证券代码：000963 证券简称：华东医药 公告编号：2025-045 华东医药股份有限公司 关于全资子公司获得美国FDA新药临床试验批准通知的公 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 6 月 6 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 美国食品药品监督管理局（以下简称"美国 FDA"）通知，由中美华东 申报的 HDM1010 片药品临床试验申请已获得美国 FDA 批准，可在 美国开展 I 期临床试验，适应症为 2 型糖尿病。现将有关详情公告如 下： | 产品名称 | HDM1010片 | | --- | --- | | 申请事项 | 新药临床试验申请 | | IND编号 | 175557 | | 适应症 | 2型糖尿病 | | 申请人 | 杭州中美华东制药有限公司 | 一、该药物基本信息 二、该药物研发及注册情况 HDM1010 片是由中美华东自主研发的 HDM1002/SGLT2 抑制剂 固定剂量复方制剂。其中 HDM1002 是由中美华东自主研发并拥有全 球 ...

Core Insights - The medical beauty industry is rapidly emerging, driven by advancements in medical technology and evolving consumer perceptions, expanding from traditional cosmetic surgery to non-invasive beauty treatments, laser skincare, and body management [1][16] - The industry is experiencing significant growth potential due to improved consumer decision-making facilitated by big data, alongside a push towards standardization through enhanced regulation [1][16] - The long-term outlook for the industry remains positive, supported by rising disposable incomes and increasing demand for quality living [1][16] Industry Overview - Medical beauty, abbreviated as "医美," utilizes medical methods, including drugs, instruments, and surgeries, to enhance external beauty and improve physiological functions [2] - The industry encompasses various segments, including facial beauty, body beauty, skin beauty, non-invasive beauty, and oral beauty [2] Market Trends - Consumer acceptance of light medical beauty is increasing, with 34% of consumers planning to engage in light medical beauty services in the coming year, reflecting a 36% year-on-year growth [5] - The emerging consumer base includes young people, men, and consumers from lower-tier markets, indicating a shift in demand driven by changing aesthetic values and rational consumption attitudes [5] Industry Structure - The medical beauty industry chain consists of upstream products and equipment, midstream service providers, and downstream customer acquisition platforms, with a stable upstream structure and a competitive midstream landscape [7][8] - Upstream manufacturers face high entry barriers due to regulatory requirements and technical challenges, making it the most profitable segment of the industry [8] - The downstream market is characterized by intense competition and low concentration, with 71% of service providers being private clinics or beauty salons [10] Market Size and Growth - The Chinese medical beauty market has shown steady growth, with a compound annual growth rate (CAGR) of 17.5% from 2017 to 2021, reaching nearly 190 billion yuan, and is projected to grow at a CAGR of 15.2% to nearly 400 billion yuan by 2026 [11] - The penetration rate of medical beauty services in China was 4.5% in 2022, indicating significant room for growth compared to Japan (11.3%), the U.S. (17.2%), and South Korea (22.0%) [11] Regulatory Environment - The industry has faced challenges such as varying qualifications, false advertising, and price transparency issues, prompting the government to enhance regulatory frameworks and industry standards [14] - Increased compliance awareness among institutions and improved consumer protection mechanisms are expected to foster a healthier development phase for the industry [14] Investment Opportunities - Key companies in the medical beauty sector include Aimeike, Huaxi Biological, Longzi Co., and Huadong Pharmaceutical, which are positioned to benefit from the industry's growth and regulatory improvements [16]

每经记者｜刘明涛 每经编辑｜赵云 6月9日上午，医药板块迎来大爆发，创新药领涨。ETF方面，港股创新药相关ETF集体飙涨，包括创新药ETF国泰（517110）在内10只港股创新药相关ETF 半日涨幅超4%，其中，港股创新药ETF（513120）半日成交金额更是接近50亿元，资金活跃度极高。 | | | 港股创新药行业相关ETF一览 | | | | | | --- | --- | --- | --- | --- | --- | --- | | 代码 | 名称 | 涨幅% | 现价 | 换手% | 规模(亿份) | 总金额(万元) | | 517110 | 创新药ETF国泰 | 4.7 | 0.668 | 2.87 | 4.29 | 814.38 | | 520700 | 港股创新药ETF基金 | 4.65 | 1.395 | 143.03 | 2.18 | 43225.67 | | 513780 | 港股创新药50ETF | 4.63 | 1.446 | 63.82 | 4.2 | 38274.82 | | 513120 | 港股创新药ETF | 4.44 | 1.128 | 48.71 | 91.57 | 4 ...

