Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has received acceptance for the market approval application of ZORYVE® 0.15% cream for treating mild to moderate atopic dermatitis in patients aged 6 and above, marking a significant milestone in the product's development [1][4] Group 1: Product Development and Market Potential - The acceptance of the ZORYVE® 0.15% cream application signifies a critical advancement in Huadong Medicine's research and development process, enhancing its core competitiveness in the treatment of autoimmune skin diseases [1][4] - ZORYVE® is a non-steroidal phosphodiesterase-4 (PDE4) inhibitor, which helps reduce inflammation by inhibiting the enzyme that increases pro-inflammatory mediators [2] - The atopic dermatitis market in China is projected to grow significantly, with an estimated market size of approximately $970 million in 2022, expected to reach $7.07 billion by 2030, reflecting a compound annual growth rate (CAGR) of 28.2% [2] Group 2: Strategic Positioning and Product Portfolio - ZORYVE® has received full recognition from the FDA in the United States, with a mature product matrix covering multiple age groups and indications, including treatments for atopic dermatitis and psoriasis [3] - Huadong Medicine is focusing on autoimmune diseases as one of its three core development directions, continuously enhancing its product introduction and independent research and development capabilities [3] - The company has a comprehensive range of products and pipeline candidates addressing various autoimmune diseases, positioning itself as one of the most diversified pharmaceutical companies in this field in China [3]

Core Viewpoint - The company announced that its subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received a Notice of Acceptance from the National Medical Products Administration (NMPA) for the marketing application of ZORYVE® (0.15% roflumilast cream) [1] Group 1: Product Development - The marketing application for ZORYVE® has been accepted, indicating progress towards commercialization in China [1] - Phase III clinical trial results demonstrate that ZORYVE® (0.15%) shows positive efficacy and good safety in patients aged 6 and above with mild to moderate atopic dermatitis [1] - The efficacy and safety data from the domestic study align with overseas research data from the partner company, Arcutis, supporting the application for market approval in China [1]

Core Viewpoint - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., has received a notice of acceptance from the National Medical Products Administration for the marketing application of ZORYVE (0.15% Roflumilast Cream) [1] Group 1: Product Development - Roflumilast cream is an innovative topical formulation introduced through a collaboration agreement signed in August 2023 between Huadong Medicine's subsidiary and Arcutis Biotherapeutics, Inc. [1] - The subsidiary holds exclusive rights for the product in Greater China (including mainland China, Hong Kong, Macau, and Taiwan) and Southeast Asia (including Indonesia, Singapore, the Philippines, Thailand, Myanmar, Brunei, Cambodia, Laos, Malaysia, and Vietnam) [1] Group 2: Regulatory Milestones - The acceptance of the marketing application by the National Medical Products Administration marks a significant regulatory milestone for the company [1] - This step is crucial for the development, registration, production, and commercialization of the product in the specified regions [1]

Core Viewpoint - Huadong Medicine (000963) announced that its wholly-owned subsidiary, Sino-American Huadong, received the Acceptance Notice from the National Medical Products Administration for the marketing application of ZORYVE® (0.15% Roflumilast Cream), which is intended for local treatment of mild to moderate atopic dermatitis in patients aged 6 and above [1] Group 1 - The marketing application for Roflumilast Cream has been accepted, indicating progress in the drug approval process [1] - The drug is specifically designed for local treatment of atopic dermatitis, targeting a significant patient demographic [1] - The acceptance by the National Medical Products Administration is a crucial step towards commercialization [1]

Core Viewpoint - Huadong Medicine (000963.SZ) announced that its wholly-owned subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd., received the acceptance notice from the National Medical Products Administration (NMPA) for the marketing authorization application of Roflumilast cream (ZORYVE) 0.15% on November 10, 2025 [1] Group 1 - ZORYVE's active ingredient, 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 trial results in China showed that 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 ZORYVE in China are similar to the overseas research data from the partner Arcutis, supporting its domestic application for marketing [1] Group 2 - In the United States, ZORYVE 0.05% cream is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years [2] - ZORYVE 0.15% cream is approved for the topical treatment of mild to moderate atopic dermatitis in patients aged 6 years and older [2] - ZORYVE 0.3% cream is approved for the topical 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 on the scalp and body in patients aged 12 years and older [2]

Core Viewpoint - East China Pharmaceutical (华东医药) announced that its wholly-owned subsidiary, Hangzhou Zhongmei East Pharmaceutical Co., Ltd., received a Notice of Acceptance from the National Medical Products Administration (NMPA) for the marketing application of Roflumilast cream (ZORYVE) 0.15% on November 10, 2025 [1] Group 1: Product Information - Roflumilast, the active ingredient in ZORYVE, 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 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 ZORYVE in China are similar to the overseas research data from the partner company, Arcutis, supporting its domestic application for marketing [1] Group 2: Regulatory Approvals - In the United States, ZORYVE 0.05% cream is approved by the FDA for the topical treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years [2] - ZORYVE 0.15% cream is approved for topical treatment of mild to moderate atopic dermatitis in patients aged 6 years and older [2] - ZORYVE 0.3% cream is approved for the topical 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 of the scalp and body in patients aged 12 years and older [2]

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]