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Hainan Free Trade Port-UAE Promotion Conference Held in Dubai

HAIKOU, China, May 20, 2025 /PRNewswire/ — A report from Hainan International Media Center (HIMC):

On May 19, the 2025 China Hainan Free Trade Port-UAE Promotion Conference was successfully held in Dubai. Over 250 government and free trade zone participants from the UAE and Hainan, along with business leaders and media representatives, attended the event. The focus was on trade and investment liberalization and facilitation, encompassing cooperation in sectors such as new energy, finance, biopharmaceuticals, healthcare, and agarwood, injecting strong momentum into the establishment of the Hainan FTP as an innovative hub for China-UAE economic and trade relations.

The 2025 China Hainan Free Trade Port-UAE Promotion Conference was held in Dubai.
The 2025 China Hainan Free Trade Port-UAE Promotion Conference was held in Dubai.

In his opening address, Feng Fei, Secretary of the CPC Hainan Provincial Committee highlighted the province’s firm commitment to creating a free trade port with a market-oriented, law-based, and internationalized business environment and “zero tariffs, low tax rates, and a simplified tax system” at its core. He further emphasized that Hainan would focus on promoting in-depth cooperation with the UAE in the digital economy and green energy. Chinese Ambassador to the UAE Zhang Yiming pointed out that the open policies of the Hainan FTP are highly consistent with the UAE’s “50-Year Development Plan,” and the cooperation between the two sides will set a new benchmark for China-Middle East economic and trade cooperation.

Abdulla Al Saleh, Under-Secretary of Foreign Trade and Industry at the UAE Ministry of Economy, said that the UAE will actively link in with the Hainan FTP’s financial liberalization and cross-border trade facilitation policies and jointly explore innovative cooperation models in cutting-edge fields such as artificial intelligence and blockchain. Dr. Ali M. Al-Khouri, Secretary-General of the Office of the Deputy Prime Minister and Minister of Interior of the UAE and Chairman of the Arab Federation for Digital Economy, Marwan Al Marri, Regional Director of Asia from Dubai Chambers, and Omar Al Muhairi, Senior Vice President for Government Affairs at DP World Group, expressed their confidence in the cooperation prospects between the UAE and the Hainan FTP.

At the event, the Hainan Provincial Bureau of International Economic Development provided a systematic breakdown of the advantageous policies and development opportunities of the Hainan FTP. Meanwhile, Hainan Provincial Financial Supervision and Administration Bureau and the Danzhou Municipal Government conducted thematic presentations on financial opening pilot initiatives, cross-border capital flows, and new investment opportunities in the Danzhou-Yangpu Economic Circle, respectively. In a bid to promote bilateral cooperation, representatives from Mingyang Group, Qilu Pharmaceutical, Mellser International Medical Center, and the Hainan Agarwood Industry Association shared information about Hainan’s distinctive industries, specialty products, and plans to expand into the Middle Eastern market.

During the meeting, Hainan signed four strategic cooperation agreements with enterprises from the UAE and Saudi Arabia, covering new energy, logistics parks, automobile trade, and headquarters base construction. A business negotiation session was arranged after the meeting, during which representatives of more than 100 Chinese and Arab companies met and laid the groundwork for future cooperation.

 

Temu Partners with International AntiCounterfeiting Coalition to Strengthen IP Enforcement

Joins IACC Marketplace Advisory Council Alongside Global Brands and Platforms

SAN DIEGO, May 20, 2025 /PRNewswire/ — Temu, the global online marketplace, has signed a Memorandum of Understanding (MoU) with the International AntiCounterfeiting Coalition (IACC) to deepen collaboration on intellectual property protection and expand efforts to combat online counterfeiting.

