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Kolmar Korea Advances ‘Clean Beauty’ with Breakthroughs from Eco-Friendly Packaging to R&D

  • Sweeps global awards with eco-friendly packaging innovations, including paper tube, paper stick, and paper pack
  • Ranked No. 125 on TIME‘s “World’s Best Companies for Sustainable Growth 2025,” the only K-Beauty company on the list

SEOUL, South Korea, Sept. 15, 2025 /PRNewswire/ — Kolmar Korea, a global cosmetics ODM company, is strengthening its commitment to “clean beauty.” From eco-friendly packaging to raw material and formulation development, as well as sustainable production processes, the company is enhancing its ESG management to secure differentiated competitiveness in the global market.

Kolmar Korea’s eco-friendly packaging innovations—paper tube (left), paper stick, and one-hand pump paper pack
Kolmar Korea’s eco-friendly packaging innovations—paper tube (left), paper stick, and one-hand pump paper pack

The company’s eco-friendly packaging has garnered the most attention. In 2020, Kolmar Korea introduced the paper tube, the industry’s first eco-friendly container to successfully achieve commercialization. It reduced plastic usage by 80%, is designed for easy separation of paper and plastic, and is durable enough to withstand over 50 kg of weight. In 2023, it developed the paper stick with mineral paper, cutting plastic use by 86%. Designed to peel away layers of paper, the stick allows consumers to use the entire product without waste, balancing sustainability with practicality. This April, the company unveiled the one-hand pump paper pack, a milk-carton-inspired design that integrates a pump function. Made from 100% recyclable materials, it provides both user convenience and the eco-friendly attributes global consumers demand.

These innovations have earned international recognition. The paper tube and paper stick achieved a “grand slam” in design by winning the world’s top three design awards—IDEA, iF Design Award, and Red Dot Design Award. The one-hand pump paper pack also won a Red Dot Design Award this year, further validating the global competitiveness of Kolmar Korea’s eco-friendly packaging.

Beyond packaging, Kolmar Korea is strengthening clean beauty in raw materials and formulations. In 2022, the company developed an eco-friendly extraction method using sunflower, lingonberry, and starflower that reduced carbon emissions by 83% while boosting active ingredient efficacy by 870%. Applied in its 2023 clean beauty sunscreen, this innovation earned Korea’s Ministry of Environment “Green Technology Product” certification. That same year, Kolmar Korea replaced microplastics in color cosmetics with natural silica, a mineral known for pore care and sebum control, improving texture and stability while advancing both functionality and sustainability.

Kolmar Korea is also driving low-carbon and eco-friendly manufacturing. The company joined the K-RE100 initiative in 2022, pledging 100% renewable energy use by 2050. At its key Sejong plant, expanded solar facilities in 2023 cut approximately 143 tons of CO₂ emissions. The company also operates a dedicated division targeting “zero landfill waste,” reducing landfill rates and boosting recycling through systematic sustainability management.

These wide-ranging efforts have gained global recognition. In 2024, TIME magazine ranked Kolmar Korea No. 125 on its “World’s Best Companies for Sustainable Growth 2025” list, the only K-Beauty company included, affirming its leadership in eco-friendly practices in the global market.

A Kolmar Korea spokesperson said, “Developing eco-friendly technologies is not a short-term achievement but a core business strategy to enhance the sustainability of the entire industry. We will continue to demonstrate leadership as a company driving sustainable growth in the global beauty sector.”

About Kolmar Korea
Kolmar Korea is a global cosmetics ODM headquartered in Seoul, South Korea. The company is recognized for innovation in formulation, packaging, and sustainable manufacturing, partnering with leading beauty brands worldwide. Through ESG-driven management and continuous R&D, Kolmar Korea advances clean beauty and eco-friendly solutions to shape a more sustainable future for the global beauty industry.

Media Contact
Kolmar Holdings
Jang-Woo Lee
jay.lee@kolmar.co.kr

Univers Named a Leader in 2025 Gartner® Magic Quadrant™ for Global Industrial IoT Platforms

SINGAPORE, Sept. 15, 2025 /PRNewswire/ — Univers, a global leader in AI for Energy, today announced that it has been positioned as a Leader in the 2025 Gartner Magic Quadrant for Global Industrial IoT Platforms.

