Sorrento Receives EUA Approval and Import License From Mexico Authority COFEPRIS For COVI-STIX™ (COVID-19 Virus Rapid Antigen Detection Test) and Plans Product Launch With Initial Shipments in July
- Sorrento received official EUA registration and product import license: COFEPRIS EUA registration number “OFICIO: CAS/10720/2021”.
- Sorrento is establishing its “Sorrento Mexico Ltd” subsidiary to enable commercialization of COVI-STIX™ and future COVID-19 related products in the country.
- Sorrento expects the first shipments for initial COVI-STIX test orders to be delivered in July.
COVI-STIX is a sensitive and rapid (approximately 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of patients ("Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2"). COFEPRIS issued Emergency Use Authorization (EUA) approval and an importation permit for COVI-STIX on
Sorrento will commercially launch the COVI-STIX test in
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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Sorrento® and the Sorrento logo are registered trademarks of
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™, COVITRACE™ and COVISTIX™ are trademarks of
SEMDEXA™ is a trademark of
ZTlido® is a registered trademark owned by
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Source: Sorrento Therapeutics, Inc.