诺和诺德将针对 减肥药Amycretin（GLP-1靶点降糖减肥药物）进行皮下注射和口服推进临床试验。 Amycretin将进入第三阶段开发。 ...

证券研究报告·公司深度研究·化学制药 华东医药（000963） 白马药企转型创新，开启发展新阶段 2025 年 06 月 09 日 买入（维持） | [Table_EPS] 盈利预测与估值 | 2023A | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | --- | | 营业总收入（百万元） | 40,624 | 41,906 | 45,915 | 49,414 | 52,228 | | 同比（%） | 7.71 | 3.16 | 9.57 | 7.62 | 5.69 | | 归母净利润（百万元） | 2,839 | 3,512 | 4,032 | 4,555 | 5,154 | | 同比（%） | 13.59 | 23.72 | 14.81 | 12.96 | 13.17 | | EPS-最新摊薄（元/股） | 1.62 | 2.00 | 2.30 | 2.60 | 2.94 | | P/E（现价&最新摊薄） | 27.06 | 21.88 | 19.05 | 16.87 | 14.91 | [Table_Tag] [Tabl ...

Group 1: Market Performance - The stock of Changshan Pharmaceutical (300255) surged by 20% on June 9, closing at 52.09 yuan per share, with a total market capitalization of 47.874 billion yuan, marking a historical high [1] - The overall index for the weight-loss drug concept rose by 4.66% on the same day, closing at 1263.62 points, indicating strong market interest [1] - Other stocks in the weight-loss drug sector, such as Shengnuo Bio and Tainkang, also saw significant gains, with daily increases of 17.58% and 13.80% respectively [1] Group 2: Industry Trends - The GLP-1 drug market is projected to reach a global scale of over $60 billion by 2025, with China's market expected to hit $4.5 billion, growing at an annual rate exceeding 28% [3] - The Chinese government has initiated a "Weight Management Year" campaign, highlighting the increasing prevalence of obesity and its health implications [3] - The market for weight-loss drugs is becoming increasingly competitive, with over twenty companies developing biosimilars for semaglutide, indicating a shift from a blue ocean to a red ocean market [4][5] Group 3: Company Developments - Changshan Pharmaceutical's stock price increase is attributed to the potential of its GLP-1 drug, Aibennate, in the billion-dollar weight-loss drug market, despite facing fundamental pressures such as debt and cash flow issues [2] - Innovative companies like Heng Rui Pharmaceutical are advancing in the GLP-1/GIP dual-target drug space, with promising clinical trial results showing significant weight loss compared to existing treatments [5][6] - The dual receptor agonist, Masitide, developed by Innovent Biologics, is set to be the first of its kind to enter the market, targeting both GLP-1 and GCG receptors for enhanced weight loss and liver fat metabolism [7]

Core Insights - The announcement by East China Pharmaceutical (华东医药) regarding its subsidiary Zhejiang Daer Biotechnology's (道尔生物) innovative long-acting triple agonist DR10624 has garnered significant attention due to its promising clinical trial results for treating obesity with hypertriglyceridemia [1][2][9] Group 1: Clinical Trial Results - DR10624 has shown remarkable efficacy in reducing liver fat content (LFC) in a Phase Ib/IIa clinical trial, with reductions of 51.9%, 77.8%, 79.0%, and 75.8% for the 12.5 mg, 25 mg, 50 mg, and 75 mg dosage groups respectively, compared to a placebo group reduction of 26.3% [2][4] - In subjects with baseline LFC ≥8%, the relative reductions were even more pronounced, with reductions of 58.3%, 83%, 89.2%, and 87.2% for the respective dosage groups, again significantly outperforming the placebo group [4][5] - A notable 66.7%, 88.9%, 100%, and 85.7% of subjects in the respective dosage groups achieved a relative reduction of LFC ≥50%, indicating a high likelihood of histological resolution of steatohepatitis [6] Group 2: Drug Development and Pipeline - DR10624 is currently undergoing additional clinical trials in China for treating metabolic-associated fatty liver disease with liver fibrosis and severe hypertriglyceridemia, with results expected in the third quarter of 2025 [6][9] - The company has a robust pipeline of over 80 innovative drug candidates, focusing on endocrine, autoimmune, and oncology fields, with significant advancements in GLP-1 targeted products [7][9] - The oral small molecule GLP-1 receptor agonist HDM1002 has completed its first subject enrollment for weight management in a Phase III trial, with further studies in diabetes also progressing [7][8] Group 3: Market Position and Future Outlook - East China Pharmaceutical is positioning itself as a leader in the endocrine field, with DR10624's breakthrough results and ongoing development of other GLP-1 related products enhancing its competitive edge [9] - The increasing focus on multi-target agonists, particularly those targeting GLP-1, GCGR, and FGF21R, is expected to drive future growth and innovation within the company [6][9] - The company's commitment to R&D is reflected in its significant investment, with a reported R&D expenditure of 2.678 billion yuan, marking a 16.77% year-on-year increase [8]

