Hanmi Pharmaceutical has come up as one of the possible candidates to sign a deal with Moderna to produce Covid-19 DNA vaccines for the domestic market.

Industry watchers are paying attention to whether Hanmi will seize the opportunity to run its Bio Plant sufficiently as a contract manufacturing organization (CMO).

Hanmi is mentioned as a possible candidate because of its large-scale Bio Plant Complex in Pyeongtaek, Gyeonggi Province. Established in 2018, the second plant can produce 100 million doses of DNA vaccines annually or 1 billion doses of RNA vaccines annually, based on microbial fermentation.

In 2016, Hanmi began building the second factory as part of a licensing-out deal with Sanofi for “Quantum Project.” Hanmi was to supply biologic agents needed for global trials and approval of investigational antidiabetic drugs.

In November 2015, Hanmi licensed out three diabetes pipelines -- efpeglenatide, long-acting insulin, and a combo of efpeglenatide and long-acting insulin -- to Sanofi. The deal was worth 5 trillion won ($4.6 billion).

At the time, Hanmi had anticipated that its second plant would accelerate the commercialization of its investigational biologic medicines.

However, Sanofi returned the two pipelines' rights, including the long-acting insulin, to Hanmi in 2016. In May 2020, Sanofi notified its intention to return the rights of the remaining efpeglenatide.

Hanmi had to drop the Quantum Project, and the two companies completed the return of all rights in September 2020.

The nullified project forced the Bio Plant’s second factory to become nearly dormant.

The Covid-19 pandemic also delayed Hanmi’s chance to keep the second plant vibrant. Hanmi had planned to receive an FDA inspection on the second plant to win U.S. approval for Rolontis, a novel drug for neutropenia. However, the FDA delayed the schedule due to U.S. restrictions on overseas business trips.

Hanmi licensed out Rolontis to Spectrum Pharmaceuticals, a U.S. pharmaceutical firm, in 2012. Spectrum finished the global phase-3 study on Rolontis and applied for FDA approval in October 2019.

However, the FDA’s schedule for the Bio Plant inspection in March 2020 had to be put back twice due to the rapid spread of Covid-19 cases worldwide.

With Covid-19 becoming a pandemic, the FDA could not meet its Hanmi inspection schedule on Oct. 24 last year. The FDA has temporarily delayed the approval schedule for Rolontis, too.

In October, Spectrum Pharmaceuticals said it received the FDA’s notice that the regulator would delay the approval procedure for Rolontis until it finishes the inspection on Hanmi’s plant in Pyeongtaek.

“We are actively working with the FDA to find a way to perform an inspection of Hanmi's Bio Plant swiftly,” the company said.

Industry watchers said a possible CMO deal between Hanmi and Moderna would give Hanmi a chance to raise the Bio Plant's operation rate.

Hanmi said facilities in the Bio Plant Complex are fully ready to win a CMO deal with Moderna.

“We’re discussing the matter, but nothing has been concluded,” an official at Hanmi said. However, if the company inks a deal with Moderna, its plant can produce both drug substances and drug products, he added.