Core Insights - Huadong Medicine's subsidiary has received full approval from the NMPA for the somatuzumab injection (ELAHERE), marking it as the first and only approved ADC drug for platinum-resistant ovarian cancer in China, the US, and the EU [1][2] - The drug is developed in collaboration with ImmunoGen, Inc. and targets the folate receptor alpha (FRα), which is highly expressed in ovarian cancer [1] - The approval is based on positive results from the pivotal Phase III MIRASOL trial, which demonstrated a 35% reduction in the risk of tumor progression or death and a 33% reduction in mortality risk compared to chemotherapy [1][3] Industry Context - Ovarian cancer, known as the "king of female cancers," poses significant treatment challenges, with a 5-year survival rate of only about 40% in China [2] - There is a pressing clinical demand for innovative therapies due to the limitations of traditional non-platinum chemotherapy, which has a response rate of less than 15% and a median progression-free survival of only 3-4 months [2] - The drug has already been launched in specific regions, with sales exceeding 45 million yuan in the first nine months of 2025, and it is expected to play a crucial role in addressing unmet clinical needs in platinum-resistant ovarian cancer [3]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Views - The report emphasizes three core investment directions: 1) Breakthroughs in cutting-edge technologies (e.g., First-in-class drugs in oncology, weight loss, autoimmune fields, and innovative devices like brain-machine interfaces); 2) Clinical validation and commercialization potential (focus on the progress of domestic innovative drugs going abroad and the clinical development progress post-BD transactions); 3) Efficiency advantages in the industry chain (CXO leaders and high-value consumables' global layout) [8] Industry Review - The pharmaceutical and biotechnology industry index increased by 0.81%, ranking 21st among 31 primary industries, outperforming the CSI 300 index which decreased by 0.27% [5][16] - The sub-industries of pharmaceutical circulation and in vitro diagnostics saw significant gains of 7.61% and 5.32% respectively, while medical research outsourcing and medical devices experienced declines of 3.49% and 1.76% [5][16] - As of November 14, 2025, the industry PE (TTM overall method, excluding negative values) was 30.89x, up from 30.67x in the previous period, indicating an upward valuation trend that remains below the average [21] - The top three PE ratios among the sub-industries were for vaccines (50.42x), hospitals (43.67x), and medical devices (37.84x), while pharmaceutical circulation had the lowest valuation at 15.46x [21] Important Industry News - The National Health Commission and others issued implementation opinions to promote and regulate the application of "AI + healthcare" [7] - The NMPA released a new version of the "Medical Device Production Quality Management Specifications" [7] - Novartis received NMPA approval for its first radioligand therapy drug "Pluvicto®" for dual indications [7] - Sanofi's innovative targeted nano-antibody "Cablivi®" was approved by NMPA for treating immune-mediated thrombotic thrombocytopenic purpura [7] - The U.S. government reached a drug price control agreement with Eli Lilly and Novo Nordisk, leading to significant price reductions for GLP-1 drugs [7]

Core Viewpoint - The approval of the supplemental application for the drug Somatuzumab injection (brand name: ELAHERE) marks a significant milestone in the product's development process for the company [1] Company Summary - The company's wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the approval notice from the National Medical Products Administration for the supplemental application of Somatuzumab injection [1] - The company plans to actively promote the commercialization of ELAHERE in the Chinese market, aiming to provide better clinical treatment options for relevant patients [1]

11月17日，华东医药（000963）(000963.SZ)宣布，其全球首创(First-in-class)药物索米妥昔单抗注射液 (爱拉赫/ELAHERE)由附条件批准转为常规批准的补充申请获国家药品监督管理局(NMPA)批准。该药物 用于治疗既往接受过1-3线系统性治疗的FRα阳性铂耐药卵巢癌(PROC)，是目前全球首个且唯一获批用 于该适应症的靶向FRα的ADC药物。 依托"港澳药械通"政策优势，爱拉赫已在国内市场实现快速布局与早期销售放量。爱拉赫2025年1-9月 已实现销售收入超4,500万元，并且该产品国内市场正式上市工作推进顺利，2025年11月，该产品已在 复旦大学附属肿瘤医院、中山大学孙逸仙纪念医院顺利开出国内首批首方。 此外，该药在海外市场亦表现出强劲的商业化增长。根据AbbVie财报，2025年第三季度ELAHERE实现 销售额1.7亿美元，同比增长22.3%；前三季度累计销售额达5.08亿美元，同比增长53.5%，显示其持续 放量趋势。 凭借华东医药成熟的商业化体系与渠道优势，爱拉赫有望依托其"首创且唯一"的先发地位，快速切入国 内空白市场。此次成功转为常规批准，不仅反映出公司前瞻性的 ...

