证券研究报告 行业研究 / 行业点评 2025 年 12 月 15 日 行业及产业 医药生物 一年内行业指数与沪深 300 指数对比走势： 资料来源：聚源数据，爱建证券研究所 相关研究 《医药行业跟踪报告：医保商保"双目录"落 地，关注支付端增量》2025-12-10 《【爱建医药】抗体偶联药物 ADC 产业投资框 架——"精准化疗"引爆千亿市场，中国创新 引领全球浪潮 20251121》2025-11-21 张智聪 S0820525020002 021-32229888-25524 zhangzhicong@ajzq.com ——医药行业跟踪报告 全球减重疗法研究进展丰富，三靶点激 动剂和 siRNA 创新疗法数据亮眼 强于大市 投资要点： 医药板块行情复盘：本周（12/8~12/14）市场整体震荡向下，沪深 300 指数-0.08%，通信 （+6.27%）、国防军工（+2.80%）、电子（+2.63）等板块领涨。本周 SW 医药生物指数 -1.04%，跑输沪深 300 指数，各细分板块中 CXO（+3.69%）和创新药涨幅靠前，而线下药 店（-4.33%）、医药流通（-4.23%）、血液制品（-4.05% ...

Investment Rating - The report maintains an "Overweight" rating for the pharmaceutical and biotechnology industry [1] Core Insights - The GLP-1 class of drugs has become a revolutionary therapy in the weight loss field, transitioning from an "adjunctive" role to a "core medication" status, significantly improving metabolic indicators while effectively reducing weight [19][20] - Multiple companies have disclosed promising weight loss data, with a focus on domestic companies such as Federated Pharmaceutical, Lepu Medical, and Greeley Pharmaceuticals [2][19] - The report highlights the potential of oral small molecule GLP-1 drugs, with significant clinical data from companies like Greeley Pharmaceuticals and Structure Therapeutics [21][22] Summary by Sections Investment Highlights - The report emphasizes the growth potential in the weight loss drug market, driven by drugs like Semaglutide and Tirzepatide, with notable clinical results from various companies [2][19] - The report suggests monitoring the development of domestic small nucleic acid drugs, which have shown promising results in reducing visceral fat and increasing lean body mass [2] Sub-industry Rankings - The report ranks sub-industries in the following order: Innovative Drugs > Research Services > CXO > Traditional Chinese Medicine > Medical Devices > Pharmacies [3][12] - Specific stock recommendations include Federated Pharmaceutical, Lepu Medical, and Greeley Pharmaceuticals from the GLP perspective, and companies like 3SBio, Kintor Pharmaceutical, and Innovent Biologics from the PD1/VEGF dual antibody perspective [3][15] Market Performance - The A-share pharmaceutical index has shown a year-to-date increase of 14.65%, while the Hang Seng Biotechnology Index has increased by 77.09% [11] - The report notes that the medical services sector has seen a price increase of 1.67%, while other sectors like chemical pharmaceuticals and medical devices have experienced declines [11] Clinical Development Updates - Greeley Pharmaceuticals' ASC30 achieved a 7.7% weight reduction in a 13-week study, while Structure Therapeutics' Aleniglipron showed a 15.3% reduction in a 36-week study [21][22] - The report highlights the competitive landscape of oral GLP-1 drugs, with Greeley's ASC30 demonstrating superior weight loss effects compared to Eli Lilly's Orforglipron [23]

Analyst’s Disclosure:I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. This article is intended to provide informational content and should not be viewed as an exhaustive an ...

