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GlycoNex announces Phase I trial of osteoporosis biosimilar in Japan

Source: Mitsubishi Gas Chemicals

Mitsubishi Gas Chemicals Co., Ltd. has announced a partnership wtih GlycoNex of Taiwan in a biosimilar of the antibody drug "denosumab" for the treatment of osteoporosis and multiple myeloma, and a decision on conducting phase I clinical trial in Japan.

In order to mass-produce antibody drugs, it is necessary to improve the productivity of cells that produce the antibody that is the drug substance and to be able to mass-cultivate the cells.

Since 2010, we have deepened exchanges of technology, information, and people regarding antibody drugs with GlycoNex, and since 2018, we have been jointly developing the market for denosumab biosimilars. We have transferred the production cells and manufacturing technology and have been developing mass culture technology at our subsidiary Cartivex, but we have completed the study of scale-up of culture purification to the scale of commercial production by last year.

Until now, we have been in discussions with domestic and overseas pharmaceutical companies that are interested in commercializing denosumab biosimilars, but the decision to conduct Phase I clinical trials has accelerated this derivation. I hope it will be done.

We will continue to develop various antibody drugs by adding the knowledge obtained from the clinical trial phase I decided this time.

About Denosumab (SPD)

The world's first antibody drug targeting the RANK ligand (a protein required for the formation and activation of osteoclasts) used in the treatment of osteoporosis, polymyelitis, and giant cell tumor of bone, and osteoclasts. It has the effect of suppressing the activity of.

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