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华森制药(002907) - 2025年7月10日投资者关系活动记录表
2025-07-10 08:52
Group 1: Company Overview and Performance - The company introduced its operational performance, product layout, market development, and production management while ensuring compliance with information disclosure regulations [2] - As of May 2025, the company has integrated its R&D pipeline with Chengdu Aorui Pharmaceutical Co., enhancing its small molecule innovative drug development capabilities [3] - The company has established multiple independent R&D platforms and has applied for 35 patents, including 17 PCT patents [3] Group 2: Innovative Drug Development - Currently, there are 7 proprietary Class 1 innovative drug projects under development, targeting various cancers and autoimmune diseases [3] - The lead project, ORIC-1940, is in clinical Phase Ia/Ib research and is expected to be the first Class 1 innovative drug for secondary hemophagocytic lymphohistiocytosis (HLH) in China [3] - The company plans to submit IND applications for two additional projects by the end of this year and the first quarter of next year [3] Group 3: Clinical Data and Future Prospects - Anticipated Phase Ib data for ORIC-1940 is expected next year, with the timeline dependent on patient enrollment speed [4] - ORIC-1940 offers a differentiated mechanism of action compared to existing therapies, potentially addressing the limitations of current HLH treatments [5] - The company is considering expanding ORIC-1940's indications to include primary HLH and other autoimmune diseases [6] Group 4: International Market Expansion - The company has achieved significant milestones in international markets, including passing the FDA's cGMP inspection in May 2023 [7] - Key traditional Chinese medicine products have received registration approvals for sale in Singapore, marking a critical milestone for the company's export strategy [7]
海创药业在成都举行氘恩扎鲁胺软胶囊上市盛典
Zheng Quan Ri Bao· 2025-07-10 06:44
Core Viewpoint - Haichuang Pharmaceutical Co., Ltd. has launched its self-developed innovative anti-cancer drug, Dihydro-Enzalutamide soft capsule, marking a significant milestone in its development journey [2][3] Group 1: Product Launch and Clinical Significance - Dihydro-Enzalutamide soft capsule is recognized as a new type of androgen receptor antagonist (ARi) and has shown significant clinical value, particularly in treating metastatic castration-resistant prostate cancer (mCRPC) [2] - Clinical studies indicate that Dihydro-Enzalutamide significantly improves disease progression and survival rates while demonstrating excellent safety profiles, with no adverse events such as falls or seizures reported [2] - Experts suggest that Dihydro-Enzalutamide has the potential to be moved forward in treatment protocols for metastatic hormone-sensitive prostate cancer (mHSPC) [2][3] Group 2: Company Development and Future Plans - The inauguration of Haichuang Pharmaceutical's headquarters and the rapid nationwide supply of Dihydro-Enzalutamide signify a critical leap from research innovation to industrial empowerment [3] - The company focuses on developing innovative drugs for cancer and metabolic diseases and plans to accelerate the global rollout of multiple anti-cancer and metabolic disease drugs [3] - Haichuang Pharmaceutical's chairman emphasized the importance of patient-centered research and the collective effort of employees and partners in achieving this milestone [3]
我国自主研发的1类抗癌新药氘恩扎鲁胺软胶囊发布上市
此前,海创药业在5月末公告称,氘恩扎鲁胺软胶囊获得国家药监局批准上市。 6月下旬,公司的微信公众号发文表示,氘恩扎鲁胺软胶囊首批产品从广州装车发货,并于20日开出全 国首张处方。该胶囊正式开启全国供应,患者凭医生开具的处方即可在全国各大省会城市DTP药店购买 到这款产品。在公司看来,该药首方的开出距离该药获批上市仅半月余,充分展现了其重要的临床价值 和紧迫的临床需求。 据公开资料,前列腺癌是常见的泌尿系统恶性肿瘤,位居全球男性癌症发病率的第二位和癌症死亡率的 第五位。2022年,全球前列腺癌新发病例数达到146.7万例。近年来,中国前列腺癌的发病率呈现上升 趋势,2022年中国前列腺癌新发病例数达到13.4万例。 对于转移性去势抵抗性前列腺癌,内分泌治疗仍是推荐的首选治疗方式。氘恩扎鲁胺软胶囊是国内第一 款针对该类患者人群获得批准上市的创新药物。 (原标题:我国自主研发的1类抗癌新药氘恩扎鲁胺发布上市) 7月4日,海创药业(688302)在成都天府国际生物城举行了总部基地启用盛典,并宣布我国自主研发的1 类抗癌新药氘恩扎鲁胺软胶囊发布上市。 海创药业董事长陈元伟表示,该产品的成功上市,离不开各方的鼎力支持,更 ...
