What Lepu Bio does

Lepu Biopharma Co., Ltd. (HKEX: 02157.HK) is an innovation-driven biopharmaceutical company headquartered in Shanghai, China, focused on developing oncology therapeutics to address unmet medical needs in cancer treatment. Founded in January 2018 by Dr. Pu Zhongjie as the biotech arm of Lepu Medical, the company operates three proprietary technology platforms: an ADC (Antibody-Drug Conjugate) technology platform covering end-to-end R&D and cGMP manufacturing, an antibody discovery platform featuring a 10^11-scale full human naive antibody library using phage display technology (enabling 4-6 week antibody development versus 4-6 months for traditional hybridoma), and an advanced process and analytical development platform for GMP-compliant cell bank construction and biopharmaceutical characterization.

The company's commercial portfolio includes two approved products: MEIYOUHENG (Becotatug Vedotin Injection), the first EGFR-targeted ADC approved in China (NMPA approval October 2025) for recurrent/metastatic nasopharyngeal cancer, and PUYOUHENG (Pucotenlimab Injection), an anti-PD-1 monoclonal antibody approved in 2022 for MSI-H/dMMR advanced solid tumors and unresectable/metastatic melanoma. The clinical-stage pipeline comprises seven drug candidates, six of which are ADCs targeting EGFR, HER2, CD20, GPC3, CDH17, and tissue factor, plus an oncolytic virus candidate (CG0070) licensed from CG Oncology.

Lepu Biopharma generates revenue through three channels: (1) direct product sales in China via dedicated sales and marketing forces distributing through hospitals and pharmacies, (2) international licensing and milestone payments from out-licensing deals, most notably with AstraZeneca for CMG901 (Claudin 18.2 ADC, up to $1.1B in milestones) and ArriVent for MRG007 (CDH17 ADC, $47M upfront plus up to $1.16B in milestones), and (3) contract development and manufacturing (CDMO) services leveraging its 2,000L GMP-compliant Beijing facility. The company reported 2025 revenue of RMB 935 million (~2.5x year-on-year growth) and achieved its first annual net profit of RMB 261 million, supported by a portfolio of 55+ issued patents globally and a manufacturing footprint spanning an operational Beijing plant plus Shanghai Biotech Park Phase 1 capacity of 12,000L (6,000L line under construction).

Name

Lepu Bio

Legal name

Lepu Biopharma Co., Ltd.

Website

https://en.lepubiopharma.com

Company type

Public

Founded year

2018

Operating status

Operating

Headcount range

1–10 employees

Short description

Lepu Biopharma is a Shanghai-based, Hong Kong-listed (02157.HK) oncology biopharmaceutical company developing ADC and immuno-oncology therapeutics, with two NMPA-approved commercial products (MEIYOUHENG and PUYOUHENG), seven clinical-stage ADC candidates, and global licensing partnerships with AstraZeneca and ArriVent.

Ownership category

akta.pro rank

Product category

Oncology Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical Preparation Manufacturing (325412)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Antibody-Drug Conjugates (ADCs) & Antibody Conjugates (HLAAAAAE)

akta.pro secondary industries

Oncology & Hematology Pharmaceuticals (HLAIAAAC), Gene Therapy Regulatory, Pharmacovigilance & Clinical Operations Services (HLAAACAM), Regulatory Strategy & IND/NDA/BLA Submissions Support (HLAIALAH)

Keywords

• Antibody-drug conjugates
• Oncology therapeutics
• Monoclonal antibodies
• Biopharmaceutical development
• Clinical-stage drug pipeline

Headquarters

HQ city

Shanghai

HQ country

China

HQ region

Asia

Offices4 records

Markets served

GTM type

B2B and B2C

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Product Sales (China): Commercial sales of approved drugs in China including MEIYOUHENG (Becotatug Vedotin Injection) for R/M NPC and PUYOUHENG (Pucotenlimab Injection) for MSI-H/dMMR solid tumors and melanoma.
2. Licensing and Milestone Payments: International licensing deals generating upfront payments, development milestones, regulatory milestones, and sales milestones plus tiered royalties. Examples: MRG007 deal with ArriVent ($47M upfront + up to $1.16B milestones); CMG901 deal with AstraZeneca (up to $1.1B milestones).
3. CDMO Services: Contract development and manufacturing organization services leveraging Beijing 2,000L GMP-compliant production line for clinical drug supply and third-party CDMO production.
4. Product Revenue (2025): 2025 annual results showed revenue of 935 million yuan with first annual net profit of 261 million yuan, demonstrating transition to profitability.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels4 records

Core offering

Lepu Biopharma is an innovation-driven biopharmaceutical company developing oncology therapeutics including antibody-drug conjugates (ADCs), monoclonal antibodies, and oncolytic viruses. The company operates three proprietary technology platforms and has two commercial-stage products (MEIYOUHENG/Becotatug Vedotin and PUYOUHENG/Pucotenlimab) approved in China, along with multiple clinical-stage candidates for solid tumors and hematological malignancies.

