FiercePharmaAsia—Biogen's, Bayer's rogue employees; Kaletra's COVID-19 trial flop; BioNTech-Fosun deal

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Bayer, Biogen, AbbVie's Kaletra, BioNTech and Fosun Pharma made our news this week. (Google)

A former Biogen employee is under investigation in Beijing for allegedly concealing her COVID-19 symptoms and putting fellow travelers at risk of infection during a flight back to China. Bayer has fired an employee for breaking a 14-day quarantine rule in China after videos of the woman's behavior went viral. A Chinese research team found AbbVie's HIV combo Kaletra offered no benefits over standard care in severe COVID-19 patients. And more.

1. Did a Biogen staffer take her COVID-19 infection on a plane to Beijing?

Chinese authorities are accusing a then-Biogen employee for lying about her health status when entering China. Li, a Chinese citizen and Massachusetts resident, allegedly took antipyretics before boarding a plane to China to hide her coronavirus symptoms. As Beijing police run a criminal investigation, the company said she is “no longer an employee of Biogen.”

2. Bayer fires employee for breaking coronavirus quarantine rule in China

A woman was seen jogging on the street without wearing a mask when she was supposed to be quarantined at home. When confronted by community workers, she started yelling in Chinese, “Help! I’m harassed!” Soon after a video of the encounter went viral in China, Bayer confirmed the woman as its employee and fired her.

3. AbbVie's HIV drug Kaletra stumbles in COVID-19 trial, but one analyst begs to differ

AbbVie’s HIV combo Kaletra (Aluvia) is among a bunch of existing therapies that have shown promise against COVID-19. However, in a 199-patient clinical trial in China, the drug failed to beat standard care at cutting the time to clinical improvement and the 28-day mortality rate. One analyst argues the med might be more helpful in less severe patients, though.

4. With weeks to go to COVID-19 vaccine trial, BioNTech lands $135M deal and advances Pfizer talks

BioNTech has signed on Fosun Pharma for Chinese rights to its coronavirus mRNA vaccine candidate BNT162. The Chinese drugmaker will pay the German biotech up to $135 million in upfront and milestone payments and future investment. Separately, BioNTech has licensed the shot’s ex-China rights to Pfizer.

5. Cipla slammed with FDA warning letter for sterile injectables plant

In a recent Form 483, the FDA slammed a Cipla sterile products plant in India for using non-dedicated equipment to make products for the U.S. market. Inspectors also noted bacillus contamination that they figured may have been caused by dirty disposable socks. Unsatisfied with the company’s remedies, the agency has issued a warning letter.

6. China's CanSino pushes coronavirus vaccine into clinical testing as Moderna kicks off trial

China’s CanSino Bio and its collaborators at the Academy of Military Medical Sciences’ Institute of Biotechnology have won Chinese go-ahead to start human testing of their recombinant coronavirus vaccine. The candidate, dubbed Ad5-nCoV, is based on the same technology used in the company’s China-approved Ebola vaccine.

7. Alibaba co-founder Jack Ma to ship 500K COVID-19 test kits to U.S.

Chinese billionaire and Alibaba co-founder Jack Ma said he would donate 500,000 test kits and 1 million face masks to assist the U.S. response to the coronavirus outbreak. “Drawing from my own country’s experience, speedy and accurate testing and adequate personal protective equipment for medical professionals are most effective in preventing the spread of the virus,” Ma wrote on Twitter.

8. I-Mab plans U.S. testing of antibody drug for inflammatory response in COVID-19 (release)

Chinese biotech I-Mab said it plans to start clinical trials of TJM2 (TJ003234) to treat cytokine storm associated with severe COVID-19. The drug is a neutralizing antibody against GM-CSF, a cytokine driving inflammatory response. Researchers at the University of Science and Technology of China reportedly found GM-CSF and IL-6 contribute to immune overreaction seen in COVID-19. IL-6 inhibitors—Roche’s Actemra, and Sanofi and Regeneron’s Kevzara—are being pushed into clinical trials for the disease.

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