Core Insights - The medical beauty materials market is entering a competitive phase in 2025, with significant approvals for new materials such as agarose and hydroxyapatite, indicating a growing diversity of products [1][10] - The approval of various injection fillers, including recombinant collagen and animal-derived collagen, highlights the rapid development and commercialization of medical beauty materials [1][4] - Investment in medical beauty materials companies has surged, with 12 companies securing funding in the first five months of 2025, reflecting strong interest from investors [4][5] Regulatory Approvals - Hydroxyapatite received two approvals in 2025, with the first compliant product for medical beauty injections approved in February [10] - Agarose also saw its first approval in January 2025, marking a significant milestone for this material in the domestic market [10] - Over 110 products for medical beauty injections have been approved in China, primarily classified as Class III medical devices [2][4] Market Dynamics - The competition for the first regulatory approval (Class III certificate) is intense, as it provides a significant market advantage [10][12] - Companies are increasingly focusing on developing new materials and applications, with many aiming to secure the first approval in various new material categories [11][12] - The market is characterized by a mix of established companies and startups, all vying for a share of the growing medical beauty sector [15][16] Investment Trends - Notable investments in medical beauty materials companies include significant funding rounds for firms like 聚源生物 and 未名拾光, indicating robust investor confidence [5][6] - The trend of startups receiving funding is expected to continue, as the demand for innovative medical beauty solutions grows [4][5] Product Development - Companies are exploring the combination of different materials to enhance product competitiveness, with a focus on safety and efficacy [14][15] - New materials such as PDRN, silk protein, and chitosan are being investigated for their applications in medical beauty and functional skincare [16][17] - The development of multi-indication products is becoming a strategic focus, with companies aiming to address various aesthetic needs [13][15] Future Outlook - The medical beauty market is anticipated to expand, driven by the introduction of new materials and innovative applications [16][17] - The interplay between medical beauty and skincare sectors is expected to create a positive feedback loop, enhancing market growth [16][17] - Ultimately, the success of new materials will depend on their clinical validation and real-world application, as safety and effectiveness remain paramount [16][17]

Group 1 - The 2025 Zhejiang Listed Companies Investor Online Reception Day and 2024 Annual Performance Briefing was held on May 13, 2025 [1] - East China Pharmaceutical's board secretary Chen Bo announced that the oral small molecule GLP-1 receptor agonist HDM1002 (conveglipron) completed the first subject enrollment for weight management indication in the Phase III clinical study in April 2025, with plans to complete all subject enrollments by the end of June 2025 [1] - The Phase II clinical study for diabetes indication is progressing smoothly, with topline results expected in Q3 2025 and entry into Phase III clinical research planned for the second half of 2025 [1] Group 2 - The GLP-1R/GIPR dual-target long-acting peptide agonist HDM1005 (poterepatide) is currently undergoing Phase II clinical trials for weight management indication, with all subjects enrolled by April 2025 and expected to enter Phase III clinical research in Q4 2025 [1] - The Phase II clinical trial for diabetes indication also completed the first subject enrollment in April 2025, and new indication IND applications for HDM1005 have been approved by NMPA for the treatment of obstructive sleep apnea (OSA) with obesity or overweight, and heart failure with preserved ejection fraction (HFpEF) with obesity or overweight [1] Group 3 - The FGF21R/GCGR/GLP-1R tri-target agonist DR10624 injection is currently conducting Phase II clinical research in China for the treatment of metabolic-associated fatty liver disease with high-risk liver fibrosis and metabolic-associated alcoholic fatty liver disease, with the first subject enrolled in April 2025 [2] - Another Phase II clinical study for DR10624 targeting severe hypertriglyceridemia in China has completed all patient enrollments, with topline results expected in Q3 2025 [2] - DR10624 has also received approval for clinical trial applications in China for type 2 diabetes and weight indications, and key research data for DR10624 in treating obesity with hypertriglyceridemia was presented at the EASL Congress 2025 in Amsterdam [2]

Core Insights - The AMAC Wholesale Retail Trade Index (AMAC批零, H11045) increased by 1.3%, closing at 1617.5 points with a trading volume of 31.254 billion [1] - Over the past month, the index has risen by 2.93%, by 1.85% over the last three months, and by 0.73% year-to-date [1] Index Composition - The AMAC Wholesale Retail Trade Index is based on 43 industry classification indices, excluding manufacturing, and is compiled according to the classification guidelines from the China Securities Association [1] - The top ten weighted stocks in the index are: Huadong Medicine (5.33%), Yonghui Supermarket (3.05%), Digital China (2.87%), Shanghai Pharmaceuticals (2.83%), Wancheng Group (2.26%), Wuchan Zhongda (2.21%), Yifeng Pharmacy (2.19%), Jiuzhoutong (1.83%), Sinopharm (1.58%), and Kidswant (1.57%) [1] Market Distribution - The market distribution of the AMAC Wholesale Retail Trade Index shows that the Shenzhen Stock Exchange accounts for 53.12%, while the Shanghai Stock Exchange accounts for 46.88% [1] Industry Breakdown - In terms of industry composition, discretionary consumption accounts for 36.90%, healthcare for 31.52%, industrials for 22.28%, staples for 4.58%, energy for 2.78%, real estate for 1.27%, and financials for 0.67% [2]

