美佑恒®(注射用维贝柯妥塔单抗)在既往经治过二线及以上系统性化疗及PD-(L)1抑制剂失败后的患者中 显示出临床意义的疗效优势，同时安全性可控。美佑恒®(注射用维贝柯妥塔单抗)用于治疗R/MNPC的 关键注册性临床研究结果于2025年美国临床肿瘤学会年会上以"重磅研究摘要(LBA)"形式公布，并于会 上作口头报告。 此外，美佑恒®(注射用维贝柯妥塔单抗)与普佑恒(普特利单抗注射液)的联合疗法呈现显著且持久的临 床效益，在该联用治疗的II期临床试验中，针对免疫治疗及铂类化疗失败的患者中实现了迄今为止最高 的确认客观缓解率(cORR)(73.3%，95%CI:54.1-87.7)及最长的无进展生存期(mPFS)(10.9m，95%CI:6.6- 15.4)，有望为抗PD-(L)1及铂类化疗失败的R/MNPC患者提供更为有效的治疗选择。上述数据已在2025 年欧洲肿瘤内科学会年会上公布。 格隆汇10月30日丨乐普生物-B(02157.HK)公告，董事会欣然宣布国家药品监督管理局("国家药监局")近 期批准候选药物美佑恒®(注射用维贝柯妥塔单抗)在中国的上市申请，该药物为公司自主研发的一种表 皮生长因子受体("EGF ...

Core Viewpoint - Lepu Biopharma-B (02157) has received approval from the National Medical Products Administration for its candidate drug Meiyouheng (injectable Vebrecatinib), marking a significant milestone for the company in the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) [1] Group 1 - Meiyouheng (injectable Vebrecatinib) is the first EGFR-targeted antibody-drug conjugate (ADC) approved in China, representing a pioneering achievement in this category [1] - The approval of Meiyouheng is expected to enhance treatment outcomes for patients suffering from R/M NPC [1] - The company plans to expand the indications for Meiyouheng based on this approval, aiming to accelerate the realization of its commercial potential [1]

Core Insights - The National Medical Products Administration of China has approved the listing application for the candidate drug Meiyouheng (injectable Vebecotuzumab) developed by the company, which is an innovative antibody-drug conjugate targeting epidermal growth factor receptor (EGFR) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/MNPC) [1][2] Company Overview - Meiyouheng is an ADC composed of an EGFR-targeting monoclonal antibody linked to a potent microtubule inhibitor, demonstrating high affinity for tumor cells expressing EGFR, which is a significant target in cancer therapy [1] - The drug targets EGFR, which is highly expressed in various malignancies, including colorectal cancer, lung cancer, and head and neck cancer, with 89% of advanced NPC cases showing EGFR expression [1] Clinical Efficacy - Meiyouheng has shown clinically meaningful efficacy in patients who have failed second-line or higher systemic chemotherapy and PD-(L)1 inhibitors, with controllable safety [2] - Key registration clinical trial results for Meiyouheng in treating R/MNPC will be presented as a "late-breaking abstract" at the 2025 American Society of Clinical Oncology annual meeting [2] - The combination therapy of Meiyouheng with Puyouheng (putilizumab injection) has demonstrated significant and durable clinical benefits, achieving the highest confirmed objective response rate (cORR) of 73.3% and the longest median progression-free survival (mPFS) of 10.9 months in patients who failed immunotherapy and platinum-based chemotherapy [2]

香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責，對其準確性 或完整性亦不發表任何聲明，並明確表示概不會就因本公告全部或任何部分內容而產生或因倚 賴該等內容而引致的任何損失承擔任何責任。 LEPU BIOPHARMA CO., LTD. 樂普生物科技股份有限公司 （於中華人民共和國註冊成立的股份有限公司） （股份代號：2157） 內幕消息公告 美佑恒® （注射用維貝柯妥塔單抗）是一種由EGFR靶向單克隆抗體與強效的微 管蛋白抑制有效載荷一甲基澳瑞他汀E分子通過纈氨酸－瓜氨酸鏈接體偶聯 而成的ADC。其以高親和力特異性地結合腫瘤細胞表面的EGFR，通過內吞 及溶酶體蛋白酶裂解後釋放強效的有效載荷，從而導致腫瘤細胞死亡。EGFR 高表達於結直腸癌、肺癌、頭頸癌等多種惡性實體瘤中，89%的晚期NPC存 在EGFR表達。因此，EGFR是癌症治療的重要靶點。 1 美佑恒® （注射用維貝柯妥塔單抗）在既往經治過二線及以上系統性化療及 PD-(L)1抑制劑失敗後的患者中顯示出臨床意義的療效優勢，同時安全性可 控。美佑恒® （注射用維貝柯妥塔單抗）用於治療R/M NPC的關鍵註冊性臨床 研究結果於202 ...

