Workflow
HUADONG MEDICINE(000963)
icon
Search documents
华东医药子公司DR10624纳入突破性治疗品种名单
Bei Jing Shang Bao· 2026-01-11 09:24
北京商报讯(记者 丁宁)1月11日晚间,华东医药(000963)发布公告称,公司控股子公司浙江道尔生 物科技有限公司自主研发的同类首创(FIC)的靶向成纤维细胞生长因子21受体(Fibroblast growthfactor21 receptor,FGF21R),胰高血糖素受体(Glucagon receptor,GCGR),和胰高血糖素样 肽-1受体(Glucagon-like peptide-1 receptor,GLP-1R)的长效三靶点激动剂DR10624被纳入突破性治疗品 种,拟定适应症为重度高甘油三酯血症(severe hypertriglyceridemia,sHTG)。 ...
华东医药(000963) - 关于控股子公司产品纳入突破性治疗品种名单的公告
2026-01-11 08:30
证券代码:000963 证券简称:华东医药 公告编号:2026-001 华东医药股份有限公司 近日,根据国家药品监督管理局药品审评中心(CDE)发布的公 示信息,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")自主研发的同类首 创(FIC)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-like peptide-1 receptor,GLP-1R) 的长效三靶点激动剂 DR10624 被纳入突破性治疗品种,拟定适应症 为重度高甘油三酯血症(severe hypertriglyceridemia,sHTG),现将 有关详情公告如下: 一、该药物基本信息 药物名称:DR10624 注射液 注册分类:治疗用生物制品 1 类 受理号:CXSB2300148 拟定适应症(或功能主治):适用于重度高甘油三酯血症 理由及依据:建议同意纳入突破性治疗程序。理由如下:经加快 审议会议议定 ...
华东医药:控股子公司产品纳入突破性治疗品种名单
人民财讯1月11日电,华东医药(000963)1月11日公告,近日,根据国家药品监督管理局药品审评中心 (CDE)发布的公示信息,公司控股子公司浙江道尔生物科技有限公司自主研发的同类首创(FIC)的靶向成 纤维细胞生长因子21受体,胰高血糖素受体,和胰高血糖素样肽-1受体的长效三靶点激动剂DR10624被 纳入突破性治疗品种,拟定适应症为重度高甘油三酯血症。 ...
胖猫咪也有减肥药了?它经济何以驶入千亿赛道
Sou Hu Cai Jing· 2026-01-07 23:20
Core Insights - The introduction of a weight management drug for cats, specifically the GLP-1 receptor agonist, marks a significant innovation in the pet healthcare market, addressing the obesity issue affecting approximately 28.1% of pet cats globally [1][2][4] - The pet economy in China is rapidly evolving, driven by emotional consumption, technological innovation, and capital investment, creating a market projected to reach hundreds of billions [4][7] Group 1: Market Dynamics - The number of pets in China is expected to grow from 310 million in 2020 to 430 million by 2024, with urban pet cat numbers reaching 71.53 million by 2024 [4][5] - The demand for pet healthcare is increasing, with a notable rise in consultations for overweight pets, leading to a shift towards specialized dietary products and medical solutions [5][6] - The pet healthcare sector is experiencing a surge in new companies, with nearly 20,000 pet medical enterprises projected by the end of 2025, indicating a robust growth phase [6][7] Group 2: Technological Advancements - Over 2,700 patents related to pet healthcare have been filed in China, with more than 60% being invention patents, showcasing a strong focus on innovation in the industry [6] - The integration of AI and blockchain technology is transforming the supply chain in pet healthcare, enhancing efficiency in drug procurement and management systems [6][7] Group 3: Consumer Trends - Pet owners are increasingly viewing their pets as family members, leading to a rise in spending on health-related products and services, including specialized diets and insurance [5][8] - The emergence of the cat weight management drug reflects a broader trend towards preventive medicine and the management of chronic conditions in pets, moving beyond traditional treatment methods [4][6] Group 4: Geographic Expansion - The pet healthcare market is expanding beyond major cities, with significant growth observed in lower-tier cities, indicating a shift in consumer behavior and market opportunities [7][8] - New business models are being adopted to penetrate these emerging markets, including local partnerships and hybrid online-offline sales strategies [7][8]
华东医药:Biomee®#1和Biomee®#2乳膏目前尚未在海外上市
Core Viewpoint - Huadong Medicine's Biomee®1 and Biomee®2 creams are not yet launched overseas and will be registered as imported cosmetics in China, bypassing the drug approval process and clinical trials [1] Group 1 - The products Biomee®1 and Biomee®2 are currently not available in international markets [1] - The registration process for these products in China will follow the imported cosmetics pathway rather than the drug registration approval route [1] - This approach allows the company to avoid the need for conducting clinical trials domestically [1]
