China's biotech sector comes of age with big licensing deals, global ambitions

 If investors in China's biotech industry needed one more sign that the sector is coming of age, then a major licensing deal RemeGen Co Ltd struck last month with Seattle-based Seagen Inc fits the bill. 

The agreement to co-develop cancer treatments using a RemeGen antibody drug conjugate is regarded as one of the biggest of its kind between a Chinese biotech and a Western firm. It provides for up to $2.4 billion in milestone payments, in addition to $200 million upfront as well as royalties if approved.

It is also at least the fifth out-licensing deal potentially worth more than $1 billion clinched by a Chinese biotech. Nearly all were signed in the past year, underscoring China's still small but growing role in developing innovative cancer drugs that will be used worldwide.

"China is clearly already an important and integral part of the global biopharma industry, not a separate ecosystem," said Franck Le Deu, senior partner at consultancy McKinsey in Hong Kong.

China's government has made cancer treatments a top priority for the industry. The world's most populous nation last year accounted for 30 per cent of cancer deaths globally and 24 per cent of newly diagnosed cases, according to one study. Supportive policies for the sector over the past five years are also now bearing fruit and Western firms have come knocking at Chinese biotech doors.

For Seagen, the RemeGen deal will allow it to directly challenge breast cancer treatments from Roche Holding and AstraZeneca/Daiichi Sankyo. The antibody also shows promise in tackling bladder and stomach tumours.

Other notable deals include a Novartis AG agreement worth up to $2.2 billion for a BeiGene Ltd drug. The two are co-developing an antibody similar to Keytruda from Merck and Opdivo from Bristol-Myers Squibb which help the immune system attack several different types of cancer and which have reaped billions of dollars in sales.

AbbVie has also partnered with I-Mab to co-develop a monoclonal antibody for several types of cancer in a deal worth up to $1.9 billion.

Chinese biotechs have proliferated in a relatively short amount of time - a key catalyst being the return of overseas-trained Chinese scientists, dubbed "sea turtles", that began a decade ago and who have become increasingly attracted by domestic opportunities as the government pushes to develop the industry.

More recently, China in 2017 and 2018 aligned regulatory standards with international norms, rapidly speeding up the review system for new drugs. The sector also has seen a surge in funding after Hong Kong's stock exchange changed its rules in 2018 to allow listings of biotechs that have yet to earn revenue.

Success in the West is still fledgling - just three drugs developed in China which include BeiGene's Brukinsa for a type of non-Hodgkin's lymphoma - have been approved by the US FDA.

Investors are also concerned about frothy valuations and it remains unclear how many firms will succeed due to the lengthy process of drug discovery and the massive costs involved. That said, there appears to be more than enough funding to propel the industry.

"We are looking at a turning point because of the capital supply and the regulatory approval regime," said Simone Song, founding partner of healthcare venture capital fund ORI Capital.

Nineteen Chinese biotechs made their trading debuts last year, mostly in Hong Kong, raising a combined $5.2 billion, up from 13 raising around $2 billion in 2019, Refinitiv data shows. So far this year, 20 have listed, raising $4.6 billion and the Hong Kong bourse has flagged nearly 30 more in the pipeline.

According to McKinsey's Le Deu, the combined market value of Chinese biotechs listed in Hong Kong, on Shanghai's STAR board and on the Nasdaq was some $180 billion as of May, which compares to just $1 billion in 2016.

The number of large out-licensing pacts for Chinese biotechs is only set to grow, industry experts say.

I-Mab, Innovent Biologics, Junshi Biosciences and Legend Biotech are likely candidates for further licensing deals with Western firms, said Morningstar analyst Jay Lee, citing their existing partnerships and pipeline assets.

I-Mab says it is seeking strategic partners to help develop and commercialise its products, while Legend said it is open to collaboration. Junshi and Innovent did not respond to requests for comment.

Legend was in 2017 one of the first Chinese biotechs to win an out-licensing deal with a major Western pharmaceutical firm. Its CAR-T bone marrow cancer drug co-developed with Johnson & Johnson is set to be reviewed by the FDA in November.

Though few in number, the more established Chinese biotechs have even bigger ambitions.

