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天宇股份:阿帕他胺原料药通过CDE审评
Zhi Tong Cai Jing· 2026-01-07 08:08
Core Viewpoint - Tianyu Co., Ltd. announced that its wholly-owned subsidiary, Zhejiang Jingsheng Pharmaceutical Co., Ltd., has recently passed the review by the National Medical Products Administration's Center for Drug Evaluation (CDE) for the active pharmaceutical ingredient (API) Apalutamide, which is used in the treatment of prostate cancer [1] Group 1 - Apalutamide is a non-steroidal anti-androgen drug that works by inhibiting the androgen receptor signaling pathway to slow disease progression [1] - The drug is primarily indicated for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC) [1] - Apalutamide is intended to be used in combination with androgen deprivation therapy under the guidance of a physician [1]
天宇股份(300702.SZ):阿帕他胺原料药通过CDE审评
智通财经网· 2026-01-07 08:04
Group 1 - The core point of the article is that Tianyu Co., Ltd. announced that its wholly-owned subsidiary, Zhejiang Jingsheng Pharmaceutical Co., Ltd., has recently passed the review by the National Medical Products Administration's Center for Drug Evaluation (CDE) for the active pharmaceutical ingredient Apalutamide [1] - Apalutamide is a non-steroidal anti-androgen drug used for the treatment of prostate cancer, functioning by inhibiting the androgen receptor signaling pathway to delay disease progression [1] - The drug is primarily indicated for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC), and it is to be used in conjunction with castration therapy under medical guidance [1]
天宇股份:子公司阿帕他胺原料药通过CDE审评
Core Viewpoint - Tianyu Co., Ltd. announced that its wholly-owned subsidiary, Jingsheng Pharmaceutical, has recently passed the review by the National Medical Products Administration (NMPA) for the active pharmaceutical ingredient (API) Apalutamide, which is used in the treatment of prostate cancer [1] Group 1: Product Information - Apalutamide is a non-steroidal anti-androgen drug that works by inhibiting the androgen receptor signaling pathway to slow disease progression [1] - The drug is primarily indicated for non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC) [1] - Apalutamide is intended to be used in conjunction with androgen deprivation therapy under the guidance of a physician [1]
天宇股份:全资子公司阿帕他胺原料药通过CDE审评
Xin Lang Cai Jing· 2026-01-07 07:53
Core Viewpoint - Tianyu Co., Ltd. announced that its wholly-owned subsidiary, Jingsheng Pharmaceutical, has recently passed the CDE review for the active pharmaceutical ingredient (API) Apalutamide, which is used for the treatment of prostate cancer [1] Group 1: Regulatory Approval - The API Apalutamide has a packaging specification of 25 kg per barrel and is registered under the number Y20240000773 [1] - The company submitted the registration application in 2024, which has been accepted [1] - The API must obtain a "compliant" public notice from the Zhejiang Provincial Drug Administration for GMP conformity inspection before it can be marketed domestically [1] Group 2: Market Competition - As of the announcement date, there are 10 other manufacturers in China that have passed the technical review for the same API [1] - Jingsheng Pharmaceutical is currently preparing to apply for the GMP conformity inspection, indicating that the timeline for market entry remains uncertain [1]
天宇股份(300702) - 关于全资子公司原料药通过CDE审评的公告
2026-01-07 07:45
证券代码:300702 证券简称:天宇股份 公告编号:2026-002 浙江天宇药业股份有限公司 关于全资子公司原料药通过 CDE 审评的公告 登记号:Y20240000773 化学原料药注册标准编号:YBY74092025 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。质量标准、标签及生产工艺照所附执行。 生产企业:浙江京圣药业有限公司 二、药品的其他相关情况 本公司董事会及全体董事保证本公告内容不存在虚假记载、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个别及连带责任。 浙江天宇药业股份有限公司(以下简称"公司")全资子公司浙江京圣药业 有限公司(以下简称"京圣药业")阿帕他胺原料药于近日通过国家药品监督管 理局药品审评中心(以下简称"CDE")审评。现将相关情况公告如下: 一、药品基本情况 化学原料药名称:阿帕他胺 包装规格:25Kg/桶 阿帕他胺是一种用于治疗前列腺癌的非甾体类抗雄激素药物,通过抑制雄激 素受体信号通路发挥作用,延缓疾病进展。它主要用于非转移性去势抵抗性前列 腺癌(nmCRPC)和转移性去势敏感性前列腺癌(mC ...
