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UK regulator warns these with historical past of serious allergic reactions

Assistant Nurse Katie McIntosh gives Vivien McKay, Clinical Nurse Manager at Western General Hospital, the first of two Pfizer / BioNTech COVID-19 stitches on the first day of the largest vaccination program in UK history in Edinburgh, Scotland, UK December 8 2020.

Andrew Milligan | Reuters

LONDON – People with a history of “significant” allergic reactions should not receive the coronavirus vaccine developed by Pfizer and BioNTech, the UK Medicines Agency said on Wednesday.

The UK drug and health products regulator has updated its guidance to UK health care providers on who should get the vaccine after two members of the UK National Health Service had allergic reactions to the shot. Both are recovering well, according to the NHS national medical director.

“People with a history of significant allergic reaction to a vaccine, drug, or food (such as a history of anaphylactoid reaction or someone recommended to wear an adrenaline auto-injector) should not receive the Pfizer BioNtech vaccine received, “the regulator said.

Stephen Powis, national medical director for the NHS, said such a precaution was “common with new vaccines”.

The UK was the first country to approve and administer the Pfizer BioNTech vaccine. A massive vaccination campaign began on Tuesday that began in hospitals, with health and nursing home workers and those over 80 being vaccinated first.

Dr. June Raine, head of MHRA, told a UK government selection committee on Wednesday that the regulator would maintain “real-time vigilance” of the vaccine after its use.

“Last night we looked at two case reports of allergic reactions,” she said.

“We know from extensive clinical studies that this was not a feature. However, if we need to step up our advice after having this experience in vulnerable populations, the priority groups, we will get that advice on the spot immediately.”

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Kids’s hospitals are pitching in to assist with the flood of grownup Covid-19 sufferers.

With Covid-19 patients on the rise threatening to overwhelm hospitals, U.S. public health officials are reaching for a safety valve the Northeast used in the spring: borrowing beds in children’s hospitals to care for adults.

U.S. hospital stays hit a record high of 104,600, according to the Covid Tracking Project, and the nation set a record for the most deaths in a seven-day period last week.

“When the fall came in and the second spike hit, we’re seeing a lot more of it now,” said Amy Knight, president of the Children’s Hospital Association, a national group that represents more than 200 US facilities.

According to Dr. Peter Jay Hotez, Professor of Pediatrics and Molecular Virology and Microbiology, it is rare in American children’s hospitals to admit adult patients or to relax their admission criteria. The fact that this is happening now speaks to the severity of the crisis at Baylor College of Medicine and co-director of Texas Children’s Hospital Center for Vaccine Development.

“I don’t even know if this happened during the first half of 2009, so I can’t think of too many modern precedents,” he said.

Since coronavirus infections appear to largely spare younger children compared to teenagers and adults, children’s hospitals and the children’s wards of general hospitals tended not to be flooded at the beginning of the pandemic.

“It was more like a trickle of children being hospitalized,” Ms. Knight said.

Since then, however, the number of children who become infected and need hospital care has risen sharply, and children’s hospitals may have less space and resources available if the need for pediatric beds due to influenza increases anyway.

“We are much less able to treat pediatric critical diseases across the country,” said Dr. Brian Cummings, who works in the intensive care unit at MassGeneral Hospital for Children in Boston. “Obviously we are overwhelming the capacity of the adult intensive care unit, and using an even scarcer resource affects all of us who care about children.”

Even so, children’s hospitals are helping with the rise in the coronavirus in a number of ways. The Association of Children’s Hospitals published guidelines in April for several possible approaches, including admitting pediatric patients from general hospitals to free up space in these facilities and increasing their maximum admission age.

St. Louis Children’s Hospital, part of BJC HealthCare, opened its doors to adult patients in November, and another St. Louis children’s hospital, Cardinal Glennon Children’s Hospital, has accepted transfers for adults without Covid-19. Oishei Children’s Hospital in Buffalo said it will temporarily raise the admission limit to admit patients up to 25 years of age.

During the first major surge in the northeast from April to June, the MassGeneral Hospital for Children admitted adult patients to its 14-bed intensive care unit. “When we saw how hospitals were overwhelmed, everyone wanted to do their part,” said Dr. Cummings.

