EUROPE Private jobs in spotlight amid data blackout Reuters
A Quantitative Analysis of the Effects of the Government Shutdown on the Economy Under Three Scenarios, as of October 29, 2025 Congressional Budget Office (.gov)
US Senate Minority Leader Chuck Schumer, Democrat from New York, speaks during a press conference at the US Capitol in Washington, DC.US economy in the dark as govt shutdown cuts off crucial data Qatar Tribune
A month without data muddles the economic picture The Spokesman-Review
US Week Ahead: Don’t focus on data blip in October employment report rbc.com
Manufacturing PMI for eurozone, U.K., Germany, France, Italy; trading update from Ryanair
Opening Call:
European stock futures traded higher early Monday. Asian stock benchmarks were up; the dollar weakened; Treasury yields were unchanged; while oil futures and gold strengthened.
Equities:
Stock futures started the new month higher, after the Organization of the Petroleum Exporting countries and their allies agreed to boost oil production next month but pause further production gains for the first three months of 2026.
Market participants would have looked to a U.S. jobs report for direction this week, but with the continuing government shutdown, the report is suspended for now. Economists and investment analysts anticipate that once more jobs data becomes available, it may reveal a more sobering picture of the labor market.
“If you enter a period where you’ve got net job losses, eventually it’s going to hit the economy and it’s going to hit equity markets,” said Luke Tilley, chief economist at Wilmington Trust.
Forex:
The U.S. dollar is likely to bottom in early 2026, as the Federal Reserve is expected to cut interest rates further and there is a lack of clarity over who the next Federal Open Market Committee chair will be, HSBC Global Investment Research said.
The bank said that dollar bears will face fresh tests this week, with several Fed speakers and U.S. activity indicators on the radar. ISM purchasing managers index readings and the ADP national employment report due this week will likely play a bigger role in driving the dollar over the coming days, it added.
Bonds:
Europe’s three biggest economies are stuck in a cycle of weak growth, leading to widening budget deficits. France is the epicenter of this shift and remains mired in a budget and political crisis, while the U.K. is eyeing tax hikes to try to narrow the gap and avoid spooking markets. Famously frugal Germany and the Netherlands are taking on debt, albeit from lower levels.
Meanwhile, southern countries like Spain have emerged as a rare bright spot for European growth, with governments that 15 years ago faced insolvency like Greece running nearly balanced books.
“The fiscal homework was done in southern Europe in the aftermath of the sovereign debt crisis,” said Filippo Taddei, a senior economist at Goldman Sachs. “In each of these countries, the fiscal outlook is remarkably more cautious than in the case of France, or even the Netherlands and Germany.”
Energy:
Brent crude oil is expected to trade in a range of $60-$65 a barrel in 2026, MBSB Research analysts said. Oil supply is projected to rise by an additional 2.4 million barrels a day next year. Downside risks are expected to persist due to a rising supply surplus that demand might struggle to absorb fully.
Growth could also be modest on the demand side, they said. However, a few factors could help support oil prices above $60 a barrel despite the anticipated supply-demand imbalance. These include China’s efforts at oil stockpiling and potentially lower Russian supply due to recent U.S. sanctions.
Metals:
“Investors in China were disappointed with new legislation from the Ministry of Finance that scrapped a long-standing gold tax incentive,” ANZ Research analysts said in a report, citing reports of China’s Finance Ministry ending a tax incentive for sales of the precious metal effective Nov. 1.
Retail investors are no longer able to offset the value-added tax when selling gold bought from the Shanghai Gold Exchange, the analysts added. The regulatory move could have wide repercussions as China is one of the world’s biggest gold consumers.
–
Copper fell, after disappointing economic data from China raised concerns about weaker demand, ANZ Research analysts said in a note. Fed Chair Powell’s comments about reining in expectations for a December rate cut also likely weighed on sentiment, they added.
–
Iron ore weakened in Asian trading. Short-term positive factors on macroeconomic levels have largely been priced in, and focus is shifting back to fundamentals, Nanhua Futures analysts said.
Supply stays elevated and port inventories continue to build, they said. If the pressures persist, current valuations could face correction risks, the analysts added.
