曲妥珠单抗

Search documents
一款国产抗癌药,“少卖”570亿元
Chang Sha Wan Bao· 2025-07-17 16:31
长沙晚报掌上长沙7月10日讯 据《中国企业家》杂志消息被"中间商赚差价"的故事,在创新药行业再次 上演。 6月2日,美国药企BMS与德国药企BNT宣布达成战略合作:双方将共同开发双抗药物BNT327,交易总 金额高达90亿美元。 两家国外药企的交易,却在国内创新药圈引发震动。因为这款被交易的药物,实则是BNT从中国药企普 米斯生物手中"收来"的。 2023年11月,成立仅5年的普米斯生物与BNT达成首笔授权:首付款仅5500万美元,授予后者除大中华 区外的全球权益,潜在里程碑(未来的特定事件,一般包括重要的临床试验节点、商业化进度等)款总 计超10亿美元。一年后,BNT又以8亿美元现金和1.5亿里程碑款全资收购了普米斯生物,将其变为自己 的中国研发中心。 在许多投资者看来,才一年多时间,这款药就溢价了80亿美元量级,普米斯"低价卖青苗",被中间商赚 了差价。"若是能等到临床试验给出更积极的表现,普米斯将收获的回报可能是一个天文数字。"医药管 理咨询公司北京百思力总经理王恒说。 这并不是第一次,"创新药一哥"恒瑞医药也曾被狠狠赚过一笔。 2023年8月,恒瑞医药将哮喘药SHR-1905海外权益以2500万美元首 ...
江苏跑出创新药械上市“加速度”
Xin Hua Ri Bao· 2025-07-15 23:50
□ 本报记者 杨 彦 2025年,江苏在生物医药产业与医疗器械领域捷报频传。苏州、无锡、南京等地企业研发的多个"全球 首个""国内首创"产品相继获批上市,为重大疾病治疗提供新的解决方案与选择。创新药械上市"加速 度"的背后,是江苏各级药品监管部门着力打造"政策高地""质量高地""发展高地",以精准帮扶不断提 升创新药械产业的整体实力,朝着打造医药产业高地的目标稳步迈进的"久久为功"。 □ 本报记者 杨 彦 从"国内首个"到"全球首创",江苏捷报频传 2024年,全省共获批上市药品352个,创新药13个、占全国总数27.08%,第三类医疗器械490个,批准 第二类医疗器械1921个,进入创新医疗(002173)器械特别审查通道产品19个,均居全国第一。 新一年,创新药械上市的速度还在被刷新。 5月29日,国家药监局官宣发布批准11款创新药上市,其中江苏获批5款创新药,4款与肿瘤相关。 在同一天5款药品获批后,7月份好消息接踵而至。苏州亚盛药业有限公司自主研发的利沙托克拉片与苏 州旺山旺水生物医药股份有限公司自主研发的盐酸司美那非片,获得国家药监局批准上市。前者是国内 首个获批的BCL-2抑制剂,填补了慢性淋巴细 ...