The unit returned to normal in the summer, but with Massachusetts cases picking up again, he said, “We’re definitely worried we’ll have patients again in the next week or two.”

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The doubtless crushing toll of rationing well being care

Presbyterian Healthcare Services’ chief medical officer, Dr. Jason Mitchell told CNBC that doctors “do everything we can” to prevent rationing care when the governor of his state signed an executive order that brought New Mexico one step closer to rationed care – the place where the patient is sake Coronavirus to be treated.

“It’s really important to realize that the goal of introducing a nursing crisis standard is to expand services so we don’t have to ration,” said Mitchell. “Also, we’re going to use places that we don’t normally use, whether it’s tents or clinics, to put up hospital beds. We’re really going to do everything. That’s what we’re going to focus on and try to make everything so that you don’t . ” Come to this point. “

The Albuquerque doctor added that hospitals will bring in doctors and nurses who normally practice in clinics, as well as rotating doctors who normally do not work in intensive care units. The intensive care units in New Mexico reached 103% capacity, the highest in the country. 935 people are being hospitalized with Covid in New Mexico, with hospital admissions more than doubling in the last month, according to the Covid Tracking Project.

Mitchell said a group of doctors, nurses, ethicists, and academics are working on an equitable route to potential ration supplies to ensure that health care providers can provide as many resources as possible to as many people as possible.

“The other important thing is that we all do this together. So every health organization uses the same criteria, the same mechanisms to ensure that equity, to ensure that patients are distributed across the state and that we are providing as much care and savings as that many lives as possible, “Mitchell said in an interview on Tuesday night about” The News with Shepard Smith “.

The United States has exceeded more than 15 million confirmed coronavirus cases. In context, that means roughly one in 22 Americans has tested positive since the pandemic began. This is evident from a CNBC analysis of the Johns Hopkins data. Mitchell told Shepard Smith that while health care professionals are already exhausted, the toll that “not having what you need for every patient” may be oppressive.

Dr. Bruce Becker, associate professor of behavioral medicine and social sciences in the School of Public Health at Brown University, echoed Mitchell’s concerns about the policy of rationing care.

“The individual frontline health worker must execute the policy on a personal level and look a patient or family member in the eye and tell them that they do not meet certain policy criteria,” Becker said. “This shatters a person’s soul, it shatters their heart, piece by piece, and day by day, as they take on the brunt of the pain and suffering of the patient or family that has been condemned by politics not to do so . ” Receive everything that exists. ”

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Some States Balk After C.D.C. Asks for Private Knowledge of These Vaccinated

“This is a new activity for us because we don’t typically report this level of detail to the federal government at this frequency,” Doug Schultz, a spokesman for the Minnesota Department of Health, said in an email. He added, “We will not provide a name, zip code, race, ethnicity or address.”

Tracking vaccinations, including collecting personal information, is not a new practice, and experts say this is especially important with a vaccine that requires two doses. But in the United States, it was a purely state effort. A push two decades ago to develop a federal registry that imploded after an uproar over patient privacy and the use of the data.

“The general philosophy in this country is that states manage public health. Therefore, the concept that we keep track of identified information at the federal level is important,” said Dr. Shaun J. Grannis, professor of medical informatics at Indiana University, who advised the CDC on data collection.

“We are 50 different states with a patchwork of regulations and different perspectives on privacy and security,” added Dr. Grannis added. “And I think people will ask the question: what does the CDC do that we cannot do regionally?”

However, the state registers differ in terms of sophistication and quality. Speaking at Monday’s briefing, Colonel RJ Mikesh of the Army, the information technology director for Operation Warp Speed, said the data collection was part of an “all America approach” to vaccine distribution.

And some experts say that amid a pandemic that has already cost nearly 284,000 lives in the US, privacy must give way to the public good and that vaccinating all Americans is a monumental task that requires federal intervention.

“We’re in a pandemic,” said Dr. Carlos del Rio, an infectious disease expert at Emory University in Atlanta. “Privacy has its role, but it can’t be what drives decision-making when you’re trying to do a monumental task like vaccinating millions of Americans with one vaccine that requires two doses.”

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Shares of Penumbra tank after brief vendor releases important report

Penumbra’s shares were down about 17% Tuesday after short seller Quintessential Capital Management released a critical report on the California-based medical device maker. The stock halted shortly after 2 p.m. ET due to outstanding news.

