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U.S. MANUFACTURING PICKED UP IN JANUARY DRIVEN BY GROWING DEMAND: GEP GLOBAL SUPPLY CHAIN VOLATILITY INDEX

  • The world’s supply chains are operating at full capacity, with the notable exception of Europe, which remains in a protracted industrial recession.
  • Asia’s manufacturing growth was reported by major exporters, led by South Korea, China, and India.
  • Despite the possibility of tariffs and significant uncertainty surrounding their implementation, global manufacturers are not stockpiling inventories.

CLARK, N.J., Feb. 12, 2025 /PRNewswire/ — The GEP Global Supply Chain Volatility Index — a leading indicator tracking demand conditions, shortages, transportation costs, inventories, and backlogs based on a monthly survey of 27,000 businesses — posted -0.21 at the start of the year. This indicates that global supply chains are effectively at full capacity, signaled when the index hits 0.

GEP Global Supply Chain Volatility Index
GEP Global Supply Chain Volatility Index

“January’s rise in manufacturers’ procurement across APAC and the U.S. signals steady growth ahead in Q1,” said John Piatek, GEP’s vice president of consulting. “Globally, companies are largely taking a wait-and-see approach to tariffs rather than absorbing the immediate cost of increasing buffer inventories. However, many Western firms are accelerating China-plus-one investments to diversify and near-shore manufacturing, assembly, and distribution. European manufacturers are especially vulnerable, as the sector has been contracting for nearly two years with no turnaround in sight. In the U.S., where manufacturing represents just 12% of GDP, the bigger concern for business is the potential revenue losses in China because of trade tensions.”

A key finding in January was the marked increase in procurement activity across North America. This increase was entirely driven by U.S. manufacturers, as purchasing managers at Mexican and Canadian factories sanctioned procurement cutbacks, indicating a darkened near-term outlook there.

In Asia, many major producers in the region bolstered their demand for inputs to meet growing production needs, led by China and India. South Korea, in particular, reported a marked pickup in January.

By contrast, Europe’s industrial economy continues to struggle, with our data indicating still-significant levels of spare capacity across the continent’s supply chains. Factories in Germany, France, Italy, and the U.K. held back on material purchases in January, implying that Europe’s manufacturing recession is set to persist a while longer.

The Global Supply Chain Volatility Index data was captured just prior to the U.S. administration’s announcement of tariffs on China, as well as the initial announcement (and subsequent pause) of tariffs on Mexico and Canada.

Interpreting the data:
Index > 0, supply chain capacity is being stretched. The further above 0, the more stretched supply chains are.
Index < 0, supply chain capacity is being underutilized. The further below 0, the more underutilized supply chains are.

JANUARY 2025 KEY FINDINGS

  • DEMAND: After some pullback in the second half of 2024, global manufacturers’ purchasing of raw materials is slowly recovering. In fact, global factory procurement in Asia is in line with its average, while in North America (driven by the U.S.), input purchasing is trending upward. This contrasts with the situation in Europe, which remains depressed as the region’s industrial sector struggles to break out from its prolonged downturn.
  • INVENTORIES: Global manufacturers’ desire to safety stockpile remains contained. Reports from factories surveyed showing an increase in inventory levels due to concerns about price or supply were low in January.
  • MATERIAL SHORTAGES: Reports of shortages for the globe’s most critical items, such as commodities, electronic components, chemicals and food products, were at their lowest in five years during January. This suggests that suppliers remain well stocked, indicating there are minimal frictions for companies obtaining necessary materials.
  • LABOR SHORTAGES: Global factory employment levels have been shrinking for several months1 and it appears that the growing labor shortage is now preventing global suppliers from completing orders as quickly. There was a rise in reports of factory backlogs rising due to inadequate labor supply in January.
  • TRANSPORTATION: Global transportation costs are increasing. In January, they rose to their highest level in six months.

REGIONAL SUPPLY CHAIN VOLATILITY

  • NORTH AMERICA: Index up to -0.22, from -0.53, a six-month high, suggesting a pick-up in procurement across the region at the start of the year.
  • EUROPE: Index down to -0.61, from -0.49, suggesting that activity levels across Europe’s supply chains remain weak.
  • U.K.: Index fell to -0.63, from -0.41 in December, a 13-month low and signaling a weaker outlook for 2025 for U.K. manufacturing.
  • ASIA: Index rises to 0.03, from -0.09, indicating that suppliers to the region are generally operating at full capacity.

For more information, visit www.gep.com/volatility.
Note: Full historical data dating back to January 2005 is available for subscription. Please contact economics@spglobal.com.
The next release of the GEP Global Supply Chain Volatility Index will be 8 a.m. ET, Mar. 12, 2025.

About the GEP Global Supply Chain Volatility Index 
The GEP Global Supply Chain Volatility Index is produced by S&P Global and GEP. It is derived from S&P Global’s PMI® surveys, sent to companies in over 40 countries, totaling around 27,000 companies. The headline figure is a weighted sum of six sub-indices derived from PMI data, PMI Comments Trackers and PMI Commodity Price & Supply Indicators compiled by S&P Global.

