Sorrento Announces Its Partner Mabpharm Has Received Marketing Approval In China For Infliximab BiobetterSorrento to Exclusively Market the Product Outside of China Including US, Japan and Europe
- China National Medical Product Administration (NMPA) has granted Mabpharm approval to market INFLIXIMAB biobetter in China.
- Sorrento holds commercialization rights outside of China and intends to meet with regulatory agencies to determine best path to registration for the US and Europe.
- The new Infliximab biobetter antibody produced in CHO cells has demonstrated a better safety profile than the parent mouse cell produced product, while maintaining its efficacy profile.
- This specific antibody product has also demonstrated efficacy in 6 autoimmune diseases and inflammation indications.
SAN DIEGO, July 20, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE) announced today that its partner Mabpharm Ltd (HK:2181) has received approval of its New Drug Application for its infliximab biobetter antibody in China.
Sorrento holds exclusive commercial rights to this product outside of China and plans to file a Biologics License Application (BLA) for the infliximab biobetter antibody in the United States and Europe in 2021.
Infliximab (currently marketed under the trade name Remicade) is an injectable monoclonal antibody prescription drug 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. Infliximab belongs to a class of drugs called tumor necrosis factor (TNF) inhibitors, which work by suppressing the action of a protein called TNF that is linked to inflammation. It is usually prescribed when other medicines or treatments have failed. Global sales revenue of infliximab in 2020 reached $4.2 billion, making the antibody one of the top 20 blockbuster drugs.
Mabpharm’s approved biobetter is an anti-TNF-α antibody using a CHO expression system, resulting in a better safety profile and lower immunogenicity when compared to the currently marketed TNF-α antibody using a murine cell line, while demonstrating the same efficacy as the parent mouse antibody. The Chinese approval covers 6 different indications including adult ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis, adult and childhood Crohn’s disease, fistula Crohn’s disease, and psoriasis.
Sorrento is planning to meet with FDA and EMA to discuss the data package and gain concurrence on the path forward to a BLA or MAA.
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to treat cancers and COVID-19. 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”, “DAR-T™”), antibody-drug conjugates (“ADCs”), and clinical stage oncolytic virus (“Seprehvir™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVI-STIX™ and COVITRACE™.
Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of post-herpetic neuralgia. RTX has completed a Phase IB trial for intractable pain associated with cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is in a pivotal Phase 3 trial for the treatment of lumbosacral radicular pain, or sciatica. ZTlido® was approved by the FDA on February 28, 2018.
For more information visit www.sorrentotherapeutics.com.
This press release and any statements made for and during any presentation or meeting contain 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 infliximab biosimilar antibody; Sorrento’s plans to commercialize and market the infliximab biosimilar antibody in the US, Japan and Europe; Sorrento’s plans to seek regulatory approval for the infliximab biosimilar antibody, including meeting with FDA and EMA; and the expected timing for submitting a Biologics License Application in the US and a Marketing Authorization Application in Europe. 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 and its subsidiaries', affiliates’ and partners’ technologies and prospects and collaborations with partners, including, but not limited to risks related to seeking regulatory approval for Mabpharm’s infliximab biosimilar antibody product; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results 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 that prior test, study and trial results may not be replicated in future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its therapeutic antibody product candidate strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2020, 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)
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