Sorrento receives EUA approval and import license from the Mexican authority COFEPRIS for COVI-STIX ™ (COVID-19 Virus Rapid Antigen Detection Test) and plans to launch the product with first deliveries in July

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  • Sorrento received the official EUA registration and product import license: COFEPRIS EUA registration number “OFICIO: CAS / 10720/2021”.
  • Sorrento establishes its subsidiary “Sorrento Mexico Ltd” to facilitate the commercialization of COVI-STIX ™ and future COVID-19 related products in the country.
  • Sorrento expects the first deliveries for the first COVI-STIX test orders to be made in July.

SAN DIEGO, June 24, 2021 (GLOBE NEWSWIRE) – Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) announced today that after receiving EUA approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) under registration number “OFICIO: CAS / 10720/2021”, she founds a local subsidiary “Sorrento Mexico Ltd” to manage the commercial activities in Mexico.

COVI-STIX is a sensitive and fast (approx. 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples from patients (“Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápsid del SARS-CoV-2 “). COFEPRIS issued an EUA (Emergency Use Authorization) and an import permit for COVI-STIX on June 14, 2021.

Sorrento will commercialize the COVI-STIX test in Mexico, with first deliveries expected in July.

About Sorrento Therapeutics, Inc.

Sorrento is an antibody-focused, clinical-stage biopharmaceutical company developing new therapies to treat cancer and COVID-19. Sorrento’s multimodal, multi-pronged approach to cancer control is enabled by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB ™ Library”), clinical-stage immunocellular therapies (“CAR-T”, “DAR-T ™”), antibody-drug conjugates (“ADCs”) and oncolytic viruses in the clinical stage (“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 reflected in our efforts to provide a world-class (TRPV1 agonist) low molecular weight non-opioid pain reliever 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® (topical lidocaine system) 1.8% for the treatment of post-therapeutic neuralgia. RTX has completed a Phase IB study in persistent pain-related cancer and a Phase 1 B study in osteoarthritis patients. SEMDEXA is in a pivotal phase 3 study for the treatment of lumbosacral radicular pain or sciatica. ZTlido® was approved by the FDA on February 28, 2018.

More information is available at http://www.sorrentotherapeutics.com

Forward-Looking Statements

This press release and any statements made for and during any presentation or meeting contain forward-looking statements regarding Sorrento Therapeutics, Inc., subject to and subject to the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 Risks and uncertainties This could mean that the actual results differ materially from those forecast. Forward-looking statements include statements regarding the establishment of a subsidiary in Sorrento, Mexico to commercialize the COVI-STIX test and future approved products; the sensitivity and speed with which COVI-STIX delivers or can deliver results; the expected time for the delivery of the first consignments from COVI-STIX; and Sorrento’s potential position in the diagnostics and therapy industries. 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 the technology and prospects of Sorrento and its subsidiaries, affiliates, and Partners and collaborations with partners, including but not limited to risks associated with the commercialization of COVI-STIX and additional regulatory approvals for Sorrento’s products; Risk of difficulties or delays in introducing COVI-STIX in Mexico; Risks in the manufacture and supply of diagnostic products; Risks related to using the expertise of its employees, subsidiaries, affiliates and partners to help the company implement its COVID-19 product marketing strategies; Risks related to the global impact of COVID-19; and other risks 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 Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set out in these filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release, and we assume no obligation to update any forward-looking statements in this press release unless required by law.

ContactAlexis Nahama, DVM (SVP Corporate Development) Email: mediarelations@sorrentotherapeutics.com

Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc.

G-MAB ™, DAR-T ™, SOFUSA ™, COVIGUARD ™, COVI-AMG ™, COVISHIELD ™, Gene-MAb ™, COVIDROPS ™, COVI-MSC ™, COVITRACK ™, COVITRACE ™ and COVISTIX ™ are trademarks of Sorrento Therapeutics , Inc.

SEMDEXA ™ is a trademark of Semnur Pharmaceuticals, Inc.

ZTlido® is a registered trademark of Scilex Pharmaceuticals Inc.

All other trademarks are property of their respective owners.

© 2021 Sorrento Therapeutics, Inc. All rights reserved.

Source: Sorrento Therapeutics, Inc.

Sorrento receives EUA approval and import license from the Mexican authority COFEPRIS for COVI-STIX ™ (COVID-19 Virus Rapid Antigen Detection Test) and plans to launch the product with first deliveries in July is available on AmericanChiro

from American Chiropractors Directory and News – Feed https://www.americanchiropractors.org/sciatica/sorrento-receives-eua-approval-and-import-license-from-the-mexican-authority-cofepris-for-covi-stix-covid-19-virus-rapid-antigen-detection-test-and-plans-to-launch-the-product-with-first-d/

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