Core Viewpoint - Huadong Medicine's subsidiary, Sino-American Huadong, received approval from the National Medical Products Administration (NMPA) for the supplemental application of Somatuzumab Injection, transitioning from conditional approval to regular approval [1] Group 1: Company Developments - The approved drug, Somatuzumab Injection (brand name: ELAHERE, R&D code: HDM2002), is indicated for adult patients with platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received 1-3 lines of systemic therapy and are positive for folate receptor alpha (FRα) [1]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received approval from the National Medical Products Administration (NMPA) for the supplemental application of the drug Somatuzumab Injection, transitioning from conditional approval to regular approval [1] Group 1 - The drug Somatuzumab Injection is marketed under the name ELAHERE® with the research code HDM2002 [1] - The approval signifies a significant regulatory milestone for Huadong Medicine, enhancing its product portfolio and market position [1]

证券代码：000963 证券简称：华东医药 公告编号：2025-102 本公司及董事会全体成员保证信息披露的内容真实、准确、完整，没有虚假 记载、误导性陈述或重大遗漏。 2025年11月14日，华东医药股份有限公司（以下简称"公司"） 全资子公司杭州中美华东制药有限公司（以下简称"中美华东"）收 到国家药品监督管理局（NMPA）核准签发的《药品补充申请批准通 知书》，中美华东申报的索米妥昔单抗注射液（商品名称：爱拉赫®/ ELAHERE ®，研发代码：HDM2002）由附条件批准转为常规批准的 补充申请获得批准。现将有关详情公告如下： 一、该药物基本信息内容 药品通用名称：索米妥昔单抗注射液 英文名：Mirvetuximab Soravtansine Injection 商品名称：爱拉赫/ELAHERE 规格：100 mg（20mL）/瓶 申请事项：境外生产药品补充申请 华东医药股份有限公司 关于全资子公司获得药品补充申请批准通知书的公告 注册分类：治疗用生物制品3.1类 受理号：JYSB2500057 通知书编号：2025B05457 原药品批准文号：国药准字SJ20240044 申报适应症：本品适用于既往 ...

Core Viewpoint - Huadong Medicine's subsidiary, Sino-American Huadong, received approval from NMPA for the conversion of the conditional approval of Somatuzumab injection to regular approval, applicable for specific ovarian cancer patients [1] Group 1: Product Approval - The product is an ADC innovative drug developed in collaboration with ImmunoGen, with Huadong Medicine holding exclusive rights in Greater China [1] - The approval was based on the results of a confirmatory Phase III clinical trial, and the product is already available in multiple locations [1] Group 2: Financial Performance - In the first three quarters of 2025, ELAHERE achieved sales revenue exceeding 45 million yuan, with global net revenue of 508 million USD [1] - The approval is expected to positively impact the company's future performance, although sales are influenced by various factors, leading to uncertainty [1]

Group 1 - The core viewpoint indicates a decline in innovative drug concept stocks, with notable drops in companies such as Kanglong Chemical, Kelun Pharmaceutical, and Xinlitai, among others [1] - The innovative drug-related ETFs have also experienced a decline, with an overall drop exceeding 2% [1] - Despite the downturn, there have been positive developments in China's biotechnology sector, including 35 research presentations at the ESMO 2025 conference and significant collaborations like the $11.4 billion partnership between Innovent Biologics and Takeda, highlighting global recognition of Chinese innovative drug value [2]

Core Viewpoint - On November 17, a total of 17 listed companies will have their restricted shares unlocked, with a total market value of approximately 22.745 billion yuan [1] Summary by Category Restricted Shares Unlocking - The total number of restricted shares unlocking on this date is significant, with a total market value of about 22.745 billion yuan [1] - Specific companies and their respective unlocking details include: - Yingte Group (000411): 273,600 shares from equity incentive [1] - East China Pharmaceutical (000963): 1,630,300 shares from equity incentive [1] - Innovation New Materials (600361): 2.867 billion shares from other types [1] - Fida Environmental Protection (600526): 152 million shares with extended lock-up period [1] - New Mileage (002219): 8.7 million shares from equity incentive [1] - Anke Bio (300009): 12.3941 million shares from equity incentive [1] - Songcheng Performance (300144): 2.16 million shares from equity incentive [1] - Keheng Co., Ltd. (300340): 511,400 shares from equity incentive [1] - Haoxiangni (002582): 1 million shares from equity incentive [1] - Zhongzhi Technology (301361): 2.252 million shares from pre-issue [1] - Jack Co., Ltd. (603337): 2.4576 million shares from equity incentive [1] - Tian'ao Electronics (002935): 105,400 shares from equity incentive [1] - Huatuo Cable (605196): 556,000 shares from equity incentive [1] - Yongshuntai (001338): 266 million shares from pre-issue [1] - New World (301277): 149 million shares from pre-issue [1] - Yongxi Electronics (688362): 130 million shares [1] - Kangxi Communication (688653): 3.184 million shares [1]