公司资金被长期占用未及时披露,维康药业及多名责任人被罚超千万
Bei Ke Cai Jing· 2025-07-01 04:58
一纸超千万的罚单再度将浙江维康药业股份有限公司(简称"维康药业")置于风口浪尖。近日,维康药 业发布公告称,因涉嫌信息披露违法违规,公司及实际控制人刘忠良被立案调查。调查结果显示,维康 药业未按规定披露关联方非经营性资金占用,且可转债募集说明书存在不准确、不完整的情况。依据相 关规定,浙江证监局拟决定对维康药业及公司多名责任人给予警告并处罚款,罚款金额总计1460万元。 实控人长期占用公司资金 2024年12月底,维康药业及其实控人刘忠良收到中国证监会下发的立案告知书,因涉嫌信息披露违法违 规,中国证监会决定对公司及公司实际控制人刘忠良立案。 最新的浙江证监局的《行政处罚事先告知书》显示,案涉期间,维康药业时任董事长、实际控制人刘忠 良组织、指使维康药业以支付工程设备款名义转出部分资金,经工程设备商后,资金最终转至刘忠良控 制的个人账户,上述行为构成关联方非经营性资金占用。 从数据来看,2020年、2021年、2022年、2023年1-6月资金占用期末余额分别为7811.88万元、8950.65万 元、1.47亿元、1.51亿元,分别占当期净资产的5.64%、6.35%、10.43%、10.24%。截至202 ...
非经营性资金占用且信披违法 维康药业与6名高管被罚1600万元
Core Viewpoint - The company Weikang Pharmaceutical (300878.SZ) has been penalized 16 million yuan due to non-operational fund occupation by its actual controller and violations in information disclosure [2][3][6]. Group 1: Regulatory Actions and Penalties - The China Securities Regulatory Commission (CSRC) has initiated an investigation into Weikang Pharmaceutical and its actual controller Liu Zhongliang for suspected violations of information disclosure [3]. - The CSRC found that from 2020 to 2023, Liu Zhongliang organized and directed the company to transfer funds under the guise of paying for engineering equipment, which were ultimately transferred to his personal accounts, constituting non-operational fund occupation [3][5]. - The total penalties include 5 million yuan for Weikang Pharmaceutical, 7 million yuan for Liu Zhongliang, and 4 million yuan for five other executives, totaling 16 million yuan [6]. Group 2: Financial Performance and Issues - Weikang Pharmaceutical has experienced a decline in performance since its listing in August 2020, with consecutive losses in 2023 and 2024 [4][10]. - The net profits from 2021 to 2023 were 97 million yuan, 49 million yuan, and a loss of 9 million yuan, respectively [9]. - In 2024, the company reported a loss of 147 million yuan, with a particularly poor performance in the fourth quarter, where revenue was negative 20 million yuan [10][11]. Group 3: Operational Challenges - The company attributes its declining performance to several factors, including reduced demand for prescription drugs due to changes in medical insurance policies and market conditions, increased competition leading to lower gross margins, and a shift in product promotion strategies [10]. - In 2024, Weikang Pharmaceutical's sales expenses were 201 million yuan, accounting for 57.26% of its revenue, while R&D expenses were only 14 million yuan, representing 4% of revenue, a decrease of 66.85% year-on-year [10]. Group 4: Corporate Governance Changes - Due to the fund occupation issues, two executives left their positions, with Liu Zhongliang resigning as chairman and director in May 2024 [7].
