The First Domestic TF ADC Drug Approved for Clinical Use: LEPU BIOPHARMA MRG004A
2021-08-05 09:08

On August 5, 2021, a clinical trial application of MRG004A, a new TF-targeted ADC drug manufactured by LEPU BIOPHARMA, was impliedly approved by the NMPA.


Acceptance No.

Drug Name

Applicant Name


Registration Classification



Shanghai Miracogen Inc.

Advanced or metastatic solid tumors



On April 13, 2021, Miracogen, a subsidiary of LEPU BIOPHARMA, registered the U.S. Phase I/II clinical trial of MRG004A at for the treatment of advanced solid tumors, with 181 patients enrolled as scheduled. MRG004A is the 4th new ADC drug manufactured by LEPU BIOPHARMA.

Tisotumab Vedotin, the first TF-targeted drug, is manufactured by Genmab using Seagen's ADC technology. A marketing application was submitted in 2020 and was recently granted priority review by the FDA. As indicated by data from a registered, single-arm Phase II clinical trial (innovaTV 204) of Tisotumab Vedotin, a response rate is 24% for the treatment of advanced cervical cancer (with one or two chemotherapies), with a complete response (CR) rate of 7% and a disease control rate of 73%, as well as a median PFS of 4.2 months and a median OS of 12.1 months in treatment with Tisotumab Vedotin, compared to a median OS of generally 6.4 to 9.0 months in a standard therapy, thus indicating the superiority of Tisotumab Vedotin.

Clinical value of this TF-targeted ADC drug has been demonstrated in advanced cervical cancer, one of the most refractory tumors. MRG004A is the first domestic TF-targeted ADC drug, with no competitors in this filed yet, thus enjoying promising clinical and market values.


Source from Armstrong