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].

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]

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 - The 18A companies in the Hong Kong stock market have experienced a significant turnaround in 2025, showcasing a surge in listings, stock price increases, and international expansion opportunities [1][2][4]. Listing Wave - In 2025, there has been a notable wave of listings for 18A companies, with 10 out of 58 newly listed companies being 18A firms, many of which performed exceptionally well on their debut [2]. - The enthusiasm from investors is evident, with companies like Zhonghui Biotechnology and Yinnuo Pharmaceutical experiencing over 4000 times and 5341 times oversubscription, respectively [2]. - There are currently 49 18A companies that have submitted applications to the Hong Kong Stock Exchange, with at least 20 awaiting approval for listing [2][4]. Price Surge - Among the 77 listed 18A companies, 17 have seen stock price increases exceeding 200%, while 26 have risen between 100% and 200% since the beginning of 2025 [5]. - Beihai Kangcheng has recorded the highest increase at 1644%, although its total market capitalization remains relatively small at approximately 1.1 billion HKD [5][6]. International Expansion - The 18A companies are leveraging unique "outbound" strategies by licensing their products to well-known overseas pharmaceutical companies, which enhances their revenue potential and showcases their technological advancements [7]. - For instance, Rongchang Biotechnology has licensed its RC28-E injection to Santen China for a total of 2.5 billion HKD in upfront payments and additional milestone payments [8]. - The trend of outbound licensing is indicative of the rapid progress of Chinese pharmaceutical companies, transitioning from imitation to innovation, and establishing a competitive edge in the global market [9][10].

Core Viewpoint - The 18A companies in the Hong Kong stock market have experienced a significant turnaround in 2023, showcasing a surge in listings, stock price increases, and international expansion opportunities [1]. Listing Wave - In 2023, the Hong Kong stock market saw a wave of 18A company listings, with 10 out of 58 newly listed companies being 18A firms, many of which performed exceptionally well on their debut [3]. - Notably, five of the top six companies with the highest first-day gains were 18A companies, indicating a growing investor interest [3]. - The IPO of Zhonghui Biotechnology on August 11 received over 4,000 times oversubscription, raising over 200 billion HKD, while Yinnuo Pharmaceutical's IPO on August 15 garnered over 300 billion HKD with 5,341 times oversubscription [3]. Price Surge - Among the 77 listed 18A companies, 17 have seen stock price increases exceeding 200%, with 26 others rising between 100% and 200% since the beginning of 2023 [8]. - The highest price increase was recorded by Beihai Kangcheng, which surged by 1,644%, although its total market capitalization remains relatively small at approximately 1.1 billion HKD [8]. International Expansion - 18A companies are increasingly adopting a unique "outbound" model by licensing their products to well-known overseas pharmaceutical companies, which has generated investor confidence in their future profitability [12]. - For instance, Rongchang Biotechnology announced a licensing agreement with Santen China, receiving an upfront payment of 250 million HKD and potential milestone payments totaling up to 520 million HKD [13]. - Similarly, Lepu Biopharma disclosed a licensing agreement with ArriVent, which could yield up to 1.2 billion USD in total payments [13]. Industry Growth - The rapid advancement of Chinese pharmaceutical companies is reflected in their transition from imitation to innovation, with a growing number of original drug candidates that are competitive on a global scale [15]. - As of the first quarter of 2025, China accounted for nearly 60% of the global transaction value for outbound licensing, indicating its emergence as a center for innovative drug transactions [15].

