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华海药业:盐酸纳洛酮注射液获得药品注册证书
Xin Lang Cai Jing· 2025-12-26 09:23
华海药业12月26日公告,公司于近日收到国家药品监督管理局核准签发的盐酸纳洛酮注射液的《药品注 册证书》。盐酸纳洛酮注射液的适应症为:1、用于阿片类药物复合麻醉术后,拮抗该类药物所致的呼 吸抑制,促使病人苏醒;2、用于阿片类药物过量,完全或部分逆转阿片类药物引起的呼吸抑制;3、解 救急性乙醇中毒;4、用于急性阿片类药物过量的诊断。 ...
华海药业(600521.SH):子公司 HB0025 注射液启动III期临床试验
Ge Long Hui A P P· 2025-12-26 09:23
Core Viewpoint - The company, Huahai Pharmaceutical, has announced the initiation of Phase III clinical trials for HB0025, a novel PD-L1/VEGF dual-specific fusion protein aimed at treating squamous and non-squamous non-small cell lung cancer [1][2]. Group 1: Clinical Development - The company’s subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., will officially start the Phase III clinical trial for HB0025 after discussions with the National Medical Products Administration [1]. - HB0025 is designed to target both PD-L1 and VEGF pathways, enhancing anti-tumor mechanisms through dual action on immune evasion and tumor angiogenesis [1][2]. - The Phase III trials will include two confirmatory studies, which are expected to provide new first-line treatment options for advanced non-small cell lung cancer patients, regardless of PD-L1 expression levels [2]. Group 2: Competitive Landscape - Currently, other PD-1/VEGF dual antibodies, such as Ivosidenib by Kangfang Biotech and PM8002 by BMS, have entered clinical Phase III, indicating a competitive market for dual-target therapies [2]. - The promising Phase II clinical data for HB0025, presented at the 2025 ESMO conference, showed good objective response rates and disease control rates, particularly in PD-L1 negative populations [2]. Group 3: Financial Investment - The company has invested approximately RMB 32.597 million in the research and development of the HB0025 project to date [3].
华海药业:子公司 HB0025 注射液启动III期临床试验
Ge Long Hui· 2025-12-26 09:19
Core Viewpoint - Company Huahai Pharmaceutical (600521.SH) has announced the initiation of Phase III clinical trials for HB0025, an innovative anti-PD-L1/VEGF bispecific fusion protein targeting non-small cell lung cancer [1][2]. Group 1: Clinical Development - The company’s subsidiary, Shanghai Huatai Biopharmaceutical Co., Ltd., will officially start the Phase III clinical trial for HB0025 after discussions with the National Medical Products Administration [1]. - HB0025 is designed to target both PD-L1 and VEGF pathways, enhancing tumor immunity and inhibiting angiogenesis, thus providing a dual mechanism for cancer treatment [1][2]. - Two confirmatory Phase III clinical trials will be launched for HB0025 [1]. Group 2: Competitive Landscape - Competing products include Kangfang Biotech's Ivosidenib (PD-1/VEGF bispecific), BMS's PM8002 (PD-L1/VEGF bispecific), and Pfizer's SSGJ-707 (PD-1/VEGF bispecific), which are in various stages of clinical development [2]. - The promising Phase II clinical data for HB0025 presented at the 2025 ESMO conference indicates a good objective response rate and disease control rate, particularly in PD-L1 negative populations [2]. Group 3: Financial Investment - The company has invested approximately RMB 325.97 million in the development of the HB0025 project to date [3].
