China's Kintor Pharmaceutical Limited is in the news after announcing a groundbreaking cure for Covid-19 pandemic. The biotech firm said in April that it completed the first patient enrollment and dosing in US clinical trial.
The Hong Kong-listed company's stock has so far soared more than 20 percent on the news. Kintor's market capitalization jumped from $3 billion (HK$23.4 billion) from $850 million as on March 1. But questions remain over the finer details of the drug, which has been named Proxalutamide.
It was the company's latest announcement about the progress of the drug, Proxalutamide. The Hong Kong-listed company's stock price has nearly quadrupled since March 1 as some analysts wrote about the big sales potential for a COVID-19 treatment. Kintor has seen its market capitalization soar to HK$23.4 billion ($3 billion) from HK$6.6 billion ($850 million) on March 1.
Treatment Has Not Started Anywhere
Despite the groundbreaking announcement, the company has not dosed any patients at all as of early May, Reuters has reported.
Chief Clinical Trial Investigator No Longer in Charge
California-based gastroenterologist Zeid Kayali, who had been in charge of the clinical trial of the drug, has said he is not in charge of the process any more. He contradicts the company, on this, and directed more questions to Kintor. Interestingly, the company has not named a new principal investigator who replaced him.
Kintor's lack of transparency, along with inconsistencies in the company's statements, raise a "red flag" about the company's claims, said Stephen Ostroff, a former U.S. Food and Drug Administration (FDA) chief scientist and two-time acting FDA commissioner.
Hard to Believe Claims
According to Kintor, a Brazilian study had shown that its Covid-19 drug had led to 92 percent reduction in mortality risk. This is too good to believe. If it's true then it is baffling that the drug has not been rolled out as thousands of patients are dying across the world every day.
No Regulatory Approval
The Reuters report points out that Proxalutamide does not have any regulatory approvals so far. Moreover, the Brazil trial results of the medicine has not been peer-reviewed either. The findings are not published anywhere.
No Information on When the Drug Will be on Sale
Kintor had sounded sanguine about rolling out the drug in March. But it is not yet on sale and there is no clear information on when it will be. "Based on the positive results ... we expect Proxalutamide could become an important tool in the global fight against COVID-19," Kintor Chief Executive Tong Youzhi had said in March.
Dubious Links with Brazil
A key figure related to the study was allegedly handpicked by Brazilian Health Ministry official who is an ally of President Jair Bolsonaro. The report points out that links to the administration of Bolsonaro, who is a vaccine skeptic who unduly promoted discredited drugs like hydroxychloroquine, makes the Chinese claim fragile.
Brazil Regulator Questions Study
Officials with Brazilian federal health regulator Anvisa themselves have questioned the trial findings on Proxalutamide. They have gone on record saying that Kintor did not file any formal request to the regulatory body for conducting clinical trial.
Originally Made for Cancer Treatment
Proxalutamide was originally made as a cancer drug. Kintor claims that FDA had allowed it to progress to a Phase III trial but has not provided any documents from the FDA.
