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World

China’s ‘great migration’ kicks-off under shadow of COVID

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SHANGHAI, Jan 7 (Reuters) – China on Saturday marked the first day of “chun yun”, the 40-day period of Lunar New Year travel known pre-pandemic as the world’s largest annual migration of people, bracing for a huge increase in travellers and the spread of COVID-19 infections.

This Lunar New Year public holiday, which officially runs from Jan. 21, will be the first since 2020 without domestic travel restrictions.

Over the last month China has seen the dramatic dismantling of its “zero-COVID” regime following historic protests against a policy that included frequent testing, restricted movement, mass lockdowns and heavy damage to the world’s No.2 economy.

Investors are hoping that the reopening will eventually reinvigorate a $17-trillion economy suffering its lowest growth in nearly half a century.

But the abrupt changes have exposed many of China’s 1.4 billion population to the virus for the first time, triggering a wave of infections that is overwhelming some hospitals, emptying pharmacy shelves of medicines and causing long lines to form at crematoriums.

The Ministry of Transport said on Friday that it expects more than 2 billion passengers to take trips over the next 40 days, an increase of 99.5% year-on-year and reaching 70.3% of trip numbers in 2019.

There was mixed reaction online to that news, with some comments hailing the freedom to return to hometowns and celebrate the Lunar New Year with family for the first time in years.

Many others, however, said they would not travel this year, with worry of infecting elderly relatives a common theme.

“I dare not go back to my hometown, for fear of bringing the poison back,” said one such comment on the Twitter-like Weibo.

There are widespread concerns that the great migration of workers in cities to their hometowns will cause a surge in infections in smaller towns and rural areas that are less well-equipped with ICU beds and ventilators to deal with them.

Authorities say they are boosting grassroots medical services, opening more rural fever clinics and instituting a “green channel” for high risk patients, especially elderly people with underlying health conditions, to be transferred from villages directly to higher level hospitals.

“China’s rural areas are wide, the population is large, and the per capita medical resources are relatively insufficient,” National Health Commission spokesman Mi Feng said on Saturday.

“It’s necessary to provide convenient services, accelerate vaccination for the elderly in rural areas and the construction of grassroots lines of defense.”

INFECTION PEAK REACHED

Some analysts are now saying the current wave of infections may have already peaked.

Ernan Cui, an analyst at Gavekal Dragonomics in Beijing, cited several online surveys as indicating that rural areas were already more widely exposed to COVID infections than initially thought, with an infection peak already reached in most regions, noting there was “not much difference between urban and rural areas.”

On Sunday China will reopen its border with Hong Kong and will also end a requirement for travellers coming from abroad to quarantine. That effectively opens the door for many Chinese to travel abroad for the first time since borders slammed shut nearly three years ago, without fear of having to quarantine on their return.

Jillian Xin, who has three children and who lives in Hong Kong, said she was “incredibly excited” about the border opening, especially as it means seeing family in Beijing more easily.

“For us, the border opening means my kids can finally meet their grandparents for the first time since the pandemic began,” she said. “Two of our children have never been able to see their grandpa, so we cannot wait for them to meet.”

China’s surge in cases has caused concern internationally and more than a dozen countries are now demanding COVID tests from travellers from China. The World Health Organisation said on Wednesday that China’s COVID data underrepresents the number of hospitalisations and deaths from the disease.

Chinese officials and state media have defended the handling of the outbreak, playing down the severity of the surge and denouncing foreign travel requirements for its residents.

On Saturday in Hong Kong, people who had made appointments had to queue for about 90 minutes at a centre for PCR tests needed for travel to countries including mainland China.

TREATMENT TO THE FORE

For much of the pandemic, China poured resources into a vast PCR testing program to track and trace COVID-19 cases, but the focus is now shifting to vaccines and treatment.

In Shanghai, for example, the city government on Friday announced an end to free PCR tests for residents from Jan. 8.

A circular published by four government ministries Saturday signalled a reallocation of financial resources to treatment, outlining a plan for public finances to subsidise 60% of treatment costs until March 31.

Meanwhile, sources told Reuters that China is in talks with Pfizer Inc (PFE.N) to secure a licence that will allow domestic drugmakers to manufacture and distribute a generic version of the U.S. firm’s COVID antiviral drug Paxlovid in China.

Many Chinese have been attempting to buy the drug abroad and have it shipped to China.

On the vaccine front, China’s CanSino Biologics Inc (6185.HK) announced it has begun trial production for its COVID mRNA booster vaccine, known as CS-2034.

China has relied on nine domestically-developed vaccines approved for use, including inactivated vaccines, but none have been adapted to target the highly-transmissible Omicron variant and its offshoots currently in circulation.

The overall vaccination rate in the country is above 90%, but the rate for adults who have had booster shots drops to 57.9%, and to 42.3% for people aged 80 and older, according to government data released last month.

China reported three new COVID deaths in the mainland for Friday, bringing its official virus death toll since the pandemic began to 5,267, one of the lowest in the world.

International health experts believe Beijing’s narrow definition of COVID deaths does not reflect a true toll, and some predict more than a million deaths this year.

