Company Overview: Lepu Biopharma (2157.HK) Industry Focus - The company operates in the biopharmaceutical industry, specifically focusing on oncology treatments, including immunotherapy, antibody-drug conjugates (ADC), and oncolytic virus therapies [1][2]. Key Points and Arguments R&D Pipeline and Product Development - Lepu Biopharma has developed a comprehensive pipeline of oncology products, covering three major areas: immunotherapy, ADC targeted therapy, and oncolytic virus drugs. The pipeline includes: - Already marketed PD-1 monoclonal antibody, Putilizumab, and MRG003 - Six ADC drugs, one introduced oncolytic virus, and one T cell engager (TCE) drug currently in clinical stages - The company is expected to enter a phase of new drug approvals over the next 3-5 years, indicating a robust pipeline [1][2]. Financial Performance - The company has achieved steady revenue growth driven by business development (BD) and sales, with a stable expense structure. - In the first half of 2025, Lepu Biopharma reported its first profit and positive operating cash flow [2]. Competitive Advantages of ADCs - MRG003 (EGFR ADC) has been approved for use in late-line nasopharyngeal carcinoma (NPC) in China, demonstrating superior survival benefits and safety compared to competitors. The drug is also being positioned for broader indications in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC) [2][3]. - MRG004A (TF-ADC) for late-line pancreatic cancer has shown strong competitive potential and is currently in Phase III trials [2][3]. - MRG006A (GPC3 ADC) targets the liver cancer market and has shown promising results in Phase I trials, with plans to initiate Phase III trials in 2026 [3]. Oncolytic Virus Therapy - The company introduced the oncolytic virus therapy CG0070 in 2019, targeting the bladder cancer market. - CG0070 has initiated a rolling Biologics License Application (BLA) with the FDA for high-risk non-muscle invasive bladder cancer (NMIBC) and is undergoing critical registration bridging trials in China. The therapy has demonstrated the best historical durability of efficacy data in the NMIBC field, with a G3+ treatment-related adverse event (TRAE) rate of 0 [3]. International Expansion - The company has made progress in international collaborations with MRG007 (CDH17 ADC) and CTM012 (a tri-antibody targeting CD3/4-1BB/DLL3), enhancing its tumor immunotherapy output [3]. Revenue Projections - Lepu Biopharma is still in the investment phase for new drug development, with projected revenues of 880 million, 1.02 billion, and 1.49 billion yuan for 2025, 2026, and 2027, respectively, representing year-on-year growth rates of 138%, 16%, and 47%. The net profit attributable to the parent company is projected to be -20 million, 10 million, and 280 million yuan for the same years [3]. Risks - Potential risks include: - Delays in clinical progress of innovative drugs - Clinical data not meeting expectations - Sales performance of newly launched drugs falling short - Geopolitical risks [4].

Summary of the Conference Call for Lepu Biopharma (2157.HK) Company Overview - Lepu Biopharma is focused on the development of innovative cancer therapies, particularly in the areas of immunotherapy, antibody-drug conjugates (ADC), and oncolytic virus drugs. The company has a robust pipeline and is expected to enter a period of new drug approvals in the next 3-5 years [1][2]. Key Points R&D Pipeline and Drug Approvals - The company has developed multiple oncology product lines, including: - PD-1 monoclonal antibody, Pralsetinib, and MRG003, which are already on the market. - Six ADC drugs, one oncolytic virus, and one T cell engager (TCE) drug currently in clinical stages. - The overall pipeline is well-structured, indicating a promising future for new drug approvals [1][2]. Financial Performance - The company has achieved its first profitability and positive operating cash flow in the first half of 2025, driven by business development (BD) and sales efforts [2]. Competitive Advantages of ADCs 1. **MRG003 (EGFR ADC)**: - Approved for use in late-line nasopharyngeal carcinoma (NPC) in China, showing superior survival benefits and safety compared to competitors. - Actively pursuing broader indications in head and neck squamous cell carcinoma (HNSCC) and non-small cell lung cancer (NSCLC), with a Phase III trial ongoing for 2L+ HNSCC [2][3]. 2. **MRG004A (TF-ADC)**: - Currently in Phase III trials for late-line pancreatic cancer, demonstrating strong competitive potential [3]. 3. **MRG006A (GPC3 ADC)**: - A first-in-class (FIC) targeting the liver cancer market, with promising results from Phase I trials, and expected to enter Phase III trials in 2026 [3]. 4. **CMG901**: - A global FIC CLDN 18.2 ADC, currently in Phase III trials [3]. 5. **MRG001 (CD20 ADC)**: - Showing potential in diffuse large B-cell lymphoma (DLBCL) [3]. Oncolytic Virus Therapy - The company introduced the oncolytic virus therapy CG0070 in 2019, targeting the bladder cancer market. - CG0070 has initiated a rolling Biologics License Application (BLA) with the FDA for high-risk non-muscle invasive bladder cancer (NMIBC) and is in critical registration bridging trials in China. - Recent Phase III data indicates historical best durability in NMIBC, with a G3+ treatment-related adverse event (TRAE) rate of 0, showcasing both efficacy and safety [3]. International Expansion - The company has successfully collaborated on international projects with MRG007 (CDH17 ADC) and CTM012 (a tri-antibody targeting CD3/4-1BB/DLL3) [3]. Revenue Projections - Revenue forecasts for the company are as follows: - 2025: 880 million CNY - 2026: 1.02 billion CNY - 2027: 1.49 billion CNY - Expected growth rates are 138% in 2025, 16% in 2026, and 47% in 2027, with net profits projected at -20 million CNY in 2025, 10 million CNY in 2026, and 280 million CNY in 2027 [3]. Investment Rating - The company’s ADC pipeline is progressing steadily, and commercial advancements are on track, leading to a "Buy" rating [4]. Risk Factors - Potential risks include: - Delays in clinical progress of innovative drugs. - Subpar clinical data for innovative drugs. - Poor sales performance post-launch of innovative drugs. - Geopolitical risks [4].