IACC President Bob Barchiesi (left) and Temu’s IP Compliance Lead for the U.S. Christine Casaceli (right) signed the MoU
IACC President Bob Barchiesi (left) and Temu’s IP Compliance Lead for the U.S. Christine Casaceli (right) signed the MoU

The MoU was signed during the IACC’s 2025 Annual Conference in San Diego last week. As part of the collaboration, Temu has joined the IACC’s newly launched Marketplace Advisory Council (MAC) as an inaugural member. The MAC is a cross-industry forum that includes leading online marketplaces, payment providers, and global brands, aimed at setting a new standard for cooperation in the fight against counterfeit goods.

“We’re pleased to welcome Temu as an inaugural member of the Marketplace Advisory Council and as a key partner in our shared fight against counterfeiting,” said Bob Barchiesi, President, International Anti-Counterfeiting Coalition. “This MoU reflects a meaningful step forward in our collaboration, grounded in transparency, accountability, and a joint commitment to consumer protection. The IACC created the MAC to bring stakeholders together in a way that drives real, sustained impact—and Temu’s participation helps strengthen that vision.”

The MAC offers a collaborative platform where e-commerce platforms, payment companies, and brand owners can work together, share insights, and forge stronger partnerships to address one of the digital economy’s most persistent challenges: the proliferation of counterfeit goods online.

“Joining this coalition underscores Temu’s commitment to building a trustworthy online marketplace,” said a Temu spokesperson. “We look forward to collaborating with other industry leaders to create a powerful, collective force against the sale of illegal goods online.”

Since launching in 2022, Temu has invested heavily in intellectual property enforcement. Measures include:

  • Comprehensive seller vetting and compliance training
  • Round-the-clock algorithmic monitoring supported by manual review
  • A dedicated IP protection portal and brand registry for streamlined takedown submissions
  • An internal enforcement team handling claims with high speed and accuracy

In addition to Temu, other members of the IACC MAC include e-commerce platforms Amazon, and eBay; payments providers Mastercard, PayPal, and Visa; as well as global brands such as Apple, Chanel, Colgate-Palmolive, Disney, Ford, Johnson & Johnson, and Nike.

About Temu

Temu is a global e-commerce platform connecting consumers with millions of manufacturers, brands, and business partners. Operating in more than 90 markets worldwide, Temu is committed to providing affordable, high-quality products that enable customers to live better lives.

SAP Reimagines How Enterprises Run With Business AI

AI Innovations Aim to Boost Business Productivity by Up to 30 Percent; Partnerships with Perplexity and Palantir Bring out Customers’ Best

ORLANDO, Fla., May 20, 2025 /PRNewswire/ — At its annual SAP Sapphire conference, SAP SE (NYSE: SAP) unveiled innovations and partnerships that put the power of Business AI in every user’s hands, revolutionizing the way work gets done. From a virtually omnipresent Joule assistant to an expanded network of Joule Agents that work across systems and lines of business, SAP heralds a new era that democratizes access to Business AI and can drive productivity gains of up to 30 percent.

“SAP combines the world’s most powerful suite of business applications with uniquely rich data and the latest AI innovations to create a flywheel of customer value,” said SAP CEO Christian Klein. “With the expansion of Joule, our partnerships with leading AI pioneers, and advancements in SAP Business Data Cloud, we’re delivering on the promise of Business AI as we drive digital transformations that help customers thrive in an increasingly unpredictable world.”

AI that boosts productivity

SAP’s generative AI assistant Joule can be everywhere you work, delivering personalized answers on everything you need to be more productive.

Joule can accompany business users throughout their day, in and out of the SAP application universe, to find data, surface real-time insights and streamline workflows. Joule’s new ubiquity includes an action bar powered by WalkMe that studies user behavior across applications, turning the assistant into an always-available, proactive AI that can anticipate users’ needs before they arise – always adhering to SAP’s strict ethical AI guidelines.

A collaboration with Perplexity, an AI-powered answer engine company, enhances Joule’s ability to draw on structured and unstructured data to solve complex business problems. Powered by Perplexity and the SAP Knowledge Graph, Joule now instantly answers questions with structured, visual answers – such as charts and graphs – grounded in real-time business data within SAP workflows. For example, a user could ask the tool how recent external events might impact their business and get a forecast based on both current events and the company’s own business data.

