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维康药业重磅新药迈入三期临床 肝纤维化中成药迎新进展
Zheng Quan Ri Bao Wang· 2025-09-25 13:41
本报讯(记者吴文婧)9月25日晚,浙江维康药业(300878)股份有限公司(以下简称"维康药业")发布公 告,当日,由维康药业与盈科瑞(珠海金湾)制药有限公司共同申办、上海中医药大学附属曙光医院牵头 的"黄甲软肝颗粒"Ⅲ期临床试验项目启动会召开。该试验旨在评价该药物治疗慢性乙型肝炎肝纤维化的 有效性和安全性,共有包括安徽医科大学第一附属医院等19家中心参与。 维康药业多年来深耕中医药领域,目前已发展成为一家现代化高科技制药企业。此次启动临床三期试验 的"黄甲软肝颗粒",适应症为"慢性乙型病毒性肝炎肝纤维化(肝郁脾虚兼瘀血阻络证)",属于乙肝的一 种疾病后期。此次临床试验将采用随机、双盲、安慰剂对照、多中心设计,计划纳入480例受试者,旨 在最终验证其安全性与有效性。已完成的Ⅱ期临床试验结果显示,"黄甲软肝颗粒"在治疗相关适应症方 面,具有良好的疗效和安全性,患者临床获益超过潜在风险。 相关资料显示,我国慢乙肝患者基数庞大,2030年消灭乙肝目标明确。根据2023年《中华肝脏病杂 志》,我国慢性乙肝诊断率和治疗率分别仅为22%和15%,仍然有较大的提升空间。 国家药品监督管理局药品审批中心(CDE)药物临床试验 ...
维康药业携手19家临床中心 启动黄甲软肝颗粒临床三期试验
针对肝纤维化为适应症,此次启动的黄甲软肝颗粒并非唯一用药。截至本公告日,在国家药品监督管理 局药品审批中心(CDE)药物临床试验登记与信息公示平台上查询,以肝纤维化为适应症开展临床试验的 中成药有4个。 目前,维康药业主要产品包括银黄滴丸、益母草软胶囊、益母草分散片等中成药,以及罗红霉素软胶囊 等西药,生产剂型覆盖硬胶囊剂、片剂、颗粒剂、软胶囊剂、丸剂(滴丸)。除医药工业外,公司还从事 中医门诊业务、区域医药商业流通业务。 此次Ⅲ期临床试验,将采用随机、双盲、安慰剂对照、多中心临床试验设计,拟纳入480例受试者,确 证黄甲软肝颗粒治疗慢性乙型病毒性肝炎肝纤维化(肝郁脾虚兼瘀血阻络证)的安全性、有效性。 公告指出,启动会后,维康药业将按照国家要求及专家建议,积极推动黄甲软肝颗粒Ⅲ期临床试验的开 展,并将根据进展情况及时履行信息披露义务。 9月25日,由维康药业(300878)与盈科瑞(珠海金湾)制药有限公司共同申办,牵头单位为上海中医药 大学附属曙光医院和参研的安徽医科大学第一附属医院、重庆大学附属三峡医院、重庆医科大学附属第 一医院等19家临床试验中心,组织召开了关于开展"评价黄甲软肝颗粒治疗慢性乙型病毒性肝 ...
维康药业重磅新药迈入三期临床,肝纤维化中成药赛道迎新进展
Core Viewpoint - The announcement of the initiation of the Phase III clinical trial for "Huangjia Soft Liver Granules" by Weikang Pharmaceutical and its partners marks a significant step in evaluating the drug's efficacy and safety for treating chronic hepatitis B liver fibrosis [1][2]. Group 1: Clinical Trial Details - The Phase III clinical trial aims to assess the effectiveness and safety of "Huangjia Soft Liver Granules" for chronic hepatitis B liver fibrosis, involving 19 centers including Anhui Medical University First Affiliated Hospital [1][2]. - The trial will include 480 participants and is designed as a randomized, double-blind, placebo-controlled, multi-center study [2]. Group 2: Market Context and Potential - There is a substantial patient base for chronic hepatitis B in China, with approximately 93 million infected individuals and 20.23 million patients as of 2023 [2]. - The World Health Organization has set a target to eliminate viral hepatitis as a public health threat by 2030, aiming for a 90% reduction in new infections and a 65% reduction in mortality [2]. Group 3: Company Background and R&D Strength - Weikang Pharmaceutical has established itself as a modern high-tech pharmaceutical company with a diverse production system covering various dosage forms [1][3]. - The company has developed a robust research and development framework, including multiple provincial-level research centers and collaborations with notable scientists, enhancing its competitive edge in the pharmaceutical industry [3]. Group 4: Future Outlook - The successful completion of the Phase III trial for "Huangjia Soft Liver Granules" could lead to new treatment options for liver fibrosis and contribute to improving the management of chronic hepatitis B in China [4]. - Weikang Pharmaceutical aims to leverage technological innovation to strengthen its R&D capabilities and expand its portfolio of quality traditional Chinese medicine products [4].