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Aleniglipron Efficacy - In the Phase 2b ACCESS trial, Aleniglipron achieved placebo-adjusted mean weight loss of 82% at 45 mg, 98% at 90 mg, and 113% at 120 mg at 36 weeks[41] - Exploratory ACCESS II study showed placebo-adjusted mean weight loss at 36 weeks of 141% at 120 mg, 144% at 180 mg, and 153% at 240 mg[72] - ACCESS Open Label Extension (OLE) study indicated that weight loss continues to increase in all arms through Week 44, with no evidence of a weight loss plateau[50] Aleniglipron Tolerability and Safety - Phase 2b ACCESS trial showed an overall 104% AE-related treatment discontinuation rate, with GI-related AEs consistent with the GLP-1RA class[41] - In the Exploratory ACCESS II trial, participants who achieved re-randomization experienced no AE-related treatment discontinuations up to the 240 mg dose at week 36[72] - Body Composition study showed improved tolerability with a lower 25 mg starting dose, with no treatment discontinuations due to AEs after a median treatment of approximately 10 weeks[83] - Across all studies with over 500 participants treated up to 44 weeks, there were no events of drug-induced liver injury, off-target safety signals, or QTc prolongation[96] Market Opportunity and Scalability - The overweight and obesity market includes over 800 million people worldwide, with projections of 15 billion people by 2030[14] - The total addressable market for obesity treatments is estimated to be over $100 billion[14] - Oral small molecules like Aleniglipron can scale to meet the needs of the global obesity patient population, offering potential advantages in accessibility and cost compared to injectable peptides[12, 15]

Placebo-adjusted mean weight loss of 11.3% (27.3 lbs) with 120 mg dose in the 36-week Phase 2b ACCESS study with a 10.4% adverse event-related treatment discontinuation Placebo-adjusted mean weight loss up to 15.3% (35.5 lbs) observed with 240 mg dose in the exploratory ACCESS II study at 36 weeks No adverse event-related treatment discontinuations observed when starting at lower 2.5 mg dose in ACCESS Open Label Extension and Body Composition Study Data comprehensively support and inform advancement to Ph ...

Group 1 - The small molecule GLP-1RA market is expected to provide new growth opportunities for weight loss and diabetes management, with Eli Lilly's Orforglipron leading the global development [1][2] - Orforglipron has completed three global Phase III clinical trials, confirming its safety, although its weight loss efficacy did not meet market expectations [2][3] - Domestic companies such as Hengrui Medicine, East China Pharmaceutical, and Genscript Biotech are actively developing small molecule GLP-1RA pipelines, with several products entering late-stage clinical trials [3] Group 2 - The pharmacokinetic characteristics of small molecule GLP-1RAs may significantly impact their efficacy, prompting companies to explore new formulations to enhance solubility [4] - Genscript's ASC30 shows higher drug exposure and receptor binding efficacy compared to Orforglipron, indicating potential for better clinical outcomes [4]

Investment Rating - The investment rating for the biotechnology industry is "Positive" (maintained) [1] Core Insights - The small molecule GLP-1RA market is expected to provide new incremental space for weight loss and diabetes management, with significant interest from multinational corporations (MNCs) accelerating their involvement in this sector [7][25] - The leading product in the small molecule GLP-1RA space is Orforglipron from Eli Lilly, which has completed multiple global Phase III clinical trials and is positioned to submit a New Drug Application (NDA) in the second half of 2025 [25][26] - Domestic companies are making substantial progress in the small molecule GLP-1RA pipeline, with several candidates entering late-stage clinical trials, indicating strong potential for commercialization and international expansion [19][25] Summary by Sections 1. Development Prospects of Small Molecule GLP-1RA - Oral GLP-1 drugs offer advantages such as ease of use and high patient compliance, with over 75% of initial treatment patients preferring daily oral therapy [14] - The small molecule GLP-1RA market is characterized by low costs and flexibility in usage scenarios, with significant recent business development (BD) transactions [14][23] 2. MNCs Accelerating Small Molecule GLP-1RA Pipeline - Eli Lilly's Orforglipron is the fastest progressing small molecule GLP-1RA product globally, with three Phase III trials achieving primary endpoints [25][27] - Other major pharmaceutical companies like AstraZeneca and Roche are also advancing their small molecule GLP-1RA pipelines, with several candidates in Phase II trials [29][30] 3. Pharmacokinetic Characteristics Impacting Efficacy - Pharmacokinetic features are crucial for the efficacy of small molecule GLP-1RA, with companies exploring new formulations to enhance solubility and absorption [6][19] 4. Investment Recommendations - The report recommends several companies as potential beneficiaries in the small molecule GLP-1RA space, including Innovent Biologics, East China Pharmaceutical, and others, highlighting their strong clinical development and commercialization potential [7][19]