SAP also unveiled an expanded library of Joule Agents that reimagine business processes and workflows from the ground up. Fueled by the world’s most powerful real-time business data and orchestrated by Joule, these AI agents work across systems and lines of business to anticipate, adapt and act autonomously so organizations can stay agile in a rapidly changing world. Partnering with industry leaders, SAP offers an ecosystem of interoperable agents that can execute end-to-end processes. The new agents span customer experience, supply chain management, spend management, finance, and human capital management.

Finally, SAP introduced an operating system for AI development that transforms how enterprises build, deploy and scale AI solutions. AI Foundation gives developers a single entry point for building, extending and running custom AI solutions at scale, making it the first real operating system for Business AI. A new prompt optimizer, designed collaboratively with the frontier AI lab Not Diamond, also helps developers create more effective AI prompts quickly, reducing work on complex use cases from days to minutes.

Data that drives smarter decisions

SAP also introduced new intelligent applications in SAP Business Data Cloud, each built for a specific line of business. These applications can continuously learn, simulate outcomes and guide actions using business-critical data, detecting changes to optimize processes, anticipate needs, and collaborate with both human and artificial thinkers to drive meaningful impact. The People Intelligence application, for instance, optimizes team performance by transforming people and skills data into workforce insights and AI-driven recommendations.

Additionally, Palantir and SAP are partnering to facilitate joint customers’ cloud migration journey and modernization programs. Seamless connectivity between Palantir and SAP Business Data Cloud will enable customers to build a harmonized data foundation across their enterprise landscape. Together the companies will responsibly deliver essential outcomes and support customers, including the U.S. government, to quickly adapt to changes and disruptions.

Applications that accelerate cloud adoption

The company also announced SAP Business Suite packages, which are designed for customers to simplify the adoption of SAP cloud solutions that address their specific business challenges. SAP Build is embedded in these packages, so organizations can customize applications to meet their unique needs.

Finally, SAP unveiled a new solution that helps customers transition to the cloud faster. With Joule as the entry point and drawing on insights from SAP solutions including SAP Signavio and SAP LeanIX, the solution delivers personalized guidance and actionable recommendations tailored to an organization’s transformation objectives and can help deliver up to 35 percent faster time to value.

Learn more in the 2025 SAP Sapphire Innovation Guide.

Visit the SAP News Center. Get SAP news via LinkedIn and Bluesky.

About SAP
As a global leader in enterprise applications and business AI, SAP (NYSE:SAP) stands at the nexus of business and technology. For over 50 years, organizations have trusted SAP to bring out their best by uniting business-critical operations spanning finance, procurement, HR, supply chain, and customer experience. For more information, visit www.sap.com.

This document contains forward-looking statements, which are predictions, projections, or other statements about future events. These statements are based on current expectations, forecasts, and assumptions that are subject to risks and uncertainties that could cause actual results and outcomes to materially differ. Additional information regarding these risks and uncertainties may be found in our filings with the Securities and Exchange Commission, including but not limited to the risk factors section of SAP’s 2024 Annual Report on Form 20-F.

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Keypoint Intelligence Forecasts Steady Growth of Digital Printing Across Packaging Segments

FAIRFIELD, N.J., May 20, 2025 /PRNewswire/ — Keypoint Intelligence has released new forecasts analyzing digital printing trends in four key packaging markets: corrugated packaging, flexible packaging, folding cartons, and narrow web labels. The findings show that while digital printing still accounts for a small portion of total production, adoption is expanding as packaging needs evolve.

In corrugated packaging, digital output is expected to increase over the next several years, driven by high-volume single pass presses and growing interest from larger converters. Flexible packaging is seeing gradual progress, especially in regions like Asia-Pacific and Latin America, where press placements are increasing and more converters are experimenting with digital options alongside traditional methods.

