Category: 3. Business

The combination of teclistamab-cqyv (Tecvayli) and daratumumab and hyaluronidase-fihj (subcutaneous daratumumab; Darzalex Faspro) demonstrated an improvement in progression-free survival (PFS) and overall survival (OS) compared with subcutaneous daratumumab plus pomalidomide and dexamethasone (DPd) or subcutaneous daratumumab plus bortezomib and dexamethasone (DVd) in patients with relapsed or refractory multiple myeloma who received 1 to 3 prior lines of therapy, according to topline data from the phase 3 MajesTEC-3 trial (NCT05083169).¹

Additionally, the safety profile of teclistamab with daratumumab was consistent with the known safety profiles of each agent as monotherapy. Full results from the phase 3 study are expected to be presented at an upcoming medical meeting and submitted to global health authorities for review.

“[Teclistamab] is the most utilized BCMA[-targeted] bispecific [antibody] in later lines of myeloma treatment, supported by extensive clinical and real-world evidence. These results [from MajesTEC-3] demonstrate the clinical benefits of teclistamab in earlier lines when used in combination, as evidenced by meaningful PFS and OS outcomes,” Maria-Victoria Mateos, MD, PhD, a consultant physician in Hematology at the University Hospital of Salamanca, stated in a news release. ” [Teclistamab and subcutaneous daratumumab] uniquely work together to target both BCMA and CD38 simultaneously, priming and activating the immune system and eliminating myeloma cells.”

In October 2022, the FDA granted accelerated approval to teclistamab for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least 4 previous lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent, and an anti-CD38 monoclonal antibody.²

Teclistamab Plus Daratumumab in R/R Multiple Myeloma

• MajesTEC-3 showed teclistamab plus subcutaneous daratumumab improved PFS and OS vs DPd or DVd in relapsed/refractory multiple myeloma after 1 to 3 prior lines of therapy.

• The safety profile of the combination was consistent with the known profiles of each agent as monotherapy.

• Full data will be presented at an upcoming medical meeting.

What was the design of the MajesTEC-3 trial?

The phase 3 MajesTEC-3 trial was a randomized, open-label study designed to evaluate the efficacy and safety of teclistamab plus subcutaneous daratumumab compared with DPd or DVd in patients with relapsed or refractory multiple myeloma.³

Eligible patients were required to have a confirmed diagnosis of multiple myeloma after 1 to 3 prior lines of therapy that included a proteasome inhibitor (PI) and lenalidomide (Revlimid). Those who received only 1 prior line of therapy needed to be refractory to lenalidomide. Other key inclusion criteria comprised evidence of progressive disease, an ECOG performance status of 0 to 2, and adequate laboratory values.

Participants were randomly assigned to receive either teclistamab/daratumumab or investigator’s choice of DPd or DVd. In the experimental arm, step-up doses of teclistamab were administered prior to the first full dose.

Along with the primary end point of PFS and key secondary end point of OS, other secondary end points included overall response rate, very good partial response or better rate, complete response or better rate, minimal residual disease–negativity rate, time to second disease progression, PFS on next line of therapy, time to next treatment, duration of response, and safety.

“The MajesTEC-3 study results of [teclistamab and daratumumab], two of our most important agents, demonstrate Johnson & Johnson’s leadership in developing regimens with complementary and synergistic mechanisms of action for patients with multiple myeloma. We are confident this combination is poised to be a new standard of care option,” Yusri Elsayed, MD, MHSc, PhD, global therapeutic area head of Oncology at Johnson & Johnson Innovative Medicine, added in a news release.¹ “The increase in PFS and OS is another example of how our portfolio is fundamentally transforming how patients with multiple myeloma are treated.”

References

1. Tecvayli plus Darzalex Faspro combination regimen significantly improves progression-free survival and overall survival versus standard of care. News release. Johnson & Johnson. October 16, 2025. Accessed October 16, 2025. https://www.jnj.com/media-center/press-releases/tecvayli-plus-darzalex-faspro-combination-regimen-significantly-improves-progression-free-survival-and-overall-survival-versus-standard-of-care
2. FDA approves teclistimab-cqyv for relapsed or refractory multiple myeloma. FDA. October 25, 2022. Accessed October 16, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma
3. A study of teclistamab in combination with daratumumab subcutaneously (SC) (Tec-Dara) versus daratumumab SC, pomalidomide, and dexamethasone (DPd) or daratumumab SC, bortezomib, and dexamethasone (DVd) in participants with relapsed or refractory multiple myeloma (MajesTEC-3). ClinicalTrials.gov. Updated October 10, 2025. Accessed October 16, 2025. https://clinicaltrials.gov/study/NCT05083169

When Chinese AI startup DeepSeek became a global sensation in January, it not only shocked Silicon Valley but also startled ByteDance, TikTok’s parent company. The Chinese tech giant had already launched Doubao, its own flagship AI assistant app with tens of millions of users. But when DeepSeek became the best-known Chinese AI company overnight, no one was talking about Doubao anymore.

