Welcome to the Reuters.com BETA. Read our Editor's note on how we're helping professionals make smart decisions.
Read more
Sign In
May 13, 20216:37 PM PDTLast Updated 3 months ago
Chinese firm’s COVID-19 drug claims draw skepticism
Gabriel Stargardter

5 minute read
China's flag is reflected in a drop on a syringe needle in this illustration taken November 9, 2020. REUTERS/Dado Ruvic/Illustration
May 14 (Reuters) - Chinese biotech firm Kintor Pharmaceutical Limited (9939.HK) saw its stock price jump by more than 20% the day after it announced on April 25 that it had “completed the first patient enrollment and dosing” in a late-stage U.S. clinical trial of its experimental COVID-19 treatment.
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 on March 1.
But the company had not dosed any patients as of early May, according to the doctor Kintor identified as its principal clinical trial investigator in documents it posted on a U.S. trials website. The doctor - California-based gastroenterologist Zeid Kayali - also told Reuters he was "not in charge" of the trial, contradicting what the company had said in the documents describing the study. Kayali declined further comment, referring questions to Kintor.
Told of Kayali's comments, Kintor Chief Financial Officer Lucy Lu said Kayali was merely one of its trial investigators. She declined further comment on the firm's announcement on patient dosing. Lu declined as well to name a different principal investigator, or the institution overseeing the trial, calling that information "confidential."
Companies are not obliged to release such information. But many pharmaceutical firms routinely provide details about who is leading their clinical trial and which research organization or medical institution is responsible for ensuring patient safety and scientific validity.
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.
Another red flag: Kintor has repeatedly touted a Brazilian study of Proxalutamide that claimed an effectiveness rate so high that Ostroff and other pharmaceutical specialists say it is hard to believe.
The Brazil study said Proxalutamide showed a 92% reduction in mortality risk among hospitalized COVID-19 patients, which Ostroff said would be "breathtakingly extraordinary" if true.
Alexandre Cavalcanti, director of Sao Paulo's HCor Research Institute, called a presentation of the study's findings by its authors "amateur" and said its claimed reduction of mortality risk is too high to be credible in light of a global struggle to find effective COVID-19 treatments.
Kintor stock turned briefly negative in morning trade in Hong Kong, but was trading up more than 4% at 0303 GMT, putting it on course to its third straight session of gains.
Proxalutamide does not have regulatory approvals and is not available for sale. The Brazil study of the drug has not been peer-reviewed or published, but the authors released a short presentation of its results during a March news conference. Kintor promoted their findings.
"Based on the positive results ... we expect Proxalutamide could become an important tool in the global fight against COVID-19," Kintor's Chief Executive Tong Youzhi said in a statement announcing the Brazilian results on March 11.
That same day, Kintor's stock price jumped by nearly 9%.
Lu, Kintor's CFO, did not answer detailed questions from Reuters about the criticisms of the Brazil study and Kintor's claims about its U.S. trial.
One of the study's authors, Brown University dermatology professor Carlos Wambier, dismissed its critics and called its results "very encouraging."
In an April 2 client note, analysts from Beijing-based brokerage China Renaissance cited Kintor's progress reports as evidence of the "potentially wider application of Proxalutamide." They gave the stock a "buy" recommendation and set a target price of HK$50.75. Kintor's stock now trades at about HK$66, having reached a record high HK$82 in late April.
"The stock price is majorly driven by the COVID-19-related clinical progress," said Sam Hu, analyst at CMB International in Hong Kong.
One of the study's authors is a consultant hired by a Brazilian Health Ministry official who is an ally of the country's President Jair Bolsonaro. The president is a vaccine skeptic and a critic of masks and lockdowns who has promoted discredited COVID-19 remedies such hydroxychloroquine. The health official, Helio Angotti, assigned a team of consultants to find evidence to support Bolsonaro's unfounded medical claims, Reuters reported in a related story today.
Angotti declined to comment. Bolsonaro's office did not respond to written questions from Reuters. The consultant who co-authored the Proxalutamide study, Ricardo Zimerman, did not respond to requests for comment.
Lu said Kintor is in talks with Brazilian federal health regulator Anvisa about conducting its own clinical trial. Anvisa said in a statement that Kintor had not filed any formal request to conduct a trial, but did not comment on any talks between the regulator and the company.
Two Anvisa staffers, speaking on condition of anonymity, questioned the results of the Brazilian Proxalutamide study, saying the authors' results presentation contained no detailed data or evidence. One of the Anvisa staffers characterized the presentation as more marketing than science. Brazil's Health Ministry, in a March technical note, concluded that "the available evidence for the drug is still incipient," with limited information on safety and outcomes.
Kintor originally conceived of Proxalutamide as a cancer treatment, before pivoting to COVID-19. Lu told Reuters that the FDA had allowed the firm to progress to a Phase III trial, skipping Phases I and II, after evaluating its previous oncology studies and the Brazil research. She declined to share any documentation from the FDA outlining that permission.
The FDA declined to comment on Kintor or its COVID-19 drug. Ostroff said it was concerning and atypical that Kintor used earlier-stage oncology trials, along with the questionable Brazil study, as shortcuts to a Phase III COVID-19 trial. The company's answers to basic questions about its clinical trial, he added, were evasive.
"Most pharmaceutical companies, especially related to COVID-19, will be quite open about what sorts of trials they're doing," he said.
Reporting Gabriel Stargardter; editing by Michele Gershberg and Brian Thevenot
Our Standards: The Thomson Reuters Trust Principles.
More from Reuters
Play video on original page
Read Next
Gymnastics-Japan crowns new 'King' as Hashimoto wins all-around
8:08 AM PDT
United States
U.S. congressmen reach back into Cold War armory to respond to China
8:10 AM PDT
Healthcare & Pharmaceuticals
Factbox: Latest on the worldwide spread of the coronavirus
8:08 AM PDT
Weightlifting-China's Shi breaks world record to win gold in 73kg category
7:59 AM PDT

Sign up for our newsletter
Subscribe for our daily curated newsletter to receive the latest exclusive Reuters coverage delivered to your inbox.
China · 12:26 AM PDT
Analysis: No gain without pain: Why China's reform push must hurt investors
Carnage in China's financial markets signals the beginning of a new era, investors say, as the government puts socialism before shareholders and regulatory changes rip apart the old playbook.
China starts blocking paid after-school tutoring by public-school teachers
2:57 AM PDT
China state-owned daily urges calm after market rout
1:52 AM PDT
China urges insurers to increase offerings for natural disaster coverage
2:32 AM PDT
U.S. congressmen reach back into Cold War armory to respond to China
8:10 AM PDT
About Reuters
About Reuters
Reuters News Agency
Brand Attribution Guidelines
Reuters Leadership
Reuters Fact Check
Reuters Diversity Report
Stay Informed
Download the App
Information you can trust
Reuters, the news and media division of Thomson Reuters, is the world’s largest multimedia news provider, reaching billions of people worldwide every day. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers.
Follow Us
Thomson Reuters Products
Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology.
The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs.
The industry leader for online information for tax, accounting and finance professionals.
Refinitiv Products
Information, analytics and exclusive news on financial markets - delivered in an intuitive desktop and mobile interface.
Refinitiv Data Platform
Access to real-time, reference, and non-real time data in the cloud to power your enterprise.
Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks.
Advertise With Us
Advertising Guidelines
Terms of Use
Site Feedback

All quotes delayed a minimum of 15 minutes. See here for a complete list of exchanges and delays.
© 2021 Reuters. All rights reserved