Coronavirus casts shadow on pharma approvals for China market

As Chinese authorities’ priorities shift to containing the novel coronavirus, concerns are rising that launch dates for drugs pending approval for the Chinese market may be postponed, according to industry sources on Sunday.

No official announcement has been made by the Chinese drug authority National Medical Products Administration, but Korean pharma insiders widely believe all drug approvals may be pushed back.

GC Pharma, Hanmi Pharmaceutical and Il Yang Pharmaceutical all have pending drugs.

GC Pharma has two rare disease treatments, Hunterase and GreenGene F, which it assumed would gain approval to begin sales in China by end-2020 or early 2021.

Hunterase is a Hunter’s syndrome treatment proposed as the only drug to treat the condition in China, and GreenGene F is a plasma-derived Hemophilia A treatment whose specific treatment type takes up 35.5 percent of the market for the illness.

Hunter’s syndrome occurs in 1 in 100,000 boys, meaning there may be at least 3,000 children in China suffering from the rare genetic disorder, a GC Pharma official said.

“Postponement is nothing that should worry company management, but the delayed drug access for patients in need of the drugs is unfortunate,” a pharma company official said.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)