苏州工业园区今年已新增6款1类创新药 占全国同期约20%
Zheng Quan Shi Bao Wang· 2025-07-15 06:19
Core Insights - The approval of innovative drugs is a significant indicator of the new productive forces in the biopharmaceutical industry, with Suzhou Industrial Park accounting for approximately 20% of the new innovative drugs approved in China this year [1][3]. Group 1: Drug Approvals - As of July 10, 2023, Ascentage Pharma's new Bcl-2 selective inhibitor, Lisatoclax, received approval for treating adult patients with chronic lymphocytic leukemia/small lymphocytic lymphoma who have undergone prior systemic therapy [1]. - On July 8, 2023, Suzhou Wangshan Wangshui Biopharmaceutical Co., Ltd. and the Shanghai Institute of Materia Medica collaborated to launch a new drug, Semaglutide, for the treatment of erectile dysfunction [1]. - On June 27, 2023, Innovent Biologics' injection, Ma Shidu, was approved for long-term weight management in adults with obesity or overweight, being the first dual receptor agonist for weight loss globally [1]. - On May 29, 2023, the injection of Trastuzumab deruxtecan was approved for treating adult patients with HER2-mutant non-small cell lung cancer who have received prior systemic therapy, marking it as the first antibody-drug conjugate for this indication in China [2]. - On the same day, BeiGene's bispecific antibody, Zhenidamab, was approved for patients with HER2-positive advanced biliary tract cancer, providing a new treatment option [2]. - On January 10, 2023, the approval of the long-acting PCSK9 monoclonal antibody, Rucaparib, was granted for treating high cholesterol levels [2]. Group 2: Industry Development - Since 2006, Suzhou Industrial Park has focused on the biopharmaceutical and health industry, attracting over 2,000 related enterprises, with a projected output value of 165.5 billion yuan by 2024 [3]. - The park has implemented a targeted investment strategy, introducing approximately 300 biopharmaceutical and health projects annually over the past three years [3]. - In May 2023, Suzhou Industrial Park announced an action plan to accelerate the growth of the biopharmaceutical and health industry, aiming to develop over five leading enterprises with international competitiveness and achieve significant sales milestones by 2027 [3].
7月15日早间重要公告一览
Xi Niu Cai Jing· 2025-07-15 03:54
Group 1 - CITIC Construction Investment expects a net profit of 4.43 billion to 4.57 billion yuan for the first half of 2025, representing a year-on-year increase of 55%-60% [1] - New Hope anticipates a net profit of 680 million to 780 million yuan for the first half of 2025, recovering from a loss of 1.217 billion yuan in the same period last year [2] - Foton Motor forecasts a net profit of approximately 777 million yuan for the first half of 2025, marking an increase of about 87.5% year-on-year [7] Group 2 - North New Road and Bridge expects a net loss of 70 million to 85 million yuan for the first half of 2025 [2] - Nanwei Co. anticipates a net loss of 12 million to 16 million yuan for the first half of 2025 [3] - Hanhua Technology projects a net loss of 45 million to 60 million yuan for the first half of 2025, widening the loss by 11.42%-18.10% compared to the previous year [6] Group 3 - Songlin Technology expects a net profit of 90 million to 95 million yuan for the first half of 2025, a decrease of 57.06%-59.32% year-on-year [4] - Fuchun Environmental Protection anticipates a net profit of 178 million to 207 million yuan for the first half of 2025, representing a year-on-year increase of 80%-110% [18] - Ansteel Group forecasts a net loss of 1.144 billion yuan for the first half of 2025, a reduction in loss of approximately 57.46% compared to the previous year [20][22] Group 4 - China Wuyi expects a net loss of 80 million to 104 million yuan for the first half of 2025, a significant decline compared to the previous year [28] - Meikailong anticipates a net loss of 1.59 billion to 1.92 billion yuan for the first half of 2025 [26] - Aijian Group projects a net profit of 140 million yuan for the first half of 2025, a decrease of 33.26% year-on-year [27]
