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iMotion Technology Establishes Japan Branch, systematically accelerating Overseas Expansion


TOKYO, JAPAN – EQS Newswire – 29 September 2026 – On September 28 2026, iMotion Technology (01274.HK) officially established its Japanese branch in Shinagawa, Tokyo. After the establishment of the Europe R&D Center (Munich, Germany) and the Malaysia Manufacturing Plant, this marks another key step in iMotion’s global expansion strategy and will help the company connect with and more deeply integrated into the global automotive supply chain.

iMotion Technology Establishes Japan Branch, systematically accelerating Overseas Expansion

iMotion will adhere to its overseas expansion strategy by serving Chinese OEMs’ overseas business on the one hand, and actively developing international customers on the other. Based on its established presence, iMotion’s products and solutions have followed its customers and been deployed across regions and countries including Europe, Southeast Asia, South Korea and Japan. This has enabled iMotion to accumulate extensive on-the-ground experience in overseas applications and develop strong localized service capabilities.

In the first half of 2026, iMotion for the first time obtained nominated projects from a customer in the Taiwan region of China and an overseas direct-supply customer, marking significant breakthroughs in both customer coverage and overseas expansion. With the establishment in Tokyo, iMotion’s Japanese Branch will serve as a bridge between Japan and iMotion in relevant business, expanding long-term business cooperation with Japanese OEM and strengthen iMotion’s global brand presence.

From product expansion to system globalization, iMotion is rapidly building an end-to-end global delivery system. iMotion’s joint venture in Malaysia has completed trial production and is currently undergoing the final customer audit process. It is expected to commence full-scale production and mass deliveries to customers in the third quarter of 2026.

Looking ahead, iMotion plans to continue strengthening its global sales and service network. Through its overseas business units and production bases, technical adaptation, ecosystem collaboration, and data compliance capabilities, iMotion aims to accelerate its integration into the direct supply chains of international automakers. In addition, iMotion will leverage the resources provided by its strategic overseas shareholders to explore new international business opportunities and establish more international strategic alliances.

Hashtag: #iMotionTechnology

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

Laos Inflation Rises to 7.8 Percent in September as Education, Utility Costs Climb

This photo is used for representational purpose only.

Laos’ inflation rate rose to 7.8 percent in September, up from 7.7 percent in August, with education, utility, and some seasonal costs contributing to the increase, according to the Ministry of Finance.

The latest increase came as the new school year began, with education costs rising 18.8 percent from a year earlier. Families also faced higher costs for tuition, uniforms, and textbooks.

The biggest increase came in housing, water, electricity, and cooking gas, where prices rose 30.7 percent from a year earlier. Transportation and communication costs also increased, while health and medicine became more expensive.

Officials attributed September’s increase to higher fuel prices, adjustments to education costs, and seasonal price increases.

Inflation Averages 7.9 Percent

Despite the September increase, inflation averaged 7.9 percent during the first nine months of 2026, down from 8.8 percent during the same period last year.

The biggest pressure over the nine-month period came from other goods and services, largely due to higher gold prices. Housing and utility costs also remained a major source of price increases, driven by electricity and water prices and higher costs for construction materials.

Education and healthcare costs continued to rise, while higher fuel prices pushed up transportation costs.

Fuel and Utilities Add Pressure

Officials linked the broader rise in prices to several factors, including higher global oil prices following conflicts in the Middle East. Higher fuel prices then fed into costs for transportation and other goods and services.

Government adjustments to electricity and water prices also contributed, while seasonal changes pushed up the prices of some goods.

Officials also acknowledged that Laos’ systems for monitoring price increases and decreases remain insufficiently strict.

Ping An Digital Bank Celebrates 6th Anniversary, Total Assets and Customer Deposits Both Surge Over 130% YoY, Net Interest Income Rises 55% YoY

Demonstrated Full-Licence Advantages, Strengthened Fee Income Capabilities, Expanding into High-End Wealth Management Segment to Forge New Growth Engines, Deepening Trade Finance to Support Government Initiatives, Serving the Real Economy via Financial Services

  • As of 30 June 2026, Ping An Digital Bank’s total assets exceeded HK$15.6 billion, while total customer deposits reached nearly HK$13.7 billion, both surging over 130% year-on-year.
  • Capitalising on its full-licence advantage, investment commissions have emerged as a new driver for fee income, boosting core profitability with net interest income rising 55% year-on-year to HK$140 million.
  • PingAnDB will continue to uphold its “Customer Experience First” vision, providing all retail customers with a user-friendly digital banking service. Meanwhile, the Bank will continuously deepen its wealth services and expand into the high-end wealth management to meet customers’ diversified asset allocation needs.
  • Responding to the government’s initiative to “take forward ‘Finance+’ to serve the real economy,” Business Banking remains committed to serving trade SMEs. Leverages fintech and alternative data to strengthen trade finance, PingAnDB empowers trade SMEs and cross-border e-commerce in global expansion.

