S1130514100001 zhaohc gjzq.com.cn S1130523080002 heguanzhou gjzq.com.cn 6 ADA 投资逻辑 近期创新药板块维持高景气度状态，重磅合作持续落地。继 AACR 和 ASCO 之后，2025 年第 85 届美国糖尿病协会(ADA) 科学会议(年会)将于 2025 年 6 月 20-23 日在美国芝加哥举行。美国糖尿病年会(ADA 年会)是世界上最大、最负盛名 的糖尿病学术会议之一，预计众多内分泌代谢药物相关企业将在会议上释放临床和研发的重要信息，建议关注内分泌 代谢领域相关标的的投资机会。同时国内暑期即将来临，建议关注医疗服务和消费、医美领域边际变化，寻找投资机 会。 药品板块：2025 年 6 月 12 日，UroGen Pharma 官网宣布 FDA（美国食药监局）批准了公司的 Zusduri(丝裂霉素)膀胱 灌注液作为首个也是唯一一个治疗复发性低度中危非肌层浸润性膀胱癌（LG-IR-NMIBC）的药物。慢病代谢领域进展 不断，礼来 Lp(a) 的口服降脂药拟纳入突破性疗法。2025 年开年以来，中国新药获批上市的数量与质量都继续提升， ...

Core Insights - Merck is undergoing a significant transformation with promising developments in its pipeline, including two important Phase III study readouts for enlicitide and FDA approval for clesrovimab, an RSV vaccine [4] - The company has nearly 20 new assets in its pipeline, with ongoing launches of WINREVAIR and others showing strong initial performance [5] Company Developments - Merck announced two key Phase III study results for enlicitide, an oral PCSK9 inhibitor, which yielded positive outcomes [4] - The FDA approved clesrovimab, marking a significant milestone for Merck's RSV vaccine efforts [4] - The company is poised for a series of data readouts and product launches in the near future, indicating a robust growth trajectory [4] Future Outlook - Merck is preparing for nearly 20 additional product launches over the next few years, which is expected to enhance its market position [5] - The ongoing launches of existing products are off to strong starts, contributing to the company's optimistic outlook [5]

Group 1: FDA Approval and Product Launch - Merck announced FDA approval for its long-acting monoclonal antibody, clesrovimab, branded as Enflonsia, for the prevention of RSV in newborns and infants [1][7] - The approval was based on data from the pivotal phase IIb/III CLEVER study, which demonstrated a significant reduction in RSV disease and hospitalization in healthy infants [2][7] - Merck plans to launch Enflonsia in the U.S. ahead of the 2025-26 RSV season, with pricing set at $556 per dose and ordering expected to start next month [3][7] Group 2: Market Competition - Enflonsia will face competition from AstraZeneca/Sanofi's RSV antibody Beyfortus, which was also approved in 2023 and achieved blockbuster status in its first full-year sales [6][7] - Sanofi announced plans to increase the supply of Beyfortus, including shipping the antibody early in the third quarter of 2025 [7] - While multiple RSV vaccines are approved for use in the U.S., only Pfizer's Abrysvo is approved for immunizing infants, contrasting with Enflonsia and Beyfortus, which can be administered directly [8] Group 3: Stock Performance - Year to date, Merck's shares have declined by 20%, while the industry has seen a modest decline of 1% [4]