Product overview

Lepu Biopharma is an innovation-driven biopharmaceutical company focused on oncology therapeutics. The company operates three technology platforms (ADC technology platform, antibody discovery platform, and advanced process/analytical development platform) to develop its pipeline of drug candidates. The commercial-stage products include MEIYOUHENG (Becotatug Vedotin Injection), the first EGFR-targeted ADC approved in China, and PUYOUHENG (Pucotenlimab Injection), an anti-PD-1 monoclonal antibody approved for MSI-H/dMMR solid tumors and melanoma. The clinical-stage pipeline comprises multiple ADCs (MRG003, MRG004A, MRG002, MRG001, MRG006A), immunotherapies (LP002, CTM012), and an oncolytic virus (CG0070). Several assets have been out-licensed to global partners including CMG901 (AstraZeneca) and MRG007 (ArriVent BioPharma).

Differentiator

Problem solved

Functional benefit

Brands

• Trispecific Antibody T Cell Engager Platform: A platform utilizing protein binding domains such as nanobodies and scFv to augment T cells' response to solid tumors
• ADC Technology Platform

Products and services

• MEIYOUHENG (Becotatug Vedotin Injection) An EGFR-targeted antibody-drug conjugate (ADC) consisting of an EGFR-targeted monoclonal antibody conjugated with monomethyl auristatin E via valine-citrulline linker. Approved in China for treatment of recurrent or metastatic nasopharyngeal cancer patients who have failed standard therapies.
• PUYOUHENG (Pucotenlimab Injection) A humanized IgG4 anti-PD-1 monoclonal antibody with extended half-life via triple mutations in Fc region. Approved in China for MSI-H/dMMR advanced solid tumors and unresectable or metastatic melanoma.
• MRG003 EGFR-targeted ADC conjugated with monomethyl auristatin E via valine-citrulline linker. In clinical development for nasopharyngeal cancer, head and neck squamous cell carcinoma, and other EGFR-positive solid tumors.
• MRG004A Tissue factor (TF)-targeted ADC with site-specific conjugation technology. Granted FDA Orphan-Drug Designation and Fast Track Designation for pancreatic cancer treatment.
• CMG901 Claudin 18.2-targeted ADC consisting of anti-CLDN18.2 monoclonal antibody, protease-degradable linker, and MMAE cytotoxic payload. Potential first-in-class Claudin 18.2 ADC for gastrointestinal cancers, globally licensed to AstraZeneca.
• MRG002 HER2-targeted ADC for treatment of HER2-positive breast cancer and HER2 over-expressing cancers with liver metastasis.
• MRG001 CD20-targeted ADC in clinical development for non-Hodgkin's lymphoma (NHL).
• MRG006A

Quantifiable outcome

• MEIYOUHENG combination therapy showed 73.3% cORR and 10.9 months mPFS in R/M NPC patients after failed IO and platinum therapy
• +4 more outcomes

Named customers3 records

Segments3 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Ten partnerships are on record, tiered minor, core and flagship.

