Hanmi Pharm and Celltrion to Produce MSD Oral Treatment 'Lagevrio'

Selection of Generic Production Companies for Supply to Low- and Middle-Income Countries
Pfizer's 'Paxlovid' Also Undergoing Selection Process

Oral COVID-19 treatment 'Lagevrio (Molnupiravir)' by MSD (Merck) in the United States [Image source=Reuters Yonhap News]

[Asia Economy Reporter Chunhee Lee] The oral COVID-19 treatment 'Lagevrio (Molnupiravir)' from the US-based Merck (MSD) will also be produced domestically in South Korea.

According to the Ministry of Health and Welfare on the 20th, three Korean companies?Hanmi Pharmaceutical, Celltrion, and Dongbang FTL?were included in the list of manufacturers producing generic Lagevrio for supply to low- and middle-income countries (LMIIC), announced by the Medicines Patent Pool (MPP) on the same day. These companies are among a total of 27 companies across 11 countries, including 5 companies producing active pharmaceutical ingredients (API), 13 companies producing both APIs and finished products, and 9 companies producing finished products. Among them, Hanmi Pharmaceutical was selected for both API and finished product production, Celltrion for finished product production, and Dongbang FTL for API production.

MPP, established in 2010 under the international procurement organization Unitaid, is an international cooperative organization that negotiates licenses with patent holders of medicines and grants sublicenses to generic manufacturers, enabling the supply of produced medicines to low- and middle-income countries at affordable prices.

In October last year, MPP signed a license agreement with MSD to supply Lagevrio to 105 low- and middle-income countries without patent royalties. Applications were accepted until November, and after a review process for selecting manufacturers, the production companies were decided as above. Patent royalties are waived until the World Health Organization (WHO) declares the end of the COVID-19 pandemic. Pfizer's oral treatment 'Paxlovid' also signed a contract with MPP last November for supply to low- and middle-income countries. However, the selection process for manufacturers is still ongoing, and results have not yet been announced.

As of this year, the generic market for oral COVID-19 treatments supplied to low- and middle-income countries through international organizations is expected to reach approximately 1.7 trillion KRW. Furthermore, by selecting generic manufacturers this time and establishing production processes and facilities, these companies are expected to gain an advantage in future country-specific tenders that may be conducted separately.

Hanmi Pharm Paltan Plant and Hanmi Precision Chemical in Pyeongtaek-si, Gyeonggi Province (from left in the photo) (Photo by Hanmi Pharm)

Accordingly, each company will begin preparations to produce generic Lagevrio as soon as possible. Hanmi Pharmaceutical, selected for both API and finished product production, plans for its affiliate, Hanmi Fine Chemical, a specialized API company, to immediately start producing the generic Lagevrio API. The produced API will be transferred to Hanmi Pharmaceutical's smart plant located in Paltan-myeon, Hwaseong-si, Gyeonggi Province, for finished product manufacturing.

Celltrion, responsible only for finished product development, plans to have its affiliate, Celltrion Pharm, handle generic finished product development and production, with Celltrion supplying overseas. A Celltrion representative explained, "To expedite commercialization, we chose to focus on finished product production rather than producing the API ourselves." Celltrion Pharm has already begun formulation research aiming to complete product development within the year and plans to proceed with bioequivalence studies, approvals, and other commercialization procedures, with production taking place at Celltrion Pharm's Cheongju plant.

Minister of Health and Welfare Kwon Deok-cheol stated, "We are pleased that Korean companies will contribute to ending the global COVID-19 pandemic through the production and supply of oral treatments alongside vaccines, and we will spare no support for domestic production."