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Fourth NDA for Kelun-Biotech’s TROP2 ADC sacituzumab tirumotecan (sac-TMT) Accepted by the Center for Drug Evaluation

CHENGDU, China, May 22, 2025 /PRNewswire/ — Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that a new indication application (the “Application”) for the Company’s trophoblast cell-surface antigen 2 (TROP2)-directed antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT, also known as SKB264/MK-2870) was accepted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China for the treatment of adult patients with unresectable locally advanced, metastatic hormone-receptor positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) breast cancer (BC) who have received prior endocrine therapy and other systemic treatments in the advanced or metastatic setting. This acceptance is based on the positive results from the registrational phase 3 OptiTROP-Breast02 study, and the Application is the fourth indication application for sac-TMT that has been accepted by the NMPA.

OptiTROP-Breast02 is a randomized, open-label, multi-center, Phase 3 clinical study that evaluates the efficacy and safety results of sac-TMT monotherapy 5mg/kg every other week (Q2W) versus chemotherapy treatment of physician’s choice for the treatment of patients with unresectable locally advanced or metastatic HR+/HER2- (Immunohistochemistry [IHC] 0, IHC 1+ or IHC 2+/ In Situ Hybridization [ISH]-) BC. Primary efficacy endpoint of this Phase 3 clinical study was reached according to a pre-specified interim analysis, where sac-TMT monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) as assessed by the blinded independent review committee (BIRC) compared with chemotherapy treatment of physician’s choice and the risk of disease progression or death was significantly reduced. Sac-TMT also demonstrated the beneficial trend for overall survival (OS).

On May 16, 2024, the CDE’s official website announced that the Application would be reviewed via the priority review and approval process. This marks the fourth sac-TMT indication to go through the CDE’s priority review and approval process, with three previous sat-TMT indications approved following priority review.

Dr. Michael Ge, CEO of Kelun-Biotech said, “We are very pleased that the NDA application for the fourth indication of our core product, sac-TMT, has been accepted by the CDE of NMPA, which is another breakthrough for the breast cancer treatment field. This not only verifies the clinical value and innovative nature of sac-TMT, but also highlights the ‘patient-centered’ mission of Kelun-Biotech. We look forward to the OS results of sac-TMT with longer follow-up. In the future, we will continue to explore sac-TMT as an oncology therapeutic agent, aiming to address new indications with unmet clinical needs, so as to benefit more oncology patients globally.”

About HR+/HER2  BC

Breast cancer is one of the most common malignant tumors that seriously threaten women’s health worldwide. In 2022, there were about 2,297,000 new cases of breast cancer and 666,000 deaths worldwide [1]. Among them, HR+/HER2- breast cancer is the most common subtype, accounting for about 70% of all breast cancer cases, and advanced HR+/HER2- breast cancer has a poor prognosis [2]. Patients with this subtype of breast cancer are often hormone-sensitive, so the preferred treatment option is endocrine therapy combined with CDK4/6 inhibitors. Rescue chemotherapy is preferred for patients with advanced HR+/HER2- breast cancer with visceral metastases who require rapid disease remission, who are previously resistant to endocrine therapy, or who do not have optimal endocrine therapy options. There is currently no standard treatment option for second- and third-line HR+/HER2-advanced breast cancer patients who have failed first-line chemotherapy. In summary, there is an unmet clinical need for patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received prior endocrine therapy and have received other systemic therapies in the advanced or metastatic stages.

About sac-TMT

Sac-TMT, a core product of the Company, is a novel human TROP2 ADC in which the Company has proprietary intellectual property rights, targeting advanced solid tumors such as non-small cell lung cancer (NSCLC), BC, gastric cancer (GC), gynecological tumors, among others. Sac-TMT is developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor with a drug-to-antibody-ratio (DAR) of 7.4. Sac-TMT specifically recognizes TROP2 on the surface of tumor cells by recombinant anti-TROP2 humanized monoclonal antibodies, which is then endocytosed by tumor cells and releases KL610023 intracellularly. KL610023, as a topoisomerase I inhibitor, induces DNA damage to tumor cells, which in turn leads to cell-cycle arrest and apoptosis. In addition, it also releases KL610023 in the tumor microenvironment. Given that KL610023 is membrane permeable, it can enable a bystander effect, or in other words kill adjacent tumor cells.

