Baricitinib, a Rheumatoid Arthritis Drug Recommended by WHO for Severe COVID-19, Already Marketed in China

On January 14 local time, the WHO International Guidelines Development Group, composed of international experts, strongly recommended the combination of baricitinib and corticosteroids for severe or critically ill COVID-19 patients.

The WHO's strong recommendation is based on moderate certainty evidence, indicating that it can improve survival rates and reduce the need for ventilation, with no observed increase in adverse reactions.

WHO experts pointed out that baricitinib has a similar effect to other arthritis drugs known as interleukin-6 (IL-6) inhibitors. Therefore, when both are available, they recommend choosing one based on cost, availability, and the clinician's experience, and do not recommend using both drugs simultaneously.

According to reports, Baricitinib was discovered by Incyte Corporation and licensed to Eli Lilly and Company. It is a tyrosine protein kinase (JAK) 1/2 inhibitor originally used for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). It can be used in combination with methotrexate or other non-biologic DMARDs. In July 2019, Baricitinib was approved for marketing in China for the treatment of adults with moderately to severely active rheumatoid arthritis under the trade name Olumiant and has been included in the 2021 edition of the National Reimbursement Drug List (Class B). Recently, Eli Lilly and Company submitted a marketing application to the National Medical Products Administration for a new indication of Baricitinib. In 2020, its global sales reached $638 million, representing a year-on-year increase of 50%.

In addition, Nanjing Youke Pharmaceutical, a pharmaceutical company in China, has completed the BE trial for Baricitinib and submitted a generic drug marketing application in August 2021. According to the CDE patent registration platform, the patent for Baricitinib will expire in 2029.

In fact, Baricitinib had already been approved for the treatment of COVID-19 patients. In November 2020, the U.S. FDA issued an Emergency Use Authorization (EUA) for the combination therapy of Baricitinib and Remdesivir, authorizing its emergency use for suspected or confirmed COVID-19 adult and pediatric (2 years of age or older) hospitalized patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). In April 2021, Japan's Ministry of Health, Labour and Welfare approved Baricitinib for use as a treatment drug for severe cases of coronavirus infectious disease.

As for why a rheumatoid arthritis treatment drug can also be used to treat COVID-19, according to a report by The Science and Technology Daily, a pharmaceutical industry insider stated: "This is mainly determined by the pathway through which JAK inhibitors work and the chemical structure of baricitinib itself. In terms of its mechanism of action, after the coronavirus invades the human body, it triggers a strong immune response—immune cells not only destroy infected cells on a large scale but may even attack normal cells and tissue structures, leading to lung damage, and in severe cases causing respiratory failure or even death. JAK inhibitors can suppress related immune responses, thereby reducing the damage. Baricitinib stands out among many JAK inhibitors because of its unique chemical structure—it can effectively prevent the coronavirus from entering normal cells and replicating within them. Only a few JAK inhibitors can achieve this."

Notably, Chengda Pharmaceutical, a Chinese drug company set to be listed on the ChiNext Board, is the active pharmaceutical ingredient (API) provider for Baricitinib. According to its prospectus, from 2018 to June 2021, Chengda Pharmaceutical generated revenues of 5.34 million yuan, 13.86 million yuan, 25.05 million yuan, and 11.33 million yuan respectively by supplying the intermediate (NP0805) for Baricitinib.

Note: The original text has been abridged.