On 18 March, the CDE proposed the inclusion of TRS005 for injection from Zhejiang Teruisi Pharmaceutical Inc..
CD20 is thought to be expressed on the surface of B-lymphocytes and is involved in the treatment of numerous tumour cells, including B-cell lymphoma, hairy cell leukaemia, B-cell chronic leukaemia and melanoma tumours. In addition, according to further studies of CD20 by scientists, the protein is also expressed on a small subset of T cells. Currently, most of the drugs in development or approved for CD20 are monoclonal antibodies, including the first-generation heavyweight anti-CD20 monoclonal antibody Rituxan.
TRS005 is an anti-CD20-MMAE ADC drug developed by Teruisi, which can deliver the highly toxic anti-mitotic drug MMAE into CD20+ tumour cells through receptor-mediated endocytosis, and is being developed for the treatment of CD20-positive non-Hodgkin's lymphoma. TRS005 has the potential to outperform related competitors in terms of safety and efficacy (key efficacy indicators including ORR, PFS, etc.) based on clinical trial data available to date, according to Teruisi.
Recently, Teruisi announced that the TRS005 programme was approved for a pivotal single-arm Phase II clinical trial and that the CDE agreed to support the marketing approval of TRS005 with conditions based on this clinical trial.
By accelerating the progress of TRS005 clinical trials, the drug is expected to become a heavyweight ADC drug in the CD20 field.
Teruisi is an innovative biopharmaceutical R&D and manufacturing company focusing on the development, pilot scale-up and commercialisation of antibody-based drugs. Currently, Teruisi has established a rich pipeline of products in development, covering innovative ADCs, biosimilars and improved monoclonal antibodies.
Among them, TRS003 is a biosimilar of bevacizumab, and its therapeutic areas cover a wide range of malignant tumours, including non-small cell lung cancer, colorectal cancer, glioblastoma and cervical cancer. Bevacizumab targets the VEGF target and inhibits the growth of tumour cells mainly by inhibiting the formation of blood vessels in tumours in order to reduce the supply of blood, oxygen and other nutrients to tumours. TRS003 is the first biosimilar in the world to be approved by the FDA for interchangeable Phase III clinical trials in the U.S. The clinical trial of TRS003 has been approved by both the U.S. and China and a series of clinical trials are currently underway.
TRS004, a trastuzumab biosimilar, is currently clinically approved in the United States and is scheduled for Phase III clinical trials under interchangeable biosimilars after completion of Phase I clinical trials. Trastuzumab is an anti-HER-2 monoclonal antibody, and as a cornerstone drug for the treatment of Her2-positive breast and gastric cancers, it has a pivotal position in the relevant cancer treatment field.
In addition, Teruisi has a number of drugs in the early stages of research in its pipeline, including a monoclonal antibody for non-Hodgkin's lymphoma and an ADC programme for other tumours.
With the further acceleration of clinical studies of TRS005, TRS005, as a rare ADC drug in the field of CD20 targets, is expected to bring more effective and safer therapies for the treatment of related diseases.