In May 2022, the Company licensed the exclusive rights to MSD (the tradename of Merck & Co., Inc., Rahway, NJ, USA) to develop, use, manufacture and commercialize sac-TMT in all territories outside of Greater China (includes Mainland China, Hong Kong, Macao, and Taiwan).

To date, two indications for sac-TMT have been approved and marketed in China for the treatment of adult patients with unresectable locally advanced or metastatic triple negative breast cancer (TNBC) who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and epidermal growth factor receptor (EGFR) mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-tyrosine kinase inhibitor (TKI) therapy and platinum-based chemotherapy. Sac-TMT became the first domestically developed and fully approved for marketing ADC in China with global intellectual property rights . It is also the world’s first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the new indication application for sac-TMT for the treatment of adult patients with EGFR-mutant locally advanced or metastatic NSCLC who progressed after treatment with EGFR-TKI therapy was accepted by the NMPA, and was included in the priority review and approval process. As of today, the Company has initiated 8 registrational clinical studies in China. MSD has initiated 14 ongoing Phase 3 global clinical studies of sac-TMT as a monotherapy or with pembrolizumab or other agents for several types of cancer. These studies are sponsored and led by MSD.

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 3 projects have been approved for marketing, 1 project is 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/.

Media: klbio_pr@kelun.com 

Reference

[1] Globalcan 2022: China.

[2] [Wang Y et al (2024)] Current status of treatment for hormone receptor-positive/human epidermal growth factor receptor 2-negative advanced breast cancer. Journal of Clinical Surgery; 32(7):780-782.

 

BAFS expands into Southeast Asia with delivery of Thai-engineered aircraft refueling vehicles for Cambodia’s new international airport, set to launch mid-year

BAFS INTECH reinforces its leadership position as a leading Thai ground support vehicle manufacturer, aggressively expanding into international markets by delivering seven aircraft refueling vehicles and ground support vehicles to Cambodia’s new international airport, positioning itself to accommodate the burgeoning aviation industry across Southeast Asia.


BANGKOK, THAILAND – Media OutReach Newswire – 22 May 2025 – M.L. Nathasit Diskul, President of Bangkok Aviation Fuel Services Public Company Limited (BAFS), said BAFS INTECH Company Limited, a subsidiary of BAFS Group, specializes in the design, manufacture, and assembly of aircraft refueling vehicles and ground support vehicles for airport operations. Leveraging the expertise of its engineering and technical teams, BAFS INTECH integrates cutting-edge innovations with advanced safety technologies to produce high-performance, durable vehicles that meet the requirements of ground handling service providers throughout the region. The company is delivering seven units, including hydrant dispensers, ground support vehicles, and mobile refueling carts, to Phnom Penh Aviation Fuel Service Co., Ltd. (PPAFS) in May 2025. These units will service Techo International Airport in Phnom Penh, Cambodia, which will be officially opened this July, marking another significant milestone that underscores BAFS’s leadership in comprehensive aircraft refueling services.

BAFS

BAFS INTECH’s aircraft refueling vehicle manufacturing business started with BAFS’s foundational knowledge and proficiency in aircraft refueling operations, enhanced by state-of-the-art technology. Its capacity to modify refueling vehicles to client specifications, offering various sizes and flow rates to fit different aircraft types and airport operational settings, is BAFS’s competitive advantage. This approach ensures optimal quality, safety compliance, and operational suitability, with manufacturing quality that conforms to the standards for supplying aviation fuel established by the Joint Inspection Group (JIG), the global benchmark for aviation refueling systems.

BAFS INTECH is committed to developing technologies related to aircraft refueling services to meet the expansion of the aviation industry, particularly in Southeast Asia, which is emerging as a regional transportation and logistics hub. Initially focusing on producing aircraft refueling vehicles for BAFS and domestic clients, the company has progressively expanded into neighboring markets. Over the past four years, BAFS INTECH has earned the trust of clients in Myanmar and Laos, who have selected the company to design and manufacture aircraft refueling vehicles and ground support vehicles.

