Hanmi Pharmaceutical and Celltrion said they would manufacture Lagevrio pills, low-cost version of Merck’s Covid-19 treatment molnupiravir, and supply them to 105 low- and-middle-income countries.

The Medicines Patent Pool has selected 27 global drugmakers, including Hanmi Pharmaceutical and Celltrion, to manufacture Lagevrio, a low-cost version of Merck’s Covid-19 pill, molnupiravir, for supply to 105 low- and-middle-income countries.
The Medicines Patent Pool has selected 27 global drugmakers, including Hanmi Pharmaceutical and Celltrion, to manufacture Lagevrio, a low-cost version of Merck’s Covid-19 pill, molnupiravir, for supply to 105 low- and-middle-income countries.

The Medicines Patent Pool (MPP) has chosen 27 drugmakers, including the two Korean companies, to make and supply Lageviro.

The MPP, a non-profit organization of the United Nations, which works to increase access to and facilitate the development of life-saving medicines for low- and middle-income countries, signed a licensing agreement with Merck last year to boost global access to the treatment.

Lagevrio received emergency use approval in the U.K. in November and in the U.S. in December as a treatment for patients who could not use other approved Covid-19 treatments. The Ministry of Food and Drug Safety is also conducting an approval review.

Hanmi Fine Chemicals will produce raw materials for Lagevrio and transfer them to Hanmi Pharm's smart plant located in Paltan, Gyeonggi Province, which will make finished drugs.

"We will start production as soon as possible in close consultation with MPP and Merck, and do our best to quickly supply high-quality medicines to the world based on Hanmi's excellent formulation technology and production capacity," a company official said.

Celltrion, on the other hand, stressed that Celltrion Pharmaceuticals, a subsidiary of Celltrion, has started research on formulation to complete product development this the year.

The company plans to produce the Covid-19 drug at its Cheongju plant in North Chugncheong Province after going through the procedures for commercialization, such as bioactivity tests and approvals.

The company's Cheongju plant, which will produce the product, has won the U.S. Food and Drug Administration (FDA) current good manufacturing practice (cGMP) and EU GMP certifications for solid drug manufacturing facilities for oral use.

"Through this license acquisition process, we were able to reconfirm that Celltrion Group's chemical drug production capacity and technology met global demand and standards," a company official said. "The agreement is very meaningful as the company has contributed to securing global access to Covid-19 treatment by participating in a global project that supplies oral treatment to the world."

The official further stressed that the manufactured treatments will not be introduced in Korea and that the MPP has not disclosed the supply quotas for 105 low- and middle-income countries.

"Securing supply quotas will have to go through a public and competitive bidding process among the 27 drugmakers that have signed a contract with MPP," the Celltrion official said to Korea Biomedical Review.

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