乐普生物（2157.HK）深度——研发布局稳扎稳打，ADC平台进入收获期 #研发覆盖ADC+IO，即将进入新药获批收获期 公司已构建多个肿瘤产品管线，覆盖免疫治疗、ADC靶向治疗和溶瘤病毒药物三大领域，除已上市的PD-1单抗普 特利单抗和MRG003外，公司还拥有6款ADC药物、1款引进的溶瘤病毒以及1款TCE药物进入临床阶段，整体看公 司管线梯度完善，未来3-5年将进入新药陆续获批上市的收获期。 （乐普生物） 乐普生物（2157.HK）深度——研发布局稳扎稳打，ADC平台进入收获期 #研发覆盖ADC+IO，即将进入新药获批收获期 （乐普生物） 2） MRG004A（TF-ADC）用于后线胰腺癌的I期具备优异竞争力，目前已进入III期试验。 3）MRG006A（GPC3 ADC）为FIC，瞄准广阔肝癌市场，I期试验剂量爬坡取得超预期成果，缩瘤效果显著，26年 有望启动III期试验。 4）参股CMG901为全球FIC的CLDN 18.2 ADC，已处于全球III期阶段；MRG001（CD20 ADC）在DLBCL展现潜 力。 #引进溶瘤病毒具备BIC潜质，新品出海已有突破 公司19年引进溶瘤病毒疗法CG0070 ...

机构：中邮证券 研究员：盛丽华/陈灿 研发覆盖ADC+IO，即将进入新药获批收获期 公司已构建多个肿瘤产品管线，覆盖免疫治疗、ADC靶向治疗和溶瘤病毒药物三大领域，除已上市的 PD-1单抗普特利单抗和MRG003外，公司还拥有6款ADC药物、1款引进的溶瘤病毒以及1款TCE药物进 入临床阶段，整体看公司管线梯度完善，未来3-5年将进入新药陆续获批上市的收获期。业绩层面，公 司BD和销售双轮驱动，收入稳步增长，费用支出稳健，25H1实现首次盈利和经营性净现金流转正。 在研ADC各具特色，布局适应症竞争优势明显1）MRG003（EGFR ADC）单药用于后线NPC国内已获 批上市，展示出优异的生存获益、相较竞品具备安全性优势、联合用药将线数进一步前移；公司同时积 极布局HNSCC和NSCLC的大适应症，单药用于2L+HNSCC处于III期试验阶段。 2） MRG004A（TF-ADC）用于后线胰腺癌的I期具备优异竞争力，目前已进入III期试验。 3）MRG006A（GPC3 ADC）为FIC，瞄准广阔肝癌市场，I期试验剂量爬坡取得超预期成果，缩瘤效果 显著，26年有望启动III期试验。 4）参股CMG901为全球 ...

Investment Rating - The report assigns a "Buy" rating for the company, Lepu Biopharma (2157.HK), marking its first coverage [1]. Core Insights - The company is entering a harvest period for new drug approvals, having established a comprehensive pipeline in oncology that includes immunotherapy, ADC (Antibody-Drug Conjugate) targeted therapy, and oncolytic virus drugs. The company has multiple ADC drugs and other therapies in clinical stages, with expectations for new drug approvals in the next 3-5 years [3][10]. - The ADC pipeline is characterized by unique features and competitive advantages in various indications, with MRG003 (EGFR ADC) already approved for NPC (nasopharyngeal carcinoma) in China and showing promising results in other indications [4][30]. - The introduction of oncolytic virus therapy CG0070 has shown potential in the bladder cancer market, with successful regulatory progress in the U.S. and ongoing clinical trials in China [5][30]. - Financially, the company has achieved its first profit and positive operating cash flow in the first half of 2025, with steady revenue growth driven by business development and sales [25]. Summary by Sections R&D Coverage and Pipeline - The company focuses on oncology treatment, with a pipeline that includes immunotherapy, ADCs, and oncolytic virus therapies. It has developed a robust ADC technology platform and has multiple products in various stages of clinical development [11][10]. - The pipeline includes 6 ADC drugs and 1 oncolytic virus therapy, with several candidates in pivotal clinical stages, indicating a well-structured development strategy [14][10]. Unique Features of ADCs - MRG003 has been approved for NPC and is in advanced trials for HNSCC (head and neck squamous cell carcinoma) and NSCLC (non-small cell lung cancer), showcasing its broad applicability and competitive edge [30][4]. - Other ADCs in development, such as MRG004A for pancreatic cancer and MRG006A for liver cancer, are also progressing well, with MRG004A entering pivotal trials [30][6]. Financial Performance and Projections - The company reported revenues of 4.66 billion yuan in the first half of 2025, a significant increase from 1.33 billion yuan in the same period of 2024. The net profit for the same period was 290 million yuan, marking a turnaround from a loss of 197 million yuan in the previous year [25][30]. - Revenue projections for 2025, 2026, and 2027 are estimated at 8.8 billion yuan, 10.2 billion yuan, and 14.9 billion yuan, respectively, with expected growth rates of 138%, 16%, and 47% [30].

