Investment Rating - The report maintains a positive outlook on the innovative drug and medical device industry, highlighting key targets for investment [5][24]. Core Insights - The innovative drug sector is experiencing high growth, with a focus on companies such as Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, and others. The report emphasizes the potential for value re-evaluation in these firms [5][24]. - Recent business development (BD) deals in the innovative drug sector are expected to catalyze market activity, with notable transactions including Jiangsu Heng Rui Medicine's agreement with Kite for a $1.20 billion upfront payment, potentially reaching $15.20 billion in total [5][24]. - The A-share pharmaceutical sector underperformed the broader market in the third week of October 2025, with the Shanghai Composite Index falling by 1.5% and the SW Biopharma index declining by 2.5% [7][18]. Summary by Sections 1. Continuous Focus on Innovative Drugs and Medical Devices - The report emphasizes the high growth potential in innovative drugs, with key investment targets including Jiangsu Heng Rui Medicine, Hansoh Pharmaceutical Group, and others. Related targets include CSPC Innovation Pharmaceutical [5][24]. 2. A-Share Pharmaceutical Sector Performance - In the third week of October 2025, the A-share pharmaceutical sector saw a decline of 2.5%, underperforming the Shanghai Composite Index, which fell by 1.5%. The report notes that the sector's premium relative to all A-shares is currently at a normal level, with a relative premium rate of 74.5% [7][14][21]. 3. Hong Kong and U.S. Pharmaceutical Sector Performance - The report indicates that the Hong Kong and U.S. pharmaceutical sectors also underperformed, with the Hang Seng Healthcare index dropping by 5.8% and the S&P 500 Healthcare index increasing by only 0.7% during the same period [18][24].

Group 1 - Company Zhejiang Daor Bio-Tech Co., Ltd., a subsidiary of Huadong Medicine, has received approval from the U.S. FDA for its clinical trial application for the drug DR10624 injection [1] - The approved clinical trial is aimed at treating Severe Hypertriglyceridemia (SHTG) [1]

Core Viewpoint - The company announced that its subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has received approval from the U.S. FDA to conduct clinical trials for the drug DR10624, which targets severe hypertriglyceridemia (SHTG) [1] Group 1 - The clinical trial application for DR10624 injection has been approved by the U.S. FDA [1] - The approved indication for DR10624 is severe hypertriglyceridemia (SHTG) [1] - The approval allows the company to initiate clinical trials in the United States [1]

华东医药股份有限公司 关于控股子公司获得药物临床试验批准通知书的公告 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。 近日，华东医药股份有限公司（以下简称"公司"） 控股子公司 浙江道尔生物科技有限公司（以下简称"道尔生物"）收到美国食品 药品监督管理局（以下简称"美国 FDA"）通知，由道尔生物申报的 DR10624 注射液药品临床试验申请已获得美国 FDA 批准，可在美国 开 展 临 床 试 验 ， 适 应 症 为 重 度 高 甘 油 三 酯 血 症 （ Severe Hypertriglyceridemia，SHTG）。现将有关详情公告如下： 证券代码：000963 证券简称：华东医药 公告编号：2025-094 二、该药物研发及注册情况 DR10624 是道尔生物自主研发的全球首创（First-in-class）的靶 向成纤维细胞生长因子 21 受体（Fibroblast growth factor 21 receptor， FGF21R）、胰高血糖素受体（Glucagon receptor，GCGR）和胰高血 糖素样肽-1 受体（Glucagon-l ...

Core Viewpoint - The company announced that its subsidiary, Zhejiang Daor Biotechnology Co., Ltd., has received FDA approval for the clinical trial application of the drug DR10624, which targets severe hypertriglyceridemia (SHTG) [1] Company Summary - Zhejiang Daor Biotechnology Co., Ltd. is a subsidiary of the company [1] - The approved drug, DR10624, is intended for the treatment of severe hypertriglyceridemia (SHTG) [1] - The FDA approval allows the company to conduct clinical trials in the United States [1] Industry Summary - The approval of DR10624 indicates potential growth opportunities in the biotechnology sector, particularly in treatments for severe hypertriglyceridemia [1]

Core Insights - The company announced that its subsidiary, Daor Bio, received FDA notification for the clinical trial application of DR10624 injection, which is approved for clinical trials in the U.S. for severe hypertriglyceridemia indications [1] - DR10624 is a globally innovative long-acting tri-specific agonist developed independently by Daor Bio, having previously completed Phase II clinical studies with positive topline results [1] - The uncertainty surrounding the drug's development is noted, but it is stated that this will not have a significant impact on the company's recent performance [1]

Group 1 - The National Medical Products Administration has officially approved the listing of the innovative drug Remabipine Injection developed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [1] - Remabipine Injection acts as a contrast agent for kidney imaging, enabling more accurate assessment of kidney function and providing better diagnostic solutions for kidney disease patients [1] - The approval of Remabipine Injection reflects the implementation of measures to accelerate the high-quality development of the biopharmaceutical industry in Hangzhou, showcasing the effectiveness of regulatory support and service empowerment [1] Group 2 - Hangzhou has been deepening the "streamlining administration and delegating power" reform to create a favorable innovation ecosystem for biopharmaceutical companies [2] - The establishment of a dynamic monitoring mechanism for innovative product demands provides customized guidance for enterprises, while the "Enterprise Reporting Platform" simplifies the application process [2] - The market regulatory department in Hangzhou aims to continue enhancing review and approval reforms to accelerate the benefits of more innovative outcomes for patients, contributing to the establishment of a health science and technology innovation hub in Hangzhou [2]

