 Home > Medical News > Medicines Company News > InnoCare announces that Tafasitamab in combination with lenalidomide has been approved for the treatment of relapsed/refractory diffuse large B-cell lymphoma in Hong Kong, China

InnoCare announces that Tafasitamab in combination with lenalidomide has been approved for the treatment of relapsed/refractory diffuse large B-cell lymphoma in Hong Kong, China

 Last Update: 2023-02-03
 Source: Internet
 Author: User

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On December 28, 2022, InnoCare (SSE: 688428; Hong Kong Stock Exchange code: 09969) today announced that tafasitamab in combination with lenalidomide has been approved by the Hong Kong Department of Health for the treatment of adult patients
with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation.

Dr.
Jisong Cui, co-founder, chairman and CEO of InnoCare, said: "The approval of Tafasitamab and lenalidomide in Hong Kong will benefit DLBCL patients in the region and will also help benefit patients in the Greater Bay Area in the near future
.
In the future, we will accelerate the clinical trial of tafasitamab in Chinese mainland, hoping to meet more unmet medical needs
.
”

Tafasitamab is a humanized monoclonal antibody targeting CD19 Fc domain-optimized that has been approved in the Boao Lecheng International Medical Tourism Pilot Zone for the treatment of eligible DLBCL patients, but tafasitamab has not been approved by the NMPA in China for any indication
.
Thanks to Boao's policy, tafasitamab combined with lenalidomide opened the first party in Boao Lecheng in July this year, and completed the first injection in China for an eligible DLBCL patient in
Ruijin Hainan Hospital.

Tafasitamab has been conditionally approved by the U.
S.
Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of relapsed/refractory DLBCL patients who are not eligible for autologous stem cell transplantation in combination with lenalidomide
.

About tafasitamab

Tafasitamab is a humanized monoclonal antibody
targeting CD19.

In 2010, MorphoSys acquired exclusive worldwide rights
to develop and commercialize tafasitamab from Xencor.

Tafasitamab contains Xencor's unique XmAb® engineered Fc domain, thereby significantly enhancing antibody-dependent cell-mediated cytotoxicity (ADCC) and antibody-dependent phagocytosis (ADCP), mediating lysis of B-cell tumors through apoptosis and immune effector mechanisms
.

In the US, Monjuvi® (tafasitamab-CXIX) is approved by the US Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (not specified), including DLBCL evolved from low malignancy lymphoma and patients
who are not eligible for autologous stem cell transplantation.
Based on the total response rate (ORR), this indication received accelerated approval
.
Subsequent approval of this indication may depend on validation of clinical benefit in confirmatory trials
.

In Europe, Minjuvi (tafasitamab) in combination with lenalidomide, followed by monotherapy with Minjuvi®, has been conditionally approved for the treatment of adult patients
with relapsed/refractory diffuse large B-cell lymphoma who are not eligible for autologous stem cell transplantation.

As a treatment option for B-cell malignancies, tafasitamab is undergoing several clinical studies of combination drugs
.

Monjuvi® and Minjuvi® are registered trademarks
of MorphoSys Corporation.
In the United States, tafasitamab is jointly marketed by Incyte and MorphoSys under the Monjuvi® brand; In Europe, the United Kingdom and Canada, Incyte is sold
under the Minjuvi® brand.
Under the agreement with MorphoSys, Incyte acquires exclusive rights
to commercialize tafasitamab outside the U.
S.
market.
In August 2021, InnoCare and Incyte signed a collaboration and license agreement
for the development and exclusive commercialization of tafasitamab for hematological and solid tumors in Greater China.

XmAb® is a registered trademark
of Xencor.

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