Chinese regulators focus on homegrown COVID-19 therapies to tackle new variants, says GlobalData

New Delhi: The National Medical Products Administration (NMPA) of China has conditionally approved two homegrown oral drugs Simcere Pharmaceutical’s Xiannuoxin and Shanghai Junshi Biosciences’ Mindevir for the treatment of mild to moderate COVID-19. Drug regulators in China are focusing on approving homegrown antiviral therapies with the ability to tackle new COVID-19 variants, says GlobalData, a leading data and analytics company.

According to GlobalData’s Pharma Intelligence Center, there are currently 16 COVID-19 drugs in clinical development in China, five of which are in Phase III. Most of these drugs in the Phase III stage are targeting various subtypes of COVID-19 omicron variants.

Anupama Mishra, Pharma Analyst at GlobalData, comments: “There are very limited antiviral drugs, such as Pfizer’s paxlovid and Genuine Biotech’s azuvidine, marketed in China. Hence, there is a need to increase the number of approved therapies.”

Currently, seven homegrown Chinese drugs have been granted either official or conditional approval for treating COVID-19. To increase market access, Chinese regulators have now added all homegrown drugs to the national medical reimbursement list, including Xiannuoxin (ritonavir and simnotrelvir) and Mindevir (remdesivir).

Xiannuoxin is a small molecule oral therapy targeting the 3C-like protease, a key enzyme in the replication and life cycle of COVID-19. Notably, Xiannuoxin’s pivotal Phase II/III clinical trial is the first in the world to investigate Chinese patients infected with the COVID-19 omicron variant. The study is ongoing and trial data is not currently available.

Furthermore, VV116 is a new oral nucleoside analogue antiviral drug, which, in a Phase III trial, demonstrated non-inferiority to paxlovid with respect to the time to sustained clinical recovery, with fewer safety concerns. These newly approved drugs will provide stiff competition to the existing antiviral COVID-19 drugs marketed in China.

According to GlobalData COVID-19 dashboard, as of 14 February 2023, China has 4,903,517 confirmed cases and 101,016 deaths due to COVID-19. The cases peaked in December 2022, after the abandonment of the Zero-COVID policy.

Mishra concludes: “It is important for Chinese pharmaceutical companies to increase market access by launching mass production and distribution of COVID-19 therapies at affordable consumer prices. Further approval of effective COVID-19 therapies will strengthen the healthcare infrastructure by increasing clinical recovery and thereby reducing hospitalizations.”