Global
Research Field

Lepu Biopharma Co., Ltd. has strategically built our pipeline with a range of oncology products, including ADCs, immunotherapies and oncolytic virus drugs. We have (i) one clinical/commercialization-stage drug, pucotenlimab; (ii) six clinicalstage drug candidates, including five ADCs; and (iii) three clinicalstage combination therapies of our own drug candidates. One of our drug candidates has obtained marketing approval with respect to two of its targeted indications, with clinical trials for other indications ongoing. Among the six clinical-stage drug candidates, five are targeted therapeutics and one is an immunotherapeutic, which is an oncolytic virus drug. We have initiated multiple clinical trials, amongst which one is ongoing in the U.S., and five have entered the stage of registrational trials in the PRC.

Technology Platform

Our biopharmaceutical research and development capabilities consist of three specialized platforms targeting a variety of biological therapies, including the ADC technology platform, the antibody discovery platform, and the advanced process and analytical development platform. This system serves as a solid foundational technology solution for discovering and developing next-generation ADC and immuno-oncology candidates.



  • ADC Technology Platform
    Our ADC technology platform enables us to design and develop...
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  • Antibody Discovery Platform
    Our Company has constructed a full human naive antibody libr...
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  • Advanced Processand Analytical Development Platform
    The cultivation and manufacturing of antibodies can be chall...
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Product Pipeline
Drug Candidates Pre-clinical Drug
ADC
Drug Candidates
Indications
Preclinical
Phase Ia/Ib
Phase II
Phase III
NDA
CTR/NTC Number
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MRG003 EGFR-targeted ADC

≥2L NPC (nasopharyngeal cancer)

≥2L HNSCC (head and neck squamous cell carcinoma）

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MRG002 HER2-targeted ADC

BC (breast cancer) HER2 (human epidermal growth factor receptor 2) over-expressing

UC (urothelial cancer)

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MRG004A TF-targeted ADC

TF-positive(tissue factor positive)advanced or metastatic solid tumors

China
U.S.

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MRG001 CD20-targeted ADC

NHL(non-Hodgkin's lymphoma)

CTR20190851

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CMG901 CLDNI8.2-targeted ADC

Solid tumors

Advanced G/GEJ carcinoma

U.S.

MRG003 EGFR-targeted ADC
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  • Indication
    ≥2L NPC (nasopharyngeal cancer)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    ≥2L HNSCC (head and neck squamous cell carcinoma）
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA and U.S./FDA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
MRG002 HER2-targeted ADC
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  • Indication
    BC (breast cancer) HER2 (human epidermal growth factor receptor 2) over-expressing
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    UC (urothelial cancer)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
MRG004A TF-targeted ADC
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  • Indication
    TF-positive(tissue factor positive)advanced or metastatic solid tumors
    DNA
    Source
    Self-developed
    Jurisdiction
    China/NMPA and U.S./FDA
    Copyright
    Global
    China
    U.S.
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
MRG001 CD20-targeted ADC
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  • Indication
    NHL(non-Hodgkin's lymphoma)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
CMG901 CLDNI8.2-targeted ADC
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  • Indication
    Solid tumors
    DNA
    Source
    Co-developed
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    Advanced G/GEJ carcinoma
    DNA
    Source
    Co-developed
    Jurisdiction
    U.S./FDA
    Copyright
    Global
    U.S.
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
Immuno-Oncology
Drug Candidates
Indications
Preclinical
Phase Ia/Ib
Phase II
Phase III
NDA
CTR/NTC Number
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HX008 Anti-PD-1 mAb

≥2L MSI-H/dMMR (high levels of microsatellite instability/ deficient mismatch repair) solid tumors

≥2L Melanoma

2L advanced G/GEJ carcinoma

CTR20181269/NCT03704246

CTR20181881/NCT04749485

CTR20201055/NCT04486651

HX008 Anti-PD-1 mAb
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  • Indication
    ≥2L MSI-H/dMMR (high levels of microsatellite instability/ deficient mismatch repair) solid tumors
    DNA
    10
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    ≥2L Melanoma
    DNA
    10
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    2L advanced G/GEJ carcinoma
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
OV
Drug Candidates
Indications
Preclinical
Phase Ia/Ib
Phase II
Phase III
NDA
CTR/NTC Number
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CG0070 Oncolytic virus

