SCMP : Nexperia China tells employees to ignore orders from Dutch head office

Nexperia China tells employees to ignore orders from Dutch head office
Letter to employees of company owned by China’s Wingtech asserts that ‘independent’ mainland entity is the one that pays workers’ salaries

Nexperia China, the local unit of the Dutch chipmaker, has told its employees to follow orders from local management and ignore instructions from the Dutch head office, according to a letter issued to employees over the weekend.

In open revolt against the headquarters in Nijmegen, the Netherlands, Nexperia China said in a Chinese-language statement on its official social media channel on Saturday that it was an “independent” Chinese entity and that Nexperia employees in China “should continue to follow instructions from Nexperia China”.

“As for any other external instructions you may have received … you have the right to reject, and your act will not form any breach of work discipline or regulations,” the letter said, making it clear that local Chinese managers would take over operations in China.

The letter – which said it applied to Nexperia China’s packaging plant in the southern city of Dongguan as well as branches in Shanghai, Beijing, Shenzhen and Wuxi – added that the salaries and wages of Nexperia China employees were paid by the local entity, not the head office in the Netherlands.

The letter represents the latest salvo in a fight for control of the Nexperia business between Dutch authorities and the company’s Chinese owner, Wingtech Technology, which bought Nexperia in 2019.

The Post reported earlier that the Dutch government feared the Chinese owners planned to move its European manufacturing operations to China. This prompted Dutch authorities to seize control of Nexperia’s management and oust its Chinese CEO, Zhang Xuezheng, citing national security concerns, a move which has sent shock waves through the global tech world.

In response, China’s Ministry of Commerce on October 4 imposed export controls on Nexperia’s Chinese subsidiary and its subcontractors, banning the export of domestically made components.

In a visit to the packaging plant in Dongguan last week, workers told the Post that they were worried about becoming collateral damage in the simmering political dispute. The Dongguan plant, which accounts for about 70 per cent of Nexperia’s annual output, has become a key bargaining chip in the dispute.

The Nexperia China letter to local employees came a day after it informed clients that the office had withheld access to work accounts and halted salaries for its employees in China, according to local news reports.
“We are deeply puzzled and disappointed,” the unit said in the letter, according to Chinese tech news outlet Electrans. The subsidiary said it faced “ruthless suppression” and noted that the current European management appeared to be “abandoning” the Chinese market.

At the same time, Nexperia’s head office said on Sunday that its employees in China still had access to company platforms and were receiving salaries as usual, a day after its China unit asserted that it had the right to operate independently of the Dutch parent, according to Reuters.

WSJ : The Auto Industry’s Bruising Year of Back-to-Back Supply-Chain Snafus

The Auto Industry’s Bruising Year of Back-to-Back Supply-Chain Snafus
Rare-earth minerals, aluminum fire, semiconductor stoppage have hit carmakers simultaneously

U.S. auto production faces several simultaneous supply-chain disruptions, including aluminum shortages and geopolitical chip export bans.
Tariffs have cost the auto industry more than $12 billion and affected production.

Assembly lines inside a Michigan factory that churns out high-end Jeep SUVs ground to a halt last week and won’t resume production until early next month.

The cause, according to an official for the United Auto Workers, is a shortage of aluminum.

Ford has paused production at three plants for the same reason. Between the two automakers, thousands of workers in Michigan and Kentucky are now collecting unemployment.

The automotive supply chain—a sprawling web of companies across the world—is in focus in a way it hasn’t been since the early 2020s, when a severe shortfall of semiconductor chips hobbled the industry. Auto executives routinely tout a lesson from that moment: Don’t rely too heavily on any one supplier. Now, supplies of multiple items are gummed up at the same time.

“The confluence of issues is once in a lifetime,” said Sam Fiorani, an analyst with consulting firm AutoForecast Solutions. “We haven’t seen this happen before. The lessons learned from semiconductors should have prepared the manufacturers for some problems in the supply chain. But all these at once are unforeseen and very difficult to navigate.”

