Sorrento Announces Its Partner Mabpharm Has Received Marketing Approval In China For Infliximab Biobetter
China National Medical Product Administration(NMPA) has granted Mabpharmapproval to market INFLIXIMAB biobetter in China.
- Sorrento holds commercialization rights outside of
Chinaand 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.
Sorrento holds exclusive commercial rights to this product outside of
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
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.
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
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Source: Sorrento Therapeutics, Inc.