Company Overview - Merck & Co. Inc. (NYSE:MRK) is recognized as one of the best value stocks in Goldman Sachs' portfolio [1] - The company is a global healthcare provider delivering medicines and vaccines across various therapeutic areas, including oncology, infectious diseases, immunology, and cardiometabolic conditions [3] Product Development - On September 19, Merck announced FDA approval for KEYTRUDA QLEX injection, the first subcutaneous version of its cancer drug KEYTRUDA [1] - QLEX can be administered subcutaneously in as little as one minute, offering a faster and more convenient option compared to the traditional intravenous (IV) form [1] Market Impact - The approval of QLEX strengthens Merck's leadership in oncology, where KEYTRUDA already has approvals across 38 cancer indications [2] - The new subcutaneous format is expected to enhance adoption in community clinics and smaller practices, improving patient experience with three-week and six-week dosing schedules [2] Financial Performance - KEYTRUDA is already generating multi-billion-dollar sales annually, and the introduction of the subcutaneous version provides Merck with a new opportunity to defend and grow its oncology franchise [3]

本研究一项多中心、随机、双盲、平行对照的1期临床研究，旨在评估HLX17与KEYTRUDA(美国市售) 在多种已切除实体肿瘤(包括非小细胞肺癌、黑色素瘤或肾细胞癌)受试者中的药代动力学(PK)特徵、有 效性、安全性和免疫原性相似性。合格的受试者将按1:1的比例随机分配至A组和B组，A组受试者每3周 接受一次HLX17治疗;B组受试者前8个周期(24周)每3周接受一次KEYTRUDA治疗，随后转为接受 HLX17治疗，所有受试者持续接受治疗至随机化后12个月(约17个周期)或研究者评估的疾病复发、死 亡、开始新抗肿瘤治疗、出现不可耐受的药物毒性、撤回知情同意书或研究终止(以先发生者为準)。本 研究的主要研究终点为首次给药后从0到21天血清药物浓度-时间曲线下面积(AUC0-21d)以及第6次给药 后稳态下单个给药间隔内的血清药物浓度-时间曲线下面积(AUCss)。次要研究终点包括其他PK参数、 有效性、安全性和免疫原性。 复宏汉霖(02696)公布，近日，公司自主研发的帕博利珠单抗生物类似药HLX17(重组抗PD-1人源化克隆 抗体注射液)(HLX17)在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国 ...

复宏汉霖晚间公告，公司自主研发的帕博利珠单抗生物类似药HLX17（重组抗PD-1人源化克隆抗体注 射液）在多种已切除实体瘤患者中开展的国际多中心1期临床研究于中国境内完成首例患者给药。本研 究是一项多中心、随机、双盲、平行对照的1期临床研究，旨在评估HLX17与KEYTRUDA 在多种已切 除实体肿瘤受试者中的药代动力学特征、有效性、安全性和免疫原性相似性。 （文章来源：第一财经） ...

mRNA-4157/V940 in combination with KEYTRUDA - At ~3 years of follow-up, the recurrence-free survival rate of mRNA-4157/V940 in combination with KEYTRUDA was 74.8%, compared to 55.6% for KEYTRUDA alone[12] - At a median planned follow-up of 34.9 months, mRNA-4157/V940 in combination with KEYTRUDA reduced the risk of recurrence or death by 49%[14] - At ~3 years of follow-up, mRNA-4157/V940 in combination with KEYTRUDA demonstrated a 62% reduction in the risk of developing distant metastasis or death compared to KEYTRUDA alone[17] Safety and Tolerability of mRNA-4157/V940 - In the adjuvant melanoma trial, any treatment-related adverse event occurred in 100% of patients (n=104) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 25% of patients[18] - Serious adverse events occurred in 14.4% of patients (n=15) receiving mRNA-4157 (V940) + pembrolizumab[18] - Immune-related adverse events occurred in 37.5% of patients (n=39) receiving mRNA-4157 (V940) + pembrolizumab, with Grade ≥ 3 events in 10.6% of patients[18] - 94.2% of patients (n=98) experienced mRNA-4157 (V940)-related adverse events, with 33.7% Grade 1, 49% Grade 2, and 11.5% Grade 3[18] Development Programs - The Phase 3 study for adjuvant melanoma with mRNA-4157/V940 is fully enrolled[21, 22] - mRNA-4359 is ongoing in Phase 1/2 study; now enrolling Phase 2 with additional indications planned[27] - mRNA-2808 is in Phase 1 development[41] - mRNA-4203: IND open, in combination with Immatics' IMA203[49]