Investment Rating - The report assigns an "Overweight" rating to the pharmaceutical industry, specifically for pharmaceutical manufacturing and pharmaceutical services [1][2]. Core Insights - Continuous attention is recommended for innovative drugs with rising prosperity, as evidenced by the record number of 73 oral reports on Chinese innovative drug assets at the 2025 ASCO annual meeting [2][36]. - The Chinese innovative drug sector is experiencing a significant demand from multinational corporations (MNCs), which is reflected in the increasing number of overseas business development (BD) transactions [36]. - The pharmaceutical sector outperformed the market in May 2025, with the SW Pharmaceutical and Biological sector rising by 6.4%, ranking first among Shenwan's primary industries [15][37]. Summary by Sections Investment Highlights - The report highlights a portfolio of A-Shares including Jiangsu Heng Rui Medicine, Huadong Medicine, Sichuan Kelun Pharmaceutical, and others, indicating a focus on companies with strong growth potential [2][5]. - The report notes that the pharmaceutical sector's premium level relative to all A-Shares is currently at a normal level, with a relative premium rate of 87.88% as of the end of May 2025 [28][37]. Performance Analysis - In May 2025, the pharmaceutical sector's performance was ranked first, with individual stock gains led by Staidson Beijing BioPharmaceuticals (+145.4%) and Sunshine Guojian Pharmaceutical (+99.4%) [15][37]. - The report also details the performance of the Hong Kong and U.S. pharmaceutical sectors, noting that the Hong Kong stock pharmaceutical sector outperformed the market while the U.S. sector underperformed [38]. Market Trends - The report emphasizes the upward trend in the innovative drug market, with traditional pharmaceutical companies emerging from centralized procurement challenges and entering a phase of profitability [36]. - The report indicates that the biopharmaceutical sector's sub-sectors, such as chemical raw materials and biological products, have shown strong performance, with increases of 10.5% and 7.3% respectively [20][37].

Group 1 - The Shanghai Composite Index opened lower but rose throughout the day, with the CSI 300 Pharmaceutical and Biotechnology Index reported at 7971.61 points [1] - The CSI 300 Pharmaceutical and Biotechnology Index has increased by 5.53% in the past month, 7.39% in the past three months, and 7.09% year-to-date [1] - The CSI 300 Index categorizes its 300 sample stocks into 11 primary industries, 35 secondary industries, over 90 tertiary industries, and more than 200 quaternary industries [1] Group 2 - The top ten holdings of the CSI 300 Pharmaceutical and Biotechnology Index are: Heng Rui Medicine (25.29%), WuXi AppTec (16.43%), Pian Zai Huang (6.37%), Yunnan Baiyao (5.21%), Kelun Pharmaceutical (5.11%), East China Pharmaceutical (4.06%), Xinhecheng (3.51%), Changchun High-tech (3.48%), Fosun Pharma (3.34%), and Shanghai Raas (3.27%) [1] - The market segments of the CSI 300 Pharmaceutical and Biotechnology Index show that the Shanghai Stock Exchange accounts for 63.65% and the Shenzhen Stock Exchange accounts for 36.35% [2] - The industry composition of the CSI 300 Pharmaceutical and Biotechnology Index includes: chemical drugs (43.80%), pharmaceutical and biotechnology services (21.66%), traditional Chinese medicine (18.52%), and biological drugs (16.02%) [2] Group 3 - The index samples are adjusted every six months, with adjustments implemented on the next trading day following the second Friday of June and December each year [2] - Weight factors are adjusted along with the periodic sample adjustments, which are generally fixed until the next scheduled adjustment [2] - Temporary adjustments occur when the CSI 300 Index samples are modified, and changes in industry classification due to special events will also lead to corresponding adjustments in the CSI 300 industry index samples [2]

