7月25日，南京江北新区生物医药谷园区企业南京维立志博生物科技股份有限公司在港交所主板成功挂 牌上市，股份代号：09887，预计募集资金总额可达1.89亿美元(含绿鞋)。这也是今年南京江北新区第二 家上市企业。 作为一家处于临床阶段的生物科技公司，维立志博于2012年成立，十余年来，团队始终专注于肿瘤、自 身免疫性疾病及其他重大疾病新疗法的发现、开发及商业化。 如今，公司已拥有涵盖14款创新候选药物的多元化产品组合，包括4款核心及主要产品，各款产品组合 均处于全球临床进度领先的候选药物之列。 不仅是LBL-024这一核心产品，维立志博还有5款其他临床阶段候选药物、8款额外临床前阶段候选药 物。不断扩展的创新管线，也赢得资本市场的瞩目，截至目前，企业已完成8轮融资。 值得一提的是，就在一个月前，南京江北新区企业药捷安康也在港交所鸣锣上市。其间，新区生物医药 谷还有两款一类新药接连获批上市：先声药业的一类新药恩泽舒，成为我国首个取得铂耐药卵巢癌全人 群适应症的靶向药；征祥医药自主研发的一类新药济可舒，为流感治疗带来新选择。 药企争相上市的背后，是南京江北新区生命健康产业发展如火如荼。截至目前，园区上市药品总数达到 ...

Investment Rating - The industry investment rating is "stronger than the market," indicating that the industry index is expected to outperform the market by more than 5% over the next six months [56]. Core Insights - The report highlights the rapid pace of the implementation of the 11th batch of national centralized procurement, with 55 varieties included, a decrease of 7 from the previous batch. The average price drop in past procurement batches ranged from 48% to 59% [4][10]. - The total sales scale of the 11th batch of procurement varieties in medical institutions is projected to exceed 49 billion yuan in 2024 [10]. - The report identifies key therapeutic areas for the 55 varieties, including blood and hematopoietic system drugs, digestive system and metabolic drugs, respiratory system drugs, and others, with varying numbers of products in each category [10][11]. Summary by Sections National Procurement Overview - The 11th batch of national centralized procurement includes 55 varieties, with a total of 515 varieties across all batches. The average price drop in previous batches was between 48% and 59% [4][6]. - The timeline from the release of procurement documents to the announcement of selected results is approximately 1-2 months, followed by 3-4 months for implementation [4][7]. Competitive Landscape - Among the 55 varieties, 37 have 10 or more qualifying companies, with 4 having 30 or more. The leading companies in terms of the number of approved varieties include Beite Pharmaceutical, Kelun Pharmaceutical, and Fosun Pharma [10][12]. Changes in Procurement Rules - The report outlines changes in procurement rules for the 11th batch, including reasons for exclusion of certain products, such as low annual procurement amounts and high clinical risks [16][19]. - The reporting method for medical institutions has shifted from generic names to specific brand names for reporting quantities [19]. Sales and Market Share - The report provides a detailed table of the expected sales and market share for various products in the 11th batch, highlighting significant sales figures for products like Dapagliflozin and Olaparib, with market shares reaching up to 100% for some products [24][26]. Investment Strategy - The report suggests focusing on innovative pharmaceutical companies with rich pipeline layouts, such as Heng Rui Medicine and BeiGene, as well as companies with significant single-product potential and leading technology platforms [30].

Policy Developments - The National Medical Products Administration (NMPA) reported five cases of illegal online sales of medical devices, including companies selling products without proper licenses and failing to meet regulatory requirements [2] Drug and Device Approvals - East China Pharmaceutical's subsidiary received approval for clinical trials of HDM2012, a novel antibody-drug conjugate targeting mucin-17, marking it as a global first-class biological product [3] - Novo Nordisk announced that the NMPA approved the new indication for Ozempic (semaglutide injection) for chronic kidney disease, making it the first GLP-1 receptor agonist approved for this use in China [4] - Wanfu Bio received a medical device registration certificate for its MSI detection kit, which is significant for various solid tumor patients [5] Financial Reports - Fuan Pharmaceutical projected a net profit decline of 39.95% to 53.81% for the first half of 2025, primarily due to price reductions from national procurement policies [6] Capital Market Activities - Kanghua Bio announced a transfer of shares that will change its controlling shareholder to Wanke Xin Bio, with a total transfer price of approximately 1.85 billion yuan [8] - Jichuan Pharmaceutical's stock will resume trading after a tender offer by Cao Fei, who will control 56.07% of the company post-offer [9] Industry Developments - A new oral antiviral drug for influenza, Marselevosavir, developed by Zhengxiang Pharmaceutical, has been approved for use in treating uncomplicated influenza in previously healthy adults [10] Public Opinion Alerts - Notai Bio is facing other risk warnings due to a prior administrative penalty for false reporting, which included inflating revenue and profits [11]

