9月24日，云南省医保局向四川百利药业有限责任公司（简称"百利药业"）发出公开问询函。 一、请详细说明你公司马来酸依那普利口服溶液的出厂价格、终端价格，以及研发投入、生产制造、期间费用等各项价格构成情况。 不同于已经进入集采的片剂，马来酸依那普利口服溶液目前还较为稀缺，根据国家药监局数据查询系统的信息，仅有两家生产企业。相较于片剂，口服溶 液的研发和生产门槛更高，需要解决药物的溶解度、稳定性、口感、防腐等一系列技术问题。 二、请详细说明你公司马来酸依那普利口服溶液近5年各年度销售量、销售金额，以及你公司作为生产研发企业的实际利润等情况。 三、请详细说明你公司马来酸依那普利口服溶液出厂价格和终端价格之间价差的合理性、必要性，以及终端价格构成中所含全部销售费用的资金支出去向 等情况。 资料显示，马来酸依那普利是一种血管紧张素转化酶抑制剂（ACEI），呈白色至灰白色结晶性粉末，临床主要用于治疗各期原发性高血压、肾性高血压 及充血性心力衰竭，并能改善症状性心衰患者的生存率及降低住院风险。 公开函件显示，百利药业生产的马来酸依那普利口服溶液挂网价格高达558元，与同通用名不同剂型（片剂，单价8元左右）存在近70倍价差。 ...

Group 1: Investment and Fundraising - Hanyu Pharmaceutical plans to raise no more than 968 million yuan for the development of semaglutide and other projects [1] - Ganfeng Lithium intends to introduce investors for a capital increase of up to 2.5 billion yuan [9] Group 2: Strategic Restructuring - Pingmei Shenma Holdings is undergoing a strategic restructuring as directed by the Henan provincial government, which will not affect the company's operations significantly [2][8] - Shennong Holdings is also involved in a strategic restructuring with no change in control or significant impact on operations [7][8] Group 3: Clinical Trials and Approvals - XinNuoWei's subsidiary received approval for clinical trials of a drug for treating mild Alzheimer's disease, marking a significant milestone in the development of biosimilar drugs [3] - Tainkang's subsidiary has received approval for clinical trials of CKBA cream for rosacea, a first-class innovative drug in China [4] - Baili Tianheng's drug, iza-bren, has been included in the list of breakthrough therapies, indicating its potential in treating advanced urinary tract cancer [5] Group 4: Contracts and Projects - Zhongyou Engineering signed an EPC contract worth 2.524 billion USD for a seawater pipeline project in Iraq, expected to positively impact future revenues [6]

Core Viewpoint - The article discusses the current state of the Chinese stock market, highlighting the rise of high-tech stocks and the ongoing debate about investment strategies, particularly the shift away from traditional sectors like liquor towards technology and innovation [2][3]. Market Performance - Several companies, including Inspur Information, Cambridge Technology, and CATL, reached historical highs [1]. - The A-share market experienced fluctuations, with the Shanghai Composite Index down 0.01%, while the Shenzhen Component and ChiNext Index rose by 0.67% and 1.58%, respectively [10]. - The total trading volume across the three markets was 23,920.16 billion yuan, an increase of 445.38 billion yuan from the previous day [10]. Sector Analysis - The technology sector, particularly AI hardware and domestic chips, is gaining traction, driven by Alibaba's significant investment in AI infrastructure [11]. - The copper supply is tightening due to the suspension of operations at the Grasberg mine, leading to a bullish outlook for copper prices, with Morgan Stanley predicting prices to rise to $11,000 per ton in Q4 [10]. - The bond market is shifting away from a long-term bull market, with the 10-year government bond yield reaching 1.92%, indicating a potential end to the low-interest-rate era [5][9]. Investment Trends - Liu Jipeng emphasized the need for investors to focus on high-tech sectors rather than traditional sectors like liquor, acknowledging the higher risks associated with technology investments [2]. - The article notes a "hit-and-run" market behavior, where hot stocks quickly rotate, and many companies are experiencing declines despite index gains [3]. Fund Flow Dynamics - The net outflow of main funds was 14.99 billion yuan, with the electronics sector seeing the largest outflow [20]. - The top sectors for net inflow included computer, power equipment, and non-ferrous metals [20]. Notable Company Developments - The domestic tungsten market is facing a supply crunch, with APT social inventory dropping below 200 tons [16]. - Micron Technology's CEO indicated an increasing imbalance in global memory chip supply, particularly for HBM, which is expected to drive growth in the storage sector [17].

公告显示，截至目前，iza-bren已有7项适应症被药审中心纳入突破性治疗品种名单，1项适应症被美国 食品药品监督管理局授予突破性疗法认定。 北京商报讯（记者 丁宁）9月25日晚间，百利天恒（688506）发布公告称，公司自主研发的全球首创 （First-in-class）、新概念（New concept）且唯一进入III期临床阶段的iza-bren（EGFR×HER3双抗 ADC）用于既往经含铂化疗及PD-1/PD-L1抑制剂治疗失败的不可手术切除的局部晚期或转移性尿路上 皮癌患者已被国家药品监督管理局药品审评中心（以下简称"药审中心"）纳入突破性治疗品种名单。 ...

