Core Viewpoint - Lepu Biopharma has successfully turned a profit for the first time since its IPO, achieving significant revenue growth and net profit in the first half of 2025, marking a pivotal moment for the company in the Hong Kong market for innovative drugs [1][14]. Financial Performance - In the first half of 2025, Lepu Biopharma reported revenue of 466 million yuan, a 350% increase from 133 million yuan in the same period last year [2]. - The net profit reached 29.3 million yuan, a turnaround from a loss of 197 million yuan in the previous year [2]. - The company achieved a positive cash flow from operating activities of 46.7 million yuan, compared to a cash outflow of 115 million yuan in the same period last year [2]. Product Performance - The rapid growth in revenue is largely attributed to the commercialization of its product, Puyouheng (Putilizumab Injection), which generated sales of 151 million yuan, a 58.8% increase year-on-year [3]. - Puyouheng is a humanized IgG4 monoclonal antibody targeting PD-1, approved for treating MSI-H/dMMR solid tumors and unresectable or metastatic melanoma [3]. Pipeline Development - MRG003, an anti-EGFR ADC, is expected to be a significant product for Lepu Biopharma, with its NDA for treating recurrent/metastatic nasopharyngeal carcinoma (NPC) under priority review by the National Medical Products Administration [4]. - MRG003 has shown promising clinical results, with an overall response rate (ORR) of 30.2% and a median progression-free survival (PFS) of 5.82 months in clinical trials [4][5]. Strategic Initiatives - The company is actively pursuing a dual strategy of commercialization and business development (BD) to enhance its revenue streams, achieving 309 million yuan from BD initiatives in the first half of 2025 [12]. - Lepu Biopharma has entered into global licensing agreements, including a deal with ArriVent for MRG007, which will provide significant milestone payments and royalties [12][13]. Future Outlook - The company is positioned for continued growth with a robust pipeline, including MRG004A and MRG006A, which target various cancers and are in advanced clinical stages [8][10]. - The development of CG0070, a first-in-class oncolytic virus for non-muscle invasive bladder cancer (NMIBC), is also underway, with plans for BLA submission in 2025 [10][11]. Conclusion - Lepu Biopharma's strategic focus on innovative therapies and effective commercialization has led to a successful transition from a biotech to a biopharma company, highlighting its long-term investment potential [14].

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.HK) reported significant revenue growth and achieved profitability for the first time, with revenue of approximately RMB 466 million for the six months ending June 30, 2025, representing 3.5 times the revenue of the same period in 2024, and a profit of approximately RMB 29.3 million compared to a loss of RMB 197 million in the previous year [1][2]. Group 1 - The company focuses on innovative biopharmaceuticals in the oncology treatment field, particularly targeted therapy and immunotherapy, utilizing advanced ADC technology [1]. - The company has established an integrated end-to-end capability covering all key aspects of the biopharmaceutical value chain, from drug discovery to clinical development and compliant production [1]. - The company aims to continuously develop differentiated product pipelines through strategic collaborations and its own innovation capabilities [1]. Group 2 - The company has strategically laid out multiple oncology product pipelines, including one clinical/commercial candidate, nine clinical candidates, and three combination therapy candidates [2]. - Among the nine clinical candidates, seven are targeted therapies and two are immunotherapies, with several candidates receiving FDA designations such as Breakthrough Therapy Designation (BTD), Orphan Drug Designation (ODD), and Fast Track Designation (FTD) [2]. - The company is actively working on establishing and developing new technology platforms as part of its innovation engine [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） 截至2025年6月30日止六個月的 中期業績公告 董事會欣然宣佈本集團截至2025年6月30日止六個月的未經審核綜合中期業績， 連同2024年同期之比較數字。 財務摘要 1 － 收入顯著增加：截至2025年6月30日止六個月的收入約為人民幣465.9百萬 元（包括來自業務開發活動的許可收入約人民幣309.0百萬元以及來自銷售 普佑恆® （普特利單抗注射液）的收入約人民幣150.6百萬元），約為2024年同 期收入的3.5倍（截至2024年6月30日止六個月：人民幣133.3百萬元）。 － 首次實現盈利：截至2025年6月30日止六個月的利潤約為人民幣29.3百萬元 （截至2024年6月30日止六個月的虧損：人民幣197.0百萬元）。 － 研發開支持續減少：截至2 ...