TODAY’S TOP HEADLINES
Europe’s Role Reversal: The Problem Economies Are Now Further North
The European debt crisis of the early 2010s created an image of a continent cleaved in two: The fiscally responsible core countries led by Germany versus the spendthrift southern periphery of Portugal, Italy, Greece and Spain-disdainfully dubbed PIGS.
Nowadays, there has been a role reversal. Europe’s three biggest economies are stuck in a cycle of weak growth, leading to widening budget deficits. France is the epicenter of this shift and remains mired in a budget and political crisis, while the U.K. is eyeing tax hikes to try to narrow the gap and avoid spooking markets. Famously frugal Germany and the Netherlands are taking on debt, albeit from lower levels.
How the U.S. Economy Has Defied Doomsday Predictions on Tariffs
When President Trump announced sweeping tariffs in April, economists predicted surging inflation and raised the odds of a recession. Companies and consumers stockpiled to get ahead of price rises. Those worries now seem overblown.
Inflation, while too high, is lower than forecasts. And the economy continues to grow despite the steepest tariffs in almost a century.
The Latest Buzzy Tech Investment: Ukrainian Drones
Ukraine has pioneered the use of drones in battle. Now Western investors are trying to get a piece of the action.
Foreign investment in Ukrainian drone makers and other defense technology has risen this year, founders and investors say, driven by the prospect of the battle-tested technology winning a slice of rising military spending.
OPEC and Allies Agree to Boost Oil Production, Then Pause
The Organization of the Petroleum Exporting Countries and its allies agreed to boost oil production next month but signaled they would soon pause output increases.
Eight OPEC+ members led by Saudi Arabia said they would raise production by 137,000 barrels a day in December-the same output increase agreed on for November and October-the group said Sunday after an online meeting.
Why Pfizer Can Still Prevail in the Obesity Fight With Novo Nordisk
The gloves are off in the obesity-drug fight. But Novo Nordisk might be swinging so hard it risks losing its balance.
The maker of Ozempic has been losing ground to Eli Lilly and a crop of copycat GLP-1 makers such as Hims & Hers Health. Novo’s new chief executive, Mike Doustdar, deserves credit for shaking up a once-stodgy Danish pharma with a move fast and break things mindset. He inherited a company rapidly ceding share, and his response has been urgent: layoffs to free up cash for reinvestment, and a dealmaking spree that included the acquisition of Akero Therapeutics, a company with a liver-disease treatment, for up to $5.2 billion.
Write to singaporeeditors@dowjones.com
Expected Major Events for Monday
01:01/IRL: Oct Ireland Manufacturing PMI
05:30/NED: Sep Retail turnover
06:00/NED: Oct Netherlands Manufacturing PMI
07:00/TUR: Oct Turkey Manufacturing PMI
07:00/TUR: Oct CPI
07:00/TUR: Oct PPI
07:30/SWI: Oct CPI
08:00/POL: Oct Poland Manufacturing PMI
08:15/SPN: Oct Spain Manufacturing PMI
08:30/CZE: Oct Czech Republic Manufacturing PMI
08:30/SWI: Oct procure.ch Purchasing Managers’ Index
08:45/ITA: Oct Italy Manufacturing PMI
08:50/FRA: Oct France Manufacturing PMI
08:55/GER: Oct Germany Manufacturing PMI
09:00/GRE: Oct Greece Manufacturing PMI
09:00/EU: Oct Eurozone Manufacturing PMI
09:30/UK: Oct S&P Global UK Manufacturing PMI
10:00/CYP: Sep Retail trade
16:59/AUT: Oct Unemployment figures
All times in GMT. Powered by Onclusive and Dow Jones.
Write to us at newsletters@dowjones.com
We offer an enhanced version of this briefing that is optimized for viewing on mobile devices and sent directly to your email inbox. If you would like to sign up, please go to https://newsplus.wsj.com/subscriptions.
This article is a text version of a Wall Street Journal newsletter published earlier today.
US President Donald Trump says he does not know who Changpeng Zhao is, despite pardoning the cryptocurrency multi-billionaire last month.
Trump was asked about the pardon during an interview with CBS News’ 60 Minutes programme, which was broadcast on Sunday.