维康药业及相关责任人被罚超1400万元 公司近年业绩持续恶化,实控人刘忠良:困难是暂时的
Mei Ri Jing Ji Xin Wen· 2025-06-29 13:46
Core Viewpoint - Weikang Pharmaceutical faces administrative penalties from the Zhejiang Securities Regulatory Bureau for information disclosure violations, including non-disclosure of related party non-operating fund occupation and inaccuracies in convertible bond prospectus [1][2][5] Group 1: Administrative Penalties - The Zhejiang Securities Regulatory Bureau plans to impose a total fine exceeding 14 million yuan on Weikang Pharmaceutical and its responsible individuals, including a 5 million yuan fine on the company and a 7 million yuan fine on its actual controller Liu Zhongliang [1][5] - Liu Zhongliang, who served as the chairman from March 2015 until May 2024, has retired and is no longer involved in the company [1][2] Group 2: Fund Misappropriation - Liu Zhongliang directed Weikang Pharmaceutical to transfer funds under the guise of paying for engineering equipment, which were ultimately transferred to his personal account, constituting non-operating fund occupation [2][3] - From 2018 to 2020, Liu Zhongliang borrowed 56.29 million yuan from the company to support a friend's new drug development, which was used for various personal and business expenses [2][3] Group 3: Financial Performance - Weikang Pharmaceutical's net profit has declined since its IPO in 2020, with losses reported in 2023 and the first quarter of 2025, showing a significant drop in revenue and profitability [6][7] - The company's gross margin has decreased from 72.41% in 2020 to 50.39% in 2023, attributed to a decline in high-margin prescription drug sales and increased costs [7] Group 4: Future Outlook - Liu Zhongliang expressed optimism about the company's future, focusing on the development and production of traditional Chinese medicine products, believing that difficulties are temporary and new growth will emerge in two to three years [7]
002424,“摘帽”!
Zhong Guo Ji Jin Bao· 2025-06-27 04:51
登录新浪财经APP 搜索【信披】查看更多考评等级 在完成内控整改后,苗药龙头即将"摘帽"。 6月26日晚间,ST百灵(贵州百灵企业集团制药股份有限公司;证券代码:002424)发布公告称,公司股票将于6月27日停牌一天,于6月30日开市起复牌 并撤销其他风险警示。 届时,该公司证券简称将由"ST百灵"变更为"贵州百灵",证券代码仍为"002424",股票交易日涨跌幅限制由5%变更至10%。 【导读】完成内控整改后,ST百灵即将"摘帽" 见习记者 庄佳 为了解决内控问题,2024年度贵州百灵围绕"摘帽扭亏"核心任务,全力开展内控整改及质量专项提升工作,主要包括:根据最新的法律法规及规范运作规 则,全面梳理、完善内部制度;在审计委员会的监督和指导下,加强内部审计部门的审计监督职能,修订完善销售费用政策,规范市场费用票据报销管理 等;新设立合规管理部,制定了一系列的业务合规管理规范制度。 根据天健会计师事务所(特殊普通合伙)出具的2024年度带强调事项段的无保留意见《内部控制审计报告》及《2023年度内部控制审计报告否定意见所涉 及事项已消除情况的专项说明》,贵州百灵2023年度《内部控制审计报告》否定意见所涉及事 ...
002424,“摘帽”!
中国基金报· 2025-06-27 04:31
【 导读 】 完成内控整改后, ST百灵即将"摘帽" 见习记者 庄佳 在完成内控整改后, 苗药龙头 即将"摘帽"。 6月26日晚间,ST百灵(贵州百灵企业集团制药股份有限公司;证券代码:002424)发布公告称,公司股票将于6月27日停牌一天,于6 月30日开市起复牌并撤销其他风险警示。 届时,该公司 证券 简称将由"ST百灵"变更为"贵州百灵",证券代码仍为"002424", 股票交易 日涨跌幅限制由5%变更至10%。 内控整改完成,成功摘帽 公告显示, 2023年度,贵州百灵被天健会计师事务所(特殊普通合伙)出具了否定意见的《内部控制审计报告》 。 根据 相关 规定, 该 公司股票 自 2024年 5 月 6 日 起 被实施其他风险警示。 根据天健会计师事务所(特殊普通合伙)出具的2024年度带强调事项段的无保留意见《内部控制审计报告》及《2023年度内部控制审计报 告否定意见所涉及事项已消除情况的专项说明》,贵州百灵2023年度《内部控制审计报告》否定意见所涉及事项影响已消除。故公司于 2025年6月18日召开第六届董事会第十七次会议,审议通过《关于申请撤销其他风险警示的议案》,并向深圳证券交易所提交了 ...
