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新股消息 | 蓝纳成递表港交所 报告期内累计亏损约3亿
智通财经网· 2025-09-29 23:22
智通财经APP获悉,据港交所9月29日披露,烟台蓝纳成生物技术股份有限公司(简称:蓝纳成)向港交所主板提 交上市申请书,中金公司为其独家保荐人。 招股书显示,蓝纳成于2021年创立,现为一家处于临床阶段的生物科技公司,致力于肿瘤诊疗放射性药物的发 现、开发及商业化。截至2025年9月22日,公司已建立由13款候选药物组成的管线,包括7款诊断放射性药物及 6款治疗放射性药物。 于该等候选药物中,公司有3款核心产品,包括18F-LNC1001,是一款处于注册阶段的PSMA靶向候选诊断放 射性药物,开发用于PSMA阳性前列腺癌患者的正电子放射断层扫描(「PET」)影像;18F-LNC1005,是一款 FAP靶向的候选诊断放射性药物,专为FAP阳性实体肿瘤(如胃癌)患者的PET影像而开发;177Lu LNC1011,是 一款PSMA靶向治疗放射性药物,专门用于治疗PSMA阳性转移性去势抵抗性前列腺癌(「mCRPC」)。 前列腺癌是全球及中国诊断出的最常见的癌症之一。全球前列腺癌药物市场预计将从2024年的193亿美元增长 至2030年的 324亿美元,复合年增长率为9.1%。于中国,前列腺癌通常于晚期获诊断,凸显早期 ...
科兴生物制药股份有限公司自愿披露关于GB10注射液临床试验注册申请获得受理的公告
Core Viewpoint - The acceptance of the clinical trial application for GB10 injection marks a significant milestone in the company's innovative drug development process, indicating progress in its dual-target antibody research strategy [3]. Group 1: Product Information - Product Name: GB10 Injection [2] - Application Type: Clinical trial registration for domestic drug production [2] - Indications: Treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME) [2] - Dosage Form: Injection [2] - Product Overview: GB10 injection is a high-concentration ophthalmic injection developed by Shenzhen Kexing, targeting both VEGF and Ang-2, with preclinical data showing efficacy comparable to international competitors [2]. Group 2: Impact on the Company - The acceptance of the clinical trial application is a crucial step in the company's drug development, potentially enhancing its product portfolio and market competitiveness if the drug successfully reaches the market [3].
百利天恒向港交所重新递交H股发行申请
Zhi Tong Cai Jing· 2025-09-29 22:44
百利天恒(688506.SH)公告,公司已于2025年9月29日向中国香港联交所重新递交了境外公开发行股票(H 股)的申请,并于同日在联交所网站刊登了本次发行的申请资料。 ...
BioLineRx Ltd. (BLRX) Investor Call (Transcript)
Seeking Alpha· 2025-09-29 19:41
Core Viewpoint - BioLineRx and Hemispherian have established a joint venture, which was announced in a press release and is available in the Investor Relations section of BioLineRx's website [2]. Group 1 - The announcement was made during a conference call led by Irina Koffler, Head of Investor Relations and Corporate Communications at BioLineRx [2]. - The company has filed the announcement as a 6-K with the U.S. Securities and Exchange Commission [2][3]. - Forward-looking statements were made during the call, indicating that actual results may differ from these projections due to various risks and uncertainties [2][3].
新股前瞻|近9亿美元BD叠加重磅siRNA疗法,靖因药业能否敲开港交所大门?
智通财经网· 2025-09-29 15:13
今年9月2日,诺华与Arrowhead就siRNA疗法ARO-SNCA达成一项2亿美元首付款以及后续高达20亿美元潜在里程碑付款的 BD交易。次日,诺华与舶望制药再次就4款siRNA药物达成超52亿美元BD交易。接连2笔累计超70亿美元的BD交易向市场 释放出强烈信号,也让投资者将目光聚焦于近年来越来越亮眼的小核酸领域。 实际上,早在今年5月,全球基因编辑巨头CRISPR Therapeutics斥资8.95亿美元(约合人民币65亿元)与国内创新药企靖因药 业达成重磅合作,携手推进siRNA创新疗法的开发。这也是中国小核酸领域第三起BD出海交易。也正是因此BD履历在 前,让靖因药业的港股IPO备受关注。 智通财经APP了解到,9月28日,靖因药业正式向港交所递交招股书,高盛、海通国际、HSBC为其联席保荐人。 siRNA疗法赛道已成下一个"香饽饽" 据弗若斯特沙利文报告,2024年全球siRNA疗法市场规模达24亿美元,预计至2040年将增长至503亿美元,复合年增长率为 20.9%。其中,其中获批上市的有22款(包含撤市的产品),包括7款siRNA药物、13款ASO药物和2款适配体。与此同时,全 球在研的小 ...