Group 1: Financial Performance - In Q1 2025, the company achieved revenue of 3.099 billion CNY, a year-on-year increase of 16% [2] - The net profit attributable to shareholders was 306 million CNY, reflecting a growth of 32.5% year-on-year [2] - Adjusted net profit was 349 million CNY, with a year-on-year growth rate of 3.1%, which is slower than revenue growth [2] Group 2: Business Segment Performance - Laboratory services generated revenue of 1.857 billion CNY, up 15.7% year-on-year, with a gross margin of 45.5%, an increase of 1.4 percentage points [4] - CMC (small molecule CDMO) services reported revenue of 693 million CNY, a growth of 19.1%, with a gross margin of 30.4%, up 2.5 percentage points [4] - Clinical research services achieved revenue of 447 million CNY, marking a 14.2% increase [4] - Revenue from large molecule and cell & gene therapy services was 99 million CNY, reflecting a growth of 7.9% [4] Group 3: Operational Insights - The strong operating cash flow reached 853 million CNY, a year-on-year increase [2] - The company’s workforce increased compared to the same period in 2024 due to new hires [2] - The second phase of the small molecule CDMO in Shaoxing is under construction, with two workshops expected to be operational by the end of 2025 [6] Group 4: Market Dynamics - Over 90% of the small molecule CDMO business comes from overseas clients, indicating a strong international market presence [7] - The company’s laboratory chemical services are expanding in scope, driven by industry recovery and new technology developments [5]

Investment Rating - The report maintains an "Outperform" rating for the pharmaceutical industry as of April 27, 2025 [1]. Core Insights - The innovation drug sector in both A-shares and Hong Kong stocks saw a total of 88 stocks rise and 20 fall during the fourth week of April 2025, with notable gains from Yiming Anke-B (40.20%), Ascentage Pharma-B (38.63%), and Rongchang Bio (30.48%) [3][20]. - The A-share innovation drug sector increased by 3.82%, outperforming the CSI 300 index by 3.44 percentage points, while the biopharmaceutical sector rose by 1.17% [21]. - The Hong Kong innovation drug sector rose by 8.10%, outperforming the Hang Seng Index by 5.37 percentage points, with the Hang Seng Healthcare index increasing by 8.44% [23]. - The XBI index in the US increased by 5.64% this week, but has seen a cumulative decline of 20.73% over the past six months [4][26]. Summary by Sections Domestic Key Innovation Drug Progress - In April, one new drug was approved for market launch in China, with no new indications approved [5][42]. - The report highlights the approval of several innovative drugs in the US, including 9 NDA approvals and 2 BLA approvals in April [6][46]. Global Key Innovation Drug Transactions - A total of 16 significant transactions occurred globally this week, with notable deals including a $555 million agreement between Quanxin Bio and Caldera Therapeutics, and a $765 million agreement between Repertoire Immune and Genentech [7]. Market Performance - Over the past six months, the A-share innovation drug sector has cumulatively increased by 4.40%, outperforming the CSI 300 index by 6.70 percentage points, while the biopharmaceutical sector has declined by 7.41% [21]. - The Hong Kong innovation drug sector has seen a cumulative increase of 24.03% over the past six months, outperforming the Hang Seng Index by 7.90 percentage points [23]. Drug Development and Clinical Trials - The report details the progress of GLP-1RA drugs for diabetes and obesity, with 11 drugs approved globally for diabetes indications and 3 for obesity [14][16]. - The report also notes the ongoing clinical trials for various drugs, including those in Phase III and NDA stages [17][18].