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.
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.
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)
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
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
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)
Obtained through Acquisition of a Subsidiary
China/NMPA and U.S./FDA
China/NMPA
China/NMPA
China/NMPA
Global
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
Obtained through Acquisition of a Subsidiary
China/NMPA
China/NMPA and U.S./FDA
China/NMPA
China/NMPA
China/NMPA
Global
MRG001 CD20-targeted ADC
NHL
CTR20190851
Obtained through Acquisition of a Subsidiary
China/NMPA
Global
MRG004A TF-targeted ADC
TF-positive advanced or metastatic solid tumors
Self-developed
China/NMPA and U.S./FDA
Global
CMG901 CLDNI8.2-targeted ADC
Solid tumors
Advanced G/GEJ carcinoma
Co-developed
China/NMPA
U.S./FDA
Global
CG0070 Oncolytic virus
BCG-unresponsive (bacillus calmette-guerin unresponsive) NMIBC (non-muscle invasive bladder cancer)
Solid tumors
In-licensed
China/NMPA and U.S./FDA
China/NMPA
Mainland China, Hong Kong and Macau
HX008+OH2
Advanced hepatocellular carcinoma
Obtained through Acquisition of a Subsidiary
China/NMPA
Global
LP002+OH2
Advanced solid tumors
Obtained through Acquisition of a Subsidiary
China/NMPA
Global
HX008+LP002
Melanoma with prior failed treatment of PD-1/PD-L1
Obtained through Acquisition of a Subsidiary
China/NMPA
Global
LP007 CD47 mAb
Solid tumors/Blood tumor
Self-developed
China/NMPA
Global
LP010 Tigit mAb
PD1/L1 relapsed/refractory solid tumor
Self-developed
China/NMPA
Global
LP008 PDL1-TGFbRII
PD1/L1 relapsed/refractory solid tumor
Self-developed
China/NMPA
Global
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.
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.
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.
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 |