All this is rattling an industry that has already been hampered by billions of dollars in tariff payments and a costly pivot away from electric vehicles. Last week, General Motors said the EV pullback would cost it $1.6 billion.

Stellantis unveiled a $13 billion U.S. investment plan that will help defray its tariff bill.

U.S. car sales are on pace this year to end slightly above the 15.9 million sold in 2024, according to S&P Global Mobility. Next year doesn’t look promising, however: Total production and sales are expected to dip, with tariffs weighing more on automakers and the average price of a vehicle remaining elevated, now around $50,000.

It wasn’t all gloom and doom at the start of the year. Many in the industry felt that President Trump’s tariffs wouldn’t be nearly as bad as expected. Then April came.

The White House imposed hefty tariffs—25% on imported vehicles and parts. Production stoppages ensued as executives hurried to crunch numbers and figure out which vehicles could be made and where.

The Trump administration has since eased the tariff burden, providing some relief for companies that meet standards set under a North American trade pact. It is only so much help, however. Industrywide, the cost exceeds $12 billion.

China, the main target of Trump’s global trade war, hasn’t made the carmaking business any easier. In retaliation for Trump’s tariffs, China strangled a vital supply of rare-earth minerals. Export restrictions forced automakers to find workarounds to keep making cars. Some weighed extreme measures, such as shipping made-in-America motors to China to have magnets installed, The Wall Street Journal reported at the time.

“The auto industry, long built on global supply chains, now finds itself at the mercy of a single nation’s industrial policy,” said Michael Dunne, a longtime China automotive industry consultant, in a newsletter last week. “This is no longer just an automaker’s problem. It is a question of economic security, industrial survival, and strategic independence.”

Three-alarm fire
In September, a three-alarm fire hit a New York aluminum plant, knocking production offline until early next year. The stoppage has disrupted manufacturing schedules of profitable Ford models and, now, pricey Jeep sport-utility vehicles. A spokesman for Jeep-maker Stellantis said it was a parts shortage that caused the shutdown of its Michigan factory but wouldn’t specify the particular part.

Eric Graham, president of the UAW local for the idled Jeep plant, said it is possible the factory will be offline longer because of the aluminum shortage.

Ford will extend a pause on assembly of highly profitable three-row SUVs, the Expedition and Lincoln Navigator, at Ford’s Kentucky Truck Plant through Oct. 26, according to a memo obtained by The Wall Street Journal. The plant also started trimming output of F-Series Super Duty trucks, some of which can cost more than $100,000, according to factory workers.

A Ford spokeswoman declined to comment on the automaker’s production moves. Ford has said it is working closely with Novelis, owner of the damaged aluminum plant, while also exploring “all possible alternatives to minimize any potential disruptions.”

Banned shipments
At the same time, a strange, and ongoing, geopolitical dispute is causing more concern that car production around the world could be upended in a matter of weeks.

Nexperia, a Netherlands-based chip maker, stopped shipments this month after the Dutch government took control of the company from its Chinese owner.

China, where 80% of Nexperia’s products are processed before being delivered, banned the parent company from exporting out of the country. Nexperia said it was trying to obtain an exemption from the restrictions. European carmakers predicted they only had a few weeks of Nexperia chips on hand to use in production.

John Bozzella, chief executive of the Alliance for Automotive Innovation, the top U.S. car industry group, warned that the Nexperia situation could deteriorate quickly and affect the global economy.

“If the shipment of automotive chips doesn’t resume—quickly—it’s going to disrupt auto production in the U.S. and many other countries and have a spillover effect in other industries,” Bozzella said. “It’s that significant.”

WSJ : Luxury Brands’ Stiffest Competition Is the Stuff They Have Already Sold

Luxury Brands’ Stiffest Competition Is the Stuff They Have Already Sold
Sales of secondhand luxury goods are growing faster than in brands’ own stores

For luxury brands trying to win back shoppers, secondhand sellers have become a potential nuisance.

