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普洛药业:关于获得药品注册证书的公告
Zheng Quan Ri Bao· 2025-10-31 11:15
Core Viewpoint - Pro Pharmaceutical announced that its subsidiary, Zhejiang Pro Kangyu Pharmaceutical Co., Ltd., has received the drug registration certificate for L-Carnitine Injection from the National Medical Products Administration [2] Group 1 - The announcement was made on the evening of October 31 [2] - The drug registration certificate is a significant regulatory milestone for the company [2]
普洛药业(000739.SZ):左卡尼汀注射液获得药品注册证书
Ge Long Hui A P P· 2025-10-31 08:10
Core Viewpoint - Pro Pharmaceutical Co., Ltd. has received a drug registration certificate for L-Carnitine Injection from the National Medical Products Administration, indicating a significant advancement in its product portfolio [1] Company Summary - Pro Pharmaceutical's subsidiary, Zhejiang Pro Kangyu Pharmaceutical Co., Ltd., is the entity that received the drug registration certificate [1] - The newly approved L-Carnitine Injection is intended for patients with chronic renal failure undergoing long-term hemodialysis, addressing secondary carnitine deficiency and its associated complications [1] Industry Summary - The approval of L-Carnitine Injection highlights the growing focus on treatments for chronic kidney disease and related conditions, which is a critical area in the pharmaceutical industry [1] - The clinical manifestations targeted by this product include cardiomyopathy, skeletal muscle disease, arrhythmias, hyperlipidemia, hypotension, and muscle cramps during dialysis [1]
普洛药业(000739) - 关于对下属公司担保的进展公告
2025-10-31 08:03
证券代码:000739 证券简称:普洛药业 公告编号:2025-59 普洛药业股份有限公司 关于对下属公司担保的进展公告 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 一、担保情况概述 1、2025 年 10 月 11 日,普洛药业股份有限公司(以下简称"公司")与中 国农业银行股份有限公司东阳市支行(以下简称"农业银行")签订《保证合同》 (合同编号:33100120250013579),同意为公司全资子公司浙江普洛家园药业 有限公司(以下简称"家园药业")与农业银行签署的《流动资金借款合同》(合 同编号:33010120250041799)中的短期流动资金贷款 5,000 万元提供连带责任 保证,担保期限 1 年。 二、担保事项履行的审议程序 公司于 2025 年 3 月 7 日、2025 年 4 月 17 日分别召开了第九届董事会第十 一次会议及 2024 年年度股东大会,审议通过了《关于对下属公司提供担保预计 的议案》,为下属 10 家子公司及孙公司在银行等金融机构的融资提供不超过人 民币 71 亿元的融资担保。本次对外担保额度授权期限为公司 202 ...
普洛药业(000739) - 关于获得药品注册证书的公告
2025-10-31 08:03
证券代码:000739 证券简称:普洛药业 公告编号:2025-60 普洛药业股份有限公司 关于获得药品注册证书的公告 4、注册分类:化学药品 4 类 5、上市许可持有人:浙江普洛康裕制药有限公司 6、生产企业:浙江普洛康裕制药有限公司 7、证书编号:2025S03118 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 近日,普洛药业股份有限公司(以下简称"公司")控股子公司浙江普洛康 裕制药有限公司收到国家药品监督管理局(以下简称"药监局")签发的左卡尼 汀注射液《药品注册证书》。现将有关情况公告如下: 一、药品注册批准情况 1、产品名称:左卡尼汀注射液 2、剂型:注射剂 3、规格:5ml:1g(以左卡尼汀计) 普洛药业股份有限公司董事会 8、药品批准文号:国药准字 H20255678 9、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 本品适用于慢性肾衰长期血透病人因继发性肉碱缺乏产生的一系列并发症 状,临床表现如心肌病、骨骼肌病、心律失常、高脂血症,以及低血压 ...
普洛药业子公司获得左卡尼汀注射液药品注册证书
Zhi Tong Cai Jing· 2025-10-31 07:59
Core Viewpoint - Pro Pharmaceutical (000739.SZ) announced that its subsidiary, Zhejiang Pro Kangyu Pharmaceutical Co., Ltd., has received the drug registration certificate for L-carnitine injection from the National Medical Products Administration of China [1] Group 1: Product Information - L-carnitine injection is indicated for patients with chronic renal failure undergoing long-term hemodialysis, addressing secondary carnitine deficiency and related complications such as cardiomyopathy, skeletal myopathy, arrhythmias, hyperlipidemia, hypotension, and muscle cramps during dialysis [1] - The projected market size for L-carnitine injection in China's hospital market for 2024 is estimated at 103 million units, with a sales value of 965 million yuan [1] Group 2: Financial Investment - The total research and development expenses incurred for L-carnitine injection up to the date of the announcement amount to 3.7629 million yuan [1]
普洛药业:获得左卡尼汀注射液药品注册证书
Zheng Quan Shi Bao Wang· 2025-10-31 07:59
Core Viewpoint - Prolo Pharmaceutical (000739) announced that its subsidiary, Zhejiang Prolo Kangyu Pharmaceutical Co., Ltd., received a drug registration certificate for L-carnitine injection from the National Medical Products Administration, indicating a significant development in its product portfolio [1] Company Summary - Prolo Pharmaceutical's subsidiary has obtained regulatory approval for L-carnitine injection, which is clinically used for complications arising from secondary carnitine deficiency in patients with chronic renal failure undergoing long-term hemodialysis [1] - The approval is expected to enhance the company's market presence in the pharmaceutical sector, particularly in the treatment of chronic kidney disease [1] Industry Summary - The market size for L-carnitine injection in China's hospital sector is projected to reach 103 million units with a sales value of 965 million yuan in 2024, indicating a substantial opportunity for growth in this therapeutic area [1]
