Workflow
Shanghai Pharma(02607)
icon
Search documents
上海医药(02607.HK):B019新适应症获得临床试验批准通知书
Ge Long Hui· 2025-07-29 08:54
Core Viewpoint - Shanghai Pharmaceuticals (02607.HK) has received approval from the National Medical Products Administration (NMPA) for clinical trials of its self-developed B019 injection, targeting refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 injection is a chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD22, designed for treating refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual-synonymous vector to express two independent CARs on T-cells, allowing for simultaneous binding to CD19 or CD22 proteins on B lymphocytes without interference [1] - The clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma were approved by NMPA in October 2023 and December 2024, respectively [1] Group 2: Financial Investment - The project has incurred approximately RMB 149,000 in research and development expenses for the new indication as of the date of the announcement [1]
上海医药(02607) - 海外监管公告
2025-07-29 08:49
香港交易及結算所有限公司和香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Holding Co., Ltd. * (於中華人民共和國註冊成立的股份有限公司) (股份代碼:02607) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而作出。 茲載列上海醫藥集團股份有限公司(「本公司」)在上海證券交易所網站(http://www.sse.com.cn) 刊登的《上海醫藥集團股份有限公司關於 B019 新適應症獲得臨床試驗批准通知書的公告》 僅供參閱。 承董事會命 上海醫藥集團股份有限公司 楊秋華 董事長 中國上海,2025 年 7 月 30 日 於本公告日期,本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明 先生;非執行董事為張文學先生;以及獨立非執行董事為顧朝陽先生、霍文遜先 生、王忠先生及萬鈞女士。 * 僅供識別 一、该项目基本信息 药物 ...
上海医药(601607.SH):B019新适应症获得临床试验批准
智通财经网· 2025-07-29 08:30
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., has received approval from the National Medical Products Administration (NMPA) to conduct clinical trials for its self-developed B019 injection, targeting refractory systemic lupus erythematosus [1] Group 1 - B019 injection is a chimeric antigen receptor (CAR) T-cell therapy targeting CD19 and CD22, designed for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual-synonymous vector to express two independent CARs on T-cells, allowing for simultaneous binding to CD19 or CD22 proteins on B lymphocytes without interference [1] - Clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma were approved by the NMPA in October 2023 and December 2024, respectively [1]
上海医药(601607) - 上海医药集团股份有限公司关于B019新适应症获得临床试验批准通知书的公告
2025-07-29 08:15
证券代码:601607 证券简称:上海医药 编号:临2025-076 上海医药集团股份有限公司 关于 B019 新适应症获得临床试验批准通知书的公告 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个别及连带责任。 二、该项目研发及注册情况 B019 注射液是靶向 CD19 和 CD22 的嵌合抗原受体自体 T 细胞注射液,拟用 于治疗难治性系统性红斑狼疮。B019 的嵌合抗原受体结构采用一个双顺反子载 体结构,可以在 T 细胞上表达两个独立的嵌合抗原受体,在互不影响的情况下分 别结合 B 淋巴细胞表面表达的 CD19 或 CD22 蛋白,以发挥治疗作用。B019 注射 1 液用于治疗复发或难治性急性 B 淋巴细胞白血病、复发或难治性 B 细胞非霍奇金 淋巴瘤这两个适应症的临床试验申请已分别于 2023 年 10 月、2024 年 12 月获得 国家药监局批准。 该项目由上药生物治疗自主研发,并拥有完全知识产权。截至本公告披露日, 在前 2 个适应症的基础上,该项目在新适应症已累计投入研发费用约 14.90 万元 人民币。 近日,上海医药 ...