  • A value above 0 indicates that supply chain capacity is being stretched and supply chain volatility is increasing. The further above 0, the greater the extent to which capacity is being stretched.
  • A value below 0 indicates that supply chain capacity is being underutilized, reducing supply chain volatility. The further below 0, the greater the extent to which capacity is being underutilized.

A Supply Chain Volatility Index is also published at a regional level for Europe, Asia, North America and the U.K. For more information about the methodology, click here.

About GEP

GEP® delivers AI-powered procurement and supply chain solutions that help global enterprises become more agile and resilient, operate more efficiently and effectively, gain competitive advantage, boost profitability and increase shareholder value. Fresh thinking, innovative products, unrivaled domain expertise, smart, passionate people — this is how GEP SOFTWARE™, GEP STRATEGY™ and GEP MANAGED SERVICES™ together deliver procurement and supply chain solutions of unprecedented scale, power and effectiveness. Our customers are the world’s best companies, including more than 1,000 Fortune 500 and Global 2000 industry leaders who rely on GEP to meet ambitious strategic, financial and operational goals. A leader in multiple Gartner Magic Quadrants, GEP’s cloud-native software and digital business platforms consistently win awards and recognition from industry analysts, research firms and media outlets, including Gartner, Forrester, IDC, ISG, and Spend Matters. GEP is also regularly ranked a top procurement and supply chain consulting and strategy firm, and a leading managed services provider by ALM, Everest Group, NelsonHall, IDC, ISG and HFS, among others. Headquartered in Clark, New Jersey, GEP has offices and operations centers across Europe, Asia, Africa and the Americas. To learn more, visit www.gep.com.

About S&P Global

S&P Global (NYSE: SPGI) S&P Global provides essential intelligence. We enable governments, businesses and individuals with the right data, expertise and connected technology so that they can make decisions with conviction. From helping our customers assess new investments to guiding them through ESG and energy transition across supply chains, we unlock new opportunities, solve challenges and accelerate progress for the world. We are widely sought after by many of the world’s leading organizations to provide credit ratings, benchmarks, analytics and workflow solutions in the global capital, commodity and automotive markets. With every one of our offerings, we help the world’s leading organizations plan for tomorrow, today.

Disclaimer

The intellectual property rights to the data provided herein are owned by or licensed to S&P Global and/or its affiliates. Any unauthorised use, including but not limited to copying, distributing, transmitting or otherwise of any data appearing is not permitted without S&P Global’s prior consent. S&P Global shall not have any liability, duty or obligation for or relating to the content or information (“Data”) contained herein, any errors, inaccuracies, omissions or delays in the Data, or for any actions taken in reliance thereon. In no event shall S&P Global be liable for any special, incidental, or consequential damages, arising out of the use of the Data. Purchasing Managers’ Index™ and PMI® are either trade marks or registered trade marks of S&P Global Inc or licensed to S&P Global Inc and/or its affiliates.

This Content was published by S&P Global Market Intelligence and not by S&P Global Ratings, which is a separately managed division of S&P Global. Reproduction of any information, data or material, including ratings (“Content”) in any form is prohibited except with the prior written permission of the relevant party. Such party, its affiliates and suppliers (“Content Providers”) do not guarantee the accuracy, adequacy, completeness, timeliness or availability of any Content and are not responsible for any errors or omissions (negligent or otherwise), regardless of the cause, or for the results obtained from the use of such Content. In no event shall Content Providers be liable for any damages, costs, expenses, legal fees, or losses (including lost income or lost profit and opportunity costs) in connection with any use of the Content.

Media Contacts

Derek Creevey
Director, Public Relations

GEP
Phone: +1 646-276-4579

Email: derek.creevey@gep.com 

Joe Hayes
Principal Economist
S&P Global Market Intelligence
Phone: +44-1344-328-099
Email: joe.hayes@spglobal.com 

S&P Global Market Intelligence

Corporate Communications

Email: Press.mi@spglobal.com 

1 Source: The S&P Global PMI survey, which encompasses the GEP Global Supply Chain Volatility Index

GEP Global Supply Chain Volatility Index
GEP Global Supply Chain Volatility Index

 

 

TriNetX and Fujitsu Launch Joint Venture to Increase Japanese Patients’ Access to Life-Changing Medicines

Partnership taps real-world data to accelerate clinical trials, research, and drug development in Japan.  

CAMBRIDGE, Mass., Feb. 12, 2025 /PRNewswire/ — TriNetX, a global leader in real-world data (RWD) and real-world evidence (RWE) solutions, has partnered with Fujitsu, a global ICT company and one of Japan’s leading electronic health record (EHR) vendors, to form TriNetX Japan K.K. This groundbreaking joint venture aims to quickly create an environment where anonymized EHR data from Japanese patients can be used to optimize clinical trials, advance healthcare research, and accelerate drug development timelines.

The initiative represents a significant step forward for integrating Japan into the global landscape of data-driven medicine and healthcare innovation. With its status as the third-largest pharmaceutical market worldwide, Japan offers unparalleled opportunities for clinical research and drug development. Additionally, Japan’s rapidly aging population provides an ideal foundation for studying age-related conditions such as cancer, cardiovascular diseases, and neurodegenerative disorders.