Summary of Conference Call Records Industry Overview - The focus is on the innovative drug sector, particularly in the context of recent significant transactions and developments in the PD(L)1*VEGF and GLP1 fields [1][2]. Key Points and Arguments PD(L)1*VEGF Dual Antibody Developments - 康方生物 and Summit announced top-line data from the global clinical trial HARMONI for Ivosidenib targeting 2L EGFRm, indicating: - The PD(L)1*VEGF dual antibody shows certain effectiveness in the post-EGFRm mutation line, although the median follow-up time is short, necessitating longer follow-up for evaluation [1] - The HARMONI study validates the consistency of clinical results between China and the U.S. [1] - The FDA stated that statistically significant overall survival benefits are necessary to support the submission for market approval, which will influence Summit's timeline for BLA submission [1] - The primary focus remains on the first-line global clinical results for Ivosidenib [1] Collaboration and Licensing Opportunities - BMS and BNTX are collaborating on the development of PD(L)1*VEGF dual antibodies, with BMS committing to: - An upfront payment of $1.5 billion, $2 billion in non-contingent annual payments, potential milestone payments of $7.6 billion, and a 50:50 cost/profit sharing arrangement [2] - The continuous licensing of PD(L)1*VEGF assets reflects MNCs' optimism regarding these types of drugs, suggesting potential for identifying advantageous subpopulations for clinical benefits [2] - Other companies such as ROG and ABBV are also expected to have demand for similar assets, with domestic firms like 荣昌生物, 宜明昂科, 华海药业, 华兰生物, and 神州细胞 making strategic moves in this area [2] GLP1/GIP Dual Agonist Transactions - Regeneron and Hansoh Pharmaceutical reached a deal for the GLP1/GIP dual agonist, with Regeneron paying an upfront fee of $80 million, $1.93 billion in milestones, and a double-digit sales share [2] - The past year has seen ABBV, REGN, and JNJ entering the diabetes and weight loss market, expanding competition against existing players like LLY, NVO, MSD, ROG, and AZN [2] - The ongoing interest from MNCs in the weight loss sector is expected to lead to a resurgence of new drug developments, particularly following data releases from conferences like ADA [2] Recommended Companies - The following companies are recommended for attention: - 恒瑞医药, 华东医药, 联邦制药, 歌礼制药, 来凯医药 [3] Market Trends - There is optimism regarding the Chinese innovative drug sector due to ongoing licensing activities, which are expected to drive a bullish market trend [4] - MNCs have reiterated their interest in Chinese assets during recent earnings calls, reflecting a strong demand for domestic innovative drugs and low policy sensitivity [4] - The continuous licensing of Chinese innovative drugs is anticipated to lead to a revaluation of overseas valuations [4] - Recommended stocks for Pharma revaluation include 恒瑞医药, 华东医药, 三生制药, 联邦制药, 中国生物制药, 石药集团/新诺威, 先声药业, 康哲药业, 科伦药业; for Biotech global competitiveness: 益方生物, 泽璟制药, 一品红, 百利天恒, 科伦博泰生物, 贝达药业, 信达生物, 百济神州, 再鼎医药, 和黄医药 [4]

Investment Rating - The investment rating for the company is "Buy" (maintained) [7] Core Views - The company is focusing on chronic diseases, tumors, and immunology, covering four major business segments: pharmaceutical manufacturing, pharmaceutical commerce, medical aesthetics, and industrial microbiology. It is continuously optimizing its product structure and transitioning from generics to innovation. The core products of its subsidiary, China Medical East, are maintaining stable market growth and increasing market share. The medical aesthetics segment is showing growth potential, and the innovative pipeline is entering a harvest period. The projected net profits for 2025-2027 are estimated at 40.61 billion, 47.16 billion, and 55.37 billion yuan, with corresponding EPS of 2.32, 2.69, and 3.16 yuan, leading to PE ratios of 16.3, 14.0, and 11.9 times, respectively [7][8][10]. Summary by Sections Company Overview - The company, established in 1993 and listed in 1999, has developed into a large comprehensive pharmaceutical company covering the entire pharmaceutical industry chain. It has transitioned towards a research and innovation-driven pharmaceutical enterprise since 2018 [18]. Business Performance - The company reported a revenue of 419.1 billion yuan in 2024, a year-on-year increase of 3.2%, and a net profit of 35.1 billion yuan, up 23.7% year-on-year. The pharmaceutical manufacturing segment generated 138.1 billion yuan in revenue, growing by 13.1%, while the medical aesthetics segment saw a slight decline in revenue [8][22]. Innovative Pipeline - The company is focusing on three core areas: oncology, endocrinology, and autoimmune diseases, with a differentiated layout in ADC and PROTAC technologies. The innovative pipeline includes over 80 projects, with several products entering clinical stages. The company is also actively pursuing collaborations and acquisitions to enhance its product offerings [9][39][55]. Financial Summary - The company’s financial metrics show steady growth, with projected revenues of 44.68 billion, 47.95 billion, and 51.83 billion yuan for 2025, 2026, and 2027, respectively. The gross margin is expected to improve from 33.6% in 2025 to 35.4% in 2027, while the net profit margin is projected to increase from 9.1% to 10.7% over the same period [10][28].