• Excalipoint TherapeuticsminorOEM/ Whitelabel/ Licensing Partner · 18 March 2026Excalipoint licensed two antibody programs from Lepu Biopharma for $10 million upfront as part of their trispecific antibody development for cancer and autoimmune diseases.
• ArriVent BioPharma (Nasdaq: AVBP)coreOEM/ Whitelabel/ Licensing Partner · 22 January 2025Exclusive licensing agreement for MRG007 (CDH17-targeted ADC for GI cancers). Lepu Biopharma grants exclusive rights outside Greater China. Receives $47M upfront and is eligible for up to $1.16B in development, regulatory and sales milestones plus tiered royalties on net sales. First IND submission planned for H1 2025 with focus on colorectal, pancreatic and other GI cancers.
• KYM Biosciences Inc.flagshipStrategic or Co-development Partner · 22 January 2025Joint venture (30% Lepu Biopharma, 70% Keymed) holding rights to CMG901. AstraZeneca partnership transacted through KYM for global license.
• AstraZeneca (LSE/STO/Nasdaq: AZN)flagshipOEM/ Whitelabel/ Licensing Partner · 23 February 2023Global exclusive license agreement for CMG901 (Claudin 18.2 ADC). AstraZeneca responsible for global research, development, manufacturing and commercialization. KYM Biosciences (joint venture of Lepu Biopharma 30% and Keymed 70%) receives up to $1.1B in milestones and tiered royalties up to low double-digits. Transaction closed H1 2023.
• Keymed Biosciences Inc. (Stock Code: 02162.HK)flagshipStrategic or Co-development Partner · 23 February 2023Joint venture KYM Biosciences Inc. established with Keymed (70% ownership) and Lepu Biopharma (30% ownership) for co-development of CMG901 Claudin 18.2 ADC. Both parties collaborate on global development while Lepu contributes manufacturing and development capabilities.
• CG Oncology, Inc. (USA)coreOEM/ Whitelabel/ Licensing Partner · 5 March 2021Licensed CG0070 oncolytic virus antineoplastic drug for product development rights and global supply rights in China. CG0070 is a genetically modified adenovirus type 5 with cancer-selective E2F-1 promoter and GM-CSF gene for tumor-selective replication and lysis.
• ShanghaiTech University - SIAISminorStrategic or Co-development Partner · 21 October 2020Scientific research cooperation for construction of fully human antibody library and development of high-throughput screening technology for antibody drugs. CtM Bio (Lepu Biopharma subsidiary) collaboration with Shanghai Institute for Advanced Immunochemical Studies.
• SynaffixcoreTechnology or IntegrationNon-exclusive licensing of ADC platform technologies including fused cyclooctyne compounds, glycosyltransferase enzymes, modified antibody conjugation processes, and sulfamide linker technologies for ADC development.
• Fudan UniversityminorStrategic or Co-development PartnerJoint development partner for MRG004A tissue factor-targeted ADC along with Miracogen Shanghai and SIMMCAS, holding all rights in Mainland China and joint development in U.S. and Japan.
• InnoCube Biosciences Inc.minorOthersU.S. subsidiary office in The Woodlands, Texas for overseas operations and potential U.S. market development.

Scale indicators17 records

Recent moves11 records

Expansion highlights2 records

Direct peers

• RemeGen Co., Ltd. Chinese biopharmaceutical company developing a pipeline of ADCs (e.g., Disitamab Vedotin) and antibody-based oncology therapeutics. Directly comparable to Lepu Bio as another China-based ADC-focused innovator with approved and clinical-stage assets.
• CSPC Pharmaceutical Group: Hong Kong-listed Chinese pharma with an oncology biologics pipeline including ADCs and monoclonal antibodies. Comparable as a large-scale domestic competitor developing novel oncology biologics for the China market.
• Innovent Biologics: China-based biopharmaceutical company with commercialized oncology biologics (PD-1, etc.) and a growing pipeline of ADCs and bispecifics. Comparable business model combining domestic commercialization with global partnership deals.
• Akeso, Inc. China-based biotech developing bispecific antibodies and ADCs. Keymed's strategic partner, with comparable platform technology and pipeline in immuno-oncology.
• Hansoh Pharmaceutical Group: Major Chinese pharma with growing ADC and oncology biologics pipeline. Comparable in therapeutic area focus (oncology) and biologics manufacturing scale, with overlapping targets in ADC development.
• Keymed Biosciences: Hong Kong-listed biotech and Lepu's joint venture partner in KYM Biosciences (KYM holds 70%, Lepu 30%). Comparable as a clinical-stage Chinese biotech developing novel oncology antibodies and ADCs with global pharma partnerships.

Emerging players

• ArriVent BioPharma: Clinical-stage biopharma that licensed MRG007 from Lepu Bio for development outside Greater China. Comparable as an emerging ADC-focused player commercializing assets originating from the same China innovation ecosystem.

Broad incumbents

• Daiichi Sankyo: Japanese pharma and global ADC leader (Enhertu, Dato-DXd). Comparable as the dominant ADC platform innovator whose partnerships (e.g., with AstraZeneca) define the competitive landscape Lepu Bio operates in.
• AstraZeneca: Global pharma partner that licensed CMG901 from Lepu Bio and is the leader in ADC commercialization. Comparable as both a partner and the global benchmark for ADC commercial execution that Lepu's pipeline must compete against.
• BeiGene: Global China-headquartered oncology biopharmaceutical with a commercial-stage PD-1 (Tislelizumab) and broad hematology/oncology pipeline. Comparable as a larger incumbent in China oncology biologics with global commercial reach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Profiles10 records

Subsidiaries3 records

Funding overview

Funding rounds5 records

Investors15 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments1 record

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lepu Bio