Univers Named a Leader in 2025 Gartner® Magic Quadrant™ for Global Industrial IoT Platforms
Univers Named a Leader in 2025 Gartner® Magic Quadrant™ for Global Industrial IoT Platforms

The Gartner assessment recognizes Univers for its EnOS™ platform for its ability to execute and its completeness of vision.

In just seven years, Univers has built a global AI-first platform that now connects 365 million devices and manages 845 GW of renewable energy — nearly one-fifth of the world’s total capacity.

“Being recognized as a Leader in the Magic Quadrant so early in our journey is a proud moment for Univers.  This recognition underscores the company’s ability to innovate at speed and deliver impact at scale,” said Michael Ding, Global Executive Director, Univers. “It affirms that that an AI-first approach to energy and industrial IoT delivers tangible business results and sustainability outcomes for customers worldwide. We believe that this recognition validates our vision and fuels our commitment to help industries decarbonize and innovate at scale.”

Rather than siloed tools, EnOS™ offers a unified platform where industries can move from automation to autonomous intelligence. With applied AI, enterprises can detect risks before they escalate, balance energy flows across global operations, and accelerate the transition to low-carbon systems.

Univers’ rapid rise also reflects its ecosystem strength: global integrators are embedding EnOS™ into large-scale deployments, while technology partners extend AI capabilities into new industrial and energy use cases.

“Looking ahead, Univers remains focused on pushing the boundaries of AI for Energy, advancing from monitoring and optimization to fully autonomous operations and empowering industries worldwide to achieve resilience, efficiency, and sustainability at scale,” added Michael.

Gartner, Magic Quadrant for Global Industrial IoT Platforms, By Scot Kim, Sudip Pattanayak et al., 8 September 2025

GARTNER is a registered trademark and service mark of Gartner, Inc. and/or its affiliates in the U.S. and internationally, Magic Quadrant is a registered trademark of Gartner, Inc. and/or its affiliates and is used herein with permission. All rights reserved. Gartner does not endorse any vendor, product or service depicted in its research publications and does not advise technology users to select only those vendors with the highest ratings or other designation. Gartner research publications consist of the opinions of Gartner’s Research & Advisory organization and should not be construed as statements of fact. Gartner disclaims all warranties, expressed or implied, with respect to this research, including any warranties of merchantability or fitness for a particular purpose.

About Univers

Univers is a global leader for AI in Energy.

Univers’ EnOS™ platform empowers enterprises across industries to solve complex energy challenges with intelligent, data-driven insights.

With 365 million devices connected, 845GW of renewable energy managed, and a global network of 800+ customers, we are the only global technology partner offering a truly comprehensive, end-to-end energy management solution, supporting enterprises at every stage of their energy transition journey.

For more information, please visit univers.com.

MINT Incorporation Limited Announces the Launch of New Subsidiary, Axonex Intelligence Limited, Expanding into Smart Facility Management Solutions


HONG KONG SAR – Media OutReach Newswire – 15 September 2025 – MINT Incorporation Limited (NASDAQ: MIMI) (“MINT” or the “Company”), a leading Hong Kong-based provider of integrated interior design and fit out works, today announced the official launch of its wholly owned subsidiary, Axonex Intelligence Limited (“Axonex”), a company incorporated with limited liability under the laws of Hong Kong, marking MINT’s expansion into the technology realm with the fast-growing smart facility management sector. Building on this foundation, MINT is extending its expertise to harness robotics, IoT, and AI technologies to enhance the way properties are managed and experienced.

Axonex provides total solutions for smart facility management, integrating advanced technologies to improve efficiency, safety, and user experience across different property types. Its key capabilities include:

  • Robotic solutions to automate routine facility management tasks, improve efficiency, and reduce manpower needs.
  • Object identification and human posture recognition for enhanced security and operational monitoring.
  • Digital twin solutions enabling real-time visualization and management of facilities.
  • AI-powered analytics to optimize maintenance, space utilization, and resource allocation.

Axonex is set to serve a diverse range of clients, including shopping malls, government premises, residential complexes, and warehouses. By leveraging its design background and new technological focus, Axonex aims to provide a holistic approach to property and facility management.

To support its solutions, Axonex is collaborating with technology partners such as AIMO and Sharp Peak, ensuring strong hardware and software integration.

With this strategic move, MINT reaffirms its commitment to innovation and its mission to provide comprehensive solutions that blend design excellence with cutting-edge technology.

Forward Looking Statements

This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include the risks and uncertainties described in the Company’s annual report on Form 20-F for the year ended March 31, 2025. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur.