HONG KONG SAR – Media OutReach Newswire – 29 September 2026 – Ping An Digital Bank (International) Limited (“Ping An Digital Bank” / “PingAnDB”) enters its 6th anniversary with strong upward momentum and standout operational performance across key indicators. Total assets and customer deposits both surged over 130% year-on-year, while net interest income rose approximately 55% year-on-year to over HK$140 million. Following the branding revamp and the launch of investment services, Ping An Digital Bank has fully leveraged its full-licence advantages, making investment commissions a new growth engine for service fee revenue. Moving forward, Ping An Digital Bank will continue to uphold its “Customer Experience First” vision, delivering a seamless and all-in-one digital banking solution through a single app. PingAnDB will also elevate its wealth platform by introducing a broader suite of investment offerings and high-end wealth management services, assisting them with diversified asset allocation and management.

Since accelerating its retail banking expansion, Ping An Digital Bank has launched wealth and offline insurance services, driven business scale and strengthening core profitability. As of 30 June 2026, total assets surged 133% year-on-year to over HK$15.6 billion, while total customer deposits reached HK$13.7 billion, increased 131% year-on-year. Following the official launch of wealth services in March this year, PingAnDB has achieved initial success in opening new channels to boost fee and commission income. As of June 30, 2026, fee and commission income grew sevenfold year-on-year to HK$6.5 million, with service fee income expected to gradually become another growth engine of the PingAnDB’s revenue.

Mr. Ronald Iu, Chief Executive of Ping An Digital Bank, said, “Ping An Digital Bank has accelerated the expansion of its retail banking arm recently. As a rising star in retail banking, we adhere to our brand vision of ‘Always with You. Always Ahead.’ By delivering precise product and service strategies, we comprehensively meet customers’ needs, driving significant leaps in asset and deposit scale, with fee income set to become another key revenue driver for us. Furthermore, Ping An Digital Bank is set to elevate its wealth services. Centered on the “Customer Experience First” vision, the Bank will continuously diversify the suite of investment offerings and introduce high-end wealth management services , creating a digital wealth management experience that balances flexibility with professional expertise.”

Mr. Iu, added, “In Business Banking, we remain steadfast in our commitment to trade SMEs. By leveraging fintech and alternative data to strengthen trade finance, we actively respond to the government’s mandate to ‘leverage financial services to support the real economy.’ As of 30 June 2026, our loan assets grew steadily, with total loans reaching HK$4.14 billion. Moving forward, we will continue to navigate global expansion for trade SMEs and cross-border e-commerce, further deepening trade finance application scenarios to serve as a robust pillar for SMEs.”

Ping An Digital Bank’s Retail Banking centers its design on usability with a “Customer Experience First” approach. Backed by Ping An Group’s strengths and its full-licence advantages, PingAnDB actively builds an exclusive financial ecosystem and integrated financial platform. Customers can enjoy a one-stop suite of financial services—including deposits, foreign exchange, cross-border remittances, wealth, and insurance—all via a single app. Additionally, Ping An Digital Bank offers a dual-strength wealth services feature enabling retail banking customers to seamlessly switch funds between investments and savings deposits. US stock trades carry a flat brokerage fee of USD0.881 per transaction regardless of transaction value or share count. Combined with a USD savings yield of up to 3.28% p.a.2, customers can park liquidity to earn interest and pivot instantly when market opportunities arise. Together with comprehensive online and offline insurance services, Ping An Digital Bank delivers smart financial experiences with a human touch.

While deepening retail financial services, as the first digital bank tailored for SMEs, Ping An Digital Bank extends its financial capability into the business banking sector, comprehensively covering business banking account, cross-border remittance, currency exchange, and loan services. As a core supporter of trade enterprises, Ping An Digital Bank has unlocked the potential of commercial data over the years to revamp account opening and credit assessment process, solving previous pain points of SMEs to achieve fast and accurate evaluations. This fully empowers enterprises to capture global market opportunities and builds a robust digital financial ecosystem.

For the interim report 2026 of Ping An Digital Bank, please visit https://www.pingandb.com/en/financial-report.html

1 Brokerage fee excludes any custody fee, securities deposit charges, nominee services fee and any third-party transaction charges such as transaction levy, stamp duty and trading fee, handling fee, securities management fee, transfer fee, capital gain tax and SEC Fee, etc.

