12月15日，华东医药（000963）股份有限公司(以下简称"华东医药"或公司)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")宣布，其研发的创新多肽类人GLP-1(胰高血糖素样肽-1)受体和GIP受 体(葡萄糖依赖性促胰岛素多肽)的双靶点长效激动剂HDM1005注射液在体重管理适应症中国II期临床试 验中取得了积极结果，展现了公司在代谢疾病领域强大的研发实力。 此外，公司另一款自主研发的ADC创新药注射用HDM2012的胃癌和胃食管交界癌、胰腺癌两项适应症 获得美国食品药品监督管理局(以下简称"美国FDA")孤儿药资格认定(Orphan Drug Designation,ODD)， 证明了其ADC研发创新性获国际认可。 这两大进度这标志着华东医药在新药研发的国际化与前沿探索方面实现了重要跨越，不仅体现了公司以 科研为基础理念的成功实践，更彰显了其在新靶点探索和研发布局上的前瞻性，为华东医药在创新领域 的持续领先奠定了坚实基础。 强效减重临床数据惊艳，创新产品获孤儿药认定 公开资料显示，HDM1005注射液是由中美华东研发并拥有全球知识产权的1类化学新药，为多肽类人 GLP-1受体和GIP受体的双 ...

Core Insights - The report emphasizes the investment strategy for the pharmaceutical and biotechnology industry, particularly focusing on undervalued stocks in the medical device and pharmacy sectors, which are expected to experience a valuation reversal [1][5]. - The overall investment rating for the sector is maintained at "outperform the market" [2]. Industry Overview - The pharmaceutical manufacturing industry showed a cumulative revenue of 18,211 billion yuan with a year-on-year decline of 2.0% for the first nine months of 2025 [8]. - The total profit for the industry during the same period was 2,535 billion yuan, reflecting a decrease of 0.7% [8]. - The retail sales of Western and Chinese medicines reached 535.1 billion yuan, with a growth of 1.3% year-on-year [8]. Sector Performance - In October 2025, the pharmaceutical sector experienced an overall decline of 1.83%, underperforming the CSI 300 index by the same margin [9]. - Among sub-sectors, the pharmaceutical commercial sector saw an increase of 2.81%, while the medical services sector faced a decline of 4.14% [14]. Investment Strategy - The report recommends focusing on low-valuation stocks in the medical device and pharmacy sectors, highlighting companies such as Weigao Group, Yifeng Pharmacy, and Mindray Medical [5]. - The CXO sector is identified as having global competitiveness, with a strong long-term growth trajectory [5]. Company Recommendations - The investment portfolio for November 2025 includes A-shares such as Mindray Medical, WuXi AppTec, and Yeye Medical, and H-shares like Kangfang Biologics and Kelun-Botai [5][6]. - Specific companies are highlighted for their growth potential, including WuXi AppTec, which is expected to see significant revenue growth in the coming quarters [5]. Regulatory Environment - The report tracks ongoing centralized procurement projects for medical devices, indicating a structured approach to managing costs and ensuring compliance within the industry [29].

Core Insights - The report emphasizes the investment strategy for the pharmaceutical and biotechnology industry, focusing on undervalued targets in the medical device and pharmacy sectors, which are expected to experience a valuation reversal [1][5]. - The overall investment rating for the sector is maintained at "outperform the market" [2]. Industry Performance Review - The pharmaceutical industry experienced a decline of 1.83% in October, underperforming the CSI 300 index by the same margin [9]. - The medical manufacturing sector reported a cumulative revenue of 1.8211 trillion yuan, down 2.0% year-on-year, with a total profit of 253.5 billion yuan, a decrease of 0.7% [8]. Sector Analysis - The report categorizes the CXO sector into three segments: CDMO, preclinical and clinical CRO, and generic drug CXO, highlighting the growth potential in each area [5]. - The CDMO segment shows promising growth with significant increases in new orders and emerging business areas such as peptides and oligonucleotides [5]. - The preclinical and clinical CRO segment is recovering with new order prices showing an upward trend [5]. - The generic drug CXO segment is facing challenges due to a reduced number of MAH clients and is actively seeking new growth points through innovation [5]. Investment Strategy - The report recommends focusing on undervalued medical device and distribution stocks, as well as the long-term positive trend in innovative drugs and their supply chains [5]. - A specific investment portfolio for November 2025 includes companies such as Mindray Medical, WuXi AppTec, and Aier Eye Hospital, among others [5][6]. Recent Developments - In October 2025, six innovative drugs or biosimilars were approved for market entry, indicating a robust pipeline for the industry [23][24]. - The report tracks ongoing centralized procurement initiatives for medical devices, which are expected to impact pricing and market dynamics [29]. Valuation Insights - The overall valuation of the pharmaceutical sector is currently at a PE (TTM) of 38.80, which is at the 81.52% historical percentile over the past five years, indicating a relatively high valuation compared to historical averages [17].