贝达药业:与博锐生物达成战略合作 由公司独家经销的安瑞泽已正式启动全国销售
news flash· 2025-07-14 12:53
Core Viewpoint - The company has entered into a strategic partnership with Hangzhou Bozhi Rui Biological Pharmaceutical Co., Ltd., acquiring the project rights for the injection of Pertuzumab and exclusive distribution rights for the injection of Trastuzumab (Anruize®) in China, which is expected to positively impact future revenue [1] Group 1 - The exclusive distribution of Anruize has officially launched nationwide, indicating a significant step in the company's commercial strategy [1] - The collaboration on "Chupa Shuangzhu" follows the previous strategic partnership on the Beianting project, showcasing the company's ongoing commitment to expanding its product offerings [1] - This partnership marks the company's comprehensive commercial layout in the breast cancer treatment sector, following its focus on lung and kidney cancer treatments [1]
生产环节“分段”,新药上市提速
Xin Hua Ri Bao· 2025-07-09 21:58
"将抗体与化学小分子结合起来的ADC(抗体偶联药物)正迎来爆发期,分段生产是众多药企的共性需 求。"王宏伟解释,ADC有着较为复杂的"抗体—连接子—毒素"三元结构,在生产工艺上,既涉及生物 制药又涉及化学合成,单一企业难以同时布局多个领域,而分段生产可最大化利用药品生产企业和 CDMO(合同研发生产组织)的生产设施设备,降低成本投入,加快研发进程。 "其中一段小分子是高毒高活化学物质,不允许与普通药物在同一车间生产。从建厂房到组团队,叠加 各项审批过程,至少需要五六年时间,不仅耗资巨大,也充满各种不确定因素。"王宏伟坦言,布局 ADC药物近4年时间,却因堵在分段环节迟迟无法突破。 其实,早在2019年新修订的药品管理法发布时,园区就嗅到释放生物制品分段生产试点的信号。"我们 开始摸排企业需求,联合企业做足准备。"倪美华说,针对辖区企业关于分段生产的共性诉求,持续开 展大量理论研究和实地调研,并探索具体实施方案的可行性,在国内率先提出"生物制品分段生产"政策 支持事项。 当然,这一模式还面临技术、法规和管理等多重挑战。倪美华举例说,分段生产后,如何保证不同厂家 生产设备的适用性?如何确保物流和供应链管理?同时, ...
千亿巨头,突然暴涨超18%!
Zhong Guo Ji Jin Bao· 2025-07-09 07:40
Core Viewpoint - Heng Rui Medicine's stock experienced a significant surge, with a maximum increase of over 18% in Hong Kong and over 8% in A-shares, following a buy rating from Citigroup, which highlighted the market's underestimation of the company's business development (BD) expectations and the rapid launch of several innovative drugs [2][5]. Group 1: Stock Performance and Analyst Ratings - On July 9, Heng Rui Medicine's Hong Kong stock price reached 68 HKD, with a rise of 12.96%, while the A-share price was 57.1 CNY, up 6.93%, resulting in a market capitalization of 380.2 billion CNY [2]. - Citigroup assigned a buy rating for Heng Rui Medicine's H-shares with a target price of 134 HKD and an A-share target price of 123 CNY, citing significant catalysts from upcoming performance and BD developments [2][5]. Group 2: Clinical Trials and Drug Approvals - Heng Rui Medicine announced the approval of clinical trials for two new drugs: SHR-2173 injection, aimed at treating primary membranous nephropathy, and HRS-9821 inhalation powder, intended for chronic obstructive pulmonary disease (COPD) maintenance therapy [4][6]. - SHR-2173 is a biologic targeting abnormally activated immune cells, while HRS-9821 is a small molecule PDE3/PDE4 inhibitor, with the latter expected to compete with Ensifentrine, which is projected to generate approximately 42 million USD in sales in 2024 [4][6]. Group 3: Research and Development Progress - Heng Rui Medicine has 23 first-class innovative drugs and 4 second-class new drugs approved in China, with 8 first-class innovative drugs launched in 2024 alone [8]. - The company has invested 46 billion CNY in R&D, with R&D expenditure accounting for 29.4% of sales revenue in 2024, positioning it among the top in the pharmaceutical industry [8]. - The company is expected to have over 40 innovative products approved for market launch in the next three years, covering various therapeutic areas including oncology, metabolism, cardiovascular, immune, and respiratory diseases [9].
千亿巨头,突然暴涨超18%!