Demand for used luxury is stronger than for new goods at the moment. The RealReal REAL -1.30%decrease; red down pointing triangle, the world’s biggest online luxury reseller, has grown sales by 10% on average over the past 18 months. Its New York-listed stock is up more than 200% in a year. Business at Fashionphile, a large privately owned reseller, is growing above 10% so far in 2025.

Meanwhile, demand for new luxury goods has been flat on average for six consecutive quarters among top European brands. More than a dozen labels have hired new designers in a push to get shoppers back into stores and spending again.

The world’s most valuable luxury company, LVMH, is making early progress. This past week, the company said that sales rose 1% in the third quarter compared with the same period of last year, sending the stock soaring on hopes of a recovery.

One headwind for these companies: The resale market seems to have switched from being mildly helpful to luxury brands to a more direct competitor. Previously, shoppers used resale websites to clear out unwanted goods, selling their old clothes and using the cash to make new purchases in the primary market. This boosted the sales of luxury brands.


But behavior has changed over the past two years, according to resellers and luxury-market analysts. More people are spending the cash they get from reselling on other secondhand goods, bypassing the primary market altogether. This behavior is more prevalent among young shoppers and puts luxury brands in competition with the billions of dollars of goods already sitting in people’s wardrobes.

Gen Z and millennial consumers are The RealReal’s fastest-growing customers. These two generations have been defecting from the primary market. Gen Z consumers spent 7% less on new luxury goods in 2024 than a year earlier, data from consulting firm Bain shows. Millennials’ spending slipped 2%.

Shoppers still love the major luxury labels, which is positive for the industry. Fashionphile’s list of most-purchased handbags is topped by Louis Vuitton, Chanel and Gucci.

But the high cost of new luxury goods following years of above-average price increases is driving people to resale websites for discounts. A shakier jobs market and economic outlook are also prompting luxury shoppers to spend more cautiously.

“Appetite for these brands and products remains high but willingness to pay current prices is low,” says Claudia D’Arpizio, global head of fashion and luxury at Bain.

The market for used luxury goods was worth $56 billion last year, according to estimates from Bain. This is nearly three times as much as a decade ago and equivalent to all of the business that luxury brands did through department stores globally in 2024.

At this scale, resale is starting to influence how people shop. More consumers are consulting prices in the secondhand market before buying new, to see how much money they might be able to claw back from a luxury purchase after a few wears.

Pricing transparency in the secondhand market is double-edged for luxury brands. It should strengthen labels that hold their value, such as Louis Vuitton and Bottega Veneta, whose handbags fetch 89% of their original sticker price on average when resold in very good condition, data from The RealReal shows. Brands that don’t hold their value could become relatively less attractive as shoppers weigh the odds of reselling them.

Luxury brands aren’t likely to jump into the resale business directly any time soon, no matter how fast it is growing. The logistics are messy. Do people cashing in their old handbags line up alongside those buying new? Telling shoppers their goods are only worth a fraction of what they originally paid for them is also a no-no for brands.

But brands are starting to track the secondhand market for clues about which of their old products are catching on again. Resellers’ algorithms, which price goods based on sales velocity, customer search activity and other factors, provide a pure barometer of consumer demand and are quick to show when an item is coming back into fashion.

For instance, the price of used Chloé Paddington handbags jumped to $724 this year on The RealReal, from $217 in 2024. The Chloé brand, owned by Swiss luxury company Richemont, has subsequently reissued the bag in the primary market to cash in on the buzz.

Louis Vuitton and Balenciaga also relaunched old handbag designs this year, partly in reaction to the demand they were seeing in the secondhand market.

Information about what consumers are looking for in the resale market is gold dust for luxury brands trying to figure out what shoppers want to buy now. But they will also need to persuade them to pay full price, rather than going for the relative bargains on resellers’ websites.

FT : Drug groups unveil advances in treating most difficult breast cancers

Drug groups unveil advances in treating most difficult breast cancers
AstraZeneca, Daiichi Sankyo and Gilead report promising trial results in ‘triple negative’ breast cancer

AstraZeneca, Daiichi Sankyo and Gilead have made big advances in treating the hardest-to-tackle type of breast cancer, boosting prospects for tens of thousands of patients a year.