华东医药:Biomee #1和Biomee #2乳膏目前尚未在海外上市
Zheng Quan Ri Bao Wang· 2026-01-07 12:41
Core Viewpoint - Huadong Medicine (000963) has confirmed that its products Biomee1 and Biomee2 creams are not yet launched overseas and will be registered as imported cosmetics in China, bypassing the drug registration approval process [1] Group 1 - The products Biomee1 and Biomee2 are currently not available in international markets [1] - In China, these products will be registered as imported cosmetics rather than through the drug registration pathway [1] - The registration process for these products does not require clinical trials in China [1]
华东医药:Biomee#1和Biomee#2乳膏目前尚未在海外上市
Zheng Quan Ri Bao· 2026-01-07 12:36
Group 1 - The core viewpoint of the article is that Huadong Medicine has clarified the registration status of its products Biomee®1 and Biomee®2, indicating they are not yet launched overseas and will be registered as imported cosmetics in China rather than through drug approval pathways [2] Group 2 - Biomee®1 and Biomee®2 will not require clinical trials in China, simplifying the registration process for these products [2]
上市:“大胖猫”有了减肥药
Si Chuan Ri Bao· 2026-01-06 21:42
Core Viewpoint - East China Pharmaceutical's new veterinary drug for weight management in obese cats has been approved for market release, addressing a significant gap in the pet weight management sector in China [2][3] Group 1: Product Development and Market Potential - The newly approved drug can lead to an average weight loss of 9.26% in obese cats within six weeks at the recommended dosage, with over 70% of trial cats losing more than 5% of their weight [2] - The pet medical market in China has reached a scale of 80 billion yuan, making it one of the fastest-growing pet markets globally [2] - There is a notable absence of weight management solutions for pets, particularly in the area of pharmaceutical interventions, which presents a significant market opportunity [2] Group 2: Industry Challenges and Consumer Concerns - Current methods for managing pet obesity primarily involve calorie control and increased exercise, which face challenges such as long duration, hunger stress, and low compliance from pets [2] - The development of veterinary drugs often follows a "human drug/animal drug for pets" model, requiring strict regulatory frameworks to ensure safety and efficacy [2] - Pet owners express concerns about the safety of new weight management drugs, indicating a cautious approach to adopting pharmaceutical solutions despite the demand [3] Group 3: Health Implications and Recommendations - Obesity in pets can lead to serious health issues, including insulin resistance, abnormal blood lipids, hypertension, diabetes, and can directly damage joints, cardiovascular, and respiratory systems [3] - Preventive measures are emphasized as crucial, with recommendations for scientific feeding, calorie control, adequate exercise, and regular weight monitoring to prevent obesity and its complications [3]
卡位百亿级黄金赛道,华东医药深化皮肤外用制剂战略布局,MC2-01乳膏完成首例受试者入组
Quan Jing Wang· 2026-01-06 15:17