维康药业上半年业绩短期承压 中药创新与灵芝产业奠基未来成长
Core Viewpoint - Zhejiang Weikang Pharmaceutical Co., Ltd. reported a revenue of 115 million yuan and a net profit of -64 million yuan for the first half of 2025, attributing the performance decline to reduced sales and the previous year's subsidiary disposal [1] Group 1: Financial Performance - The company experienced a revenue of 115 million yuan and a net profit of -64 million yuan in the first half of 2025 [1] - The decline in performance is linked to a slowdown in the pharmaceutical retail industry and a strategic decision to optimize the business structure by divesting its wholly-owned subsidiary engaged in pharmaceutical retail [1] Group 2: R&D and Innovation - R&D capability is a core driving force for the company's development, with the appointment of Nobel Prize winner Michael Levitt as chief scientist to enhance R&D and internationalization [2] - The company has established several high-level R&D platforms, including provincial high-tech enterprise R&D centers and expert workstations, to build a leading innovation system [2] - The company’s products, such as Yipingfeng Granules and Fengliao Gastrointestinal Dispersible Tablets, have received provincial recognition, indicating effective market competitiveness [2] Group 3: Market Strategy and Product Development - The company is actively expanding into the traditional Chinese medicine health sector, focusing on the market layout of Ganoderma lucidum spore powder and developing a product line for future growth [2] - Utilizing the advantages of being located in "the first town of Ganoderma lucidum" in Longquan, Zhejiang, the company has established a high-standard quality system for cultivation [3] - The company has implemented a dual-channel sales strategy, combining online and offline efforts to enhance market penetration and sales volume [3] - Strategic partnerships with well-known pharmacy enterprises have been formed to enhance brand influence and terminal cooperation capabilities [3]
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
Core Viewpoint - Zhejiang Weikang Pharmaceutical Co., Ltd. is under investigation for information disclosure violations, leading to a total fine of 14.6 million yuan due to improper disclosure of related party non-operating fund occupation and inaccuracies in convertible bond prospectus [1][2][3] Group 1: Investigation and Penalties - The company and its actual controller, Liu Zhongliang, are being investigated by the China Securities Regulatory Commission (CSRC) for suspected violations of information disclosure laws [2] - The Zhejiang Securities Regulatory Bureau has issued a warning and imposed fines totaling 14.6 million yuan, including 5 million yuan for the company and 7 million yuan for Liu Zhongliang [3][4] - The penalties also include fines for other executives, with a total of 1.46 million yuan in fines for various responsible individuals [3] Group 2: Financial Misconduct - Liu Zhongliang allegedly organized the transfer of funds under the guise of paying for engineering equipment, which were ultimately diverted to his personal accounts, constituting non-operating fund occupation [2] - The occupied funds from 2020 to 2023 amounted to 142 million yuan, with the end-of-period balances being 78.12 million yuan, 89.51 million yuan, 147 million yuan, and 151 million yuan, respectively [2][6] - The company failed to disclose these fund occupations in its annual reports from 2020 to 2022 and the semi-annual report for 2023 [2] Group 3: Financial Performance - Weikang Pharmaceutical has experienced a decline in net profit since its listing, with losses starting in 2023, reporting net profits of 136 million yuan, 96.5 million yuan, 44.44 million yuan, -8.04 million yuan, and -147 million yuan from 2020 to 2024 [7] - The company attributed its declining performance to its products being removed from various provincial medical insurance directories, affecting sales [8] - In 2024, the company reported a significant impairment of fixed assets amounting to 87.42 million yuan due to underutilization of capacity and declining sales [8] Group 4: Future Strategies - The company plans to enhance sales of core products like Yinhuang滴丸 and expand sales channels while investing in research and development for innovative traditional Chinese medicine [9] - Weikang aims to strengthen its market position by focusing on the development of new products and exploring the health sector's potential [9]
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].
