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健讯Daily|《医疗器械管理法》立法调研在京开展;翰森ADC药物卖给罗氏
Policy Developments - The State Administration for Market Regulation and the National Medical Products Administration conducted legislative research on the Medical Device Management Law, emphasizing the importance of scientific, democratic, and legal legislation to enhance the quality of laws and promote implementation [2] Drug and Device Approvals - East China Pharmaceutical's subsidiary received a drug registration certificate for Remabizine injection, which is used in conjunction with MediBeacon's device to assess patients' kidney function [4] - Kelun Pharmaceutical's subsidiary obtained approval for its targeted antibody-drug conjugate, Boduocizumab, for treating HER2-positive breast cancer patients who have received prior anti-HER2 therapies, showing significant improvement in progression-free survival [5] Financial Reports - Wowo Pharmaceutical reported a net profit increase of 179.34% year-on-year for the first three quarters, with revenues of 625 million yuan [7] - Pianzaihuang's third-quarter net profit decreased by 28.82% year-on-year, attributed to reduced sales in the pharmaceutical manufacturing sector and declining gross margins [8] Capital Market Activities - Weigao Blood Products is planning to acquire 100% of Shandong Weigao Purui Pharmaceutical Packaging Co., leading to a stock suspension for up to 10 trading days [11] - Hansoh Pharmaceutical entered a licensing agreement with Roche, potentially earning up to $1.45 billion in milestone payments for the development of HS-20110, a targeted antibody-drug conjugate for colorectal cancer [12][13] - Maipu Medical plans to acquire 100% of Guangzhou Yijie Medical Technology for 335 million yuan and raise additional funds [15] Industry Developments - Sanofi announced the launch of its insulin raw material project in Beijing, with a total investment of 1 billion euros, expected to be completed by 2032 [18]
《医疗器械管理法》立法调研在京开展;翰森ADC药物卖给罗氏
Policy Developments - The State Administration for Market Regulation and the National Medical Products Administration conducted legislative research on the draft Medical Device Management Law, emphasizing the importance of scientific, democratic, and legal legislation to enhance the quality of laws and promote implementation [1] Drug and Device Approvals - East China Pharmaceutical's subsidiary received a drug registration certificate for Remabizine injection, which is used in conjunction with MediBeacon's device to assess patients' glomerular filtration rate [2] - Kelun Pharmaceutical's subsidiary obtained approval for its ADC product, Botuzumab, for treating HER2-positive breast cancer, showing significant improvement in progression-free survival compared to T-DM1 [3] Financial Reports - WoHua Pharmaceutical reported a net profit increase of 179.34% year-on-year for the first three quarters, with revenue of 625 million yuan [4] - Pianzihuang's third-quarter net profit decreased by 28.82%, with revenue down 26.28% year-on-year, attributed to reduced sales in the pharmaceutical manufacturing sector [5] Capital Market Activities - Weigao Blood Products is planning to acquire 100% of Shandong Weigao Puri Pharmaceutical Packaging Co., leading to a stock suspension for up to 10 trading days [7] - Hansoh Pharmaceutical entered a licensing agreement with Roche, potentially earning up to $1.45 billion in milestone payments for the development of HS-20110, a targeted ADC for colorectal cancer [8] Industry Developments - Sanofi announced the launch of its insulin raw material project in Beijing, with a total investment of 1 billion euros, expected to be completed by 2032 [12]
ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司关于董事会换届完成并聘任高级管理人员及证券事务代表的公告
2025-10-17 13:45
证券代码:605199 证券简称:ST 葫芦娃 公告编号:2025-078 海南葫芦娃药业集团股份有限公司 关于董事会换届完成并聘任高级管理人员及 证券事务代表的公告 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。 海南葫芦娃药业集团股份有限公司(以下简称"公司")于 2025 年 10 月 17 日召开 2025 年第二次临时股东大会,会议选举产生了公司 3 名非独立董事和 3 名独立董事,并与 2025 年 10 月 15 日召开的职工代表大会选举产生的 1 名职工 代表董事共同组成公司第五届董事会。在完成董事会换届选举后,公司于同日召 开了第四届董事会 2025 年第一次临时会议,选举产生了董事长、各专门委员会, 并聘任第四届高级管理人员及证券事务代表。现将相关情况公告如下: 一、公司第四届董事会组成情况 1、战略与 ESG 委员会 主任委员:刘景萍 委员:林慧、王清涛 2、审计委员会 主任委员:刘秋云 委员:王世贤、汤琪波 3、提名委员会 以上任期从公司 2025 年第二次临时股东大会审议通过之日起三年。 二、高级管理 ...
ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司关于拟与关联方签署技术合作开发合同暨关联交易的公告
2025-10-17 13:45
海南葫芦娃药业集团股份有限公司 重要内容提示: 证券代码:605199 证券简称:ST 葫芦娃 公告编号:2025-079 关于拟与关联方签署技术合作开发合同暨关联交易的公告 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。 ● 交易简要内容:海南葫芦娃药业集团股份有限公司(以下简称"公司")拟与 杭州康领先医药科技有限公司(以下简称"康领先")签署两个项目的《技术合作开发 合同》(以下简称"本项目"或"项目"),共同开发"昂丹司琼口溶膜"、"依达拉 奉右莰醇注射用浓溶液"项目,合同金额预估分别为 910 万元和 215 万元,共计 1,125 万元。 ● 本次交易构成关联交易,未构成重大资产重组。 ● 本次关联交易已经公司第四届董事会 2025 年第一次临时会议审议通过,并已经 独立董事专门会议事先审议通过,无需提交股东大会审议。 (二)关联人基本情况 ● 至本次关联交易为止,过去12个月内公司与同一关联人康领先发生的关联交易 累计0次,累计金额0万元,与不同关联人之间未发生交易类别相关的关联交易。 ● 鉴于药物研发周期较长, ...
ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司2025年第二次临时股东大会决议公告
2025-10-17 13:45
证券代码:605199 证券简称:ST 葫芦娃 公告编号:2025-076 海南葫芦娃药业集团股份有限公司 2025年第二次临时股东大会决议公告 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: 本次会议是否有否决议案:无 一、 会议召开和出席情况 (一)股东大会召开的时间:2025 年 10 月 17 日 (二)股东大会召开的地点:海南省海口市秀英区安读一路 30 号公司会议室 (三)出席会议的普通股股东和恢复表决权的优先股股东及其持有股份情况: | 1、出席会议的股东和代理人人数 | 233 | | --- | --- | | 2、出席会议的股东所持有表决权的股份总数(股) | 303,558,250 | | 3、出席会议的股东所持有表决权股份数占公司有表决权股 | | | 份总数的比例(%) | 75.8689 | 1、公司在任董事7人,列席7人,其中独立董事列席 3 人; 2、公司在任监事3人,列席3人; 3、董事会秘书王清涛先生列席本次会议;公司全体高级管理人员列席会议。 二、 议案审议情况 (一)非累 ...
ST葫芦娃(605199) - 海南葫芦娃药业集团股份有限公司第四届董事会2025年第一次临时会议决议公告
2025-10-17 13:45
证券代码:605199 证券简称:ST 葫芦娃 公告编号:2025-077 海南葫芦娃药业集团股份有限公司 第四届董事会 2025 年第一次临时会议决议公告 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、董事会会议召开情况 (一)海南葫芦娃药业集团股份有限公司(以下简称"公司")第四届董事会 2025 年第一次临时会议的召开符合《公司法》《公司章程》和《董事会议事规则》的有关规 定,会议合法有效。 (二)会议通知于 2025 年 10 月 17 日以口头方式发出,全体董事同意豁免提前 3 日发出会议通知的期限。 (三)会议于 2025 年 10 月 17 日在海南省海口市秀英区安读一路 30 号公司会议室 以现场方式召开。 (四)公司董事会会议应出席董事 7 人,实际出席董事 7 人。 (五)本次董事会会议由董事长刘景萍女士主持,公司全体高级管理人员列席会议。 二、董事会会议审议情况 (一)审议通过了《关于选举第四届董事会董事长的议案》 同意选举刘景萍女士为公司第四届董事会董事长,任期自本次董事会审议通过之日 起至本届董 ...
