Core Viewpoint - Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the Acceptance Notification from the National Medical Products Administration (NMPA) for the marketing application of Roflumilast Cream (ZORYVE®) 0.15% on November 10, 2025 [1] Group 1 - Roflumilast is a highly active and selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor, which can reduce inflammation by inhibiting the production of pro-inflammatory mediators [1] - The Phase III clinical study results in China showed that Roflumilast Cream (ZORYVE®) 0.15% demonstrated positive efficacy and good safety in subjects aged 6 years and older with mild to moderate atopic dermatitis, achieving the primary endpoint [1] - The overall efficacy and safety data of Roflumilast Cream (ZORYVE®) are similar to the overseas research data from the partner Arcutis, supporting its application for domestic marketing [1] Group 2 - In the United States, ZORYVE® 0.05% cream is approved by the FDA for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years [2] - ZORYVE® 0.15% cream is approved for local treatment of mild to moderate atopic dermatitis in patients aged 6 years and older [2] - ZORYVE® 0.3% cream is approved for local treatment of plaque psoriasis in patients aged 6 years and older, while ZORYVE® 0.3% foam is approved for seborrheic dermatitis in patients aged 9 years and older and for plaque psoriasis in patients aged 12 years and older [2]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, received acceptance for the marketing application of Roflumilast cream (ZORYVE®) 0.15% from the National Medical Products Administration (NMPA) in China, indicating a significant step towards market entry for this treatment for atopic dermatitis [1] Group 1 - ZORYVE® contains Roflumilast, a highly selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor, which helps reduce inflammation by inhibiting the production of pro-inflammatory mediators [1] - The Phase III clinical trial results in China demonstrated positive efficacy and good safety for ZORYVE® 0.15% in patients aged 6 years and older with mild to moderate atopic dermatitis, achieving the primary endpoint [1] - The efficacy and safety data from the Chinese study are similar to those from overseas studies conducted by the partner company, Arcutis, supporting the domestic application for market approval [1] Group 2 - In the United States, ZORYVE® 0.05% cream is approved by the FDA for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years [2] - ZORYVE® 0.15% cream is approved for local treatment of mild to moderate atopic dermatitis in patients aged 6 years and older [2] - ZORYVE® 0.3% cream is approved for local treatment of plaque psoriasis in patients aged 6 years and older, while the 0.3% foam formulation is approved for seborrheic dermatitis in patients aged 9 years and older and for plaque psoriasis in patients aged 12 years and older [2]

证券代码：000963 证券简称：华东医药 公告编号：2025-101 华东医药股份有限公司 关于全资子公司收到药品注册受理通知书的公告 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。 2025年11月10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）签发的《受理通知书》（受理号： JXHS2500126），罗氟司特乳膏（ZORYVE ®）0.15%上市许可申请获 得受理。现将有关详情公告如下： 一、该药物基本信息内容 药物名称：罗氟司特乳膏 申请事项：境外生产药品注册上市许可 申请人：Arcutis Biotherapeutics INC 注册代理机构：杭州中美华东制药有限公司 结论：根据《中华人民共和国行政许可法》第三十二条的规定， 经审查，决定予以受理。 二、该药物研发及注册情况 第 1 页 共 3 页 罗氟司特乳膏是公司全资子公司中美华东与美国纳斯达克上市公 司Arcutis Biotherapeutics, Inc. （NASDAQ: ARQT）（以下简称 ...