Core Viewpoint - Huadong Medicine has entered into a strategic partnership with MC2 Therapeutics to commercialize the Biomee skincare series in Greater China, enhancing their collaboration following the successful introduction of the Wynzora ointment for psoriasis treatment [1][2]. Group 1: Partnership and Product Development - Huadong Medicine's subsidiary, Hangzhou Zhongmei Huadong Pharmaceutical, has secured exclusive commercialization rights for the Biomee series in Greater China [1]. - The partnership builds on previous successful collaborations, particularly the introduction of the Wynzora ointment, and aims to expand into the dermatological market [2][3]. - A Phase III clinical trial for the MC2-01 ointment, which combines calcipotriol and betamethasone, has commenced, marking a significant milestone in product development [1][3]. Group 2: Market Potential and Product Features - The Biomee series, developed using MC2's PAD technology, addresses common skin issues such as dryness and discomfort, with a focus on providing effective and safe relief [2][3]. - The Chinese dermatological skincare market has shown rapid growth, increasing from 8.52 billion yuan in 2017 to 31.17 billion yuan in 2023, with projections to reach 65 billion yuan by 2028 [3]. - The Biomee series targets widespread skin concerns, making it appealing across various age groups and enhancing market potential [3]. Group 3: Strategic Positioning and Future Outlook - The introduction of the Biomee series is part of Huadong Medicine's comprehensive strategy in the dermatological sector, combining partnerships and in-house development [5][6]. - The company has established a leading product portfolio in the psoriasis treatment space, including biologics and topical prescription drugs, ensuring comprehensive patient care [5]. - Huadong Medicine's collaboration with MC2 on the Biomee series signifies a strategic advancement in the skin health sector, aiming to meet the growing and diverse demands for skin health solutions in Greater China [6].
HTI 医药 2026 年 1 月月报:景气延续,持续重点推荐创新药械产业链-20260105
Investment Rating - The report maintains an "Outperform" rating for the following A-share targets: Jiangsu Heng Rui Medicine, Sichuan Kelun Pharmaceutical, Huadong Medicine, Jiangsu Nhwa Pharmaceutical, Xiamen Amoytop Biotech, Zhejiang Jingxin Pharmaceutical, Innovent Biologics, WuXi AppTec, Hangzhou Tigermed Consulting, Lepu Medical, MicroPort EP MedTech [5][36][8] - The report also maintains an "Outperform" rating for the following H-share targets: Hansoh Pharmaceutical Group, 3SBio, PATEO Biotech, Akeso, and related targets: Innovent Biologics, WuXi AppTec [8][36] Core Insights - The report continues to recommend the innovative drug and device industry and its supply chains, indicating a positive outlook for this sector [1][36] - In December 2025, the pharmaceutical sector underperformed the market, with the SW Pharmaceutical and Biological index falling by 4.1%, while the SHCOMP rose by 2.1%, ranking 26th among Shenwan primary industries [15][37] - The report highlights that the premium level of the pharmaceutical sector relative to all A-shares is currently at a normal level, with a relative premium rate of 63.2% as of the end of December 2025 [25][37] Summary by Sections A-Share Targets - The report includes a monthly portfolio of A-share targets that outperformed the pharmaceutical index, with a monthly average decline of 1.8% compared to the overall pharmaceutical index decline of 3.9% in December 2025 [11][36] - The top three stock gains in December 2025 were Luyan Pharma (+118.8%), CareRay Digital Medical Technology Co., Ltd. (+36.6%), and Hubei Hongyuan Pharmaceutical Technology Co., Ltd. (+34.0%) [24][37] H-Share Targets - The report notes that the Hong Kong stock pharmaceutical sector also underperformed the market, with the Hang Seng Healthcare index falling by 9.5% and the Hong Kong Biological Technology index falling by 10.6% in December 2025 [26][38] U.S. Market Performance - In December 2025, the U.S. pharmaceutical sector underperformed the market, with the S&P 500 Healthcare Select Sector declining by 1.5% while the S&P 500 fell by only 0.1% [26][39]