2 Applicable only to USD savings deposits between USD 15,000 and USD 60,000 and subject to the “USD Savings Interest Rate Offer” terms and conditions. Interest on USD deposits will be calculated on a daily basis on a 360-day year and is determined at the Bank’s discretion from time to time.

USD Savings Balance Interest Rate (p.a.)
First US$14,999.99 0.50%
US$15,000 to 60,000 3.28%
Above US$60,000 2.00%

Hashtag: #平安數字銀行 #PingAnDB #中期業績 #InterimResults

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

Ping An Digital Bank

Ping An Digital Bank (International) Limited (“Ping An Digital Bank,” “PingAnDB”) is a wholly-owned subsidiary of Lufax Holding Ltd (“Lufax”) (SEHK: 6623; NYSE: LU) and a member of Ping An Insurance (Group) Company of China, Ltd. (“Ping An”) (SEHK: 2318; SSE: 601318). Ping An Digital Bank was granted a banking licence by the Hong Kong Monetary Authority in May 2019 to offer retail banking and business banking services. Backed by Ping An’s advanced technology, Ping An Digital Bank is elevating banking experience, serving customers in Hong Kong and the Greater Bay Area, establishing itself as Ping An Group’s integrated financial platform in Hong Kong.

Slope Collapse Hits Workers’ Camp at Pak Beng Hydropower Project in Northern Laos, No Casualties Reported

A landslide struck a workers’ camp at Laos’ Pak Beng hydropower project, prompting an evacuation before the slope collapsed.

A section of hillside collapsed beneath a workers’ residential camp at the Pak Beng hydropower project in northern Laos at 1 AM on 28 September, burying or damaging several buildings, according to an eyewitness account from the scene.

The slope collapsed below worker housing in Pak Khaen village, Ngeun District, on the Xayaboury side of the Mekong River near the border with Oudomxay Province.

Photographs from the site widely shared on social media show several dormitory-style buildings with white walls and red roofs, partly buried under mud and debris. A wide scar of exposed earth is visible on the hillside above the camp.

A representative of Lao Assistance, a Laos-based medical emergency and evacuation service currently on the ground in the Pak Beng area, said a truck driver returning from the dam site on the evening of 27 September spotted cracks forming on the hillside above the camp and raised the alarm. 

The source said the hillside had appeared unstable for some time, but the driver recognized signs that the situation was becoming dangerous.

No official figures on casualties or missing people have been reported so far.

No photo description available.

Mekong Hydropower Project

The camp is near the site of the Pak Beng hydropower dam, one of several hydropower projects planned or under construction along the mainstream Mekong River.

Pak Beng Power Company Ltd. is a joint venture between China Datang Overseas Investment Co. Ltd., which holds a 51 percent stake, and Thailand’s Gulf Energy Development Public Co. Ltd., which holds the remaining 49 percent.

The land subsidence comes amid heightened flood and landslide risks across the region. 

Laos has experienced flooding and landslides in several areas this month, while Thailand issued warnings for dozens of provinces over possible flash floods and landslides linked to a monsoon system in the days before the collapse.


This report is based on eyewitness accounts and information provided directly to The Laotian Times by sources at the scene. Anyone with new verified information from the scene can contact The Laotian Times newsroom via email at laotiantimes@rdkgroup.la

MIHAS 2026 Delivers RM6.78 Billion In Sales, Expanding Opportunities For Malaysian Businesses And SMEs


KUALA LUMPUR, MALAYSIA – Media OutReach Newswire – 29 September 2026 – MIHAS 2026 has delivered a strong four-day performance, recording total sales of RM6.78 billion from 23 to 26 September 2026 — an increase of RM730 million or 12.0% compared with RM6.05 billion recorded in 2025.

The achievement also exceeded the RM5.0 billion sales target by RM1.78 billion, or 35.5% increase, further reinforcing MIHAS’ role as a key halal marketplace for connecting Malaysian businesses with international markets and translating trade engagements into commercial opportunities.

Commenting on the outcome, Dato’ Indera Abu Bakar Yusof, Chief Executive Officer of MATRADE, said, “MIHAS 2026 demonstrates that the platform is not only growing in terms of sales, but is also creating greater opportunities for Malaysian businesses, particularly Small and Medium Enterprises (SMEs), to access international markets. We remain committed to strengthening SMEs and Mid-Tier Companies (MTCs) to expand into global markets especially the emerging and non-traditional markets.”

