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     169  0 Kommentare 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.

    SAN DIEGO, June 24, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that following its receipt of EUA approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) under registration number “OFICIO: CAS/10720/2021”, it is establishing a local “Sorrento Mexico Ltd” subsidiary to manage commercial operations in Mexico.

    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 June 14, 2021.

    Sorrento will commercially launch the COVI-STIX test in Mexico with the first shipments expected to be delivered in July.

    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.

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    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 …