The folding carton market is showing renewed interest as a result of improvements in B1 format presses, which better match the needs of high-speed operations. Many converters are monitoring developments in solutions that align with existing finishing processes. Meanwhile, the narrow web labels segment remains the most developed for digital print, with hybrid presses gaining ground as converters look for flexibility and faster turnaround.

Across all segments, changes in customer expectations, regulations, and production requirements are prompting a shift in how packaging is designed and produced. More companies are looking for ways to respond faster to orders, reduce waste, and handle shorter production runs efficiently—areas where digital printing is especially well suited.

“Digital printing in packaging is no longer just a specialty—it’s becoming a practical choice for more converters,” said Jeff Wettersten, Vice President of Packaging at Keypoint Intelligence. “Each segment is moving forward at its own pace, but the direction is clear. Companies are finding value in the speed, flexibility, and responsiveness that digital can bring to their operations.”

The forecasts include data on press placements, installed base growth, and projected output across global regions. Based on interviews with manufacturers, packaging companies, and industry experts, the reports provide a clear view of where the market is today and where it’s heading over the next few years.

For more information about our Labels and Packaging Advisory Service, click here, or to inquire about obtaining the full reports, contact us at info@keypointintelligence.com.

About Keypoint Intelligence
For over 60 years, clients in the digital imaging industry have relied on Keypoint Intelligence for independent hands-on testing, lab data, and extensive market research to drive their product and sales success. Keypoint Intelligence has been recognized as the industry’s most trusted resource for unbiased information, analysis, and awards due to decades of analyst experience.

DIGITIMES ASIA: OCP Targets 1MW Racks to Cut Data Center Energy Losses to 7%

TAIPEI, May 20, 2025 /PRNewswire/ — The Open Compute Project Foundation (OCP) is redesigning data center power architecture to support AI’s growing demands, introducing “1 Megawatt racks” that could slash energy losses from 40% to just 7%, according to Chief Innovation Officer Cliff Grossner.

With AI infrastructure stretching the limits of current systems, OCP’s community of over 400 corporate members is developing open standards to address critical bottlenecks in compute density, power distribution, and cooling.

“The industry is at an inflection point,” said Grossner. “We no longer assume that all processors can be generic. We need to create custom processors for specific workloads.”  

Power Revolution

Current power conversion processes waste approximately 40% of energy when converting from high voltage to chip-level voltage—a significant inefficiency as facilities increasingly consume hundreds of megawatts.

OCP’s proposed “1 Megawatt racks” would move power supplies out of server racks into separate units. Eventually, power generation could move entirely outside computing floors, with facilities re-architected to supply 400 or 800 volt DC power.

Future data centers may incorporate on-site renewable energy generation through solar, wind, and potentially small nuclear reactors as part of an ecosystem approach to power management.

Environmental Focus

With data centers projected to consume 3% of global electricity by 2030, sustainability has become a priority. OCP is developing metrics beyond traditional Power Usage Effectiveness (PUE) to address water consumption and equipment efficiency.

“A data center is not a standalone object in the future,” Grossner noted. “It’s going to be part of an ecosystem that includes potentially a wind farm next to it, and proximity to buildings that can use the heat produced.”

The organization is also investigating alternative concrete formulations to reduce carbon emissions in construction and collaborating with Infrastructure Masons on standardized carbon accounting for IT equipment.

Cooling Transformation

Increasing computational density is forcing a transition from air to liquid cooling systems.

“The thermal management needs of current and next-generation silicon make it pretty clear that chips will be cooled either by single or two-phase liquid cooling,” Grossner said.

OCP is working to standardize liquid cooling delivery systems, including specifications for connectors, pressures, and fluid properties to ensure interoperability across vendors.

Silicon Innovation

OCP has established a marketplace with over 25 suppliers offering modular semiconductor components, positioning itself as the “front door to the open chiplet economy.” This approach enables specialized silicon components to be combined for optimal performance.

The organization envisions distinct roles in this ecosystem: companies creating chiplets, businesses building ASICs, and firms providing support through design tools and testing services.