Core Viewpoint - The company is entering a new drug approval phase with a well-structured pipeline in oncology, focusing on immunotherapy, ADC targeted therapy, and oncolytic virus drugs, which is expected to yield multiple new drug approvals in the next 3-5 years [1][2]. Pipeline Development - The company has developed multiple oncology products, including two already marketed drugs (PD-1 monoclonal antibody Prutilizumab and MRG003) and has six ADC drugs, one oncolytic virus, and one TCE drug in clinical stages [1]. - MRG003 (EGFR ADC) has been approved for post-line NPC in China, showing superior survival benefits and safety compared to competitors, with ongoing trials for HNSCC and NSCLC [1]. - MRG004A (TF-ADC) for post-line pancreatic cancer is currently in Phase III trials after demonstrating strong competitive advantages in Phase I [2]. - MRG006A (GPC3 ADC) is targeting the liver cancer market, with promising results in Phase I trials and plans to initiate Phase III trials in 2026 [1][2]. Oncolytic Virus Therapy - The company has introduced the oncolytic virus therapy CG0070 for bladder cancer, which is currently undergoing a rolling BLA application with the FDA and is in critical registration bridging trials in China [2]. - CG0070 has shown the best historical durability efficacy data in the NMIBC field, with a G3+TRAE rate of 0, indicating excellent efficacy and safety [2]. Financial Projections - The company is still in the investment phase for innovative drug development, with projected revenues of 880 million, 1.02 billion, and 1.49 billion yuan for 2025, 2026, and 2027, respectively, representing year-on-year growth of 138%, 16%, and 47% [2]. - The net profit attributable to the parent company is expected to be -20 million, 10 million, and 280 million yuan for the same years [2]. Investment Recommendation - The company is rated as a "buy" due to the steady progress of its ADC pipeline and successful commercialization efforts [2].

Sales Performance - The sales of growth hormone have maintained steady growth in Q1 2025, with ongoing academic promotion efforts aimed at achieving recovery growth [1] - The sales revenue of Trastuzumab exceeded 100 million CNY in 2024, with a continuous upward trend since its launch, and significant growth expected in 2025 [1] Clinical Development - The HuA21 injection, targeting HER2, has completed the enrollment of subjects for Phase Ib/II clinical studies and plans to initiate Phase III trials based on mid-term analysis results [2] - The company is actively constructing production lines compliant with FDA and EU certifications, with ongoing validation and data organization for international market commercialization [2] mRNA Drug Development - The company is collaborating with Hefei Afana to develop mRNA drugs, specifically the AFN0328 injection for treating HPV-related cancers, currently in Phase I clinical trials [2] Oncolytic Virus Therapy - The company’s partner, Yuansong Biotech, has received clinical trial approval for the recombinant L-IFN adenovirus injection (YSCH-01), which is currently undergoing Phase I-IIa trials for advanced solid tumors [4]