“Since our full-scale entry into the Japanese market in 2022, TriNetX has been enabling pharmaceutical companies and researchers to securely leverage anonymous patient data through our federated system while ensuring compliance with Japan’s strict data privacy regulations,” said Gadi Lachman, Founding CEO of TriNetX. “This joint venture with Fujitsu will open new research pathways and strengthen Japan’s position in global healthcare, allowing us to connect critical therapies to patients.”

The new entity will integrate the TriNetX LIVE™ Platform, TriNetX’s global network of over 200 million patient records, with Fujitsu’s cloud-based platform for the healthcare sector in Japan, offering a seamless connection between leading medical institutions and life sciences innovators. Through the integrated advanced analytics and data utilization platforms, researchers and pharmaceutical companies will gain secure, efficient access to large-scale EHR datasets, revolutionizing clinical trials and precision medicine initiatives.

Tatsuki Araki, Head of Healthy Living of Fujitsu, remarked, “Fujitsu is proud to collaborate with TriNetX to advance healthcare and life sciences innovation in Japan. Together with TriNetX, we will create an environment where Japanese medical data, previously underutilized, can be efficiently leveraged for clinical research. As part of our business model ‘Fujitsu Uvance,’ which is based on addressing social issues, Fujitsu aims to eliminate drug loss in Japan and achieve a society where everyone can choose the treatment that best suits them by creating an ecosystem leveraging medical data.”

The TriNetX-Fujitsu joint venture aligns with the growing number of Japanese medical institutions joining the TriNetX network. Researchers are already conducting novel studies using TriNetX data and technology, while pharmaceutical companies are increasingly offering clinical trial opportunities to these institutions.

Shogo Wakabayashi, TriNetX’s Country Manager, Japan will lead TriNetX Japan K.K. Steve Kundrot, Chief Operating Officer of TriNetX and Elizabeth Schwert, Vice President, M&A and Business Development of TriNetX, will serve on the entity’s Board of Directors.

About TriNetX, LLC
TriNetX is a global network of healthcare organizations and life sciences companies dedicated to advancing real-world research and expediting the development of new therapies. Through its self-service, HIPAA-, GDPR-, and LGPD-compliant platform of federated deidentified and anonymous electronic health record datasets and consulting partnerships, TriNetX empowers its global community to improve clinical trial protocol design, streamline trial operations, refine safety signals, and enrich real-world evidence generation. For more information, please visit TriNetX at www.trinetx.com or follow TriNetX on LinkedIn.

About Fujitsu
Fujitsu’s purpose is to make the world more sustainable by building trust in society through innovation. As the digital transformation partner of choice for customers in over 100 countries, our 124,000 employees work to resolve some of the greatest challenges facing humanity. Our range of services and solutions draw on five key technologies: Computing, Networks, AI, Data & Security, and Converging Technologies, which we bring together to deliver sustainability transformation. Fujitsu Limited (TSE:6702) reported consolidated revenues of 3.7 trillion yen (US$26 billion) for the fiscal year ended March 31, 2024 and remains the top digital services company in Japan by market share. Find out more: www.fujitsu.com.

Media Contact
TriNetX
Karen Tunks
Email: Karen.Tunks@TriNetX.com

Hyundai Mobis leads innovation in the field of automotive interior design with a new movable sound system

  • Development of a movable sound system synchronized with the rollable display system
  • Delivering a differentiated user experience through sound optimization and luxury automotive interior design
  • Innovative integration of a premium display + sound system targeting the global market

SEOUL, South Korea, Feb. 12, 2025 /PRNewswire/ — Advancing as a future mobility technology specialist, Hyundai Mobis (KRX 012330) is driving innovation in automotive interior design with a new technology. Automobiles are no longer merely a means of transportation; they are evolving into a multifunctional space where people can relax, entertain themselves and interact with one another. Accordingly, automotive interior design is undergoing transformation to not only ensure passenger safety and convenience but also to deliver a differentiated user experience.

The movable sound system adjusts the angle of each speaker according to the display deployment situation to deliver vivid sound quality to the user. (From left to right in the photo: speaker deployment in stationary mode, low-speed driving mode, and high-speed driving mode)
The movable sound system adjusts the angle of each speaker according to the display deployment situation to deliver vivid sound quality to the user. (From left to right in the photo: speaker deployment in stationary mode, low-speed driving mode, and high-speed driving mode)

On 12, Hyundai Mobis has announced its recent development of a new movable sound system synchronized with the movement of the display installed in the driver’s seat (cockpit). This technology is part of its effort to create a unique interior design and ensure optimal sound quality in various display scenarios.

The movable sound system is designed to work in perfect synchronization with the rollable display. Hyundai Mobis developed the world’s first rollable display that moves up and down two years ago. This innovative technology features a large 30-inch display that can be adjusted according to driving conditions, providing users with information including navigation, music and videos. When the display is operational, the speakers installed on the right, left and center of the vehicle’s front adjust their angle and move to minimize interference from surrounding sound waves and ensure optimal quality.

