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Just! The anti-CCR4 antibody "mowglizumab" was approved in China

 Last Update: 2022-10-20
 Source: Internet
 Author: User

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Today (October 14), the drug approval certificate released on the official website of the China National Medical Products Administration (NMPA) shows that the mowglizumab injection declared by Kyowa Kirin has been approved for marketing
.
According to public information, this is an antibody targeting CCR4, which has been granted breakthrough therapy designation and priority review qualification
by the US FDA.
According to the priority review public information, the indications approved by the drug in China this time are two common types of cutaneous T-cell lymphoma
.

Mowglizumab injection is an antibody that targets CCR4, two common types of cutaneous T-cell lymphoma

Screenshot source: NMPA official website

Mogamulizumab (KW-0761) is a humanized CC chemokine receptor 4 (CCR4) monoclonal antibody
.
CCR4 protein is a protein frequently expressed on the surface of lymphocytes in patients with hematological malignancies, and is also expressed in
patients with cutaneous T-cell lymphoma.
According to the public information of Concord Kyunlin, the company reduces the fucose component in the sugar chain structure of mowglizumab through its original technology, which is expected to enhance antibody-dependent cytotoxicity and treat
malignant blood diseases.

A humanized CC chemokine receptor 4 (CCR4) monoclonal antibody

In July 2021, the Center for Drug Evaluation (CDE) of the China National Medical Products Administration accepted the marketing application for mowglizumab and included it in the priority review
.
According to the priority review announcement, the drug is applied for the treatment of adult patients with fungoides granuloma (MF) or Sézary syndrome (Sezari syndrome, SS), two common types of cutaneous T-cell lymphoma
, who have received at least one previous systemic treatment.

Granuloma fungoides (MF) Sézary syndrome (Sezari syndrome, SS) in adults are two common types of cutaneous T-cell lymphoma

Screenshot source: CDE official website

The efficacy of mowglizumab has been clinically proven
.
In August 2018, the FDA approved mowglizumab for the treatment of adult patients
with relapsed or refractory fungoides or cezzari syndrome who have received at least one systemic therapy.
According to public information, this is the first time that the FDA has approved a drug for Sezari syndrome, and it also provides more treatment options
for patients with fungomycosis.

This is the first time the FDA has approved a drug for Sezari's syndrome, and it also provides more treatment options for people with fungomycosis

THE FDA'S APPROVAL OF THE DRUG IS BASED ON DATA
FROM A PHASE 3 TRIAL CALLED MAVORIC.
The results of this study showed a significant increase in progression-free survival (PFS) in patients treated with mowglizumab, with a mean PFS of 7.
6 months (vs 3.
1 months) and an overall response rate of 28% (vs 5%)
.

Progression-free survival (PFS) was significantly longer in patients treated with mowglizumab, with mean PFS of 7.
6 months (vs 3.
1 months) and an overall response rate of 28% (vs 5%)

Cutaneous T-cell lymphoma is a rare type of non-Hodgkin lymphoma
.
Among them, fungomycosis and Sezari syndrome are the two most common types of
cutaneous T-cell lymphoma.
According to publicly available information, fungomycosis accounts for 50%-70% of all cutaneous lymphomas, which can cause itchy rashes and skin wounds and can spread to other parts
of the body.
Sezari syndrome is a rare cutaneous lymphoma
that affects the blood and lymph nodes.
These patients are in dire need of new treatment options
.

It is hoped that mowglizumab can come to patients as soon as possible and give them new treatment options
.

Resources:

[1] October 14, 2022 Drug approval certificate to be received information release .
Retrieved Oct 14, 2022, from

[1] October 14, 2022 Drug approval certificate to be received information release .
Retrieved Oct 14, 2022, from [2] Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome.
Retrieved August 8, 2018, from

[2] Kyowa Kirin Announces FDA Approval of Poteligeo® (mogamulizumab-kpkc) for the Treatment of Mycosis Fungoides and Sézary Syndrome.
Retrieved August 8, 2018, from [3] Kyowa Hakko Kirin : Announces Positive Results of the Phase 3 Clinical Study of Mogamulizumab (KW-0761) in Patients with Cutaneous T-cell Lymphoma.
Retrieved April 7, 2017, from

[3] Kyowa Hakko Kirin : Announces Positive Results of the Phase 3 Clinical Study of Mogamulizumab (KW-0761) in Patients with Cutaneous T-cell Lymphoma.
Retrieved April 7, 2017, from [4] China's original innovative drug cedamide landed in overseas markets.
Retrieved Jun 24, 2021, from https://mp.
weixin.
qq.
com/s/DjRCp0ji96Bntvb8jme9Cg

[4] China's original innovative drug cedamide landed in overseas markets.
Retrieved Jun 24, 2021, from https://mp.
weixin.
qq.
com/s/DjRCp0ji96Bntvb8jme9Cg

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