天宇股份(300702) - 关于变更签字注册会计师的公告
2026-01-06 08:00
证券代码:300702 证券简称:天宇股份 公告编号:2026-001 浙江天宇药业股份有限公司 关于变更签字注册会计师的公告 本公司董事会及全体董事保证本公告内容不存在虚假记载、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个别及连带责任。 浙江天宇药业股份有限公司(以下简称"公司")于 2025 年 4 月 17 日召开 第五届董事会第十二次会议、第五届监事会第十次会议,审议通过了《关于续聘 2025 年度审计机构的议案》,同意续聘天健会计师事务所(特殊普通合伙)(以 下简称"天健事务所")担任公司 2025 年度审计机构。公司于 2025 年 5 月 12 日召开 2024 年度股东大会,审议通过上述议案。具体内容详见公司于 2025 年 4 月 18 日在巨潮资讯网(http://www.cninfo.com.cn)披露的《关于续聘 2025 年度 审计机构的公告》(公告编号:2025-022)。 三、本次变更对公司的影响 近日,公司收到天健事务所出具的《关于变更签字注册会计师的函》,现将 具体情况公告如下: 一、本次变更签字注册会计师的基本情况 天健事务所作为公司2025年度财务报 ...
天宇股份(300702) - 浙江天宇药业股份有限公司章程
2025-12-23 08:46
浙江天宇药业股份有限公司 第四章 股东和股东会 第五章 董事和董事会 第六章 高级管理人员 第七章 财务会计制度、利润分配和审计 第八章 通知和公告 章程 二〇二五年十一月 目 录 第三章 股 份 第九章 合并、分立、增资、减资、解散和清算 第一节 合并、分立、增资和减资 第二节 解散和清算 第十章 修改章程 第十一章 附 则 1 第一章 总 则 第二章 经营宗旨和范围 第一节 股份发行 第二节 股份增减和回购 第三节 股份转让 第一节 股东的一般规定 第二节 控股股东和实际控制人 第三节 股东会的一般规定 第四节 股东会的召集 第五节 股东会的提案与通知 第六节 股东会的召开 第七节 股东会的表决和决议 第一节 董事的一般规定 第二节 董事会 第三节 独立董事 第四节 董事会专门委员会 第一节 财务会计制度 第二节 内部审计 第三节 会计师事务所的聘任 第一节 通 知 第二节 公 告 浙江天宇药业股份有限公司 章 程 第一章 总 则 第一条 为维护公司、股东、职工和债权人的合法权益,规范公司的组织和行 为,根据《中华人民共和国公司法》(以下简称《公司法》)、《中华人民共和 国证券法》(以下简称《证券法》)和 ...
天宇股份(300702) - 关于完成《公司章程》备案的公告
2025-12-23 08:45
证券代码:300702 证券简称:天宇股份 公告编号:2025-086 浙江天宇药业股份有限公司 关于完成《公司章程》备案的公告 浙江天宇药业股份有限公司(以下简称"公司")于 2025 年 10 月 29 日召 开第五届董事会第十六次会议、第五届监事会第十四次会议,于 2025 年 11 月 18 日召开 2025 年第三次临时股东大会,审议通过了《关于修订〈公司章程〉的 议案》。具体内容详见公司于 2025 年 10 月 30 日披露的《关于修订〈公司章程〉、 修订及制定公司部分管理制度的公告》(公告编号:2025-076)。 公司于近日完成上述事项的工商备案手续,根据浙江省市场监督管理局的要 求,公司调整了章程中个别条款的措辞(不涉及实质内容的变更),具体情况如 下: | 修改前 | 修改后 | | --- | --- | | 第一百〇九条 公司设董事会,董事会由七 | 第一百〇九条 公司设董事会,董事会由八 | | 至九名董事组成,其中独立董事三名,职工 | 名董事组成,其中独立董事三名,职工董事 | | 董事一名。董事会设董事长一名。董事长由董 | 一名。董事会设董事长一名。董事长由董事 | | 事 ...