The drugmakers are unveiling trial results for existing blockbuster drugs in “triple negative” breast cancer — so-called because it is not one of the three main types. These include the first ever study showing a medicine can extend the life of patients who cannot be treated with immunotherapy drugs, the majority of triple negative cases.

Patients with triple negative breast cancer make up about 10 per cent to 20 per cent of people diagnosed. Breast cancer is the most common type of the disease in the UK, and the second most common after skin cancer in the US.

AstraZeneca and Japanese pharma company Daiichi’s drug Datroway improved overall survival for patients by 23 per cent, and increased the time they lived without the cancer getting worse by 43 per cent, compared with those treated with chemotherapy.

David Fredrickson, executive vice-president for oncology at AstraZeneca, said the results showed an “outstanding opportunity” to expand treatment to more patients. The company has had 10 positive late-stage trial results in oncology this year, five of which have been in breast cancer.

“It’s been an exceptional year,” he said. “The breast cancer studies alone have the opportunity to reach nearly half a million patients.”

Fredrickson added AstraZeneca’s oncology sales rose 16 per cent year-on-year in the first half and he hopes they will contribute half of the company’s goal of $80bn of sales by 2030.

AstraZeneca and Daiichi also announced positive trial results for their Enhertu breast cancer drug in earlier-stage patients. The treatment is approved for later-stage patients but it is not available on the NHS in England, even though it is in many other countries including Scotland.

One of two Enhertu studies found a three-year disease-free survival rate of 92 per cent, compared with 84 per cent with the most commonly used drugs.

Fredrickson said there needs to be a “modernisation” of NHS methodologies, including valuing the end of life more, to ensure patients can get access.

The results were presented at the European Society for Medical Oncology this weekend, where US drugmaker Gilead also reported positive results for its cancer drug Trodelvy in patients with triple negative breast cancer.

Trodelvy, which is already approved for breast cancer, reduced the risk of cancer progression or death by 38 per cent versus other forms of chemotherapy. Survival rates were extended with the drug to 9.7 months versus 6.9 months for chemotherapy, the company said.

Trodelvy generated $657mn for Gilead in the first six months of 2025, up 5 per cent from the same period last year. Oncology accounts for about 12 per cent of the company’s sales.

The latest data for Trodelvy marks a bounceback for the drug. A year ago, Gilead withdrew it for certain urinary tract cancers after it failed a drug trial.

Eli Lilly also reported encouraging data. Its Verzenio drug prolonged survival for certain high-risk early breast cancers by 15.8 per cent versus conventional treatments. It is the first therapy in more than two decades to demonstrate a significant overall survival benefit in certain, high-risk early breast cancers.

FT : Apollo Global chief says Europe ‘at war with itself’ over finance regulatio

Apollo Global chief says Europe ‘at war with itself’ over finance regulation
Marc Rowan tells FT that regulators have yet to catch up with political drive to boost competitiveness

Marc Rowan, chief executive of Apollo Global Management, has said Europe is “at war with itself” as excessive regulation of its financial sector stifles growth and undermines competitiveness with the US.

Rowan, who co-founded the New York-based private capital group, said Europe had made little progress in implementing the reforms needed to secure investment and revive the region’s ailing economy.

“I see Europe a little bit at war with itself with respect to financial regulation,” Rowan said at the Financial Times private capital summit.

“On the political side, you have all the signals of embracing risk-taking, equitisation and private markets. [But] on the regulatory side, not so much,” he said.

Rowan added: “There are lots of problems to look at in the US. Every problem that we have in the US is worse here [in Europe], every single problem.”

Mario Draghi, the former head of the European Central Bank, last year warned of an “existential challenge” if the continent did not improve its productivity, setting out almost 400 recommendations in a landmark report on competitiveness.

Private capital firms have spotted an opportunity to supply capital to fund European infrastructure projects to boost productivity.

Apollo and its rivals Blackstone, KKR and Brookfield are all planning to increase investment in the region substantially over the next decade.