BeiGene, which is 20.5 per cent owned by Amgen Inc and valued at $34 billion, out-licenses some products but built its own US and European sales teams for Brukinsa. It has also announced it will build a new R&D and manufacturing centre in New Jersey.

"We are really trying to brand ourselves as a global company...we just happen to have labs right now in China," said Angus Grant, BeiGene's chief business executive.

Hutchmed, the first Chinese company to have an in-house innovative cancer drug unconditionally approved in China, is not planning to partner in the United States or at home now that it has grown, said Chief Executive Christian Hogg.

"We have got around $1.2 billion in cash on our balance sheets, we have got the capabilities, resources, financial and organisational resources to pretty much do whatever we want to do outside of China," he said.

https://www.thedailystar.net/business/global-economy/news/chinas-biotech-sector-comes-age-2177811

FDA staff say Pfizer COVID-19 boosters improve immunity but may not be needed

 U.S. Food and Drug Administration scientists said on Wednesday that booster doses of Pfizer's COVID-19 vaccine may not be needed, even though the third shot generates a higher immune response in recipients.

The FDA staff members said in a document prepared for outside advisors that it is still unproven that the efficacy of Comirnaty - the COVID-19 vaccine Pfizer developed with Germany's BioNTech SE - is declining.

"Some observational studies have suggested declining efficacy of Comirnaty over time against symptomatic infection or against the Delta variant, while others have not," they said in the document.

However, overall, data indicate that currently U.S.-licensed or authorized COVID-19 vaccines still afford protection against severe COVID-19 disease and death in the United States."

The FDA staff did say the booster dose met pre-specified conditions the regulator had set to show that the shot was generating an immune response.

However, they said in the document that licensure for the boosters should also consider ability to prevent hospitalization and death, as well as the dynamics of the pandemic in the United States.

The agency released the document on Wednesday for consideration by a committee of outside experts who will meet on Friday to decided whether to recommend if U.S regulators should approve the extra round of shots.

The FDA staff view reflects that of many scientists who have questioned whether the boosters are necessary broadly, even as U.S. President Joe Biden has pushed for the additional shots in the face of surging hospitalizations and deaths caused by the highly contagious Delta variant of the coronavirus.

Biden set a Sept. 20 target to begin administering 100 million booster shots in the United States.

After the FDA meets, a panel of advisors to the U.S. Centers for Disease Control and Prevention is planning to meet next week to make its recommendation, according to White House Press Secretary Jen Psaki.

PFIZER ARGUES BOOSTER APPROVAL

Pfizer, in a document it prepared for the meeting, argued that U.S. regulators should approve a booster shot of its vaccine for use six months after the second dose due to waning effectiveness over time.

Pfizer said data from its own clinical trials showed that the vaccine's efficacy diminished by around 6% every two months after the second dose. It also said the incidence of breakthrough COVID-19 cases in that trial was higher among people who received their shots earlier.

The company also pointed to real world data from Israel and the United States showing declining effectiveness of the Pfizer/BioNTech vaccine.

The U.S drugmaker said in a roughly 300-participant clinical trial, the third dose generated a better immune response than the second. It also pointed to data from the booster program recently started in Israel to show that a third dose restores high levels of protection from the virus.

Earlier this week, two top FDA vaccine scientists were among the authors of an article saying they do not believe the current data supports giving the shots. One of those scientists - Marion Gruber, director of the FDA's Office of Vaccines Research and Review - will be speaking at Friday's meeting.

Some U.S. officials are hoping boosters might prevent mild cases and reduce transmission of the virus as well as reducing COVID-19 hospitalizations and deaths, which could hasten America's recovery.

Some countries have already begun COVID-19 booster campaigns. The United States authorized extra shots for people with vulnerable immune systems last month.

https://www.ctvnews.ca/health/coronavirus/u-s-fda-staff-say-pfizer-covid-19-boosters-improve-immunity-but-may-not-be-needed-1.5586380

Italy makes COVID-19 health pass mandatory for all workers

 The Italian government approved on Thursday some of the strictest anti-COVID-19 measures in the world, making it obligatory for all workers either to show proof of vaccination, a negative test or recent recovery from infection.