M.L. Nathasit said, “With over 40 years of experience in providing international-standard aviation fuel supply services and a commitment to elevating ground handling services through Thai-designed and manufactured products, this delivery underscores BAFS INTECH’s capabilities and readiness as a leader in the design and manufacture of airport ground support vehicles. We have 16 more vehicles in production awaiting delivery this year, and we anticipate orders for 17 units in 2025. BAFS INTECH plans to penetrate international markets more extensively, particularly in Southeast Asia, by emphasizing our capabilities to produce high-performance vehicles tailored to meet Asian operational requirements. We aim to expand into Vietnam, Malaysia, the Philippines, and Singapore within the next five years.”
Hashtag: #BAFSINTECH #BAFS #refueling #vehicle


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

Baiduri Bank Opens Representative Office In Singapore


SINGAPORE – Media OutReach Newswire – 22 May 2025 – Baiduri Bank, Brunei Darussalam’s largest conventional bank, proudly announces the opening of its first overseas representative office in Singapore. Located at Marina Bay Financial Centre (MBFC) Tower 2, this expansion marks a significant milestone in the Bank’s 30-year journey in the financial sector.

Yang Amat Mulia Pengiran Muda Dr Abdul Fattaah, Chairman of Baiduri Bank (Middle); Baiduri Bank Chief Executive Officer Ti Eng Hui (3-R); Board Member of Baiduri Bank Dato Paduka Timothy Ong Teck Mong (3-L); members of Baiduri Bank’s management committee and Baiduri Bank’s Chief Representative Officer Young Yi (2-L) at the launch of Baiduri Bank’s Representative Office in Singapore
Yang Amat Mulia Pengiran Muda Dr Abdul Fattaah, Chairman of Baiduri Bank (Middle); Baiduri Bank Chief Executive Officer Ti Eng Hui (3-R); Board Member of Baiduri Bank Dato Paduka Timothy Ong Teck Mong (3-L); members of Baiduri Bank’s management committee and Baiduri Bank’s Chief Representative Officer Young Yi (2-L) at the launch of Baiduri Bank’s Representative Office in Singapore

Since its establishment in 1994, Baiduri Bank has undergone a remarkable transformation—evolving from a home-grown bank into a leading financial institution that has played a pivotal role in Brunei’s economic development. Its evolution over the past three decades has been marked by rapid growth, innovation, and expanded capabilities in retail, corporate, and institutional banking.

Today, Baiduri Bank is internationally recognised for its financial strength and innovation, reflected by its A-/A-2 stable rating from S&P Global Ratings. It has also been honoured with multiple international awards including “Bank of the Year 2024” by The Banker, “Best Bank in Brunei” by Euromoney and Global Finance, and “Best Banking Group in Brunei 2024” by World Finance. These accolades reinforce the Bank’s credibility and its strategic readiness to expand its regional footprint.

A strategic expansion into Singapore – Beyond Brunei

The launch of the Singapore Representative Office represents the next chapter in this trajectory. It is a strategic move to strengthen Baiduri Bank’s regional presence, promote its corporate and institutional banking capabilities, and enhance engagement with counterparty banks and financial institutions.

Singapore, as one of the world’s leading financial hubs, offers immense opportunities for the Bank to identify strategic partners and alliances. By acting as a bridge between Bruneian opportunities and Singapore’s vibrant financial ecosystem, the office supports Brunei’s economic diversification agenda while creating pathways for Singapore-based institutions and investors to access new markets and forge cross-border collaborations.

Leading the Representative Office

Leading the Baiduri Bank Representative Office is Mr Young Yi, Chief Representative Officer, a seasoned corporate banker with over 25 years of corporate banking experience across local and international banks, including Deutsche Bank, HSBC, Societe Generale, ANZ and Westpac. With a strong background in corporate banking, relationship management, Mr Young is a valuable addition to support Baiduri Bank’s presence in Singapore.

Commenting on the launch, Mr Young stated: “I am excited and privileged to be part of Baiduri Bank’s journey in Singapore and I look forward to leveraging on my network, fostering strong meaningful collaborations to achieve win-win outcomes for Baiduri Bank and our partners. With our deep local knowledge of the Bruneian market, we offer ourselves as a trusted advisor to companies based in Singapore looking to invest in Brunei. The Representative Office will also serve as a referral conduit to our banking partners for Bruneian companies looking to expand into Singapore and the region”.

Strengthening regional economic collaboration

Brunei presents a compelling value proposition for businesses, offering a stable operating environment, strong governance, and attractive tax schemes. As a signatory to the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), Brunei provides tariff-free access to one of the world’s fastest-growing economic regions. With its well-educated workforce, absence of capital controls, and 1:1 currency interchangeability with the Singapore Dollar, Brunei is well-positioned as a gateway for regional business expansion.

