HONG KONG – Celltrion Inc. has received the European CE mark for Tekitrust, its COVID-19 tests kit developed with Mico Biomed Co. Ltd.

“Mico, which is a diagnostic device specialist, partnered with Celltrion to combine both companies’ strengths in the test kit sector,” a Celltrion spokesperson told BioWorld. Mico will manufacture the kits, while Celltrion handles marketing and sales.

Tekitrust checks the production of neutralizing antibodies in patients vaccinated against COVID-19 via an enzyme-linked immunosorbent assay (ELISA). Developed using Mico’s ELISA biotechnology and raw materials, namely antibodies and antigens, from Celltrion, the test kit has a 94.4% clinical sensitivity and 100.0% specificity, said Seongnam, South Korea-based Mico.

“Unlike existing COVID-19 antibody test kits which confirm whether antibodies are produced after infection, Tekitrust can confirm whether neutralizing antibodies that actually act as a defense mechanism have been generated after one is vaccinated,” said the Celltrion spokesperson.

This could allow authorities to detect whether a person has been inoculated against COVID-19 or not. Incheon, South Korea-based Celltrion is now betting on an accelerating rate of COVID-19 vaccinations globally as well as Tekitrust’s cost-effectiveness. The pair are now focused on distributing the freshly CE-marked test kit globally, but with a particular focus on regions that are accelerating their COVID-19 vaccine rollout, including the U.S. and Europe. An application to obtain an emergency use approval (EUA) from the FDA via Celltrion’s U.S. arm Celltrion USA Inc. is also underway.

Test kits galore

South Korea’s Ministry of Food and Drug Safety also recently granted conditional approval to Celltrion’s Diatrust COVID-19 Ag Home Test, co-developed with Humasis. Users can self-test via a nasal swab without a medical professional’s help, with results available within 15 minutes.

The company also recently won regulatory approval for its Point of Care (POC) antigen rapid test kit Diatrust COVID-19 Ag Rapid Test from the FDA following European Commission certification in November 2020.

Different countries are at different stages in their fight against COVID-19, and this in turn will impact Celltrion’s export strategy.

“We will distribute Tekitrust in those countries where vaccinations rates are rising, while distributing the Diatrust test kits to those countries where the number of COVID-19 cases are still high,” a Celltrion official said.

The Tekitrust and both Diatrust test kits are not the only ones that Celltrion is currently developing. The Diatrust COVID-19 IgG/IgM rapid test kit, again co-developed with Humasis, is a one-step in vitro diagnostic test based on an immunochromatographic assay which rapidly detects COVID-19 antibodies.

The Sampinute COVID-19 Antigen MIA, co-developed with BBB Tech Inc., is an electrochemical immunoassay test that detects the SARS-CoV-2 antigen from nasopharyngeal swab samples.

Celltrion applied for the FDA’s EUA for both test kits in July 2020 and planned to launch second-generation rapid antibody and antigen diagnostic kits, also co-developed with Humasis.

“We are in the process of getting approvals for our other test kits,” said the Celltrion representative.

Meanwhile, Seongnam-si, South Korea-based Mico will also brand the test kit under its own Veri-Q name. Mico is also seeking approval for the domestic sales of COVID-19 self-diagnostic antibodies (IgG/IgM) rapid detection kits and hopes to start clinical trials soon, the company said.

Celltrion’s next steps

Test kits are not the only contribution Celltrion has made to the fight against COVID-19. Its anti-COVID-19 monoclonal antibody, Regkirona (regdanvimab, also known as CT-P59) received conditional marketing authorization from MFDS in February 2021, making Celltrion the first company to receive approval for a COVID-19 antibody treatment developed in South Korea.

Celltrion recently released top-line results from a randomized, double-blind, and placebo controlled global phase II/III clinical trial for CT-P59. The first part of the trial tested the drug on 327 patients with mild-to-moderate symptoms of COVID-19, in which approximately 60% of patients with moderate symptoms suffered from COVID-19 related pneumonia.

The company said that at day 28, compared to the placebo, CT-P59 treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderate patients and 68% for moderate patients aged 50 years and over.

CT-P59 treated patients also had a significantly shortened time to clinical recovery, and rapidly and significantly reduced viral load through day seven compared to placebo. The results also said that CT-P59 has a positive safety profile, with no serious adverse advents reported.

The European Medicines Agency’s Committee for Medicinal Products for Human Use is also evaluating the drug under a rolling review.

Outside the COVID-19 sphere, Celltrion is also currently conducting global phase III clinical trials for candidates in its biosimilar pipeline. The candidates include Xolair (omalizumab) biosimilar CT-P39 treating asthma and urticaria, Prolia (denosumab) biosimilar CT-P41 treating osteoporosis, Eylea (aflibercept) biosimilar CT-P42 treating diabetic macular edema and Stelara (ustekinumab) biosimilar CT-P43 treating psoriasis, Crohn's disease as well as ulcerative colitis.