The new rules will come into force on Oct. 15 in the latest effort by Prime Minister Mario Draghi's broad coalition to persuade people to get inoculated and blunt contagion in one of the countries worst-hit by the virus.

Any worker who fails to present a valid health certificate will be suspended on no pay, but cannot be sacked, ministers told reporters after the cabinet approved the measures.

People who ignore the decree and go to work regardless will face a fine of between 600 to 1,500 euros (US$705-$1,175). The sanction for employers will be 400-1000 euros.

"Nothing like this has been done in Europe ... we are putting ourselves in the forefront internationally," said Public Administration Minister Renato Brunetta.

He added that the government expected an "enormous" acceleration of jabs simply by the announcement of the decree, so that much of its desired effect could be achieved before it actually comes into effect in a month's time.

While some European Union states have ordered their health workers to get vaccines, none have made the so-called "Green Pass" mandatory for all employees, making Italy a test case for the continent.

The pass was originally conceived to ease travel around Europe, but Italy was among a group of countries that swiftly also made it a requirement for those wanting to access venues such as museums, gyms and indoor dining in restaurants.

Draghi, who was not present at Thursday's news conference, had previously faced resistance against his extension of the Green Pass from right-wing leader Matteo Salvini, one of the main stakeholders in his government.

However, Salvini's League party is split on the issue and the cabinet finally approved the decree unanimously.

There have been sporadic protests around the country in recent weeks against the growing pressure to get a jab, but most political parties as well as the main employers' federation have backed the move, hoping it will prevent further lockdowns.

Union leaders have been more lukewarm, saying tests should be given free of charge to workers who refuse to be vaccinated, enabling them to remain on the job.

The government rejected this request, but said the price of tests would be capped at 15 euros for work purposes, significantly below the current cost.

VACCINES WORK

Italy has the second-highest COVID-19 death toll in Europe after Britain, with more than 130,000 people dying of the disease since the pandemic surfaced in early 2020.

Around 74% of its 60-million-strong population have had at least one COVID-19 shot and 68% are fully vaccinated, figures broadly in line with most other EU countries.

Underscoring the importance of jabs, Italy's health foundation Gimbe said in a report on Thursday that almost all COVID-19 sufferers currently in hospital were unvaccinated.

The report said vaccines had helped reduce deaths in Italy by 96.3%, hospitalisations by 93.4% and intensive care admissions by 95.7%.

Italy in March ordered health workers to get vaccinated or face suspension. As of today, 728 doctors have been suspended, the doctors' federation said on Thursday. It was not immediately clear how many nurses or carers had refused to comply.

A similar measure in France came into force on Wednesday. Health Minister Olivier Veran said on Thursday that around 3,000 health workers had been suspended for their failure to get vaccinated.

https://www.ctvnews.ca/health/coronavirus/italy-makes-covid-19-health-pass-mandatory-for-all-workers-1.5587865

FDA revises Lilly's COVID-19 antibody combo EUA to be used after exposure to virus

 The U.S. FDA said on Thursday it has revised its emergency use authorization for Eli Lilly's COVID-19 antibody cocktail to encompass to be used in patients who have been uncovered to the virus and are at excessive possibility for progression to extreme disorder.

The cocktail, bamlanivimab and etesevimab, became licensed in February for use in people 12 years and above with gentle-to-reasonable infection and are at high risk for progression to extreme COVID-19.

youngsters, the FDA observed on Thursday the cocktail isn't an alternative choice to vaccination towards COVID-19. (https://bit.ly/2XqtHln)

The FDA mentioned that bamlanivimab and etesevimab, which might be administered collectively, may be also used as put up-publicity prevention for patients who are not totally vaccinated or who aren't anticipated to mount an ample immune response to complete vaccination or have been exposed to an individual contaminated with the virus.

The revision comes a day after the U.S. govt bought 388,000 extra doses of Lilly's COVID-19 antibody therapy.

https://frontline-news.blogspot.com/2021/09/fda-revises-lillys-covid-19-antibody.html

Moderna says COVID-19 vaccine protection wanes, makes case for booster

 New data from Moderna's large COVID-19 vaccine trial shows that the protection it offers wanes over time, supporting the case for booster doses, the company said in a news release on Wednesday.