Apollo has recently lent billions to Intel to build a semiconductor fabrication plant in Ireland, and financed EDF’s construction of the Hinkley Point C nuclear power station in the UK and a large energy grid venture with German power utility RWE.

Rowan said: “My own projection — and our projection as a firm — is on a relative basis, Europe will grow faster than the US with respect to private capital because it needs it more.”

He said European businesses and governments were embracing private capital groups to increase the competitiveness of their technology sectors.

“They do not want to be, I saw the word this morning, a technology colony,” said Rowan. “They want to be leaders — they want to actually have their own infrastructure, their own defence base, their own everything. To do that, you’re going to need massive amounts of capital.”

While the billionaire financier offered a harsh critique of Europe, he also said President Donald Trump had not made progress in improving the public finances of the US, an issue he and other top investors have called the main economic risk to the world’s largest economy.

Rowan, who was previously a contender to become Trump’s Treasury secretary, said the president had “absolutely not” made a dent in the US debt or its deficit.

“In the US we have, we’ve been running a large deficit, we’ve been piling up debt, but fundamentally our budget is a math problem,” he said.

“The willingness of politicians in the US, and I would say [in the UK], and in Europe, and in almost every western democracy, to do something fundamental outside of crisis is nil.”

WWD : At Hermès, a New Menswear Designer May Not Bring Much Disruption

At Hermès, a New Menswear Designer May Not Bring Much Disruption
Luxury experts expect the brand to choose continuity over radical change.

PARIS — With the news that Véronique Nichanian is stepping down as men’s artistic director at Hermès after 37 years, the French luxury brand is facing the kind of generational handover that has become rare in a world of revolving doors.

In a statement on Friday, Hermès said Nichanian, fashion’s longest-serving creative director, would depart after presenting her final collection on Jan. 24 during Paris Men’s Fashion Week.

The house is expected to announce her replacement in the next few days, and sources believe an internal successor could be named. Among Nichanian’s longest-serving deputies is designer Benjamin Brett, who joined Hermès in 2010 from Yves Saint Laurent, according to his LinkedIn profile.

Another alternative would be for Hermès to broaden the remit of Nadège Vanhee, its artistic director of women’s ready-to-wear. Or the house, whose past creative directors include Martin Margiela and Jean Paul Gaultier, could bring on board another star designer.

Among the leading menswear figures currently without a portfolio are Kim Jones, who stepped down as artistic director of men’s collections at Dior in January, and Hedi Slimane, who left his post as artistic, creative and image director of Celine in October 2024.

“It wouldn’t be out of the realm of possibility that a star designer goes there again,” said Mary Gallagher, senior consultant at Find executive consulting. “It would just probably have to be one that would conform to being in this legacy family company.”

Whatever happens, luxury experts expect Hermès to choose continuity over radical change, especially since its ready-to-wear business is strong.

“I see this as a natural transition, and I don’t attach great consequence to the change. Creative directors will continue to have limited visibility at Hermès, as the brand prevails more than at other houses,” said Luca Solca, analyst at Bernstein. “Having said that, Hermès has done very well with rtw, and I expect they will work to keep this performance going.”

The handover comes as brands battle to reverse a slowdown in luxury consumption worldwide, with aspirational consumers turning their backs on high-ends goods after several years of steep price increases in the wake of the coronavirus pandemic.

Hermès has benefited from its safe-haven status, as the rarity of its handbags make them investment pieces that see their value often increase, rather than decrease, over time.

The brand’s ready-to-wear and accessories division has also proved a solid earner, with sales rising 6 percent in the first half, helping the company outperform its sector peers. The division now accounts for 28 percent of sales at Hermès.

Taking the Long View
Jean Vigneron, a consultant specialized in the creative industries at executive search company Egon Zehnder, said the length of Nichanian’s tenure was matched by only a handful of industry figures, among them Karl Lagerfeld at Chanel, and founders like Giorgio Armani and Ralph Lauren.

