--- title: "First-half profit may be no less than 24 million yuan, Lepu Biopharma's 'break-even technique' works" type: "Topics" locale: "en" url: "https://longbridge.com/en/topics/32760243.md" description: "Lepu Biopharma has sounded the horn of profitability. Recently, the company announced that, based on a preliminary assessment of the unaudited consolidated management accounts for the six months ending June 30, 2025, and the information currently available to the board, it is expected to achieve a profit of no less than 24 million yuan, compared to a loss of approximately 197 million yuan in the same period last year. This marks Lepu Biopharma's first profitable period, making it one of the few Hong Kong-listed 18A innovative biopharmaceutical companies (including those that have removed the 'B' designation) to achieve breakeven. According to the announcement, Lepu Biopharma's turnaround is primarily attributed to a significant increase in revenue..." datetime: "2025-08-08T13:20:18.000Z" locales: - [en](https://longbridge.com/en/topics/32760243.md) - [zh-CN](https://longbridge.com/zh-CN/topics/32760243.md) - [zh-HK](https://longbridge.com/zh-HK/topics/32760243.md) author: "[医药研究社](https://longbridge.com/en/profiles/15545088.md)" --- # First-half profit may be no less than 24 million yuan, Lepu Biopharma's 'break-even technique' works Lepu Biopharma has finally sounded the horn of profitability. Recently, the company announced that based on a preliminary assessment of the unaudited consolidated management accounts for the six months ending June 30, 2025, and the information currently available to the board, it is expected to achieve a profit of no less than RMB 24 million, compared to a loss of approximately RMB 197 million in the same period last year. This marks Lepu Biopharma's first profitable period, making it one of the few Hong Kong-listed 18A innovative biopharmaceutical companies (including those that have removed the 'B' designation) to achieve breakeven. According to the announcement, Lepu Biopharma's turnaround is primarily attributed to a significant increase in revenue, mainly from the licensing collaboration with ArriVent BioPharma, Inc. for MRG007, as well as sales revenue from Puyouheng® (Pulituzumab Injection). It is evident that Lepu Biopharma is now exploring a more stable development path by focusing on both business development (BD) and product sales. **Two Core Assets Behind the Turnaround** As mentioned earlier, the two products driving Lepu Biopharma's revenue growth are MRG007 and Puyouheng®. Specifically, both products have significant market potential. First is the investigational product MRG007. Lepu Biopharma describes MRG007 as an antibody-drug conjugate (ADC) targeting CDH17, composed of a novel humanized IgG1 antibody conjugated with the cytotoxic agent Exatecan, featuring a balanced drug-to-antibody ratio. Preclinical studies have shown that the drug exhibits strong anti-tumor activity and a high therapeutic index in gastrointestinal cancer models, with initial clinical development focusing on colorectal cancer, pancreatic cancer, and other gastrointestinal malignancies. Currently, gastrointestinal cancers represent an area of urgent unmet medical need. According to the latest report on the prevalence of malignant tumors in China by the National Cancer Center, an estimated 4.825 million new cases of malignant tumors were diagnosed nationwide in 2022. Among these, digestive system tumors—including colorectal, liver, gastric, esophageal, and pancreatic cancers—ranked among the top 10 most common malignancies, with a total of 1.586 million new cases, equivalent to three new diagnoses every minute. Thus, MRG007's application value and scope are highly promising, making it a key factor in securing BD deals. Public information shows that in January 2025, Lepu Biopharma entered into a global exclusive agreement with ArriVent BioPharma. Under the agreement, Lepu Biopharma granted ArriVent exclusive rights to develop, manufacture, and commercialize MRG007 outside Greater China, receiving an upfront payment of $47 million and potential milestone payments of up to $1.16 billion, plus tiered royalties ranging from high single-digit to low double-digit percentages based on net sales in licensed regions. The earnings preview indicates that Lepu Biopharma has already received some BD-related payments. Next is the commercialized product Puyouheng®. This is a humanized IgG4 monoclonal antibody targeting PD-1, developed by Lepu Biopharma, and is commercially available for treating microsatellite instability-high/mismatch repair-deficient (MSI-H/dMMR) solid tumors and unresectable or metastatic melanoma in patients who have failed prior therapy. As Lepu Biopharma's first commercialized product, Puyouheng® has seen significant sales growth, reaching RMB 300 million in revenue as of December 31, 2024, three times the revenue from the same period last year. Behind this, Lepu Biopharma has been actively expanding its commercialization efforts, such as building an efficient sales and marketing team to promote the product and enhance brand awareness among doctors and patients. The company has also completed tendering procedures on procurement platforms in 27 Chinese provinces, covering approximately 81 cities through various sales channels. In the first half of this year, the product is expected to have further expanded its market presence, accelerating Lepu Biopharma's transition into a harvest period. Looking ahead, the company's product pipeline suggests no significant growth gaps. **Continuing the 'Commercialization + BD' Dual Strategy** On the commercialization front, a blockbuster product, MRG003, may soon follow Puyouheng®. Lepu Biopharma describes MRG003 as a potentially first-in-class EGFR ADC. Currently, the new drug application (NDA) for MRG003 in treating recurrent/metastatic nasopharyngeal carcinoma (R/M NPC) has been accepted and is under priority review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). At the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, key clinical trial results for MRG003 in treating R/M NPC were presented as a 'Late-Breaking Abstract (LBA)': the objective response rate (ORR) was 30.2% in the MRG003 group versus 11.5% in the chemotherapy control group, while the disease control rate (DCR) was 77.9% versus 56.3%, respectively. In terms of safety, the incidence of treatment-related adverse events (TRAEs) was similar between the MRG003 and chemotherapy groups, with most adverse reactions being grade 1-2. The incidence of grade ≥3 TRAEs was 45.3% and 50.6%, respectively, and adverse reactions were manageable. Given its favorable efficacy profile, MRG003 has broad application potential. Professor Han Fei from Sun Yat-sen University Cancer Center noted, 'The global distribution of nasopharyngeal carcinoma is highly uneven, with 70% of cases occurring in East and Southeast Asia, and China accounting for half of global new cases. While immunotherapy combined with chemotherapy is the current standard for advanced nasopharyngeal cancer, there remains a lack of standardized second-line treatments.' Against this backdrop, as the first EGFR-targeted ADC in China and one of the most advanced in global clinical development, MRG003 could quickly address this unmet need and deliver substantial incremental revenue for Lepu Biopharma upon commercialization. Meanwhile, BD efforts continue. For example, Lepu Biopharma recently announced a BD agreement with Excalipoint Cayman. Under the agreement, Excalipoint gains exclusive global rights to develop and commercialize two preclinical T-cell engager (TCE) assets (CTM012 and CTM013). Lepu Biopharma will receive a $10 million upfront cash payment, a 10% stake in Excalipoint Cayman's expanded ordinary shares, and up to $847.5 million in development and commercialization milestone payments, plus sales royalties. Overall, Lepu Biopharma's current approach to stability involves accelerating product launches while actively pursuing BD collaborations to advance R&D and monetize its pipeline. According to last year's annual report, Lepu Biopharma's pipeline includes one clinical/commercial-stage candidate, seven clinical-stage candidates (including one co-developed through a joint venture), and three combination therapies, spanning ADC, cancer immunotherapy, and oncolytic virus technologies. This pipeline suggests that Lepu Biopharma is still awaiting its true breakout period. Source: Pharmaceutical Research Society ### Related Stocks - [02157.HK](https://longbridge.com/en/quote/02157.HK.md)