证券代码:600521 证券简称:华海药业 公告编号:临2025-131号 债券代码:110076 债券简称:华海转债
Core Viewpoint - The company announces the right for holders of "Huahai Convertible Bonds" to sell back part or all of their unconverted bonds, with a buyback price set at RMB 100.30 per bond, including accrued interest and tax [1][4]. Group 1: Buyback Terms - Holders of "Huahai Convertible Bonds" can exercise their right to sell back the bonds if the company's stock price remains below 70% of the conversion price for 30 consecutive trading days during the last two interest years of the bond [2]. - The buyback price is calculated to include accrued interest, which for the sixth year at a coupon rate of 2.00% over 54 days amounts to approximately RMB 0.30 per bond, leading to a total buyback price of RMB 100.30 [5][10]. Group 2: Buyback Period and Procedures - The buyback period is set from December 22, 2025, to December 26, 2025, with funds to be disbursed on December 31, 2025 [4][11]. - During the buyback period, "Huahai Convertible Bonds" will continue to trade but will not be convertible into shares [13]. Group 3: Additional Information - If the total face value of the convertible bonds in circulation falls below RMB 30 million due to the buyback, trading will continue until the end of the buyback period, after which an announcement will be made [13]. - The company will disclose the results of the buyback and its impact on the company after the buyback period concludes [12].
华海药业(600521) - 浙江华海药业股份有限公司关于“华海转债”可选择回售的第九次提示性公告
2025-12-25 09:47
证券代码:600521 证券简称:华海药业 公告编号:临 2025-131 号 债券代码:110076 债券简称:华海转债 浙江华海药业股份有限公司 关于"华海转债"可选择回售的第九次提示性公告 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: 浙江华海药业股份有限公司(以下简称"公司")的股票自 2025 年 11 月 2 日 至 2025 年 12 月 12 日连续 30 个交易日收盘价格低于公司可转换公司债券(以下 简称"华海转债")当期转股价格的 70%。根据《浙江华海药业股份有限公司公开 发行可转换公司债券募集说明书》(以下简称"《募集说明书》")的约定,可转债 回售条款生效。 现依据《上市公司证券发行管理办法》《可转换公司债券管理办法》《上海证 券交易所股票上市规则》和《募集说明书》等有关规定,就回售有关事项向全体 "华海转债"持有人公告如下: 一、回售条款 1 / 3 回售价格:100.30 元人民币/张(含当期利息、含税) 回售期:2025 年 12 月 22 日至 2025 年 12 月 26 ...
浙江华海药业股份有限公司 关于“华海转债”可选择回售的第八次提示性公告
Core Viewpoint - The company announces the right for holders of "Huahai Convertible Bonds" to sell back part or all of their unconverted bonds, with the buyback price set at RMB 100.30 per bond, including accrued interest and tax [1][4]. Group 1: Buyback Terms - Holders of "Huahai Convertible Bonds" can exercise their right to sell back the bonds if the company's stock price remains below 70% of the conversion price for 30 consecutive trading days during the last two interest years of the bond [2]. - The buyback price is calculated to include accrued interest, which for the sixth year at a coupon rate of 2.00% results in a total buyback price of RMB 100.30 per bond [5][10]. - The buyback period is set from December 22, 2025, to December 26, 2025, with funds to be disbursed on December 31, 2025 [4][11]. Group 2: Buyback Process - The buyback is not mandatory; bondholders have the option to choose whether to participate [6]. - Bondholders must submit their buyback requests through the Shanghai Stock Exchange trading system during the specified buyback period [7]. - If a buyback request is not successful on the first day, bondholders can continue to submit requests on subsequent days within the buyback period [8]. Group 3: Trading During Buyback Period - "Huahai Convertible Bonds" will continue to trade during the buyback period but will not allow conversion into shares [13]. - If the total face value of the bonds in circulation falls below RMB 30 million due to buybacks, trading will still continue until the end of the buyback period [13].
华海药业(600521) - 浙江华海药业股份有限公司关于“华海转债”可选择回售的第八次提示性公告
2025-12-24 09:17
证券代码:600521 证券简称:华海药业 公告编号:临 2025-130 号 债券代码:110076 债券简称:华海转债 浙江华海药业股份有限公司 关于"华海转债"可选择回售的第八次提示性公告 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: 浙江华海药业股份有限公司(以下简称"公司")的股票自 2025 年 11 月 2 日 至 2025 年 12 月 12 日连续 30 个交易日收盘价格低于公司可转换公司债券(以下 简称"华海转债")当期转股价格的 70%。根据《浙江华海药业股份有限公司公开 发行可转换公司债券募集说明书》(以下简称"《募集说明书》")的约定,可转债 回售条款生效。 现依据《上市公司证券发行管理办法》《可转换公司债券管理办法》《上海证 券交易所股票上市规则》和《募集说明书》等有关规定,就回售有关事项向全体 "华海转债"持有人公告如下: 一、回售条款 1 / 3 回售价格:100.30 元人民币/张(含当期利息、含税) 回售期:2025 年 12 月 22 日至 2025 年 12 月 26 ...