上海医药:B019新适应症获得临床试验批准
news flash· 2025-07-29 07:59
Core Viewpoint - Shanghai Pharmaceuticals announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., has received approval from the National Medical Products Administration for clinical trials of its self-developed drug "B019" for the treatment of refractory systemic lupus erythematosus [1] Group 1 - B019 injection is a chimeric antigen receptor T-cell injection targeting CD19 and CD22, aimed at treating refractory systemic lupus erythematosus [1] - The project has accumulated research and development expenses of approximately 149,000 RMB for this new indication [1]
上海医药(02607) - 海外监管公告
2025-07-28 10:05
香港交易及結算所有限公司和香港聯合交易所有限公司對本公告的內容概不負責,對其準確性 或完整性亦不發表任何聲明,並明確表示,概不對因本公告全部或任何部分內容而產生或因依賴 該等內容而引致的任何損失承擔任何責任。 上 海 醫 藥 集 團 股 份 有 限 公 司 Shanghai Pharmaceuticals Holding Co., Ltd. * 证券代码:601607 证券简称:上海医药 编号:临 2025-075 (於中華人民共和國註冊成立的股份有限公司) (股份代碼:02607) 海外監管公告 本公告乃根據香港聯合交易所有限公司證券上市規則第 13.10B 條而作出。 茲載列上海醫藥集團股份有限公司(「本公司」)在上海證券交易所網站(http://www.sse.com.cn) 刊登的《上海醫藥集團股份有限公司關於硫酸沙丁胺醇注射液通過仿製藥一致性評價的公 告》僅供參閱。 承董事會命 上海醫藥集團股份有限公司 楊秋華 董事長 中國上海,2025 年 7 月 29 日 於本公告日期,本公司的執行董事為楊秋華先生、沈波先生、李永忠先生及董明 先生;非執行董事為張文學先生;以及獨立非執行董事為顧朝陽先生、霍文遜 ...
上海医药(601607) - 上海医药集团股份有限公司关于硫酸沙丁胺醇注射液通过仿制药一致性评价的公告
2025-07-28 09:15
关于硫酸沙丁胺醇注射液通过仿制药一致性评价的公告 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个别及连带责任。 近日,上海医药集团股份有限公司(以下简称"公司")下属上海禾丰制药 有限公司(以下简称"上药禾丰")的硫酸沙丁胺醇注射液(以下简称"该药品") 收到国家药品监督管理局(以下简称"国家药监局")颁发的《药品补充申请批 准通知书》(通知书编号:2025B03280),该药品通过仿制药质量和疗效一致 性评价。 一、该药品基本情况 药品名称:硫酸沙丁胺醇注射液 剂型:注射剂 规格:1ml:0.5mg(按 C13H21NO3计) 注册分类:化学药品 申请人:上海禾丰制药有限公司 药品批准文号:国药准字 H20258131 审批结论:本品通过仿制药质量和疗效一致性评价。 证券代码:601607 证券简称:上海医药 编号:临 2025-075 上海医药集团股份有限公司 二、该药品相关的信息 硫酸沙丁胺醇注射液主要用于治疗支气管哮喘或喘息型支气管炎等伴有支 气管痉挛的呼吸道疾病。2024 年 2 月,上药禾丰就该药品新增规格合并仿制药 一致 ...
16家A股上市公司本周披露并购重组最新公告 汇绿生态拟购买武汉钧恒49%股权并于明日复牌
news flash· 2025-07-27 11:21
Core Viewpoint - A total of 16 A-share listed companies disclosed their latest merger and acquisition announcements during the week of July 21 to July 27, with notable transactions including Huylin Ecological's plan to acquire a 49% stake in Wuhan Junheng, and the resumption of trading for its stock on July 28 [1][3]. Group 1: Company Announcements - Huylin Ecological announced on July 25 its intention to purchase a 49% stake in Wuhan Junheng, with its stock set to resume trading on July 28 [3]. - Western Gold announced on July 25 its plan to acquire 100% of Xinjiang Meisheng for 1.655 billion yuan [3]. - Guochuang High-tech announced on July 25 its plan to acquire 100% of Ningbo Guopei for 22.5 million yuan [3]. - Shanghai Pharmaceuticals announced on July 25 its intention to acquire a 10% stake in a financial company held by Shashi Dongtan [3]. - Heng Rui Medicine announced on July 25 its plan to acquire a 1.4587% stake in Chengdu Shengdi Medicine for 4.0144 million yuan [3]. - Yuanli Co. announced on July 24 its intention to purchase 100% of Tongsheng Co., with its stock set to resume trading [3]. - Angel Yeast announced on July 24 its plan to acquire a 55% stake in Zuitong Sugar Industry for 506 million yuan [3]. - Jinlong Co. announced on July 23 its intention to acquire a 29.32% stake in Zhisuang Company [3]. - Huayu Mining announced on July 23 its plan to acquire an 11% stake in Asia Pacific Mining for 300 million yuan [3]. - Titan Technology announced on July 23 its intention to acquire 100% of ASL for approximately 55.85 million yuan [3]. - GoerTek announced on July 22 its plan to acquire Mia Precision Technology Co. and Changhong Industrial Co. for approximately 10.4 billion Hong Kong dollars [3]. - Geer Software announced on July 22 its intention to acquire more than 51% of Weipin Zhiyuan, which owns an intelligent orchestration platform [3]. - Tianrun Industrial announced on July 22 its plan to acquire 100% of Shandong Altai for 13.5 million yuan [3]. - Hanyi Co. announced on July 22 its intention to acquire a 39% stake in Shanghai Pidong Cultural Media for 10.2 million yuan [3]. - ST Xifa announced on July 21 its plan to cash purchase a 50% stake in Lhasa Beer held by Carlsberg, which is expected to constitute a major asset restructuring [3]. - Beiding Co. announced on July 21 its intention to acquire 100% of Zhongshan Kairui for 156 million yuan [3].