Zhao, who is also known as “CZ”, pleaded guilty to enabling money laundering in 2023. He served four months in prison and agreed to step down as the chief executive of Binance, the crypto exchange he co-founded.
His companies have partnered with firms linked to Trump on new digital-currency projects including Dominari Holdings, where his sons sit on the board of advisers and which is based in Trump Tower.
The host of 60 Minutes, Norah O’Donnell, asked Trump why he pardoned Zhao even though government prosecutors had said he caused “significant harm to US national security.”
“Okay, are you ready? I don’t know who he is”, the president responded.
Trump added that he did not recall meeting Zhao and had “no idea who he is”, only that he had been told that the businessman was a victim of a “witch hunt” by the administration of former US president Joe Biden.
During the interview, Trump also discussed his support for cryptocurrencies and said that the US had to make sure it was a leader in the industry or risk China and its rivals gaining an advantage in the emerging technology.
The president’s pardon lifts restrictions that had stopped Zhao from running financial ventures, but it is unclear whether it changes his standing with US regulators or his role at Binance.
At the time of the pardon, White House Press Secretary Karoline Leavitt called Zhao’s prosecution under the Biden administration part of a “war on cryptocurrency”, pushing back on critics who said the pardon appeared motivated by Trump’s personal financial interests.
“This was an overly prosecuted case by the Biden administration,” she said, adding that the case had been “thoroughly reviewed”. “So the president wants to correct this overreach of the Biden administration’s misjustice and he exercised his constitutional authority to do so.”
The Binance platform remains the most used crypto exchange in the world for trading digital assets.
The Trump administration previously halted a fraud case against crypto entrepreneur Justin Sun, after his investments in the Trump family’s crypto firm, World Liberty Financial.
He has also pardoned founders of the crypto exchange BitMEX, who faced charges related to money laundering, and Ross Ulbricht, founder of the Silk Road, the dark web marketplace known as a place for drug trade.
Traders work on the floor at the New York Stock Exchange on Sept. 17, 2025.
Brendan McDermid | Reuters
Stock futures were little changed on Monday morning, as a new month of trading begins.
S&P 500 futures ticked higher by 0.17%, while Nasdaq-100 futures were up 0.26%. Dow Jones Industrial Average futures advanced 49 points, or 0.1%.
Wall Street is coming off a winning session that added to the benchmark’s October gains. The S&P 500 and Dow industrials climbed 2.3% and 2.5%, respectively, for the month. The Nasdaq Composite outperformed, gaining 4.7%.
Those gains were driven in part by continued momentum in the artificial intelligence trade as well as signs of easing trade tensions between the U.S. and China.
More than 300 S&P 500 companies have posted third-quarter results thus far. Of those, over 80% have beaten expectations, according to FactSet. Wall Street will get another 100-plus companies reporting this week, including AI-related names Palantir and AMD.
“Fundamentally, the U.S. earnings picture remains strong and supported by these 3 factors: AI spending visibility remains strong and Amazon’s strong 3Q25 report is the latest evidence of this; financials are driving innovation via blockchain; the Fed is dovish and lowering interest rates; and QT (quantitative tightening) is ending Dec 1,” wrote Tom Lee, head of research at Fundstrat.
Wall Street may get a seasonality boost this month. Data from the Stock Trader’s Almanac shows the S&P 500 averages a 1.8% gain in November, making it the strongest month historically for the benchmark.
Investors also kept an eye on Washington, as the U.S. government remains shut down. The stoppage has delayed several key economic data releases, including the monthly jobs report.
On top of that, the Supreme Court is expected to hear oral arguments on legality of the Trump administration’s tariffs.
Advertisers used to call the weeks following Halloween heading into Christmas the “hard eight”. Today, the commercial calendar is morphing in the face of altered shopping habits and brands that refuse to wait a month to capture market demand.
More than one-fourth (28%) of U.S. consumers (and 37% of millennial consumers) said they had begun their holiday shopping before October; only 11% said they planned to start shopping from Black Friday onwards, per a McKinsey survey. An Experian study also found that 45% of shoppers started purchasing before November. Principally that’s driven by cost-of-living worries; 39% of U.S. consumers say their day-to-day spending was the most stressful element of their lives, up 9% on last year per a survey of 24,000 people by the Kearney Consumer Institute.
