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SINGAPORE, Jan. 31, 2025 /PRNewswire/ -- SHEIN today announced that it conducted over two million product safety tests in 2024, reinforcing its ongoing commitment to ensuring high standards in product quality and consumer safety. The tests were conducted in collaboration with leading third-party testing agencies such as Intertek, SGS, Bureau Veritas (BV), and TÜV, as well as at a CNAS-accredited laboratory. In 2025, SHEIN plans to invest more than US$15 million to further strengthen its product safety testing and compliance protocols. A Continuous Multi-Faceted Product Safety System SHEIN has built and implemented a multi-faceted product safety protocol to ensure product compliance with applicable laws and regulations, as well as to SHEIN's own standards of product safety. The system, which spans before, during, and after the sale process, is focused on overseeing product safety and ensuring that products meet compliance requirements: 1. Standards and Policies: SHEIN vendors are required to comply with the applicable product safety laws and regulations in the countries we operate in, as well as the controls and standards that SHEIN has put in place, such as SHEIN's Restricted Substances List (RSL), and SHEIN's codes of conduct for vendors. 2. Documentation and Certification Review: Vendors are required to submit documentation for products from categories such as electronics, children's toys, children's products, baby products, cosmetics, medical devices, light industry products, personal protective equipment (PPE), and textiles with specific regulatory requirements for SHEIN's system checks and manual reviews. Simultaneously, SHEIN is dedicated to providing comprehensive education and training for vendors, in order to continually improve their understanding of product compliance requirements. 3. Monitoring and Testing: Product safety tests, including chemical tests, are carried out throughout the sales cycle, in collaboration with leading third-party testing agencies such as Intertek, SGS, Bureau Veritas (BV), and TÜV, as well as at a CNAS-accredited laboratory. In 2024, SHEIN performed more than two million tests, including chemical tests, with third-party these agencies, as well as a CNAS-accredited laboratory. 4. Dynamic Evaluations: SHEIN conducts dynamic evaluations of vendors based on multi-dimensional aspects such as the product testing pass rate and negative feedback rate. Once a vendor's performance is assessed to be non-compliant or in violation of our requirements, SHEIN will take measures against the vendor such as removing the product listing, vendor point deductions, putting in place re-order restrictions, or even termination of the partnership, depending on the severity of the case. Upon learning of any claim against a product, SHEIN immediately removes the product as a precautionary measure while we conduct an investigation. Over the last year, the company has terminated its engagement with more than 260 sellers on its marketplace who did not meet compliance requirements. "Ensuring that our customers can shop with peace of mind is paramount at SHEIN," said Leonard Lin, President of EMEA and Global Head of Public Affairs for SHEIN. "From design to delivery, we all work to protect our customers at every step of the process. We have continued to expand our rigorous testing efforts, working with some of the world's top global testing agencies, to ensure that our products meet the highest standards and we continue to invest in enhancing our approach." Advancing Corporate Responsibility Initiatives As part of its broader commitment to corporate responsibility, SHEIN has also recently announced several key initiatives: 1. Appointment of Mustan Lalani as Head of Global Sustainability SHEIN has appointed Mustan Lalani as its Head of Global Sustainability, further strengthening its commitment to driving responsible business practices across its supply chain. Mustan will lead SHEIN's efforts to help address the challenges that face the entire industry through innovation and technology, as part of our evoluSHEIN roadmap, SHEIN's comprehensive strategy for addressing social and environmental issues. 2. Breakthrough in Polyester Recycling with Donghua University SHEIN earlier announced the development of an innovative polyester recycling process that accepts a wider range of feedstock materials, including both pre- and post-consumer textile waste and PET bottles. This technology also improves the cost efficiency of recycled polyester for SHEIN compared to the recycled polyester options currently used in its products. The technology, developed in partnership with Donghua University, chemically breaks down, refines and reconstitutes polyester at the polymer level, allowing it to be recycled repeatedly without compromising the material properties of the resulting polyester fibres. SHEIN is working with selected fibre manufacturers to scale up production, with the first facility set to begin large-scale operations in June 2025, targeting an annual production output of 3,000 metric tons of recycled polyester fibres. 