上海医药: 上海医药集团股份有限公司关于收购上海上实集团财务有限公司10%股权暨关联/连交易的公告
Zheng Quan Zhi Xing· 2025-07-25 16:25
Core Viewpoint - Shanghai Pharmaceuticals plans to acquire a 10% stake in Shanghai Shihua Group Financial Co., Ltd. for approximately RMB 143 million, increasing its ownership from 30% to 40% without changing the consolidation scope of the financial statements [1][2]. Group 1: Transaction Overview - The acquisition will be funded by the company's own capital and is classified as a related party transaction, but it does not constitute a major asset restructuring [2][6]. - The financial company has shown steady growth since its establishment in 2014, with cumulative cash dividends of approximately RMB 230 million since 2016 [2][16]. - The transaction is expected to enhance the company's control over significant decisions of the financial company and provide stable investment returns [2][16]. Group 2: Financial Information of the Target - The financial company has total assets of approximately RMB 1.17 billion and total liabilities of about RMB 1.03 billion, resulting in net assets of approximately RMB 143 million [8][9]. - The financial company reported operating income of approximately RMB 13 million and net profit of about RMB 6 million [8][9]. Group 3: Valuation and Pricing - The transaction price will be based on an evaluation report from a qualified asset appraisal agency, with the assessed value of the 10% stake being approximately RMB 143 million [9][11]. - The valuation methods used include the asset-based approach and market approach, with the asset-based approach being deemed more reflective of the company's market value [9][10]. Group 4: Approval and Compliance - The transaction requires internal approvals and regulatory filings, including approvals from state-owned asset supervision and financial regulatory authorities [12][15]. - The board of directors has approved the transaction, with related party director Yang Qiuhua abstaining from the vote [16].
上海医药: 上海医药集团股份有限公司第八届董事会第二十三次会议决议公告
Zheng Quan Zhi Xing· 2025-07-25 16:25
证券代码:601607 证券简称:上海医药 公告编号:临2025-073 上海医药集团股份有限公司 第八届董事会第二十三次会议决议公告 详见本公司公告临 2025-072 号。 本议案已经过公司第八届董事会独立董事专门会议第九次会议审议通过,同 意提交董事会审议。 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个别及连带责任。 上海医药集团股份有限公司(以下简称"本公司")第八届董事会第二十三 次会议(以下简称"本次会议")于 2025 年 7 月 25 日以通讯方式召开。本次会 议应到董事 9 名,实到董事 9 名,符合《中华人民共和国公司法》和本公司章程 关于董事会召开法定人数的规定。本次会议审议并通过了以下议案: 关联/连董事杨秋华先生主动回避该议案的表决,八位非关联/连董事全部投 票同意。 表决结果:赞成 8 票,反对 0 票,弃权 0 票 特此公告。 上海医药集团股份有限公司 董事会 二零二五年七月二十六日 同意公司以自有资金约人民币 1.43 亿元(以最终国资备案价格为准)收购 上海实业东滩投资开发(集团)有限公司持有的上海 ...