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和誉-B(02256):默克行使匹米替尼全球商业化选择权,多个创新管线快速推进中
Guotou Securities· 2025-08-23 12:23
默克行使匹米替尼全球商业化选择权,预计在 2025 年下半年向 FDA 递交 NDA。2025 年 5 月 29 日公司收到默克根据双方签订的授 权协议支付的行使匹米替尼(ABSK021)全球商业化选择权行权费 8,500 万美元;该合作中公司可收取最多 6.055 亿美元的款项, 包括首付款、开发及商业化里程碑付款,以及匹米替尼全球实际 年净销售额的两位数比例销售提成。目前,匹米替尼在国内已被 CDE 纳入优先审评,用于需要系统性治疗的腱鞘巨细胞瘤(TGCT) 成人患者;在海外,预计在 2025 年下半年向 FDA 递交 NDA,后续 获批上市销售放量值得期待。 其他多个创新管线快速推进中。其中,FGFR4 抑制剂 ABSK011 针 对既往接受过治疗的 FGF19+肝细胞癌(HCC)患者的注册试验已正 式启动;口服小分子 PD-L1 抑制剂 ABSK043 联合三代 EGFR TKI 一 线治疗 EGFR 突变 NSCLC 的 2 期临床、一线治疗 FGFR2 突变胃癌 的 2 期临床正在开展中,后续将启动联用 KRAS G12C 抑制剂一线 治疗 KRAS G12C 突变 NSCLC 2 期临床;FGF ...
再鼎医药(09688):维持全年收入指引,下半年多个里程碑事件值得期待
Guotou Securities· 2025-08-23 08:24
下半年多个里程碑事件值得期待。 1)2025 年下半年有望向 NMPA 提交上市申请方面:贝玛妥珠单抗 (FGFR2b)预计提交用于胃癌一线治疗的上市许可申请、肿瘤电 场治疗预计提交用于一线胰腺癌治疗的上市许可申请、艾加莫德 (FcRn)预计提交艾加莫德预充式皮下注射用于 gMG 和慢性炎性 脱髓鞘性多发性神经根神经病(CIDP)的上市许可申请。 2)近期有望获得 NMPA 批准的上市许可申请方面:呫诺美林曲司 氯铵(KarXT)(M1/M4 型毒蕈碱乙酰胆碱受体激动剂)有望获批用 于精神分裂症、维替索妥尤单抗(TIVDAK,组织因子 ADC)有望获 批用于化疗期间或之后病情进展的复发或转移性宫颈癌、瑞普替 尼(ROS1/TRK)有望获批用于 NTRK 阳性实体瘤。 3)预期的临床开发和数据公布方面:ZL-1310(DLL3 ADC)用于 二线 ES-SCLC 将公布数据更新,并于 2025 年下半年启动 ZL-1310 单药治疗的全球注册性研究;用于一线 ES-SCLC ZL-1310 联用阿 替利珠单抗的剂量递增研究数据的读出。ZL-1503(IL-13/IL-31R) 将在 2025 年下半年推进启动用 ...
宝济药业递表港交所 中信证券、海通国际为联席保荐人
Zheng Quan Shi Bao Wang· 2025-08-22 00:56
公司拥有商业化规模的生产能力,并推行"两抗"战略,开发抗体药物和抗生素的皮下制剂。公司的业务 模式结合了自主研发与外部合作,并具备成本效益和标准化生产能力。 (文章来源:证券时报网) 宝济药业是一家临床阶段的生物技术公司,专注于利用合成生物技术在中国开发重组生物药物。公司拥 有涵盖四个治疗领域的七款候选药物,包括三款核心产品KJ017、KJ103和SJ02,以及五项临床前资 产。 核心产品在全球范围内受知识产权保护,拥有9项授权专利和10项专利申请。KJ017用于大容量皮下给 药,KJ103用于治疗自身免疫性疾病,SJ02用于辅助生殖。所有核心产品均已在中国进入临床后期阶段 或NDA注册阶段。 宝济药业已向港交所提交上市申请。中信证券、海通国际为其联席保荐人。 ...