"This is only one estimate, but we do believe this means as you look toward the fall and winter, at minimum we expect the estimated impact of waning immunity would be 600,000 additional cases of COVID-19," Moderna President Stephen Hoge said on a conference call with investors.

Hoge did not project how many of the cases would be severe, but said some would require hospitalization.

The data stands in stark contrast with data from several recent studies that suggested Moderna's vaccine protection lasts longer than a similar shot from Pfizer Inc and German partner BioNTech SE.

Experts said the difference is likely due to Moderna's higher dose of messenger RNA (mRNA) and the slightly longer interval between the first and second shots.

Both vaccines proved to be exceedingly effective at preventing illness in their large Phase III studies.

Wednesday's analysis, however, showed higher rates of infection among people vaccinated roughly 13 months ago compared with those vaccinated roughly eight months ago. The study period was from July-August, when Delta was the predominant strain. It has yet to undergo peer review.

Moderna on Sept. 1 submitted its application to the U.S. Food and Drug Administration seeking authorization for a booster shot.

Hoge said data from its booster studies shows the vaccine could increase neutralizing antibodies to levels even higher than were seen after the second dose.

"We believe this will reduce COVID-19 cases," he said. "We also believe that a third dose of mRNA-1273 has a chance of significantly extending immunity throughout much of next year as we attempt to end the pandemic."

Briefing documents from the FDA's analysis of Pfizer's booster application, released earlier on Wednesday, suggest that a key issue the agency will consider is whether vaccine protection is waning.

In its analysis, Moderna compared the vaccine's performance in more than 14,000 volunteers vaccinated between July and October of 2020 with some 11,000 volunteers originally in the placebo group who were offered the shot between December 2020 and March 2021 following its U.S. emergency use authorization.

In the two-month period from July-August, researchers identified 88 COVID-19 cases among those who got the two shots more recently, compared with 162 cases among those vaccinated last year. Overall, only 19 cases were considered severe, a key benchmark in assessing waning protection.

Moderna said there was a trend toward a lower rate of severe cases among the more recently vaccinated, although the finding was not statistically significant.

Data from a separate study presented on Wednesday conducted with Kaiser Permanente Southern California health system, meanwhile, shows that Moderna's vaccine continued to perform well against the Delta variant.

Researchers compared data on more than 352,000 people who got two doses of the Moderna vaccine with the same number of unvaccinated individuals and found the Moderna vaccine was 87% effective at preventing a COVID-19 diagnosis, and 96% effective at preventing hospitalization.

Hoge said the vaccine's initial performance is strong, but argued that protection shouldn't be allowed to wane.

"The first six months are great, but you can't count on that being stable out to a year and beyond," he said.

https://www.ctvnews.ca/health/coronavirus/moderna-says-covid-19-vaccine-protection-wanes-makes-case-for-booster-1.5588050

Unum Vaccine Verification Tool for Companies to Manage Federal Mandate

 Insurer Unum Group said on Thursday it will launch a new digital product to help companies verify vaccination status of employees, days after the Biden administration mandated large employers should have their workers inoculated against COVID-19.

Unum will provide a self-service portal for employees to report vaccination status and upload documentation. The portal will also manage test result documentation for employees who are not vaccinated, sending weekly reminders and employer notification.

The new product, which is called Unum Vaccine Verifier, will also help companies manage employee vaccine exemptions, including medical and non-medical exemption requests.

Last week, President Joe Biden announced policies requiring most federal employees to get COVID-19 vaccinations and pushing large employers to have their workers inoculated or tested weekly.

Unum, which has decades of experience in handling sensitive medical records and navigating regulatory details, also manages employee leaves and several other HR technology solutions.

https://www.usnews.com/news/technology/articles/2021-09-16/unum-to-launch-vaccine-verification-tool-for-companies-to-manage-federal-mandate

Brazil official wants halt to teen COVID shots after death; health agency says no evidence for move

 Brazil's federal government wants to halt COVID-19 vaccinations for most adolescents, citing a death under investigation and adverse events after some 3.5 million teens have already been immunized, but several state governments vowed to press on.

https://www.reuters.com/world/americas/brazil-seeks-halt-teen-vaccines-some-state-governors-resist-2021-09-16/