Macroeconomic Insights - Global asset performance shows mixed results, with the Hang Seng Index up 1.29% and the Shanghai Composite Index up 1.08%, while developed markets like the S&P 500 fell by 1.63%[6] - In October, the U.S. ISM Manufacturing PMI declined, indicating economic slowdown, while consumer confidence continued to drop according to the University of Michigan index[7] Inflation and Prices - October CPI in China rose by 0.2% year-on-year, while PPI decreased by 2.1%, indicating a stable inflation environment with core service prices reaching their highest level since March 2024[11] - The rise in core CPI is attributed to reduced food drag and increased service contributions, with gold prices significantly impacting jewelry costs[13] Trade and Exports - In October, China's exports fell by 1.1% year-on-year, while imports grew by 1.0%, leading to a slight decrease in trade surplus[16] - The export structure shows weakness in non-U.S. markets, particularly the EU, while exports to the U.S. and ASEAN remained strong[18] Investment Strategies - The asset allocation report suggests an overweight position in Chinese A-shares and industrial commodities, with equity allocation set at 45% and bonds at 45%[22] - The report emphasizes the importance of AI industry trends and the potential for volatility in global equity markets, recommending a focus on quality assets[23] Market Dynamics - The trading activity has decreased, with turnover rates and transaction volumes declining across indices, indicating a cautious market sentiment[28] - The report highlights a decrease in northbound capital flow, with a net outflow of 2.6 billion CNY in the recent week, reflecting investor sentiment shifts[34]

证券代码：000963 证券简称：华东医药 公告编号：2025-100 华东医药股份有限公司 关于控股股东部分股份质押及解除质押的公告 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。 华东医药股份有限公司（以下简称"本公司"或"公司"）近日 接到控股股东中国远大集团有限责任公司（以下简称"远大集团"） 通知，获悉远大集团将其所持有的本公司部分股份办理了质押，部分 股份办理了解除质押。具体事项如下： 一、股东股份质押基本情况 | 股东名 | 是否为控 股股东或 | 本次质押 | 占其所 | 占公司 | 是否为 限售股 | 是否 为补 | 质押起始 | | | 质押 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 称 | 第一大股 东及其一 | 数量（股） | 持股份 比例 | 总股本 比例 | （如是， 注明限 | 充质 | 日 | 质押到期日 | 质权人 | 用途 | | | 致行动人 | | | | 售类型） | 押 | | | | | | 中国远 大集团 有限责 ...

Core Insights - Huadong Medicine's subsidiary, Zhejiang Daer Biotechnology, announced significant results from the Phase II clinical study of the first-in-class long-acting triple agonist DR10624 for treating severe hypertriglyceridemia (SHTG) at the AHA 2025 conference [1][3] Group 1: Product and Clinical Research - DR10624 is a first-in-class long-acting triple-target agonist that uniquely targets FGFR1c/Klothoβ (FGF21R), GLP-1R, and GCGR, designed using the MultipleBody technology platform [2] - The drug intervenes in metabolic regulation by enhancing lipid oxidation, suppressing fat generation, improving insulin sensitivity, promoting fat breakdown, and effectively reducing appetite [2] - The Phase II clinical study results for DR10624 were presented as a groundbreaking report at AHA 2025, marking a significant achievement for Chinese cardiovascular research [3] Group 2: Market Potential and Competitive Landscape - SHTG poses a growing public health burden, with limited effective clinical treatment options currently available, highlighting a significant unmet medical need [3] - Huadong Medicine is preparing for the Phase III clinical study of DR10624, having submitted a clinical trial application to the FDA in September 2025, which was approved in October 2025 [4] - The focus on the FGF21 target presents a high barrier to entry and scarcity in the global market, with few similar drugs in clinical stages, indicating substantial future growth potential [4][5] Group 3: Strategic Positioning - Huadong Medicine's strategic evolution in endocrine therapy has progressed from traditional glucose-lowering drugs to weight management and now to cutting-edge indications like SHTG, enhancing its technological moat [5]