“This really shows us once again that Hermès operates on its own timeline — it’s not driven by trends. What’s fascinating is how stable it’s remained, with a long-term perspective that feels very deliberate. It’s less about reacting to what’s going on in the world and more about staying true to a clear identity,” he said.

Far from stodgy, that approach is reaping dividends amidst upheaval at many leading houses, Vigneron noted. “Paradoxically, at a time when the world feels incredibly fragmented and complex, the brands that are the most steady, the ones that don’t wildly change direction, seem to be the ones thriving,” he said.

A graduate of the École de la Chambre Syndicale de la Couture Parisienne, Nichanian began her career at Cerruti, working under Nino Cerruti.

She was asked to join Hermès in 1988 by its legendary chief executive officer Jean-Louis Dumas, becoming one of the few women leading a menswear division at a major luxury house. During her tenure, the brand has grown into an industry behemoth, with revenues of 15.2 billion euros in 2024.

“Working for Hermès since 1988 has been an immense pleasure. I am very proud to be part of this big family in which I have been able to flourish and enjoy total creative freedom,” the 71-year-old designer said in the statement issued by Hermès.

Her spring 2026 was a condensé of her signature style, combining sensual textures — think leather openwork weave on shirts and trousers, rough edges on jaunty silk twill bandanas, and ribbed and nubby knits — with a breezy sense of luxury.

“My wish has always been to create clothes of today for the long term. To me, there is not an Hermès man; there are Hermès men,” she said.

Laia Farran Graves, author “The Story of the Hèrmes Scarf,” said that while Nichanian remained under the radar, her impact on the industry has been considerable.

“What she’s done is pretty incredible. She has brought together comfort, luxury, utility, beauty and simplicity of lines, combined with the heritage, and created this very specific look,” she said.

Above all, Nichanian managed to project a seamless elegance. “There’s so much work involved — a bit like when you see a swan, but underneath, they’re doing all the work,” said Farran Graves.

A Loyal Team
Hermès lauded her knack for “chic, discreet and timeless elegance” and continuous research around materials, know-how and color.

“We thank Véronique warmly for her eye, her vision, her generosity, her energy and her curiosity. Propelled by her talent, conviction and whimsy, she has guided the destiny of a man who walks with allure. The success of the men’s universe owes much to her,” it said.

One key to her success has been inspiring loyalty in her team, meaning there is a deep well of in-house talent to ensure continuity at the brand.

“The menswear team has remained very stable. Many of them have grown in stature inside the house and know it inside out. And honestly, I think in menswear, you need a star designer far less than you do in womenswear,” Vigneron said.

The question is whether anyone from that team is ready to step into a more visible role. “She was never a showboat designer, but it also depends on who likes the limelight and who doesn’t,” Gallagher said.

Vanhee, meanwhile, has been with the house since 2014. She is widely expected to lead its planned foray into haute couture, which could launch in late 2026 or early 2027, and could also be charged with overseeing the men’s division.

“I don’t think that adding couture into Nadège’s remit and adding men to Nadège’s remit would necessarily overextend her. I think the structure would form around her,” said Gallagher, noting that brands like Givenchy already cumulate all three divisions under one designer.

But what sets Hermès apart from other luxury houses is that the creative directors of all its divisions report to artistic director Pierre-Alexis Dumas, the son of Jean-Louis Dumas and cousin of the current CEO, Axel Dumas.

“They’ve got trusted people leading each creative department, people who really understand the codes of the house, but there’s an overarching vision, so they’re able to keep everything aligned, like a shepherd keeping the flock together,” Vigneron said.

“With so many creative directions and specialized roles, that macro perspective is essential. These are individuals who have the brand’s DNA in their veins — they really get it, and that’s invaluable,” he said.

With that in mind, Nichanian’s replacement will have to align with the house’s identity and avoid alienating the core Hermès customer.

“I don’t see a big change coming. The menswear at Hermès is like the brand itself: elegant, timeless and efficient,” Vigneron said. “If someone younger were to come in, sure, they might bring a sharper sensitivity to certain social topics — that’s natural and generational — but it would be a matter of nuance.”

