SYDNEY, March 10, 2026 /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 the Phase III AMPLIFY trial (NCT06970847)^[1] has now consented  in excess of the planned number of participants following strong demand for study participation at sites in the United States (US) and Australia. Consenting of new patients has stopped at all sites pending completion of remaining screening assessments and confirmation of final enrolment numbers.

AMPLIFY (⁶⁴Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants with Biochemical Recurrence of Prostate Cancer) 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 at clinical sites across the US and Australia.  

The aim of this registrational study is to investigate the diagnostic ability of ⁶⁴Cu-SAR-bisPSMA PET/computed tomography (CT) to detect recurrence of prostate cancer in men with PSA levels above 0.2 ng/mL. Evaluation will be across two imaging timepoints: Day 1 (1-4 hours post-administration, same-day imaging) and Day 2 (approximately 24 hours post administration, next-day imaging).

AMPLIFY commenced in May 2025, seeking to enrol approximately 220 participants, and the first trial participant was imaged in the same month at XCancer with Dr Luke Nordquist (Omaha, NE). The data from this study will complement the Phase I/II COBRA^[2] and Phase II Co-PSMA^[3] trials. Both studies have demonstrated enhanced imaging capabilities of ⁶⁴Cu-SAR-bisPSMA over standard-of-care (SOC) prostate-specific membrane antigen (PSMA) PET imaging in patients with biochemical recurrence (BCR) of prostate cancer. As a pivotal trial, the final study results from AMPLIFY are intended to provide 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 BCR of prostate cancer.

⁶⁴Cu-SAR-bisPSMA is also currently being evaluated in another registrational Phase III trial, CLARIFY (NCT06056830)^[4], which is expected to close recruitment in CY2026. Building on the Phase I PROPELLER^[5] study, the objective of CLARIFY is to assess the diagnostic performance of ⁶⁴Cu-SAR-bisPSMA PET across same-day and next-day imaging in detecting prostate cancer within the pelvic lymph nodes in patients who are scheduled to undergo radical prostatectomy and pelvic lymph node dissection. The CLARIFY results are intended to support an FDA approval application for ⁶⁴Cu-SAR-bisPSMA in prostate cancer patients who are candidates for definitive therapy.

Dr Alan Taylor, Executive Chairperson of Clarity Pharmaceuticals, commented, “We are about to enter the realm of a select few Australian companies who have developed a drug at the benchtop of Australian science and completed an international Phase III clinical trial with that drug, taking us one step closer to commercialisation. Our team is excited to have reached this initial recruitment milestone in the AMPLIFY trial in just 9 months since we imaged our first participant in the study. This is no small feat, given we achieved this phenomenal pace of recruitment despite three SOC products already in the market, commercialised by four different companies.

“True to our commitment to the highest standards of clinical research, we recruited participants at numerous different sites across the US and Australia to ensure the trial reflected the broad patient population, real-world clinical settings and various PET cameras in which this product is intended to be used. This strategy required careful planning to allow for all participating sites to contribute to the recruitment, based on allocation of participant numbers to be enrolled per site, resulting in what we believe will be a robust and well-balanced dataset and supporting the integrity and quality of the AMPLIFY study.

“Despite the variations in the sites’ activation times, the speed of enrolment in this trial not only highlights the unmet need in the BCR space but also indicates the strong demand for ⁶⁴Cu-SAR-bisPSMA from clinicians and patients seeking more effective and accurate prostate cancer detection diagnostics. With persistent outreach from participating sites to enrol more patients, clinicians and patients would rather use an unapproved product, undertaking additional demands of a clinical trial, than rely on the findings of the current SOC PSMA PET.

“To date, we have imaged approximately 600 patients with prostate cancer with ⁶⁴Cu-SAR-bisPSMA, and just in the last year we scanned over 350 of them. The growing demand for better imaging is driven by so many men around the world with prostate cancer who seek accurate and timely identification of disease location and recurrence. We are committed to answering these needs of patients, clinicians and imaging facilities with a next-generation diagnostic imaging agent specifically designed to deliver significant benefits in efficacy, clinical management, quality of life and operational flexibility across the prostate cancer care pathway.

“The results on ⁶⁴Cu-SAR-bisPSMA generated to date, from our initial discovery and pre-clinical work, to the recently announced Co-PSMA and the COBRA trials, constitute an extensive body of evidence against SOC, demonstrating that maximal clinical benefit of PSMA PET can be derived through the combination of the proprietary SAR-bisPSMA agent and optimised imaging timepoints facilitated by the half-life of copper-64. Achieving a two to three times improvement in lesion detection over SOC in BCR is an incredible achievement. We believe we can grow the blockbuster PSMA PET market even further with a product that has shown impressive efficacy in clinical trials coupled with many logistical and supply chain benefits. Our team will be working closely with our vendors and participating sites to advance the final data package and with regulatory authorities to get this product to patients in need as soon as possible.