If shoppers are buying before advertisers’ holiday campaigns kick in, that’s an issue for brands. “Now, the holiday shopping season starts in October. If your brand isn’t there competing during this time, you can be behind the eight ball,” said Phil Carney, manager of account management at Adroll, a digital marketing platform that’s often used by e-commerce businesses to place media buys.
The holidays are already a peak spending period for brands; globally, retailers spent $46 billion on advertising in the fourth quarter of 2024, per WARC projections. According to media agencies, so-called “holiday creep” led to some sending upper-funnel spending into flight earlier in the season in an effort to influence shoppers farther in advance of the season’s peak.
“We’ve definitely seen clients planning ahead for earlier holiday shopping,” said Ashley Terpstra, media director at Collective Measures. Upper-funnel spending — she highlighted channels such as TV, podcasts, out-of-home, YouTube, and paid social — had kicked in earlier, Terpstra said.
“We’re seeing a bigger or much bigger uptick in October, especially in the last two weeks, compared to the last handful of years,” said David Dweck, general manager at Go Fish Digital. Dweck estimated client spending in October was 2.5 times higher than in previous years but he didn’t provide a specific dollar amount. “We went into the cycle basically telling our advertisers to be prepared with multiple promo offers and to be ready to deploy them pretty quickly. We’re seeing very value-conscious consumers right now.”
Just how early brands are pushing their spend differs from vertical to vertical. Dan Rolli, chief investment officer of OMD U.S., told Digiday that in the main, advertisers are stretching budgets over a longer duration rather than adding incremental dollars. “We’re starting a lead-in to those brand-focused moments a little bit earlier… extending that flight,” said Rolli.
Programmatic and media companies have also picked up on ad spend migrating earlier in the year. John Campbell, svp entertainment and streaming solutions at Disney, said brand partners began booking holiday-related brand messaging as early as August this year, a full month earlier than usual.
“People are thinking about it way earlier, and we’re seeing brands want to get their message out much earlier,” he said.
Oscar Rondon, vp of data and measurement solutions at Nexxen, also told Digiday that advertisers began planning for the fourth quarter earlier than usual, a sign that spending was also being spread over a longer period of time. “Anecdotally, in July and August we had several key partners starting to reach out,” he said. (Neither Campbell nor Rondon shared specific dollar projections.)
Spending on lower-funnel channels like search — heavily relied upon by brands during this key sales period — remain focused on Thanksgiving and November, the media execs suggested, indicating that Black Friday remains a powerful sales opportunity.
Liz Cooney, group director, media strategy at Wpromote, told Digiday that 40% of the media agency’s clients had shifted more investment into September and October. “Most of the budget shift is in upper-funnel media to drive awareness and consideration as shoppers begin browsing,” she said, adding that “Conversion budgets remain focused on peak shopping periods such as Black Friday and Cyber Monday.”
But pushing campaigns to earlier in the season isn’t the only option available. While more shoppers are spending more in advance of the season, buyers warn against “leaving demand on the table” November through December. “Not being present can mean losing out on incremental purchases,” said Terpstra.
Rolli also warned against consulting consumer polls too closely. “We’ve heard early survey data that says they will be more budget-conscious… [but] even with the sales potentially starting earlier, that does not always translate to buying earlier,” he cautioned.
After all, consumer sentiment surveys have marked a gloomy tone throughout 2025, with tariffs and political strife looking large on the news agenda. Actual consumer spending data shows a more positive picture, however. “What someone says and what they do are sometimes two different things,” said Rolli.
Home loan applications have surged in response to the government’s expanded 5% deposit scheme, according to Westpac, as first home buyers pile into a hot property market accelerating at its fastest pace in years.
Applications for government-guaranteed mortgages at the big bank more than doubled in October 2025 compared to October 2024, after a 150% jump when the scheme expanded on 1 October, Nathan Goonan, the bank’s chief financial officer, said on Monday.