国信证券张立超、王开:构筑新质生产力投资框架体系
Zhong Guo Zheng Quan Bao· 2025-08-19 23:29
Group 1: Core Concepts of New Quality Productivity - New quality productivity is a key engine driving high-quality economic development in China, representing a deep integration of technological innovation and industrial upgrading [1][2] - The concept emphasizes the cultivation of strategic emerging industries such as new energy, new materials, advanced manufacturing, and electronic information, aiming to enhance new development momentum [2][3] - The transition to new quality productivity marks a significant improvement in total factor productivity, driven by technological innovation and the restructuring of industrial value chains [3][4] Group 2: Development Pathways for Enterprises - Enterprises are the main practitioners of new quality productivity, focusing on upgrading traditional industries and strategically positioning emerging industries [4][5] - Traditional industries are essential for economic development and serve as a fertile ground for new quality productivity, while emerging industries inject new momentum into economic growth [7][8] - The development of commercial aerospace exemplifies the transition from government-led initiatives to commercial operations, highlighting the rapid growth of the industry in China [7][9] Group 3: Regional Development Strategies - Different regions in China should adopt tailored approaches to develop new quality productivity based on their resource endowments and industrial foundations [8][9] - The Guangdong-Hong Kong-Macao Greater Bay Area is a key region for cultivating new quality productivity, characterized by a complete industrial system and strong economic complementarity [9][10] - Major cities like Beijing, Shanghai, and Guangdong are focusing on specific industries such as integrated circuits, smart connected vehicles, and advanced manufacturing to drive regional economic growth [8][9] Group 4: Investment Opportunities - Investment strategies should focus on sectors that integrate digital and traditional economies, emerging industries with rapid market penetration, and future industries with technological breakthroughs [10] - The importance of selecting the right market segments is emphasized, with attention to opportunities in information technology, finance, and industrial sectors [10]
最近几个月投资活跃度最高的基金,我打赌你没注意过它
Sou Hu Cai Jing· 2025-08-19 08:49
作者 | Judy 来源 | IT桔子 图片|公众号AI生成 翻看IT 桔子的"近期活跃机构"排行,发现第一名是个非常陌生的名字——麓山科投——数据显示,8 月 还没过完,它当月已经出资了 13 家公司。 效率甚至超过了大家耳熟能详的出手王——奇绩创坛。 于是我们想看看,这是一家什么样的机构? 原来,麓山科投近期主要通过湖南省的大学生创业投资基金在出资。 就在今年 1 月,湖南省政府官方发文《五亿基金,点燃大学生在湘创业"燎原之火"》,明确表示推出全 国首只大学生创业投资基金,总规模达5.05亿元。之后便紧锣密鼓的行动,在湖南各个高校举办 20 多 场创投宣传活动。 从 IT桔子记录到的投资交易来看,湖南的这只大学生创业投资基金,来真格的了—— 投资界的新兴力量 在股权投资领域,湖南麓山科投旗下的湖南省大学生创业投资基金近期表现尤为活跃,其独特的投资策 略与布局方向备受业内关注。 从投资轮次分布来看,数据呈现出鲜明的早期投资倾向:天使轮投资占比高达 71.74%,A 轮占 15.22%,种子轮占 8.70%,Pre-A 轮和战略投资各占 2.17%。这种布局符合基金针对大学生初创企业的 发展阶段特点。 投资项 ...
