"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， ...

□ 本报记者杨彦 近日，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。据统计，今年以来江苏 已获批7款国产1类创新药。 百济神州(苏州)生物科技有限公司申报的注射用泽尼达妥单抗，适用于既往接受过全身治疗的HER2高 表达(IHC3+)的不可切除局部晚期或转移性胆道癌患者。 江苏恒瑞医药（600276）股份有限公司申报的1类创新药苹果酸法米替尼胶囊，该药联合注射用卡瑞利 珠单抗用于既往接受含铂化疗治疗失败但未接受过贝伐珠单抗治疗的复发或转移性宫颈癌患者。 江苏泰康生物医药有限公司申报的注射用阿格司亭α，适用于成年非髓性恶性肿瘤患者在接受容易引起 发热性中性粒细胞减少症的骨髓抑制性抗癌药物治疗时，降低以发热性中性粒细胞减少症为表现的感染 发生率。 今年以来，省药监局全面深入贯彻《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业高 质量发展的意见》，着力打造医药产业发展的政策高地、服务高地、创新高地、质量高地。年初，省药 监局制定《关于持续深化药品医疗器械监管改革优化"面对面"对接服务助力医药产业高质量发展的工作 方案》，全系统深入摸排、组织座谈会、实地走访等形式，优化"一品一专班"服务 ...

[Table_Reportdate] 2025年06月03日 [table_invest] 超配 行 业 周 报 杜永宏 S0630522040001 dyh@longone.com.cn 证券分析师 赖菲虹 S0630525050001 lfhong@longone.com.cn 联系人 付婷 futing@longone.com.cn [table_stockTrend] -25% -17% -8% 1% 10% 18% 27% 24-05 24-08 24-11 25-02 申万行业指数:医药生物(0737) 沪深300 [相关研究 table_product] 1.重磅BD交易再次带动创新药热度 — — — — 医 药 生 物 行 业 周 报 （2025/05/19-2025/05/25） [Table_NewTitle 创新药密集上市， ] 关注后续医保谈判 ————医药生物行业周报（2025/05/26-2025/06/01） [table_main] 投资要点： ➢ 市场表现： 上周（05月26日-05月30日）医药生物板块整体上涨2.21%，在申万31个行业中排第 2位，跑赢沪深300指数3. ...

"同一天获批三款创新药！"5月29日晚间，恒瑞医药（600276.SH，股价54.74元，市值3614.77亿元）相 关人士在朋友圈连发三条朋友圈，庆祝当天公司获批的三款1类创新药。 当天，国家药监局公布了近日获批上市的11款创新药。 创新药景气度不断提升，资本市场热情高涨。5月30日，恒生医药ETF近1年净值上涨47.76%。恒生医药 ETF（159892）盘中创阶段性新高，个股方面，百利天恒（688506.SH，股价301.18元，市值1207.73亿 元）报收301.18元/股，创历史新高，舒泰神、海南海药、科兴制药等延续近日上涨行情。 交银国际指出，2025年美国临床肿瘤学会（ASCO）年会召开在即（5月30日至6月3日）。"2025 ASCO 摘要"中，中国创新药入选数量再创新高，印证中国创新药企研发竞争力实现跨越式突破，国际影响力 日渐提高。 11款创新药近期获批上市，恒瑞医药"一键三连" 5月29日，恒瑞医药单日获批3款药物的消息，在医药圈"刷屏"。 获批的三款药物（疗法）为注射用磷罗拉匹坦帕洛诺司琼（商品名：瑞坦宁）、自主研发的HER2 ADC （抗体偶联药物）、1类新药注射用瑞康曲妥珠单抗（ ...