Core Viewpoint - Huadong Medicine is a leading comprehensive pharmaceutical enterprise in China, with core businesses covering pharmaceutical manufacturing, distribution, and medical aesthetics, benefiting from a full industry chain advantage [1] Group 1: Business Performance - In Q3 2025, Huadong Medicine achieved a revenue of 32.664 billion yuan, ranking first among 110 companies in the industry, exceeding the industry average by 2.8 billion yuan and the median by 838 million yuan [2] - The net profit for the same period was 2.742 billion yuan, ranking third in the industry, above the industry average by 299 million yuan and the median by 782.9 million yuan [2] Group 2: Financial Ratios - As of Q3 2025, Huadong Medicine's debt-to-asset ratio was 38.65%, down from 39.80% year-on-year, but higher than the industry average of 35.26% [3] - The gross profit margin for Q3 2025 was 33.52%, up from 32.55% year-on-year, but lower than the industry average of 57.17% [3] Group 3: Shareholder Information - As of September 30, 2025, the number of A-share shareholders decreased by 1.50% to 68,800, while the average number of circulating A-shares held per household increased by 1.53% to 25,500 [5] Group 4: Management and Compensation - The chairman of Huadong Medicine, Lv Liang, received a salary of 2.4 million yuan in 2024, unchanged from 2023 [4] Group 5: Innovation and Growth - The company reported a significant increase in revenue from innovative products, with sales and agency service income reaching 1.675 billion yuan in the first three quarters, a year-on-year growth of 62% [6][7] - The company maintains high R&D investment, with the approval of a new drug, Maleic Acid Mevanertinib Tablets, in October 2025 [6] - The medical aesthetics business is under pressure, while the industrial microbiology segment showed a revenue growth of 28.48% year-on-year [6] Group 6: Future Projections - Analysts project Huadong Medicine's net profit for 2025-2027 to be 3.841 billion, 4.464 billion, and 5.005 billion yuan, reflecting year-on-year growth rates of 9.4%, 16.2%, and 12.1% respectively [6] - Another analysis anticipates net profits of 3.88 billion, 4.54 billion, and 5.28 billion yuan for the same period, with growth rates of 10.4%, 17.0%, and 16.5% respectively [7]

Core Viewpoint - Huadong Medicine has received acceptance for the marketing authorization application of its innovative topical formulation Roflumilast Cream (ZORYVE) 0.3%, aimed at treating plaque psoriasis in patients aged 6 and above, which is expected to enhance the company's competitiveness in the autoimmune disease sector and provide breakthrough treatment options for psoriasis patients in China [1][4]. Market Opportunity - The active ingredient Roflumilast is a highly selective non-steroidal phosphodiesterase-4 (PDE4) inhibitor, approved by the FDA for treating various skin conditions, including plaque psoriasis, and is the first topical PDE4 inhibitor approved for this indication globally [2][3]. - The psoriasis market in China has shown significant growth, with the market size increasing from $604 million in 2018 to $1.436 billion in 2022, reflecting a compound annual growth rate (CAGR) of 24.2% [4]. - The Chinese psoriasis drug market is projected to reach ¥139 billion in 2023 and is expected to grow to ¥894 billion by 2032, with a CAGR of 59.1% [4]. Product Advantages - Roflumilast Cream demonstrates significant clinical advantages, including rapid onset of action, effective reduction of plaques, and significant relief from itching, while its unique HydroARQ technology enhances user comfort [2][3]. - The cream is non-hormonal, allowing for long-term use without restrictions, making it suitable for sensitive areas such as the face and underarms [2]. Company Strategy and Pipeline - Huadong Medicine is focusing on the autoimmune disease sector, which is experiencing rapid global growth, with the market expected to rise from $132.3 billion in 2022 to $176.7 billion by 2030 [5]. - The company has developed a diverse product pipeline in the autoimmune field, covering various conditions, and has over 20 innovative products in development [6]. - Huadong Medicine has established a "golden product combination" for psoriasis treatment, including monoclonal antibodies and both oral and topical formulations, aiming to provide comprehensive treatment options for patients [6]. Future Outlook - The acceptance of the Roflumilast Cream application marks the seventh marketing application milestone for Huadong Medicine in 2023, indicating a strong pipeline of innovative products [6]. - The company is expected to see multiple innovative drugs approved between 2025 and 2026, further solidifying its competitive position in the pharmaceutical market [9]. - Huadong Medicine aims to enhance its core competitiveness and market position by focusing on clinical needs and integrating global innovative resources [9].