Summary of Key Points from the Conference Call of Lepu Biopharma Company Overview - **Company**: Lepu Biopharma - **Industry**: Biopharmaceuticals, focusing on ADC (Antibody-Drug Conjugates) and immunotherapy Core Products and Development Progress - **EGFR ADC (MRG003)**: - Targeting nasopharyngeal carcinoma (NPC) and head and neck squamous cell carcinoma - Expected approval in China between late 2025 and early 2026 for NPC, and in 2027 for head and neck cancer [2][3] - Positive feedback received at ASCO conference regarding clinical data [2][3] - **TFADC (MRG004A)**: - Targeting tissue factor, showing promising results in pancreatic ductal adenocarcinoma - Completed domestic expansion trials, with data to be presented at ASCO in October [2][6] - **GPC3 ADC (MRG006A)**: - Targeting liver cancer, currently in Phase I clinical trials - Expected to share Phase I data in 2026 and seek overseas collaboration opportunities [2][7][8] - **Claudin 18.2 ADC (CMG901)**: - Jointly developed with Connora, currently in global Phase III trials - NDA submission expected by the end of 2026 [2][9] - **CDH17 ADC (MRG007)**: - Targeting colorectal cancer, IND approval received in China, clinical trials to start soon - Total transaction value includes $47 million upfront and over $1.2 billion in milestone payments [2][10] Financial and Operational Outlook - **R&D Expenses**: - Estimated at approximately 400 million RMB for 2025, with a focus on advancing key pipelines [4][25] - **Profitability Expectations**: - Anticipated to achieve overall profitability by around 2028, aligning with the commercialization of core products [4][29] Market Potential and Sales Strategy - **Market Potential for EGFR ADC**: - Estimated peak sales in China could reach approximately 3 billion RMB, targeting NPC and head and neck cancer [2][27] - **Sales Team Expansion**: - Plans to expand the sales team from 200 to about 250 to support the commercialization of PD-1 and EGFR ADC products [18][21] Upcoming Data Releases and Conferences - **Data Presentations**: - Planned presentations at ASCO, ESMO, and ASH conferences, focusing on various ADC products and combination therapies [19] Competitive Landscape and Intellectual Property - **Patent Protection**: - Strong patent protection for EGFR ADC, preventing competitor products from entering the U.S. market [24] Future Development Focus - **TCE Platform**: - Focused on developing new ADC molecules targeting unmet clinical needs, while also exploring partnerships for other projects [28] Conclusion - **Overall Strategy**: - Lepu Biopharma is positioned to leverage its robust pipeline of ADC products and immunotherapies to achieve significant market presence and profitability in the coming years, with a clear focus on advancing clinical trials and expanding its sales capabilities [30]

Group 1 - The core viewpoint is that the Hong Kong stock market is experiencing a technical bull market, leading to a revaluation of innovative pharmaceutical companies, driven by improved liquidity and policy expectations [1][17] - The Hang Seng Index has risen over 20% this year, while the Hang Seng Healthcare Index has increased by over 40%, indicating strong market performance [1] - The revaluation of the innovative drug sector is attributed to global capital reassessing the long-term logic of China's innovative drug industry [1][19] Group 2 - AI medical technology breakthroughs, comprehensive policy support, and enhanced commercialization capabilities are expected to provide greater valuation expansion potential for Hong Kong's innovative drug sector compared to A-shares [4] - Companies with differentiated innovative pipelines and commercialization potential are becoming market focal points, entering a phase of valuation expansion [4][21] - Lepu Biopharma's 2024 financial report validates this logic, showcasing rapid commercialization and differentiated advantages in its three major pipelines [4][21] Group 3 - Lepu Biopharma achieved approximately 368 million yuan in revenue for 2024, with its main product, Pu You Heng®, generating around 300 million yuan, marking a threefold increase from the previous year's 100 million yuan [6] - The company has established a complete commercialization loop through a specialized marketing team, enhancing its market penetration and professional trust [6][7] - Lepu Biopharma has completed access to procurement platforms in 27 provinces and covers approximately 81 key cities with its sales channels [6] Group 4 - Lepu Biopharma's R&D pipeline focuses on three major areas: ADC, cancer immunotherapy, and oncolytic viruses, which collectively build competitive barriers [9][16] - The ADC pipeline, particularly the core product MRG003, demonstrates significant clinical potential and has received priority review from NMPA and orphan drug designation from FDA [11][13] - The company is also advancing other ADC candidates, such as MRG004A and MRG006A, which show promising clinical results and potential for broad application across various cancers [13][14] Group 5 - The supportive policy environment and recovering capital market are expected to accelerate industry growth and enhance valuation recovery [19][21] - The global healthcare financing activities are rebounding, with an estimated total of $58.2 billion in 2024, indicating a positive trend after two years of decline [19] - Lepu Biopharma is positioned at a critical point for performance and valuation growth, driven by strengthened commercialization capabilities and breakthroughs in its pipeline [21]