Quintessential Capital is short in Penumbra, which means they are betting that the stock will fall. The company first began targeting penumbra last month, releasing a report of more than 100 slides claiming, among other things, its JET 7 catheter had been linked to at least 18 deaths and 39 injuries. Quintessential Capital also alleged penumbra misled doctors and investors alike.

In its most recent report, Quintessential Capital claims that an “essential part” of the company’s scientific research was carried out by a fake person named Dr. Antique Bose. “This person is a fake. We have no doubts,” said Gabriel Grego, managing partner of Quintessential Capital, on Tuesday in CNBC’s “mid-term report”.

Quintessential Capital directed its allegations of misconduct to the US Food and Drug Administration and wrote to the regulator on Tuesday to open an investigation. According to records that Grego shared with CNBC, the company has also given the SEC a whistleblower tip.

Penumbra has a market cap of around $ 7 billion as of Tuesday afternoon. At the time of Quintessential Capital’s November report for the company, its market cap was approximately $ 9.4 billion.

In a statement accompanying the Mid-Term Report, Penumbra denied Quintessential Capital’s claims, saying that its “innovative medical devices have helped save the lives of hundreds of thousands of patients suffering from life-threatening diseases since its inception in 2004”.

“This attack by bad QCM short sellers reads like an internet conspiracy written by teenagers. It is impossible to deny the facts because there are no facts,” the company said in an email. “Penumbra is very comfortable finding that none of the claims made in the diatribe of these short sellers are true. The claims are nothing more than a baseless campaign of shameless short sellers willing to risk lives for a quick profit. “

– CNBC’s Lora Kolodny contributed to this report.

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For a Nation on Edge, Antacids Turn into Exhausting to Discover

At first it was toilet paper. Then it was meat.

Now it’s antacids.

People who search for over-the-counter belly pacifiers online or in stores are finding that parts of the country cannot simply buy antacids like tums, pepcid, and the generic version famotidine. A few weeks ago Wegmans Food Markets took the step of restricting buyers to two packets of famotidine products per trip.

During a hoarding pandemic, this can be the most unexpected.

Americans are stressed out. They are concerned about the rising number of coronavirus cases. They care about their work. Distance learning is a nightmare, and grocery shopping is no walk in the park. Not to mention the elections. And now the holidays are coming. The result is that some people are experiencing “pandemic stomach,” acid-generating episodes that increase the demand for over-the-counter and prescription antacids.

And antacids are also popular with people who are new to indigestion or heartburn. People started stocking up on them after preliminary studies suggested that famotidine could relieve symptoms of the coronavirus. Another wave of purchases hit this fall when President Trump was under treatment for coronavirus and White House officials said he was given famotidine along with zinc and vitamin D.

For those in need of relief, the bottlenecks are insane.

When 24-year-old Maia Callahan, a young early education graduate who teaches families and teaches distance learning in Greenfield, Massachusetts, attempted to put her usual order of Pepcid in her online Stop & Shop shopping cart in early September, it said again and again that the product is out of stock.

“I thought, OK, I’m going to place an order through Amazon,” said Ms. Callahan, who has an autoimmune disease and has been taking medication to treat her heartburn since she was 17. “That was the worst. One of the heartburn drugs was three times as expensive as usual. I took Tums for two weeks.”

Doctors said when the quarantines were lifted this spring, they noticed more patients reporting symptoms of heartburn and acid reflux.

“I think part of that is the stress of everything that’s going on in the world,” said Dr. Lauren Bleich, a gastroenterologist in Acton, Massachusetts, about 25 miles northwest of Boston, who said she saw a 25 percent increase in patients reporting heartburn and similar symptoms.

But she also said that the coronavirus, which has uprooted people’s normal lives and forced many to work from home, has led to many “dietary indiscretions” that trigger these symptoms.

“We are more relaxed than before with alcohol, sweets or our comfort food,” said Dr. Pale. “And then there is a lack of activity or movement. Weight gain definitely contributes to heartburn and acid reflux. “

Another perpetrator appeared in early November.

“We had many people with upset stomachs, heartburn and indigestion related to the elections,” she said.