Reporting by Casey Hall in Shanghai, Julie Zhu in Hong Kong and Kevin Huang
Additional reporting by Jindong Zhang
Editing by Tony Munroe and Frances Kerry

Our Standards: The Thomson Reuters Trust Principles.

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Business

Eisai, Biogen receives U.S. FDA approval for Alzheimer’s drug, applies for full approval

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Jan 7 (Reuters) – The U.S. Food and Drug Administration on Friday approved the Alzheimer’s drug lecanemab developed by Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) for patients in the earliest stages of the mind-wasting disease.

Eisai and Biogen said on Saturday the Japanese drugmaker had applied for full FDA approval of the drug.

The drug, to be sold under the brand Leqembi, belongs to a class of treatments that aims to slow the advance of the neurodegenerative disease by removing sticky clumps of the toxic protein beta amyloid from the brain.

Nearly all previous experimental drugs using the same approach had failed.

“Today’s news is incredibly important,” said Dr. Howard Fillit, chief science officer of the Alzheimer’s Drug Discovery Foundation. “Our years of research into what is arguably the most complex disease humans face is paying off and it gives us hope that we can make Alzheimer’s not just treatable, but preventable.”

Eisai said the drug would launch at an annual price of $26,500. Biogen shares, which had been halted, were up 3% at $279.40.

The Japanese company said it also plans to apply for marketing authorization for Leqembi in Japan and the European Union by the end of its business year on March 31.

Eisai estimated the number of U.S. patients eligible for the drug would reach around 100,000 within three years, increasing gradually from there over the medium to long term.

Dr. Erik Musiek, A Washington University neurologist at Barnes-Jewish Hospital, said he was “pleasantly surprised” by the drug’s price.

“Considering the marketplace and the fact that we have no other good disease-modifying treatments, I think it’s in the ballpark of what I would expect,” he said.

Initial patient access will be limited by a number of factors including reimbursement restrictions by Medicare, the U.S. government insurance program for Americans aged 65 and older who represent some 90% of individuals likely to be eligible for Leqembi.

“Without Centers for Medicare & Medicaid Services (CMS) and insurance coverage … access for those who could benefit from the newly-approved treatment will only be available to those who can pay out-of-pocket,” the Alzheimer’s Association said in a statement.

Leqembi was approved under the FDA’s accelerated review process, an expedited pathway that speeds access to a drug based on its impact on underlying disease-related biomarkers believed to predict a clinical benefit.

“This treatment option is the latest therapy to target and affect the underlying disease process of Alzheimer’s instead of only treating the symptoms of the disease,” FDA neuroscience official Billy Dunn said in a statement.

CMS said on Friday that current coverage restrictions for drugs approved under the accelerated pathway could be reconsidered based on its ongoing review of available information.

If the drug receives traditional FDA approval, CMS said it would provide broader coverage. Eisai officials have said the company plans to submit data from a recent successful clinical trial in 1,800 patients as the basis for a full standard review of Leqembi.

The CMS decision was largely in response to a previous Alzheimer’s treatment from Eisai and Biogen. Aducanumab, sold under the brand name Aduhelm, won accelerated approval in 2021 with little evidence that the drug slowed cognitive decline and despite objections by the FDA’s outside experts.

Biogen initially priced Aduhelm at $56,000 per year before cutting the price in half. With limited acceptance and insurance coverage, sales were only $4.5 million in the first nine months of 2022.

Lecanemab is intended for patients with mild cognitive impairment or early Alzheimer’s dementia, a population that doctors believe represents a small segment of the estimated 6 million Americans currently living with the memory-robbing illness.

To receive the treatment, patients will need to undergo testing to show they have amyloid deposits in their brain – either through brain imaging or a spinal tap. They will also need to undergo periodic MRI scans to monitor for brain swelling, a potentially serious side effect associated with this type of drug.

The medicine’s label says doctors should exercise caution if lecanemab patients are given blood clot preventers. This could be a safety risk, according to an autopsy analysis published this week of a lecanemab patient who had a stroke and later died.

In the large trial of lecanemab, which is given by infusion, the drug slowed the rate of cognitive decline in patients with early Alzheimer’s by 27% compared to a placebo. Nearly 13% of patients treated with Leqembi in the trial had brain swelling.

Dr. Babak Tousi, a neuro-geriatrician at the Cleveland Clinic, said the approval will make a “big difference” in the field because it is based on biomarkers rather than just symptoms.

“It’s going to change how we make a diagnosis for Alzheimer’s disease, with more accuracy,” he said.

Tousi acknowledged that the benefit of the drug will likely be modest. “Still, it is a benefit that we were not able to achieve” before this approval.

Reporting by Deena Beasley in Los Angeles and Bhanvi Satija in Bengaluru, additional reporting Jaiveer Shekhawat; Editing by Bill Berkrot, David Gregorio and William Mallard

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Business

Congressional report: U.S. FDA broke own protocols in approving Biogen Alzheimer’s drug

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WASHINGTON, Dec 29 (Reuters) – The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s (BIIB.O) Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.

The FDA’s interactions with Biogen were “atypical” and did not follow the agency’s documentation protocol, according to a staff report on the findings of an 18-month investigation conducted by two House of Representatives committees into the drug’s regulatory review, approval, pricing, and marketing.