业 及 产 业 2025 年 07 月 20 日 本周医药上涨 4.0%，第十一批国 采启动报量，禾元重组人白蛋白获 批上市 看好 ——医药行业周报（2025/7/14-2025/7/18） 本期投资提示： 相关研究 《本周医药上涨 1.8%，中方限制采购欧盟 医疗器械，默沙东百亿美元获取 COPD 新 药——医药行业周报（2025/7/7- 2025/7/11）》 2025/07/13 《本周医药上涨 3.6%，创新药及高端器械 再迎支持政策，医保目录谈判正式启动， AZ/Summit 或达成超 150 亿美元交易 — —医药行业周报（2025/6/30- 2025/7/4）》 2025/07/06 证券分析师 张静含 A0230522080004 zhangjh@swsresearch.com 李敏杰 A0230523070006 limj2@swsresearch.com 医药生物 证 券 研 究 报 告 请务必仔细阅读正文之后的各项信息披露与声明 本研究报告仅通过邮件提供给 中庚基金 使用。1 行 行 业 研 究 / 行 业 点 评 ⚫ 市场表现：本周申万医药生物指数上涨 4.0%，同期上证指数上涨 ...

中证报中证网讯(记者李梦扬)7月18日，国家药品监督管理局官网显示，抗流感1类创新药济可舒(通用 名：玛硒洛沙韦片)获批上市。 据介绍，济可舒是我国自主研发、具有全球自主知识产权的新一代靶向流感病毒RNA聚合酶PA抑制 剂，通过特异性抑制病毒mRNA的转录发挥抗病毒作用。研究显示，济可舒的临床研究对象均源于中国 患者，临床用药依据更具针对性和适用性，契合国人体质特点，为抗击流感提供治疗方案。 据了解，济可舒治疗青少年无并发症的单纯性流感Ⅲ期临床研究已经递交上市申请(NDA)，5岁-11岁儿 童无并发症单纯性流感的有效性及安全性等多项Ⅲ期临床研究正在开展，以满足患者差异化用药需求。 随着流感季的常态化，高效、安全、便捷的治疗方案成为临床与患者的共同需求。公司称，济可舒有望 为流感患者提供差异化用药选择，为抗击流感贡献了中国智慧，也为全球抗流感药物市场注入了新的活 力。 据悉，济川药业（600566）与征祥医药于2023年围绕济可舒注册、生产、推广、渠道管理及商业销售达 成战略合作，济川药业享有济可舒在中国的独家推广和销售权益。 由国家传染病医学中心、复旦大学附属华山医院感染科主任张文宏教授，中国医学科学院北京协 ...

7月18日，国家药监局官网显示，流感抗病毒口服药物玛硒洛沙韦片（商品名：济可舒）获批上市， 用于治疗既往健康的成人单纯性甲型和乙型流感患者，不包括存在流感相关并发症高风险的患者。玛 硒洛沙韦是征祥医药自主研发的新一代聚合酶酸性蛋白（PA）核酸内切酶抑制剂，具有广谱抗流感 病毒的特性，对甲、乙型流感病毒、高致死禽流感病毒等均具有抗病毒活性。 ...

据国家药监局官网7月18日消息，流感抗病毒口服药物玛硒洛沙韦片（商品名：济可舒）获批上市，用 于治疗既往健康的成人单纯性甲型和乙型流感患者，不包括存在流感相关并发症高风险的患者。 （国 家药监局） ...