Workflow
MicuRx(688373)
icon
Search documents
盟科药业(688373) - 上海盟科药业股份有限公司关于会计师事务所履职情况评估报告
2025-03-17 11:30
二、2024 年年审会计师事务所基本情况 (一)会计师事务所基本情况 上海盟科药业股份有限公司 关于会计师事务所 2024 年度履职情况评估报告 根据《中华人民共和国公司法》《中华人民共和国证券法》《上市公司治理准则》 《国有企业、上市公司选聘会计师事务所管理办法》等规定和要求,上海盟科药业股份 有限公司(以下简称"公司")对立信会计师事务所(特殊普通合伙)(以下简称"立 信")在 2024 年度的审计工作的履职情况进行了评估。经评估,公司认为,立信资质 等方面合规有效,履职能够保持独立性,勤勉尽责,公允表达其意见。具体情况如下: 一、变更会计师事务所的情况说明及履行的程序 公司前任会计师事务所为普华永道中天会计师事务所(特殊普通合伙)(以下简称 "普华永道中天"),对公司 2023 年度财务报告的审计意见类型为标准无保留意见。 2024 年,因普华永道中天已经连续多年为公司提供审计服务,为更好地保证审计工 作的独立性、客观性及公允性,并综合考虑公司业务发展和未来审计服务需求,变更立 信为公司 2024 年度财务审计机构及内部控制审计机构。 公司已就变更会计师事务所的相关事宜与前、后任会计师事务所进行了沟通, ...
盟科药业(688373) - 上海盟科药业股份有限公司第二届监事会第十次会议决议公告
2025-03-17 11:30
证券代码:688373 证券简称:盟科药业 公告编号:2025-011 上海盟科药业股份有限公司 第二届监事会第十次会议决议公告 本公司监事会及全体监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。 一、 监事会会议召开情况 上海盟科药业股份有限公司(以下简称"公司")第二届监事会第十次会 议(以下简称"本次会议")于2025年3月17日在公司会议室,通过现场表决与 通讯表决相结合的方式召开。本次会议通知及相关资料已于2025年3月6日通过 邮件送达全体监事。本次会议应出席监事3人,实际出席监事3人。本次会议由 监事会主席卢亮先生召集并主持。本次会议的召集和召开符合《中华人民共和 国公司法》等相关法律、行政法规、规范性文件和《上海盟科药业股份有限公 司章程》(以下简称"《公司章程》")的规定,会议形成的决议合法、有效。 二、 监事会会议审议情况 (一)审议通过《关于<公司2024年年度报告及其摘要>的议案》 经审议,监事会认为:公司2024年年度报告编制和审议程序符合法律法规、 《公司章程》和公司内部管理制度的各项规定;报告内容真实、准确、完整 ...
盟科药业(688373) - 2024 Q4 - 年度财报
2025-03-17 11:25
Financial Performance - The company reported a net profit attributable to the parent company of negative value, indicating it has not yet achieved profitability[5]. - The company plans not to distribute cash dividends, issue bonus shares, or increase capital reserves for the 2024 fiscal year[9]. - In 2024, the company's operating revenue reached CNY 130.27 million, a year-on-year increase of 43.51%, primarily driven by the sales growth of its self-developed product, Contizole Tablets[30]. - The net loss attributable to shareholders increased by CNY 19.60 million, while the net loss after deducting non-recurring gains and losses increased by CNY 5.17 million compared to the previous year[30]. - Basic earnings per share for 2024 were -CNY 0.67, and the diluted earnings per share were also -CNY 0.67[29]. - The company reported a significant increase in revenue, achieving a total of 2.19 billion in sales for the year[85]. - The company has received a standard unqualified audit report from its accounting firm, ensuring the accuracy of its financial statements[7]. - The company has increased its sales expenses due to expanded academic promotion and distribution network efforts since the commercialization of Contizolam tablets[188]. Research and Development - The company has incurred significant research and development expenses, leading to cumulative losses that continue to increase[6]. - The company is focused on developing innovative drugs for infectious diseases, which typically require long development cycles and substantial investment[5]. - The company continues to enhance its core competitiveness by enriching its new drug pipeline, with multiple innovative drugs in critical clinical trial stages[30]. - The company maintains a high level of overall R&D investment to support ongoing projects[30]. - The R&D expenditure as a percentage of operating revenue was 282.92%, a decrease of 96.98 percentage points compared to the previous year[29]. - The company has established a comprehensive antibacterial new drug R&D system, covering the entire process from early design to clinical development and production management[184]. - The total R&D investment for the year was approximately ¥368.56 million, representing a 6.87% increase from the previous year[178]. - The company has filed 33 new patent applications this year, bringing the total number of applications to 82[175]. Product Development and Pipeline - The core product, Kangtaizuoan tablets, has been launched, with multiple other products in clinical trials both domestically and internationally[5]. - The company has one marketed drug, four drugs in clinical stages, and multiple drugs in preclinical research, indicating a robust R&D pipeline[186]. - The company is actively advancing the development of MRX-8 for resistant Gram-negative bacterial infections, with the Phase I clinical trial in China successfully completed[46]. - The company has initiated a Phase II clinical trial for oral Contizolam tablets in treating complex skin and soft