Dr. Atul Maini, the medical director of the Heartburn Center at St. Joseph’s Health in Syracuse, NY, said that while the specialized center did not see an increase in patients, it did see a huge difference between the patients it has treated since the coronavirus quarantines have been lifted.

“The heartburn patients were now very anxious and depressed,” he said. “Something else had changed.”

Companies that make over-the-counter drugs are trying to meet demand.

“We are aware that there may be supply shortages,” said a spokeswoman for GlaxoSmithKline, which manufactures Tums, in an email.

However, for some antacids, the surge in demand may be linked to various preliminary studies suggesting that famotidine, the main ingredient in Pepcid, may reduce symptoms of the coronavirus.

In the spring, some patients with Covid-19 at Northwell Health in the New York City area received intravenous famotidine as part of a clinical trial following reports of use in China. The study was halted in May as patient volumes decreased and no conclusions were drawn. An observational study published earlier this fall by Hartford Hospital in Connecticut found positive results were also seen in coronavirus patients given famotidine.

Of the roughly 900 Hartford Hospital patients treated for coronavirus this spring, 83 were given famotidine at some point during their hospital stay. Those who received famotidine had lower hospital death rates and needed less help breathing a ventilator, the hospital said in its research report.

Still, the medical community is cautious about early results. In late June, the Infectious Diseases Society of America recommended the use of famotidine unless it was done in a clinical trial due to insufficient data.

Even before the preliminary research reports were published, demand for famotidine and Pepcid had risen sharply after the Food and Drug Administration asked companies to stop selling all forms of the heartburn drug Zantac in April and recommended consumers take it over the counter have version known as ranitidine, stop that. Small amounts of a carcinogenic chemical have been found in samples of the drug.

As consumers and doctors switched from Zantac to generic famotidine and pepcid, drug makers struggled to keep up. Some manufacturers reported drug shortages to the FDA earlier this year.

Johnson & Johnson, makers of Pepcid, did not respond to a request for comment. In July, company executives announced that US over-the-counter drug sales rose 30 percent in the second quarter, driven by strong demand for Tylenol, Pepcid, and other adult products.

For those who have taken Pepcid or generic versions of Famotidine, the past few months have been a struggle.

“I got a bottle in February but haven’t had one since,” said Mackenzie Doyle, a 21-year-old student at the University of Nebraska at Lincoln who is taking Pepcid with prescription strength to treat her immune disease. It will also be difficult to find over-the-counter Pepcid this spring, she said. When she visited her parents in Alabama during the spring break, Pepcid was sold out in the four stores she visited.

“When the first round of panic buying went on, it was impossible to find Pepcid,” said Ms. Doyle, who eventually found a generic famotidine at Walgreens and took double the dose to reach her prescription strength.

Ms. Doyle admits she has mixed feelings about the pre-studies on famotidine and coronavirus. While assisting the research, she wonders if the names of the drugs used could be withheld until more became known.

And then there are the just-in-case hoarders.

“They make me a little angry,” said Ms. Doyle. “There are so many people who have my immune disorder and who are worse than me and who need these drugs to stay alive. Having people buy it and keep it in their bathroom cabinet and never open the bottle makes me nervous. “

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Oxford-AstraZeneca vaccine is protected and efficient, researchers

In this September 9, 2020 image, a vaccine marked with a test tube can be seen in front of the AstraZeneca logo.

Given Ruvic | Reuters

LONDON – Developed by UK pharmaceutical company AstraZeneca in partnership with Oxford University, the coronavirus vaccine is the first whose late-stage study results have been independently reviewed and published in a medical journal.

The interim results from the Phase 3 studies with the Oxford-AstraZeneca vaccine were published in the Lancet on Tuesday. Peer review means that articles or studies are reviewed by other experts in the field before they are published and serve as an additional quality control measure on the results.

The study replicated the vaccine study results published a few weeks ago, which showed an average of 70% effectiveness in protecting against the coronavirus.

The two dosage regimens used were also repeated, with the two full doses showing 62% effectiveness and 90% effectiveness shown with the half-full dosage regimen.

This is breaking news. Please try again later.

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The UK Simply Accepted the Pfizer Covid Vaccine. What Occurs Subsequent?