In support of this goal, Baiduri Bank is working closely with the Brunei Economic Development Board (BEDB) to encourage greater investment engagement and regional business connectivity. The Bank’s Singapore Representative Office will serve as a touchpoint to facilitate conversations with potential investors and explore new opportunities linked to Brunei. By aligning efforts with BEDB, Baiduri Bank hopes to contribute meaningfully to Brunei’s broader economic diversification goals—while helping connect Bruneian businesses to regional markets and Singapore-based stakeholders to emerging opportunities in Brunei.

Launch and networking reception

The launch ceremony of Baiduri Bank’s Singapore office at MBFC Tower 2 was a distinguished event, attended by esteemed guests, including Yang Amat Mulia Pengiran Muda Dr Abdul Fattaah, Chairman of Baiduri Bank, senior government officials, and prominent leaders from the banking sector of Brunei and Singapore.

Baiduri Bank’s CEO, Ti Eng Hui, delivered an address outlining the Bank’s vision for regional growth, followed by the unveiling of a meticulously crafted 3D replica of Baiduri Bank’s headquarters presented alongside iconic landmarks of Brunei and Singapore – symbolising the strong economic ties between the two nations.

Following the official ceremony, Baiduri Bank hosted a networking cocktail reception at the Mandarin Oriental Singapore, attended by over 300 guests, including representatives and senior leaders from regional financial institutions and corporations.

Hashtag: #company #singaporeexpansion #bankingandfinance


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

Baiduri Bank

Baiduri Bank Group is one of the largest providers of financial products and services in Brunei Darussalam. The Group comprises Baiduri Bank, Baiduri Finance and Baiduri Capital, providing banking services to institutions or corporations, retail banking, consumer financing, securities trading and wealth management.

Established in 1994, Baiduri Bank’s shareholders include Baiduri Holdings and Darussalam Assets. With a combination of global outlook combined with extensive local knowledge and commitment to the Brunei market, the Bank has been acknowledged as the leading conventional bank in the country with a track record of financial innovations and pioneering activities.

In 2024, Baiduri Bank was awarded ‘Bank of the Year 2024’ by The Banker, ‘Best Bank in Brunei 2023’ by Euromoney, ‘Best Bank in Brunei 2024’ by Global Finance, ‘Best Banking Group in Brunei 2024’ by World Finance, ‘Domestic Retail Bank of the Year, Brunei 2024’ by the Asian Banking & Finance and ‘Best Retail Bank in Brunei 2024’ by the Asian Banker. The Bank was awarded the 2nd ASEAN Outstanding Social Welfare and Development Award (AOSWADA) in recognition of its CSR efforts in 2023.

Standard & Poor’s maintained the Bank’s credit rating to ‘A-/A-2’ with Stable Outlook in July 2024. https://www.baiduri.com.bn/

Octa receives the ‘Best CSR program by CFD broker Asia 2025’ award


KUALA LUMPUR, MALAYSIA – Media OutReach Newswire – 22 May 2025 – A global broker deeply involved in implementing social initiatives worldwide, Octa, recently received an award for one of its CSR (corporate social responsibility) projects. Given by Global Banking and Finance Review, the ‘Best CSR program by CFD broker Asia 2025’ award reflects Octa’s commitment to bringing long-lasting change to local communities.

Octa Broker

Octa broker’s charity focus

Throughout its 14-year track record in the financial industry, Octa broker has consistently carried out targeted charity initiatives. As the primary focus of its humanitarian efforts, the company aims to facilitate better education opportunities for a wide range of beneficiaries and provide emergency relief to victims of natural disasters.

The educational component of Octa’s charity agenda is built around creating new points of growth in those areas where it matters most. For example, last year, the broker’s initiatives included improving school infrastructure in Indonesia and contributing to children’s literacy development in Nigeria.

Octa’s award-winning program

The ‘Best CSR program by CFD broker Asia 2025’ award was handed to Octa based on the STATUS 200 coding bootcamp that took place in Kuala Lumpur, Malaysia.

Organised in cooperation with Ideas International, this charity project was held on-site between April and November 2024. The STATUS 200 bootcamp aimed to create new career opportunities for dedicated Malaysian students passionate about programming.