tissue infections in children aged 6 to 17, with 12 centers obtaining ethical approval[45]. - The international multi-center Phase III clinical trial for injectable MRX-4 has been approved in nearly 20 countries, with 324 patients enrolled[46]. - The company is exploring a full oral treatment strategy including MRX-5 for patients with NTM infections, aiming for safer and more effective treatment options[48]. - The company is focused on expanding its market presence and enhancing its product offerings through innovative research and development initiatives[54]. Market and Competitive Landscape - The overall business performance is maintaining a good growth trend, supported by continuous innovation and market demand[41]. - The company is committed to developing core competencies in drug discovery and targeting unmet clinical needs, with a focus on both domestic and international markets[41]. - The company is focusing on expanding its product line with new antibiotics targeting resistant strains, which is expected to enhance market competitiveness[85]. - The company aims to expand potential indications for MRX-4 by initiating a Phase III clinical trial for treating resistant Gram-positive bacterial infections[63]. - The company is leveraging its existing products to deepen its engagement in the antibiotic market, particularly for multi-drug resistant infections[160]. Risks and Challenges - The company emphasizes the risks associated with its ongoing research and development activities, which may affect future profitability[6]. - The company faces risks related to clinical trial progress, potential failures, and regulatory approvals for its pipeline products[192]. - The company has no independent production capability and relies on a single supplier, which poses a risk of supply shortages[194]. - The company is currently unprofitable, which may impact its ability to sustain R&D investments and operational stability[189]. Antimicrobial Resistance - The focus on antimicrobial resistance highlights the importance of developing new antibiotics to combat resistant strains, a key area of research for the company[74]. - The company is focused on developing new antimicrobial drugs and diagnostic tools to combat the global resistance issue, as highlighted by the World Health Organization's global action plan[77]. - The company recognizes the urgent need for investment in new drugs, vaccines, and diagnostic tools to optimize the use of existing antimicrobials and combat resistance[77]. - The company is committed to addressing the challenges posed by bacterial infections, which can spread through various transmission routes, including contact and airborne methods[78]. Clinical Trials and Approvals - The company is advancing its MRX-1 and MRX-4 candidates into Phase III clinical trials for the treatment of multi-drug resistant Gram-positive infections[132]. - The FDA has declined approval for Solithromycin and Iclaprim, while Levonadifloxacin is in Phase III trials and expected to be the first approved treatment for Gram-positive multi-drug infections[132]. - The company has received approval from the National Medical Products Administration to conduct clinical trials for MRX-5 tablets in China[67]. Strategic Initiatives - The company is exploring potential mergers and acquisitions to bolster its research and development capabilities and expand its product portfolio[85]. - The company is actively participating in national medical insurance negotiations to improve product accessibility for patients[73]. - A new strategic partnership has been established to enhance distribution channels, aiming to improve product availability in key markets[85].
盟科药业(688373) - 上海盟科药业股份有限公司关于自愿披露美国子公司提起诉讼的公告
2025-02-25 09:15
证券代码:688373 证券简称:盟科药业 公告编号:2025-008 上海盟科药业股份有限公司 关于自愿披露美国子公司提起诉讼的公告 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、准确性和完整性依法承担法律责任。 重要内容提示: 一、 本次诉讼事项受理的基本情况 公司全资子公司盟科美国于北京时间2025年2月24日收到美国俄亥俄州南区 联邦地区法院西部分院起诉立案确认通知,盟科美国诉Medpace, Inc.(以下简称 "Medpace")合同纠纷一案已完成起诉立案。 截至本公告披露日,上述案件尚未开庭审理。 二、 本次诉讼的基本情况 1、原告:盟科美国 1、案件所处的诉讼阶段:法院已立案,尚未开庭审理。 2、上市公司所处的当事人地位:上海盟科药业股份有限公司(以下简称" 公司")的全资子公司MicuRx Pharmaceuticals, Inc.(以下简称"盟科美 国")为原告 3、涉案的金额:盟科美国提起的诉讼申请暂未提及具体金额,需以法院判 决或执行结果为准 4、是否会对上市公司损益产生负面影响:截至本公告披露日,本次诉讼尚 未开庭审理,最终实际 ...