BCG-unresponsive (bacillus calmette-guerin unresponsive) NMIBC (non-muscle invasive bladder cancer)

China

CG0070 Oncolytic virus
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  • Indication
    BCG-unresponsive (bacillus calmette-guerin unresponsive) NMIBC (non-muscle invasive bladder cancer)
    DNA
    Source
    In-licensed
    Jurisdiction
    China/NMPA and U.S./FDA
    Copyright
    Mainland China, Hong Kong and Macau
    China
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
Combo Within Pipeline
Drug Candidates
Indications
Preclinical
Phase Ia/Ib
Phase II
Phase III
NDA
CTR/NTC Number
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PUYOUHENG (Pucotenlimab Injection) +MRG003

EGFR positive solid tumors

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PUYOUHENG (Pucotenlimab Injection) +MRG002

HER2-expressing solid tumors

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CG0070 + PUYOUHENG (Pucotenlimab Injection)

NMIBC(non-muscle invasive bladder cancer)BCG-unresponsive(bacillus calmette-guerin unresponsive)

PUYOUHENG (Pucotenlimab Injection) +MRG003
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  • Indication
    EGFR positive solid tumors
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
PUYOUHENG (Pucotenlimab Injection) +MRG002
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  • Indication
    HER2-expressing solid tumors
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
CG0070 + PUYOUHENG (Pucotenlimab Injection)
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  • Indication
    NMIBC(non-muscle invasive bladder cancer)BCG-unresponsive(bacillus calmette-guerin unresponsive)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
Pre-clinical Drug Candidates
Drug Candidates
Indications
Preclinical
Phase Ia/Ib
Phase II
Phase III
NDA
CTR/NTC Number
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LP010 Tigit mAb

PD1/L1 relapsed/refractory solid tumor

EXPLORE MORE

LP008 PDL1-TGFbRII

PD1/L1 relapsed/refractory solid tumor

EXPLORE MORE

MRG 006A target undisclosed

Solid tumors

LP010 Tigit mAb
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  • Indication
    PD1/L1 relapsed/refractory solid tumor
    DNA
    Source
    Self-developed
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
LP008 PDL1-TGFbRII
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  • Indication
    PD1/L1 relapsed/refractory solid tumor
    DNA
    Source
    Self-developed
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
MRG 006A target undisclosed
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  • Indication
    Solid tumors
    DNA
    Source
    Self-developed
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
Manufacturing Plants

We have manufacturing sites in Beijing and Shanghai. Our manufacturing plant in Beijing houses a 2,000L GMP-compliant antibody production line in operation and an oncolytic virus production line under construction with a designed capacity of 200L. We are also building up a biologics manufacturing plant in Shanghai Biotech Park with laboratories and manufacturing facilities, which will house two production lines with a designed capacity of 6,000L each.In October 2022, our research and development center in the Shanghai Biotech Park was put into operation.

  • BEIJING MANUFACTURING PLANT
    BEIJING MANUFACTURING PLANT
    BEIJING MANUFACTURING PLANT

    A 2,000L antibody production line came into operation in 2019 with 13,442 sq.m of floor space in support of clinical trials for our Company’s antibody products. This facility was issued a drug manufacturing license by the Beijing Municipal Medical Products Administration. In addition, an oncolytic virus production line is currently under construction with a designed capacity of 200L.

  • Shanghai Biotech Park
    Shanghai Biotech Park
    Shanghai Biotech Park

    We are building manufacturing facilities in the Shanghai Biotech Park. The first phase has a designed total capacity of 12,000L, and one production line with capacity of 6,000L is under construction.

