乐普生物 20250710 摘要 乐普生物的 EGFR ADC（MRG003）针对鼻咽癌适应症预计 2025 年底 至 2026 年初获批上市，头颈鳞癌适应症预计 2027 年内获批。注册性 临床数据在 ASCO 会议上获得积极反馈，商业化策略已在讨论中。 TFADC（MRG004A）靶向组织因子，在胰腺导管腺癌方面显示良好信 号，已完成国内扩组实验，并计划在 ASCO 大会上公布数据。公司已向 中国 CDE 提交注册性临床沟通交流申请，寻求一线治疗方案。 GPC3 ADC（MRG006A）针对肝癌，具有全球首创潜力，目前正在进 行一期临床试验。预计 2026 年分享一期临床数据，并寻求海外合作机 会，肝癌市场潜力巨大。 Claudin 18.2 ADC（CMG901）由乐普生物与康诺亚共同开发，已授 权给阿斯利康，目前处于全球注册性三期临床阶段，预计 2026 年底提 交 NDA 申报。 CDH17 ADC（MRG007）针对结直肠癌，已授权给美国 Biotech Avent，获得国内 IND 批件，即将启动临床试验。总交易金额包括 4,700 万美元首付款及超过 12 亿美元里程碑付款。 Q&A 乐普生物 ...

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]