Education Initiatives

OCP recently launched the OCP Academy to support adoption of its standards and provides access to hundreds of OCP-recognized products through its marketplace. OCP aims to remain the premier organization for AI infrastructure by standardizing silicon, power, cooling, and interconnects; supporting complete system development; and providing industry education.

As AI continues to redefine computing requirements, OCP’s role in fostering open, sustainable, and scalable infrastructure appears increasingly vital to managing the environmental impact of explosive computational growth.

Global Expansion

With 30% of its membership in Asia-Pacific (primarily Taiwan), OCP will hold its APAC Summit in Taipei on August 5-6, 2025. “Taiwan’s semiconductor industry is a key partner,” Grossner emphasized.

Event Link: https://www.opencompute.org/summit/2025-ocp-apac-summit

H World Group Accelerates Hotel Expansion and Brand Upgrades in Q1 2025, Strengthens Position as Hospitality Leader

SINGAPORE and SHANGHAI, China, May 20, 2025 /PRNewswire/ — H World Group Limited (NASDAQ: HTHT) (HK: 01179), one of the world’s leading hospitality groups, began 2025 with continued momentum in growth, asset-light transformation and brand loyalty, according to its first-quarter results released today.

Orange Hotel Shanghai Tianlin Road
Orange Hotel Shanghai Tianlin Road

A Scalable Model for Mass-Market Hospitality
H World Group achieved 538 net hotel openings in the first quarter ended March 31, taking the total number of hotels in operation to 11,685. The number of rooms worldwide totaled 1,142,158, a 20% increase over last year.

The company now covers 1,394 cities across China, with plans to reach 2,000 cities in the future – from major hubs to the most remote and underserved regions.As of March 31, H World had a total of 2,888 hotels in its pipeline.

Advancing the Asset-Light Transformation
H World continued to advance its asset-light strategy in this quarter, with revenue from manachised and franchised hotels rising 21% year-over-year to RMB 2.5 billion (US$344 million). The company’s distinct manachise model — combining the scalability of franchising with the operational control of management — remains a key enabler of efficient, brand-consistent growth.

Loyalty Growth & Direct Booking Strength
As of the end of Q1, H Rewards membership reached 277 million, making it one of the largest loyalty platforms in the global hospitality industry. Direct booking from members accounted for over 65% of total reservations – a 5.4 percentage point increase year-on-year, reflecting growing digital engagement, improved margins, and greater customer lifetime value.

Ongoing Experience Upgrade
H World continued to advance its product upgrade initiatives to enhance consumer experience across core brands including Hanting, JI, and Orange. As of Q1:

  • 40% of Hanting Hotels had reached version 3.5 or above
  • 78% of Ji Hotels had reached Ji 4.0+
  • 70% of Orange Hotels met the Orange 2.0 standard

The first quarter also marked rapid growth in the upper-midscale segment, which includes brands such as Intercity Hotel, Crystal Orange Hotel, MAXX by Steigenberger, and CitiGo Hotel, with a 36% year-on-year increase in operating hotels and a 22% expansion of the development pipeline.

Looking Ahead
“We are confident we will achieve our full-year network expansion target of approximately 2,300 gross hotel openings,” said H World CEO Jin Hui. “To achieve sustainable long-term growth, we will continue advancing our asset-light strategy, focusing on high-quality network expansion, enhancing brand positioning and ‘service excellence’, and strengthening sales capabilities centred around our H Rewards membership program.”

For the full release please visit:
https://ir.hworld.com/news-releases/news-release-details/h-world-group-limited-reports-first-quarter-2025-unaudited

1. The conversion of Renminbi (“RMB”) into United States dollars (“US$”) is based on the exchange rate of US$1.00=RMB7.2567 on March 31, 2025, as set forth in H.10 statistical release of the U.S. Federal Reserve Board and available at http://www.federalreserve.gov/releases/h10/hist/dat00_ch.htm.