Intellectual Property Rights
The following table summarizes the details of the material granted patents owned by Lepu Biopharma or shared with Lepu Biopharma’s collaborators on our Company’s clinical-stage drug candidates:
Product Applicant Patentee Title of Patent/Patent Application Jurisdiction Commercial Rights
HX008 Taizhou Hanzhong and Akeso Anti-PD-1 Monoclonal Antibody Mainland China All rights in Mainland China
Taizhou Hanzhong and Akeso Monoclonal Antibody Resisting Against PD-1 and Applications Thereof Mainland China All rights in Mianland China
Taizhou Hanzhong and Akeso Monoclonal Antibody Resisting Against PD-1 and Applications Thereof U.S., European Union All rights in the related jurisdictions
Taizhou Hanzhong and Akeso Anti-PD-1 monoclonal antibody PCT (Japan, U.S and European Union) All rights in related jurisdictions
Han X Method for increasing binding affinity of IGG-Like antibody to FcRn and prolonging serum half-life period thereof PCT (Japan) Non-exclusive license to develop and commercialize in Japan
LP002 I-Mab Shanghai Anti-PD-L1 and thereof Mainland China Exclusive license to develop and commercialize in Mainland China
I-Mab Shanghai Anti-PD-L1 Antibodies and Uses Thereof PCT (Mainland China, US, South Korea, Japan, Australia, Chile, Colombia, Indonesia, Israel, New Zealand) Exclusive license to develop and commercialize in related jurisdictions
MRG003 Miracogen Shanghai Antibody-Drug Conjugate Mainland China All rights in Mainland China
Miracogen Shanghai Antibody-Drug Conjugate U.S. All rights in the U.S.
JMT Humanized antibody against epidermal growth factor receptor and application thereof Mainland China Exclusive license to develop and commercialize in Mainland China
MRG004A (mAb TF) Miracogen Shanghai and Fudan University Antibody Targeted to TF, Preparation Method Thereof, and Use Thereof Mainland China All rights
Miracogen Shanghai and Fudan University Antibody Targeted to TF, Preparation Method Thereof, and Use Thereof (U.S, Japan) Joint development and technology transfer
MRG004A (ADC) Miracogen Shanghai, Fudan University and SIMMCAS Tissue Factor-Targeted Antibody-Drug Conjugate Mainland China All rights
Miracogen Shanghai, Fudan University and SIMMCAS Tissue Factor-Targeted Antibody-Drug Conjugate PCT (Japan) Joint development and technology transfer
ADC Platform Synaffix Fused Cyclooctyne Compounds and Their Use in Metal-Free Click Reactions PCT (Mainland China, European Union, Japan, U.S., India) Non-exclusive license to develop and commercialize in related jurisdictions
Synaffix Fused Cyclooctyne Compounds and Their Use in Metal-Free Click Reactions PCT (U.S.) Non-exclusive license to develop and commercialize in related jurisdictions
Synaffix Enzymes for Trimming Of Glycoproteins PCT (U.S.) Non-exclusive license to develop and commercialize in related jurisdictions
Synaffix Modified Antibody, Antibody-Conjugate and Process for the Preparation Thereof PCT (Mainland China, European Union, Japan, U.S.) Non-exclusive license to develop and commercialize in related jurisdictions
Synaffix Modified Antibody, Antibody-Conjugate and Process for the Preparation Thereof PCT (U.S.) Non-exclusive license to develop and commercialize in related jurisdictions
Synaffix Process for the Modification of a Glycoprotein Using a Glycosyltransferase that is or is Derived from a ß(1,4)-N- Acetylgalactosaminyl transferase PCT (European Union, U.S., Japan) Non-exclusive license to develop and commercialize in related jurisdictions
Synaffix Sulfamide Linker, Conjugates Thereof, and Methods of Preparation PCT (Mainland China, European Union, Japan, U.S.) Non-exclusive license to develop and commercialize in related jurisdictions
Synaffix Sulfamide Linker, Conjugates Thereof, and Methods of Preparation PCT (U.S.) Non-exclusive license to develop and commercialize in related jurisdictions
Synaffix Improved Sulfamide Linkers for Use in Bioconjugates PCT (U.S.) Non-exclusive license to develop and commercialize in related jurisdictions
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