“The first home buyers guarantee scheme has certainly stimulated some interest,” Goonan told analysts.
“That mortgage market has been accelerated and … we’re certainly feeling that or seeing that, we’ve had increases in pretty much every channel.”
Mortgage brokers have previously reported a surge in applications from prospective buyers using the guarantee, which led to long processing delays.
Westpac declined to specify the number or value of applications but advised brokers that applications would take two weeks to process.
The 5% guarantee slashed the deposit requirements for a loan, reducing the savings wait time for many first-time homeowners.
The splash of new owner-occupiers contrasts with a market that has otherwise been dominated by investors, many of whom have used equity in their existing housing portfolios to outbid prospective first home buyers at auctions.
Westpac’s new lending to first home buyers had been going backwards, amounting to just $12bn in the 12 months before the expansion of the guarantee, down from $14bn in the previous year.
Sign up: AU Breaking News email
Investor lending accounted for most of the growth in the bank’s lending over the same period, rising nearly $8bn to $44bn over the same period, while other mortgages rose about $4bn.
House prices have been helped by the Reserve Bank’s decision to cut the official cash rate on three occasions this year to 3.6%, fuelling national home lending and house price growth, which Westpac predicted would continue to accelerate over the next 12 months.
Lower interest rates have also helped more mortgage holders get on top of their repayments. The bank reported its delinquency rate for Australian home loans more than 90 days behind fell to 0.73%, from 1.12% a year ago.
Hopes of further interest rate relief were recently dashed amid signs of rising inflation.
Investors are still very active in the property market, with national data showing new loans to investors in September accelerating at their fastest monthly pace in more than a decade.
The Australian Prudential Regulatory Authority on Friday said it was carefully monitoring whether falling interest rates led to riskier lending. It was discussing limits on new investor, interest-only or small-deposit loans.
The Westpac chief executive, Anthony Miller, said the bank planned to fight for more of the investor market, while acknowledging it faced risks if it went “too far, too fast”.
skip past newsletter promotion
after newsletter promotion
Flexible work
Miller stood firm on Monday on the organisation’s work-from-home position in the wake of a precedent-setting Fair Work Commission ruling that overturned an order from the bank for one of its employees to attend a corporate office two days a week.
“No, I don’t feel the need to change that particular setting,” Miller said.
“We have one of the most flexible work-from-home … positions in the marketplace.”
Miller said the bank was reflecting on its response to the decision and would decide on its next step within the next two weeks.
Westpac updated its sustainability report to show it has closed funding avenues available to thermal coalminers, which traditionally rely on banks for direct finance, or by raising money through the issuing of bonds.
Westpac’s report said it had “reduced to zero our corporate lending to institutional thermal coalmining customers” and no longer provided bond facilitation for customers that derived significant revenue from thermal coalmining. Thermal coal is burnt to produce electricity.
While some Australian financiers have ruled out direct loans to thermal coalmines, they have left indirect financing avenues open through bond facilitation.
Kyle Robertson, head of research at activist group Market Forces, said while Westpac had officially exited all lending to companies mining coal for power, it continued to lend significant sums to the oil and gas extraction sector.
The bank reported a 2% slide in annual profit to $6.9bn at its full-year results, down from $7.1bn a year ago.
It will pay a full-year dividend of $1.53 per share.
Volunteers for the 8th China International Import Expo take their oath on Oct 29, ready to welcome participants from worldwide. [Photo/Shanghai Observer]
As the 8th China International Import Expo approaches, 3,865 volunteers, affectionately known as “little leaves”, are preparing to assist participants.
These young volunteers, recruited from local schools, earn their nickname from the expo venue’s resemblance to a four-leaf clover.
This year, the volunteers, including 30 international students, will be stationed across various functions such as onsite guidance, registration management, guest liaison, media support, data collection, IT assistance, and healthcare services.
To enhance multilingual services for exhibitors and buyers, the volunteer service team has partnered with nine higher education institutions in Shanghai, including Fudan University, Tongji University, East China Normal University, and Shanghai International Studies University.
This collaboration has created a multilingual volunteer talent pool and established the CIIE Multilingual Volunteer Alliance. A total of 129 volunteers proficient in 12 languages, including German, French, Spanish, Russian, and Arabic, have been recruited for this year’s expo.
