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格隆汇公告精选(港股)︱心玮医疗-B(06609.HK)盈喜:预计中期净利润不少于4000万元
Ge Long Hui· 2025-07-29 14:59
Group 1 - Heartway Medical-B (06609.HK) expects a net profit of no less than RMB 40 million for the six months ending June 30, 2025, a significant turnaround from a net loss of approximately RMB 5.1 million for the corresponding period ending June 30, 2024 [1] - The anticipated profit and performance improvement are primarily due to business growth, leading to increased revenue and a decrease in overall expenditure ratio compared to the corresponding period [1] Group 2 - Baoshan International (03813.HK) expects a mid-term net profit of approximately RMB 187.6 million, a year-on-year decrease of 44.1% [2] - Baio Family Interaction (02100.HK) anticipates a mid-term profit increase of approximately 134.9% to 141.6% [2] - Skyworth Group (00751.HK) warns of an expected mid-term post-tax profit decline of about 50% year-on-year [2] Group 3 - China CNR Corporation (01766.HK) recently signed a significant contract worth approximately RMB 32.92 billion [2] - China Power (02380.HK) reported a total electricity sales volume of 11.299 million megawatt-hours in June, a year-on-year decrease of 5.04% [2]
上海医药(601607.SH):硫酸沙丁胺醇注射液通过仿制药一致性评价
Ge Long Hui· 2025-07-29 11:36
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Hefeng Pharmaceutical Co., Ltd. (referred to as "Hefeng"), received a Supplementary Application Approval Notice from the National Medical Products Administration for its Salbutamol Sulfate Injection, which has passed the consistency evaluation of quality and efficacy for generic drugs [1] Group 1 - The Salbutamol Sulfate Injection is primarily used for treating bronchial asthma or wheezing bronchitis and other respiratory diseases associated with bronchospasm [1]
上海医药(601607.SH):B019新适应症获得临床试验批准通知书
Ge Long Hui· 2025-07-29 11:36
Core Viewpoint - Shanghai Pharmaceuticals (601607.SH) announced that its subsidiary, Shanghai Pharmaceuticals Group Biotherapy Technology Co., Ltd., 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 - The clinical trial approval allows the company to advance its research on B019, which targets a significant unmet medical need in the treatment of systemic lupus erythematosus [1] - B019 is positioned as a potential innovative therapy in the biopharmaceutical sector, reflecting the company's commitment to developing new treatments [1] - The approval marks a critical milestone in the drug development process, potentially leading to future commercialization opportunities for the company [1]
上海医药:B019新适应症获临床试验批准通知书
人民财讯7月29日电,上海医药(601607)7月29日晚间公告,公司下属上药生物治疗自主研发 的"B019"收到国家药监局核准签发的《药物临床试验批准通知书》,同意其开展难治性系统性红斑狼 疮(简称"新适应症")的临床试验。 ...
上海医药下属公司B019注射液新适应症获临床试验批准
Bei Jing Shang Bao· 2025-07-29 09:29
Core Viewpoint - Shanghai Pharmaceuticals has received approval from the National Medical Products Administration for clinical trials of its self-developed B019 injection, aimed at treating refractory systemic lupus erythematosus [2]. Company Summary - B019 injection is a chimeric antigen receptor T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [2]. - The drug has previously been approved for clinical trials for two other indications: relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma, with approvals granted in October 2023 and December 2024, respectively [2].
上海医药:B019新适应症获得临床试验批准通知书
Zhi Tong Cai Jing· 2025-07-29 09:09
Core Viewpoint - Shanghai Pharmaceuticals (601607) has received approval from the National Medical Products Administration for its self-developed drug "B019" to conduct clinical trials for refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 is a chimeric antigen receptor (CAR) T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual promoter vector, allowing T-cells to express two independent CARs that can bind to CD19 or CD22 proteins on B lymphocytes without interference [1] Group 2: Clinical Trial Approvals - Clinical trial applications for B019 to treat relapsed or refractory acute B-cell leukemia and relapsed or refractory B-cell non-Hodgkin lymphoma have been approved by the National Medical Products Administration in October 2023 and December 2024, respectively [1]
上海医药(02607):B019新适应症获得临床试验批准通知书
智通财经网· 2025-07-29 09:09
Core Viewpoint - Shanghai Pharmaceuticals (02607) has received approval from the National Medical Products Administration for its self-developed drug "B019" to conduct clinical trials for refractory systemic lupus erythematosus [1] Group 1: Product Development - B019 is a chimeric antigen receptor (CAR) T-cell injection targeting CD19 and CD22, intended for the treatment of refractory systemic lupus erythematosus [1] - The CAR structure of B019 utilizes a dual promoter vector, allowing T-cells to express two independent CARs that can bind to CD19 or CD22 proteins on B lymphocytes without interference [1] Group 2: Clinical Trial Approvals - 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 National Medical Products Administration in October 2023 and December 2024, respectively [1]
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]