3. Establishment of the SHEIN Foundation & €5M Commitment to Africa Collect Textiles (ACT) SHEIN has also recently announced the launch of the SHEIN Foundation, alongside a commitment of €5 million (US$5.30 million) to the Africa Collect Textiles (ACT) Foundation, the charitable arm of ACT. The SHEIN Foundation is a non-profit organization that aims to foster more inclusive and sustainable communities in places where SHEIN operates and will be the philanthropic arm of the SHEIN Group. ACT is a social enterprise that has developed a used textiles collection and recycling pilot program in Kenya. Through these initiatives, SHEIN continues to invest in responsible business practices, product innovation, and industry-leading sustainability efforts to make fashion accessible, safe, and environmentally conscious for its global community. "At SHEIN we are prioritising the decarbonization of our supply chain, but also working on the adoption and promotion of new technologies and processes that have a lower environmental impact and enhance circularity. Mustan brings a wealth of experience in these areas from his previous roles, and will significantly strengthen our bench as we continue our journey to become a more sustainable and responsible business. He will lead our efforts to help solve industry-wide challenges, through innovation and technology, as part of our evoluSHEIN roadmap, SHEIN's comprehensive strategy for addressing social and environmental challenges," said Leonard Lin, President of EMEA and Global Head of Public Affairs for SHEIN. For more information, visit www.sheingroup.com
The Company Invests Over US$25 Million in 512 NVIDIA H200 GPUs to Drive 20% Earnings Growth KUALA LUMPUR, Malaysia, Jan. 27, 2025 (GLOBE NEWSWIRE) -- VCI Global Limited (NASDAQ: VCIG) (“VCI Global”), through its AI subsidiary, AI Computing Center Malaysia Sdn. Bhd. (“AICC” or the “Company”) proudly announces a major AI asset acquisition through Super Micro Computer, Inc. (NASDAQ: SMCI) (“Supermicro”). This strategic investment entails the procurement of state-of-the-art 64 Supermicro servers equipped with 512 NVIDIA H200 Tensor Core Graphics Processing Units (“NVIDIA H200 GPUs”), for the launch of its AI cloud business. AICC’s investment of over US$25 million marks a significant milestone in its journey to becoming a leading AI infrastructure provider. This investment is expected to generate approximately US$6 million in annual revenue, representing a projected 20% increase in earnings by 2026. The AICC’s first AI computing center, located in Cyberjaya, Malaysia, is slated to go live in Q2 2025. The NVIDIA H200 GPUs represent a groundbreaking leap in AI technology. As the newest innovation in the NVIDIA’s Hopper family, the NVIDIA H200 GPUs features exceptional performance capabilities, including advanced tensor cores and enhanced memory bandwidth, enabling it to efficiently process vast datasets and perform complex computations. Its architecture is specifically designed to accelerate large-scale AI and high-performance computing (HPC) workloads, making it an ideal choice for generative AI, natural language processing, and advanced machine learning models. “Through this strategic investment, AICC is proud to be the first in Malaysia to provide AI cloud services powered by NVIDIA H200 GPUs. This acquisition of state-of-the-art AI assets not only unlocks a new revenue stream for AICC but also reinforces its position in advancing AI cloud services. We are confident in the growth of our AI cloud business, leveraging opportunities in the cloud computing industry while further strengthening Malaysia’s AI ecosystem and contributing to its economic development,” said Dato’ Victor Hoo, Group Executive Chairman and Chief Executive Officer of VCI Global. About VCI Global Limited VCI Global is a diversified holding company headquartered in Kuala Lumpur, Malaysia. The Company operates through five core businesses: Capital Market Consultancy, Fintech, Real Estate, AI & Robotics, and Cybersecurity. In Capital Market Consultancy, we provide IPO solutions, investor relations (IR) and public relations (PR) consultancy, and M&A consultancy. Our Fintech arm offers a proprietary financing platform. In Real Estate, we offer specialized real estate consultancy services. The AI business delivers GPU servers, GPU cloud computing services, AI and large language model (LLM) solutions, while the Robotics segment focuses on post-harvest robotics systems. Our Cybersecurity segment provides comprehensive cybersecurity consultancy services and solutions. Committed to fostering innovation and delivering exceptional value, VCI Global has established a strong presence across the Asia-Pacific region, the United States, Europe, and the Middle East, driving growth and transformation on a global scale. For more information on the Company, please log on to https://v-capital.co/. About Super Micro Computer, Inc. Supermicro is a global technology leader committed to delivering first-to-market innovation for Enterprise, Cloud, AI, Metaverse, and 5G Telco/Edge IT Infrastructure. We are a Rock-Scale Total IT Solutions provider that designs and builds an environmentally friendly and energy saving portfolio of servers, storage systems, switches, software, along with global support services. For more information, please visit http://www.supermicro.com/en/ . Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company’s ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements are based only on our current beliefs, expectations, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including without limitation, the Company’s ability to achieve profitable operations, customer acceptance of new products, the effects of the spread of coronavirus (COVID-19) and future measures taken by authorities in the countries wherein the Company has supply chain partners, the demand for the Company’s products and the Company’s customers’ economic condition, the impact of competitive products and pricing, successfully managing and, general economic conditions and other risk factors detailed in the Company’s filings with the United States Securities and Exchange Commission (“SEC”). The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update the forward-looking statements in this release, except in accordance with applicable law. CONTACT INFORMATION: For media queries, please contact: VCI GLOBAL LIMITEDenquiries@v-capital.co
SYDNEY, Jan. 24, 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 children and adults with cancer, is pleased to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for 64Cu-SAR-bisPSMA for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive prostate cancer lesions in patients with biochemical recurrence (BCR) of prostate cancer following definitive therapy. This milestone builds on Clarity's earlier receipt of an FTD for 64Cu-SAR-bisPSMA in patients with suspected metastasis of prostate cancer who are candidates for initial definitive therapy[1]. These 2 FTDs enable the Company to accelerate the development of its comprehensive diagnostic program with this product. The FDA's FTD is designed to expedite the development and regulatory review of novel drugs addressing serious conditions with significant unmet medical needs. For 64Cu-SAR-bisPSMA, it provides a number of product development advantages. The designation paves the way for a faster review process once Clarity submits its product approval applications. Additionally, it enables more frequent communication with the FDA, allowing for rapid resolution of queries during development. Furthermore, Clarity can submit completed sections of its application as they are ready, rather than waiting for the entire package to be finished before it can be lodged with the FDA. These benefits would reduce the review time needed to bring this innovative prostate cancer imaging agent to market, potentially improving diagnosis and treatment planning for patients sooner. The FTD submission highlighted several advantages of 64Cu-SAR-bisPSMA over currently approved PSMA PET agents due to the bivalent structure of bisPSMA and the longer half-life of 64Cu (12.7 hours vs. <2 hours for 18F and 68Ga). These advantages include improved diagnostic performance, flexible imaging schedule and broader availability. The data for this FTD submission was primarily focused on the results of the Phase I/II COBRA study, which assessed the safety and diagnostic performance of 64Cu-SAR-bisPSMA in detecting prostate cancer in patients with BCR of their disease who had a negative or equivocal standard of care (SOC) scan at study entry. Advantages have been shown with same-day and next-day imaging, however, the standout was next-day 64Cu-SAR-bisPSMA PET imaging, showing localised disease in up to 80% of participants and detecting lesions as small as 2 mm. This compares favourably against the current SOC PSMA PET agents, with which the detection of lesions smaller than 5 mm is challenging. The number of lesions detected by 64Cu-SAR-bisPSMA on next-day imaging almost doubled compared to same-day imaging, and 64Cu-SAR-bisPSMA was also able to identify more lesions at much earlier timepoints compared to approved PSMA PET agents. The COBRA trial paved the way for Clarity's second diagnostic registrational trial, AMPLIFY, and an investigator-initiated trial (IIT) Co-PSMA, led by Prof Louise Emmett at St Vincent's Hospital Sydney. The AMPLIFY trial will be a non-randomised, single-arm, open-label, multi-centre, Phase III diagnostic clinical trial of 64Cu-SAR-bisPSMA PET in approximately 220 participants with rising or detectable PSA after initial definitive treatment. As a pivotal trial, the final study results are intended to provide sufficient evidence to support an application to the FDA for approval of 64Cu-SAR-bisPSMA as a new diagnostic imaging agent in prostate