List of new drugs recommended for marketing by the EU CHMP in 2022

Among the new drugs recommended by CHMP this year, there are 8 new drugs in the world, of which 7 are biotechnology drugs, including 2 gene therapy drugs, 1 cell therapy drug, 3 antibody drugs and 1 protein drug, and chemical small molecule drugs occupy another seat (Table 1).

Table 1: CHMP recommended for the first batch of new drugs in the world in 2022

Gene therapy and cell therapy drugs have been included in the management of advanced therapeutic medical products (ATMP) in the EU, and in 2021, the EU updated and improved the guidelines for the development of gene and cell therapy drugs to actively guide and support the development of
ATMP.
This year, CHMP recommended the approval of 3 gene therapy drugs and 3 cell therapy drugs, of which 2 gene therapy drugs and 1 cell therapy drug are among the first new drugs
in the world 。 They are: PTC Intra-brain injection gene therapy Upstaza (eladocagene) developed by Therapeutics to treat the rare disease aromatic L-amino acid decarboxylase (AADC) deficiency exuparvovec), the severe hemophilia A gene therapy Roctavian (valoctocogene) developed by BioMarin Pharmaceutical roxaparvovec) and Atara Biotherapeutics and Pierre Fabre collaborated to develop the allogeneic T cell therapy Ebvallo (tabelecleucel).

It is worth mentioning that unlike the highly customized autologous CAR-T therapy on the market, Ebvallo uses EBV from donors T cells, which can be quickly delivered to patients within three days, will be a milestone in the commercialization of universal cell therapies
.

Bispecific antibodies are regarded as the second generation of antibody therapy for tumor treatment, and it seems to have ushered in an "outbreak" period
in 2022.
Among the antibody drugs recommended by CHMP this year, there are 3 bispecific antibody drugs, two of which are the world's first first-in-class products, CD20 developed by Roche x CD3 targets the bispecific antibody Lunsumio (mosunetuzumab) and the first fully humanized BCMA x CD3 developed by Johnson & Johnson Targeting the bispecific antibody Tecvayli (teclistamab).

The above two drugs are a boon
for patients with different types of multiple recurrent or refractory hematological tumors.

The status of the first new drugs in the EU