Summary of the Conference Call for Lepu Biopharma Company Overview - **Company**: Lepu Biopharma - **Industry**: Biopharmaceuticals, specifically focusing on Antibody-Drug Conjugates (ADCs) Key Points and Arguments 1. **Patent Dispute with CSPC**: Lepu Biopharma is involved in a patent dispute with CSPC following CSPC's acquisition of Jinmant. CSPC is currently seeking to invalidate Lepu's antibody patent, which could impact the commercialization of the EGFR ADC [2][3][4] 2. **Clinical Development**: Lepu's GP104 ADC is in Phase I trials and shows promise in treating second-line liver cancer, with plans to present detailed data at the SGO conference in 2026 [2][5] 3. **Revenue Growth**: Lepu Biopharma reported a revenue of 368 million RMB in 2024, a 63% increase year-on-year. The company anticipates its core product MRG003 will be launched by late 2025 or early 2026, with an expected profit of over 20 million RMB in 2025 [2][6] 4. **NDA Submission**: The EGFR ADC (MRG003) for nasopharyngeal carcinoma has submitted a New Drug Application (NDA) and received priority review status, expected to be approved in early 2026 [2][6] 5. **Platform Upgrade**: The ADC platform has been upgraded from second-generation to third-generation, enhancing its potential for international collaboration, as evidenced by licensing agreements with AstraZeneca and Arrivant totaling 1.2 billion USD [2][7] 6. **Pipeline and Market Potential**: Lepu's pipeline focuses on unmet clinical needs in major diseases such as pancreatic cancer, liver cancer, and colorectal cancer, indicating a strategic direction towards high-demand therapeutic areas [2][5][10] 7. **Clinical Data**: Recent data from the SGO conference showed that Lepu's ADC outperformed chemotherapy in terms of Objective Response Rate (ORR) and Progression-Free Survival (PFS), with a notable safety profile [3][11] 8. **Market Size**: The combined peak sales potential for nasopharyngeal and head and neck squamous cell carcinoma is estimated at 2.7 billion RMB, with head and neck cancer representing a larger market opportunity [12] 9. **Future Catalysts**: Key upcoming events include the presentation of clinical data at the ESMO conference in October 2025 and the potential for breakthrough therapy designation for the 004 drug, which would enhance its market entry prospects [9][10] 10. **Valuation**: Lepu Biopharma's valuation is based on pipeline progress and projected sales multiples, estimated at approximately 22.4 billion HKD, indicating room for growth in the current market [19] Other Important but Overlooked Content - **Acquisition Strategy**: Lepu has grown through mergers and acquisitions, integrating various small companies and collaborating on multiple projects, which strengthens its market position [10] - **Emerging Technologies**: The company is also exploring the use of oncolytic viruses, with plans for a BLA submission in the U.S. by the end of 2025, which could further diversify its product offerings [8][10] - **Competitive Landscape**: The ADC market is competitive, with several companies, including Innovent and AstraZeneca, developing similar products, highlighting the need for Lepu to maintain a strong clinical and commercial strategy [16][17] This summary encapsulates the critical insights from the conference call, focusing on Lepu Biopharma's current status, future prospects, and the competitive landscape within the biopharmaceutical industry.