The FDA approved Aduhelm in June 2021 under an accelerated approval pathway over the objections of its panel of outside advisers, who did not believe data definitively proved the drug’s benefit to patients.

It was authorized based on evidence that it could reduce brain plaques, a likely contributor to Alzheimer’s, rather than proof that it slowed progression of the lethal mind-wasting disease.

The Medicare program restricted its coverage, which has led to severely limited use of the Biogen drug.

Biogen set an “unjustifiably high” price by initially setting Aduhelm’s price at $56,000 per year despite a lack of demonstrated clinical benefit in a broad patient population, the report said, adding that the company’s own internal projections showed it expected the drug to be a burden to Medicare and costly to patients.

“The findings in this report raise serious concerns about FDA’s lapses in protocol and Biogen’s disregard of efficacy and access in the approval process for Aduhelm,” the report, prepared by the staffs of the House Committee on Oversight and Reform and House Committee on Energy and Commerce, concluded.

The agency should ensure that all substantive interactions with drug sponsors are properly memorialized, establish a protocol for joint briefing documents with drug sponsors, and update its industry guidance on the developments and review of new Alzheimer’s Drugs, the report recommended.

Biogen and other drugmakers should communicate to the FDA any concerns over safety and efficacy to the FDA as well as take value and patient access into consideration when setting prices, the report said.

An FDA spokesperson said the FDA’s decision to approve Aduhelm was based on scientific evaluation of the data contained in the application.

He pointed to the FDA’s internal review finding its staff’s interactions with Biogen appropriate.

“It is the agency’s job to frequently interact with companies in order to ensure that we have adequate information to inform our regulatory decision-making. We will continue to do so, as it is in the best interest of patients,” he said, adding that the agency will continue to use the accelerated approval pathway whenever appropriate.

The FDA has already begun implementing some of the report’s recommendations, the spokesperson said.

“Biogen stands by the integrity of the actions we have taken,” the Cambridge, Mass.-based biotech company said in an emailed statement.

“As stated in the congressional report, an (FDA) review concluded that, ‘There is no evidence that these interactions with the sponsor in advance of filing were anything but appropriate in this situation,'” Biogen said.

Documents obtained by the committees show that FDA staff and Biogen held at least 115 meetings, calls, and email exchanges over a 12-month period starting July 2019.

The total number of meetings is unknown because the FDA failed to keep a clear record of informal meetings and interactions between its staff and Biogen representatives. The investigation identified an additional 66 calls and email exchanges that were not memorialized.

The FDA inappropriately collaborated with Biogen on a joint briefing document for the Peripheral and Central Nervous System (PCNS) Advisory Committee, the report said, with FDA and Biogen staff working closely for months ahead of the Nov. 6, 2020 meeting to prepare the document, which failed to adequately represent differing views within the agency.

“Using a joint briefing document afforded Biogen advance insight into FDA’s responses and direct guidance from the agency in drafting the company’s own sections. For example, in an exchange of the draft briefing document on October 9, 2020, FDA staff asked Biogen to move a paragraph drafted by the agency into Biogen’s section of the memorandum—a change reflected when the document was finalized,” the report made public to media organizations said.

When none of the advisory panel members voted to approve Aduhelm, the FDA pivoted to using its accelerated approval pathway – typically used for rare diseases or small patient populations that lack access to effective treatments – despite having considered the drug under the traditional approval pathway for nine months, the report said.

It did so on a substantially abbreviated timeline, approving it after three weeks of review, and for a broad label indication of “people with Alzheimer’s disease” that was unsupported by clinical data, the report said.

Internal documents obtained by the investigation showed that Biogen accepted the indication despite its own reservations over the lack of evidence Aduhelm could help patients at disease stages outside of its clinical trials.

Reporting by Ahmed Aboulenein; editing by Diane Craft

Our Standards: The Thomson Reuters Trust Principles.

Ahmed Aboulenein

Thomson Reuters

Washington-based correspondent covering U.S. healthcare and pharmaceutical policy with a focus on the Department of Health and Human Services and the agencies it oversees such as the Food and Drug Administration, previously based in Iraq and Egypt.

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World

First foreign COVID vaccines head to China from Germany

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  • Batch of BioNTech shots on the way to China
  • German citizens will get shot; Berlin pushes for wider use
  • Shipment comes after Scholz visit to China last month
  • Comes as infections spike in world’s No. 2 economy

BERLIN, Dec 21 (Reuters) – Berlin has sent its first batch of BioNTech (22UAy.DE) COVID-19 vaccines to China to be administered initially to German expatriates, a German government spokesperson said on Wednesday, the first foreign coronavirus vaccine to be delivered to the country.

No details were available on the timing and size of the delivery, although the spokesperson said Berlin is pushing for foreigners other than German nationals, estimated at about 20,000, to be allowed access to the shot if they want it.

The shipment comes after China agreed to allow German nationals in China to get the shot following a deal during Chancellor Olaf Scholz’s visit in Beijing last month, with the German leader pressing for Beijing to allow the shot to be made freely available to Chinese citizens as well.

