Concord Kirin mogamulizumab monoclonal antibody submitted a marketing application in China for skin T-cell lymphoma

In August 2017, the US FDA granted Japan’s lymphoma drug breakthrough drug certification, which has been used in Japan for many years to treat patients with skin T lymphoma
.

The drug is mogamulizumab, a research product of Tokyo Kyowa Hakko Kirin Co.

FDA lymphoma

July 2, 2021, Chinese State Drug Administration Bureau Center for Drug Evaluation (CDE) publicity, Kyowa Kirin (China) Pharmaceutical Co.
, Ltd.
has submitted a listing application Mowgli natalizumab injection, and were entertained
.

Public information shows that mogamulizumab is a CCR4 targeting antibody that has been approved by the FDA for breakthrough therapy and priority review, and has been approved for marketing in the United States for the treatment of mycosis fungoides ( MF) or Sezari syndrome (SS) in adult patients

Manage a CCR4 targeting antibody , which has been approved by the FDA for breakthrough therapy and priority review, and has been approved for marketing in the United States for the treatment of adult patients with mycosis fungoides (MF) or Sezari syndrome (SS)

The fucose component in the sugar chain structure of mogamulizumab is reduced, which is expected to enhance antibody-dependent cytotoxicity

In an open-label, multi-center, randomized phase 3 trial called MAVORIC, a total of 372 patients with mycosis fungoides and Sezari syndrome received mogamulizumab or control drugs
.

The results showed that the progression-free survival (PFS) of patients treated with mogamulizumab was significantly prolonged, with an average PFS of 7.

Progression-free survival (PFS) was significantly extended, with an average PFS of 7.

This is the first time the FDA has approved a drug for Sezari syndrome, and it also provides more treatment options for patients with mycosis fungoides

Therefore, cutaneous T-cell lymphoma may involve the skin, blood, lymph nodes, and internal organs, with the risk of disfigurement and debilitating
.

The advanced stage of skin T-cell lymphoma is even more related to significant morbidity and mortality.

Cutaneous T-cell lymphoma may involve the skin, blood, lymph nodes, and internal organs, and carries the risk of disfigurement and debilitating

The company said they are collaborating with researchers in an effort to release clinical trial results
.

Mogamulizumab has been in development for some time and has been used in combined research with other companies (including Bristol-Myers Squibb)

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