聚焦肿瘤免疫，ADC 联合 IO 差异化竞争：首次覆盖 乐普生物-B(2157) MRG003 获批在即，联合 PD-1 大有可为 [Table_Invest] [Table_CurPrice] [Table_Market] 公司是国内 ADC 联合 IO 布局领先内资创新药企，我们预计 MRG003 获批上市后将 较快放量。同时，公司产品管线有出海 BD 预期，我们看好公司长期发展。 投资要点： | 财务摘要(百万人民币) | 2024A | 2025E | 2026E | 2027E | | --- | --- | --- | --- | --- | | 营业总收入 | 368 | 853 | 1204 | 1665 | | (+/-)% | 63% | 132% | 41% | 38% | | 毛利润 | 292.97 | 724.82 | 1,023.09 | 1,415.20 | | 净利润 | -411 | -18 | -80 | -29 | | (+/-)% | -1762% | 96% | -350% | 64% | | PE | -10.04 | -622.79 | -138.30 | -3 ...

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]

Core Viewpoint - Lepu Biopharma-B (02157) has seen a significant stock price increase of over 12%, currently trading at 9.33 HKD with a transaction volume of 448 million HKD, driven by positive developments in its clinical trials [1] Group 1: Clinical Trials - On August 1, Lepu Biopharma registered a Phase III clinical trial for MRG004A, which will compare its efficacy and safety against a placebo in patients with advanced pancreatic cancer [1] - The Phase III trial aims to explore the potential of MRG004A as a new treatment option for advanced pancreatic cancer patients [1] - Additionally, Lepu Biopharma has initiated a Phase I/II clinical study for MRG007, focusing on its safety, tolerability, efficacy, and pharmacokinetics in patients with unresectable locally advanced or metastatic solid tumors [1] Group 2: Licensing and Financials - The rights for MRG007 outside Greater China have been licensed to ArriVent, with an upfront payment and recent milestone payments totaling 47 million USD [1] - The company is entitled to receive up to 1.16 billion USD in milestone payments and sales royalties from the agreement with ArriVent [1]

Core Viewpoint - Lepu Biopharma-B (02157) has seen a significant stock price increase of over 12%, reaching HKD 9.33 with a trading volume of HKD 448 million, following the announcement of new clinical trials for its drug candidates [1] Group 1: Clinical Trials and Developments - Lepu Biopharma has registered a Phase III clinical trial for MRG004A, which will compare its efficacy and safety against a placebo in patients with advanced pancreatic cancer [1] - The Phase III trial aims to explore the potential of MRG004A as a new treatment option for pancreatic cancer patients [1] - The company has also initiated a Phase I/II clinical study for MRG007, focusing on its safety, tolerability, efficacy, and pharmacokinetics in patients with unresectable locally advanced or metastatic solid tumors [1] Group 2: Licensing and Financial Aspects - The rights for MRG007 outside Greater China have been licensed to ArriVent, with an upfront payment and recent milestone payments totaling USD 47 million [1] - Lepu Biopharma is entitled to receive up to USD 1.16 billion in milestone payments and sales royalties from the licensing agreement [1]

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]