“We also look forward to closing recruitment in the CLARIFY trial this year and progressing our theranostic Phase I/IIa SECuRE trial towards completion. Together with three Fast Track Designations we have for SAR-bisPSMA and positive interactions with the US FDA to date, these milestones place us closer than ever to commercialisation of this exciting agent through the entirety of the prostate cancer journey, from first detection to late-stage metastatic disease.”

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

⁶⁴Cu-SAR-bisPSMA and ⁶⁷Cu-SAR-bisPSMA are unregistered products. Their safety and efficacy 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 worldwide^[6]. Prostate cancer is the second-leading cause of cancer death in American men. The American Cancer Institute estimates there will be about 333,830 new cases of prostate cancer in the US in 2026 and around 36,320 deaths from the disease^[7].

For more information, please contact:

References

1. ClinicalTrials.gov Identifier: NCT06970847. https://clinicaltrials.gov/study/NCT06970847 
2. 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.
3. Clarity Pharmaceuticals. Co-PSMA: Cu-64 SAR-bisPSMA more than doubled prostate cancer lesion and patient detection vs. Ga-68 PSMA-11 in head-to-head trial. https://www.claritypharmaceuticals.com/news/abstract-eau-2026/
4. ClinicalTrials.gov Identifier: NCT06970847. https://clinicaltrials.gov/study/NCT06907641
5. Veronica Wong, Nat Lenzo, Michelle Parker and Louise Emmett. ⁶⁴Cu-SAR-bisPSMA (PROPELLER) positron emission tomography (PET) imaging in patients with confirmed prostate cancer. JCO 41, 5039-5039(2023). DOI:10.1200/JCO.2023.41.16_suppl.5039
6. 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
7. American Cancer Society: Key Statistics for Prostate Cancer. https://www.cancer.org/cancer/prostate-cancer/about/key-statistics.html

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

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Under the theme “FUTURE VINTAGE — Carrying the Memories of the Past into the Future, New Creation,” diverse programs unfold primarily across nine iconic areas of Tokyo.

TOKYO, March 10, 2026 /PRNewswire/ — The Tokyo Creative Salon Executive Committee will host TOKYO CREATIVE SALON 2026 (TCS 2026) over 10 days from Friday, March 13 to Sunday, March 22, 2026, primarily across Akasaka, Ginza, Shibuya, Shinjuku, Nihonbashi, Haneda, Harajuku, Marunouchi, and Roppongi. Admission is free.

At the heart of TCS 2026 is the City Wide Program, where the experience itself—encountering creativity while exploring Tokyo—becomes the content. Grounded in the festival theme, each area draws on its own history, culture, and character to present creative content across fashion, design, art, and craft.

City Wide Program: Area Concepts
Akasaka — “A Sophisticated Social Hub That Continues to Evolve While Preserving Its Heritage”: tradition reinterpreted through new creations bridging past and future.
Ginza — “A City That Inherits Tradition and Creates Tomorrow Through Continuous Evolution”: strolling and hands-on programs across cultural and commercial venues.
Shibuya — “A Crossroads at the Cutting Edge, Where Trends Converge”: urban fashion-driven initiatives reflecting the district’s leading-edge energy.
Shinjuku — “FUTURE VINTAGE SO/ME/RU SHINJUKU”: dyeing and vintage-focused programs showcasing future-minded creativity.
Nihonbashi — “Nihonbashi Open Craft”: craftsmanship as living culture, experienced while walking the neighborhood.
Haneda — “FUTURE BLOOM JAPAN — Traveling with Cherry Blossoms Through Japan’s Beauty and Craftsmanship”: exhibitions and experiences reframing regional skills and culture at Japan’s gateway.
Harajuku — “Harajuku, Where Street Cultures Intersect”: participatory programs that spark fashion-and-culture encounters as you explore.
Marunouchi — “Sustainable Creation Born from a City of Work”: easy-to-join, sustainability-minded experiences across a business district.
Roppongi — “A City Where Diverse Talents Gather and Intersect”: programs resonating with museums, galleries, and the urban landscape.