About H World Group Limited

Originated in China, H World Group Limited (NASDAQ:HTHT; HK:01179) is a key player in the global hotel industry. H World’s brands include HanTing Hotel, JI Hotel, Crystal Orange Hotel, Steigenberger Hotels & Resorts, MAXX, Jaz in the City, IntercityHotel, Zleep Hotels and Steigenberger Icons. In addition, H World also has the rights as master franchisee for Mercure, Ibis and Ibis Styles, and co-development rights for Grand Mercure and Novotel, in the pan-China region.

For more information, please visit H World’s website: https://ir.hworld.com

H World undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, unless required by applicable law.

For m edia i nquiry, please contact:

Lihuan Wang media@hworld.com
Zheming Xing zheming@taskforce-china.cn
Zhibin Lang  zhibin.lang@taskforce-china.cn

 

HTX Unveils Finalists for $6M Mars Program Special Edition, Space Journey Selection Enters Final Phase

SINGAPORE, May 20, 2025 /PRNewswire/ — HTX, a leading global cryptocurrency exchange, has officially announced five new finalists for its Mars Program: Special Edition, a once-in-a-lifetime spaceflight campaign personally funded by Advisor to HTX and Founder of TRON, Justin Sun. This brings the total number of candidates vying for a seat on a historic $6 million space voyage to twelve, as the program enters its final selection phase.

The five new candidates were chosen based on multiple factors including user registration duration, trading activity, asset balance, and referral contributions.

The UIDs of the newly selected candidates are: 269****10, 394****24, 448***68, 470****46 and 545****46. These five will join the seven previously selected Mars Program finalists—UIDs: 305****92, 416****94, 427****63, 436****64, 449****70, 464****24 and 471****74—forming a shortlist of 12 final candidates who will compete for one seat on a commercial spaceflight with Justin Sun in July 2025.

Official Announcement: https://www.htx.com.ec/support/85001963095003

The Mars Program: Special Edition is fully sponsored by Justin Sun, and represents a $6 million investment to make space exploration accessible to the broader crypto community. As the first initiative of its kind in the industry, the campaign underscores HTX’s mission to push the boundaries of user engagement and bring real-world value to its global community. Since its launch, the campaign has attracted a large number of participants from around the world.

Following the selection of the 12 finalists, the program now enters a critical evaluation phase. Candidates will undergo training and assessment organized by the HTX team. The final space representative will be selected based on performance during this stage. The winner and further updates will be announced through HTX’s official channels.

HTX emphasized that this initiative is not only a continuation of the Mars Program, which has completed seven previous rounds, but also a strategic effort to enhance the platform’s global visibility and user loyalty. By offering extraordinary experiences to everyday users, HTX demonstrates its commitment to innovation, inclusion, and long-term value creation within the Web3 ecosystem.

About HTX
Founded in 2013, HTX has evolved from a virtual asset exchange into a comprehensive ecosystem of blockchain businesses that span digital asset trading, financial derivatives, research, investments, incubation, and other businesses.

As a world-leading gateway to Web3, HTX harbors global capabilities that enable it to provide users with safe and reliable services. Adhering to the growth strategy of “Global Expansion, Thriving Ecosystem, Wealth Effect, Security & Compliance,” HTX is dedicated to providing quality services and values to virtual asset enthusiasts worldwide.

To learn more about HTX, please visit HTX Square or https://www.htx.com/, and follow HTX on XTelegram, and Discord.

 

Registrational Phase III AMPLIFY trial in biochemical recurrence of prostate cancer commences

SYDNEY, May 20, 2025 /PRNewswire/ — Clarity Pharmaceuticals (ASX: CU6) (“Clarity” or “Company”), a clinical-stage radiopharmaceutical company with a mission to develop next-generation products that improve treatment outcomes for patients with cancer, is pleased to announce that it has commenced its second registrational Phase III 64Cu-SAR-bisPSMA diagnostic trial in prostate cancer, AMPLIFY (NCT06970847)1, with the initiation of the first clinical site at XCancer in Omaha, NE.