格隆汇9月25日丨百利天恒(688506.SH)公布，自主研发的全球首创（First-in-class）、新概念 （Newconcept）且唯一进入III期临床阶段的iza-bren（EGFR×HER3双抗ADC）用于既往经含铂化疗及 PD-1/PD-L1抑制剂治疗失败的不可手术切除的局部晚期或转移性尿路上皮癌患者已被国家药品监督管 理局药品审评中心（简称"药审中心"）纳入突破性治疗品种名单，近日已完成公示。 ...

Core Viewpoint - The company has announced that its self-developed drug, iza-bren, has been included in the list of breakthrough therapies by the National Medical Products Administration, marking a significant milestone in the treatment of advanced or metastatic urothelial carcinoma [1] Group 1 - The drug iza-bren is a first-in-class and new concept EGFR×HER3 dual antibody ADC [1] - It is specifically designed for patients with unresectable locally advanced or metastatic urothelial carcinoma who have failed previous platinum-based chemotherapy and PD-1/PD-L1 inhibitors [1] - The drug has successfully entered the Phase III clinical trial stage [1]

证券代码：688506 证券简称：百利天恒 公告编号：2025-064 四川百利天恒药业股份有限公司 自愿披露关于注射用 iza-bren（EGFR×HER3 双抗 ADC）用 于局部晚期或转移性尿路上皮癌患者纳入突破性治疗品种名 单的公告 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、准确性和完整性依法承担法律责任。 四川百利天恒药业股份有限公司（以下简称"公司"）自主研发的全球首创 （First-in-class）、新概念（New concept）且唯一进入 III 期临床阶段的 iza-bren（EGFR ×HER3 双抗 ADC）用于既往经含铂化疗及 PD-1/PD-L1 抑制剂治疗失败的不可手 术切除的局部晚期或转移性尿路上皮癌患者已被国家药品监督管理局药品审评中心 （以下简称"药审中心"）纳入突破性治疗品种名单，近日已完成公示，现将主要 情况公告如下： 截至目前，iza-bren 已有 7 项适应症被药审中心纳入突破性治疗品种名单，1 项 适应症被美国食品药品监督管理局授予突破性疗法认定。除本次新纳入外，其他 7 项适应症具体如下： 2024 ...

百利天恒公告，公司自主研发的注射用iza-bren（EGFR×HER3双抗ADC）用于局部晚期或转移性尿路 上皮癌患者已被国家药品监督管理局药品审评中心纳入突破性治疗品种名单，近日已完成公示。这是该 药品继多个适应症后再次获得突破性治疗品种资格。 ...

智通财经APP讯，百利天恒(688506.SH)发布公告，公司自主研发的全球首创(First-in-class)、新概念 (New concept)且唯一进入III期临床阶段的iza-bren(EGFR×HER3 双抗 ADC)用于既往经含铂化疗及 PD- 1/PD-L1 抑制剂治疗失败的不可手术切除的局部晚期或转移性尿路上皮癌患者已被国家药品监督管理局 药品审评中心(简称"药审中心")纳入突破性治疗品种名单，近日已完成公示。 Iza-bren 是全球首创(First-in-class)、新概念(New concept)且唯一进入III期临床阶段的 EGFR×HER3 双抗 ADC，iza-bren 正在中国和美国进行40 余项针对多种肿瘤类型的临床试验。截至目前，iza-bren 已有7项 适应症被药审中心纳入突破性治疗品种名单，1项适应症被美国食品药品监督管理局授予突破性疗法认 定。 ...

牛市来了还没上车？上天天基金APP搜索777注册即可领500元券包，优选基金10元起投！限 量发放！先到先得！ 近期，定增市场话题不断升温，多位重量级基金经理集中亮相百利天恒定增，引发市场高度关注。 券商中国记者注意到，葛兰、赵蓓、朱少醒等知名基金经理旗下均有产品参与了此次百利天恒的定增。与 此同时，近期多个定增产品的获配名单里也频现知名基金经理身影，这些项目已录得浮盈，凸显出公募资 金在震荡市中的灵活把握与配置热情。 业内人士认为，知名基金经理参与定增项目，不仅体现了对标的成长性的认可，也显示出公募在二级市场 之外积极寻求超额收益的能力。随着政策环境趋稳与市场机制优化，定增有望成为公募主动管理价值加速 释放的重要舞台。 明星产品集中亮相百利天恒定增 9月23日，中欧基金公告披露，旗下由葛兰管理的中欧医疗健康和中欧医疗创新参与了百利天恒非公开发 行股票的认购。这是葛兰最新现身的定增项目，也再次将市场关注的焦点汇聚到医药主题基金上。 百利天恒是一家专注全球生物医药前沿领域的企业，具备ADC药物、大分子生物药和小分子化学药的全系 列研发能力，拥有从中间体、原料药到制剂的一体化优势。公告显示，百利天恒于9月19日完 ...