Core Viewpoint - The report highlights the performance and growth prospects of Huadong Medicine, focusing on its financial results, R&D investments, and innovative product pipeline. Financial Performance - For the first nine months of 2025, Huadong Medicine achieved revenue of 32.664 billion yuan, a year-on-year increase of 3.77% [2] - The net profit attributable to shareholders was 2.748 billion yuan, up 7.24% year-on-year [2] - The company’s R&D investment in the pharmaceutical industry reached 2.186 billion yuan, a significant increase of 35.99% [2] R&D and Innovation - The company’s innovative product sales and agency service revenue reached 1.675 billion yuan, a substantial growth of 62% year-on-year [4] - Huadong Medicine is advancing over 90 innovative drug pipeline projects, with five products approved for market and six under review as of 2025 [4] - The global first innovative drug, Remabizine injection, received domestic approval in October 2025 [4] Segment Performance - The pharmaceutical industrial segment, including CSO business, generated revenue of 11.045 billion yuan, a year-on-year increase of 11.10% [3] - The medical beauty segment faced challenges, with revenue declining by 17.90% to 1.568 billion yuan [5] - The industrial microbiology segment continued to grow rapidly, with a year-on-year increase of 28.48% [11] Future Product Pipeline - Upcoming products expected to be approved include Semaglutide injection and Insulin Degludec injection, among others [7] - The company anticipates significant sales potential for its innovative products, including the newly approved Malatonic Mevanetidine tablets, which could reach a peak sales potential of 1 billion yuan [6][7] Market Outlook - Despite current challenges in the medical beauty sector, the company remains optimistic about future growth driven by new product approvals and market expansion [7] - The company is actively pursuing international market opportunities, particularly in the medical beauty segment [7]

Financial Performance - For the first nine months of 2025, the company achieved a revenue of CNY 32.664 billion, a year-on-year increase of 3.77% [2] - The net profit attributable to shareholders was CNY 2.748 billion, up 7.24% year-on-year [2] - The net profit excluding non-recurring gains and losses was CNY 2.694 billion, reflecting an 8.53% increase [2] - In Q3 2025, the company reported a revenue of CNY 10.989 billion, a 4.53% increase year-on-year, and a net profit of CNY 0.933 billion, up 7.71% [3] R&D Investment - R&D investment for the first nine months of 2025 reached CNY 2.186 billion, a 35.99% increase year-on-year [2] - Direct R&D expenditure was CNY 1.767 billion, marking a 53.76% increase, which accounted for 16.21% of the pharmaceutical industrial revenue [2][14] Product Development and Approvals - The company has 90 innovative drug pipeline projects in progress [4] - Five new products have received market approval in 2025, with six applications under review [4] - The innovative product sales and agency service revenue reached CNY 1.675 billion, a significant increase of 62% year-on-year [17] Market Challenges and Opportunities - The aesthetic medicine segment faced challenges, with a revenue of CNY 1.568 billion, down 17.90% year-on-year [5] - The industrial microbiology segment showed robust growth, with a revenue increase of 28.48% [15] - The company anticipates a recovery in the aesthetic medicine sector as new products are launched [5][9] Future Product Pipeline - Expected product approvals in the next year include Semaglutide injection, Insulin degludec injection, and others [7] - The company is also preparing for the launch of several aesthetic products, including YY001 and Ellansé® [7][9] Clinical Trials and Research - The GLP-1 receptor agonist HDM1002 has completed patient enrollment for its clinical trials [10] - The three-target agonist DR10624 has shown promising results in clinical studies and will be presented at the AHA Scientific Sessions 2025 [10][19] Sales Projections - The sales peak for the drug Ustinumab is projected to reach CNY 2 billion [18] - The MediBeacon® TGFR product is expected to exceed CNY 1 billion in sales potential [6]