中国基金报· 2025-07-09 07:29
【导读】恒瑞医药港股午后突然大幅拉升,最大涨幅超18% 中国基金报记者 卢鸰 千亿医药巨头突然暴涨。 7月9日,恒瑞医药港股午后突然大幅拉升,最大涨幅超18%,A股同时最高暴涨超8%。 花旗7月9日发布报告称,首次给予恒瑞医药H股买入评级,目标价为134港元,A股目标价为 123元。花旗称,市场没有充分反映恒瑞医药的BD(商务拓展)预期,以及多款创新药的快 速放量,后续的业绩和BD进展都会是重要催化剂。 7月8日晚,恒瑞医药发布公告称,近日,公司子公司广东恒瑞医药有限公司收到国家药监局 核准签发关于SHR-2173注射液和HRS-9821吸入粉雾剂的《药物临床试验批准通知书》, 将于近期开展临床试验。 据公告披露,SHR-2173注射液是公司自主研发的治疗用生物制品,能够通过靶向异常激活 的免疫细胞,发挥抗炎和抑制免疫的生物学效应,有望降低自身抗体水平,改善原发性膜性 肾病患者的疾病活动状态,为患者带来新的治疗选择。目前国内外尚无同类药物上市或在临 床研发阶段。 HRS-9821是小分子PDE3/PDE4抑制剂,可有效抑制呼吸道炎症、扩张支气管,临床拟用于 慢性阻塞性肺疾病(COPD)的维持治疗。目前全球同类 ...
华兰生物: 关于对参股公司华兰基因工程有限公司增资暨关联交易的公告
Zheng Quan Zhi Xing· 2025-07-08 11:24
证券代码:002007 证券简称:华兰生物 公告编号:2025-030 华兰生物工程股份有限公司 (1)成立日期:2013年6月25日 (2)注册地址:新乡市平原新区黄河大道中段1号楼568室(新乡市平原示范区黄 河路甲1-1号) (3)法定代表人:安康 本公司及董事会全体成员保证信息披露的内容真实、准确和完整,没有虚假 记载、误导性陈述或重大遗漏。 一、关联交易概述 华兰基因工程有限公司(以下简称"基因公司")为本公司参股公司,目前注册 资本 20,000 万元人民币,其中本公司出资 8,000 万元,占注册资本的 40%;本公 司实际控制人安康先生出资 12,000 万元,占注册资本的 60%。根据生产经营需要, 基因公司拟增资 50,000 万元,其中 10,000 万元用于增加注册资本,40,000 万元用 于增加资本公积,为此原有股东按照原出资比例对基因公司进行增资,其中,本公 司拟按照 40%的比例以货币增资人民币 20,000 万元,认购基因公司新增的 4,000 万 元注册资本;安康先生按照 60%的比例以货币增资人民币 30,000 万元,认购基因 公司新增的 6,000 万元注册资本。增资 ...
今年上半年全球9款肺癌新药获批
Bei Ke Cai Jing· 2025-07-01 08:17
2813款正在开发肺癌适应症的药物中,小分子化药最多,共有1028款,其次为单抗、ADC(抗体偶联 药物)、双抗,分别有264款、226款、110款。从药物靶点来看,EGRF、PD-1、PD-L1排在前三位,分 别为66款、42款、27款。 今年上半年,全球共有9款肺癌创新药获批肺癌相关适应症,为肺癌患者的治疗带来了新的希望。这9款 获批肺癌适应症的新药分别为强生的埃万妥单抗、科伦博泰的芦康沙妥珠单抗、百事美施贵宝的欧狄沃 单抗、奥赛康药业的利厄替尼、康方生物的依沃西单抗、翰森制药的阿美替尼、恒瑞医药的瑞康曲妥珠 单抗、加科思/艾力斯的戈来雷塞片、艾伯维的Telisotuzumab vedotin(Teliso-V),其中前8款均是在国内 获批肺癌相关适应症。 作为全球发病率和死亡率排名第一的癌症,肺癌已经连续十年高居全球癌症死亡率首位。针对这一"头 号杀手",多年来,全球科学家一直在努力开展针对肺癌的各种创新药物研究。新京报记者查询智慧芽 新药情报库显示,截至7月1日,全球有2813款药物在开发肺癌适应症,针对非小细胞肺癌的最多。今年 以来,全球共有9款创新药的肺癌适应症相继获批上市,为医生围剿"头号杀手" ...