The bootcamp’s program consisted of three stages, each filled with intense learning and challenging assignments. All participants started with no coding background, and by the end of the bootcamp, those who accomplished Stages 2 and 3 acquired a skill level that corresponds to a junior web developer position.

Octa’s partner in this initiative, Ideas International, is a Malaysian academy focusing on providing high-quality, affordable education for youths with diverse backgrounds. A great example of socially beneficial cooperation, Octa broker and Ideas International have been working together for several years, carrying out charity projects to lay the basis for a better future for Malaysia through facilitating new education opportunities. According to Octa, the broker looks forward to continuing this fruitful partnership and generating more exciting joint projects.

Octa broker’s charity agenda and plans for the future

Octa is involved in a comprehensive network of charitable and humanitarian initiatives, including improving educational infrastructure and funding short-notice relief projects supporting local communities. By carrying out our charity projects, Octa works towards ensuring inclusive and equitable quality education and promoting lifelong learning opportunities for all.

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Hashtag: #Octa

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

Octa

is an international CFD broker that has been providing online trading services worldwide since 2011. It offers commission-free access to financial markets and various services used by clients from 180 countries who have opened more than 52 million trading accounts. To help its clients reach their investment goals, Octa offers free educational webinars, articles, and analytical tools.

The company is involved in a comprehensive network of charitable and humanitarian initiatives, including improving educational infrastructure and funding short-notice relief projects to support local communities.

In Southeast Asia, Octa received the ‘Best Trading Platform Malaysia 2024’ and the ‘Most Reliable Broker Asia 2023’ awards from Brands and Business Magazine and International Global Forex Awards, respectively.

Thailand Falls Behind in Sustainable Tourism as Laos Wins Global Praise

Thailand Falls Behind in Sustainable Tourism as Laos Wins Global Praise
A tourist in China Town in Bangkok (Adobe Stock)

Thailand is falling behind in the race for sustainable tourism, industry leaders warned at the Thailand Tourism Forum 2025, held on 7 May in Bangkok.

New chapter in China-LAC cooperation: Though oceans apart, kindred spirits remain connected

BEIJING, May 22, 2025 /PRNewswire/ — A news report from China.org.cn on the cooperation between China and Latin American and Caribbean countries:


New chapter in China-LAC cooperation: Though oceans apart, kindred spirits remain connected

It may never have occurred to Paolo Martínez, a young Colombian engineer, that the dream of building a subway in the capital city Bogotá would come true so soon. What he likely imagined even less was that before ever riding a subway in his own city, he would have voyaged all the way to China to learn how to operate one.

Nestled among three mountain ranges, Bogotá is among the world’s most congested cities. On some roads, cars move even more slowly than pedestrians, and commutes of two to three hours are a daily reality. For several decades, the residents of Bogotá have longed for an efficient and convenient subway system.

In 2019, a Chinese consortium won the contract to build the Bogotá Metro Line 1 project. The Chinese team worked closely with the local teams to develop a construction plan that is not only safe and efficient, but also responsive to the needs of local communities and respects cultural heritage. Well aware that sustainable operations and maintenance depend on local expertise, two batches of young Colombian talents were selected for professional training in China. Paolo Martínez, whom we introduced earlier, is one of them.

Today, construction of the metro project is more than halfway complete; the metro line is expected to begin operating officially in 2028, benefiting about three million local residents and unlocking a horizon of new opportunities for Bogotá’s future development.

While looking into the future, this May, new sparks have been added to the story between China and Colombia. Following the Fourth Ministerial Meeting of the China-CELAC Forum, the two governments signed a cooperation plan for jointly building the Belt and Road Initiative. The two countries also signed documents to promote policy dialogue and exchanges of experience in areas concerning the macroeconomy, BRI cooperation, trade and investment, among others.

In recent years, China and Latin American and Caribbean countries have stood shoulder to shoulder in solidarity and mutual support, continuously deepening political mutual trust. Powered by mutual benefit and win-win, both sides have been committed to boosting steady and long-term cooperation. The relations between China and the Latin American and Caribbean countries have entered a new phase marked by equal stances, mutual benefits, innovation, openness, and a people-centered approach.

