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海正药业(600267) - 浙江海正药业股份有限公司关于召开2026年第一次临时股东会的提示性公告
2025-12-26 08:45
证券代码:600267 证券简称:海正药业 公告编号:临2025-84号 浙江海正药业股份有限公司 (四)现场会议召开的日期、时间和地点 关于召开2026年第一次临时股东会的提示性公告 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。 重要内容提示: 浙江海正药业股份有限公司(以下简称"公司")于2025年12月18日在《中 国证券报》《上海证券报》《证券时报》和上海证券交易所网站(www.sse.com.cn) 上刊登了《浙江海正药业股份有限公司关于召开2026年第一次临时股东会的通知》 (公告编号:临2025-79号)。本次股东会采用现场和网络投票相结合的方式召 开,现发布本次临时股东会提示性公告。 一、 召开会议的基本情况 (一)股东会类型和届次 2026年第一次临时股东会 召开的日期时间:2026 年 1 月 5 日 14 点 00 分 召开地点:浙江海正药业股份有限公司会议室(台州市椒江区外沙路 46 号) 股东会召开日期:2026年1月5日 本次股东会采用的网络投票系统:上海证券交易所股东会网络投票系统 (二)股东会 ...
浙江海正药业股份有限公司关于获得药品补充申请批准通知书的公告
Shang Hai Zheng Quan Bao· 2025-12-23 20:10
Group 1 - Company has received approval for a supplemental application for Everolimus tablets, adding a new 2.5mg specification to the existing 5mg specification [1][2] - The approved drug, Everolimus, is indicated for various conditions including advanced renal cell carcinoma and neuroendocrine tumors [2][3] - The company has invested approximately 740,420 RMB in the development of the 2.5mg specification of Everolimus [3] Group 2 - The company’s subsidiary has received approval for veterinary products, including Doxycycline tablets and a vaccine for swine fever, enhancing its product line in the veterinary sector [6][8] - Doxycycline is indicated for infections caused by various bacteria, while the swine fever vaccine has an immunity period of six months [7][8] - The approval of these veterinary products is expected to strengthen the company's market position in the veterinary medicine sector [10]
海正药业:关于获得药品补充申请批准通知书的公告
Zheng Quan Ri Bao Zhi Sheng· 2025-12-23 11:41
Core Viewpoint - The company, Haizheng Pharmaceutical, has received approval from the National Medical Products Administration for a supplemental application for Everolimus tablets, adding a new 2.5mg specification to the already approved 5mg version [1] Group 1 - The company announced the approval of a new specification for Everolimus tablets, which is based on the previously approved 5mg version [1] - The approval notification includes the drug's registration number: Guoyao Zhunzi H20253002 [1]
海正药业:获得药品补充申请批准通知书
Ge Long Hui· 2025-12-23 09:19
Core Viewpoint - The company has received approval from the National Medical Products Administration for a supplemental application for Everolimus tablets, adding a new 2.5mg specification to the already approved 5mg version [1] Group 1: Product Approval - The new 2.5mg specification of Everolimus is intended for adult patients with advanced renal cell carcinoma who have failed previous treatments with Sunitinib or Sorafenib [1] - Everolimus is also indicated for various other conditions, including advanced pancreatic neuroendocrine tumors and tuberous sclerosis complex-related tumors [1] - The original manufacturer of Everolimus is Novartis, and the product has been approved under the new category 4, which is considered equivalent to passing the consistency evaluation [1] Group 2: Market Statistics - The global sales of Everolimus tablets are projected to be approximately $1.013 billion in 2024, with domestic sales around $11.7842 million [2] - For the first half of 2025, global sales are estimated at about $497 million, with domestic sales expected to be around $5.4255 million [2] - The company has invested approximately 7.4042 million RMB in the research and development of the 2.5mg specification of Everolimus [2]
海正药业(600267.SH):获得药品补充申请批准通知书
Ge Long Hui A P P· 2025-12-23 09:17
Core Viewpoint - The company has received approval from the National Medical Products Administration for a supplemental application for Everolimus tablets, adding a new 2.5mg specification to the already approved 5mg version [1] Group 1: Product Approval - The new 2.5mg specification of Everolimus is intended for adult patients with advanced renal cell carcinoma who have failed previous treatments with Sunitinib or Sorafenib [1] - Everolimus is also indicated for various other conditions, including advanced pancreatic neuroendocrine tumors and tuberous sclerosis complex-related tumors [1] - The original manufacturer of Everolimus is Novartis, and the product has been approved under the new category 4, which is considered equivalent to passing the consistency evaluation [1] Group 2: Market Statistics - The global sales of Everolimus tablets are projected to be approximately $1.013 billion in 2024, with domestic sales around $11.7842 million [2] - For the first half of 2025, global sales are estimated at about $497 million, with domestic sales expected to be around $5.4255 million [2] - The company has invested approximately 7.4042 million RMB in the research and development of the 2.5mg specification of Everolimus [2]