In a letter to be sent to German citizens in mainland China, the government said it would offer basic immunisations and booster shots of vaccines approved for use in the European Union for free to anyone over 12 years of age.

Family members of other nationalities would not be included. Vaccinations for children under 12 may follow at a later date.

“We are working on the possibility that besides Germans also other foreigners can be vaccinated with BioNTech,” the spokesperson told journalists in Berlin.

The shots will be delivered to German companies in China as well as embassy locations and talks are underway with other EU governments about getting them to citizens of other nationalities, a source familiar with the situation said.

China would need to approve expanding access beyond German nationals, the source said.

In return, Chinese citizens in Europe can be vaccinated with China’s SinoVac (SVA.O), the spokesperson said.

The comment comes after a report earlier this month that Germany’s health ministry had granted a permit allowing China’s Sinovac COVID-19 vaccine to be imported to Germany to be given to Chinese citizens in that country.

The shot has not been approved for use by Europe’s drug regulator, but the World Health Organization has given its green light for its use.

Beijing has so far insisted on using only domestically produced vaccines, which are not based on the Western mRNA technology but on more traditional technologies.

The shipment comes amid Beijing dismantling its strict “zero-COVID” regime of lockdowns, which has led to a surge of cases that caught a fragile health system unprepared.

Experts predict that the country of 1.4 billion people could face more than a million COVID deaths next year.

Allowing German expats access to a Western shot is a big gesture to Berlin, reflecting Beijing’s effort to strengthen ties with EU’s biggest economy after years of tensions over trade and climate between the two countries.

Shares in BioNTech rose on news of the shipment, closing 2.3% higher in Frankfurt while Pfizer shares in New York were up 1.25% in late morning New York trade.

BioNTech was not immediately available to comment on the situation on Wednesday.

China is stuck between rising Covid-19 cases and stalled vaccination rates

NO WESTERN SHOTS

China has nine domestically developed COVID vaccines approved for use, more than any other country. But none has been updated to target the highly infectious Omicron variant, as Pfizer-BioNTech and Moderna (MRNA.O) have for boosters in many developed countries.

The two shots developed by Pfizer-BioNTech and Moderna are the most widely used around the world.

Early on in the pandemic, BioNTech struck a deal with Shanghai Fosun Pharmaceutical (600196.SS) with a view to supply the shots to greater China.

While the shots became available in Hong Kong, Macau and Taiwan, the regulatory review for mainland China has not been concluded. BioNTech has said that decision was up to Chinese regulators and has not given a reason for the delay.

China’s zero-COVID policy and lockdown measures have kept death and infection rates minimal over the past months but caused massive disruptions both domestically and in global trade and supply chains.

China uses a narrow definition of COVID deaths and reported no new fatalities for Tuesday, even crossing one off its overall tally since the pandemic began, now at 5,241 – a fraction of the tolls of many much less populous countries.

The National Health Commission said on Tuesday only deaths caused by pneumonia and respiratory failure in patients who had the virus are classified as COVID deaths.

Reporting by Thomas Escritt, Alexander Ratz and Christian Kraemer; additional reporting by Danilo Masoni in Milan and Amanda Cooper in London;
Writing by Miranda Murray;
Editing by Josephine Mason and David Evans

Our Standards: The Thomson Reuters Trust Principles.

Thomas Escritt

Thomson Reuters

Berlin correspondent who has investigated anti-vaxxers and COVID treatment practices, reported on refugee camps and covered warlords’ trials in The Hague. Earlier, he covered Eastern Europe for the Financial Times. He speaks Hungarian, German, French and Dutch.

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Business

Positive Moderna, Merck cancer vaccine data advances mRNA promise, shares rise

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CHICAGO, Dec 13 (Reuters) – An experimental cancer vaccine from Moderna Inc (MRNA.O) based on the messenger RNA (MRNA) technology used in successful COVID-19 vaccines has been shown to work against melanoma, sending Moderna shares more than 20% higher and driving up of other biotechs working on similar treatments.

A combination of Moderna’s personalized cancer vaccine and Merck & Co’s (MRK.N) blockbuster immunotherapy Keytruda cut the risk of recurrence or death of the most deadly skin cancer by 44% compared with Keytruda alone in a mid-stage trial, the companies said on Tuesday.

The result was considered a “statistically significant and clinically meaningful improvement,” the companies said.

Moderna shares were up nearly 23% at $202.80 on Tuesday, while Merck’s shares rose 1%. Shares of BioNTech SE (22UAy.DE), which also has successful mRNA vaccine technology, were up 6%, and tiny Gritstone Bio Inc (GRTS.O), which has a cancer vaccine in development, jumped 20% to $3.09.

The study is the first randomized trial to show that combining mRNA vaccine technology with a drug that revs up the immune response would offer a better result for melanoma patients and potentially for other cancers.

“It’s a tremendous step forward in immunotherapy,” Eliav Barr, Merck’s head of global clinical development and chief medical officer, said in an interview.

Paul Burton, Moderna’s chief medical officer, said in a separate interview that the combination “has the capacity to be a new paradigm in the treatment of cancer.”