Market Performance - The pharmaceutical and biotechnology index rose by 0.35% from October 20 to October 24, underperforming the Shanghai Composite Index by 0.36 percentage points, marking five consecutive weeks of underperformance [1] - The innovative drug index (BK1106) saw a slight increase of 0.03%, ending a four-week decline [1] - The Hang Seng Healthcare Index fell by 0.77%, although the decline was less severe than the previous week, indicating a continued downward trend [1] - The Hong Kong innovative drug ETF (513120) decreased by 2.82%, failing to capitalize on positive news from the ESMO conference and significant business development transactions by Innovent Biologics [1] IPO Developments - Jiangxi Biological Products Research Institute Co., Ltd. has submitted a new application for listing on the Hong Kong Stock Exchange, following a failed attempt in April 2023 [2] - Jiangxi Biological is the largest provider and exporter of human tetanus antitoxin (TAT) in China, holding a global market share of 36.6% and a domestic market share of 65.8% in 2024 [2] - The company's revenue is relatively low, projected at 221 million yuan in 2024 and 99.7 million yuan in the first half of 2025, primarily due to the low price of TAT, which averages 3.6 yuan per unit for exports, about 30% of the domestic price [2] Clinical Trials - From October 20 to October 26, the National Medical Products Administration disclosed 95 new clinical trial registrations, with 30 of these being innovative drugs in Phase II or higher, mainly in oncology, cardiovascular, and dermatology fields [6] Drug Approvals - Three small molecule innovative drugs were approved last week, including a PDE4B inhibitor for idiopathic pulmonary fibrosis (IPF), marking the first successful approval for IPF treatment in nearly a decade [9] - The drug, developed by Boehringer Ingelheim, achieved its primary endpoint in Phase III trials and was approved in both the U.S. and China within two weeks [9] - Other approved drugs include a first-line treatment for advanced non-small cell lung cancer (NSCLC) and a new oral hypoglycemic agent for type 2 diabetes [10][11] Company Performance - Huahao Zhongtian Pharmaceutical-B has seen a cumulative decline of over 33% in the past two weeks, attributed to low trading volumes and a general downturn in the innovative drug sector [12] - The company reported a revenue of 14.78 million yuan in the first half of the year, a decrease of 55.36% year-on-year, with a net loss of 54.04 million yuan, slightly improved from the previous year's loss [12]

Core Viewpoint - The National Medical Products Administration of China has approved the launch of the innovative drug Mevanertinib (brand name: Maiyidong), providing a new treatment option for adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 21 (L858R) substitution mutations [1] Group 1: Drug Approval - The drug Mevanertinib is classified as a Class 1 innovative drug [1] - It is developed by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd [1] - The approval is significant as it offers a first-line treatment option for a specific patient population [1]

Core Insights - The company reported a revenue of 32.664 billion yuan for the first three quarters of 2025, representing a year-on-year growth of 3.77% [1] - The net profit attributable to shareholders reached 2.748 billion yuan, with a year-on-year increase of 7.24% [1] - The company significantly increased its R&D investment in the pharmaceutical industry to 2.186 billion yuan, a growth of 35.99% year-on-year, with direct R&D expenses accounting for 16.21% of pharmaceutical industrial revenue [1] Pharmaceutical Industrial Performance - The pharmaceutical industrial segment achieved a revenue of 11.045 billion yuan, reflecting a year-on-year growth of 11.10% [2] - The net profit for this segment was 2.475 billion yuan, up 15.62% year-on-year [2] - Innovative product sales and agency service revenue reached 1.675 billion yuan, marking a substantial increase of 62% [2] Innovation and Product Development - The company has made significant breakthroughs in three core therapeutic areas: endocrinology, oncology, and autoimmune diseases [3] - The company has launched five new products and received six listings, with 18 IND approvals in China or the U.S. [3] - The CAR-T product, Zewokaiolun, has gained a strong market presence, with 170 effective orders placed in Q3 2025, surpassing the total orders from the previous year [2][3] Microbial Industrial Growth - The microbial industrial segment reported a revenue growth of 28.48% for the first three quarters of 2025 [4] - The company is focusing on four core business areas: xRNA raw materials, specialty APIs & intermediates, health & biological materials, and animal health [4] - The company aims to become a global leader in the aesthetic medicine sector, with a comprehensive product matrix covering various health and beauty applications [4][5] Clinical Research and Product Registration - The company has made progress in clinical research, with the KIO021 solution completing its first subject injection in China [5] - The YY001 botulinum toxin for improving glabellar lines has completed its BLA application and is currently under technical review [5] - The company is advancing its aesthetic medicine business with ongoing registration efforts in both domestic and international markets [4][5]