In Peru, the Chancay Port, a flagship project of the BRI cooperation between China and Peru, is not only the first world-class deep-water port that features smart technology and green development in Latin America, but is also poised to establish a new land-sea transport corridor between Latin America and Asia. In Brazil, from soybeans and coffee to photovoltaic plants and satellites, the extensive cooperation with China spells “new” and “pragmatic.” In Trinidad and Tobago, the Phoenix Park Industrial Estate, a flagship BRI project between the two countries, has become the first eco-friendly light industrial park in Latin America with full 5G coverage. In Chile, over 90% of its cherries are exported to China, while nearly 98% of the country’s products, including cherries, enjoy zero-tariff treatment under the two countries’ bilateral free trade agreement.

People-to-people exchanges between China and the Latin American and Caribbean countries have grown increasingly frequent and earnest. From the cross-cultural exhibition showcasing dialogue between China’s ancient Shu civilization and Peru’s Inca civilization, to the joint archaeological exploration conducted by Chinese and Honduran experts, and the steadily rising number of exchange students between China and the Latin American and Caribbean countries, all these have been echoed in a Chinese poem: “True friendship knows no distance; even thousands of miles apart, we remain close neighbors.” It is apparent that China and the Latin American and Caribbean countries are growing ever closer as friends and partners, bonded by their kindred spirits.

The world has every reason to look forward to a more enchanting new chapter in building a China-Latin America and Caribbean community with a shared future — one that will continue to be an exemplar of South-South Cooperation, while injecting a dose of stability and positivity into a turbulent world.

China Mosaic 
http://www.china.org.cn/video/node_7230027.htm 

New chapter in China-LAC cooperation: Though oceans apart, kindred spirits remain connected
http://www.china.org.cn/video/2025-05/21/content_117887107.shtml 

Unleashing Next Generation Storage Power | HIKSEMI Showcases Latest Storage Solutions at COMPUTEX 2025

TAIPEI, May 22, 2025 /PRNewswire/ — HIKSEMI, a global provider of professional data storage solutions, showcased its latest innovations under the theme “Unleashing Next Generation Storage Power” at COMPUTEX 2025. The company highlighted breakthroughs in PCIe 5.0 and DDR5 technologies, demonstrating advancements in high-performance storage and illustrating how these innovations enhance everyday life across a wide range of applications.

Focusing on green technology and immersive experiences, COMPUTEX 2025 set trends in the global ICT industry. HIKSEMI aligned with these themes by presenting solutions across four core areas: gaming, photography, personal and family backups, and industrial storage, emphasizing “storage beyond boundaries.”

The highlight was the enhanced FUTURE gaming series, featuring the FUTURE PCIe 5.0 SSD, FUTURE RGB DDR5, and FUTURE RGB PSSD. Building on the success of the 2023 PCIe 4.0 series, which gained acclaim in markets like Thailand and Japan, the new lineup offers superior performance and versatility, targeting next-generation gamers and content creators.

For photographers, the CAPTURE series offered high-speed memory cards and magnetically secured portable storage devices for efficient data import and secure backups. Personal and family users benefited from intelligent cloud-based backup solutions and NAS-specific products, ensuring reliable management of digital assets.

In industrial sectors, HIKSEMI showcased robust storage solutions for data centers, smart manufacturing, and rail transit, featuring high reliability, low power consumption, and wide temperature adaptability to aid digital transformation.

At COMPUTEX 2025, HIKSEMI showcased its innovation in storage technology and commitment to customer needs. Industry partners and tech enthusiasts experienced the future of data storage, exploring how next-generation solutions are driving digital transformation forward.

AnnJi Pharmaceutical Company Announces Positive Phase 1/2a Results for AJ201 in Spinal and Bulbar Muscular Atrophy (SBMA) Patients

TAIPEI, May 22, 2025 /PRNewswire/ — AnnJi Pharmaceutical Co., Ltd., a clinical-stage Taiwanese biotechnology company focused on addressing unmet medical needs in dermatology, neurology, and rare diseases, today announced positive results from its Phase 1/2a randomized, double-blind, placebo-controlled, first-in-patient clinical trial of AJ201 in adults with Spinal and Bulbar Muscular Atrophy (SBMA). Conducted across six U.S. clinical sites, the study evaluated the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of AJ201 (ClinicalTrials.gov Identifier: NCT05517603). While not powered to assess efficacy, exploratory endpoints revealed meaningful treatment-related improvements that support continued clinical development.

