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汇宇制药(688553.SH):注射用紫杉醇(白蛋白结合型)获得境外上市许可
智通财经网· 2025-10-09 08:22
Core Viewpoint - Seacross Pharma (Europe) Ltd., a subsidiary of the company, has received marketing approvals for its injectable paclitaxel (albumin-bound) from regulatory authorities in the Netherlands, Ireland, Finland, and Sweden [1] Group 1: Product Approval - The injectable paclitaxel (albumin-bound) is indicated as a monotherapy for adult patients with metastatic breast cancer who have not responded to first-line treatment and for whom standard anthracycline-based therapy is not suitable [1] - The product is also indicated for use in combination with gemcitabine for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma [1] - Additionally, it is indicated for use in combination with carboplatin for the initial treatment of adult patients with non-small cell lung cancer who are not suitable for potentially curative surgery and/or radiotherapy [1]
汇宇制药:公司产品注射用紫杉醇(白蛋白结合型)获得多国境外上市许可
Core Viewpoint - Seacross Pharma (Europe) Ltd., a subsidiary of Huayu Pharmaceutical, has received marketing authorization for its injectable paclitaxel (albumin-bound) from regulatory authorities in the Netherlands, Ireland, Finland, and Sweden, indicating a significant advancement in the company's product offerings for treating metastatic breast cancer patients [1] Group 1 - The product, injectable paclitaxel (albumin-bound), is primarily indicated as a monotherapy for adult patients with metastatic breast cancer who have not responded to first-line treatment and for whom standard anthracycline-based therapy is not suitable [1]
汇宇制药(688553) - 关于自愿披露公司产品获得境外上市许可的公告
2025-10-09 08:00
证券代码:688553 证券简称:汇宇制药 公告编号:2025-081 二、药品的其他相关情况 注射用紫杉醇(白蛋白结合型)主要单药疗法适用于治疗成人转移性乳腺癌 患者(这些患者在一线治疗转移性疾病后病情未见好转,且标准的含蒽环类药物 治疗方案不适用);与吉西他滨联合使用适用于成人转移性胰腺腺癌患者的首次 治疗;与卡铂联合使用,适用于不适合接受可能具有治愈效果的手术和/或放疗 的成年非小细胞肺癌患者的初始治疗。 公司注射用紫杉醇(白蛋白结合型)研发成功后已进行了多国注册申报,目前 已在丹麦、荷兰、爱尔兰、芬兰、瑞典获得上市许可。截至目前,公司已在包含 英国、意大利、法国、西班牙等 9 个国家提交注册申请。 三、对公司的影响及风险提示 公司研发的注射用紫杉醇(白蛋白结合型)分别获得荷兰、爱尔兰、芬兰、瑞 典的上市许可,有利于公司在国际市场产品管线的丰富,提升市场的品牌形象, 四川汇宇制药股份有限公司 关于自愿披露公司产品获得境外上市许可的公告 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。 四川汇宇制药股份有限公司(以下简称 ...
汇宇制药(688553) - 关于为全资子公司提供担保的进展公告
2025-10-09 08:00
证券代码:688553 证券简称:汇宇制药 公告编号:2025-080 关于为全资子公司提供担保的进展公告 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、准确性和完整性承担法律责任。 一、担保情况概述 (一)担保的基本情况 近日,四川汇宇制药股份有限公司(以下简称"公司"、"汇宇制药")与中 国工商银行股份有限公司新津支行(以下简称"工商银行"、"债权人")签署《保 证合同》,约定由公司为其全资子公司汇宇海玥向工商银行的借款 1,800.00 万元 提供连带责任保证。保证范围包括主债权本金及其利息、罚息、复利、违约金、 损害赔偿金、实现债权和担保权利的费用。保证期间为汇宇海玥履行债务期限届 满之日起三年。本次担保无反担保。 (二)内部决策程序 公司于 2025 年 9 月 26 日召开了第二届董事会第十九次会议,审议通过了《关 于拟为全资子公司提供担保的议案》。具体内容详见公司于 2025 年 9 月 27 日在 上海证券交易所网站(www.sse.com.cn)披露的《关于拟为全资子公司提供担保 的公告》。本次担保系在上述经董事会批准的额度范围内,无需 ...