Farran Graves agreed that Hermès has little to gain by tinkering with a winning formula.

“I don’t have a crystal ball, but given the structure of the brand and how strong the family ethos is, it would make sense to me that they hire within and keep it really tight and close, because they’re doing really well, unlike some of the other brands,” she said. “I would say it’s still a time to play safe.”

>>> Novo Nordisk : Confirms US FDA approval of oral semaglutide for cardiovascul

Novo Nordisk : Confirms US FDA approval of oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event
  • Rybelsus® (semaglutide) tablets 7 mg or 14 mg, the only FDA-approved oral GLP-1 medicine available, now indicated to reduce the risk of major adverse cardiovascular events (MACE) such as CV death, heart attack, or stroke in adults with type 2 diabeteswho are at high risk for these events1
  • In the SOUL trial, oral semaglutide 14 mg reduced the risk of MACE by 14% compared to placebo, in addition to standard therapies
  • Milestone underscores the robust data supporting oral semaglutide and demonstrates Novo Nordisk's cardiometabolic leadership and commitment to people living with chronic disease

Novo Nordisk announced today that the US Food and Drug Administration (FDA) has approved Rybelsus®, the only oral GLP-1 medication available, for reducing the risk of major adverse cardiovascular events (MACE) such as cardiovascular (CV) death, heart attack, or stroke in adults with type 2 diabetes who are at high risk for these events, whether they've had a prior CV event or not (primary and secondary prevention).

Results of the SOUL trial reinforce the clinical profile of the semaglutide molecule, which has been studied across a variety of therapeutic areas.

This new indication makes Rybelsus® the only oral GLP-1 medicine approved to reduce the risk of MACE in adults with type 2 diabetes who are at high risk for these events. It serves for both primary prevention (reducing the risk of major adverse cardiovascular events by preventing or managing risk factors in adults who are at high risk for these events) and secondary prevention (reducing the risk of another event in people who have had a serious CV event).

The primary objective of the phase 3b SOUL trial was to evaluate the effects of oral semaglutide 14 mg, in addition to standard of care, on reducing the risk of MACE in adults with type 2 diabetes at high risk for major cardiovascular events. The primary endpoint of the study was the time to first occurrence of MACE (a 3-point composite of CV death, non-fatal myocardial infarction, or nonfatal stroke). MACE events occurred in 579/4825 participants (12.0%) of the semaglutide group and 668/4825 participants (13.8%) of the placebo group (HR 0.86; 95% CI, 0.77-0.96; p=0.006).2 Oral semaglutide 14 mg demonstrated a statistically significant 14% relative reduction in risk of MACE at 4 years (2% absolute risk reduction at 3 years) compared with placebo.2 These results add to the extensive body of randomized clinical trial and real-world evidence supporting semaglutide.

The overall safety profile of oral semaglutide 14 mg in SOUL was consistent with that seen in previous trials, with safety data collection focused on serious adverse events, those of special interest, and those leading to discontinuation.2 The most common serious adverse events (SAEs) in the oral semaglutide 14 mg and placebo groups were cardiac disorders (17.8% and 19.8%, respectively) and infections/infestations (15.0% and 16.5%, respectively). SAEs were less common with oral semaglutide 14 mg (47.9%) than with placebo (50.3%), although there was a higher incidence of gastrointestinal disorders with oral semaglutide 14 mg (5.0% versus 4.4%). Adverse events that led to permanent discontinuation of oral semaglutide or placebo occurred in 749 participants (15.5%) in the oral semaglutide group and in 559 participants (11.6%) in the placebo group. Such events were mainly gastrointestinal disorders as well as infections or infestations.2

The FDA initially approved Rybelsus® in 2019 as the first and only GLP-1 medicine in pill form, along with diet and exercise, to improve glycemic control for adults with type 2 diabetes.1

Separately, Novo Nordisk has also submitted a supplemental application in the US for a once-daily oral formulation of semaglutide under the trade name Wegovy® for the treatment of obesity. A decision is expected later this year.