Core Insights - The National Medical Products Administration has approved the launch of the innovative drug Remabizine Injection by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd, which is used in conjunction with MediBeacon Inc's TGFR device to assess patients' glomerular filtration rate (GFR) [1][2] - This approval reflects Hangzhou's commitment to high-quality development in the biopharmaceutical industry, translating policy into practice through regulatory support and service empowerment [1][2] Group 1 - The Hangzhou Market Supervision Administration has implemented a "one-stop" service system to address the challenges of long, complex, and difficult drug development cycles, enhancing communication and support for key enterprises [1][2] - The city has established a collaborative "Hangzhou service model" that includes a three-level coordination mechanism to ensure timely communication of policies and responses to issues [1][2] Group 2 - The administration has adopted a full lifecycle service approach for the innovative drug project, optimizing drug registration and inspection processes to expedite approvals [2] - By coordinating with higher-level agencies and providing tailored support, the administration has significantly shortened the approval timeline for the drug, showcasing the acceleration of innovative services in Hangzhou [2] - The successful approval of Remabizine Injection exemplifies the synergy between market regulation and corporate innovation, with plans for continued reforms to further enhance the biopharmaceutical industry's development [2]

Investment Rating - The investment rating for the pharmaceutical and biotechnology industry is "Positive" and the rating has been maintained [1] Core Insights - The pharmaceutical and biotechnology industry index declined by 3.65% during the reporting period, ranking 21st among 31 primary industries, underperforming the CSI 300 index which fell by 2.73% [4][16] - The valuation of the pharmaceutical and biotechnology industry as of October 17, 2025, is a PE (TTM overall method, excluding negative values) of 30.08x, down from 31.23x in the previous period, indicating a downward trend and below the average [4][21] - Key sub-industries include vaccines (55.76x), hospitals (39.64x), and medical devices (38.84x), with the lowest valuation in pharmaceutical circulation (14.29x) [4][21] - The report highlights significant innovations presented at the 2025 ESMO conference, indicating a shift in global oncology drug development from "single-agent breakthroughs" to "combination therapy strategies" [6][8] - The newly released regulations by the State Council aim to standardize clinical research pathways, promoting innovation while ensuring safety [7][25][26] Industry Overview - The report notes that 26 listed companies in the pharmaceutical and biotechnology sector experienced a net reduction in shareholder holdings amounting to 501 million yuan, while 4 companies increased their holdings by 519 million yuan [4] - The report emphasizes the importance of monitoring third-quarter earnings to validate the fundamentals of companies, particularly those with innovative product launches and significant performance improvements [8] Important Industry News - The approval of the first domestic PDE4 inhibitor by He Mei Pharmaceutical marks a significant milestone in the industry [6][34] - The approval of a new indication for GSK's recombinant shingles vaccine expands its application to adults at increased risk due to immunodeficiency [6][36] - The U.S. Senate passed a revised version of the Biosecurity Act, which continues to impose restrictions on certain Chinese biotechnology companies [6][44] - The collaboration between Bai Li Tian Heng and BMS on the iza-bren project has reached a milestone, triggering a payment of 250 million USD [6][47] - The IPO of Xuan Zhu Biotechnology on the Hong Kong Stock Exchange saw a significant oversubscription and a substantial increase in share price during the dark trading period [6][49]

Market Overview - The medical consumables supply chain SPD sector increased by 0.41% compared to the previous trading day, with Jianfa Zhixin leading the gains [1] - The Shanghai Composite Index closed at 3863.89, up 0.63%, while the Shenzhen Component Index closed at 12813.21, up 0.98% [1] Stock Performance - Jianfa Zhixin (301584) closed at 29.30, up 4.46% with a trading volume of 186,400 shares and a transaction value of 534 million [1] - Dajia Weikang (301126) closed at 11.75, up 3.07% with a trading volume of 53,500 shares and a transaction value of 62.22 million [1] - Jianmo Information (605186) closed at 19.55, up 2.68% with a trading volume of 17,200 shares and a transaction value of 33.43 million [1] - Other notable performers include Hefei China (603122) up 1.91%, Langma Information (300288) up 1.48%, and Seli Medical (603716) up 1.48% [1] Capital Flow - The SPD sector experienced a net outflow of 43.97 million from institutional investors, while retail investors saw a net inflow of 16.33 million [2] - The sector's overall capital flow indicates a mixed sentiment, with institutional investors pulling back while retail investors are more active [2] Individual Stock Capital Flow - Seli Medical (603716) had a net inflow of 12.83 million from institutional investors, but a net outflow of 12.61 million from speculative funds [3] - Dajia Weikang (301126) saw a net inflow of 5.24 million from speculative funds, but a net outflow of 5.91 million from retail investors [3] - Huadong Pharmaceutical (000963) had a net inflow of 2.37 million from speculative funds, while retail investors experienced a net outflow of 4.64 million [3]