15家境外企业来深寻找好项目
Shen Zhen Shang Bao· 2025-08-19 07:25
Group 1 - The event "Chain Connection Abroad: Gathering Strength in Longhua - 2025 Overseas Quality Project Industry Cooperation Exchange Conference" was successfully held, aiming to build a bridge for domestic and foreign industrial cooperation and inject new momentum into Longhua's economic high-quality development [1] - The conference showcased the innovative achievements and development vitality of four leading industries: intelligent manufacturing, electronic information, life health, and fashion creativity, allowing foreign enterprises to perceive Longhua's industrial potential and investment opportunities [1] - The "Long Dance Huazhang" talent policy presentation systematically interpreted Longhua's comprehensive support policies in talent cultivation, introduction, and services, signaling a strong commitment to attracting talent and supporting enterprise development [1] Group 2 - Fifteen foreign enterprise representatives conducted roadshows focusing on fields such as pharmaceuticals, AI technology, biotechnology, and health, introducing core technologies, market layouts, and cooperation needs in China [2] - The event included a government-enterprise discussion session where foreign representatives actively asked questions, and relevant department heads responded, discussing cooperation models and resource guarantees [2] - Attendees visited various local innovation and entrepreneurship centers and technology companies to further experience Longhua's innovative ecosystem and future potential [2]
澳洲生物技术巨头CSL宣布分拆流感疫苗部门,并裁员15%
Ge Long Hui A P P· 2025-08-19 00:45
Group 1 - CSL plans to spin off its flu vaccine division, CSL Seqirus, into an independent publicly listed company by the end of fiscal year 2026 [1] - The company will implement a 15% workforce reduction as part of this restructuring [1] - CSL aims to resume its share buyback program, targeting AUD 750 million (approximately USD 486.98 million) in stock repurchases by the end of fiscal year 2026 [1]
15家境外企业来深寻找好项目 龙华区举办境外优质项目产业合作交流会
Shen Zhen Shang Bao· 2025-08-18 16:44
Group 1 - The event "Chain Connecting Overseas: Gathering Strength in Longhua - 2025 Overseas Quality Project Industry Cooperation Exchange Conference" was successfully held, aimed at building bridges for domestic and foreign industrial cooperation to inject new momentum into Longhua's economic high-quality development [1][2] - The conference showcased Longhua's four leading industries: intelligent manufacturing, electronic information, life health, and fashion creativity, highlighting their innovative achievements and development vitality to attract overseas enterprises [1] - The "Long Dance Huazhang" talent policy presentation detailed Longhua's comprehensive support policies in talent cultivation, introduction, and services, signaling strong intentions to attract talent and support enterprise development [1][2] Group 2 - Fifteen overseas enterprise representatives conducted roadshows focusing on fields such as pharmaceuticals, AI technology, biotechnology, and health, discussing core technologies, market layouts, and cooperation needs in China [2] - The event included a government-enterprise discussion where overseas representatives actively engaged with department heads, exploring cooperation models and resource guarantees [2] - Attendees visited various local innovation and entrepreneurship centers and technology companies to further understand Longhua's innovative ecosystem and future potential [2]
嘉必优: 嘉必优生物技术(武汉)股份有限公司第四届监事会第七次会议决议公告
Zheng Quan Zhi Xing· 2025-08-18 16:33
Meeting Details - The fourth meeting of the supervisory board of Jia Bi You Biotechnology (Wuhan) Co., Ltd. was held on August 18, 2025, via communication methods, with all supervisors notified on August 8, 2025 [1][2] - The meeting complied with relevant laws, regulations, and the company's articles of association regarding attendance and voting procedures [1] Resolutions Passed - The supervisory board approved the proposal regarding the 2025 semi-annual report and its summary, affirming that the report accurately reflects the company's financial status and operational results without any false statements or omissions [1][2] - The board also approved the proposal concerning the special report on the storage and usage of raised funds for the first half of 2025, confirming compliance with relevant regulations and ensuring no harm to shareholders' interests, particularly minority shareholders [2]
百济神州上涨2.04%,报327.93美元/股,总市值388.44亿美元
Jin Rong Jie· 2025-08-18 14:00
Core Insights - BeiGene, Ltd. (百济神州) is a commercial-stage biotechnology company focused on developing and commercializing innovative molecular targeted and immunotherapy drugs for cancer treatment [2] Financial Performance - As of June 30, 2025, BeiGene reported total revenue of $2.433 billion, representing a year-over-year growth of 44.73% [1] - The company's net profit attributable to shareholders was $95.59 million, showing a significant increase of 125.73% year-over-year [1] Product Portfolio - BeiGene has a comprehensive product portfolio that includes six internally developed clinical candidates, three of which are in late-stage clinical trials: zanubrutinib (BTK inhibitor), tislelizumab (PD-1 antibody), and pamiparib (PARP inhibitor) [2] - The company has also obtained licenses for five drugs and investigational drugs, including three drugs (ABRAXANE, REVLIMID, and VIDAZA) exclusively licensed from Celgene that are already marketed in China, along with two investigational drugs in clinical stages [2] Company Background - Founded in Beijing in 2010, BeiGene was listed on the NASDAQ Global Select Market in February 2016 [2] - As of July 2018, the company had a global team of over 1,300 employees, showcasing its comprehensive capabilities in research, clinical development, manufacturing, and commercialization [2]