The rollable display expands to its maximum size, enabling driver and passengers to enjoy music and videos when the vehicle is in idle or in autonomous mode. At this point, the movable sound system reclines and directs sound toward the vehicle’s windshield to prevent sound interference caused by the fully expanded display. In contrast, the display expands to only one-third of its original size during driving to ensure that the driver’s view remains unobstructed and only a minimum of driving information is displayed. During this time, the speaker orientates toward the driver, providing audio output. The speaker’s position is dynamically adjusted based on the display’s dimensions to deliver more vivid sound quality to the driver and passengers.

Hyundai Mobis has developed this innovative display-synchronized movable sound system in the view that the latest vehicle display pursues features such as large screen, high resolution and slim design in differentiating automotive interior design. This innovation also reflects the confidence of Hyundai Mobis in its technological prowess in premium automotive display and sound systems.

 Leading innovation through new technology integration with its automotive part technologies including the next-generation display and premium sound

At this year’s CES, Hyundai Mobis has unveiled a real vehicle with its Holographic Windshield Transparent Display, which uses the windshield as a display without the need for physical display devices. It also has a range of the world’s first original premium in-vehicle systems, including rollable, swivel and QL displays.

The company is also making inroads into the global premium sound system market through a partnership with Meridian, a British audio pioneer, and is accelerating global open innovation to secure special in-vehicle sound technologies.

With its technological prowess, Hyundai Mobis is presenting the integration of technologies in the field of IVI (In-Vehicle Infotainment) for user experience innovation and enhanced mobility convenience. Its next-level solution, which integrates its advanced display and sound system technologies, is one example. “Hyundai Mobis is delivering its differentiated brand value in the mobility sector through its future-oriented innovative products targeting the global market”, said Han Young-Hoon, the head of HMI Development Group, Hyundai Mobis.

About Hyundai Mobis

Hyundai Mobis is the global no. 6 automotive supplier, headquartered in Seoul, Korea. Hyundai Mobis has outstanding expertise in sensors, sensor fusion in ECUs and software development for safety control. The company’s products also include various components for electrification, brakes, chassis and suspension, steering, airbags, lighting, and automotive electronics. Hyundai Mobis operates its R&D headquarters in Korea, with four technology centers in the United States, Germany, China, and India. For more information, please visit the website at http://www.mobis.com

Media Contact 
Choon Kee Hwang: ckhwang@mobis.com
Jihyun Han: jihyun.han@mobis.com

OnCusp Therapeutics Receives FDA Fast Track Designation for CUSP06 for the Treatment of Platinum-Resistant Ovarian Cancer

PRINCETON, N.J., Feb. 12, 2025 /PRNewswire/ — OnCusp Therapeutics, Inc., a clinical stage biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CUSP06, a Cadherin-6 targeting Antibody-Drug Conjugate (CDH6 ADC) and the company’s lead program, for the treatment of patients with platinum-resistant ovarian cancer (PROC).

“We are extremely pleased that the FDA granted Fast Track Designation to CUSP06,” said Eric Slosberg, PhD, Chief Development Officer of OnCusp Therapeutics. “The early results from our Phase 1 trial have been encouraging, and this designation will expedite our efforts to bring this potentially transformative therapy to patients. Given the need for new therapeutic options in this underserved population, we are committed to working closely with the FDA to accelerate its development.”

The ongoing Phase 1 multicenter study is evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of CUSP06 in adults with platinum-refractory/resistant ovarian cancer and other advanced solid tumors (CUSP06-1001). Early data from the trial have shown promising anti-tumor activity and a manageable safety profile, supporting further development of the program.

About CUSP06

CUSP06, a CDH6 ADC, is composed of a proprietary antibody with high CDH6 binding affinity, a protease-cleavable linker, and an exatecan payload (a potent and clinically validated topoisomerase-1 inhibitor). The linker is designed to complement the exatecan payload, enabling a stable and homogenous ADC. The payload is a weak substrate for BCRP/P-gp, which are drug efflux pumps that drive chemoresistance to many therapies. In preclinical data, this linker-payload has been shown to have an increased “bystander effect” compared to competitor ADCs. CUSP06 has a drug-to-antibody ratio of eight. OnCusp obtained the exclusive global rights (outside of China) to lead the development and commercialization of CUSP06 from Multitude Therapeutics in 2022. CUSP06 is being evaluated in a Phase 1 study in patients with platinum-refractory/resistant ovarian cancer and other advanced solid tumors. Additional information on the CUSP06-1001 (NCT06234423) trial can be found at clinicaltrials.gov.

About Platinum-Resistant Ovarian Cancer

Ovarian cancer is the leading cause of death from gynecologic malignancies in the United States, with approximately 20,000 new cases diagnosed annually.[1] Platinum-based chemotherapy is a standard first-line treatment, but approximately 80% of patients who respond to initial treatment will develop platinum resistance, typically within two years.[2] Platinum-resistant ovarian cancer is defined as disease progression within six months of completing platinum-based therapy and carries a particularly poor prognosis, with median survival of only 9-12 months and limited effective treatment options.[2] Despite recent therapeutic advances, the 5-year survival rate for patients with platinum-resistant disease remains around 15%, highlighting a critical unmet need for new therapeutic approaches.[1],[3]

About Fast Track Designation

Fast Track Designation is intended to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need. Programs with FTD may benefit from more frequent meetings with the FDA, eligibility for Accelerated Approval and Priority Review if relevant criteria are met, and the potential for a rolling review of the Biologics License Application (BLA).