Hashtag: #MINTIncorporation #AxonexIntelligence

The issuer is solely responsible for the content of this announcement.

About MINT Incorporation Limited

The Company is a Hong Kong-based interior design and fit out works provider, with a strategic focus on providing integrated and industry-specific interior design and fit out works for commercial properties. The Company’s work encompasses offices of different industries and various kinds of retail stores with a view to reflect its customers’ corporate values and conceptualizing our customers’ brands. The Company’s commercial projects cover internationally renowned retail stores, F&B outlet chains and offices and other premises of a premier charitable organization in Hong Kong. The Company also provides integrated interior design and fit out works for luxury residential properties in order to enhance both the aesthetics and functionality of the interior space.

About Axonex Intelligence Limited
Axonex Intelligence Limited, a company incorporated with limited liability under the laws of Hong Kong and subsidiary of MINT Incorporation Limited, delivers comprehensive solutions for smart facility management through the integration of robotics, IoT devices, and AI-powered analytics. By enabling real-time monitoring, predictive insights, and digital twin technologies, Axonex helps clients optimize operations and elevate user experiences across diverse property types. Guided by its vision of being a one-stop partner, Axonex is committed to helping organizations seamlessly integrate cutting-edge technologies into their daily operations.

Rona Therapeutics Announces IND Filing of RN3161, a Highly Potent and Durable INHBE siRNA for Obesity

SHANGHAI and SANTA BARBARA, Calif., Sept. 15, 2025 /PRNewswire/ — Rona Therapeutics, a global leader in developing next-generation RNAi therapeutics, announced today the successful submission of RN3161 to the Australian Human Research Ethics Committee (HREC). RN3161 is a proprietary GalNAc-conjugated siRNA targeting INHBE, a novel therapeutic mechanism for adults with overweight and obesity.

Obesity is a global health crisis, but treatments often cause significant side effects, including nausea, vomiting and muscle loss, and are difficult to adhere to over time. The INHBE gene, found in the liver, produces Activin E, a protein that helps control fat metabolism. People with certain INHBE gene changes have better fat distribution, body composition, healthier cholesterol levels, and lower risks of type 2 diabetes or heart disease. This makes INHBE a promising target for improved obesity treatments.

RN3161, a novel siRNA developed through Rona’s proprietary GAIA™ platform, targets INHBE to reduce fat while preserving lean mass, setting it apart from existing treatments. Engineered with optimized GalNAc-conjugated delivery and chemical modifications, it minimizes off-target risks and demonstrated more than 90% INHBE mRNA knockdown in monkeys with a low single dose. RN3161’s long-lasting gene silencing supports Q6M to Q12M dosing, enhancing patient adherence and suitability for long-term obesity management. As the fourth clinical candidate from GAIA™, RN3161 underscores Rona’s consistent excellence to advance innovative RNAi medicines from bench to bedside.

Alex M. DePaoli, CMO, said, “The successful HREC submission of RN3161 marks an exciting step in advancing a novel therapeutic to treat obesity. RN3161 offers the potential benefit of losing weight with preserved muscle mass, but also the potential to enhance the metabolic benefits associated with fat loss. Further, infrequent dosing offers better adherence and weight loss maintenance. This represents a potential new paradigm in the field of obesity management. “

Stella Shi, CEO, added, “RN3161 could maintain high quality weight loss post GLP-1 era. This milestone reflects our ambition to reshape the obesity treatment paradigm for healthier weight loss. It renews our mission to bring innovative and durable therapies to patients worldwide. We’re committed to translating cutting-edge siRNA technologies into therapies in multiple areas.”

About Rona Therapeutics

Rona Therapeutics is a pioneering RNAi platform company dedicated to addressing cardiometabolic diseases and obesity worldwide. Rona’s pipeline is fueled by highly effective and proprietary liver and extra-hepatic delivery platforms. The company has raised $100M USD since inception.

The Korea Industry Daily: Industrial AI EXPO 2025 Concludes, Marking Milestone in Korea’s AI-Driven Industrial Transformation

SEOUL, South Korea, Sept. 15, 2025 /PRNewswire/ — The first-ever Industrial AI EXPO wrapped up at COEX Magok Convention Center after a three-day run from September 3 to 5, positioning itself as a key platform for accelerating the adoption of artificial intelligence across Korea’s industrial sectors.