Safety and Pharmacokinetics

The safety and pharmacokinetic profiles in SBMA patients were consistent with prior healthy volunteer data.  AJ201 was generally well tolerated, and no systemic drug accumulation was observed.

Positive Clinical Signals

After 12 weeks of oral treatment, AJ201 recipients showed clinically meaningful improvements in physical and muscle function compared to placebo, including a 17.6-meter gain in the 6-Minute Walk Test (6MWT) and a 0.8-point increase in the SBMA Functional Rating Scale (SBMAFRS) on average, while the placebo group experienced slight declines. AJ201 also led to reduction in serum creatine kinase and myoglobin levels—suggesting a positive therapeutic effect. Most responders are in the AJ201 group: 11 of 15 for 6MWT, 6 of 7 for SBMAFRS, 14 of 14 for creatine kinase, and 11 of 12 for myoglobin, further supporting AJ201’s benefit. Additionally, patients in AJ201 group reported significant improvement in physical function component of SF36v2 quality-of-life questionnaire, while placebo group a decline (p=0.026).

Biomarker Findings and RNA Sequencing Reveal Mechanistic Support

Mutant androgen receptor (mAR) levels, a proposed biomarker for SBMA, were assessed via muscle biopsies. Nuclear mAR levels were reduced by more than 50% in 53% of AJ201-treated patients, compared to 17% of placebo, indicating potential therapeutic activity.

RNA sequencing of muscle biopsies from AJ201-treated patients revealed activation of the Nrf2 pathway, along with modulation of several disease-relevant signaling cascades. These changes, absent in the placebo group, offer support for AJ201’s therapeutic mechanism of action.

Conclusion and Expert Commentary

Consistent improvements across functional, biochemical, and molecular markers observed in this study support continued development of AJ201 for SBMA.

“The study results are highly encouraging. AJ201 has shown evidence of clinical benefit, demonstrated through improvements in functional assessments, positive shifts in serum biomarkers, and RNA sequencing data supporting activation of the Nrf2 pathway. Together, these findings reinforce the therapeutic potential of AJ201,” said Dr. Christopher Grunseich, Principal Investigator of the study. Dr. Grunseich is a Lasker Clinical Research Scholar and Head of the Inherited Neuromuscular Diseases Unit at the National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH).

“SBMA is a slowly progressing neuromuscular disorder, and I am greatly encouraged by the positive clinical outcomes observed after a relatively short course of AJ201 treatment,” said Wendy Huang, Ph.D., Chief Executive Officer and Chairperson of the Board at AnnJi. “AnnJi is committed to advancing the program into Phase 3 clinical trials, with the aim of delivering a safe, effective, and much-needed therapeutic option for patients living with SBMA—a disease that currently lacks any FDA-approved treatments.”

About SBMA and AJ201

SBMA, or Kennedy’s disease, is a rare X-linked inherited neuromuscular disorder caused by CAG repeat expansion in the androgen receptor (AR) gene. The resulting mutant AR protein contributes to muscle and neuron degeneration through mechanisms involving cellular toxicity, oxidative stress, and neuroinflammation. SBMA affects ~1 in 40,000 males globally and currently has no FDA-approved treatment.

AJ201, also known as JM17, is a novel investigational compound that has shown potential in reducing mutant AR toxicity and improving motor function in preclinical SBMA models. At the molecular level, it promotes degradation of pathogenic mAR protein, induces expression of antioxidant enzymes, proteasome subunits, and heat shock proteins, all of which may slow disease progression (Bott et al., 2016).

About AnnJi Pharmaceutical

AnnJi Pharmaceutical Co., Ltd., founded in 2014, is a clinical-stage biotech company focused on developing first-in-class small molecule therapies for serious and underserved diseases. Our pipeline spans neurology, dermatology, and rare disorders like SBMA. AnnJi is committed to translating cutting-edge science into differentiated treatments and advancing them through global collaboration and commercialization. For more information, visit: www.ajpharm.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding AnnJi’s plans, programs, and expected results. These statements are based on current assumptions and subject to risks and uncertainties that could cause actual outcomes to differ materially. AnnJi undertakes no obligation to update forward-looking statements except as required by law.

Contact

Anne Yu
AnnJi Pharmaceutical Co., Ltd.
(+886) 2-2365-5677
anne.yu@ajpharm.com