实控人违占资金超1.5亿 维康药业将收千万罚单
Core Viewpoint - The investigation into Weikang Pharmaceutical (300878) revealed a four-year-long financial misconduct involving the misappropriation of funds by the actual controller, Liu Zhongliang, leading to significant penalties and ongoing operational challenges for the company [1][2]. Group 1: Financial Misconduct - Weikang Pharmaceutical received a penalty exceeding 14 million yuan due to undisclosed related-party fund misappropriation and false statements in convertible bond prospectuses [1]. - From 2020 to mid-2023, Liu Zhongliang transferred over 150 million yuan from the company to personal accounts under the guise of engineering equipment payments, with the highest annual misappropriation exceeding 10% of net assets [2]. - The scale of fund misappropriation increased from 78.11 million yuan in 2020 to 151 million yuan in 2023, with corresponding percentages of net assets being 5.64%, 6.35%, 10.43%, and 10.24% [2]. Group 2: Operational Performance - Weikang Pharmaceutical has experienced a continuous decline in performance since its IPO, with net profits dropping from 108 million yuan in 2020 to a loss of 147 million yuan in 2024 [3]. - The company's revenue in the first quarter of 2025 fell by 65.10% year-on-year to 69.77 million yuan, with losses expanding to 9.85 million yuan [3]. - The gross margin decreased significantly from 72.41% in 2020 to 42.23% in 2024, reflecting a 30 percentage point drop over five years [3]. Group 3: Strategic Changes - In response to ongoing challenges, Weikang Pharmaceutical divested its retail pharmaceutical business in September 2024 to focus on traditional Chinese medicine research and health products [4]. - Despite the recognition of its flagship product, Yinhuang Diban, as the top cold medicine in retail for 2024, the company has not been able to reverse its declining performance [4]. Group 4: Investor Rights and Compensation - Following the administrative penalties, investors who purchased Weikang Pharmaceutical shares between March 31, 2021, and December 27, 2024, may claim compensation for losses incurred [5]. - As of June 2025, Weikang Pharmaceutical's stock price was 17.04 yuan, with a market capitalization of 2.47 billion yuan, reflecting a significant decline in investor confidence [5].
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]
维康药业核心产品技术获奖,中医药创新再进一步
Zhong Guo Ji Jin Bao· 2025-06-11 11:35
Core Viewpoint - Vikon Pharmaceutical has been recognized for its innovative patent in traditional Chinese medicine, showcasing its technological strength and market potential in the healthcare industry [4]. Group 1: Patent and Recognition - Vikon Pharmaceutical's patent for "a sustained-release heat-resistant pill matrix and the silver-yellow pill containing this matrix" won the "25th China Patent Excellent Award," indicating national-level recognition of the company's technological capabilities in modernizing traditional Chinese medicine [4]. - The core product, Silver Yellow Pill, has demonstrated significant advantages in treating acute and chronic throat inflammation, tonsillitis, and upper respiratory infections, leading to its recognition in various industry awards [2][4]. Group 2: Research and Development - The company has established multiple research platforms, including provincial high-tech enterprise R&D centers and expert workstations, enhancing its competitiveness in pharmaceutical research and development [2]. - The completion of Phase II clinical trials for Silver Yellow Pill targeting recurrent oral ulcers indicates ongoing efforts to expand its application scenarios, potentially driving future market growth [2]. Group 3: Market Strategy and Growth - Vikon Pharmaceutical is leveraging the advantages of its production location in Longquan, known for its "Chinese Ganoderma first town," to create a pollution-free and additive-free product line, enhancing its market appeal [3]. - The application of low-temperature physical ultra-micro wall-breaking technology has improved the bioavailability of its Ganoderma spore powder products, contributing to a competitive edge in the market [3]. - The company is actively engaging with capital markets, as evidenced by a recent visit from a securities firm, indicating potential for further collaboration in capital operations and industrial upgrades [3].
维康药业:银黄滴丸再获殊荣 灵芝孢子粉构建第二成长曲线
Zhong Guo Ji Jin Bao· 2025-05-29 10:15
Core Insights - Weikang Pharmaceutical (维康药业) has been recognized for its strong R&D capabilities and excellent products in the traditional Chinese medicine industry, receiving the "2025 Hongding List VIP Cooperation Enterprise" award at the 2025 Health Industry Pharmaceutical Conference [1] - The company's flagship product, Yinhuang Diban (银黄滴丸), has been included in the "Top 10,000+ Pharmacy Star Products" list, highlighting its market acceptance and clinical efficacy [1] - Weikang is focusing on the secondary development of Yinhuang Diban, with a Phase II clinical trial for recurrent oral ulcers successfully completed and discussions for Phase III trials ongoing [1] Product Development - Yinhuang Diban is composed of honeysuckle and Scutellaria baicalensis extracts, known for its safety and effectiveness in treating various throat and respiratory conditions [1] - The product has received multiple industry accolades, including the top position in the "China Pharmaceutical Brand List" for adult cold medications and a prestigious patent award [1] - The company is also developing a second growth engine centered around broken-spore Ganoderma lucidum powder, leveraging its production advantages from the "Hometown of Chinese Ganoderma" in Longquan, Zhejiang [4] Market Strategy - Weikang is implementing a dual-channel strategy, optimizing both online and offline sales channels, including e-commerce platforms and health product counters [4] - The company plans to expand its product line to include high-value items such as Ganoderma lucidum oil and slices, aiming to tap into the market potential of the Ganoderma series [4] - The company’s mission of "Maintaining Life, Committed to Health" drives its continuous R&D efforts and deepens its presence in the traditional Chinese medicine health sector [4] Future Outlook - The company is expected to enhance its market competitiveness through R&D innovation, technological upgrades, and channel optimization in the growing traditional Chinese medicine health industry [5] - With the iterative upgrades of core products and accelerated commercialization of new products, Weikang is poised to expand its market share and strengthen its profit growth drivers [5]