“The RM6.78 billion in sales achieved at MIHAS 2026 represents valuable opportunities. With the integration of Agentic AI, MIHAS is evolving into a more connected and digitally enabled trade facilitation ecosystem, helping Malaysian companies identify potential buyers, build meaningful business relationships and pursue new export opportunities beyond the exhibition floor. Under the MADANI Digital Trade Platform (MDTP), we shall provide Malaysian exporters with continuous connectivity with global buyers and support them in securing sustainable export opportunities,” he added.

MIHAS 2026 attracted 69,104 visitors from 93 countries, up from 50,340 visitors in 2025 — an increase of 18,764 visitors or 37.3%, the highest since its inception in 2004. The event also brought together participating exhibitors and INSP buyers from 58 countries, further strengthening MIHAS’ international reach and appeal as a global halal trade exposition.

The growth was supported by strong performance across the key components of MIHAS. The International Sourcing Programme (INSP) generated RM4.02 billion, compared with RM3.63 billion in 2025, representing an increase of RM394.5 million or 10.9%. INSP facilitates structured business meetings between Malaysian sellers and international buyers, creating targeted opportunities for sourcing, business matching and potential export transactions.

Meanwhile, the MIHAS Exhibition recorded approximately RM1.99 billion, compared with RM1.89 billion in 2025, an increase of RM103.9 million or 5.5%. Among the top products driving exhibition sales were processed food and confectionery, food technology and packaging, frozen food, and fertilisers and agrochemicals, reflecting the diverse range of halal products showcased at MIHAS.

Creating More Opportunities for Malaysian SMEs

Importantly, the success of MIHAS is also reflected in its sustained contribution to Malaysian SMEs.

At MIHAS Exhibition 2026, Malaysian SMEs generated RM620 million in sales, compared with RM557 million in 2025, representing an increase of approximately RM63 million or 11.3%. This builds on the strong growth recorded over the past six editions, with SME participation increasing from 64 companies in 2021 to 339 companies in 2026, representing a significant 429.7% increase.

The strong performance of Malaysian SMEs comes against the backdrop of Malaysia’s growing halal export sector. Malaysia’s halal exports reached RM68.52 billion in 2025, an increase of 10.9% from RM61.79 billion in 2024. Under RMK13, Malaysia has set a target of RM80 billion in halal exports, highlighting the significant opportunity for Malaysian companies, particularly SMEs, to further expand into international markets.

MIHAS 2026 continues to support this ambition by providing Malaysian SMEs with access to international buyers, business matching, sourcing opportunities and digital tools to expand their market reach and strengthen their export capabilities.

AI Transforming Business Connections

The 2026 edition also marked a significant step forward in MIHAS’ digital transformation through the integration of Agentic AI.

More than 22,000 AI-assisted business appointments were generated during MIHAS 2026, demonstrating how AI is transforming the way businesses connect and pursue new trade opportunities.

Of these AI-assisted appointments, 324 matches reported RM28 million in sales associated with these completed AI-assisted appointments.

Importantly, the AI platform will continue to operate until 2027, enabling participating businesses to continue connecting, engaging with potential buyers and pursuing new trade opportunities beyond the four-day exhibition.

Overall, MIHAS 2026 demonstrates how the trade platform is evolving beyond a conventional trade exhibition — combining strong sales performance, growing international participation, SME development and AI-powered business matching to create a more connected and digitally enabled trade facilitation ecosystem for Malaysian businesses.

Hashtag: #MIHAS2026

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

Malaysia International Halal Showcase (MIHAS) 2026

Since it began in 2004, the Malaysia International Halal Showcase (MIHAS) has grown into a major platform for Halal trade and has helped strengthen the global industry’s position in Halal standards, governance, and market access.

Recognised as a Guinness World Records holder and hosted by the Ministry of Investment, Trade and Industry (MITI) with the Malaysia External Trade Development Corporation (MATRADE) as organiser, MIHAS now covers 14 sectors, from food and beverages and pharmaceuticals to Islamic finance, modest fashion, personal care, technology, services, and Muslim-friendly tourism. The 22nd edition of MIHAS, themed “Shaping Trust, Driving Resilience”, will focus on regulated-by-design governance and technology-enabled trade.

MATRADE

The Malaysia External Trade Development Corporation (MATRADE) was established on 1 March 1993 as the national trade promotional arm under Malaysia’s Ministry of Investment, Trade and Industry (MITI).

MATRADE’s primary role is to assist Malaysian exporters in developing and expanding their export markets. Aligned with Malaysia’s commercial diplomacy efforts, MATRADE is the nation’s trade facilitator and champion of Malaysian-made products and services on the global stage.