Investment Rating - The report initiates coverage with an "Outperform" rating for Lepu Biopharma-B (2157) [4] Core Views - The company is a leading domestic innovative pharmaceutical enterprise focusing on ADC combined with IO in oncology, with expectations for rapid market penetration following the approval of MRG003 [1][4] - The product pipeline is expected to expand internationally, indicating strong long-term growth potential for the company [1] Financial Summary - Projected total revenue for 2024A, 2025E, 2026E, and 2027E is 368 million, 853 million, 1,204 million, and 1,665 million RMB respectively, reflecting growth rates of 63%, 132%, 41%, and 38% [3] - Gross profit is expected to increase from 292.97 million in 2024A to 1,415.20 million in 2027E, with a gross margin projected to be around 79.66% to 85% [3] - Net profit is forecasted to improve from -411 million in 2024A to -29 million in 2027E, indicating a significant reduction in losses [3] Company Overview - Lepu Biopharma was established in January 2018 and focuses on oncology, particularly targeted and immunotherapy [9] - The company has built a diverse product pipeline through acquisitions and partnerships, including PD-1 antibodies and ADCs [9] - The management team is experienced, with a high concentration of ownership, ensuring stability and strategic direction [13][15] Market Potential - The global and Chinese cancer immunotherapy market is expected to grow significantly, with a CAGR of 16.3% and 25.1% respectively from 2025 to 2030 [28][31] - The PD-1 therapy market in China is projected to reach 582 billion RMB by 2030, with a CAGR of 30.5% from 2020 to 2025 [33][35] ADC Market Growth - The global ADC market is anticipated to reach 66.2 billion USD by 2030, with a CAGR of 30.3% from 2023 to 2030 [41] - The ADC market in China is expected to grow at a CAGR of 72.6% from 2023 to 2028, reaching 38.3 billion RMB [44][45] Product Pipeline and Clinical Development - MRG003 is currently under NDA review and has shown promising results in clinical trials for R/M NPC, with a significant improvement in overall response rates compared to chemotherapy [56][61] - The company is actively exploring combination therapies with PD-1 inhibitors, which may enhance treatment efficacy [60][65]

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]

Investment Rating - The report assigns an "Accumulate" rating to the company [5]. Core Insights - The company is a leading domestic innovative pharmaceutical enterprise focusing on ADC combined with IO, with expectations for rapid growth following the approval of MRG003 [2]. - The product pipeline includes plans for international business development, indicating a positive long-term outlook for the company [2]. Financial Summary - Projected total revenue for 2024A is 368 million RMB, with a growth rate of 63%. By 2027E, revenue is expected to reach 1,665 million RMB, with a growth rate of 38% [4]. - The company is projected to achieve a net profit of -411 million RMB in 2024A, improving to -29 million RMB by 2027E [4]. - The price-to-earnings (PE) ratio is expected to improve from -10.04 in 2024A to -389.49 in 2027E, while the price-to-book (PB) ratio is projected to increase from 5.87 to 18.86 over the same period [4]. Company Overview - The company was established in January 2018 and focuses on innovative treatments for cancer, particularly targeted therapies and immunotherapies [13]. - The company has built a robust product pipeline through acquisitions and partnerships, including PD-1 antibodies and ADC drugs [13][15]. - The management team is experienced, with a high concentration of ownership, ensuring stability and strategic direction [15][19]. Market Potential - The global and Chinese cancer immunotherapy market is expected to grow significantly, with a projected CAGR of 16.3% and 25.1% respectively from 2025 to 2030 [30]. - The PD-1 therapy market in China is anticipated to reach 582 billion RMB by 2030, with a CAGR of 30.5% from 2020 to 2025 [33]. Product Pipeline and Development - The company has multiple tumor product pipelines covering immunotherapy, ADC targeted therapy, and oncolytic virus drugs [20]. - MRG003 is currently under NDA review for treating R/M NPC, with potential for significant market impact [22]. - The company is also exploring combination therapies with PD-1 antibodies, which may enhance treatment efficacy [20]. Sales Growth - The company's first commercial product, the PD-1 antibody, has seen rapid sales growth, achieving 300 million RMB in revenue in 2024, three times the revenue of 2023 [23][36]. - The company has expanded its sales network across 118 cities in China, enhancing its market presence [36].

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]

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 2025 price-to-sales (PS) ratio of 23X, leading to a reasonable valuation of 10.87 yuan/11.81 HKD [1] - A price-to-book (PB) ratio of 25X is also applied, resulting in a valuation of 9.55 yuan/10.38 HKD [1] Group 2: Product Pipeline and Development - Lepu Biopharma has established a diverse pipeline in oncology, focusing on immunotherapy, ADC targeted therapy, and oncolytic virus drugs [1] - The cornerstone of its immunotherapy is the anti-PD-1 antibody candidate, with advanced ADC technology being utilized for innovative drug development [1] - The company is also exploring combination therapies involving PD-L1 and ADC drugs [1] Group 3: Regulatory Approvals - MRG003 has received priority review qualification from the CDE for the treatment of recurrent/metastatic nasopharyngeal carcinoma (R/MNPC) and is expected to be approved domestically soon [2] - MRG003, in combination with the PD-1 antibody, has been officially included as a breakthrough therapy by the NMPA for specific treatment indications [2]

Core Insights - Lepu Biotech's MRG006A, a targeted GPC3 antibody-drug conjugate (ADC), has successfully completed the first patient enrollment in a Phase II clinical trial for advanced hepatocellular carcinoma (HCC), marking it as the first GPC3 ADC to enter this stage globally [1][2] - MRG006A utilizes Lepu Biotech's Hi-TOPi ADC technology platform, which allows for precise targeting of GPC3-positive tumor cells, thereby releasing toxins specifically within the tumor to achieve targeted cell destruction [1] - GPC3 is a cancer embryonic antigen that is highly expressed in 70%-80% of HCC cases but has minimal expression in normal tissues, making it a promising target for precision therapy [1] Clinical Development - The Phase I clinical trial of MRG006A showed promising results, with significant tumor shrinkage observed in GPC3-positive patients during the dose-escalation study, indicating strong therapeutic potential [2] - The advancement of MRG006A into Phase II clinical research represents a significant breakthrough in Lepu Biotech's ADC pipeline and has the potential to address unmet clinical needs in HCC treatment [2]