Research Field

Our pipeline has been designed with a range of oncology products. The anti-PD-1 and anti-PD-L1 antibody candidates, underpinning our immunotherapy, are the backbone of our pipeline. Our Company believes the broad spectrum of indications covered by anti-PD1 antibody drugs would prompt us to rapidly expand our commercialization capabilities. In June 2021, our Company filed an NDA with the NMPA for our anti-PD-1 antibody candidate HX008 (pucotenlimab) in melanoma. In October 2021, our Company filed an NDA with the NMPA for HX008 in MSI-H/dMMR solid tumors. The experience and recognition to be gained from the commercialization of HX008 is expected to help our Company swiftly penetrate various indications of oncology therapeutics as well as different levels of medical institutions, establish a dedicated commercialization team of a considerable scale and strengthen our commercialization capabilities.The Company obtained IND clearance for HX008 in the U.S. in January 2022.

 

Our Company is also devoted to the development of ADC and oncolytic virus drug products. Our Company houses the leading ADC drug candidate pipeline in China in terms of the number of clinical-stage ADC drug candidates, according to Frost & Sullivan. Our ADC drug candidates are the core of our targeted therapies. Our Company has developed ADC drug candidates, including MRG003, MRG002 and MRG001 in-house since our acquisition of Miracogen Shanghai, developed in-house our ADC drug candidate MRG004A and owns their global rights. MRG003 is the advanced EGFR-targeted ADC in clinical-stage development in China. MRG002 is an innovative HER2-targeted ADC. MRG001 is a clinically advanced CD20-targeted ADC. Our Company received IND approval of MRG004A, a novel TF-targeted site-specifically conjugated ADC, from the NMPA in August 2021. Our Company is also co-developing CMG901, the first CLDN18.2-targeted ADC to have received the IND approval globally, according to Frost & Sullivan, through a joint venture, KYM.The Company also achieved first patient in for MRG002 for HER2 over-expressing BC in March 2022. Furthermore, the Company obtained an IND approval from the NMPA for the combination therapy of MRG003 and HX008. In April 2022, the drug candidate CMG901 (co-developed by us and Keymed) has been granted the Fast Track Designation for the treatment of relapsed/ refractory GC/ GEJ adenocarcinoma and received the Orphan-drug Designation from the FDA.

 

Our oncolytic virus drug candidates include CG0070, for which our Company owns the development and commercialization rights in Mainland China, Hong Kong and Macau, and OH2 which we co-developed with a business partner. Our Company believes that our comprehensive ADC and oncolytic virus pipeline creates synergies and maximizes our competitive strength in commercialization.The Company also plan to submit an IND for the combination therapy of CG0070 and HX008.

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...
  • Antibody Discovery Platform
    Our Company has constructed a full human naive antibody libr...
  • Advanced Processand Analytical Development Platform
    The cultivation and manufacturing of antibodies can be chall...
Immuno-Oncology
Drug Candidates
Indications
Preclinical
Phase Ia/Ib
Phase II
Phase III
NDA
CTR/NTC Number
Source
Jurisdiction
Copyright
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HX008 Anti-PD-1 mAb

≥2L Melanoma

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

2L advanced G/GEJ carcinoma

1L (first-line) NSCLC

1L TNBC (triple-negative breast cancer)

1L advanced G/GEJ carcinoma

NMIBC

HCC (hepatocellular carcinoma)

Registration trial
Registration trial
Registration trial

CTR20181881/NCT04749485

CTR20181269/NCT03704246

CTR20201055/NCT04486651

CTR20202387/NCT04750083

CTR20191353/NCT04750382

CTR20181270

0319

NMIBC

Obtained through Acquisition of a Subsidiary

China/NMPA

China/NMPA

China/NMPA

China/NMPA

China/NMPA

China/NMPA

China/NMPA

China/NMPA

Global

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LP002 Anti-PD-L1 mAb

1L ES-SCLC (extensive stage small-cell lung cancer

Solid tumors

Advanced digestive system cancer

CTR20201477/NCT04740021

Obtained through Acquisition of a Subsidiary

China/NMPA

China/NMPA

China/NMPA

Global

HX008 Anti-PD-1 mAb
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  • Indication
    ≥2L Melanoma
    DNA
    10
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Registration trial
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • 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
    Registration trial
    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
    Registration trial
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    1L (first-line) NSCLC
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    1L TNBC (triple-negative breast cancer)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    1L 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
  • Indication
    NMIBC
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    HCC (hepatocellular carcinoma)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
LP002 Anti-PD-L1 mAb
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  • Indication
    1L ES-SCLC (extensive stage small-cell lung cancer
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    Solid tumors
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    Advanced digestive system cancer
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
ADC
Drug Candidates
Indications
Preclinical
Phase Ia/Ib
Phase II
Phase III
NDA
CTR/NTC Number
Source
Jurisdiction
Copyright
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MRG003 EGFR-targeted ADC

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

≥2L NPC (nasopharyngeal cancer)

Advanced NSCLC (non-small cell lung cancer)

BTC (biliary tract cancer)

China
U.S.