Core Insights - The article highlights the significant achievements of Huadong Medicine's subsidiary, Zhejiang Daor Bio, in the development of DR10624, a first-in-class long-acting triple agonist for treating severe hypertriglyceridemia (SHTG), which was showcased at the AHA 2025 conference [1][3] Group 1: Clinical Trial Results - DR10624 demonstrated a rapid and significant reduction in triglyceride levels, atherosclerotic lipids, and liver fat content in patients with SHTG during its Phase II clinical trial [1][3] - The trial results indicated that 89.5% of patients treated with DR10624 achieved triglyceride levels below 500 mg/dL, and 19.1% reached levels below 150 mg/dL, with a median percentage reduction in triglycerides of up to 75% [6][9] - After 12 weeks of treatment, DR10624 significantly reduced liver fat content, with a median percentage reduction of up to 67% compared to the placebo group [8] Group 2: Mechanism of Action - DR10624 is designed as a long-acting triple-target agonist, uniquely targeting FGFR1c/Klothoβ, GLP-1R, and GCGR, which allows it to intervene in metabolic regulation from multiple dimensions [2][10] - The drug enhances lipid oxidation, suppresses fat generation, improves insulin sensitivity, promotes fat breakdown, and effectively suppresses appetite, showcasing its unique advantages in treating metabolic diseases [2][10] Group 3: Strategic Positioning and Market Potential - The recognition of DR10624 at the AHA conference marks a historic breakthrough for Chinese scholars in cardiovascular research and drug development [3][10] - Huadong Medicine's focus on the FGF21 target, which has high barriers to entry and limited competition, positions the company favorably in the metabolic disease treatment landscape [10][11] - The global interest in FGF21 has led to significant investments from major pharmaceutical companies, indicating a strong consensus on its potential as a core target for metabolic disease therapies [10][11] Group 4: Future Developments - Huadong Medicine is preparing for Phase III clinical trials for DR10624, having submitted clinical trial applications to the FDA and received approvals for various indications [9][12] - The company is expanding its product pipeline, including multiple GLP-1 related products, which are progressing through clinical development for diabetes and weight management [12][13]

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical sector, specifically recommending the innovative drug and medical device industry chain [5][10]. Core Insights - The pharmaceutical sector shows a positive recovery trend in Q3 2025, with overall revenue growth of 0.6% year-on-year and a net profit increase of 0.3% year-on-year. This indicates a return to growth after previous declines [6][13]. - Specific segments such as medical devices and medical research outsourcing are experiencing significant growth, with revenue and net profit growth rates of 10.6% and 0.6% for medical devices, and 10.9% and 47.9% for medical research outsourcing, respectively [13][14]. - The report highlights a continued recommendation for specific A-share and H-share stocks, including 恒瑞医药 (Hengrui Medicine), 科伦药业 (Kelun Pharmaceutical), and others, indicating strong potential for investment [7][10]. Summary by Sections 1. Continued Recommendation for Innovative Drug and Medical Device Industry Chain - The report continues to recommend the innovative drug and medical device industry chain, maintaining "Overweight" ratings for several A-share stocks including 恒瑞医药, 科伦药业, and others, and H-share stocks like 翰森制药 and 三生制药 [7][10]. 2. Recovery Trend in Pharmaceutical Sector Q3 2025 - The pharmaceutical sector's overall revenue increased by 0.6% year-on-year in Q3 2025, with net profit rising by 0.3%. Medical devices and medical research outsourcing are leading this recovery with notable growth rates [13][14]. 3. Performance of Pharmaceutical Sector in October 2025 - In October 2025, the pharmaceutical sector underperformed compared to the broader market, with the SW pharmaceutical index declining by 1.8% while the Shanghai Composite Index rose by 1.9% [15][26]. 4. Performance of Hong Kong and US Pharmaceutical Sectors - The Hong Kong pharmaceutical sector also underperformed, with the Hang Seng Healthcare index down by 11.1%, while the US pharmaceutical sector showed strength with a 3.5% increase in the S&P healthcare index [26][27]. 5. Valuation and Premium Levels - As of October 31, 2025, the pharmaceutical sector's premium level relative to all A-shares is at a normal level, with a current relative premium rate of 76.7% [25][28].

