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.
MRG003 EGFR-targeted ADC
≥2L NPC (nasopharyngeal cancer)
≥2L (second-line) HNSCC (head and neck squamous cell carcinoma)
MRG002 HER2-targeted ADC
BC (breast cancer) HER2 (human epidermal growth factor receptor 2) over-expressing with liver metastasis
BC HER2-positive
UC (urothelial cancer)
MRG004A TF-targeted ADC
TF-positive(tissue factor positive)advanced or metastatic solid tumors
MRG001 CD20-targeted ADC
NHL(non-Hodgkin's lymphoma)
CTR20190851
MRG006A GPC3-targeted ADC
Solid tumor
CMG901 CLDN18.2-targeted ADC
G/GEJ carcinoma (gastric and gastroesophageal junction carcinoma) and other solid tumors
MRG007 target undisclosed ADC
Solid tumor
PUYOUHENG (Pucotenlimab Injection)* Anti-PD-1 mAb
≥2L Melanoma3
≥2L MSI-H/dMMR (high levels of microsatellite instability/ decient mismatch repair) solid tumors2
2L advanced G/GEJ carcinoma
CTR20181881/NCT04749485
CTR20181269/NCT03704246
CTR20201055/NCT04486651
CTM012 T cell agonistic mAb
Solid tumor
CG0070 Oncolytic virus
BCG-unresponsive (bacillus calmette-guerin unresponsive) NMIBC (non-muscle invasive bladder cancer)
PUYOUHENG (Pucotenlimab Injection) +MRG003
EGFR positive solid tumor
PUYOUHENG (Pucotenlimab Injection) +MRG002
HER2-expressing solid tumor
CG0070 + PUYOUHENG (Pucotenlimab Injection)
BCG-unresponsive NMIBC
CTM012 T cell agonistic mAb
Solid tumor
We have manufacturing sites in Beijing and Shanghai. We have been operating a 2,000L GMP-compliant bioreactor production line at our Beijing manufacturing plant, which mainly supports the production of clinical drug supply and offers CDMO production services. The building construction of the Shanghai Biotech Park has been preliminarily completed and accepted, and the research and development center in the Shanghai Biotech Park has been put in use. The manufacturing facilities in the Shanghai Biotech Park has a designed total capacity of 12,000L, and it has obtained the environmental impact assessment report for the production of mAb and ADC. Going forward, we will continue to build the manufacturing facilities based on our business needs arising from the commercialization of ADC.
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 |