About OnCusp Therapeutics

OnCusp Therapeutics, Inc., headquartered in Princeton, New Jersey, is a clinical stage biopharmaceutical company dedicated to transforming cutting-edge preclinical innovation into clinically validated treatments for cancer patients. OnCusp was co-founded by Dr. Bing Yuan, Dr. Eric Slosberg, and Dr. Andy Fu, and has built a strong team of accomplished veterans with proven track records in building startup biotechs, leading successful preclinical and clinical programs, and creating value through global partnerships. The company is committed to accelerating the advancement of globally competitive oncology assets for patients. OnCusp raised an oversubscribed $100 million Series A financing round in January 2024, co-led by Novo Holdings, OrbiMed, and F-Prime Capital.

References

[1].      American Cancer Society. “Cancer Facts & Figures 2023.” Atlanta: American Cancer Society, 2023.

[2].      Lheureux, Stephanie, Charlie Gourley, Ignace Vergote, and Amit M. Oza. “Epithelial Ovarian Cancer.” The Lancet 393, no. 10177 (2019): 1240-1253.

[3].      National Cancer Institute. “Surveillance, Epidemiology, and End Results (SEER) Program.” Cancer Stat Facts: Ovarian Cancer. Accessed 2023. https://seer.cancer.gov/statfacts/html/ovary.html 

 

CONTACT: Becky Zhang, becky@chancebest.com 

Actinogen announces peer-reviewed clinical pharmacology manuscript for Xanamem (emestedastat) published in Clinical Pharmacology in Drug Development journal

Confirms the utility of the 10 mg daily oral dose of Xanamem being studied in late-stage clinical trials in Alzheimer’s disease and major depressive disorder 

SYDNEY, Feb. 12, 2025 /PRNewswire/ — Actinogen Medical Limited (ASX: ACW) announces that the publication of its most recent peer-reviewed journal article entitled Clinical Pharmacology and Approach to Dose Selection of Emestedastat, a Novel Tissue Cortisol Synthesis Inhibitor for the Treatment of Central Nervous System Disease in Clinical Pharmacology in Drug Development, the journal associated with the American College of Clinical Pharmacology.

The review confirms the utility of the 10 mg daily dose of Xanamem® being used in current clinical trials. From a drug development perspective, it demonstrates the value of using central pharmacodynamics (PD), including positron emission tomography (PET) and computerized cognitive testing, to supplement pharmacokinetic (PK) and endocrine-based PD for determining the target dose range for clinical efficacy testing.

Earlier PK modeling suggested that 20 mg daily would be optimal to maintain cerebrospinal fluid concentrations above the brain half maximal inhibitory concentration. However, subsequent PET scanning suggested that Xanamem doses of 10 mg or even 5 mg daily may be sufficient to adequately inhibit its 11β-HSD1 enzyme target. With once-daily doses of 5-20 mg in cognitively normal, older volunteers, a consistent pattern of pro-cognitive benefit, without dose-response, was seen as improvement in attention and working memory but not episodic memory. Taken in combination, this confirms that the target dose range for Xanamem therapeutic activity is ≤ 10 mg daily and not higher.

The journal article can be accessed here.

Dr Dana Hilt, Actinogen’s Chief Medical Officer, said:

“The detailed and thorough drug development steps taken by Actinogen to confirm the target dose range of ≤ 10 mg daily demonstrate the value of careful and stepwise clinical pharmacology testing and use of measures of direct brain effects.”

“Paired with the positive effects on depressive symptoms seen in the XanaCIDD phase 2a trial with a 10 mg dose, we have full confidence in the design and 10 mg dose being used in our current XanaMIA phase 2b/3 Alzheimer’s trial.” 

About Actinogen Medical

Actinogen Medical (ACW) is an ASX-listed, biotechnology company developing a novel therapy for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol. There is a strong association between cortisol and detrimental changes in the brain, affecting cognitive function, harm to brain cells and long-term cognitive health.

Cognitive function means how a person understands, remembers and thinks clearly. Cognitive functions include memory, attention, reasoning, awareness and decision-making.

Actinogen is currently developing its lead compound, Xanamem, as a promising new therapy for Alzheimer’s Disease and Depression and hopes to study Fragile X Syndrome and other neurological and psychiatric diseases in the future. Reducing cortisol inside brain cells could have a positive impact in these and many other diseases. The cognitive dysfunction, behavioural abnormalities, and neuropsychological burden associated with these conditions is debilitating for patients, and there is a substantial unmet medical need for new and improved treatments.

Clinical Trials

The XanaMIA Phase 2b/3 Alzheimer’s disease trial is a double-blind, 36-week treatment, placebo-controlled, parallel group design trial in 220 patients with mild to moderate AD and progressive disease, determined by clinical criteria and confirmed by an elevated level of the pTau181 protein biomarker in blood. Patients receive Xanamem 10 mg or placebo, once daily, and its ability to slow progression of Alzheimer’s disease is assessed with a variety of endpoints. The primary endpoint of the trial is the internationally-recognized CDR-SB (Clinical Dementia Rating scale – Sum of Boxes). The trial is being conducted in Australia and the US. Initial results from an interim analysis of the first 100 participants are anticipated in Q4 2025 and final results H2 2026.