Core Insights - Merck & Co., Inc. is recognized as one of the 13 best Fortune 500 dividend stocks to invest in, highlighting its appeal to income-focused investors [1] - The company received FDA approval for KEYTRUDA QLEX™ injection, which is expected to enhance its market position and attract further investor interest [3][4] Financial Performance - For Q2 2025, Merck reported an Adjusted EPS of $2.13, exceeding the consensus estimate of $2.03, indicating strong operational efficiency [2] - Worldwide sales reached $15.8 billion, reflecting a slight decline of 2% year-over-year, primarily due to decreased Gardasil sales in China [2] - Sales of KEYTRUDA increased by 9% to $8.0 billion, showcasing the drug's continued strong performance in the oncology market [2] Regulatory Developments - The FDA approval for KEYTRUDA QLEX™ allows for subcutaneous administration in adults for most solid tumor indications, marking a significant advancement in treatment options [3] - The approval is viewed positively by healthcare providers, emphasizing the importance of immunotherapies in cancer treatment [4] Dividend Appeal - Merck offers a dividend yield of 4%, which is attractive to investors seeking income-generating stocks [4]

Group 1: Company Overview - Pfizer Inc. is a global pharmaceutical leader focusing on mRNA vaccines, oncology, immunology, and infectious diseases, with notable recognition for its COVID-19 vaccine collaboration with BioNTech [1][2] - The company is advancing its mRNA vaccine portfolio, recently announcing progress with its LP.8.1-adapted COMIRNATY 2025-2026 formula [1] Group 2: Vaccine Development - In September 2025, Pfizer reported positive Phase 3 topline data showing a fourfold increase in neutralizing antibodies in adults aged 65+ and high-risk adults aged 18–64, supporting FDA approval [2] - The adaptive vaccine targets emerging SARS-CoV-2 sublineages, reinforcing Pfizer's strategic direction to maintain vaccine efficacy amid changing pandemic conditions [2] Group 3: Oncology and Specialty Medicines - Pfizer is advancing oncology and specialty medicines, with combination therapy PADCEV plus KEYTRUDA showing improved survival rates in bladder cancer [3] - The company is also progressing with HYMPAVZI for hemophilia treatment, demonstrating its commitment to high-need therapeutic areas [3] Group 4: Research and Development Focus - Despite facing regulatory challenges and patent litigation over Paxlovid, Pfizer continues to invest in R&D and strategic partnerships [4] - The company's focus on adaptive mRNA technology, AI-driven development, and precision medicine highlights its leadership among biotech innovators [4]

Group 1 - Pfizer Inc. is recognized as a global pharmaceutical leader, advancing innovative medicines and vaccines across various therapeutic areas, including oncology and immunology [1] - The company gained significant attention for its COVID-19 vaccine developed in collaboration with BioNTech, contributing to global pandemic response efforts [1] - Pfizer's recent Phase 3 data for its updated COVID-19 vaccine formula shows a four-fold increase in neutralizing antibody titers in older adults and high-risk populations, supporting FDA approval [2] Group 2 - Pfizer is making strides in oncology, with recent combinations of PADCEV and KEYTRUDA showing improved survival rates for bladder cancer, and XTANDI with leuprolide enhancing outcomes in high-risk prostate cancer [3] - The company is also advancing in hematology with HYMPAVZI, a treatment for hemophilia A or B that significantly reduces bleeding episodes compared to traditional therapies [4] - Pfizer is targeting $4.5 billion in cost savings by the end of 2025, with plans to reinvest in R&D to sustain innovation amid patent expirations [5] Group 3 - Global licensing agreements, such as the deal with 3SBio, are part of Pfizer's strategy to expand its market reach [5]

Financial Data and Key Metrics Changes - Merck is in a transformation phase with a diversified set of growth drivers, aiming for over $50 billion in revenues by the mid-2030s from its pipeline [3][4] - The company is launching 20 products, most of which have blockbuster potential [3][4] Business Line Data and Key Metrics Changes - KEYTRUDA continues to show strong growth with 42 approved indications in the U.S. across 18 tumor types, with expectations for continued growth from new indications [6][7] - The subcutaneous formulation of KEYTRUDA is anticipated to achieve 30% to 40% adoption within 18 to 24 months post-launch [9][11] Market Data and Key Metrics Changes - The company is well-positioned to manage the impact of tariffs and has a diverse supply chain footprint [41][42] - The impact of the Most Favored Nation (MFN) policy is expected to be manageable, as it only accounts for less than 10% of revenues [42][43] Company Strategy and Development Direction - Merck is focused on innovation and expanding its pipeline, with plans to increase R&D investments due to a strong pipeline of 80 Phase III clinical programs [51][52] - Business development remains a priority, with a focus on bringing in innovative science that addresses unmet medical needs [67][68] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the loss of exclusivity for KEYTRUDA and emphasized the importance of their pipeline in driving future growth [5][6] - The company is optimistic about the readouts from its oncology and HIV pipelines in the coming year [80][81] Other Important Information - The company is preparing for the launch of its oral PCSK9 inhibitor, which is expected to democratize access to this treatment [60][62] - Merck is also excited about its cancer vaccine program, focusing on early-stage cancers with potential curative opportunities [39][40] Q&A Session Summary Question: What are the growth avenues for KEYTRUDA? - Management expects continued growth from new indications, including early-stage lung cancer and women's cancers [7][8] Question: How will the adoption of the subcutaneous formulation of KEYTRUDA be affected? - Factors such as pricing, access, and the J code will influence adoption rates, with expectations of 30% to 40% adoption within 18 to 24 months [10][11] Question: What is the confidence level in the TROP-two ADC program? - Management expressed confidence based on early signals and extensive clinical trials, highlighting its unique properties and potential in maintenance settings [17][18] Question: How does Merck plan to address macroeconomic headwinds like tariffs? - The company has a diverse supply chain and is well-positioned to manage tariff impacts, focusing on innovation and product launches [41][42] Question: What is the outlook for Gardasil in China? - Gardasil is not expected to drive significant growth in China, with future growth anticipated from international markets and new product launches [69][70] Question: What are the expectations for the cancer vaccine program? - The program is focused on early-stage cancers, with positive readouts expected in the next couple of years [39][40]