宜明昂科-B(01541):IMM0306治疗滤泡性淋巴瘤的III期临床试验申请
智通财经网· 2025-09-29 15:07
Core Viewpoint - The company has submitted an application for the Phase III clinical trial of IMM0306 to the National Medical Products Administration of China, marking a significant step in its development of a dual-targeting bispecific molecule for cancer treatment [1] Group 1: Product Development - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-FcɣRIIa and Fc-FcɣRIIIa to activate macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, which could improve treatment outcomes [1] Group 2: Intellectual Property and Commercial Rights - The company holds global intellectual property and commercialization rights for IMM0306 as of the date of the announcement [1]
宜明昂科-B(01541.HK)已向药监局提交IMM0306治疗滤泡性淋巴瘤的III期临床试验申请
Ge Long Hui· 2025-09-29 15:06
Core Viewpoint - The company has submitted an application for the Phase III clinical trial of IMM0306 to the National Medical Products Administration of the People's Republic of China, marking a significant step in its development of a novel dual-targeting bispecific molecule [1] Group 1: Product Development - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, thereby enhancing the activation of macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, which allows for effective elimination of malignant B cells while minimizing toxicity, potentially improving treatment outcomes [1] Group 2: Intellectual Property and Commercialization - The company holds global intellectual property and commercialization rights for IMM0306 as of the date of the announcement [1]
宜明昂科-B:IMM0306治疗滤泡性淋巴瘤的III期临床试验申请
Zhi Tong Cai Jing· 2025-09-29 15:04
Core Viewpoint - The company has submitted an application for the Phase III clinical trial of IMM0306 to the National Medical Products Administration of China, marking a significant step in the development of a novel dual-targeting bispecific molecule for cancer treatment [1] Group 1: Product Development - IMM0306 is a dual-targeting bispecific molecule that targets CD47 and CD20, making it the first of its kind to enter clinical stages globally [1] - The mechanism of IMM0306 involves inhibiting the CD47-SIRPα interaction to block the "don't eat me" signal, enhancing the interaction between Fc-Fc RIIa and Fc-Fc RIIIa to activate macrophages and NK cells [1] - The molecule preferentially binds to CD20 rather than CD47, effectively eliminating malignant B cells while minimizing toxicity, thereby improving therapeutic outcomes [1] Group 2: Intellectual Property and Commercialization - The company holds global intellectual property and commercialization rights for IMM0306 as of the date of the announcement [1]
长春高新:向香港联交所递交境外上市外资股(H股)发行上市申请并刊发申请资料
3 6 Ke· 2025-09-29 14:14
36氪获悉,长春高新公告,公司已于2025年9月29日向香港联合交易所有限公司(以下简称"香港联交 所")递交了发行境外上市外资股(H股)股票并在香港联交所主板上市(以下简称"本次发行上市") 的申请,并于同日在香港联交所网站刊登了本次发行上市的申请资料。本次发行上市事项的相关申请资 料为公司按照香港证券及期货事务监察委员会及香港联交所的要求编制和刊发,为草拟版本,其所载资 料可能会适时作出更新及修订,投资者不应根据其中的资料作出任何投资决定。 ...
凯赛生物授权子公司互保,额度不超20亿
Ge Long Hui· 2025-09-29 13:57
Core Viewpoint - Shanghai Kaisa Biotechnology Co., Ltd. announced the authorization for its non-wholly-owned subsidiaries to provide guarantees for credit applications and daily operations, with a total guarantee limit not exceeding 2 billion yuan [1] Group 1 - The total amount of guarantees provided by non-wholly-owned subsidiaries as of the announcement date is 500 million yuan, all of which are inter-subsidiary guarantees [1] - The main entities being guaranteed include Kaisa (Taiyuan) Biomaterials Co., Ltd. and Kaisa (Taiyuan) Biotechnology Co., Ltd., both of which have a debt-to-asset ratio not exceeding 70% [1] - The authorization has been approved by the board of directors and does not require shareholder meeting approval, indicating that the guarantee risks are controllable and do not harm the interests of the company and its shareholders [1]