The XanaCIDD Phase 2a depression trial was a double-blind, six-week proof-of-concept, placebo-controlled, parallel group design trial in 167 patients with moderate, treatment-resistant depression and a degree of baseline cognitive impairment. Participants were evenly randomized to receive Xanamem 10 mg once daily or placebo, in most cases in addition to their existing antidepressant therapy, and effects on cognition and depression were assessed. Trial results were reported in August 2024 and showed clinically and statistically significant benefits on depression symptoms with positive effects on the MADRS scale (a validated scale of depression symptom measurement) and the PGI-S (a valid patient reported assessment of depression severity).

About Xanamem (emestedastat)

Xanamem’s novel mechanism of action is to control the level of cortisol in the brain through the inhibition of the cortisol synthesis enzyme, 11β-HSD1, without affecting production of cortisol by the adrenal glands. Xanamem is a first-in-class, once-a-day pill designed to deliver high levels of cortisol control in the brain.

Chronically elevated cortisol is associated with progression in Alzheimer’s Disease and excess cortisol is known to be toxic to brain cells. Cortisol itself is also associated with depressive symptoms and when targeted via other mechanisms has shown some promise in prior clinical trials. The recent XanaCIDD trial demonstrated clinically and sometimes statistically significant benefits on depressive symptoms.

The Company has studied 11β-HSD1 inhibition by Xanamem in approximately 400 volunteers and patients in eight clinical trials. Xanamem has a promising safety profile and has demonstrated clinical activity in patients with depression, patients with biomarker-positive Alzheimer’s disease and cognitively normal volunteers. High levels of target engagement in the brain with doses as low as 5 mg daily have been demonstrated in a human PET imaging study.

Xanamem is an investigational product and is not approved for use outside of a clinical trial by the FDA or by any global regulatory authority. Xanamem® is a trademark of Actinogen Medical.

Disclaimer

This announcement and attachments may contain certain “forward-looking statements” that are not historical facts; are based on subjective estimates, assumptions and qualifications; and relate to circumstances and events that have not taken place and may not take place. Such forward looking statements should be considered “at-risk statements” – not to be relied upon as they are subject to known and unknown risks, uncertainties and other factors (such as significant business, economic and competitive uncertainties / contingencies and regulatory and clinical development risks, future outcomes and uncertainties) that may lead to actual results being materially different from any forward looking statement or the performance expressed or implied by such forward looking statements. You are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Actinogen Medical does not undertake any obligation to revise such statements to reflect events or any change in circumstances arising after the date hereof, or to reflect the occurrence of or non-occurrence of any future events. Past performance is not a reliable indicator of future performance. Actinogen Medical does not make any guarantee, representation or warranty as to the likelihood of achievement or reasonableness of any forward-looking statements and there can be no assurance or guarantee that any forward-looking statements will be realised.


® Xanamem is a registered trademark of Actinogen Medical Limited

 

[Herald Interview] Fescaro CTO stresses comprehensive approach to vehicle cybersecurity

SUWON, South Korea, Feb. 12, 2025 /PRNewswire/ — This is an interview with Fescaro Chief Technology officer Lee Hyun-jung published in The Korea Herald:

Addressing hacking threats to vehicle software programs has become increasingly critical as vehicles evolve into “computers on wheels,” relying more heavily on chips and software.

Lee Hyun-jung, the chief technology officer at mobility software solutions provider Fescaro, emphasizes the need for a comprehensive approach to ensure robust vehicle cybersecurity.

Based in Suwon, Gyeonggi Province, Fescaro collaborates with Korean automakers to provide security software that protects vehicles from hacker attacks and information leaks.

“Vehicles are increasingly connected to external environments via software, interacting with urban infrastructure, personal communication devices and even other vehicles, while exchanging information in real time,” said Lee.

The CTO, a former white hat or ethical security hacker, added, “Enhancing cybersecurity for just vehicles will hardly ensure the safety of the entire mobility ecosystem. A flaw in the connected network could spread cyber threats throughout the entire value chain.”

In many countries, including the European Union, China and Korea, automakers can only sell their products if they provide systematic management of vehicle cybersecurity throughout the entire product lifecycle — from design to production and disposal.

“Korean automakers are obtaining European certifications for cybersecurity management systems and software update management systems to enter the regional market and comply with their legislation,” said Lee.

Fescaro has helped multiple Korean companies acquire European qualifications and the ISO/SAE 21434 certification.

ISO/SAE 21434 is an international standard for automotive cybersecurity engineering jointly developed by the International Organization for Standardization (ISO) and the Society of Automotive Engineers (SAE).

The SAE is a prominent professional association based in the US, with approximately 128,000 engineers and technical experts primarily involved in the mobility industry.