盟科药业(688373) - 2024 Q4 - 年度业绩
2025-02-14 07:55
证券代码:688373 证券简称:盟科药业 公告编号:2025-007 上海盟科药业股份有限公司 2024 年度业绩快报公告 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。 本公告所载上海盟科药业股份有限公司(以下简称"公司")2024 年度主要 财务数据为初步核算数据,未经会计师事务所审计,具体数据以公司 2024 年年 度报告为准,敬请投资者注意投资风险。 (一)报告期的经营情况、财务情况及影响经营业绩的主要因素 1、经营情况 公司 2024 年度实现营业总收入 13,027.28 万元,同比增长 43.51%;实现归 属于母公司所有者的净利润-44,072.12 万元,同比增加亏损 1,959.67 万元;实现 归属于母公司所有者的扣除非经常性损益的净利润-45,917.24 万元,同比增加 亏损 516.73 万元。 2、财务状况 一、2024 年度主要财务数据和指标 单位:人民币万元 | 项目 | 本报告期 | 上年同期 | 增减变动幅度(%) | | --- | --- | --- | --- | | 营业总收 ...
盟科药业(688373) - 2024 Q4 - 年度业绩预告
2025-01-16 07:46
Revenue Projections - The company expects 2024 annual revenue to be approximately between 120 million and 140 million CNY, an increase of 29.22 million to 49.22 million CNY compared to the previous year, representing a growth of 32.19% to 54.23% year-on-year[3]. - The previous year's revenue was 90.78 million CNY[5]. Net Loss Projections - The projected net loss attributable to the parent company for 2024 is expected to be between 480 million and 440 million CNY, an increase in loss of 18.88 million to 58.88 million CNY compared to the previous year, reflecting a year-on-year increase in loss of 4.48% to 13.98%[3]. - The expected net loss attributable to the parent company after deducting non-recurring gains and losses for 2024 is projected to be between 500 million and 460 million CNY, an increase in loss of 5.99 million to 45.99 million CNY compared to the previous year, indicating a year-on-year increase in loss of 1.32% to 10.13%[3]. - The previous year's net loss attributable to shareholders was 421.12 million CNY[6]. Business Growth Factors - The increase in main business revenue is attributed to the growth in the number of hospitals covered and the increase in prescription volume[8]. Expenses and Losses - The continued losses are primarily due to increased R&D expenses as clinical projects progress and higher sales expenses due to active sales efforts[9]. Financial Data and Risks - The financial data in this forecast has not been audited by registered accountants[4]. - The forecast data is preliminary and the accurate financial data will be disclosed in the audited 2024 annual report[11]. - Investors are advised to pay attention to investment risks related to the preliminary nature of the forecast data[11].
盟科药业(688373) - 上海盟科药业股份有限公司关于2023年限制性股票激励计划首次授予部分第一个归属期符合归属条件的公告
2025-01-07 16:00
证券代码:688373 证券简称:盟科药业 公告编号:2025-002 上海盟科药业股份有限公司 关于2023年限制性股票激励计划首次授予部分 第一个归属期符合归属条件的公告 1、 本次股权激励计划的主要内容 本次拟归属股票数量:395,407股 归属股票来源:上海盟科药业股份有限公司(以下简称"公司")向激 励对象定向发行的公司人民币 A 股普通股股票 (1) 股权激励方式:第二类限制性股票 (2) 授予数量:本激励计划授予激励对象的限制性股票数量为 1,000.00 万股,占本激励计划草案公告日公司股本总额65,521.0084万股的 1.53%。其中,首次授予限制性股票800.00万股,占本激励计划草 案公告日公司股本总额的1.22%,占本激励计划拟授予限制性股票 总数的80.00%;预留200.00万股,占本激励计划草案公告日公司 股本总额的0.31%。 (3) 授予价格:5.00元/股 本激励计划首次授予的限制性股票的各批次归属比例安排如下表所示: | 归属安排 | 归属期间 | 归属比例 | | --- | --- | --- | | 第一个归属期 | 自首次授予部分限制性股票授予日起12个月后的 ...