Oil prices climbed in early Asian trade on Monday after OPEC+ decided to hold off production hikes in the first quarter of next year.
Olga Rolenko | Moment | Getty Images
Oil prices climbed in early Asian trade on Monday after OPEC+ decided to hold off production hikes in the first quarter of next year, easing rising fears of a supply glut.
Brent crude futures rose 47 cents, or 0.73%, to $65.24 a barrel by 2336 GMT after closing 7 cents higher on Friday. U.S. West Texas Intermediate crude was at $61.43 a barrel, up 45 cents, or 0.74%, after settling up 41 cents in the previous session.
The Organization of the Petroleum Exporting Countries and their allies, known as OPEC+, agreed on Sunday to raise output by 137,000 barrels per day in December, the same as for October and November.
“Beyond December, due to seasonality, the eight countries also decided to pause the production increments in January, February, and March 2026,” the group said in a statement.
RBC Capital analyst Helima Croft said: “There is ample ground for a cautious approach given the uncertainty over the Q1 supply picture and the anticipated demand softness.”
She added that Russia remains a key supply wild card in the wake of the U.S. imposing sanctions on Rosneft and Lukoil as well as the ongoing strikes on Russian energy infrastructure.
A Ukrainian drone attack struck on Sunday the Tuapse port, one of Russia’s main Black Sea oil ports, causing a fire and damaging at least one ship.
Brent and WTI fell more than 2% for a third straight month in October, hitting a five-month low on October 20 on fears of a supply glut and economic concerns about U.S. tariffs.
Analysts are holding their oil price forecasts largely unchanged as rising OPEC+ output and lackluster demand offset geopolitical risks to supply, a Reuters poll showed. Estimates of oil market surplus ranged anywhere from 0.19 to 3 million bpd.
The Energy Information Administration reported on Friday that U.S. crude oil output rose 86,000 bpd to a record 13.8 million bpd in August.
On Friday, President Donald Trump denied he was considering strikes inside Venezuela amid intensifying expectations that Washington may soon expand drug-trafficking-related operations.
Shares of several Chinese electric-vehicle makers surged sharply Monday, after they reported robust October sales over the weekend.
XPeng and NIO rose 3.8% and 2.9%, respectively by midday, after XPeng delivered a record high 42,013 units in October. NIO also posted a record sales for the month, at 40,397 units, up 93% compared with the same period a year earlier.
Xiaomi's shares gained 3.5% after news its delivered more than 40,000 units last month. Zhejiang Leapmotor's shares rose 0.8% after it said October sales were 84% higher at 70,289 units.
Zeekr Group, which is being taken private by its parent, Geely Automobile, posted strong sales of 21,423 units.
The auto giant BYD sold 441,706 units last month. Its shares fell 2.4% in Hong Kong weighed by news of lower net profit and revenue in the third quarter.
Chinese auto sector is seeing some recovery in demand as the peak season for sales approaches and as auto makers try to clear inventories in the final quarter of the year.
HONG KONG, Nov. 2, 2025 /PRNewswire/ — Akeso (9926.HK) announced that its first-in-class bispecific antibody, ivonescimab (PD-1/VEGF bispecific antibody), in combination with chemotherapy for first-line treatment of triple-negative breast cancer (TNBC) has been granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) from China’s National Medical Products Administration (NMPA).
The Phase III multicenter, randomized, double-blind clinical trial (HARMONi-BC1/AK112-308) for this combination therapy is ongoing in China. The BTD designation is expected to further expedite the clinical development and regulatory approval process of ivonescimab for the treatment of TNBC. This marks the fourth BTD granted by the CDE for ivonescimab. The previous three designations include:
Ivonescimab combined with chemotherapy for locally advanced or metastatic NSCLC resistant to EGFR-TKI therapy, which has now been approved for marketing in China and added to China’s National Reimbursement Drug List.
First-line treatment of PD-L1-positive locally advanced or metastatic NSCLC, which has also been approved for marketing in China.
