)或 0.314 克(以硫酸氨基葡萄糖氯化钠 计) 注册分类:化学药品 4 类 生产企业:北京双鹭药业股份有限公司 药品批准文号:国药准字 H20244233 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品 注册的有关要求,批准注册,发给药品注册证书。同意本品按(甲类)非处方药管理。 二、药品其他相关情况 公司于 2023 年 3 月 14 日向国家药品审评中心递交上市申请并获得受理。 氨基葡萄糖是人体生理状态下存在的一种天然的氨基单糖,是人体关节软骨 ...
双鹭药业:北京双鹭药业股份有限公司关于获得依帕司他片药品注册证书的公告
2024-06-28 11:31
证券代码:002038 证券简称:双鹭药业 公告编号:2024-026 北京双鹭药业股份有限公司 关于获得依帕司他片药品注册证书的公告 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。 北京双鹭药业股份有限公司(以下简称"公司")于近日收到国家药品监督管理局 (以下简称"国家药监局")核准签发的依帕司他片(商品名:依点®)(50mg)《药品 注册证书》,现将药品相关情况介绍如下: 一、药品基本信息 药品名称:依帕司他片 剂 型:片剂 生产企业:北京双鹭药业股份有限公司 药品批准文号:国药准字 H20244121 审批结论:根据《中华人民共和国药品管理法》及有关规定,经审查,本品符合药品 注册的有关要求,批准注册,发给药品注册证书。 二、药品其他相关情况 公司于 2023 年 2 月 9 日向国家药品审评中心递交上市申请并获得受理。 依帕司他片主要用于治疗糖尿病性神经病变。依帕司他是一种可逆性的醛糖还原酶非 竞争性抑制剂,对醛糖还原酶具有选择性抑制作用,通过抑制神经内山梨醇的积蓄,达到 改善糖尿病末梢神经障碍的并发自觉症状和神经功能异常的功效。 依帕司他片原研企业 ...