The ongoing study involved 157 patients with stage III/IV melanoma whose tumors were surgically removed before being treated with either the drug/vaccine combo or Keytruda alone with the aim of delaying disease recurrence.

The combination was generally safe and demonstrated the benefit compared with Keytruda alone after a year of treatment. Serious drug-related side effects occurred in 14.4% of patients who received the combination compared with 10% with Keytruda alone.

A PROMISING FIELD

In October, Merck exercised an option to jointly develop and commercialize the treatment, known as mRNA-4157/V940, sharing costs and any profits equally. Merck and Moderna plan to discuss the results with regulatory authorities and start a large Phase III study in melanoma patients in 2023.

The Merck/Moderna collaboration is one of several combining powerful drugs that unleash the immune system to target cancers with mRNA vaccine technology. They are designed to target highly mutated tumors.

The personalized vaccine works in concert with Merck’s Keytruda, a so-called checkpoint inhibitor designed to disable a protein called programmed death 1, or PD-1, that helps tumors to evade the immune system.

To build the vaccine, researchers took samples of patients’ tumors and healthy tissue. After analyzing the samples to decode their genetic sequence and isolate mutant proteins associated only with the cancer, that information was used to design a tailor-made cancer vaccine.

When injected into a patient, the patient’s cells act as a manufacturing plant, producing perfect copies of the mutations for the immune system to recognize and destroy.

Moderna’s personalized vaccine can be made in about eight weeks, a time frame the company eventually hopes to halve, Burton said.

Barr said the companies intend to study the approach in other highly mutated cancers, such as lung cancer. Other such cancers include bladder cancers and some breast cancers.

Moderna mRNA rival BioNTech has several cancer vaccine trials in the works including one with Memorial Sloan Kettering Cancer Center in New York testing a personalized vaccine in combination with Roche’s (ROG.S) Tecentriq in patients with pancreatic cancer.

Gritstone is testing a personalized, self-amplifying mRNA vaccine in combination with Bristol Myers Squibb’s (BMY.N) immunotherapies Opdivo and Yervoy in a midstage trial in patients with advanced solid tumors.

Experts said the personalized vaccines were among several promising cancer vaccine ideas in the works after many failures in the field.

“In general, I think cancer vaccines are kind of at a tipping point, and there are going to probably be a lot of vaccines coming down the pipeline in the next five years,” said Dr. Mary Lenora Disis, director of the UW Medicine Cancer Vaccine Institute in Seattle.

Although the COVID-19 pandemic demonstrated the speed, ease and safety of mRNA vaccines, they came out of years of cancer vaccine research, Disis said.

Reporting by Julie Steenhuysen in Chicago, Michael Erman in New Jersey and Aditya Samal in Bengaluru; Editing by Caroline Humer, Edwina Gibbs and Bill Berkrot

Our Standards: The Thomson Reuters Trust Principles.

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Business

U.S. adds China’s YMTC and 30 other firms to ‘unverified’ trade list

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WASHINGTON, Oct 7 (Reuters) – The United States on Friday added China’s top memory chipmaker YMTC and 30 other Chinese entities to a list of companies that U.S. officials have been unable to inspect, ratcheting up tensions with Beijing and starting a 60 day-clock that could trigger much tougher penalties.

The new listings were the first of a slew of new restrictions announced on Friday on exports of technology to China aimed at blocking military advances. The crackdown included curbs on access to chipmaking tools for Chinese firms including Yantze Memory Technologies Co (YMTC), as reported by Reuters a day earlier. read more

U.S. senators from both parties have been calling for YMTC, China’s fast-growing chip manufacturer, to be placed on a trade blacklist known as the “entity list.” The company, founded in 2016, poses a “direct threat” to U.S. chip companies, according to the Biden administration.

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YMTC and the Chinese embassy in Washington did not respond to requests for comment.

YMTC is under investigation by the Commerce Department over whether it violated U.S. export controls by selling chips to blacklisted Chinese telecommunications company Huawei Technologies Co Ltd. Its chips also are being evaluated by Apple Inc for inclusion in some of its iPhones in China, a major concern for U.S. lawmakers and the Biden administration.

Companies are added to the unverified list because the United States could not complete on-site visits to determine whether they can be trusted to receive sensitive technology exports from the United States. U.S. inspections of Chinese companies require the approval of China’s commerce ministry.

U.S. exporters must conduct additional due diligence before sending goods to entities placed on the “unverified list,” like the 31 added on Friday, and may have to apply for more licenses.

Under the Biden administration’s new policy, if a government prevents U.S. officials from conducting site checks at companies placed the unverified list, Washington will start the process for adding them to the entity list after 60 days.

Entity listing YMTC would further escalate tensions with Beijing and force its U.S. suppliers to seek difficult-to-obtain licenses from the U.S. government before shipping them even the most low-tech items.

Not all the measures announced on Friday were bad news for China. The United States removed a unit of Wuxi Biologics, maker of ingredients for AstraZeneca’s COVID-19 vaccine, from the unverified list. Reuters reported last summer that U.S. officials had been able to conduct an inspection at the Wuxi city site, a stepping stone to removal from the list.

