Korea’s pharmaceutical companies who vowed to develop Covid-19 vaccines and treatments are disposing of related pipelines one after another.
In a public filing Friday, NeoImmuneTech said it would voluntarily suspend the phase 1 clinical trial for NJT-116, a Covid-19 treatment candidate substance. The announcement came three years after it won approval from the U.S. Food and Drug Administration for the phase 1 trial.
The company planned to search for the safety and preliminary efficacy of NJT-116 in 27 adult Covid-19 patients with light symptoms, along with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Health (NIH).
“Unlike the situation of 2020 when we first planned the research in the United States, the number of daily confirmed cases remained at 33,126, and hospitalized patients were even far smaller than that on March 6, 2023,” NeoImmuneTech said while explaining the reason for deciding to suspend the trial.
Due to the popularization of the vaccine, light Covid-19 patients are hard to find, making it impossible to differentiate it from ordinary influenza, the company said, adding that few people visit patients due to such symptoms, making it impossible for them to recruit patients.
Until it reached the decision, the company had recruited seven patients equivalent to the 60ug/kg, or Dose Level 1, administration group, and the result and data of the research will be released in a report or research paper.
NeoImmuneTech is not the first Korean biopharmaceutical company that disposed of the Covid-19-related pipelines. However, most companies that expressed their intention to develop Covid-19 treatments or vaccines during the pandemic have not suspended clinical trials or withdrawn applications for trials.
In May of last year, HK inno.N said it would suspend the domestic phase 1 clinical trial for the Covid-19 vaccine INJ-B009. In July, Chong Kun Dang also suspended phase 3 clinical trial for Nafabeltan (nafamostat) with Covid-19 as an indication. In December, Daewoong Pharmaceutical said it would suspend the phase 3 clinical trial for DWJ1248, an oral Covid-19 treatment.
In February, Korea United Pharm said it would suspend developing inhaler-type Covid-19 treatment. The company received approval for a phase 2 clinical trial from the Ministry of Food and Drug Safety in May 2021. However, due to difficulty recruiting patients, the company decided to focus on its initial aim of developing an asthma treatment.
Some companies have terminated contract manufacturing organization (CMO) service contact due to their disposal of vaccine pipelines.
For example, Hanmi Pharmaceutical said in a public disclosure on Feb. 27 that it had agreed to terminate Covid-19 vaccine CMO contact with Genexine. The termination of the contract, worth 23.4 billion won ($17.9 million), was due to Genexine’s decision to discontinue developing GX-19N, a Covid-19 vaccine. Instead, the two companies agreed to produce GX-19N at Hanmi’s Bioplant Two in Pyeongtaek, Gyeonggi Province, in May 2021.
In contrast, other companies expressed their intention to push ahead with developing, licensing, and commercializing Covid-19 pipelines.
Eubiologics is one of them.
In January, the company said it had completed vaccine injection in its phase 3 comparison clinical trial overseas for EuCorVac-19, a Covid-19 vaccine candidate substance. Eubiologics has also completed the second administration of EuCorVac in 2,500 patients each in the Republic of Congo and the Philippines and plans to conduct additional monitoring.
Ildong Pharmaceutical, which is developing Covid-19 treatment jointly with Japan’s Shionogi and Co., is waiting for a permit from the Ministry of Food and Drug Safety for S-217622 (ensitrelvir fumaric acid, with the Japanese product name Xokova).
“We are conducting a review at the Rapid Screening Division,” a ministry official said, commenting on the screening progress of the S-217622.