Ivonescimab combined with docetaxel for locally advanced or metastatic NSCLC patients who have failed previous PD-1/L1 inhibitors and platinum-based chemotherapy. The Phase III clinical trial for this indication in China is currently ongoing.
Receiving four Breakthrough Therapy Designations affirms ivonescimab’s substantial clinical benefit across multiple major cancer types and reinforces Akeso’s commitment to addressing critical unmet medical needs. The therapy is currently advancing in 14 Phase III clinical trials worldwide, including four international multicenter studies. These large pivotal studies, backed by repeated regulatory recognition, position ivonescimab to deliver transformative, life-saving outcomes for patients worldwide.
Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, “Akeso”) contains “forward-looking statements”. These statements reflect the current beliefs and expectations of Akeso’s management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso’s other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law.
About 依达方® (PD-1/VEGF Bispecific, Ivonescimab)
Ivonescimab is a first-in-class, PD-1/VEGF bispecific immuno-oncology agent developed by Akeso. In May 2024, it received approval from the China National Medical Products Administration (NMPA) for the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer (nsq-NSCLC) after EGFR-TKI therapy. This approval made ivonescimab the world’s first bispecific antibody based on a synergistic “immunotherapy plus anti-angiogenesis” mechanism. In November 2024, ivonescimab was also included in China’s National Reimbursement Drug List (NRDL).
Additionally, ivonescimab has been approved as a first-line treatment for advanced NSCLC with positive PD-L1 expression. In the Phase III HARMONi-2 study, ivonescimab demonstrated superior efficacy compared to pembrolizumab, resulting in significantly improved clinical outcomes.
In 2025, the final overall survival (OS) analysis from the HARMONi-A study showed that ivonescimab met the OS endpoint, providing clinically meaningful and statistically significant OS benefits. As the first final OS analysis in a Phase III trial of ivonescimab, these results reaffirm the agent’s groundbreaking value in both progression-free survival (PFS) and overall survival for patients. Moreover, a head-to-head Phase III trial comparing ivonescimab plus chemotherapy to tislelizumab plus chemotherapy in first-line treatment for squamous NSCLC also yielded promising results. These findings position ivonescimab as a substantial clinical breakthrough whether in comparison to PD-1 monotherapy in immuno-oncology, the current standard of care (SOC) of PD-1 inhibitors combined with chemotherapy, or VEGF-targeted therapies in the anti-angiogenesis field. This underscores ivonescimab’s significant potential in cancer treatment.
As ivonescimab continues to demonstrate substantial clinical value and the potential to redefine treatment standards, its presence in key immuno-oncology indications is expanding rapidly. In lung cancer, the most prevalent cancer globally, ivonescimab is currently involved in 8 registrational/Phase III clinical studies, including:
First-line NSCLC (squamous and non-squamous, compared to pembrolizumab + chemotherapy, international multicenter)
First-line squamous NSCLC (compared to tislelizumab + chemotherapy)
NSCLC after EGFR-TKI progression (HARMONi-A and HARMONi)
First-line PD-L1-positive NSCLC (compared to pembrolizumab)
First-line PD-L1-highly expressed NSCLC (compared to pembrolizumab)
IO-resistant NSCLC
Consolidation therapy for limited-stage small cell lung cancer post-concurrent chemoradiotherapy
In other major tumor types, ivonescimab is rapidly advancing first-line indications with ongoing Phase III trials in:
First-line biliary tract cancer (compared to durvalumab + chemotherapy)
First-line PD-L1–positive head and neck squamous cell carcinoma in combination with ligufalimab (CD47) (compared to pembrolizumab)
In the challenging area of cold tumors, ivonescimab has received its fourth Breakthrough Therapy Designation for first-line triple-negative breast cancer. Additionally, Phase III studies are underway for first-line MSS/pMMR colorectal cancer (which accounts for 95% of CRC cases) and first-line pancreatic cancer. Further Phase III studies are also being prepared.
With nearly 20 Phase II studies across more than 10 additional indications, ivonescimab has established a robust data foundation to support the rapid global expansion of Phase III trials.
About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world’s first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise.
For more information, please visit https://www.akesobio.com/en/about-us/corporate-profile/ and follow us on Linkedin.