“(When working with an automaker to obtain CSMS and SUMS), Fescaro formed an IT infrastructure system that integrates all cybersecurity management tasks into a unified platform, automating processes to enhance seamless workflows,” Lee explained.

“The system was also designed to monitor security-related events after the mass production of car models to prevent potential issues and track the effects of vehicle software updates,” Lee added, emphasizing the company’s ability to offer long-term solutions addressing various aspects of vehicle cybersecurity.

As recognition for Fescaro’s contributions to obtaining security certifications, Korean sport utility vehicle maker KG Mobility selected the company as its excellent business partner for 2024.

Lee anticipated that the importance of vehicle cybersecurity would grow even further as electric vehicles and autonomous driving systems become more prevalent.

“Autonomous driving requires a connection to external networks for precise and detailed recognition of the surrounding environment,” said Lee.

“Cybersecurity is also crucial for EV chargers, as they are directly connected to EVs. This connection may allow external networks to access sensitive personal information, such as the vehicle’s identification and payment data.”

To address these concerns, Fescaro’s business portfolio spans future mobility solutions. The company has collaborated with autonomous driving solution providers and EV charger manufacturers.

“There is no perfect mobility cybersecurity system. Therefore, leading businesses must continuously upgrade their cybersecurity systems while also reducing costs. In response to this demand, Fescaro is developing the ‘CSMS Portal,'” said Lee.

The platform, built on Fescaro’s experience working with mobility companies, offers streamlined and automated cybersecurity maintenance solutions. It aims to facilitate continuous monitoring and updates of companies’ cybersecurity status with ease.

“We plan to launch the portal in the first half of 2025. We hope to contribute to solving the challenges facing the mobility industry and enhance future competitiveness,” Lee said.

HKMU receives precious manuscripts and relics from Eileen Chang, Stephen Soong and Mae Fong Soong; Literary treasures to be digitally preserved to promote modern Chinese literature research

HONG KONG, Feb. 12, 2025 /PRNewswire/ — This year marks the 30th anniversary of the passing of renowned Chinese writer Eileen Chang, who has a significant place in the modern Chinese literary world. Hong Kong Metropolitan University (HKMU) is honoured to receive a generous donation from Dr Roland Soong and his elder sister, Mrs Elaine Soong Kingman, administrators of Eileen Chang’s estate, which includes Eileen Chang’s manuscripts, relics, and correspondence with her best friends, Stephen Soong and his wife, Mae Fong Soong, and others. The collection sheds light on Chang’s creative journey and the influence of the Soong couple on her career development and personal life. It will be the permanently housed at HKMU, providing an invaluable collection of cultural heritage for the literary community and researchers, and further promoting modern Chinese literary research and the innovative development of the digital humanities.

HKMU hosted a ceremony today marking the donation of manuscripts and relics of Eileen Chang, Stephen Soong and Mae Fong Soong, and introducing plans to preserve and promote the donated items through a digital humanities approach. The officiating guests were Dr Roland Soong (5th left) and his elder sister, Mrs Elaine Soong Kingman (5th right), the administrators of Eileen Chang's estate; Ir Dr Conrad Wong Tin-cheung (4th left), HKMU Council Chairman; and Prof. Paul Lam Kwan-sing (4th right), HKMU President. (Photo provided by HKMU)
HKMU hosted a ceremony today marking the donation of manuscripts and relics of Eileen Chang, Stephen Soong and Mae Fong Soong, and introducing plans to preserve and promote the donated items through a digital humanities approach. The officiating guests were Dr Roland Soong (5th left) and his elder sister, Mrs Elaine Soong Kingman (5th right), the administrators of Eileen Chang’s estate; Ir Dr Conrad Wong Tin-cheung (4th left), HKMU Council Chairman; and Prof. Paul Lam Kwan-sing (4th right), HKMU President. (Photo provided by HKMU)

The donation ceremony held today (12 February) was officiated by Dr Roland Soong, Mrs Elaine Soong Kingman, Ir Dr Conrad Wong Tin-cheung, HKMU Council Chairman, and Prof. Paul Lam Kwan-sing, HKMU President. The donation includes thousands of manuscripts and personal items from Eileen Chang and the Soong couple. Selected items from the collection were featured in a preview for guests and media at the event, including some of Eileen Chang’s original manuscripts, her correspondence with the Soong couple and personal photographs. The preview also included letters exchanged between Mr Soong and distinguished Chinese literary scholars and writers, like Qian Zhong-shu (錢鍾書), reflecting Mr Soong’s footprint and contribution to the Chinese cultural realm.

At the ceremony, Dr Soong said that the most important aim for him and his sister, as administrators of the estates of Eileen Chang and their parents, was to ensure the manuscripts and relics of the three will be properly preserved through this donation, for research and literature promotion. “It is rare to find such a significant literary collection of manuscripts and relics of Eileen Chang and my parents in Hong Kong,” he said. “I hope that through HKMU, we can help foster the preservation and inheritance of, and research on, modern literary works, allowing more people to appreciate their works from different perspectives and promoting Chinese literature in Hong Kong and around the world.”