海正药业(600267.SH):子公司获得兽药产品批准文号批件
Ge Long Hui A P P· 2025-12-23 09:17
Group 1 - Company Hai Zheng Pharmaceutical (600267.SH) announced that its subsidiaries, Hai Zheng Animal Health and Yunnan Biotech, received approval from the Ministry of Agriculture and Rural Affairs of the People's Republic of China for two veterinary products: doxycycline hydrochloride tablets and a recombinant virus inactivated vaccine for swine fever (WH-09 strain) [1] - Doxycycline hydrochloride tablets are indicated for infections caused by Gram-positive bacteria, Gram-negative bacteria, and mycoplasma. The application for the product approval was submitted on September 13, 2025 [1] - The swine fever vaccine has an immunity period of six months and the application for its approval was submitted on October 30, 2025. Yunnan Biotech is the fourth company in China to receive approval for this vaccine [1] Group 2 - Other major manufacturers of doxycycline hydrochloride tablets include Henan Zhongmu Weifeng Biological Engineering Co., Ltd. and Anhui Kangmu Animal Health Products Co., Ltd. [1] - Other major manufacturers of the swine fever vaccine include Shandong Haili Biological Products Co., Ltd., Wuhan Keqian Biological Co., Ltd., and Anhui Dongfang Diwei Biological Products Co., Ltd. [1] - Currently, the company has not obtained specific sales revenue data for similar products from other companies through public channels [1]
海正药业(600267) - 浙江海正药业股份有限公司关于获得药品补充申请批准通知书的公告
2025-12-23 09:15
证券代码:600267 证券简称:海正药业 公告编号:临 2025-83 号 浙江海正药业股份有限公司 关于获得药品补充申请批准通知书的公告 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、准确性和完整性承担法律责任。 近日,浙江海正药业股份有限公司(以下简称"公司")收到国家药品监督 管理局(以下简称"国家药监局")核准签发的依维莫司片《药品补充申请批准 通知书》。本产品是在公司已获批的依维莫司片(规格:5mg,批准文号:国药 准字 H20253002)基础上,申请新增 2.5mg 规格。现就相关情况公告如下: 剂型:片剂 规格:2.5mg 注册分类:化学药品 原药品批准文号:国药准字 H20253002 药品注册标准编号:YBH34062025 申请内容:增加 2.5mg 规格 受理号:CYHB2500448 一、药品的基本情况 药品名称:依维莫司片 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 此次申请事项符合药品注册的有关要求,批准本品如下申请事项:在原有规格基 础上增加 2.5mg 规格,核发新批准文号。 上市许可持有人、生 ...
海正药业(600267) - 浙江海正药业股份有限公司关于子公司获得兽药产品批准文号批件的公告
2025-12-23 09:15
证券代码:600267 证券简称:海正药业 公告编号:临 2025-82 号 浙江海正药业股份有限公司 关于子公司获得兽药产品批准文号批件的公告 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、准确性和完整性承担法律责任。 近日,浙江海正药业股份有限公司(以下简称"公司")控股子公司浙江海 正动物保健品有限公司(以下简称"海正动保公司")、海正动保公司全资子公司 云南生物制药有限公司(以下简称"云南生物")分别收到中华人民共和国农业 农村部核准签发的盐酸多西环素片、猪瘟病毒 E2 蛋白重组杆状病毒灭活疫苗 (WH-09 株)兽药产品批准文号批件。现就相关情况公告如下: 一、批件基本信息 (一)通用名称:盐酸多西环素片 兽药产品批准文号:兽药字 110802603、兽药字 110801354、兽药字 110801355 批准文号有效期:2025-12-15 至 2030-12-14 生产地址:浙江省杭州市富阳区东洲街道高尔夫路 208 号 (二)通用名称:猪瘟病毒 E2 蛋白重组杆状病毒灭活疫苗(WH-09 株) 兽药产品批准文号:兽药生字 25012115 ...
海正药业:依维莫司片新增2.5mg规格获药品补充申请批准
Xin Lang Cai Jing· 2025-12-23 08:59
Core Viewpoint - The company has received approval from the National Medical Products Administration for a new specification of Everolimus tablets, which will enhance its market competitiveness in the oncology sector [1] Group 1: Product Approval - The company announced the approval of a supplementary application for Everolimus tablets, adding a new 2.5mg specification to the existing 5mg [1] - The new approval number is H20258293, with a validity period until 2030 [1] Group 2: Market Potential - The global sales forecast for Everolimus is approximately $1.013 billion in 2024, with domestic sales expected to be around $11.7842 million [1] - For the first half of 2025, global sales are projected to be about $497 million, with domestic sales around $5.4255 million [1] Group 3: Investment and R&D - The company has invested approximately $7.4042 million in the development of this new specification [1] - The approval is expected to enhance the company's competitive position in the market [1]
浙江海正药业股份有限公司 关于公司HS387片获得美国FDA新药临床试验批准通知的公告
Zhong Guo Zheng Quan Bao - Zhong Zheng Wang· 2025-12-23 06:43
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。 HS387片是一款由公司自主研发的选择性KIF18A抑制剂,拟用于高级别浆液性卵巢癌、非小细胞肺癌 等晚期实体瘤治疗。该药品已经获得国家药品监督管理局颁发的《药物临床试验批准通知书》,详见公 司于2025年7月2日披露的《关于获得药物临床试验批准通知书的公告》(公告编号:临2025-37号)。 2025年11月,公司完成向美国FDA递交HS387片的临床试验申请,并于近日获得FDA批准。截至目前, 国内外有多款KIF18A抑制剂进入临床研发阶段,目前尚无药物上市。 近日,浙江海正药业股份有限公司(以下简称"公司")收到美国食品药品监督管理局(以下简称"美国 FDA")的通知,由公司申报的HS387片药品临床试验申请已获得美国FDA批准,可以在美国开展临床 试验。现就相关情况公告如下: 一、药品基本情况 药品名称:HS387片 IND编号:IND 178632 申请事项:新药临床试验申请 申请人:浙江海正药业股份有限公司 二、该药品研发及相关情况 董事会 二○二五年十二月二十三日 ...