Core Viewpoint - Lepu Biopharma-B (02157) has seen a significant stock increase of over 6%, currently trading at 9.66 HKD, following the announcement of its ADC drug MRG004A being included in the list of breakthrough therapies by the National Medical Products Administration [1] Company Developments - MRG004A is a novel ADC drug targeting tissue factor (TF) using innovative coupling technologies, marking a major breakthrough in ADC drug development for Lepu Biopharma [1] - The drug has received IND approval in both China and the U.S., along with orphan drug designation and fast track status from the FDA for the treatment of pancreatic cancer [1] - Lepu Biopharma has initiated a Phase III clinical trial for MRG004A in pancreatic cancer as of August 1, 2023, aiming to provide a new treatment option for patients [1] Clinical Research Insights - Previous Phase I clinical studies in the U.S. and China have shown anti-tumor activity signals in indications such as pancreatic cancer, triple-negative breast cancer, and cervical cancer [1]

Core Viewpoint - Lepu Biopharma-B (02157) has seen a significant stock increase of over 6%, currently trading at 9.66 HKD with a transaction volume of 207 million HKD, following the announcement of its ADC drug MRG004A being included in the list of breakthrough therapies by the National Medical Products Administration [1] Group 1: Drug Development Progress - MRG004A is a targeted tissue factor (TF) ADC drug developed by Lepu Biopharma, utilizing innovative coupling technology and is the first TF ADC drug to enter clinical trials in China [1] - The drug has received IND approval in both China and the United States, along with orphan drug designation and fast track designation from the FDA for the treatment of pancreatic cancer [1] - Initial Phase I clinical studies in the US and China have shown anti-tumor activity signals in pancreatic cancer, triple-negative breast cancer, and cervical cancer [1] Group 2: Clinical Trials - On August 1, Lepu Biopharma initiated a Phase III clinical trial for MRG004A targeting pancreatic cancer, aiming to provide a new treatment option for patients [1]

Group 1 - The core viewpoint of the article highlights the recent stock performance of Lepu Biopharma-B, which saw a decline of 5.01% to 8.91 CNY per share, with a trading volume of 308 million CNY [1] - Lepu Biopharma focuses on biopharmaceutical research and development in the oncology treatment field, particularly in targeted therapy and immunotherapy, and has established a comprehensive end-to-end capability in drug discovery, clinical development, CMC, and GMP-compliant production [1] - The company has built a professional sales and marketing team aimed at meeting clinical needs and providing optimized and innovative drug solutions [1] Group 2 - As of the 2024 annual report, Lepu Biopharma reported total operating revenue of 368 million CNY and a net profit of -411 million CNY [2] - A forecast for the mid-2025 performance indicates an expected profit of approximately 24 million CNY, representing a year-on-year increase of 112.18% [3]

Core Viewpoint - The article discusses the significant market volatility following the mid-year earnings disclosures of Hong Kong-listed companies, highlighting the mixed performance and reactions of various firms in the market [1][13]. Group 1: Company Earnings Reports - On August 6, companies such as BeiGene, Cathay Pacific, and Uni-President China released their mid-year earnings, while others like Mifeng and Lepu Biopharma provided earnings forecasts [2]. - Cathay Pacific reported a revenue of HKD 54.309 billion for the first half of 2025, a year-on-year increase of 9.5%, and a net profit attributable to shareholders of HKD 3.651 billion, up 1.1% [4]. - BeiGene achieved total revenue of RMB 17.518 billion in the first half of 2025, marking a 46.0% year-on-year growth, and reported a net profit of RMB 450 million, indicating its first half-year profit [7]. Group 2: Market Reactions - Following the earnings announcements, Cathay Pacific's stock fell sharply, dropping 9.66% on August 6 and continuing to decline by 2.58% on August 7 [6]. - BeiGene's stock experienced a slight opening increase but fluctuated, with a drop exceeding 3% during the trading session [9]. - Lepu Biopharma's stock fell over 8% after announcing a projected net profit of at least RMB 24 million for the six months ending June 30, 2025, compared to a net loss of approximately RMB 197 million in the same period last year [9]. Group 3: Market Outlook - The article notes that the peak period for earnings disclosures in Hong Kong is approaching, with companies that report below expectations likely to face selling pressure [14]. - According to CITIC Securities, the overall revenue growth of the Hang Seng Index is expected to rise significantly year-on-year, although profit growth may moderate [14]. - China Galaxy Securities anticipates that the Hong Kong stock market may experience a volatile upward trend in the second half of 2025, supported by various policies and a relatively low valuation compared to global equity markets [15].