Obtained through Acquisition of a Subsidiary

China/NMPA and U.S./FDA

China/NMPA

China/NMPA

China/NMPA

Global

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MRG002 HER2-targeted ADC

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

≥2L G/GEJ (gastric or gastroesophageal junction) carcinoma

UC (urothelial cancer)

BC HER2 low-expressing

BTC

China and U.S

Obtained through Acquisition of a Subsidiary

China/NMPA

China/NMPA and U.S./FDA

China/NMPA

China/NMPA

China/NMPA

Global

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MRG001 CD20-targeted ADC

NHL

CTR20190851

Obtained through Acquisition of a Subsidiary

China/NMPA

Global

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MRG004A TF-targeted ADC

TF-positive advanced or metastatic solid tumors

China
U.S.

Self-developed

China/NMPA and U.S./FDA

Global

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CMG901 CLDNI8.2-targeted ADC

Solid tumors

Advanced G/GEJ carcinoma

U.S.

Co-developed

China/NMPA

U.S./FDA

Global

MRG003 EGFR-targeted ADC
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  • Indication
    ≥2L (second-line) HNSCC (head and neck squamous cell carcinoma)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA and U.S./FDA
    Copyright
    Global
    China
    U.S.
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • 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
    Advanced NSCLC (non-small cell lung cancer)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    BTC (biliary tract cancer)
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
MRG002 HER2-targeted ADC
EXPLORE MORE
  • 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
    ≥2L G/GEJ (gastric or gastroesophageal junction) carcinoma
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA and U.S./FDA
    Copyright
    Global
    China and U.S
    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
  • Indication
    BC HER2 low-expressing
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    BTC
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
MRG001 CD20-targeted ADC
EXPLORE MORE
  • Indication
    NHL
    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
EXPLORE MORE
  • Indication
    TF-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
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
OV
Drug Candidates
Indications
Preclinical
Phase Ia/Ib
Phase II
Phase III
NDA
CTR/NTC Number
Source
Jurisdiction
Copyright
EXPLORE MORE

CG0070 Oncolytic virus

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

Solid tumors

China
U.S.

In-licensed

China/NMPA and U.S./FDA

China/NMPA

Mainland China, Hong Kong and Macau

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
    U.S.
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
  • Indication
    Solid tumors
    DNA
    Source
    In-licensed
    Jurisdiction
    China/NMPA
    Copyright
    Mainland China, Hong Kong and Macau
    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
Source
Jurisdiction
Copyright
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HX008+OH2

Advanced hepatocellular carcinoma

Obtained through Acquisition of a Subsidiary

China/NMPA

Global

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LP002+OH2

Advanced solid tumors

Obtained through Acquisition of a Subsidiary

China/NMPA

Global

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HX008+LP002

Melanoma with prior failed treatment of PD-1/PD-L1

Obtained through Acquisition of a Subsidiary

China/NMPA

Global

HX008+OH2
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  • Indication
    Advanced hepatocellular carcinoma
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
LP002+OH2
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  • Indication
    Advanced solid tumors
    DNA
    Source
    Obtained through Acquisition of a Subsidiary
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
HX008+LP002
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  • Indication
    Melanoma with prior failed treatment of PD-1/PD-L1
    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
Source
Jurisdiction
Copyright
EXPLORE MORE

LP007 CD47 mAb

Solid tumors/Blood tumor

Self-developed

China/NMPA

Global

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LP010 Tigit mAb

PD1/L1 relapsed/refractory solid tumor

Self-developed

China/NMPA

Global

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LP008 PDL1-TGFbRII

PD1/L1 relapsed/refractory solid tumor

Self-developed

China/NMPA

Global

LP007 CD47 mAb
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  • Indication
    Solid tumors/Blood tumor
    DNA
    Source
    Self-developed
    Jurisdiction
    China/NMPA
    Copyright
    Global
    Preclinical
    Ia/Ib Stage
    II Stage
    III Stage
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
Manufacturing Plants

All of our Company’s products currently remained in the research and development stage, and our manufacturing activities are mainly conducted in support of our clinical trials. 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.

  • 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