普洛药业(000739.SZ)子公司获得左卡尼汀注射液药品注册证书
智通财经网· 2025-10-31 07:56
Core Viewpoint - Prolo Pharmaceutical (000739.SZ) announced that its subsidiary, Zhejiang Prolo Kangyu Pharmaceutical Co., Ltd., has received the drug registration certificate for L-carnitine injection from the National Medical Products Administration of China [1] Company Summary - The L-carnitine injection is indicated for patients with chronic renal failure undergoing long-term hemodialysis, addressing complications arising from secondary carnitine deficiency, including cardiomyopathy, skeletal myopathy, arrhythmias, hyperlipidemia, hypotension, and muscle cramps during dialysis [1] - As of the date of the announcement, the total research and development expenses incurred for L-carnitine injection amounted to RMB 3.7629 million [1] Industry Summary - The projected market size for L-carnitine injection in China's hospital market for the year 2024 is estimated to be 103 million doses, with a sales value of RMB 966.5 million [1]
普洛药业的前世今生:祝方猛掌舵下原料药龙头崛起,原料药中间体营收36.03亿占比66.18%,CDMO成增长新引擎
Xin Lang Zheng Quan· 2025-10-30 23:36
Core Viewpoint - Puluo Pharmaceutical, a leading domestic raw material pharmaceutical company, has reported strong revenue figures but faces challenges in net profit and profitability metrics compared to industry averages [2][3][6]. Group 1: Company Overview - Puluo Pharmaceutical was established on May 6, 1997, and listed on the Shenzhen Stock Exchange on May 9, 1997, with its headquarters in Dongyang, Zhejiang Province [1]. - The company specializes in raw material intermediates, CDMO (Contract Development and Manufacturing Organization), and has a full industry chain advantage [1]. Group 2: Financial Performance - For Q3 2025, Puluo Pharmaceutical achieved a revenue of 7.764 billion yuan, ranking first among 47 companies in the industry, with a net profit of 700 million yuan, ranking second [2]. - The revenue composition includes raw material intermediates at 3.603 billion yuan (66.18%), innovative drug R&D services at 1.236 billion yuan (22.71%), and pharmaceuticals at 583 million yuan (10.71%) [2]. Group 3: Financial Ratios - As of Q3 2025, the company's debt-to-asset ratio was 46.34%, down from 50.61% year-on-year, but still above the industry average of 27.75% [3]. - The gross profit margin for Q3 2025 was 25.02%, an increase from 24.23% year-on-year, yet lower than the industry average of 35.38% [3]. Group 4: Shareholder Information - As of September 30, 2025, the number of A-share shareholders decreased by 19.66% to 41,300, while the average number of shares held per shareholder increased by 24.47% to 28,000 [5]. - Notable shareholders include Hong Kong Central Clearing Limited and various mutual funds, with some increasing their holdings [5]. Group 5: Business Highlights - CDMO services have become the primary growth driver, with revenue of 1.69 billion yuan in the first three quarters, a nearly 20% increase year-on-year [6][7]. - The API intermediates segment is at a historical low, but profitability is expected to improve with increased capacity utilization and gross margins [6]. - The formulation business is facing temporary pressure due to domestic procurement renewals, but product structure improvements and overseas market expansion are anticipated to provide ongoing growth [6].
普洛药业:公司产品拟中选第十一批全国药品集中采购
Zheng Quan Shi Bao Wang· 2025-10-28 10:57
Core Viewpoint - Pro Pharmaceutical (000739) announced that its subsidiary, Zhejiang Pro Kangyu Pharmaceutical Co., Ltd., has participated in the 11th national centralized drug procurement organized by the National Organization for Drug Procurement Office, with its product, injection adenosine methionine bisulfate, expected to be selected for this procurement [1] Group 1 - The selected product is anticipated to obtain the Drug Registration Certificate in November 2024, which is equivalent to passing the consistency evaluation of generic drug quality and efficacy [1]
普洛药业(000739) - 关于公司产品拟中选第十一批全国药品集中采购的公告
2025-10-28 10:52
普洛药业股份有限公司 关于公司产品拟中选第十一批全国药品集中采购的公告 证券代码:000739 证券简称:普洛药业 公告编号:2025-58 | 产品名称 | 适应症 | 中选规格 | 拟中选价 | 拟中选数量 | 拟供地区 | 采购 | | --- | --- | --- | --- | --- | --- | --- | | | | | 格(元/支) | (万支) | | 周期 | | 注射用丁 | 适用于肝硬化前和肝硬 | 0.5g(以 | 6.82 | 123.7594 | 福建、广 | 3 年 | | 二磺酸腺 | 化所致肝内胆汁淤积。 | 腺苷蛋氨 | | | 西、湖南、 | | | 苷蛋氨酸 | 适用于妊娠期肝内胆汁 | 酸计) | | | 云南、海 | | | | 淤积。 | | | | 南 | | 1.上述品种的拟中选价格及拟中选数量均以联合采购办公室发布的最终数 据为准。 2. 按照相关规定,本次拟中选产品的采购周期自中选结果执行之日起至 2028 年 12 月 31 日。 二、对公司的影响 本公司及董事会全体成员保证信息披露的内容真实、准确、完整,没有虚假 记载、误导性陈述或重大遗漏。 ...