A Wuxi Biologics spokeswoman said the company was pleased the Wuxi site was removed from the list, given the inspection in June. The company looks forward to scheduling an inspection of its Shanghai subsidiary, which also was placed on the unverified list in February, she added.

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Reporting by Karen Freifeld; Editing by Chris Gallagher, Chris Sanders, Chizu Nomiyama, Mark Porter and Richard Chang

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Business

U.S. aims to hobble China’s chip industry with sweeping new export rules

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Oct 7 (Reuters) – The Biden administration on Friday published a sweeping set of export controls, including a measure to cut China off from certain semiconductor chips made anywhere in the world with U.S. tools, vastly expanding its reach in its bid to slow Beijing’s technological and military advances.

The rules, some of which go into effect immediately, build on restrictions sent in letters earlier this year to top toolmakers KLA Corp (KLAC.O), Lam Research Corp (LRCX.O) and Applied Materials Inc (AMAT.O), effectively requiring them to halt shipments of equipment to wholly Chinese-owned factories producing advanced logic chips.

The raft of measures could amount to the biggest shift in U.S. policy toward shipping technology to China since the 1990s. If effective, they could set China’s chip manufacturing industry back years by forcing American and foreign companies that use U.S. technology to cut off support for some of China’s leading factories and chip designers.

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In a briefing with reporters on Thursday previewing the rules, senior government officials said many of the measures sought to prevent foreign firms from selling advanced chips to China or supplying Chinese firms with tools to make their own advanced chips. They conceded, however, that they have not yet secured any promises that allied nations will implement similar measures and that discussions with those nations are ongoing.

“We recognize that the unilateral controls we’re putting into place will lose effectiveness over time if other countries don’t join us,” one official said. “And we risk harming U.S. technology leadership if foreign competitors are not subject to similar controls.”

The expansion of U.S. powers to control exports to China of chips made with U.S. tools is based on a broadening of the so-called foreign direct product rule. It was previously expanded to give the U.S. government authority to control exports of chips made overseas to Chinese telecoms giant Huawei Technologies Co Ltd (HWT.UL) and later to stop the flow of semiconductors to Russia after its invasion of Ukraine.

On Friday, the Biden administration applied the expanded restrictions to China’s IFLYTEK, Dahua Technology, and Megvii Technology, companies added to the entity list in 2019 over allegations they aided Beijing in the suppression of its Uyghur minority group.

The rules published on Friday also block shipments of a broad array of chips for use in Chinese supercomputing systems. The rules define a supercomputer as any system with more than 100 petaflops of computing power within a floor space of 6,400 square feet, a definition that two industry sources said could also hit some commercial data centers at Chinese tech giants.

U.S. Senate Democratic leader Chuck Schumer welcomed the announcement, arguing the rules would “protect our country’s innovations from China’s predatory actions.”

The Semiconductor Industry Association, which represents chipmakers, said it was studying the regulations and urged the United States to “implement the rules in a targeted way – and in collaboration with international partners – to help level the playing field.”

Earlier on Friday, the United States added China’s top memory chipmaker YMTC and 30 other Chinese entities to a list of companies that U.S. officials cannot inspect, ratcheting up tensions with Beijing and taking aim at a firm that has long troubled the Biden administration. read more

The “unverified list” is a potential precursor to tougher economic blacklists, but companies that comply with U.S. inspection rules can come off the list. On Friday, U.S. officials removed nine such firms, including a unit of China’s Wuxi Biologics, which makes ingredients for AstraZeneca Plc’s (AZN.L) COVID-19 vaccine.

The new regulations will also severely restrict export of U.S. equipment to Chinese memory chip makers and formalize letters sent to Nvidia Corp (NVDA.O) and Advanced Micro Devices Inc (AMD) (AMD.O) restricting shipments to China of chips used in supercomputing systems that nations around the world rely on to develop nuclear weapons and other military technologies.

Reuters was first to report key details of the new restrictions on memory chip makers, including a reprieve for foreign companies operating in China and the moves to broaden restrictions on shipments to China of technologies from KLA, Lam, Applied Materials, Nvidia and AMD. read more read more

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Reporting by Stephen Nellis in San Francisco and Karen Freifeld in New York
Additional reporting by David Shepardson in Washington
Editing by Alexandra Alper, Chris Sanders and Matthew Lewis

Our Standards: The Thomson Reuters Trust Principles.

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Business

Eisai, Biogen say Alzheimer’s drug succeeds in slowing cognitive decline

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Sept 27 (Reuters) – Eisai Co Ltd (4523.T) and Biogen Inc (BIIB.O) on Tuesday said their experimental Alzheimer’s drug significantly slowed cognitive and functional decline in a large trial of patients in the early stages of the disease, marking a rare win in a field littered with failed drugs.

The drug, lecanemab, slowed progress of the brain-wasting disease by 27% compared with a placebo, meeting the study’s main goal, and potentially offering hope for patients and their families desperate for an effective treatment.

“It’s not a huge effect, but it’s a positive effect,” said Ronald Petersen, director of the Mayo Clinic Alzheimer’s Disease Research Center in Rochester, Minnesota.