The first-ever Industrial AI EXPO wrapped up at COEX Magok Convention Center after a three-day run from September 3 to 5, positioning itself as a key platform for accelerating the adoption of artificial intelligence across Korea’s industrial sectors.
The first-ever Industrial AI EXPO wrapped up at COEX Magok Convention Center after a three-day run from September 3 to 5, positioning itself as a key platform for accelerating the adoption of artificial intelligence across Korea’s industrial sectors.

The exhibition brought together 133 companies across 320 booths, unveiling a wide range of industrial AI equipment and solutions for the first time. The event opened with a series of high-level activities, including a memorandum of understanding (MOU) on building a data-sharing ecosystem for manufacturing and a Minister of Trade, Industry and Energy Award ceremony, recognizing 25 individuals and organizations for their contributions to industrial digital transformation and AI utilization.

Government officials and industry leaders—including executives from HD Hyundai, LG CNS, Microsoft Korea, Dassault Systèmes, HP Korea, Salesforce, and major domestic institutions—attended the opening ceremony, underscoring collective commitment to advancing industrial AI.

Vertical AI Showcases and Technology Debuts

The expo highlighted 12 key industrial AI task areas, covering market forecasting, supply chain optimization, process control, predictive maintenance, safety, workforce training, and cybersecurity. Exhibitors demonstrated how AI can improve efficiency and resilience in manufacturing and beyond.

Notably, HD Hyundai shared AI adoption cases from shipbuilding and construction equipment, while debuting its broader AIX (AI Transformation) strategy. Robotics, on-device AI, and physical AI technologies also made their first appearances, reflecting the next phase of industrial automation.

Global players including Microsoft, Dassault Systèmes, HP, NVIDIA (with domestic partner Leaders Systems), and Salesforce joined with Korean partners to showcase AI-driven innovations in manufacturing, customer management, and design—expanding both domestic B2B pipelines and global collaboration opportunities.

Conferences, Forums, and Business Networking

Beyond the exhibition floor, the event hosted a series of programs designed to strengthen the industrial AI ecosystem:

  • Industrial AI Conference – case studies and business models from leading corporations
  • AI-Tech Seminars – new technology launches and commercialization success stories
  • 1:1 Business Matching – connecting suppliers with demand-side enterprises
  • Startup IR and Investment Networking – pitches, mentoring, and investor sessions
  • Industrial AI International Certification Forum – discussions on reliability, safety, and standards with global stakeholders

Visitors also participated in guided docent tours, LG Science Park programs, and interactive events that highlighted industrial AI use cases across physical AI, manufacturing AI, and AI agent domains.

Building Korea’s Industrial AI Ecosystem

Lee Gil-seon, Executive Managing Director of the Korea Smart Manufacturing Industry Association, emphasized:

“As the country’s first vertical AI exhibition, Industrial AI EXPO presented a wealth of successful application cases. By serving as a matching platform between supply and demand, the expo will accelerate the adoption of AI across industries, strengthen Korea’s industrial AI ecosystem, and enhance global competitiveness.”

The successful conclusion of the Industrial AI EXPO 2025 underscored Korea’s determination to leverage artificial intelligence not only as a technological tool but as a transformative driver of industrial innovation.

AUKEY Releases MagFusion 1X: Fast, Stylish, and Affordable Qi2.2 Wireless Charging Stand

LOS ANGELES, Sept. 15, 2025 /PRNewswire/ — Global wireless charging leader AUKEY today announced the official release of MagFusion 1X, a sleek and affordable wireless charging stand for a single device. Designed for users who value fast, safe, and convenient charging without compromising on style, MagFusion 1X combines high-performance charging with modern aesthetics. Available in four trendy colors, it’s a versatile addition to any environment—from home and office to study spaces or bedside tables.

AUKEY MagFusion 1X Magnetic Wireless Charging Stand
AUKEY MagFusion 1X Magnetic Wireless Charging Stand

Fast and Reliable Charging
MagFusion 1X is Qi2.2-certified (also known as Qi2 25W), delivering up to 25W ultra-fast wireless charging for compatible devices. Compared with standard 15W Qi2 chargers, it can charge a phone to full power about 25 minutes faster, based on AUKEY lab tests using an iPhone 16 Pro Max. Strong magnetic alignment keeps devices securely in place throughout charging, ensuring more efficient power transfer.

Designed for Modern Use
The stand-style design supports hands-free operation, allowing users to charge and use their devices simultaneously. With adjustable angles up to 35°, it offers flexible viewing for video calls, streaming, or browsing. A vacuum silicone suction base adds anti-slip stability, preventing tipping or accidental displacement.

