Group 1 - The company is a leading domestic innovative pharmaceutical enterprise in the ADC and IO layout, with expectations for rapid market penetration of MRG003 upon approval [1] - The company has a robust product pipeline and is exploring business development opportunities abroad, indicating strong long-term growth potential [1] - The initial coverage rating is set to "Buy," with projected revenues of 853 million, 1.204 billion, and 1.665 billion yuan for 2025-2027, respectively [1] Group 2 - MRG003 has received priority review qualification from the CDE for the treatment of R/M NPC, with an NDA submission expected in March 2025, indicating a high likelihood of domestic approval soon [2] - In combination therapy, MRG003 has been officially included as a breakthrough therapy by the NMPA for patients with recurrent or metastatic nasopharyngeal carcinoma who have failed prior platinum and PD-1/L1 treatments [2]

Core Viewpoint - Cathay Securities has initiated coverage on Lepu Biopharma-B (02157) with a "Buy" rating, projecting significant revenue growth from 2025 to 2027, driven by a robust product pipeline and imminent approval of MRG003 [1][2] Group 1: Financial Projections - Revenue forecasts for Lepu Biopharma are set at 853 million, 1.204 billion, and 1.665 billion yuan for 2025, 2026, and 2027 respectively [1] - The company is assigned a target price of 9.55 to 10.38 HKD based on a cautious approach using both PS and PB valuation methods [1] Group 2: Product Pipeline and Development - Lepu Biopharma has developed a diverse pipeline of oncology products, focusing on immunotherapy, ADC targeted therapy, and oncolytic virus drugs [1] - The cornerstone of the company's immunotherapy is an anti-PD-1 antibody candidate, with advanced ADC technology being utilized for innovative drug development [1] Group 3: Regulatory Approvals and Clinical Trials - MRG003 has received priority review qualification from the CDE for the treatment of R/MNPC, with an NDA submission expected in March 2025 [2] - MRG003 has also been included in the list of breakthrough therapy drugs by the NMPA for use in combination with PD-1 antibody for specific cancer indications [2]

报告中称，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。 公司以抗PD-1抗体候选药物为免疫疗法的基石，通过先进的ADC技术开发平台开发创新型ADC，差异 化布局溶瘤病毒，旨在开发出更优化、更创新的药物，更好地服务于癌症患者的未被满足的临床需求。 此外，公司还积极探索PD-L1与ADC类药物联合疗法。 公司MRG003单药用于治疗R/MNPC已于2024年9月获CDE优先审评资格，并于2025年3月提交NDA审 评，我们认为近期有望在国内获批。在联合疗法方面，2025年9月，MRG003联合PD-1抗体普特利单抗 HX008被中国国家药品监督管理局(NMPA)药品审评中心(CDE)正式纳入突破性治疗药物品种，针对适 应症为：既往至少经过铂类和PD-1/L1治疗失败的复发或转移性鼻咽癌。 智通财经APP获悉，国泰海通发布研报称，首次覆盖乐普生物-B(02157)，给予增持评级。预测2025- 2027年营业收入为8.53/12.04/16.65亿元，参考可比公司2025年平均PS 34.1X，考虑公司产品布局完善， 以及公司MRG003获批在即，给予公司2025年23XPS，对 ...