盟科药业(688373) - 上海盟科药业股份有限公司关于作废部分已授予尚未归属的限制性股票的公告
2025-01-07 16:00
证券代码:688373 证券简称:盟科药业 公告编号:2025-003 上海盟科药业股份有限公司 关于作废部分已授予尚未归属的限制性股票的公告 上海盟科药业股份有限公司(以下简称"公司")于2025年1月7日召开了 第二届董事会第十一次会议、第二届监事会第九次会议,审议通过了《关于作 废部分已授予尚未归属的限制性股票的议案》,现将相关事项公告如下: 一、 本次限制性股票激励计划已履行的决策程序和信息披露情况 1、2023年3月28日,公司召开了第一届董事会第二十次会议,会议审议通 过了《关于<上海盟科药业股份有限公司2023年限制性股票激励计划(草案)> 及其摘要的议案》、《关于<上海盟科药业股份有限公司2023年限制性股票激励 计划实施考核管理办法>的议案》以及《关于提请股东大会授权董事会办理2023 年限制性股票激励计划相关事宜的议案》。公司独立董事就本激励计划相关议 案发表了同意的独立意见。 同日,公司召开了第一届监事会第十一次会议,会议审议通过了《关于<上 海盟科药业股份有限公司 2023 年限制性股票激励计划(草案)>及其摘要的议 案》、《关于<上海盟科药业股份有限公司 2023 年限制性股票激励计 ...
盟科药业(688373) - 上海盟科药业股份有限公司独立董事关于公司第二届董事会第十一次会议相关事项的独立意见
2025-01-07 16:00
综上,我们一致同意公司 2023 年限制性股票激励计划首次授予部分第一个 归属期规定的归属条件已经成就,并同意公司按照《激励计划》相关规定为符 合条件的 47 名激励对象办理归属相关事宜。 二、《关于作废部分已授予尚未归属的限制性股票的议案》的独立意见 根据《激励计划》和《考核管理办法》的相关规定及公司 2022 年年度股东 大会对董事会的授权,由于《激励计划》项下首次授予的 24 名激励对象因个人 原因离职,不再具备激励对象资格;54 名激励对象自愿放弃或部分放弃本次归 属;3 名激励对象 2023 年度个人考核评价结果为"C",其在本次归属项下对 应的个人考核层面的归属系数为 50%;本次归属公司考核指标层面的归属系数 为 75%,故相应作废公司 2023 年限制性股票激励计划中部分已授予尚未归属的 限制性股票合计 2,262,835 股。公司作废处理 2023 年限制性股票激励计划部分 已授予尚未归属的限制性股票,符合《上市规则》、《管理办法》等法律法 规、规范性文件及《激励计划》的相关规定,不存在损害公司及股东利益的情 形。 关于公司第二届董事会第十一次会议相关事项的独立意见 依据《中华人民共和国公司 ...
盟科药业(688373) - 上海盟科药业股份有限公司第二届董事会第十一次会议决议公告
2025-01-07 16:00
证券代码:688373 证券简称:盟科药业 公告编号:2025-004 上海盟科药业股份有限公司 第二届董事会第十一次会议决议公告 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。 一、 董事会会议召开情况 具体内容详见公司同日披露于上海证券交易所网站(www.sse.com.cn)的 《上海盟科药业股份有限公司关于2023年限制性股票激励计划首次授予部分第 一个归属期符合归属条件的公告》(公告编号:2025-002)。 (二)审议通过《关于作废部分已授予尚未归属的限制性股票的议案》 根据《激励计划》和《考核管理办法》的相关规定及公司2022年年度股东 大会对董事会的授权,由于《激励计划》项下首次授予的24名激励对象因个人 原因离职,不再具备激励对象资格;54名激励对象自愿放弃或部分放弃本次归 属;3名激励对象2023年度个人考核评价结果为"C",其在本次归属项下对应 的个人考核层面的归属系数为50%;本次归属公司考核指标层面的归属系数为 75%,董事会决定相应作废公司2023年限制性股票激励计划中部分已授予尚未 归属的限制 ...