汇宇制药跌3.81% 上市即巅峰募24.7亿中信建投保荐
Zhong Guo Jing Ji Wang· 2025-09-29 09:45
Core Viewpoint - Huyou Pharmaceutical's stock has experienced a decline, currently trading at 21.45 yuan, down 3.81%, indicating a state of breaking [1] Group 1: Company Overview - Huyou Pharmaceutical was listed on the Shanghai Stock Exchange's Sci-Tech Innovation Board on October 26, 2021, with an initial public offering of 63.6 million shares at a price of 38.87 yuan per share [1] - The company raised a total of 2.472 billion yuan, with a net amount of 2.361 billion yuan after deducting issuance costs, exceeding the original fundraising plan by 453 million yuan [2] Group 2: Financial Performance - From 2021 to 2023, the company's operating revenues were 1.824 billion yuan, 1.493 billion yuan, and 927 million yuan, while net profits attributable to shareholders were 446 million yuan, 249 million yuan, and 140 million yuan respectively [3] - In 2024, the company achieved an operating revenue of 1.094 billion yuan, a year-on-year increase of 18.05%, and a net profit of 325 million yuan, a significant increase of 132.78% [3] - For the first half of 2025, the company reported an operating revenue of 453 million yuan, a year-on-year decrease of 14.86%, and a net loss of 80.72 million yuan compared to a profit of 65.21 million yuan in the same period last year [4]
汇宇制药跌3.81% 上市即巅峰募24.7亿中信建投保荐
Zhong Guo Jing Ji Wang· 2025-09-29 09:37
Core Insights - Huyou Pharmaceutical's stock closed at 21.45 yuan, down 3.81%, currently in a state of decline since its IPO [1] - The company went public on October 26, 2021, on the Sci-Tech Innovation Board, issuing 63.6 million shares at a price of 38.87 yuan per share [1][2] - The total funds raised amounted to 2.472 billion yuan, with a net amount of 2.361 billion yuan after deducting issuance costs, exceeding the initial plan by 453 million yuan [2] Financial Performance - From 2021 to 2023, the company's revenue was 1.824 billion yuan, 1.493 billion yuan, and 927 million yuan respectively, with net profits of 446 million yuan, 249 million yuan, and 140 million yuan [3] - In 2024, the company projected revenue of 1.094 billion yuan, an increase of 18.05%, with net profit expected to reach 325 million yuan, a growth of 132.78% [3] - For the first half of 2025, the company reported revenue of 453 million yuan, a decrease of 14.86%, and a net loss of 80.72 million yuan [4]
汇宇制药股价跌5.11%,大成基金旗下1只基金重仓,持有43.15万股浮亏损失49.19万元
Xin Lang Cai Jing· 2025-09-29 03:51
Group 1 - The core viewpoint of the news is that Huili Pharmaceutical's stock has experienced a significant decline, with a 5.11% drop on September 29, leading to a cumulative decline of 11.16% over three consecutive days [1][2] - Huili Pharmaceutical, established on October 12, 2010, and listed on October 26, 2021, specializes in the research, production, and sales of oncology drugs and complex injectable drugs [1] - The company's main revenue sources are drug sales (97.27%), technical services (1.66%), and other income (1.07%) [1] Group 2 - Dachen Fund has a significant holding in Huili Pharmaceutical, with its Dachen Medical Health Stock A fund holding 431,500 shares, representing 4.07% of the fund's net value [2] - The fund has incurred a floating loss of approximately 491,900 yuan today and a total floating loss of 1,208,100 yuan during the three-day decline [2] - Dachen Medical Health Stock A fund was established on September 16, 2021, with a current size of 153 million yuan and has achieved a year-to-date return of 33.89% [2]
华鑫证券-汇宇制药-688553-公司动态研究报告:业绩符合预期,创新管线持续推进-250927
Xin Lang Cai Jing· 2025-09-28 09:11
Group 1 - The company achieved a revenue of 453 million yuan in the first half of 2025, a year-on-year decrease of 14.86%, and a net profit attributable to shareholders of -81 million yuan, a year-on-year decrease of 223.78%. The company remains focused on R&D-driven strategies, specializing in innovative oncology drugs and high-quality generic drugs [1] - The company is accelerating its innovative drug layout, with multiple new drugs making significant progress in the development of biological innovative drugs and small molecule innovative drugs, particularly in antibody-drug conjugates (ADC), T cell engagers (TCE), and trispecific antibody immunotherapy [1] - The company's globalization strategy is deepening, with overseas sales revenue reaching 93 million yuan in the first half of 2025, a year-on-year increase of 27.18%. The company has 25 products approved for sale in overseas markets and has achieved sales in 68 countries and regions [1] Group 2 - The company forecasts revenues of 1.205 billion yuan, 1.407 billion yuan, and 1.701 billion yuan for 2025, 2026, and 2027 respectively, with EPS of 0.21 yuan, 0.48 yuan, and 0.72 yuan. The current stock price corresponds to PE ratios of 107.8, 46.4, and 31.1 times [1]