Now, ByteDance has gotten its revenge. By August, Doubao regained the throne as the most popular AI app in China with over 157 million monthly active users, according to QuestMobile, a Chinese data intelligence provider. DeepSeek, with 143 million monthly active users, slipped to second place. The same month, venture capital firm a16z also ranked Doubao as the fourth-most-popular generative AI app globally, just behind the likes of ChatGPT and Google’s Gemini.

Doubao, which launched in 2023, was deliberately designed to be personable. Unlike most popular AI chatbots, Doubao’s app icon features a human-looking avatar—a female cartoon character with a short bob that greets people when they open the app for the first time. The name Doubao literally translates to “steamed bun with bean paste,” mimicking “the nickname a user would give to an intimate friend,” ByteDance vice president Alex Zhu said in a public speech in 2024.

Compared to Western AI apps, “there’s a warmer, more welcoming feel,” says Dermot McGrath, a Shanghai-based investor and technologist. “ChatGPT, for example, feels like a tool you open to complete a task and then close again. Doubao has more features and a more colorful user interface that keeps you interested longer.”

The Everything App

Doubao offers users a little bit of everything—it’s like ChatGPT, Midjourney, Sora, Character.ai, TikTok, Perplexity, Copilot, and more in a single app. It can chat via text, audio, and video; it can generate images, spreadsheets, decks, podcasts, and five-second videos; it allows anyone to customize an AI agent for specific scenarios and host it on Doubao’s platform for others to use. One of the most important things about the app, however, is that it’s deeply integrated with Douyin, the Chinese version of TikTok, allowing it to both attract users from the video platform and send traffic back to it.

Somehow, ByteDance’s ambitiously sprawling strategy for Doubao has turned out to be exactly what Chinese users wanted. A little over two years since its launch, Doubao has quietly become the AI app that Chinese people—particularly those who aren’t very AI savvy—are actually using. But it has almost no name recognition in the West.

“It’s marketed at people who are not the most technologically informed, people who may prefer voice chat and video interaction over text,” says Irene Zhang, a researcher at ChinaTalk, a newsletter about Chinese tech. “Some of the earliest Doubao users I heard of were my friends’ grandmothers and aunties.”

An IAEA meeting on the Generic RoadMap project, which supports nuclear newcomer countries in developing nuclear safety infrastructure, highlighted the critical role of capacity building in sustaining national safety infrastructure.

“As countries look for ways to address their energy needs,  nuclear power is attracting increasing attention,” said Anna Bradford, Director of the IAEA Division of Nuclear Installation Safety. “New modalities and initiatives are needed to support efforts to strengthen the global nuclear safety regime.”

The Generic RoadMap

Launched in 2020, the Generic RoadMap (GRM) is part of the IAEA’s efforts to strengthen nuclear safety infrastructure. The GRM guides countries embarking on a nuclear power programme with practical information on how to establish and maintain a comprehensive national nuclear safety infrastructure. This includes practical guidance and information on implementing actions recommended in SSG-16 (Rev.1) to establish and maintain the safety infrastructure for an initial nuclear reactor while meeting all applicable safety requirements.

The GRM is supported by training materials, peer review services and a series of topical publications that complement IAEA safety standards. These resources incorporate lessons learned, challenges identified and solutions implemented by countries that have embarked on or expanded nuclear programs.

Establishing and Integrating Safety Infrastructure

The draft GRM Safety Report, which provides guidance to member countries on meeting IAEA safety standards, was presented to global experts attending the event. The report takes a strategic approach that outlines priorities and associated tasks within a typical timeline from planning to operation. Discussions focused on how to establish and integrate safety infrastructure for a nuclear power plant programme, with presentations on all phases of nuclear reactor projects, from pre-planning to construction and operation. 

Designed to be flexible and scalable, the report’s guidance addresses the needs of both embarking and expanding countries. Member countries with established safety infrastructure were encouraged to conduct a tailored gap analysis to ensure that safety measures are adapted according to their specific contexts.

“The GRM can be utilized by Member States at various levels of ‘nuclear maturity’ and across different phases to establish or enhance their nuclear safety infrastructure,” said Idris Yau Usman, the meeting’s  Co-chair and Chairman of the Nigerian Nuclear Regulatory Authority, adding that “it supports the integration of lessons learned, helps avoid common challenges and promotes the harmonization of international regulatory practices.” 