LONDON – The first rigorously tested coronavirus vaccine was given the green light for use in the UK on Wednesday. The vaccine doses of the American pharmaceutical giant Pfizer and a small German company, BioNTech, will be injected from next week, the government said.

When the UK jumped before the United States to allow mass vaccination, it put pressure on American drug regulators, who were called to the White House by President Trump’s chief of staff on Tuesday to explain why they were unwilling to do the same.

The two countries study vaccines differently.

Rather than accepting the vaccine manufacturers’ results, American regulators are carefully re-analyzing the raw data from the studies to validate the results, considering what regulators described as thousands of pages of documents. Dr. Stephen Hahn, the commissioner for the Food and Drug Administration, said Tuesday that the FDA is “one of the few regulators in the world actually looking at the raw data.”

Regulators in the UK and other European countries rely more on in-house analysis. Instead of sifting through the raw study data and figuring out the numbers themselves, regulators often examine a drug manufacturer’s reports and, if there are no anomalies, justify their decisions in company-provided documents.

Whether the UK was rushing to approve a vaccine or whether the US was wasting valuable time as the virus kills around 1,500 Americans a day sparked a lively debate among scientists and industry experts on Wednesday. European regulators said UK approval is so limited that it only applies to certain lots of the vaccine, a claim Pfizer denied and which UK officials failed to address.

Dr. Paul Offit, a professor at the University of Pennsylvania and a member of the FDA’s Vaccine Advisory Council, said in an interview Wednesday that regulators’ success in getting vaccines approved while minimizing unforeseen errors justifies a rigorous approach.

“It is remarkable that we were able to access viruses with so few casualties,” he said, adding that American regulators were only days away from completing their own review.

The FDA has scheduled a meeting of an independent panel of experts on December 10th to review Pfizer’s vaccine. UK regulators also seek opinions from a technical committee, but this group has the flexibility to review and meet data as needed so that it can be implemented more quickly.

“In the UK, they could just say, ‘We have the data, we have the meeting,” said Stephen Evans, Professor of Pharmacoepidemiology at the London School of Hygiene & Tropical Medicine.

To speed up the process, the UK Medicines and Health Products regulator had their experts review vaccine dates as soon as they were available, and separate teams worked in parallel on different parts of the process rather than waiting for another to complete.

“If you are climbing a mountain, prepare,” said Dr. June Raine, executive director of the agency, on Wednesday. “We started this in June.”

When the first results came in on November 10, she said, “We were in base camp.” And later she said, “When we got the final analysis, we were ready for the final sprint.”

The UK has left the European Union’s regulatory orbit to get early approval for a vaccine as the bloc gives countries emergency powers in the event of a pandemic. Once the UK separates from the European Union on December 31, those vaccine-only powers will become permanent.

The countries remaining in the European Union are waiting for their regulator, the European Medicines Agency, to approve a vaccine. Like the FDA, the European regulator has scheduled a meeting on December 29th to consult outside experts and provide an opinion on the Pfizer vaccine.

The agency’s task is made more difficult by its obligation to seek the views of all 27 EU countries. This process was sped up during the pandemic, but it will be a few more days for countries to weigh in after the meeting, which will likely delay vaccinations until early January.

Pfizer plans to ship 800,000 cans to the UK in the coming days. As of Tuesday evening, these cans were being prepared for shipment at a factory in Puurs, Belgium, BioNTech said.

The cans are packaged in cardboard boxes, using dry ice to keep them at the south pole-like temperatures they need, before being placed on trucks or planes and taken to the UK. They will arrive at state distribution warehouses over the weekend, Pfizer said on Wednesday.

UK hospitals have already started emailing staff to inform them of vaccination schedules. A London hospital system states that the first doses are given on Monday at 7 a.m. The UK has placed pre-orders for 40 million doses of the Pfizer vaccine, but most of them are expected to be administered over the next year. Each patient needs two, one month apart.

A government advisory council released its list of vaccine priority groups on Wednesday. At the top of the list are residents and workers of nursing homes, followed by people over the age of 80 and health and social care workers.

In practice, however, government officials said Wednesday that they would initially limit vaccinations to a network of 50 hospitals due to the difficulty of storing and shipping the Pfizer vaccine. As a result, nurses, doctors, nursing home staff, and people 80+ who had made appointments would come first for the vaccine before residents of the nursing home.