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Eisai, leader of the 50-50 partnership’s lecanemab program, is seeking FDA approval under an accelerated pathway, with a decision expected in early January. On Tuesday the Japanese drugmaker said it will use the new efficacy results to submit lecanemab for traditional FDA review as well.

The company said it will also seek authorization in Japan and Europe during its current fiscal year, ending March 31.

Eisai said results from the 1,800-patient trial prove the longstanding theory that removal of sticky deposits of a protein called amyloid beta from the brains of people with early Alzheimer’s can delay advance of the debilitating disease.

“This means that treating amyloid is a step in the right direction,” Petersen said.

Shares of Biogen and Eisai were halted, but shares of Eli Lilly & Co , which is also developing an Alzheimer’s drug, rose as much as 6.7% in after hours trade.

The lecanemab data suggest “a potentially new multi-billion dollar franchise,” Jefferies analyst Michael Yee said in a research note.

Lecanemab, like the partners’ previous drug Aduhelm, is an intravenous antibody designed to remove amyloid deposits. Unlike Aduhelm, lecanemab targets forms of amyloid that have not yet clumped together.

“If you can slow a disease by almost 30% that’s fantastic. This is what we have been looking for,” said Dr. Jeff Cummings, director of the Chambers-Grundy Center for Transformative Neuroscience at the University of Nevada Las Vegas.

The so-called amyloid hypothesis has been challenged by some scientists, particularly after the U.S. Food and Drug Administration’s controversial approval of Aduhelm in 2021 based on its plaque-clearing ability rather than proof that it helped slow cognitive decline. The decision came after the FDA’s own panel of outside experts had advised against approval.

Aduhelm was the first new Alzheimer’s drug approved in 20 years after a long list of high-profile failures for the industry. read more

Patient advocacy groups hailed the news of positive lecanemab trial results.

“This is important because it demonstrates that each of these drugs is different … I would hope that the FDA approves the drug in January,” USAgainstAlzheimer’s Chairman George Vradenburg told Reuters.

The Phase III trial evaluated the drug’s ability to reduce cognitive and functional decline based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB), a numerical scale used to quantify the severity of dementia in patients in areas such as memory, orientation, judgment and problem solving and personal care.

BRAIN SWELLING

The rate of a brain swelling side effect associated with anti-amyloid treatments was 12.5% in the lecanemab group, versus 1.7% in the placebo group. But many cases did not cause symptoms, with symptomatic brain swelling seen in 2.8% of those in the lecanemab group, the companies said.

Micro hemorrhages in the brain occurred at a rate of 17% in the lecanemab group, and 8.7% in the placebo group.

Petersen said the side effect rate was much less than with Aduhelm and “certainly tolerable.”

Aduhelm’s approval was a rare bright spot for Alzheimer’s patients, but critics have called for more evidence that amyloid-targeting drugs are worth the cost.

The controversy and reluctance by some payers to cover Aduhelm led Biogen to slash the drug’s price to $28,000 per year from an initial $56,000.

But Medicare, the U.S. government health plan for people 65 and older, this year said it would only pay for Aduhelm and other similar drugs if patients were enrolled in a valid clinical trial, which sharply curtailed the medication’s use. Since Alzheimer’s is a disease of aging, an estimated 85% of patients eligible for the drug are covered by the government plan.

Michael Irizarry, Eisai’s deputy chief clinical officer, said on a conference call that the company will have discussions with the Medicare agency regarding coverage of lecanemab.

The number of Americans living with Alzheimer’s is expected to rise to around 13 million by 2050 from more than 6 million currently, according to the Alzheimer’s Association. Globally, that figure could rise to 139 million by 2050 without an effective treatment, according to Alzheimer’s Disease International.

Other plaque-targeting antibodies in late-stage development for Alzheimer’s patients include Roche Holding AG’s (ROG.S) gantenerumab and Eli Lilly’s donanemab.

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Reporting by Deena Beasley in Los Angeles and Julie Steenhuysen in Chicago; Editing by Bill Berkrot and Richard Pullin

Our Standards: The Thomson Reuters Trust Principles.

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Business

China approves Genuine Biotech’s HIV drug for COVID patients

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BEIJING, July 25 (Reuters) – China on Monday gave conditional approval to domestic firm Genuine Biotech’s Azvudine pill to treat certain adult patients with COVID-19, adding another oral treatment option against the coronavirus.

The availability of effective COVID vaccines and treatments is crucial in laying the groundwork for China’s potential pivoting from its “dynamic COVID zero” policy, which aims to eliminate every outbreak – however small – and relies on mass testing and strict quarantining.

The Azvudine tablet, which China approved in July last year to treat certain HIV-1 virus infections, has been given a conditional green light to treat adult patients with “normal type” COVID, the National Medical Products Administration said in a statement.

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“Normal type” COVID is a term China uses to refer to coronavirus infections where there are signs of pneumonia, but the patients haven’t reached a severe stage.

China in February allowed the use of Pfizer’s oral treatment Paxlovid in adults with mild-to-moderate COVID and high risk of progressing to a severe condition. In 2020, it approved the use of Lianhuaqingwen capsules, a traditional Chinese medicine-style formula, to alleviate symptoms of COVID such as fever and cough.

