Sorrento Announces Filing for Approval of Infliximab Biobetter Antibody by Its Partner Mabpharm in China
January 06 2020 - 7:00AM
Sorrento Therapeutics (Nasdaq: SRNE) announced today that its
partner Mabpharm (HK:2181) filed recently a New Drug Application
for the Infliximab biosimilar antibody in China. Sorrento plans to
file a Biologics License Application (BLA) for the Infliximab
biobetter antibody in the United States in 2020.
Infliximab (currently commercialized under the trade name
Remicade® - trademark of Janssen) is an injectable monoclonal
antibody prescription drug that's used to treat rheumatoid
arthritis, Crohn's disease, ulcerative colitis, ankylosing
spondylitis (a type of spinal arthritis), psoriatic arthritis, and
the red, scaly skin patches of plaque psoriasis. Usually prescribed
when other medicines or treatments have failed, infliximab belongs
to a class of drugs called tumor necrosis factor inhibitors (TNFs),
which work by suppressing the action of a protein called TNF, which
has been tied to inflammation.
Sorrento, through a global licensing agreement with Mabpharm,
owns the global rights to the Mabpharm Infliximab biobetter
antibody outside of China. Mabpharm recently submitted a new drug
application with the National Medical Products Administration (the
NMPA) for a recombinant anti-TNF-alpha chimeric monoclonal antibody
based on infliximab. This variant uses CHO expression system,
resulting in a potentially better safety profile and lower
immunogenicity when compared to the currently marketed competitive
drugs.
Sorrento is planning to file all the required document for a
Biologics License Application (BLA) by the end of 2020.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to turn
malignant cancers into manageable and possibly curable diseases.
Sorrento's multimodal multipronged approach to fighting cancer is
made possible by its’ extensive immuno-oncology platforms,
including key assets such as fully human antibodies (“G-MAB™
library”), clinical stage immuno-cellular therapies (“CAR-T” and
“DAR-T”), antibody-drug conjugates (“ADC”), and clinical
stage oncolytic virus (“Seprehvir®”).
Sorrento's commitment to life-enhancing therapies for cancer
patients is also demonstrated by our effort to advance a
first-in-class (TRPV1 agonist) non-opioid pain management small
molecule in Resiniferatoxin (“RTX”) and ZTlido®. Resiniferatoxin is
completing a Phase 1b trial in terminal cancer patients and
osteoarthritis. ZTlido was approved by US FDA on 02/28/18.
For more information visit www.sorrentotherapeutics.com
Forward-Looking Statements
This press release contains forward-looking statements related
to Sorrento Therapeutics, Inc. under the safe harbor provisions of
Section 21E of the Private Securities Litigation Reform Act of 1995
and subject to risks and uncertainties that could cause actual
results to differ materially from those projected. Forward looking
statements include statements regarding the developments of and
prospects for the Infliximab biobetter antibody ; Sorrento's
products and technologies, including its antibody products and
technologies; timing Sorrento’s ability to file a BLA for the
Infliximab biobetter antibody in the United States , Sorrento's
ability to leverage the expertise of its employees, subsidiaries,
affiliates and partners to assist the company in the execution of
its strategies; outcome of the data from a clinical trial for
Infliximab biobetter antibody); Sorrento's M&A and licensing
strategy; and Sorrento's and its partners’ ability to accelerate
the development of any lead programs in the clinic.. Risks and
uncertainties that could cause our actual results to differ
materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: risks
related to Sorrento's, its subsidiaries' and partners’ technologies
and prospects; risks that Biologics License Application (BLA) for
the Infliximab biobetter antibody in the United States may not meet
any or all endpoints of a clinical study and that any data
generated from such studies may not support a regulatory submission
or approval; risks related to seeking regulatory approvals and
conducting clinical trials; and other matters that are described in
Sorrento's Annual Report on Form 10-K for the year ended December
31, 2018, and subsequent Quarterly Reports on Form 10-Q filed with
the Securities and Exchange Commission, including the risk factors
set forth in those filings. Investors are cautioned not to place
undue reliance on these forward-looking statements, which speak
only as of the date of this release and we undertake no obligation
to update any forward-looking statement in this press release
except as required by law.
Media and Investor Relations
Contact: Alexis Nahama, DVM (SVP Corporate Development)
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Website: www.sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.
ZTlido® and G-MAB™ are trademarks owned by Scilex
Pharmaceuticals Inc., a wholly-owned subsidiary of Sorrento and
Sorrento, respectively.
Seprehvir®, is a registered trademark of Virttu Biologics
Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and
part of the group of companies owned by Sorrento Therapeutics,
Inc.
All other trademarks are the property of their respective
owners.
© 2020 Sorrento Therapeutics, Inc. All Rights Reserved.
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