Pfizer has said the vaccine can survive for five days in a regular refrigerator. However, the UK’s National Health Service has yet to consider issues such as staffing at locations outside the hospital and transportation difficulties within the country to decide how to administer the vaccine.

The National Health Service has around 150,000 doctors and more than 330,000 nurses and midwives.

The British decision will not in itself bring vaccinations any closer. However, Pfizer executives said Wednesday they had heard from other countries that they wanted to speed up their own approval processes in the face of UK approval.

American regulators, despite months of pressure from Mr. Trump, have claimed that they will follow their plan and review Pfizer’s vaccine to FDA standards.

The US has pre-ordered 100 million doses of the Pfizer vaccine. Most of the supply will come from a separate factory in Kalamazoo, Michigan. Still, many questions remain unanswered as to how vaccine manufacturers like Pfizer will fulfill the orders of wealthier nations that have pre-sourced supplies.

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Shares shut 55% increased on market debut

A woman stands next to signage with the JD.com logo and the company’s mascot “Joy” at the company’s headquarters in Beijing, China.

Qilai Shen | Bloomberg | Getty Images

GUANGZHOU, China – JD Health, the health division of Chinese e-commerce giant JD.com, rose on its debut in Hong Kong.

JD Health issued 381.9 million shares at a price of Hong Kong $ 70.58 each. These stocks traded at Hong Kong $ 94.5 at launch. That was 34% more than the offer price.

Shares rebounded during the day, hitting a daily high of $ 123.3 Hong Kong, up nearly 75% from the offer price. The stock closed at $ 110 Hong Kong.

The company said the net proceeds from the IPO were Hong Kong dollars 26.46 billion ($ 3.41 billion).

JD Health’s shares were valued at the high end of the Hong Kong dollar 62.8 to Hong Kong dollar 70.58 marketed to investors, CNBC previously reported.

The investment banks could decide to exercise the so-called over-allotment option, in which 57,285,000 additional shares would be issued. That would result in raising another $ 3.98 billion in Hong Kong through the IPO. The over-allotment must be exercised by December 31st.

Business growth plans

JD Health said 40% of net sales will be used for business expansion over the next 3 to 5 years, 30% will be used for research and development over the next 2 to 3 years, while the remaining money will be spent on potential investments. Acquisitions and General Corporate Purposes.

The company’s business is focused on online health services such as consultations with doctors, as well as the online pharmacy. JD Health posted sales of 8.78 billion yuan ($ 1.34 billion) for the six months ended June 30, compared to 4.99 billion yuan for the same period last year.

Citing a Frost & Sullivan report, the company claimed in its prospectus that it was the top-selling online health platform in China in 2019.

CEO Xin Lijun declined on Tuesday to say whether the company could keep that position. He stressed that the company’s focus is on improving the user experience, which of course would generate revenue.

“The Chinese health and medicine industry is playing like ‘go,'” Xin said, according to a CNBC translation of his Mandarin-language remarks made during a briefing with reporters in Beijing. He was referring to an ancient board game in which two players fight for most of the territory.

China’s healthcare industry is difficult for startups to navigate. The government is heavily involved in medical care and runs mass insurance programs to reimburse patients.

“It’s not a market-based scenario,” Xin said, noting that it limits the areas startups can do and that each line of business has its own challenges. “In theory, of course, our biggest challenge is to educate more customers about JD Health’s services and better integrate online healthcare with offline services.”

Xin said JD Health could invest in offline drug stores and work more with overseas health organizations.

JD Health’s listing is another big win for the Hong Kong Stock Exchange, where big Chinese companies have gone there to raise money. JD Health’s parent company, JD.com, conducted a secondary listing in Hong Kong in June. Another Chinese internet company, NetEase, also made a secondary listing in Hong Kong that month.

China’s tech giants have stepped up their focus on digital health care following the coronavirus outbreak earlier this year. Internet search giant Baidu is in talks with investors to raise up to $ 2 billion for a new biotech company within three years, CNBC reported in September.

JD.com will remain the majority shareholder of JD Health even after the IPO. A number of so-called cornerstone investors have been brought on board, including Hillhouse, Tiger Global, Lake Bleu Prime, the China Structural Reform Fund, Blackrock and Singapore’s sovereign wealth fund GIC.