On behalf of HKMU, Ir Dr Wong expressed his heartfelt gratitude to the Soong family for their generous donation, which provides valuable resources for the Hong Kong academic and cultural communities and stands as recognition of the University’s commitment to the preservation and research of modern literary works. “The University will cherish and make the best use of these cultural treasures,” he said. “Through research, exhibitions and digital humanities innovations, we aim to allow our faculty, students, the public, researchers and even tourists to experience the charm of these cultural gems up close. It will help enhance the University’s influence in promoting modern Chinese literature and advancing digital humanities innovation in Hong Kong and beyond.”

Prof. Lam thanked the Soong family for their trust in the University, noting that the donation is believed to be the largest collection of Eileen Chang and the Soong couple in the Chinese-speaking world. “HKMU is dedicated to enhancing students’ knowledge and advancing research capacity, and the digital humanities and literature have been one of its strategic research areas,” he said. “This cultural heritage collection housed at HKMU will give new impetus to the University and related literary studies, and help promote interdisciplinary, cross-institutional and cross-regional research to gain deeper insights into modern Chinese literature and foster cultural inheritance.”

To preserve and pass on these precious documents and drive related research, Prof. Charles Kwong Che-leung, HKMU Vice President (Administration and Corporate Development), said that the School of Arts and Social Sciences and the Library have teamed up to build a database of archival documents and digital collections by adopting a digital humanities approach. The Library will also establish two specific sections, namely the “Special Collection of Eileen Chang” and the “Special Collection of Stephen Soong and Mae Fong Soong“. Additionally, an open exhibition is being planned to let the public gain a deeper understanding of the literary works and remarkable achievements of Eileen Chang and the Soongs, as well as Hong Kong’s crucial role in the development of Chinese literature worldwide.

In the sharing session, Dr Rebecca Leung Mo-ling, convenor of the donation programme and Associate Dean (Administration and Development) of the School of Arts and Social Sciences at HKMU, who specialises in Modern Chinese Literature research, talked about the significant role Stephen Soong played in the Chinese cultural field. In addition to being a literary critic, translator and poet with an extensive personal network, he was an indispensable intermediary in the development of Eileen Chang’s writing career. Dr Leung said she hoped the donation and associated promotional activities would inspire more people to explore the world of modern Chinese literature.

Mr Owen Tam Man-lik, University Librarian and another convener of the donation programme, said the collection, preservation, digitisation and promotion of the donated items represent an important step by the HKMU Library to preserve and promote cultural heritage. He hoped the collection would not only enrich the resources of the University Library but also provide valuable academic research materials for scholars worldwide and benefit the public interested in modern Chinese literature and the works of Eileen Chang and the Soong couple.

Please click on the following link to visit the HKMU Modern Chinese Literature Collection:

https://repository.lib.hkmu.edu.hk/mcl/

List of the preview items (Chinese only)

https://www.hkmu.edu.hk/PAO/events/2025/250212_Dr Roland Soong and Mrs Elaine Soong Kingman Donation Ceremony/HKMU donation ceremony_factsheet_exhibited items.pdf

 

IFS named a Leader in two IDC MarketScape 2024-2025 Vendor Assessments: Manufacturing ERP and Remanufacturing Management Software

LONDON, Feb. 12, 2025 /PRNewswire/ — IFS, the leading enterprise cloud and Industrial AI software provider, announces that it has been positioned as a Leader in two IDC MarketScape reports: the IDC MarketScape: Worldwide SaaS and Cloud-Enabled Manufacturing ERP Applications 2024–2025 Vendor Assessment (doc #US51752524, December 2024), and the IDC MarketScape: Worldwide Remanufacturing Management Software 2024 Vendor Assessment (doc #US51036724, September 2024).  

The IDC MarketScape report for Worldwide SaaS and Cloud-Enabled Manufacturing ERP Applications noted, “IFS is focused on six industries (and their subindustries) and has the technology and capabilities (i.e., industry-specific next-gen capabilities) to cater to their unique needs. It includes standard industry-specific dashboards with a line-of-business (LOB) process flow.”  

Similarly, the IDC MarketScape report for Worldwide Remanufacturing Management Software evaluates vendors based on a comprehensive set of criteria, including product capabilities, go-to-market strategy, and business execution. The report for remanufacturing management software noted, “If you are looking for a comprehensive remanufacturing suite that addresses cost and operations management while being fully embedded within IFS’ cloud manufacturing offering, consider working with IFS. Consider IFS if you are looking for a solution that is being continuously developed and enhanced with features to keep up with market requirements.”  

Max Roberts, Chief Operations Officer at IFS, said: “IFS is deeply proud of our industry focused approach to technology and Industrial AI innovation. We believe it is critical to continue to invest in developing innovative and flexible solutions that meet the evolving needs of the manufacturing industry, enabling efficiency and success in their end-to-end operations.” 

The IDC MarketScape reports evaluate vendors based on a rigorous scoring methodology that includes both qualitative and quantitative criteria.  

Contact Information
EMEA / APJ: Adam Gillbe 
IFS, Director of Corporate & Executive Communications 
Email: adam.gillbe@ifs.com 

NORTH AMERICA / LATAM: Mairi Morgan 
IFS, Director of Corporate & Executive Communications 
Email: mairi.morgan@ifs.com

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