AMPLIFY is a study of 64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer. It is a non-randomised, single-arm, open-label, multi-centre, diagnostic clinical trial of 64Cu-SAR-bisPSMA positron emission tomography (PET) in participants with rising or detectable prostate-specific antigen (PSA) after initial definitive treatment.

The aim of this Phase III trial is to investigate the ability of 64Cu-SAR-bisPSMA PET/computed tomography (CT) to detect recurrence of prostate cancer. Evaluation will be across 2 imaging timepoints, Day 1 (day of administration, same-day imaging) and Day 2 (approximately 24 hours post administration, next-day imaging).

The study will enroll approximately 220 participants at multiple clinical sites across the United States (US) and Australia, and the first participant is expected to be imaged in the coming weeks. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the US Food and Drug Administration (FDA) for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in biochemical recurrence (BCR) of prostate cancer.

Clarity’s Executive Chairperson, Dr Alan Taylor, commented, “We are very excited to commence our second registrational Phase III trial with the optimised SAR-bisPSMA agent in patients that are experiencing the return of their disease following treatment of the primary cancer.

“The recent devastating news that former US President, Joe Biden, has been diagnosed with aggressive prostate cancer that has metastasised to the bone is yet another reminder that no man is safe from this insidious disease, and he joins over 3.3 million men in the US who live with prostate cancer today2. Australia is also not immune. A recent public announcement revealed that MP Barnaby Joyce has recently been diagnosed with prostate cancer, and he joins over 250,000 Australian men who are living with prostate cancer today3. These large numbers highlight the need for more timely and accurate diagnosis to safely and effectively treat the cancer with suitable therapies.”

The AMPLIFY trial is based on favourable preclinical and clinical data generated to date, including the Phase I/II COBRA trial in patients with BCR of prostate cancer and the Phase I PROPELLER trial in patients with confirmed prostate cancer pre-prostatectomy4,5. These earlier studies demonstrated an excellent safety profile and exciting efficacy results, especially in comparison to current standard of care imaging. PROPELLER showed improved diagnostic performance of 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 on same-day imaging, including higher number of lesions identified and 2-3 times higher uptake and tumour-to-background ratio, favouring 64Cu-SAR-bisPSMA. The COBRA trial showed that more lesions and more patients with a positive scan were identified on 64Cu-SAR-bisPSMA PET compared to conventional scans and on next-day vs. same-day imaging. 64Cu-SAR-bisPSMA also allowed for the identification of lesions in the 2-mm range. The most recent findings from the COBRA trial demonstrated that 64Cu-SAR-bisPSMA was able to detect lesions from 29 days to more than 6 months earlier than standard-of-care (SOC) prostate-specific membrane antigen (PSMA) PET agents.

“These compelling findings, along with preliminary theranostic SECuRE trial data6, laid the foundation for the receipt of three Fast Track Designations (FTD) for SAR-bisPSMA from the US FDA within six months7-9, highlighting how impressive our science and clinical development are, the significance of the data so far and the high unmet need for better therapies and diagnostics in prostate cancer. We believe 64Cu-SAR-bisPSMA could become a best-in-class product and look forward to progressing its clinical development through several trials in prostate cancer: AMPLIFY in BCR, our first Phase III CLARIFY study in pre-prostatectomy patients, the investigator-initiated trial led by Prof Louise Emmett, Co-PSMA (head-to-head study comparing the diagnostic performance of 64Cu-SAR-bisPSMA vs. SOC 68Ga-PSMA-11 in BCR), and the theranostic SECuRE study in metastatic castration-resistant prostate cancer (mCRPC). The FTDs will enable us to accelerate the development of this comprehensive program to be used in patients with prostate cancer throughout the management of their cancer, from initial to late-stage disease, with an opportunity to completely change the entire treatment landscape for the large prostate cancer market.

