格隆汇8月4日丨汇宇制药(688553.SH)公布，全资子公司四川汇宇海玥医药科技有限公司（简称"汇宇海 玥"）自主研发的1类生物创新药注射用HY05350（项目研发代号为"HY-0005"）正在开展用于治疗晚期 实体瘤的I期临床试验，于近日成功完成首例受试者给药。注射用HY05350在获得国家药品监督管理局 的药物临床试验批准后，根据国内化学药品创新药相关指导原则，启动"一项评价注射用HY05350在 MSLN阳性晚期实体瘤患者中的安全性、耐受性、药代动力学特征和初步临床有效性的多中心、开放标 签的I/II期临床研究"。该研究的主要目的是在剂量递增阶段评价注射用HY05350单药治疗晚期实体瘤患 者的安全性和耐受性；探索最大耐受剂量（MTD）并为II期或后续临床研究提供推荐剂量（RP2D）及 合理的给药方案；剂量扩展阶段评价注射用HY05350的抗肿瘤疗效。 ...

人民财讯8月4日电，汇宇制药(688553)8月4日晚间公告，公司全资子公司四川汇宇海玥医药科技有限公 司自主研发的1类生物创新药注射用HY05350(项目研发代号为"HY-0005")正在开展用于治疗晚期实体瘤 的I期临床试验，于近日成功完成首例受试者给药。 ...

Investment Rating - The report maintains a positive outlook on the pharmaceutical and biotechnology industry, emphasizing the transition from "Made in China" to "Created in China" for innovative drugs [10]. Core Insights - The report highlights that domestic innovative drugs are gaining global competitiveness and are currently in the first and second stages of international expansion, primarily through licensing agreements and partnerships [10][12]. - The report identifies key areas of focus for investment, including PD-(L)1 plus, ADCs, and GLP-1 drugs, which are expected to drive future growth and business development (BD) opportunities [10][51]. Summary by Sections Section 1: Transition from "Manufacturing" to "Innovation" - The policy reforms initiated in 2015 have stimulated a shift from generic to innovative drug development in China, with significant increases in R&D investment since 2018 [19][21]. - The number of First-in-Class (FIC) drugs developed in China has risen from 9 in 2015 to 120 in 2024, indicating a substantial increase in innovation [25][26]. Section 2: Continued BD Opportunities - PD-(L)1 plus is identified as a cornerstone for next-generation cancer treatments, with significant demand and potential for new products [51]. - The report notes that ADCs are transitioning towards more differentiated targets, focusing on unmet clinical needs, with promising candidates like PD-L1, DLL3, and EGFR [51]. - The GLP-1 market is experiencing rapid growth, with a focus on multi-target, oral, combination, and long-acting formulations [51]. Section 3: Investment Recommendations - For PD-(L)1 plus, companies such as Kangfang Biotech, Shansheng Pharmaceutical, and Junshi Biosciences are recommended for investment due to their strong pipelines [5]. - In the ADC space, companies like Fuhong Hanlin and Zai Lab are highlighted for their potential in addressing unmet clinical needs [5]. - In the GLP-1 sector, firms such as Borui Pharmaceutical and Zai Lab are noted for their promising developments [5].

Group 1: Government Initiatives - The Ministry of Finance announced the establishment of a "Childcare Subsidy Fund" with an initial budget of approximately 90 billion yuan for this year [1][2] - The National Development and Reform Commission is soliciting public opinions on guidelines for government investment funds, emphasizing the need to control investment amounts and promote effective market-government collaboration [2] Group 2: Industry Developments - The China Metal Materials Circulation Association issued a proposal to resist "involution-style competition" in the steel circulation industry, advocating for compliance with laws and encouraging cooperative models in logistics and processing [3] - The Anhui Provincial Department of Industry and Information Technology is seeking opinions on a plan to optimize the non-ferrous metal industry, focusing on enhancing supply chains and promoting high-end, intelligent, and green development [3] Group 3: Market Trends - The sports industry is experiencing a surge in interest, with several sports-related stocks seeing significant gains following the announcement of the "Hunan Super League" and the upcoming World Games in Chengdu [5][6] - The baby and toddler sector is gaining momentum due to the implementation of the childcare subsidy system, with stocks in this sector showing strong performance [7] Group 4: Financial Performance - Nine funds have seen their net values double this year, driven by the ongoing performance of the innovative drug sector, with specific funds reporting returns exceeding 100% [13] - XGIMI Technology expects a revenue of 1.626 billion yuan for the first half of 2025, a year-on-year increase of 1.63%, while Longjiang Electric Power anticipates a revenue of 36.587 billion yuan, up 5.02% year-on-year [9]

Core Viewpoint - Sichuan Huiyu Pharmaceutical Co., Ltd. has successfully completed the first administration of its innovative drug injection HY0001a in a Phase I clinical trial for treating advanced solid tumors [1][2]. Group 1: Drug Overview - Injection HY0001a is a first-class innovative biological product developed by the company's wholly-owned subsidiary, Huiyu Haiyue Pharmaceutical Technology Co., Ltd., aimed at treating advanced solid tumors [1][2]. - The clinical trial application for HY0001a was accepted by the National Medical Products Administration (NMPA) in April 2025, and the clinical trial approval notice was received in June 2025 [1]. Group 2: Research and Development Progress - Following the approval from NMPA, a multi-center, open-label Phase I/II clinical study has been initiated to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical efficacy of HY0001a in patients with advanced malignant solid tumors [2]. - The main objectives of the study include assessing the safety and tolerability of HY0001a as a monotherapy, exploring the maximum tolerated dose (MTD), and providing recommended dosing for subsequent clinical studies [2]. - As of June 30, 2025, the cumulative R&D investment in this project is approximately RMB 60.10 million (unaudited) [2]. Group 3: Market Potential - Research indicates that CDCP1 is highly expressed in various cancers such as gastric, breast, lung, colorectal, and pancreatic cancers, making it an important target for ADC drug development [3]. - Preclinical studies have shown that HY0001a exhibits excellent anti-tumor effects and good safety profiles across multiple solid tumor models, indicating significant clinical development value [3].