Core Insights - The annual adjustment of the National Medical Insurance (NMI) catalog has progressed, with negotiations for the 2025 NMI drug catalog and commercial insurance innovative drug catalog taking place from October 30 to November 3, involving 120 domestic and foreign companies [1] - The introduction of the commercial insurance innovative drug catalog is a significant highlight, marking its first establishment, with 141 submissions and 121 passing the preliminary review [1][2] - The NMI's focus is on "basic protection," which has led to high-value innovative drugs like CAR-T therapies not being included in the basic catalog, while the commercial insurance catalog aims to cover high-innovation drugs that exceed basic insurance limits [2] Group 1 - The NMI negotiations involved 127 drugs for the basic catalog and 24 for the commercial insurance catalog, with the new catalogs expected to be released in early December and implemented on January 1 [1] - The commercial insurance innovative drug catalog respects the market position of commercial insurance companies, differing from the NMI catalog adjustments [2] - Five CAR-T therapies are in the preliminary review for the commercial insurance catalog, indicating a growing acceptance of high-value therapies in the market [2][3] Group 2 - The support from commercial insurance for high-value innovative products like CAR-T therapies is seen as essential for risk-sharing among patients and promoting industry development [3] - There is a need for national involvement to enhance the role of commercial insurance in rare disease coverage, as profitability concerns may limit insurance companies' willingness to cover patients with pre-existing conditions [3] - The potential for innovative drugs included in both NMI and commercial insurance catalogs to experience rapid revenue growth is highlighted, benefiting patients and leading to increased flexibility for related companies [4]

Investment Rating - The report maintains a focus on innovative pharmaceuticals and medical devices, highlighting key A-share and H-share targets for investment [6][32]. Core Insights - The pharmaceutical sector showed a good recovery in Q3 2025, with overall revenue increasing by 0.6% year-on-year and net profit attributable to shareholders rising by 0.3% year-on-year [11][32]. - Medical equipment benefited from procurement recovery, with Q3 revenue and net profit growth of 10.6% and 0.6% year-on-year, respectively [11][32]. - Medical R&D outsourcing continued to achieve high growth, with Q3 revenue and net profit growth of 10.9% and 47.9% year-on-year [11][32]. - The offline pharmacy sector improved, with Q3 revenue and net profit growth of 2.1% and 37.8% year-on-year [11][32]. Summary by Sections 1. Focus on Innovative Pharmaceuticals and Medical Devices - Key A-share targets include Jiangsu Heng Rui Medicine, Sichuan Kelun Pharmaceutical, Huadong Medicine, Changchun High-tech Industry, Jiangsu Nhwa Pharmaceutical, WuXi AppTec, Hangzhou Tigermed Consulting, Lepu Medical, APT Medical, and related target Guangdong Zhongsheng Pharmaceutical [6][32]. - Key H-share targets include Hansoh Pharmaceutical Group, 3SBio, Akeso, and related target Innovent Biologics, WuXi AppTec [6][32]. 2. Q3 2025 Pharmaceutical Sector Recovery - The pharmaceutical sector's overall revenue increased by 0.6% year-on-year, with net profit attributable to shareholders up by 0.3% year-on-year [11][32]. - Specific segments such as medical devices and medical R&D outsourcing showed significant growth [11][32]. 3. October 2025 Market Performance - In October 2025, the pharmaceutical sector underperformed the market, with the SW Pharmaceutical and Biological index falling by 1.8% while the SHCOMP rose by 1.9% [14][32]. - The relative premium of the pharmaceutical sector compared to all A-shares was at a normal level, with a current relative premium rate of 76.7% [23][32]. 4. Hong Kong and U.S. Market Performance - The Hong Kong pharmaceutical sector underperformed, with the Hang Seng Healthcare index falling by 11.1% [24][32]. - In contrast, the U.S. S&P 500 healthcare sector rose by 3.5% [24][32].