Financial Data and Key Metrics Changes - The company is in a transformation phase with a diversified set of growth drivers, expecting over $50 billion in revenues by the mid-2030s from its pipeline [3][4][5] - The company is launching 20 products, most of which have blockbuster potential [3][4] Business Line Data and Key Metrics Changes - KEYTRUDA continues to show strong growth with 42 approved indications across 18 tumor types, with new indications expected to drive future growth [6][7][8] - The subcutaneous formulation of KEYTRUDA is anticipated to achieve 30% to 40% adoption within 18 to 24 months post-launch [9][11] - The company has 24 oncology assets in clinical trials, focusing on immune stimulation, chemotherapy improvements, and specific targeting agents [13][15] Market Data and Key Metrics Changes - The company is well-positioned to manage tariff impacts due to a diverse supply chain and manufacturing footprint [42][43] - The impact of the Most Favored Nation (MFN) policy is expected to be manageable, with less than 10% of revenues affected [43][44] Company Strategy and Development Direction - The company is focused on innovation and expanding its pipeline, with a commitment to reinvest $3 billion in annual cost savings into R&D [51][52] - Business development remains a priority, with a focus on bringing in innovative science that addresses unmet medical needs [66][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in navigating the loss of exclusivity for KEYTRUDA and emphasized the importance of new product launches [5][6] - The company is optimistic about the future, with expectations for positive readouts from its pipeline and successful product launches [78][79] Other Important Information - The company is excited about the potential of its oral PCSK9 inhibitor, which showed a 60% reduction in LDL cholesterol in Phase II trials [59][60] - The company is also exploring opportunities in the GLP-1 space, with an oral formulation expected to enter Phase I trials [62][64] Q&A Session Summary Question: What are the growth avenues for KEYTRUDA? - Management highlighted new indications in lung cancer and women's cancers as key growth opportunities [6][7] Question: How does the company plan to handle tariff impacts? - The company has a diverse supply chain and believes the impact of tariffs is manageable [42][43] Question: What is the strategy for the new PD-1 VEGF bispecifics? - The company is focusing on specific patient strata and therapeutic indications to differentiate from existing treatments [32][33] Question: How will the company approach pricing in light of MFN? - The company plans to price products based on the value they bring, ensuring broad access while being mindful of MFN implications [44][46] Question: What is the outlook for the cancer vaccine program? - Management is optimistic about the enthusiasm from investigators and the potential for early-stage cancer treatments [39][40] Question: How does the company view the future of Gardasil in China? - Gardasil is not expected to drive significant growth in China, with focus shifting to international markets [68][69]

Core Insights - HCW Biologics has developed a second-generation, pembrolizumab-based immune checkpoint inhibitor that shows promise against solid tumors, particularly pancreatic and ovarian cancer, utilizing its proprietary TRBC product discovery platform [1][3][4] - Immune checkpoint inhibitors (ICIs) have been recognized as a breakthrough in cancer therapy since 2011, but their efficacy is limited, with less than 20% of patients responding durably to treatment [2][3] - The new pembrolizumab-based fusion molecules aim to enhance the immune response by neutralizing immunosuppressive cytokines and promoting immune cell infiltration into tumors, potentially outperforming existing therapies [3][4] Company Overview - HCW Biologics Inc. is a clinical-stage biopharmaceutical company focused on developing novel immunotherapies to combat diseases linked to chronic inflammation, particularly age-related conditions [7] - The company has created over 50 molecules using its TRBC platform, which allows for the construction of various classes of immunotherapeutic compounds targeting cancer and other diseases [7] - The lead product candidate, HCW9302, was developed using the legacy TOBI platform, while the TRBC platform represents a new approach to immunotherapy [7] Market Context - Immune checkpoint inhibitors generated over $40 billion in global sales in 2024, indicating a significant market presence despite their limited efficacy [3] - The ongoing research into second-generation ICIs reflects a broader trend in the industry to improve treatment outcomes for patients with difficult-to-treat solid tumors [4][5]