Financial Data and Key Metrics Changes - The company is anticipating over $50 billion in revenue by the early to mid-2030s, driven by a diversified set of therapeutic areas including cardiometabolic, immunology, ophthalmology, vaccines, and HIV [4][5] - The company has invested over $12 billion in manufacturing strategy from 2018 to 2024, with an additional $9 billion planned to bring more manufacturing back to the U.S. [16][18] Business Line Data and Key Metrics Changes - The company has nearly 20 new assets and product launches planned over the next few years, marking a significant period of transformation and growth [3][4] - The oral PCSK9, enlicitide, has shown promising results in Phase III studies, with ambitions to be the most potent LDL cholesterol-lowering pill [3][50] Market Data and Key Metrics Changes - The U.S. market for cholesterol management shows that 70% of individuals are not at their cholesterol goals, indicating a significant opportunity for the company's PCSK9 products [49] - The company continues to see elevated inventories in the Chinese market for Gardasil, with expectations for future growth once market conditions improve [36] Company Strategy and Development Direction - The company is focused on executing its pipeline and leveraging its R&D capabilities across both human and animal health sectors, with a strong emphasis on operational synergies [71][72] - The company is committed to addressing drug pricing issues and is engaged in constructive dialogue with the administration regarding the MFN executive order [9][12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the safety and efficacy of their vaccines, particularly klezrovimab, despite regulatory uncertainties [23][24] - The company is optimistic about its growth trajectory, with more product launches planned than ever before in a five-year window [47] Other Important Information - The company is actively pursuing business development opportunities, with a focus on identifying strategic assets that align with its scientific goals [40][41] - The company is expanding its immunology focus, particularly around the TL1A class, which is seen as a significant therapeutic target [42][43] Q&A Session Summary Question: What are the expectations regarding the political environment and MFN pricing? - Management indicated ongoing constructive dialogue with the administration and a willingness to collaborate on drug pricing solutions [7][9] Question: How is the company addressing the manufacturing shift for KEYTRUDA? - The company is bringing back KEYTRUDA manufacturing to the U.S. through a phased approach, with significant investments in infrastructure [18][19] Question: What is the outlook for Gardasil sales in the U.S.? - Management acknowledged potential headwinds from discussions around lower dosing recommendations but remains confident in the vaccine's value [26][34] Question: What is the company's strategy for business development? - Management emphasized that the recent slowdown in business development activity is due to timing rather than a change in strategy or urgency [40][41] Question: How does the company view the competitive landscape in oncology? - The company is focused on advancing its broad ADC program and is committed to moving quickly in the oncology space [62][64]

Financial Data and Key Metrics Changes - The company has nearly tripled the number of phase three assets since 2021, now having over 20 unique assets with blockbuster potential launching in the next three to five years [5][6] - The company has invested over $70 billion into business development over the last few years, enhancing its pipeline and portfolio [9] Business Line Data and Key Metrics Changes - The late-stage pipeline is strong, with two assets, WIN Revere and Cat Baxtive, already in the midst of launching and performing well [5][6] - The early-stage pipeline includes 50 different programs moving from phase one to phase two, indicating robust development activity [6] Market Data and Key Metrics Changes - The company is focusing on US manufacturing to mitigate tariff risks and has invested $12 billion in manufacturing capital in the US from 2018 to 2024 [14][15] - The company plans to invest an additional $9 billion in manufacturing and R&D facilities by 2028 [15] Company Strategy and Development Direction - The company aims to grow through the KEYTRUDA loss of exclusivity (LOE) by focusing on innovation and expanding its product portfolio [8][10] - The strategic framework includes investing in and augmenting the pipeline, with a focus on oncology and expanding into cardiometabolic and immunology sectors [9][91] Management's Comments on Operating Environment and Future Outlook - Management acknowledges significant macroeconomic challenges, including MFN (Most Favored Nation) pricing and tariffs, but remains focused on innovation as the path to long-term sustainability [10][12] - The company is actively engaging with the administration regarding drug pricing reforms and believes that addressing middlemen costs is crucial for lowering drug prices [29][32] Other Important Information - The company is committed to producing both drug product and drug substance in the US by 2026, which aligns with its strategy to enhance domestic manufacturing capabilities [21][23] - The company is exploring opportunities in combination therapies and bispecific antibodies to enhance its pipeline in immunology [88][90] Q&A Session Summary Question: How does the company rank the various sectoral pressures? - Management identified MFN as the most significant policy question, followed by tariffs and FDA changes, but noted that these have not yet had a direct impact on operations [12][16] Question: What steps has the company taken regarding KEYTRUDA and tariffs? - The company has shifted to US manufacturing for KEYTRUDA and brought in inventory to mitigate tariff impacts, viewing this as a no-regret move [20][21] Question: What is the company's strategy for the subcutaneous KEYTRUDA? - The company plans to price the subcutaneous version competitively to maximize adoption and access, ensuring it aligns with the IV pricing [53][54] Question: What is the outlook for WIN Revere? - The launch of WIN Revere is progressing well, with expectations for steady growth driven by physician confidence and safety profiles [57][58] Question: What is the potential for enicetide in the market? - The company believes enicetide can democratize access to LDL cholesterol lowering, with a significant unmet need in cardiovascular disease [71][76]