In the demanding terrain of pharmaceutical research and development (R&D), allegations from Rep. Kim Yeung-shik of the ruling People Power Party during the National Assembly's audit, scrutinizing Celltrion's Regkirona, its Covid-19 treatment, as an unsuccessful development, demands a balanced examination.

With a focus on the significant government funding for Regkirona, approximating 52 billion won ($38.7 million), Kim accused the company of not delivering on its promises and the relevant ministries of neglecting thorough research performance evaluation, even coining it a "typical R&D cartel" during a National Assembly ministry audit.

Kim stressed that the government needs to reorganize the evaluation method after the R&D budget support, and root out the forces that use the R&D budget private gains.

However, it's pivotal to recognize the inherent risks and uncertainties entwined with scientific R&D for pharmaceuticals. The journey from a concept to a viable pharmaceutical product is treacherous, and many promising projects don't reach fruition.

Not every endeavor, even with substantial funding and expertise, assures success, and to say that Celltrion's Regkirona is a total failure is simply not true.

Although the endeavor did not materialize as anticipated, Celltrion's response to the urgent global need for Covid-19 therapeutics deserves acknowledgment because the company is still the only Korean company to have localized a Covid-19 treatment.

Throughout 2020 and into 2021, Celltrion went through phase 1, 2, and 3 clinical trials for Regkirona, its Covid-19 treatment, achieving both conditional approval in Korea in February 2021 and formal product approval in September.

Yet, this promising journey was soured by two main controversial points. The first is the effectiveness against emerging variants. The therapeutic, while effective against initial strains, including the Delta, was found less effective against the Omicron variant, which became the major source of concern from early 2022.

Regkirona demonstrated limited capability in controlling the activation of the Omicron variant within the body, a notable falter that was illuminated through pharmacological testing by the Ministry of Food and Drug Safety.

Then, there was the issue of political and public scrutiny over funding, especially considering the efficacy issues with emerging variants.

The discontinuation of Regkirona's distribution in February 2022, as the variants emerged, not only cast a shadow over the company's initial success but also raised questions about the initial investment and subsequent project evaluation.

However, it is important to note that after receiving approval in Korea, Celltrion administered the treatment to approximately 52,000 patients.

A phase 3 clinical trial, which was the basis of the drug's full approval in Korea, also showed that the drug was effective in reducing Covid-19 exacerbations to severe disease, with statistically significant reductions in time to clinical recovery.

According to the Ministry of Food and Drug Safety, the rate of severe morbidity among 446 high-risk patients with mild to moderate COVID-19 who took Regkinora was reduced by 72 percent compared to placebo (434), and the clinical recovery period was shortened by 4.12 days compared to placebo (12.3 days).

While the drug was ineffective against the Omicron variant, developing a drug anticipating future variants that had not appeared at the time is impossible. 

It's worth noting that the company obtained approval from various global regulators, including the EU. The European Commission granted final sales approval for the treatment in November 2021, which serves as international validation of the product.

The drug also won conditional approvals in Switzerland, Australia, Peru, Brazil, and Indonesia.

Concluding that the drug was a failure implies sweeping disapproval from numerous international regulatory bodies that approved the drug.

Thus, while criticism regarding transparency in funding utilization and a deeper delve into the entire R&D process might be warranted, classifying Celltrion's efforts in developing Regkirona as a complete failure overlooks the nuances and partial successes of the scientific R&D trajectory.

Copyright © KBR Unauthorized reproduction, redistribution prohibited