cancer in patients with BCR. The Co-PSMA IIT will aim to build on the evidence generated so far, evaluating the diagnostic performance of 64Cu-SAR-bisPSMA in comparison to SOC 68Ga-PSMA-11 for the detection of recurrent prostate cancer lesions with curative intent. Clarity's Executive Chairperson, Dr Alan Taylor, commented, "Receiving the second FTD for 64Cu-SAR-bisPSMA and well within the 60-day period following our application submission, reserved by the U.S. FDA for review, is yet another significant milestone in our bisPSMA program. This highlights the high unmet need for novel diagnostics in prostate cancer and the high quality of data we presented to the FDA. "The market for first-generation diagnostic PSMA PET today is approximately US$2 billion (AU$3.2 billion) in the U.S. alone, with little differentiation between products. It is expected to further grow to US$3 billion (AU$4.75 billion) by 2029. The development pipeline of new products coming to market, outside of 64Cu-SAR-bisPSMA, also offers no differentiation from the existing offering, with some new entrants commercialising the unpatented 68Ga-PSMA-11 agent, which has been capitalised on by three separate groups already. "Being able to now fast-track the development of 64Cu-SAR-bisPSMA for patients with BCR as well as for patients prior to initial definitive therapy is incredibly exciting. The news is especially timely as we are actively preparing to commence recruitment for our second registrational trial, AMPLIFY, in the coming months. The designation will allow us to work closely with the FDA to facilitate the development process and accelerate the approval of what could become a best-in-class diagnostic. "The dual targeting structure of bisPSMA enables increased uptake and retention of the product in the lesions, while the longer half-life of copper-64 provides greater flexibility with imaging scheduling, including next-day imaging (something that gallium-68 and fluorine-18 based products cannot support). When combined, these features make 64Cu-SAR-bisPSMA stand out from its competitors who are known to have issues with sensitivity. We have seen 2-3 times higher uptake in prostate cancer lesions and the identification of more lesions using 64Cu-SAR-bisPSMA compared to 68Ga-PSMA-11 in pre-prostatectomy patients in our PROPELLER study. The COBRA trial results showed great diagnostic performance in the BCR setting, with lesions identified by 64Cu-SAR-bisPSMA in the 2-mm range and visualised many months before SOC PSMA PET agents are able detect them. "Not only are we developing a product that may have improved diagnostic performance compared to SOC PSMA PET agents, but the longer half-life of copper-64 also enables a longer shelf-life of 64Cu-SAR-bisPSMA than currently used diagnostic radiopharmaceuticals, allowing for centralised manufacture and wider distribution. These attributes have the potential to reduce disparities in prostate cancer care and ensure that most patients, regardless of geographic location, can benefit from the latest advances in diagnostic technology. "This designation highlights the unique opportunity for 64Cu-SAR-bisPSMA in this very large market by addressing the limitations of the current-generation diagnostic radiopharmaceuticals and providing patients with prostate cancer with a more accurate diagnosis leading to more optimal treatment options. As such, we are fully committed to advancing the development of this best-in-class product to address the critical need for more accurate and accessible diagnostic tools in prostate cancer management." 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. 64Cu-SAR-bisPSMA is an unregistered product. The safety and efficacy of 64Cu-SAR-bisPSMA has not been assessed by health authorities such as the U.S. FDA or the Therapeutic Goods Administration (TGA). There is no guarantee that this product will become commercially available. Among 82 patients who received 64Cu-SAR-bisPSMA in PROPELLER and COBRA, 2 adverse reactions were reported in 2 participants (mild occasional metallic taste and moderate worsening of type II diabetes, both resolved)[2],[3]. 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[4]. 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 U.S. and around 35,770 deaths from the disease[5]. 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 in children and adults. 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] Clarity Pharmaceuticals. Clarity receives FDA Fast Track Designation for 64Cu-SAR-bisPSMA. https://www.claritypharmaceuticals.com/news/fast-track/ [2] Lengyelova et al. 64Cu-SAR-bisPSMA (PROPELLER) positron emission tomography (PET) imaging in patients with confirmed prostate cancer. ASCO, 2023. [3] 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. [4] Global Cancer Statistics 2022: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries, https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21834 [5] 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.