TCS 2026 will also present two official initiatives at Shinjuku Sumitomo Building Triangle Plaza from March 13–15, 2026. Tokyo Vintage Fashion Week, the world’s first vintage fashion week, features a Vintage Market with approximately 100 shops and fashion shows highlighting the “historical context” and “stories” embodied in vintage garments. Focus Exhibition “Tokyo Trace” explores the traces of Tokyo embedded within a designer’s creative practice; its inaugural edition spotlights “NOMARHYTHM TEXTILE.”

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SINGAPORE, March 9, 2026 /PRNewswire/ — Math Magic recently announced the release of Hitem3D v2.0, the latest upgrade to its AI image-to-3D platform, as developers and creators increasingly evaluate AI modeling tools based on their suitability for specific production workflows. The update focuses on improving geometry reliability and workflow efficiency across 3D printing and digital content pipelines.

According to testing data released alongside Hitem3D v2.0, the platform emphasizes texture-aware generation through what it describes as “structure-aware integrated texture generation.” This process produces geometry and texture simultaneously, aiming to reduce mesh issues such as non-manifold edges and flipped normals that can interrupt slicing workflows.

Other AI modeling platforms in the category often focus on broader creative production, offering multimodal generation features and tools designed for animation, game assets, or media content pipelines.

Resolution and print readiness

Hitem3D emphasizes higher-resolution internal representations and structure-aware reconstruction to better align with the structural requirements of 3D printing workflows. This approach prioritizes geometric stability and fabrication reliability during the generation stage.

In contrast, some AI creative platforms prioritize multimodal generation and asset flexibility, enabling creators to refine and adapt models for animation, rendering, or other digital-first environments.

Users cited in Hitem3D materials reported that models often pass print pre-checks with minimal cleanup, while creative-focused platforms may offer stronger support for workflows involving rigging, animation, and multi-format content production.

Multi-view reconstruction and structural consistency

Hitem3D supports up to four reference images in its multi-view mode to improve structural consistency and reduce the uncertainty common in single-image reconstruction.

Many creative pipelines rely more heavily on downstream editing and refinement, which can provide flexibility for stylized asset development but may introduce additional workflow steps for users preparing models for fabrication.

Use-case alignment

Different AI 3D platforms are increasingly optimized for different production scenarios.

Hitem3D is commonly applied to:

• 3D printing
• figurine production
• CNC and fabrication workflows

Other AI modeling tools are often used for:

• game asset development
• animation pipelines
• multimodal creative projects

The differences reflect a broader segmentation emerging in the AI image-to-3D space as platforms evolve to support distinct creative and manufacturing workflows.

Hitem3D v2.0 is now available worldwide. Learn more about Hitem3D v2.0 and explore sample outputs at hitem3d.ai and hitem3d.ai/3dprinting/use-case.

About Hitem3D

Hitem3D, pioneered by Math Magic (founded 2024), converts single or multi-view images into production-ready 3D models for 3D printing, industrial design, and game asset creation. The platform serves users in more than 150 countries and integrates into professional digital production workflows.

Website: https://www.hitem3d.ai/

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CHENGDU, China, March 9, 2026 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (“Kelun-Biotech” or the “Company”, 6990.HK) and Harbour BioMed (HKEX: 02142) today announced that the National Medical Products Administration (NMPA) of China has approved the Investigational New Drug (IND) application for SKB575/HBM7575, a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed target co-developed by the two parties, for the treatment of atopic dermatitis.

Atopic dermatitis is a chronic, inflammatory skin disease characterized by persistent itching, redness, and irritation. It affects around 20% of children and up to 10% of adults worldwide^[1]. Though not infectious, atopic dermatitis has a profound impact on patients’ quality of life due to its cyclical nature of flare-ups and remissions. Current treatments, including topical corticosteroids, biologics, and Janus kinase (JAK) inhibitors, provide symptomatic relief for many patients, but often fail to deliver sustained disease control, especially in moderate-to-severe cases. Therefore, there is an urgent need for safer, more effective, and durable treatments that address underlying disease mechanisms and improve long-term outcomes.

Dr. Michael Ge, CEO of Kelun-Biotech, stated: “We are delighted to see the approval of SKB575/HBM7575 for clinical trials in atopic dermatitis. This marks an important milestone in our strategic expansion in the field of autoimmune diseases and holds promise for offering a novel therapeutic option to patients with atopic dermatitis. As a bispecific antibody with a differentiated innovative mechanism and a long-acting profile, SKB575/HBM7575 holds the potential to deliver durable and stable disease control while improving patient treatment experience through reduced dosing frequency.”

Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed, commented: “The NMPA’s IND approval for HBM7575/SKB575 marks an important step forward in addressing the significant unmet needs in autoimmune diseases such as atopic dermatitis. By targeting TSLP, a key upstream driver of type 2 inflammation, and an undisclosed target, HBM7575/SKB575 has the potential to be a best-in-class bispecific antibody for this disease. We look forward to advancing this investigational therapy through clinical development and believe its long-acting profile may offer a differentiated treatment option for patients worldwide.”

About SKB575/HBM7575

SKB575/HBM7575 is a long-acting bispecific antibody targeting thymic stromal lymphopoietin (TSLP) and an undisclosed antigen, with a dual mechanism of action. On one hand, by blocking the interaction between TSLP and its receptor, it inhibits TSLP-mediated signaling pathways and the activation of Th2 immune cells. On the other hand, binding to and blocking the undisclosed target generates a synergistic effect, overcoming resistance issues associated with TSLP single-target antibodies. SKB575/HBM7575 has been engineered to possess an extended half-life and favorable developability, enabling subcutaneous administration. Based on preclinical half-life data, the anticipated human half-life is expected to support dosing intervals of more than three months, positioning it as a potential best-in-class therapy.

According to the collaboration agreement between the Company and Harbour BioMed, SKB575/HBM7575 is led by Kelun-Biotech in its design, global development and commercialization, with Harbour BioMed participating in the investment and development of this asset and sharing the benefits as agreed.

About Kelun-Biotech

Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical, which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. Kelun-Biotech focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. Kelun-Biotech is committed to becoming a leading global enterprise in the field of innovative drugs. At present, Kelun-Biotech has more than 30 ongoing key innovative drug projects, of which 4 projects with 8 indications have been approved for marketing, 1 project is in the NDA stage and more than 10 projects are in the clinical stage. Kelun-Biotech has established one of the world’s leading proprietary ADC and novel DC platforms, OptiDC™, and has 2 ADC projects with 5 indications approved for marketing, and multiple ADC and novel DC assets in clinical or preclinical research stage. For more information, please visit https://en.kelun-biotech.com/.

About Harbour BioMed

Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions.

Harbour BioMed’s proprietary antibody technology platform, Harbour Mice^®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE^®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICA^TM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice^®, HBICE^®, and HBICA^TM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit www.harbourbiomed.com.

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SYDNEY, March 9, 2026 /PRNewswire/ — BLUETTI, a technology pioneer in clean energy, has announced the Australian launch of its new Elite 400 wheeled power station, available from March 9, 2026. Combining nearly 4kWh of high capacity with suitcase-like mobility, the Elite 400 rolls around to support home backup, outdoor activities, small businesses, and off-grid operations.

BLUETTI Launches Elite 400 Rolling Power Station in Australia

Roll-in Power for All Scenarios

Despite its large capacity, the Elite 400 is designed for easy transport. A pull rod, durable wheels, and integrated handles allow one person to move the unit between locations, from living room to vehicle to worksite.

Built for versatility, the Elite 400 provides 2,600W of continuous AC output, with up to 3,900W lifting power to handle high-startup appliances, including fridges, freezers, induction cooktops, and power tools. Its pure sine wave output through seven versatile ports offers stable, clean power delivery for DJ setups, market stalls, and outdoor events.

Long-Lasting Operation, Least Downtime

On a full charge, the Elite 400 can operate a 50W portable fridge for over 131 hours, a 1,000W ice maker for approximately 3.2 hours, or a 120W speaker for about 25 hours, supporting extended use without refuels, emissions, or noise.

When it’s depleted, the AC+solar combined input of 3,300W gets it back to 80% recharge in one hour under optimal conditions. This fast turnaround ensures non-stop operation for rural farms, remote properties, and off-grid sheds seeking clean and cost-effective energy solutions.

Fast UPS Backup with Smart Control

As an interrupted power supply, Elite 400 switches to battery power within 15ms, keeping security cameras, POS machines, and work-from-home gear intact during sudden outages. Its 3W ultra-low self-consumption guarantees long standby periods.

Smart monitoring and control are available through the BLUETTI app via Bluetooth and Wi-Fi. Users can track real-time power usage, schedule charging, and automate power routines for day-to-day convenience.

The BLUETTI Elite 400 will retail at AUD $2,999 on the official BLUETTI Australia website from March 9, 2026.

About BLUETTI

Founded in 2009, BLUETTI is a technology pioneer in clean energy, specializing in innovative portable power stations and home power backup for power outages. With in-house R&D and manufacturing, and a growing patent portfolio, BLUETTI continually raises the standard for performance, safety, and sustainability in the industry, empowering over 4 million users across 110+ countries.

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