内控整改完成6月30日将“摘帽” ST百灵:经营发展将重回正轨
6月26日晚间,ST百灵(002424)发布公告,该上市公司关于撤销其他风险警示的申请已获得深交所审核 同意,ST百灵将顺利实现"摘帽"。 公告显示,ST百灵股票交易将于6月27日停牌一天,并于6月30日开市起复牌交易。经深交所审核同 意,根据《深圳证券交易所股票上市规则(2025 年修订)》的相关规定,ST百灵股票将于2025年6月30 日开市起撤销其他风险警示,证券简称由"ST百灵"变更为"贵州百灵",日涨跌幅限制由5%恢复为 10%。 回溯2023年度,ST百灵被天健会计师事务所(以下简称"天健所")出具了否定意见的《内部控制审计 报告》,根据规定,该上市公司最近一年被出具无法表示意见或者否定意见的内部控制审计报告或者鉴 证报告,深交所对公司股票实施其他风险警示。 目前,ST百灵旗下的"百灵鸟"商标相关产品广泛覆盖心脑血管疾病、呼吸道疾病、妇科疾病、骨科疾 病等中医药优势领域,并占据重要市场份额。其中,复方一枝黄花喷雾剂近年在中国三大终端六大市场 的销售规模均超亿元;今年3月,该产品的中药品种保护初保申请得到了国家药品监督管理局受理。 ST百灵方面表示,历时一年的内部控制整改已全面完成,上市公司经营发展 ...
ST百灵: 天健会计师事务所(特殊普通合伙)问询函专项说明
Zheng Quan Zhi Xing· 2025-06-26 16:40
Core Viewpoint - The company, Guizhou BaiLing Pharmaceutical Group Co., Ltd., has faced significant challenges in its financial performance for the year 2024, with a notable decrease in revenue and a mixed picture regarding profitability and cash flow [14][22]. Financial Performance - The company reported operating revenue of 3.825 billion yuan, a decrease of 10.26% year-on-year [14]. - The net profit attributable to shareholders was 33.62 million yuan, showing an increase compared to a net loss of 82.44 million yuan in the previous year, marking an 81.33% improvement [14][22]. - The net cash flow from operating activities was 9.02 million yuan, a significant decrease of 92.83% year-on-year [14]. Revenue Breakdown - The revenue composition for 2024 included: - Traditional Chinese medicine: 3.381 billion yuan, down 12.00% - Western medicine: 293.07 million yuan, down 0.68% - Chinese medicinal materials: 22.04 million yuan, up 30.24% - Medical services: 66.68 million yuan, up 13.21% - Others: 62.56 million yuan, up 25.57% [17]. Cost and Expense Analysis - The total operating costs were 1.603 billion yuan, down 15.88% year-on-year, primarily due to decreased sales volume [18]. - Sales expenses decreased by 19.77% to 1.854 billion yuan, reflecting cost-cutting measures [18]. - The gross profit margin improved to 58.09%, up 2.80% from the previous year, attributed to lower raw material prices [19]. Internal Control and Audit Opinions - The company received a qualified audit opinion for 2023 due to significant internal control deficiencies related to sales expense recognition [5][8]. - In 2024, the company implemented corrective measures and received a clean audit opinion with an emphasis on matters, indicating improvements in internal controls [10][11]. Customer and Supplier Concentration - The top five customers accounted for 39.13% of total sales, while the top five suppliers represented 46.05% of total purchases, indicating a high concentration risk [14][28]. Market Conditions - The pharmaceutical industry faced challenges due to decreased demand for cold and flu medications, as consumers had stocked up during previous health crises [17]. - The overall market for pharmaceutical products has seen price reductions, contributing to the revenue decline [17]. Quarterly Performance Fluctuations - The company experienced significant fluctuations in quarterly performance, with the first and fourth quarters showing higher revenues due to seasonal demand for cold and flu medications [25][26]. - The cash flow from operating activities was notably negative in the first and third quarters, primarily due to delayed receivables [27]. Conclusion - The company is navigating a challenging financial landscape with a focus on improving internal controls and addressing revenue declines through strategic adjustments in operations and cost management [14][22].