The head of the International Monetary Fund has admitted that worrying about the risks building up in non-bank lending markets keeps her awake at night.

Kristalina Georgieva on Thursday urged countries to pay more attention to the private credit market, after the failure of sub-prime auto lender Tricolor and the car parts supplier First Brands.

Speaking at the IMF’s annual meeting in Washington DC, Georgieva said the fund was concerned about the “very significant shift of financing” from the banking sector to non-bank financial institutions (NBFIs).

Those NBFIs are not regulated as closely as the banking sector, she pointed out, meaning the world could end up in “a difficult place” if the private credit sector continues to grow significantly and the global economy then weakens.

“This is why we are urging more attention to the non-bank financial institutions,” Georgieva told reporters, suggesting there should be more oversight of the sector. “You are asking the question that keeps me awake every so often at night.”

First Brands and Tricolor had both been backed by private credit within the so-called shadow banking sector, which is not directly regulated and is not forced to disclose the level of risks on their books.

On Tuesday, the head of JP Morgan, Jamie Dimon, warned that more “cockroaches” could emerge from the private credit industry.

“My antenna goes up when things like that happen. I probably shouldn’t say this but when you see one cockroach, there’s probably more. And so everyone should be forewarned at this point,” Dimon said.

Georgieva says the IMF is being “very watchful”, but argues that “so far, not that many cockroaches” have been spotted.

She said she was encouraged that countries across the globe have better policy frameworks than were in place before the global financial crisis of 2008, while “systemically significant economies” have accumulated massive reserves to cope with problems.

But, she cautioned that many countries have exhausted their fiscal buffers, meaning they have little budget headroom to handle a financial crisis, while central banks are still battling inflation, and urged vigilance over the non-bank sector.

“In this environment, of course, the security blanket is covering us, but maybe we have a foot out in the cold. We have to be vigilant. What do we do? We watch it very carefully,” Georgieva said.

She also cited the “stretched valuations” in the stock market as a concern, in the event that the enthusiasm about AI doesn’t pay off, or its benefits take too long to arrive.

Back in June, BlackRock predicted that the private credit sector’s assets under management would grow to $4.5tn by 2030, up from an estimated $3tn today.

BlackRock’s Amanda Lynam and Dominique Bly argued that there is an “expanding addressable market” of both investors and borrowers for private credit. “Indeed, private credit has evolved from an asset class that was best placed to accommodate niche financing solutions, or lending to smaller, middle-market borrowers, to a sizeable, scalable, stand-alone asset class,” they added.

Earlier this week, the IMF warned that the growing exposure to NBFIs is generating concentration risk among some banks in the US and Europe.

The fund is concerned that banks are increasingly lending to private credit funds because these loans often deliver higher returns on equity than traditional commercial and industrial lending, thanks to the lower capital requirements allowed by their collateral structure.

It also warned US stock markets – which have rallied during the AI boom – are at risk of a “sudden, sharp correction” while government bond markets are under mounting pressure.

I am happy to share that SAP Cloud ERP has been recognized as a Leader in the Gartner Magic Quadrant for Cloud ERP for Service-Centric Enterprises for the fourth year in a row.

This recognition is based on our Completeness of Vision and Ability to Execute in the cloud ERP market for service-centric enterprises.

As businesses navigate constant change, they need systems that connect every function, scale intelligently, and provide infrastructure for continuous innovation. I believe this recognition underscores SAP’s commitment to deliver exactly that.

SAP Cloud ERP is the foundation of our broad portfolio of applications, and the centerpiece of the SAP Business Suite. It’s an out-of-the-box enterprise management solution with embedded AI, real-time insights, and the agility to support growth at any stage. Verticalized from day one with industry-specific best practices and capabilities, SAP Cloud ERP helps organizations scale intelligently, stay compliant, and adapt quickly.

When we speak to customers, they appreciate that SAP Cloud ERP is part of a broader portfolio, including our cloud platform SAP Business Technology Platform (SAP BTP), and that it allows customers to quickly take advantage of the latest AI innovations with Joule. In addition, SAP stands out for our extensive, global network of implementation partners.

For us, this recognition is a milestone, but it also pushes us to keep innovating and delivering even greater value to our customers. We hear from customers that we need to be clearer in our value proposition, make adoption easier, and speed up innovation delivery. We take this feedback seriously:

• Cross-functional complexity: We are accelerating the SAP Business Suite strategy to deliver tighter native integration, a unified user experience, and simplified end-to-end processes across finance, supply chain, procurement, HCM, and CX.
• Live customers in complex organizations: Building on global deployments like Bain & Company, we are expanding programs, references, and accelerators to further invest in our industry and geographic scale.
• Pricing clarity: To make planning and TCO more predictable, we have launched persona-based bundles that simplify pricing and clarify the path to adopting AI and extensibility at scale.