KUALA LUMPUR, Malaysia, Jan. 24, 2025 /PRNewswire/ -- Pantai Hospital Kuala Lumpur (PHKL) is proud to announce its recognition as Asia's Top Private Hospital for 2025, awarded by Newsweek in collaboration with Statista. This accolade underscores PHKL's unwavering dedication to delivering world-class healthcare, pioneering medical advancements, and exceptional patient care. Pantai Hospital Kuala Lumpur The prestigious ranking highlights hospitals across Asia renowned for excellence in specific disciplines. PHKL was lauded for its exceptional expertise in knee surgeries and knee replacements, solidifying its position as a leader in orthopaedic care. This recognition reflects the hospital's commitment to adopting cutting-edge technologies and patient-centred approaches that align with its mission to provide sustainable healthcare solutions. PHKL's orthopaedic team has long been at the forefront of medical innovation, performing minimally invasive procedures and introducing advanced robotic-assisted surgeries such as its use of the Mako Robotic-Arm Assisted Surgery System, which combining with advanced imaging technology with robotic assistance, enables orthopaedic surgeons to create customised surgical plans tailored to each patient's unique anatomy. The Mako system supports a range of robotic orthopaedic surgeries, including Robotic Knee Replacement (both Partial and Total Knee Arthroplasty) and Hip Arthroplasty, ensuring precision, improved outcomes, and faster recovery times for patients. These advancements not only enhance precision but also significantly improve patient recovery times. Patients benefit from tailored treatment plans and state-of-the-art care delivered in PHKL's newly remodelled facilities, ensuring both comfort and optimal outcomes. PHKL was previously ranked in the Top 5 for World's Best Hospitals - Malaysia by Newsweek in 2024. These accolades reinforce PHKL's legacy of excellence and its role as a trusted healthcare provider for generations. As PHKL looks to the future, it remains steadfast in its dedication to advancing healthcare through strategic investments in technology, facility upgrades, and collaborative partnerships. The hospital's continued focus on sustainability ensures it will meet the evolving needs of patients and set new benchmarks in medical excellence. For more information on Pantai Hospital Kuala Lumpur and its award-winning services, visit www.pantai.com.my/kuala-lumpur. Download the press release and images from this link. About Pantai Hospital Kuala Lumpur Pantai Hospital Kuala Lumpur has been the heartbeat of Kuala Lumpur, steadfastly delivering exceptional care to patients from all walks of life. Since its inception in 1974 with just 68 beds and 20 medical specialists, the hospital has grown into a healthcare icon today with 507 beds, over 200 consultants and counting. Our pursuit of quality healthcare, clinical excellence, and cutting-edge technology is underscored by our service quality and dedication towards clinical research. This has earned us accreditations from the Malaysian Society for Quality in Health (MSQH) and the Joint Commission International (JCI). Additionally, we hold certification as a Baby-Friendly Hospital and is a preferred hospital in Malaysia by the World Health Organization (WHO). As we celebrate our 50th anniversary, Pantai Hospital Kuala Lumpur looks to the future, unwaveringly committed to continuing its legacy of excellence with world-class healthcare services and innovative treatments for generations to come. Learn more at www.pantai.com.my/kuala-lumpur.