Fashion Meets Function
Available in Frost White, Dark Gray, Desert Gold, and Black, MagFusion 1X blends seamlessly with both home and office décor. Its stylish design makes it an ideal accessory for daily use—whether working, studying, or relaxing at home.

Availability
MagFusion 1X is available starting today in the U.S. via AUKEY’s official website for $28.99, delivering premium wireless charging at an affordable price.

For More Information
AUKEY official website: www.aukey.com
Media inquiries: pr@aukey.com 
Sales inquiries: b2b@aukey.com 

About AUKEY

AUKEY is a globally leading provider of cutting-edge consumer electronics designed for both practical performance and visual appeal. With a strong user-centric focus, AUKEY’s ever-expanding product portfolio creates a unique space where technology meets aesthetics. The brand’s MagFusion series of wireless charging products has earned multiple international accolades, including the iF Design Award and Red Dot Design Award, and continues to garner worldwide acclaim.

 

TCTM Kids IT Education Inc. Announces Name Change to VisionSys AI Inc.

BEIJING, Sept. 15, 2025 /PRNewswire/ — TCTM Kids IT Education Inc. (NASDAQ: VSA) (“VSA” or the “Company“), an emerging technology services company, specializing in brain machine interaction businesses leveraging the core algorithms and related software and hardware systems, is pleased to announce that it has changed its name to “VisionSys AI Inc” after receiving the Certificate of Incorporation on Change of Name from the Registry of Companies, Cayman Islands, on September 10, 2025. The change of name will be effective on Nasdaq on September 19, 2025. The Company’s ADSs will continue trading on the Nasdaq Capital Market under the trading symbol “VSA”, and the CUSIP number shall remain unchanged.

About VisionSys AI Inc (formerly known as TCTM Kids IT Education Inc.)

VSA is an emerging technology services company, specializing in brain machine interaction businesses leveraging the core algorithms and related software and hardware systems. We are dedicated to advancing AI-powered healthcare and biotech solutions that transform industries. Our mission is to empower individuals and organizations through intelligent systems, bridging innovation with real-world impact to create a smarter, more connected future.

Safe Harbor Statement

This announcement contains forward-looking statements made under the “safe harbor” provisions of Section 21E of the Securities Exchange Act of 1934, as amended, and the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “confident” and similar statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s control. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

For further information, please contact:

Investor Relations Contact
VisionSys AI Inc (formerly known as TCTM Kids IT Education Inc.)
Email:  info@visionsysai.com 

Biostar Pharma Successively Achieved First Patient Dosing for Two Phase II/III Multiregional Clinical Trials of Utidelone Capsule (UTD2)

SAN FRANCISCO, Sept. 15, 2025 /PRNewswire/ — Biostar Pharma, Inc., the US subsidiary of Beijing Biostar Pharmaceuticals Co., Ltd. (“Biostar”, Stock Code: 2563.HK) which is a synthetic biology driven biopharma company focusing on the discovery, development and commercialization of innovative oncology drugs, is pleased to announce that the first patients have been dosed for two phase II/III multiregional clinical trials (MRCT) of “Utidelone Capsule (UTD2) first-line treatment for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma” (NCT06841679) and “UTD2 treatment for platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer” (NCT07044349) on September 11, 2025 and September 12, 2025, respectively.

Utidelone has demonstrated excellent clinical data in gastric cancer: in a completed Phase II study of Utidelone Injection (UTD1) combined with PD-1 inhibitor and oxaliplatin for the first-line treatment of unresectable locally advanced or recurrent/metastatic HER2-negative gastric cancer, 23 patients had completed efficacy evaluation. Among them, 15 achieved partial response (PR) and 8 achieved stable disease (SD), resulting in a 65.2% objective response rate (ORR) and 100% clinical benefit rate (CBR). The median progression-free survival (mPFS) was 6.1 months. The combination regimen was generally well-tolerated. Most treatment-related adverse events (TRAEs) were Grade 1-2, reversible, and manageable. The longest treatment duration received by a patient was 22 cycles [1]. Consequently, Utidelone was granted an Orphan Drug Designation by the U.S. FDA for the treatment of advanced gastric cancer.