In a late-stage clinical trial, 40.4% of patients taking Azvudine showed improvement in symptoms seven days after first taking the drug, compared with 10.9% in the control group, Henan province-based Genuine Biotech said in a statement earlier this month, without providing detailed readings.

Other Chinese companies developing potential oral COVID treatments include Shanghai Junshi Biosciences (688180.SS) and Kintor Pharmaceutical (9939.HK).

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Reporting by Roxanne Liu and Ryan Woo
Editing by Louise Heavens and Mark Potter

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World

N.Korea reports first COVID outbreak, orders lockdown in “gravest emergency”

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  • North Korea declares ‘gravest national emergency’
  • Potential for ‘unprecedented crisis’ for Kim Jong Un – expert
  • Isolated state has declined offers of vaccine
  • No North Korean civilians are believed vaccinated

SEOUL, May 12 (Reuters) – North Korea reported its first COVID-19 outbreak on Thursday, calling it the “gravest national emergency” and ordering a national lockdown, with state media saying an Omicron variant had been detected in the capital, Pyongyang.

North Korea had never confirmed a COVID infection before Thursday although South Korean and U.S. officials have said there could have been earlier cases in the isolated country, given its trade and travel with China before it sealed its border to block the virus in early 2020.

“The state’s most serious emergency has occurred: A break emerged in our emergency epidemic prevention front that had been firmly defended until now,” the official KCNA news agency said.

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The first public admission of COVID infections highlights the potential for a major crisis in a country that lacks medical resources and has refused international help with vaccinations and kept its borders shut.

As of March, not only had no cases of COVID been reported, according to the World Health Organization (WHO), but there was no official record of any North Koreans being vaccinated.

KCNA said that samples taken on May 8 from people in Pyongyang who were experiencing fevers showed a sub-variant of the Omicron virus, also known as BA.2. It did not give the number of cases or say what the source might have been.

Earlier on Thursday, Chinese state television reported North Korea has imposed a stay-at-home order since Tuesday citing “suspected flu symptoms” among some people.

North Korean leader Kim Jong Un convened a meeting of the ruling Workers’ Party’s powerful politburo, ordering a “strict lockdown” nationwide and the mobilisation of emergency reserve medical supplies.

“The state epidemic prevention work shall be switched over to the maximum emergency epidemic prevention system,” KCNA said.

State television showed Kim wearing a mask upon arrival for the meeting, before taking it off as it began. All other attendees wore masks.

In past footage of such meetings, everyone but him wore a mask. There was no sign of masks in pictures of a recent big military parade.

NO VACCINE, SCARCE RESOURCES

People wearing protective face masks walk amid concerns over the new coronavirus disease (COVID-19) in Pyongyang, North Korea May 15, 2020, in this photo released by Kyodo. Mandatory credit Kyodo/via REUTERS

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For more than two years Kim has enforced tight restrictions to stop COVID including a ban on travel between provinces. In July 2020, he declared an emergency and imposed a three-week lockdown on Kaesong town, near the inter-Korean border, after a man who defected to the South in 2017 returned to the city showing COVID symptoms.

According to the latest WHO data, as of the end of March, 64,207 of North Korea’s 25 million people had been tested for COVID and all were negative.

North Korea had declined vaccine supplies from the COVAX sharing programme and the Sinovac Biotech vaccine from China, possibly leaving the vast majority of people in a relatively young country exposed to higher risk of infection. read more

The office of South Korea’s new president, Yoon Suk-yeol, who was sworn in on Tuesday, said it would not link humanitarian aid to political differences with North Korea.

Kwon Young-se, Yoon’s nominee for unification minister responsible for inter-Korean ties, told his confirmation hearing that he would prepare humanitarian assistance for the North, including COVID treatment, syringes and other medical supplies.

China’s foreign ministry spokesman said it was ready to provide “all-out efforts” to help North Korea fight the outbreak.

The border with China was reopened for trade early this year but China had said the main crossing between its Dandong city and the North Korean town of Sinuiju was closed in April because of the COVID situation on the Chinese side. read more

News of the outbreak came after U.S. and South Korean officials warned North Korea could conduct its first nuclear test since 2017 as early as this month, after breaking a 2017 moratorium on long-range missile testing. read more

Kim told the politburo emergency measures were aimed at curbing the virus and eliminating the source of transmission. The politburo criticised the “slackness, irresponsibility and incompetence” of anti-virus officials, KCNA said.

A failure to contain infections could be an “unprecedented crisis” for Kim, said Lim Eul-chul, a professor of North Korean studies at Kyungnam University in South Korea.

“Given a more inferior vaccination situation and testing capacity and public health infrastructure compared to China, plus the lack of intensive care units, there’s potential for scores of casualties,” he said.

South Korea’s central bank said last July the North’s economy had suffered its biggest contraction in 23 years in 2020, weighed down by border controls, U.N. sanctions and bad weather. read more

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Reporting by Soo-hyang Choi and Joori Roh in Seoul, Ryan Woo and Yew Lun Tian in Beijing; Additional reporting and writing by Hyonhee Shin; Editing by Jack Kim and Gerry Doyle, Robert Birsel

Our Standards: The Thomson Reuters Trust Principles.

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