Lepu Biopharma
Founded in January 2018 by Dr. Pu Zhongjie, Lepu Biotech specializes in tumor immunotherapy, as well as the R&D, manufacturing, and commercialization of targeted therapies. In 2025, Lepu Biopharma is gaining momentum with notable progress in its innovative ADC platform and drug pipeline. Key highlights include a major global licensing deal for MRG007, promising developments for its nasopharyngeal carcinoma candidate MRG003, and ongoing strategic partnerships aimed at accelerating drug development and expanding global reach.
The company has advanced two ADC assets: MRG006A, which holds global first-in-class potential, and MRG007, positioned as a global best-in-class candidate. Both have demonstrated encouraging preclinical results and secured IND approvals in China. Notably, preclinical data for MRG007 were presented at the AACR Annual Meeting in April 2025, further validating the company’s innovation and attracting strong investor interest.
"Lepu Biotech is accelerating global momentum in 2025 with innovative ADC programs, a major licensing deal for MRG007, and international recognition of its TOPAbody platform."
Beyond ADCs, Lepu Biotech entered a licensing agreement with Excalipoint for two preclinical assets developed through its proprietary T-cell engager TOPAbody platform. Under the agreement, Lepu Biotech will receive a US$10 million upfront payment, up to US$847.5 million in development and commercial milestone payments, as well as sales royalties, while retaining a 10% equity interest. This deal underscores international recognition of the platform’s value and reflects the company’s strong foundation and global vision within the rapidly growing Chinese biopharmaceutical market.
TOPAbody platform
Lepu Biopharma’s TOPAbody platform is a proprietary technology for creating T-cell engager antibodies, a targeted approach to cancer therapy. Separate from its ADC (Antibody-Drug Conjugate) platform, TOPAbody has produced promising preclinical candidates such as MRG006A and MRG007. Recently, Lepu Biopharma licensed IP from this platform to Excalipoint, highlighting its global recognition and value.
Market revenue of Lepu Biopharma
Since 2021, Lepu Biopharma has demonstrated a consistent upward trajectory in revenue, reflecting an average year-over-year growth rate of approximately 15%. This steady expansion underscores the company’s strong commercial execution and the growing market acceptance of its therapies.
Looking ahead to 2025, Lepu Biopharma’s revenue is poised for a significant increase, fueled by robust licensing income and rising sales of its core product PUYOUHENG (Pucotenlimab Injection). Notably, the company reported a 3.5-fold revenue growth in the first half of 2025 compared to the same period in 2024, marking a major leap forward in financial performance.
Building on this momentum, Lepu Biopharma is advancing plans to expand market penetration and broaden its commercial portfolio. Key drivers include the planned commercialization of MRG003, alongside the continued growth of existing assets, positioning the company for sustained revenue acceleration and long-term value creation.
"Lepu Biopharma reported 3.5-fold revenue growth in H1 2025, driven by PUYOUHENG sales and licensing income, signaling strong momentum for sustained expansion."
Five-year market revenue of Lepu Biopharma (2021- H1 2025)
Fig 16: Market revenue of Lepu Biopharma
Lepu Biopharma Pipeline Analysis: Transforming Cancer Treatment with ADCs and Immuno-Oncology
Lepu Biopharma is advancing a broad and innovative oncology pipeline with multiple candidates progressing through key clinical and regulatory stages. Its lead asset, MRG003 (EGFR-ADC), is under NDA review with priority status in China for recurrent/metastatic nasopharyngeal carcinoma, supported by strong Phase IIb data presented at ASCO 2025, while a Phase III trial in combination with PUYOUHENG is underway and further studies are expanding into head and neck cancers in China and Europe. MRG004A (TF-ADC) has moved into Phase III following encouraging early-stage data in pancreatic cancer and has been granted Breakthrough Therapy Designation by the CDE. MRG006A (GPC3-ADC) entered Phase I trials in China after receiving IND clearance from the U.S. FDA, with preclinical studies showing potent anti-tumor activity. MRG007 (CDH17-ADC) advanced into first-in-human trials in China, with ArriVent securing exclusive rights outside Greater China in a deal worth up to US$1.16 billion. Meanwhile, CG0070, an oncolytic virus therapy, has been granted Breakthrough Therapy Designation and is in a multinational Phase III program with a bridging trial in China planned. Strategic partnerships, global licensing, and combination approaches with PUYOUHENG continue to strengthen Lepu Biopharma’s position as it accelerates development and expands its international footprint.
Expanding Leadership Through a Robust Late-Stage ADC Portfolio
1. Strong ADC Portfolio Leadership
- The company’s backbone lies in its broad ADC pipeline, with at least six ADC candidates targeting validated antigens, including EGFR (MRG003), HER2 (MRG002), TF (MRG004A), CD20 (MRG001), GPC3 (MRG006A), and CLDN18.2 (CMG901).
- Several ADCs, including MRG003, MRG002, and CMG901, have progressed to pivotal or Phase III trials, indicating late-stage maturity and near-term commercialisation potential.
- The inclusion of global pivotal trials (e.g., CMG901) suggests a focus on international expansion and regulatory readiness.
2. Broad Indication Coverage
- The candidates address a wide range of solid and hematologic malignancies, including nasopharyngeal cancer, breast cancer, gastric cancer, and non-Hodgkin’s lymphoma.
- Multiple programs target tumors with high unmet needs, such as HER2-low, TF-positive, and CLDN18.2-expressing cancers.
3. Combination Therapy Development
- Several ADCs and immunotherapies are being tested in combination regimens, reflecting a modern approach to maximise therapeutic synergy and overcome resistance mechanisms.
- The inclusion of combination trials for HER2 and BCG-unresponsive tumors demonstrates a translational and adaptive R&D strategy.
Advancing Innovative Immunotherapy Programs
Expanding Immuno-oncology Presence
- Beyond ADCs, the company is advancing PUYOUHENG (Pucotenlimab), an anti–PD-1 monoclonal antibody, in pivotal and NDA stages, underscoring diversification into checkpoint inhibition.
- The pipeline also includes a T-cell agonistic mAb (CTM012) and an oncolytic virus (CG0070), showcasing next-generation immunotherapy innovation.