趋势研判!2025年中国化疗药物行业全景速览:随着癌症患者人数不断增多,市场对化疗药物的需求持续增长,国内企业不断上市,市场竞争加剧[图]
Chan Ye Xin Xi Wang· 2025-09-28 01:32
Core Viewpoint - The chemotherapy drug market in China is experiencing growth due to increasing cancer patient numbers and rising consumer spending, despite competition from targeted therapies. Chemotherapy drugs remain dominant due to their stable efficacy, broad anti-cancer properties, and relatively low prices [1][4][5]. Group 1: Industry Overview - Chemotherapy drugs are a crucial method for cancer treatment, classified into various types such as alkylating agents, antimetabolites, and plant-derived anticancer drugs [2][3]. - The demand for chemotherapy drugs in China is projected to reach 3.858 billion units with a market size of 135.59 billion yuan in 2024, led by plant alkaloids and antimetabolites [5][6]. - The global chemotherapy drug market is expected to grow from 33.53 billion USD in 2024 to 36.84 billion USD in 2025, with the Asia-Pacific region holding a significant share [4][5]. Group 2: Market Dynamics - The Chinese chemotherapy drug market is characterized by a dual driving force of strong demand for certain drug types while facing pressure from generics and targeted therapies [5][10]. - The production of chemotherapy drugs in China is anticipated to increase to 3.432 billion units by 2025, reflecting a growth trend in domestic manufacturing capabilities [6][10]. - The competitive landscape is intensifying with local companies like Heng Rui Medicine and Qilu Pharmaceutical making significant strides in both generic and innovative drug development [10][11]. Group 3: Regulatory Environment - The Chinese government has implemented supportive policies to encourage the development of innovative cancer treatment drugs, providing a favorable environment for industry growth [8][9]. - The industry is witnessing accelerated drug approval processes and procurement policies that favor local manufacturers, enhancing competition [10][11]. Group 4: Future Trends - The chemotherapy drug sector is expected to evolve towards precision medicine, with advancements in targeted therapies and combination treatments [11]. - Innovations in drug delivery systems, such as nanotechnology, are anticipated to enhance treatment efficacy and patient outcomes [11].
关于拟为全资子公司提供担保的公告
Core Viewpoint - The company plans to provide a guarantee of up to 100 million RMB for its wholly-owned subsidiary, Sichuan Huiyu Pharmaceutical Co., Ltd., to support its liquidity needs for bank loans [1][5]. Group 1: Guarantee Details - The guarantee amount will not exceed 100 million RMB, and the specific amount will be determined based on the agreement with the bank [1]. - The guarantee is intended to meet the operational development needs of the subsidiary, ensuring its stable business growth [5]. - The guarantee is within the company's board approval authority and does not require shareholder meeting approval, as it does not exceed 30% of the company's latest audited total assets [2]. Group 2: Internal Decision Process - The company's board of directors held a meeting on September 26, 2025, where the proposal for the guarantee was approved unanimously [10][12]. - The board believes that the guarantee aligns with the company's operational needs and will enhance overall financing efficiency [12]. Group 3: Financial Implications - As of the announcement date, the company has provided a total of 12.02 million RMB in guarantees to its subsidiaries, which is 0.302% of the latest audited net assets [6]. - With the new guarantee, the total amount of guarantees provided to subsidiaries will rise to 11.202 million RMB, representing 2.815% of the latest audited net assets [6]. Group 4: Risk Management - The company asserts that the guarantee risk is manageable and does not pose a threat to the interests of the company or its shareholders, particularly minority shareholders [5][12]. - There are currently no overdue guarantees or litigation-related guarantees involving the company or its subsidiaries [7].