InnoCare Announces the Acceptance of Biologics License Application for Tafasitamab in Combination with Lenalidomide for the treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma in Adult Patients in China
June 20 2024 - 7:28AM
Business Wire
InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading
biopharmaceutical company focusing on the treatment of cancer and
autoimmune diseases, announced today that China National Medical
Products Administration (NMPA) has accepted and granted priority
review to a biologics license application (BLA) for tafasitamab in
combination with lenalidomide for adult patients with relapsed or
refractory diffuse large B-cell lymphoma (DLBCL) who are not
eligible for autologous stem cell transplant (ASCT).
Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare,
said, “Today's BLA acceptance marks an important milestone for
InnoCare. DLBCL is the most common type of non-Hodgkin lymphoma
globally, and there is a significant unmet need for DLBCL patients
in China. We believe that tafasitamab regimen will bring a novel
treatment therapy to DLBCL patients in China.”
Tafasitamab, a humanized Fc-modified cytolytic CD19-targeting
immunotherapy, in combination with lenalidomide has already been
approved for the treatment of eligible DLBCL patients in Hong Kong.
Furthermore, under the early access program in the Bo’ao Lecheng
International Medical Tourism Pilot Zone and the Guangdong-Hong
Kong-Macao Greater Bay Area, prescriptions of tafasitamab in
combination with lenalidomide were issued at the Ruijin Hainan
Hospital and Guangdong Clifford Hospital for eligible DLBCL
patients.
Tafasitamab is approved under accelerated approval by the U.S.
Food and Drug Administration (FDA), and conditional approved by the
European Medicines Agency (EMA), in combination with lenalidomide
for the treatment of relapsed or refractory DLBCL adult patients
who are not eligible for ASCT.
DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and
its incidence accounts for 31% to 34% of NHL globally. In China,
DLBCL accounts for 45.8% of all NHLs1.
About Tafasitamab
Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting
monoclonal antibody. In 2010, MorphoSys licensed exclusive
worldwide rights to develop and commercialize tafasitamab from
Xencor, Inc. Tafasitamab incorporates an XmAb® engineered Fc
domain, which mediates B-cell lysis through apoptosis and immune
effector mechanism including Antibody-Dependent Cell-Mediated
Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis
(ADCP).
MorphoSys and Incyte entered into: (a) in January 2020, a
collaboration and licensing agreement to develop and commercialize
tafasitamab globally; and (b) in February 2024, an agreement
whereby Incyte obtained exclusive rights to develop and
commercialize tafasitamab globally.
In August 2021, Incyte entered into a collaboration and license
agreement with InnoCare for the development and exclusive
commercialization of tafasitamab in hematology and oncology in
Greater China.
In the United States, Monjuvi® (tafasitamab-cxix) received
accelerated approval by the U.S. Food and Drug Administration in
combination with lenalidomide for the treatment of adult patients
with relapsed or refractory DLBCL not otherwise specified,
including DLBCL arising from low grade lymphoma, and who are not
eligible for autologous stem cell transplant (ASCT). In Europe,
Minjuvi® (tafasitamab) received conditional Marketing Authorization
from the European Medicines Agency in combination with
lenalidomide, followed by Minjuvi monotherapy, for the treatment of
adult patients with relapsed or refractory diffuse large B-cell
lymphoma (DLBCL) who are not eligible for autologous stem cell
transplant (ASCT).
XmAb® is a registered trademark of Xencor, Inc.
Monjuvi, Minjuvi, the Minjuvi and Monjuvi logos and the
“triangle” design are registered trademarks of Incyte.
About InnoCare
InnoCare (HKEX: 09969; SSE: 688428) is a commercial stage
biopharmaceutical company committed to discovering, developing, and
commercializing first-in-class and/or best-in-class drugs for the
treatment of cancer and autoimmune diseases with unmet medical
needs in China and worldwide. InnoCare has branches in Beijing,
Nanjing, Shanghai, Guangzhou, Hong Kong, and United States.
InnoCare Forward-looking Statements
This report contains the disclosure of some forward-looking
statements. Except for statements of facts, all other statements
can be regarded as forward-looking statements, that is, about our
or our management's intentions, plans, beliefs, or expectations
that will or may occur in the future. Such statements are
assumptions and estimates made by our management based on its
experience and knowledge of historical trends, current conditions,
expected future development and other related factors. This
forward-looking statement does not guarantee future performance,
and actual results, development and business decisions may not
match the expectations of the forward-looking statement. Our
forward-looking statements are also subject to a large number of
risks and uncertainties, which may affect our short-term and
long-term performance.
1 Hematology Branch of Chinese Medical Association
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