Core Viewpoint - The 18A companies in the Hong Kong stock market have experienced a significant turnaround in 2023, showcasing a surge in listings, stock price increases, and international expansion opportunities [1]. Listing Wave - In 2023, there has been a notable listing wave for 18A companies, with 10 out of 58 newly listed companies being 18A firms, many of which performed exceptionally well on their debut [3]. - The IPO of Zhonghui Biotechnology on August 11 received over 4000 times oversubscription, with total subscription amount exceeding 200 billion HKD, while Yinnuo Pharmaceutical's IPO on August 15 saw over 300 billion HKD in subscription [3]. - The top six companies with the highest first-day gains included five 18A companies, indicating strong investor interest [3]. Price Surge - Among the 77 listed 18A companies, 17 have seen stock price increases exceeding 200%, with 26 companies experiencing gains between 100% and 200% since the beginning of 2023 [8]. - The highest price increase was recorded by Beihai Kangcheng, with a staggering 1644% rise, although its market capitalization remains relatively small at approximately 1.1 billion HKD [8]. International Expansion - The 18A companies are leveraging unique "outbound" models to generate revenue through licensing agreements with international pharmaceutical firms, despite many still not generating significant income [12]. - Rongchang Biotechnology announced a licensing agreement with Santen China, which includes a non-refundable upfront payment of 250 million HKD and potential milestone payments totaling up to 520 million HKD [12]. - Lepu Biopharma disclosed a licensing agreement with ArriVent, which could yield up to 1.2 billion USD in total payments, including upfront and milestone payments [13]. Industry Progress - The impressive performance of biopharmaceutical companies is attributed to the rapid advancement of Chinese pharmaceutical firms, transitioning from imitation to innovation since 2015 [14]. - Chinese innovative drug companies are now actively developing original drugs, with a significant increase in the number of clinical trials and a growing international competitive edge [15]. - By Q1 2025, China accounted for nearly 60% of global innovative drug licensing transactions, marking its emergence as a center for innovative drug deals [15].

Core Viewpoint - The company has reported significant revenue growth and profitability improvements in its interim results, driven by successful commercialization of its product pipeline and strategic partnerships in the oncology sector [1][2][3] Financial Performance - The company achieved revenue of RMB 466 million, a year-on-year increase of 249.59% [1] - Profit attributable to owners was RMB 41.75 million, compared to a loss of RMB 192 million in the same period last year [1] - Basic earnings per share were RMB 0.02 [1] - Revenue from MRG007 licensing was RMB 309 million, up from RMB 20.7 million in the same period last year [1] - Sales of Puyuheng (Petrilizumab injection) generated RMB 151 million, a significant increase of 58.8% compared to RMB 94.8 million in the previous year [1] - Revenue from CDMO services was RMB 6.3 million, down from RMB 17.8 million in the same period last year [1] Product Pipeline and Development - The company has strategically developed multiple oncology product pipelines, including one candidate drug in the clinical/commercialization stage and nine in clinical stages [2] - Among the nine clinical candidates, seven are targeted therapies and two are immunotherapies [2] - MRG003 has received FDA designations including BTD, ODD, and FTD for treating NPC [2] - MRG002 and CMG901 have also received FDA designations for their respective indications [2] - The company is focused on building and developing new technology platforms as part of its innovation strategy [2] Commercialization Strategy - The company aims to commercialize its product pipeline in China through a professional sales and marketing team while expanding into international markets via strategic partnerships [3] - Puyuheng has completed the commercialization process and is experiencing rapid sales growth [3] - CMG901's global rights have been licensed to AstraZeneca, and MRG007's rights outside Greater China have been licensed to ArriVent [3] - The company has established end-to-end commercialization capabilities in the domestic market and is positioning itself as a global biotech company [3]

Group 1: Financial Performance - The company reported a revenue of RMB 466 million for the six months ending June 30, 2025, representing a year-on-year increase of 249.59% [1] - Profit attributable to the owners of the company was RMB 41.75 million, a significant turnaround from a loss of RMB 192 million in the same period last year [1] - Basic earnings per share were RMB 0.02 [1] Group 2: Product Pipeline and Development - The company has strategically developed multiple oncology product pipelines, including one candidate drug in the clinical/commercialization stage and nine candidate drugs in clinical stages [2] - Among the nine clinical-stage candidates, seven are targeted therapies and two are immunotherapies, with several receiving FDA designations such as Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) [2] - The company is focused on building and developing new technology platforms as part of its innovation engine [2] Group 3: Commercialization and Strategic Partnerships - The company aims to commercialize its product pipeline in China through a professional sales and marketing team while expanding into international markets via strategic partnerships [3] - The product "普佑恆®" (Putilizumab Injection) has completed the full commercialization process and is currently experiencing rapid sales growth [3] - The global rights for CMG901 have been licensed to AstraZeneca, and the rights for MRG007 outside Greater China have been licensed to ArriVent, establishing a solid foundation for future commercialization and global collaboration [3]