华海药业(600521) - 浙江华海药业股份有限公司关于“华海转债”可选择回售的第七次提示性公告
2025-12-23 09:47
证券代码:600521 证券简称:华海药业 公告编号:临 2025-129 号 债券代码:110076 债券简称:华海转债 浙江华海药业股份有限公司 关于"华海转债"可选择回售的第七次提示性公告 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: 浙江华海药业股份有限公司(以下简称"公司")的股票自 2025 年 11 月 2 日 至 2025 年 12 月 12 日连续 30 个交易日收盘价格低于公司可转换公司债券(以下 简称"华海转债")当期转股价格的 70%。根据《浙江华海药业股份有限公司公开 发行可转换公司债券募集说明书》(以下简称"《募集说明书》")的约定,可转债 回售条款生效。 现依据《上市公司证券发行管理办法》《可转换公司债券管理办法》《上海证 券交易所股票上市规则》和《募集说明书》等有关规定,就回售有关事项向全体 "华海转债"持有人公告如下: 一、回售条款 1 / 3 回售价格:100.30 元人民币/张(含当期利息、含税) 回售期:2025 年 12 月 22 日至 2025 年 12 月 26 ...
浙江华海药业股份有限公司 关于“华海转债”可选择回售的第六次提示性公告
Core Viewpoint - The company announces the right for holders of "Huahai Convertible Bonds" to sell back part or all of their unconverted bonds, with a buyback price set at RMB 100.30 per bond, including accrued interest and tax [1][4]. Group 1: Buyback Terms - Holders of "Huahai Convertible Bonds" can exercise their right to sell back the bonds if the company's stock price remains below 70% of the conversion price for 30 consecutive trading days during the last two interest years of the bond [2]. - The buyback price is calculated to include accrued interest, which for the sixth year at a coupon rate of 2.00% results in a total buyback price of RMB 100.30 per bond [5][10]. - The buyback period is set from December 22, 2025, to December 26, 2025, with funds to be disbursed on December 31, 2025 [4][11]. Group 2: Buyback Process - The buyback is voluntary, allowing bondholders to choose whether to participate [6]. - Bondholders must submit their buyback requests through the Shanghai Stock Exchange trading system during the specified buyback period [7]. - If a buyback request is not successful on the first day, bondholders can continue to submit requests on subsequent days within the buyback period [8]. Group 3: Trading During Buyback Period - "Huahai Convertible Bonds" will continue to trade during the buyback period but will not allow conversion into shares [13]. - If the total face value of the bonds in circulation falls below RMB 30 million due to buybacks, trading will still continue until the end of the buyback period [13].
华海药业(600521) - 浙江华海药业股份有限公司关于“华海转债”可选择回售的第六次提示性公告
2025-12-22 09:46
证券代码:600521 证券简称:华海药业 公告编号:临 2025-128 号 债券代码:110076 债券简称:华海转债 浙江华海药业股份有限公司 关于"华海转债"可选择回售的第六次提示性公告 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: 浙江华海药业股份有限公司(以下简称"公司")的股票自 2025 年 11 月 2 日 至 2025 年 12 月 12 日连续 30 个交易日收盘价格低于公司可转换公司债券(以下 简称"华海转债")当期转股价格的 70%。根据《浙江华海药业股份有限公司公开 发行可转换公司债券募集说明书》(以下简称"《募集说明书》")的约定,可转债 回售条款生效。 现依据《上市公司证券发行管理办法》《可转换公司债券管理办法》《上海证 券交易所股票上市规则》和《募集说明书》等有关规定,就回售有关事项向全体 "华海转债"持有人公告如下: 一、回售条款 1 / 3 回售价格:100.30 元人民币/张(含当期利息、含税) 回售期:2025 年 12 月 22 日至 2025 年 12 月 26 ...