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HJB - Your Trusted Biologics CDMO Partner


Jul, 2021

HJB Congratulates Miracogen for receiving IND acceptance for MRG004A from NMPA

MRG004A is one of the few tissue factor-targeted antibody–drugs (TF ADC) in the world that entering clinical phase.  And it is the first in class TF ADC in China. Before the NMPA IND acceptance, MRG004A’s clinical trial targeting TF positive late-stage tumor or metastatic cancer was approved by U.S.FDA in February this year. HJB finished the technical transfer activities and started the tox material production within 6 weeks. HJB’s experienced team carried out the GMP in manufacturing in an effective manner to guarantee MRG004A’s success.

“It is a great milestone for Miracogen to have MRG004A IND approval to enter clinical phase. We are glad to work with HJB to move this project forward. HJB completes the antibody GMP manufacturing for this project to guarantee the success of IND application. We are looking forward to the approval from NMPA for MRG004A’s IND application. And we hope this product will performs well in clinical trial and provide cancer patients a new therapy.” Said Dr Hanhong Hu, CEO of Miracogen.

“Congratulations to Miracogen on receiving acceptance from NMPA for MRG004A’s IND application. We are glad to participate in this project. With strong expertise and capabilities to develop and manufacturing innovative biologics, HJB will continue to deliver high quality, reliable, and rapid service which empowering our global partners to accelerate their innovative treatment development.” said Dr. Jerry Yang, General Manager of HJB.

About Miracogen

Shanghai Micrcogen Inc. is wholly owned subsidiary of company profile Lepu Biopharma Co., Ltd. Miracogen is committed to develop advancing antibody drug conjugates (ADC). Currently, the company has 4 self-developed innovative ADCs in clinical phase for the treatment of rectal cancer, esophageal cancer, lung cancer, breast cancer, stomach cancer, and lymphoma, etc.

About HJB

HJB employs an integrated leading technology platform capable of substantially accelerating R&D process and reducing cost for speedy commercialization. We offer our clients complete, flexible, and reliable development and manufacturing services for the entire lifecycle of their biologic’s product from research, preclinical, IND to all clinical phases and commercial production.