Besides gastric cancer, Utidelone has also shown considerable potential for treating ovarian cancer in previous clinical studies. A US Phase I clinical study of UTD2 as a monotherapy for advanced solid tumors had 12 evaluable patients, including one ovarian cancer patient with a complete response (CR) and another with PR, who had previously undergone 7 and 9 lines of therapy, respectively [2]. A Phase II clinical study of UTD1 as monotherapy for the treatment of advanced solid tumors had 10 evaluable patients in advanced ovarian cancer cohort, among them there were 1 PR and 3 SD.

Compared to taxanes, which are difficult for oral formulation development, Utidelone is not susceptible to P-glycoprotein thus cannot be pumped out of the cancer cell by P-glycoprotein and has the advantage for higher oral bioavailability and lower risk of developing cross-resistance. By utilizing its technology platform, Biostar developed Utidelone Capsule, and its efficacy and safety have been confirmed in both US and China’s studies. Utidelone Capsule will significantly improve the convenience of administration, compliance of patients, decrease in treatment cost and ease of combination therapy with other oral anti-cancer drugs, and more suitable for adjuvant or maintenance therapy. Beyond gastric and ovarian cancers, Biostar is actively planning and advancing multiple clinical studies to expand UTD2’s indications, including breast cancer adjuvant intensification therapy, pancreatic cancer, esophageal cancer, colorectal cancer, and so on.

About NCT06841679 Study

This study is a multi-national, open-label, randomized phase II/III clinical study of UTD2 combined with standard of care to evaluate the efficacy and safety in first-line patients with locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma, untreated with systemic treatment in the advanced setting. For the Phase II part, 78 subjects are planned to be enrolled in China, US, Europe and Japan. Its primary objectives are to evaluate the safety, efficacy, and pharmacokinetic profile of UTD2 in combination therapy. The Phase III part plans to enroll 700 subjects across multiple countries/regions. The primary endpoint is overall survival (OS), with secondary endpoints including PFS, ORR, and safety.

About NCT07044349 Study

This study is a multi-national, open-label, randomized Phase II/III clinical trial of UTD2 for the treatment of patients with platinum-resistant advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer. The Phase II part plans to enroll approximately 84 subjects. Its primary objective is to evaluate the safety, efficacy, and pharmacokinetic (PK) characteristics of UTD2 under different dosing regimens in the target patient population and to recommend a dose for Phase III. The Phase III part plans to enroll 480 subjects and is planned to be conducted in multiple countries and regions worldwide. Its primary objective is to evaluate the efficacy and safety of UTD2 compared to the investigator’s choice of standard treatment in the target patient population. The primary endpoint is PFS, with secondary endpoints including OS, ORR, and others.

About Utidelone

Utidelone is a new-generation genetically engineered microtubule inhibitor, and has similar mechanism of action with that of taxanes while demonstrating multiple advantages, including better anti-tumor activity, broader anti-tumor spectrum, better safety profile with very low hematologic toxicity, effective against multidrug-resistant tumors, less prone to developing drug resistance, capability of crossing the blood-brain barrier to prevent and treat brain tumors, and high oral bioavailability. Biostar has developed two formulations of Utidelone: injection (UTD1) and capsule (UTD2). UTD1 has been launched in China in 2021 for the treatment of metastatic breast cancer (MBC), who have progressed after at least one anthracycline- or taxane-containing chemotherapy regimen. The phase III study data showed that UTD1 plus capecitabine achieved both PFS and OS benefits versus capecitabine for heavily pretreated MBC patients, and the results were orally presented twice at ASCO annual meetings and published in prestigious journals [3-4].

About Biostar

Biostar is an integrated biopharma company focusing on the development of innovative anti-cancer drugs utilizing its synthetic biology R&D platform. The company is listed on the Hong Kong Stock Exchange (HK 2563) in 2024. We are actively selecting reliable global partners through out-licensing or co-development of Utidelone assets. We believe that our strong capabilities of R&D and manufacturing, coupled with our enriched commercial expertise, make us the preferred partner for global biopharmaceutical companies who share our goal of bringing innovative anti-cancer products to patients around the world. For additional information on partnering with Biostar, please contact our business development team at bd@biostar-pharma.com.

Reference
[1] 2025 ASCO Abstract #: 4040
[2] 2025 ASCO Abstract #: 3030
[3] B. Xu, T. Sun, Q. Zhang, et al. Annals of Oncology, 2021, 32(2): 218-228
[4] Pin Zhang, Tao Sun, Qingyuan Zhang, et al. Lancet Oncol 2017; 18: 371-83