Pursuing innovation

Today, the need for clarity and alignment across every business function is critical. Businesses run on a unique mix of applications and data sources, often creating heterogenous landscapes that are difficult to connect. To meet their goals, businesses need a solution that goes beyond isolated applications for individual challenges. 

SAP Business Suite offers a path to connecting every business function, including: an end-to-end portfolio that unifies connected applications, powerful AI agents, and contextualized data on SAP Business Technology Platform. Together, they orchestrate cross-functional processes across an interconnected landscape.

And as the foundation of SAP Business Suite, SAP Cloud ERP ensures seamless integration across finance, supply chain, procurement, and more. With SAP Cloud ERP at the core, SAP Business Suite streamlines critical business functions into a unified system. Our scalable, flexible solutions ensure businesses of all sizes benefit from modern, tailored ERP. 

I believe this recognition from Gartner highlights the need for intelligent, modular cloud ERP. With SAP’s integrated approach, organizations can harmonize data, automate at scale, and expand across regions and industries. As we celebrate this recognition, we remain focused on continuing to lead through innovation and impact. 

Read the full report.

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Eric van Rossum is chief marketing officer of SAP Business Suite and CPO Globalization & Industries at SAP.

Gartner, Magic Quadrant for Cloud ERP for Service-Centric Enterprises, 13 October 2025, Robert Anderson Et Al.
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It was Sue Rizzello’s husband who persuaded her to see a doctor, concerned about the bloating in her abdomen that was making her more and more uncomfortable. Rizzello, then in her late 40s, had assumed it was menopausal weight gain, but agreed to go to her GP. “A smart locum said, ‘There’s something wrong here’, and sent me for a blood test … And that saved my life.”

It was the worst news: Rizzello had stage 3 ovarian cancer that had begun to spread. She would need to begin chemotherapy immediately and prepare for the complete removal of her uterus, ovaries, fallopian tubes and omentum, a procedure that would put her into immediate menopause.

It was the summer of 2012 and her husband, a chef, was working at one of the Olympic venues in Windsor, near to their then home in Slough. For Rizzello, however, “that whole summer was a blur” of painful treatment, including a clinical trial that was so tough, she was told, that many others had been unable to see it through.

Six months later, the marketing consultant was told her cancer had gone. “But I was never the same. It was massive. It was an earth-shaking experience that really shook my confidence to the core.”

Rizzello, now 60, was lucky, but she does not believe her cancer was just “one of those things” – she believes it was caused by talc.

She is one of about 3,000 British-based people – overwhelmingly women – who on Thursday brought a landmark legal action in the high court in London against the pharmaceuticals company Johnson & Johnson, claiming they or a family member contracted cancer after a lifetime using J&J’s baby powder.

Backed by a specialist law firm, the claimants argue that the US-based multinational knew for decades that its talc products might contain dangerous asbestos but failed to warn consumers and carried on selling the products in the UK until 2023.

J&J denies the allegations. A spokesperson for Kenvue, J&J’s former consumer health division that was spun off two years ago, said the talc used in baby powder complied with regulations, did not contain asbestos, and does not cause cancer.

Rizzello says she was in the dark about the origin of her disease, after genetic tests showed she did not carry the BRCA genes that significantly increase the risk of ovarian cancer. “And then I found out about the talc claims, and I thought, hang on.”

“I’ve used talc all my life. I mean, when I was a child, everybody did,” she says, whether after swimming or after a bath. “It was just always there. It was just always something you use.

“I’m totally convinced this was the cause of my own illness, and all the nightmare of treatment and trials that followed.”

J&J has been the subject of long-running lawsuits in the US over similar allegations of cancer links to talc, which it wholly disputes. Two years ago it spun off its consumer health division as Kenvue, which has responsibility for talc-related claims outside the US and Canada.

Kenvue said: “We sympathise deeply with people living with cancer. We understand that they and their families want answers – that’s why the facts are so important.

“The high-quality cosmetic-grade talc that was used in Johnson’s Baby Powder was compliant with any required regulatory standards, did not contain asbestos, and does not cause cancer.”

Two years ago, to mark the 10-year anniversary of being given the all clear, Rizzello asked friends to sponsor her to shave her hair again to raise money for cancer charities, in memory of others with the disease who did not survive. “I felt I really had to do something,” she says. “Many of the women I’ve met along the way had died, and so I always feel like it’s for them as much as it is for me.

“I value some things much more highly than I did before. I think I’ve always dreaded the idea of getting older. I don’t mind getting older now, and I’m so grateful to have a chance to get older.”