12月22日晚间重要公告一览
Xi Niu Cai Jing· 2025-12-22 10:37
Group 1 - Rongchang Biotech plans to repurchase shares worth between 20 million and 40 million yuan, with a maximum price of 95 yuan per share, aiming to buy back approximately 21,050 to 42,110 shares, representing about 0.04% to 0.07% of total share capital [1] - Nanya New Materials intends to raise no more than 900 million yuan through a private placement for AI computing power-based high-frequency high-speed copper-clad laminate R&D and working capital [2] - Xiechuang Data has signed a strategic cooperation agreement with Ping An Financial Leasing, aiming for a cooperation scale of 2 billion yuan over three years [3] Group 2 - Chuangshi Technology's controlling shareholder is under investigation and has been placed under detention, having resigned from all positions in the company [4] - Deep Kangjia A has reported overdue shareholder loans to Yikang Technology and Chuzhou Kangxin, totaling approximately 233 million yuan and 395 million yuan respectively, due to repayment issues [5] - Ningbo Yuanyang announced the resignation of two directors due to work adjustments [6] Group 3 - China Merchants Energy has delivered the world's first methanol dual-fuel VLCC oil tanker, with 15 oil tanker orders in hand [7] - Tianyu Co., Ltd. has received a drug registration certificate for hydrochloride trazodone tablets, which are used for treating depression [8] - Haizheng Pharmaceutical has received FDA approval for clinical trials of HS387 tablets for treating advanced solid tumors [9] Group 4 - Warner Pharmaceuticals has obtained a drug registration certificate for isoproterenol hydrochloride injection, used for treating shock and complete atrioventricular block [10] - Hekang New Energy's subsidiary received a government subsidy of 1.5 million yuan, which accounts for 14.57% of the company's latest audited net profit [11] - Duku Culture is planning a change in company control, with stock suspension expected for no more than two trading days [12] Group 5 - Haisco has received acceptance for an IND application for HSK46575 tablets for prostate cancer treatment [13] - *ST Xinyan is executing a capital reserve transfer to increase share capital, resulting in a stock suspension [14] - Nanjing Public Utilities is transferring a 45% stake in a subsidiary for 23.6443 million yuan [15] Group 6 - Action Education plans to repurchase shares worth between 20 million and 25 million yuan, with a maximum price of 45 yuan per share [16] - Bai'ao Tai has received government subsidies totaling 29 million yuan [18] - Weisi Medical intends to sell assets worth 119 million yuan, expecting a profit impact of approximately 10 million yuan [19] Group 7 - Tongyu Communications plans to increase capital by 10 million yuan to introduce investment from Wuchuang Institute [20] - Dongtu Technology's subsidiary is introducing strategic investor Guofeng Investment Fund with a capital increase of 11 million yuan [21] - China General Nuclear Power Technology's shareholder is facing a judicial auction of 2.91% of the company's shares [22] Group 8 - Nanshan Aluminum plans to repurchase shares worth between 300 million and 600 million yuan, with a maximum price of 7.52 yuan per share [23] - Yipin Hong's controlling shareholder has committed to transferring 9.07% equity in Arthrosi without compensation [24] - Sanli Pharmaceutical has signed a technology transfer contract worth 200 million yuan with Hainan University [25] Group 9 - Xin Nuo Wei plans to jointly invest 450 million yuan with Zhongqi Pharmaceutical to establish a joint venture focusing on innovative metabolic drugs [26] - Li Qun Co. has been approved to issue 1 billion yuan in medium-term notes to optimize debt structure and supplement working capital [27] - Dongfang Ocean's subsidiary has received a medical device registration certificate for a procalcitonin test kit [28] Group 10 - Tibet Mining's chairman has resigned due to work adjustments [29] - Wantai Biological's subsidiary has been shortlisted for a national immunization program vaccine procurement project, with a bid price of 27.5 yuan [30] - Xingfu Blue Sea has appointed Zhang Chen as the new deputy general manager [31] Group 11 - Changyuan Donggu has elected Li Yixuan as the vice chairman of the board [32] - Ningbo Huaxiang's subsidiary has signed a strategic cooperation agreement with Dahuang Robotics for collaboration in humanoid robot development [33] - Yongda Co. has been pre-selected for a procurement project worth approximately 350 million yuan [34] Group 12 - Fuan Pharmaceutical's subsidiary has received a drug registration certificate for hydrochloride trazodone tablets [35] - Nanjing Food reported a 71.03% year-on-year decrease in net profit for November due to rising raw material costs [36] - Changqing Technology's special polymer monomer project has commenced production [37]
天宇股份盐酸曲唑酮片获药品注册证书
Bei Jing Shang Bao· 2025-12-22 10:15
Core Viewpoint - Tianyu Co., Ltd. announced that its wholly-owned subsidiary, Zhejiang Nuode Pharmaceutical Co., Ltd., has received the drug registration certificate for Clomipramine Hydrochloride Tablets from the National Medical Products Administration, valid until December 15, 2030, indicating a significant advancement in its product portfolio for treating depression [1] Group 1 - The drug is indicated for the treatment of depression, effective for patients with or without anxiety [1]