The lockdown of Shanghai prompted by Covid-19 has entered the third week, and it is likely to disrupt Korean pharmaceutical and biotech firms’ clinical trials there, observers said.
According to ClinicalTrials.gov, a U.S. clinical trial registry site, SK Biopharm and HanAll Biopharma were conducting trials in Shanghai directly or through a partner company as of Wednesday.
SK Life Science, a U.S. subsidiary of SK Biopharm, is testing cenobamate (U.S. brand: Xcopri), an epilepsy drug, to treat people aged 18 or more with partial-onset seizures in phase 3 NCT04557085 study.
The trial is part of a multinational study in Korea, China, and Japan to market cenobamate in Asia. The study in China takes place at Huashan Hospital of Fudan University in Shanghai.
SK Biopharm said it completed patient enrollment. However, it is expected to be difficult for patients to visit the clinical center regularly in Shanghai.
Regarding concerns over a possible delay of the trial due to the lockdown of Shanghai, SK Biopharm declined to comment.
HanAll Biopharma is conducting trials through its Chinese partner, Harbour BioMed, which licensed in HL161, an autoimmune disease treatment candidate. The studies will be done at many medical institutions, including Shanghai Ninth People's Hospital and Shanghai Jiaotong University School of Medicine, targeting various indications.
Harbour BioMed named the treatment candidate HBM6161.
On Monday, the company registered the phase 3 trial to evaluate subcutaneous injection in patients with severe muscle weakness at clinical trial sites, including Huashan Hospital of Fudan University in Shanghai.
As the Covid-10 pandemic kept delaying and impeding clinical trials, introducing decentralized clinical trials (DCTs), a new type of clinical study, will accelerate, industry officials said.
According to a report by the Korea National Enterprise for Clinical Trials (KoNECT) on Monday, challenges for clinical trials still exist even after the pandemic. They include a shortage of clinical trial experts, a delay in funding and the regulatory review process, and the possibility of the emergence of a new, fatal Covid-19 variant.
“To help clinical trial conductors to adapt to external conditions such as a city lockdown, we will keep introducing new trial methods such as DCTs,” KoNECT said.