This Acquisition Strengthens VCI Global’s Digital Marketing Capabilities While Enhancing the Company’s Presence in the Singapore Market KUALA LUMPUR, Malaysia, Jan. 23, 2025 (GLOBE NEWSWIRE) -- VCI Global Limited (NASDAQ: VCIG) (“VCI Global,” or the “Company”), today announced that it is advancing the acquisition of Roots Digital Pte. Ltd. (“Roots Digital”), a digital marketing firm, marking its entry into Singapore. The acquisition, valued at approximately US$2.2 million (or approximately SG$3 million), reflects a price-to-earnings (P/E) ratio of nearly 3.5. This acquisition is driven by Roots Digital’s strong financial performance, having achieved over US$3 million in revenue and nearly US$0.9 million in profit in 2024, with an impressive 84% year-on-year revenue growth over the past three years. Roots Digital is an award-winning digital agency that specializes in performance marketing across various digital channels. The digital marketing firm distinguishes itself from competitors by reducing customer churn and maintaining an average retention rate of 24 months. The firm primarily serves clients in Malaysia and Singapore, including well-known names such as the National University Cancer Institute, Singapore (NCIS), Microsoft Corporation, Parkway College of Nursing and Allied Health, and Orita Sinclair School of Design & Music, among others. Additionally, Roots Digital is pre-approved vendor under the Infocomm Media Development Authority’s (IMDA) Productivity Solutions Grant (PSG), enabling it to help eligible local SMEs secure up to 50% funding for digital marketing services. This recognition highlights Roots Digital’s proven track record for its products. The acquisition opens-up new opportunities for both VCI Global and Roots Digital, fostering synergies and expanding market presence in Singapore. Through this acquisition, VCI Global strengthens its capabilities in areas like SEO, paid media, and social media advertising, while enhancing its footprint in the Singapore market. By Combining VCI Global’s expertise with Roots Digital regional insights, the strategic move is set to deliver substantial ROI for the clients across key industries. The global digital marketing market is projected to grow to approximate US$1.2 trillion by 2033, reflecting a compound annual growth rate (CAGR) of 11.22% from 2025 to 2033. This growth is largely driven by the increasing internet penetration, as reported by IMARC Group’s research. As internet penetration rises, the potential customer base has expanded, enabling marketers to utilize a variety of online platforms—such as social media, search engines, email, and websites—to connect with users and promote their offerings. This shift has transformed the marketing landscape, prompting businesses to allocate more resources to digital marketing in order to remain competitive in an increasingly digital world. “With this acquisition, we are excited to expand in Singapore, with this move paving the way for future acquisitions that will broaden our offerings and add greater value to clients. The acquisition also serves as a strategic move that will synergize our other key strengths, such as IPO consultancy and AI-related services,” said Dato’ Victor Hoo, Group Executive Chairman and CEO of VCI Global. About VCI Global Limited VCI Global is a diversified holding company headquartered in Kuala Lumpur, Malaysia. The Company operates through five core businesses: Capital Market Consultancy, Fintech, Real Estate, AI & Robotics, and Cybersecurity. In Capital Market Consultancy, we provide IPO solutions, investor relations (IR) and public relations (PR) consultancy, and M&A consultancy. Our Fintech arm offers a proprietary financing platform. In Real Estate, we offer specialized real estate consultancy services. The AI business delivers GPU servers, GPU cloud computing services, AI and large language model (LLM) solutions, while the Robotics segment focuses on post-harvest robotics systems. Our Cybersecurity segment provides comprehensive cybersecurity consultancy services and solutions. Committed to fostering innovation and delivering exceptional value, VCI Global has established a strong presence across the Asia-Pacific region, the United States, Europe, and the Middle East, driving growth and transformation on a global scale. For more information on the Company, please log on to https://v-capital.co/. About Roots Digital Pte. Ltd. Roots Digital Pte. Ltd. is a digital marketing company, operating in Singapore, servicing clients mainly from Singapore and Malaysia. The Company obtains its business by providing various services including digital advertising, search engine optimization, web maintaining, web designing and more. It is also a certified Google Partner, specializing in Search, Display, Mobile, and Video Ads. For more information about Roots Digital, please visit: https://www.rootsdigital.com.sg/. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company’s ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. These forward-looking statements are based only on our current beliefs, expectations, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Therefore, you should not rely on any of these forward-looking statements. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including without limitation, the Company’s ability to achieve profitable operations, customer acceptance of new products, the effects of the spread of coronavirus (COVID-19) and future measures taken by authorities in the countries wherein the Company has supply chain partners, the demand for the Company’s products and the Company’s customers’ economic condition, the impact of competitive products and pricing, successfully managing and, general economic conditions and other risk factors detailed in the Company’s filings with the United States Securities and Exchange Commission (“SEC”). The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update the forward-looking statements in this release, except in accordance with applicable law. CONTACT INFORMATION: For media queries, please contact: VCI GLOBAL LIMITED enquiries@v-capital.co
CHENGDU, China, Jan. 23, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company received marketing authorization in China from National Medical Products Administration (NMPA) for the programmed cell death ligand 1(PD-L1)-directed innovative humanized monoclonal antibody ("mAb") tagitanlimab (formerly KL-A167) used in combination with cisplatin and gemcitabine for the first-line treatment of patients with recurrent or metastatic nasopharyngeal cancer (NPC). The approval is based on a randomized, double-blinded, placebo controlled, multi-center, phase III clinical study evaluates the efficacy and safety results of tagitanlimab in combination with cisplatin and gemcitabine versus placebo in combination with cisplatin and gemcitabine for the treatment of recurrent or metastatic NPC, which was led by Professor Shi Yuankai of the Cancer Hospital Chinese Academy of Medical Sciences as the principal investigator. According to the study results, tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment for recurrent or metastatic NPC could have better progression-free survival (PFS), higher objective response rate (ORR) and extended duration of response (DoR) compared with chemotherapy, where all the patients could benefit regardless of the PD-L1 expression. The median PFS for tagitanlimab in combination with chemotherapy is not reached compared to 7.9 months for placebo in combination with chemotherapy (HR=0.47, 95% CI: 0.33-0.66, p<0.0001), and the risk of disease progression and death is reduced by 53%; ORR is 81.7% vs 74.5%; median DoR is 11.7 vs 5.8 months (HR=0.48, 95% CI: 0.32-0.70), which has nearly doubled compared to placebo arm; currently the median overall survival (OS) is still not mature, however the beneficial trend for OS of tagitanlimab in combination with chemotherapy has already been observed (HR=0.62, 95％CI: 0.32-1.22), and its risk of death is reduced by 38%[1]. Tagitanlimab also showed a manageable safety profile. This is the second indication approved for tagitanlimab. Previously, NMPA has approved the marketing in China of tagitanlimab monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy. Dr. Micheal Ge, CEO of Kelun-Biotech said, "We are pleased that the second indication of our self-developed PD-L1 monoclonal antibody was successfully approved for marketing and demonstrated statistically significant and clinically meaningful improvements in PFS. For domestic NPC patients, Tagitanlimab has realized a breakthrough in therapeutic coverage and innovation from the backline to the frontline, which once again strongly validates the excellent strength of Kelun-Biotech's new drug research and development. In the future, the company will always be based on unmet clinical needs, source innovation, and explore more and more excellent clinical therapeutic solutions to benefit more patients." About Kelun-Biotech Kelun-Biotech（6990.HK）is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company 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. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 2 projects have been approved for marketing, 2 projects are in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/. [1] Label of tagitanlimab
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