ST葫芦娃(605199.SH):拟与关联方签署技术合作开发合同
Ge Long Hui A P P· 2025-10-17 13:39
Core Viewpoint - ST HuLuWa (605199.SH) aims to enhance its core competitiveness and accelerate drug development by integrating R&D resources and sharing R&D risks through a technical cooperation agreement with related parties [1] Group 1: Company Actions - The company held a special meeting of independent directors and an extraordinary board meeting on October 17, 2025, to approve the proposal for signing a technical cooperation development contract [1] - The expected total R&D cost for the projects "Ondansetron Oral Soluble Film" and "Ibutamoren Right-Arm Injection Concentrate Solution" is budgeted to not exceed 11.25 million yuan [1] - Following board approval, the company will sign a technical cooperation development contract with Kang Lianxian to jointly develop the aforementioned projects [1]
ST葫芦娃(605199) - 北京国枫律师事务所关于海南葫芦娃药业集团股份有限公司2025年第二次临时股东大会的法律意见书
2025-10-17 13:30
北京市在城区建国门内大街26号新闻大厦7层、8层 邮编:100005 电话: 010-88004488/66090088 传真:010-66090016 北京国枫律师事务所 关于海南葫芦娃药业集团股份有限公司 2025 年第二次临时股东大会的 法律意见书 国枫律股字[2025]A0507 号 致: 海南葫芦娃药业集团股份有限公司 (贵公司) 北京国枫律师事务所(以下简称"本所")接受贵公司的委托,指派律师出席并见 证贵公司2025年第二次临时股东大会(以下简称"本次会议")。 本所律师根据《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》")、《上市公司股东会规则》(以下简称 "《股东会规则》")、《律师事务所从事证券法律业务管理办法》(以下简称"《证 券法律业务管理办法》")、《律师事务所证券法律业务执业规则(试行)》(以下简 称"《证券法律业务执业规则》")等相关法律、行政法规、规章、规范性文件及《海 南葫芦娃药业集团股份有限公司章程》(以下简称"《公司章程》")的规定,就本次 会议的召集与召开程序、召集人资格、出席会议人员资格、会议表决程序及表决结果等 ...
ST葫芦娃:拟与关联方签署技术合作开发合同
Core Viewpoint - ST Huluwawa (605199) announced on October 17 that it plans to sign two technology cooperation development contracts with its affiliate Hangzhou Kanglixian Pharmaceutical Technology Co., Ltd. to jointly develop "Ondansetron Oral Soluble Film" and "Ibandronate Sodium Injection Concentrate Solution" projects, with a total estimated contract amount of 11.25 million yuan [1] Group 1 - The company intends to collaborate on two specific pharmaceutical projects [1] - The estimated contract amounts for the projects are 9.1 million yuan and 2.15 million yuan respectively [1] - The total estimated contract value for both projects is 11.25 million yuan [1]
海南自贸区概念涨2.58% 主力资金净流入这些股
Group 1 - The Hainan Free Trade Zone concept rose by 2.58%, ranking first among concept sectors, with 22 stocks increasing, including Haixia Co., Haima Automobile, and ST Huawen hitting the daily limit [1][2] - Notable gainers included Haikou Group, Hainan Haiyao, and Kangzhi Pharmaceutical, which rose by 6.38%, 6.14%, and 5.69% respectively [1] - The stocks with the largest declines were Hainan Huatie, Junda Co., and *ST Shuangcheng, which fell by 1.30%, 1.23%, and 1.06% respectively [1] Group 2 - The Hainan Free Trade Zone concept saw a net inflow of 358 million yuan from main funds, with 18 stocks receiving net inflows, and 6 stocks exceeding 50 million yuan [2] - The top net inflow stock was Haixia Co., with a net inflow of 108 million yuan, followed by HNA Holding, Hainan Development, and Haide Co. with net inflows of 89.09 million yuan, 82.73 million yuan, and 64.19 million yuan respectively [2][3] - The highest net inflow ratios were seen in Haide Co., ST Huawen, and Hainan Haiyao, with ratios of 14.30%, 13.37%, and 12.49% respectively [3] Group 3 - The top stocks in the Hainan Free Trade Zone concept included Haixia Co. with a daily increase of 10.03% and a turnover rate of 6.55%, followed by HNA Holding with a 1.80% increase and a turnover rate of 2.30% [3][4] - Other notable performers included Hainan Development with a 2.99% increase and a turnover rate of 8.46%, and Haikou Group with a 6.38% increase and a turnover rate of 7.54% [4] - Stocks such as Hainan Huatie and Junda Co. experienced declines of 1.30% and 1.23% respectively, with negative main fund flows [4]