Group 1 - Guangyang Co., Ltd. has decided to terminate the plan to acquire 100% equity of Ningbo Yinqiu Technology Co., Ltd. and will resume trading on May 30, 2025 [1] - Longjing Environmental Protection plans to invest 75.075 million yuan to acquire 20% equity in Zhejiang Jitai Intelligent Technology Co., Ltd. [1] - Fengmao Co., Ltd. intends to invest up to 1.5 billion yuan to establish an automotive parts production base in Jiaxing [2] Group 2 - JinkoSolar has received a government subsidy of 98 million yuan [2] - Huayuan Real Estate has completed the registration of its name change to "Huayuan Holdings," effective June 5, 2025 [2][3] - Haisen Pharmaceutical's general manager plans to reduce his stake by 0.97% of the company's total shares [4][5] Group 3 - Shandong Highway plans to issue bonds not exceeding 8 billion yuan [6] - Mengguli's shareholders plan to collectively reduce their stake by up to 5% [7] - Yihua Tong has terminated its fuel cell comprehensive testing evaluation center project, originally planned for 220 million yuan [9] Group 4 - Ouma Software is the first candidate for the banking industry association's professional qualification examination service project, with a bid of 39.90 yuan per subject [11] - ST Dehao's subsidiary plans to invest 50 million yuan in an automotive LED packaging project [11] - Shuanglin Co., Ltd. plans to raise no more than 1.5 billion yuan through a private placement [12] Group 5 - Huaci Co., Ltd. plans to raise no more than 700 million yuan for the ASEAN Ceramic Valley project [13] - Aisi Kai intends to sign a procurement framework agreement for ceramic 3D printers, not exceeding 7.5 million yuan [14] - Baolingbao's major shareholder plans to reduce their stake by up to 3% [15] Group 6 - Heng Rui Pharmaceutical's subsidiary has received conditional approval for the launch of a class 1 innovative drug for lung cancer treatment [16][17] - *ST Jinguang is facing delisting due to continuous false reporting in annual reports from 2020 to 2023 [18] - Guangxi Broadcasting plans to swap 100% equity of Guangdian Technology for 51% equity of Jiaoke Group, with both assets valued at 1.411 billion yuan [19][20] Group 7 - ST Ruike's stock will be delisted from risk warnings and will change its name to "Guorui Technology" effective June 3, 2025 [21][22]

Core Viewpoint - The company has received conditional approval from the National Medical Products Administration for its innovative drug, SHR-A1811, which targets HER2 mutations in non-small cell lung cancer (NSCLC) patients, marking a significant advancement in treatment options for this rare mutation type [1][2]. Group 1: Product Approval and Significance - SHR-A1811 is the first antibody-drug conjugate (ADC) approved in China for HER2 mutation NSCLC patients, addressing a critical need as traditional treatments have limited efficacy [1][2]. - The approval is based on the HORIZON-Lung study, which reported a median follow-up of 14.2 months, with an objective response rate (ORR) of 74.5% and a median progression-free survival (mPFS) of 11.5 months [2]. Group 2: Market Context and Competitors - Existing similar products in the market include Kadcyla and Enhertu, with combined global sales projected to reach approximately $6.557 billion in 2024 [3]. - The company has invested around 1.17007 billion yuan in the development of SHR-A1811, indicating a strong commitment to research and development [3]. Group 3: Future Potential and Research - SHR-A1811 is being explored for its potential in first-line treatment for HER2 mutation NSCLC and other cancer types, with eight indications receiving breakthrough therapy designation from the National Medical Products Administration [2].

开门七件事，柴米油盐酱醋茶。万事安为先，筑生命健康防线。 治：防惩结合，全链监管深一度 刚刚过去的"五一"假期，苏式美食惊艳八方来客。由苏州市市场监管局开展的"你点我检 服务惠民 生"食品安全专项抽检行动，则为市民和游客添安心。在假期之前，市民点选的热门食品抽检结果出 炉，来自农贸市场、餐饮单位、超市及食杂店的220批次样品，农药残留、兽药残留、食品添加剂、微 生物、重金属等安全指标一一过关，抽检食品清单、具体安全状况集中向社会公布，针对儿童节、端午 节的"你点我检"工作也同步启动。 食品药品安全，是与百姓息息相关的大事，不仅是城市软实力不可或缺的核心要素，更是公众获得 感、幸福感持续提升的重要保障。 20.9万家食品生产经营主体，4200家生物医药企业，苏州食品、药品行业体量大发展快，稳固守住 安全底线是唯一前提。近年来，苏州以"最严谨的标准、最严格的监管、最严厉的处罚、最严肃的问 责"推动全市食品药品安全工作取得显著成效。苏州食品安全"六化"建设等多项创新做法获国务院食安 办肯定并广泛推广，连续五年在全省食品安全专项考核中获优秀等次，在2024年市县药品监管能力标准 化建设评估中获全省第一，食品药品安全形 ...