今日焦点 宁德时代：上半年实现净利润305亿元同比增长33.02% 宁德时代公告，上半年实现收入1789亿元，同比增加7.27%；净利润305亿元，同比增长33.02%。报告 期内，本集团实现毛利448亿元，相比2024年同期增加14.45%；综合毛利率为25.02%，相比2024年同期 的23.45%上升1.57个百分点。 上纬新材：多次触及股票交易异常波动和严重异常波动情形明起停牌核查 上纬新材公告称，公司股票自2025年7月9日至7月30日期间多次触及股票交易异常波动及严重异常波动 情形。公司将于7月31日开市起停牌，预计停牌时间不超过3个交易日。公司基本面未发生重大变化，但 股票交易价格已严重脱离基本面，投资者参与交易可能面临较大市场风险。此外，公司股票价格涨幅显 著高于同期相关指数涨幅，换手率显著高于前期水平，市盈率显著高于行业平均水平。公司主营业务和 生产经营未发生重大变化，收购方未来十二个月内不存在资产重组计划，但控制权变更事项仍存在重大 不确定性风险。 金橙子：筹划购买萨米特光电55%股权，股票停牌 金橙子公告称，公司正在筹划以发行股份及支付现金的方式购买长春萨米特光电科技有限公司55%的股 ...

Group 1 - The core point of the article is that Huayu Pharmaceutical announced that its wholly-owned subsidiary, Sichuan Huayu Haiyue Pharmaceutical Technology Co., Ltd., has initiated a Phase I clinical trial for its innovative biological drug HY0001a, aimed at treating advanced solid tumors, with the first patient successfully dosed recently [2] Group 2 - The drug HY0001a is classified as a first-class innovative biological drug, indicating its potential significance in the pharmaceutical market [2] - The commencement of the clinical trial marks a critical milestone in the drug development process, reflecting the company's commitment to advancing cancer treatment options [2]

一、注射用 HY0001a 的基本情况 证券代码：688553 证券简称：汇宇制药 公告编号：2025-057 四川汇宇制药股份有限公司 自愿披露注射用 HY0001a I 期临床试验首例受试者给药的 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。 四川汇宇制药股份有限公司（以下简称"汇宇制药"或"公司"）全资子公 司四川汇宇海玥医药科技有限公司（以下简称"汇宇海玥"）自主研发的 1 类生 物创新药注射用 HY0001a（项目研发代号为"HY-0001"）正在开展用于治疗晚 期实体瘤的 I 期临床试验，于近日成功完成首例受试者给药。现将相关情况公告 如下： 四、风险提示 由于医药产品具有高科技、高风险、高附加值的特点，药品的前期研发以及 产品从研制、临床试验报批到投产的周期长、环节多，容易受到一些不确定性因 素的影响。敬请广大投资者谨慎决策，注意防范投资风险。 公司将按国家有关法规的规定积极推进上述研发项目，并严格按照有关规定 及时对项目后续进展情况履行信息披露义务。有关公司信息请以上海证券交易所 网站和公司指定披露 ...

Core Viewpoint - Huiyu Pharmaceutical (688553.SH) announced that its wholly-owned subsidiary Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd. has initiated a Phase I clinical trial for its self-developed innovative biological drug injection HY0001a, aimed at treating advanced solid tumors, with the first patient successfully dosed recently [1] Group 1: Product Development - Injection HY0001a is an antibody-drug conjugate classified as a Class 1 innovative therapeutic biological product [1] - As of the announcement date, there are no approved products targeting the same site in both domestic and international markets [1] Group 2: Research and Efficacy - Research indicates that CDCP1 is highly expressed in various tumors such as gastric cancer, breast cancer, lung cancer, colorectal cancer, and pancreatic cancer, while normal tissues show low or no expression, making it a significant potential target for ADC drug development [1] - Preclinical studies demonstrate that HY0001a exhibits excellent anti-tumor effects and good safety in multiple solid tumor models, indicating substantial clinical development value [1]

Core Viewpoint - Huiyu Pharmaceutical (688553.SH) announced that its wholly-owned subsidiary, Sichuan Huiyu Haiyue Pharmaceutical Technology Co., Ltd., has initiated a Phase I clinical trial for its self-developed innovative biological drug, HY0001a, aimed at treating advanced solid tumors, with the first patient successfully dosed recently [1] Group 1 - HY0001a is an antibody-drug conjugate classified as a Class 1 innovative therapeutic biological product, with no approved products targeting the same site in both domestic and international markets as of the announcement date [1] - Research indicates that CDCP1 is highly expressed in various tumors such as gastric cancer, breast cancer, lung cancer, colorectal cancer, and pancreatic cancer, while normal tissues show low or no expression, making it a significant potential target for ADC drug development [1] - Preclinical studies demonstrate that HY0001a exhibits excellent anti-tumor effects and good safety in various solid tumor models, indicating substantial clinical development value [1]