“We have received a lot of interest in the AMPLIFY trial and look forward to seeing this study progress in such an important patient population. Knowing whether or not their prostate cancer has returned following initial treatment and where the cancer lesions are located are essential for the appropriate treatment of BCR patients. Identifying lesions as early as possible can arm clinicians with important information to help determine the right treatment regimen and ensure positive long-term treatment outcomes. We would like to thank all clinicians and patients who participate in our clinical trials and who trust us in delivering on our promise of developing best-in-class products. Our team and collaborators look forward to bringing this next-generation PSMA diagnostic to prostate cancer patients around the world,” said Dr Taylor.

About SAR-bisPSMA

SAR-bisPSMA derives its name from the word “bis”, which reflects a novel approach of connecting two PSMA-targeting agents to Clarity’s proprietary sarcophagine (SAR) technology that securely holds copper isotopes inside a cage-like structure, called a chelator. Unlike other commercially available chelators, the SAR technology prevents copper leakage into the body. SAR-bisPSMA is a Targeted Copper Theranostic (TCT) that can be used with isotopes of copper-64 (Cu-64 or 64Cu) for imaging and copper-67 (Cu-67 or 67Cu) for therapy.

Disclaimer

67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA are unregistered products. The safety and efficacy of 67Cu-SAR-bisPSMA and 64Cu-SAR-bisPSMA have not been assessed by health authorities such as the US FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that these products will become commercially available.

About Prostate Cancer

Prostate cancer is the second most common cancer diagnosed in men globally and the fifth leading cause of cancer death in men worldwide10. Prostate cancer is the second-leading causes of cancer death in American men. The American Cancer Institute estimates in 2025 there will be about 313,780 new cases of prostate cancer in the US and around 35,770 deaths from the disease2.

About Clarity Pharmaceuticals

Clarity is a clinical stage radiopharmaceutical company focused on the treatment of serious diseases. The Company is a leader in innovative radiopharmaceuticals, developing Targeted Copper Theranostics based on its SAR Technology Platform for the treatment of cancers.

www.claritypharmaceuticals.com

For more information, please contact:

Clarity Pharmaceuticals

Dr Alan Taylor

Catherine Strong

Executive Chairperson 

Investor/Media Relations

ataylor@claritypharm.com   

c.strong@morrowsodali.com 

+61 406 759 268

References

1.     ClinicalTrials.gov Identifier: NCT06970847, https://clinicaltrials.gov/ct2/show/NCT06970847

2.     American Cancer Society: Key Statistics for Prostate Cancer, https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

3.     Prostate Cancer Foundation of Australia. Facts and Figures, https://www.prostate.org.au/risk-and-symptoms/facts-figures/

4.     Lengyelova & Emmett et al. 64Cu-SAR-bisPSMA (PROPELLER) positron emission tomography (PET) imaging in patients with confirmed prostate cancer. ASCO 2023. Poster available at: https://www.claritypharmaceuticals.com/pipeline/scientific_presentations/

5.     Nordquist et al. COBRA: Assessment of safety and efficacy of 64Cu-SAR-bisPSMA in patients with biochemical recurrence of prostate cancer following definitive therapy. EANM, 2024.

6.     Clarity Pharmaceuticals. SECuRE trial update: 92% of pre-chemo participants experience greater than 35% drop in PSA levels across all cohorts. Cohort Expansion Phase commences. https://www.claritypharmaceuticals.com/news/secure-update/

7.     Clarity Pharmaceuticals. Clarity receives FDA Fast Track Designation for Cu-64 SAR-bisPSMA. https://www.claritypharmaceuticals.com/news/fast-track/

8.     Clarity Pharmaceuticals. Clarity receives U.S. FDA Fast Track Designation for Cu-64 SAR-bisPSMA in biochemical recurrence of prostate cancer. https://www.claritypharmaceuticals.com/news/ftd-2/

9.     Clarity Pharmaceuticals. Clarity receives US FDA Fast Track Designation for the treatment of metastatic castration-resistant prostate cancer patients with Cu-67 SAR-bisPSMA. https://www.claritypharmaceuticals.com/news/ftd-67cu-sarbispsma

10.  Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660

This announcement has been authorised for release by the Executive Chairperson.