AsiaPay Pilot Launches Voice Pay for merchants in Asia

An AI-Powered UI for Smarter Convenient Payments

HONG KONG, Sept. 29, 2026 /PRNewswire/ — AsiaPay, a leading digital payment service and technology provider in Asia, announced on 23 September 2026 the pilot  launch of Voice Pay, an AI-powered voice payment experience that lets consumers speak into their mobile device and instruct payment using their preferred payment method — from digital wallets to cards. Voice Pay brings secure, hands-free checkout to everyday commerce, making payments faster, more accessible and more intuitive for consumers while helping merchants increase conversions and reduce friction.

With Voice Pay, customers can confirm purchases through natural speech on their mobile phone or other supported device. Behind the scenes, AsiaPay connects the voice instruction to the customer’s chosen payment method, while its intelligent payment engine manages authentication, routing, fraud protection and processing.

With the voice payments market set to nearly double from $10.9 billion in 2025 to $22.7 billion by 2030, and 81% of consumers already using voice technology weekly, early adopters are recovering 35% of abandoned carts via AI voice agents. As the payments industry shifts from static rules to adaptive AI, AsiaPay is embedding further intelligence into fraud scoring and routing.

“The way consumers shop is changing – and so is the way payments are processed behind the scenes,” said Joseph Chan, CEO of AsiaPay. “With Voice Pay, we are giving merchants a voice front-end to an AI-powered payment interface that reduces friction for customers and improves economics for businesses. In an industry where payment networks and PSPs are racing to embed AI into their infrastructure and service, Voice Pay is AsiaPay’s answer paving the way for agentic commerce.”

AsiaPay Voice Pay is built for immediate use. Existing AsiaPay merchants can unlock this new user experience instantly with Zero-Code Enablement—requiring no development effort or system changes. For new merchants, the API-based gateway integration ensures smooth deployment across leading eCommerce platforms, supporting multi-wallet compatibility including Apple Pay, Google Pay, WeChat Pay, Alipay, and Octopus and others in Asia, with built-in biometric and tokenized security.

About AsiaPay

Founded in 2000, AsiaPay, a premier digital payment service and technology solution provider, strives to bring advanced, secure, integrated, and cost-effective electronic payment processing solutions and services to banks, corporations, and e-Businesses in the worldwide market, covering an array of prevailing international credit card, debit card, prepaid card, net banking, wallets, BNPL and QR code payment.

Headquartered in Hong Kong SAR, AsiaPay also offers its professional advanced digital payment service and solution consultancy, and quality local service support from its 17 offices across the Asia Pacific region including Australia, Thailand, Philippines, Singapore, Malaysia, Mainland China, Taiwan region, Vietnam, Indonesia, Cambodia and India.

For more information, please visit www.asiapay.com.

Sensitive Choice-Certified Coway Airmega Offers Trusted Relief for Spring Allergy Season

  • Highlights Sensitive Choice certified Airmega 350 for open-plan living alongside 11-time Wirecutter winner Airmega Mighty
  • Offers up to 44% off on Amazon Australia Prime Big Deal Days to support 2.8 million Australians living with respiratory conditions

SYDNEY, Sept. 29, 2026 /PRNewswire/ — Coway, South Korea’s leading wellness tech company, today announced a major spring allergen campaign in Australia, offering discounts of up to 44% on its National Asthma Council Australia ‘Sensitive Choice’ certified air purifiers during Amazon Australia’s Prime Big Deal Days. To support the 2.8 million Australians living with respiratory conditions and help households breathe easier this allergen season, exclusive discounts will be available on Amazon Australia from Tuesday, September 29 to Monday, October 5, 2026.

Sensitive Choice-Certified Coway Airmega Offers Trusted Relief for Spring Allergy Season
Sensitive Choice-Certified Coway Airmega Offers Trusted Relief for Spring Allergy Season

Preparing Early to Counter Australia’s Springtime Pollen Spike

For millions of Australians, spring brings long-awaited sunny days alongside severe seasonal health challenges. According to the Australian Institute of Health and Welfare (AIHW), 25% of Australians suffer from allergic rhinitis (hay fever), and 2.8 million live with asthma in 2022. In Southern Australia, the grass pollen season peaks sharply through October and November. As airborne triggers reach their highest levels, maintaining clean indoor air becomes vital for managing asthma and allergy symptoms.

Coway Airmega: Certified Relief with Sensitive Choice

To help households navigate these seasonal triggers, Coway reinforces its commitment to healthier indoor living through products approved under the National Asthma Council Australia’s Sensitive Choice® program. Established to help consumers identify products independently assessed to reduce exposure to triggers, the program highlights the effectiveness of advanced filtration.

Both the Airmega 350 and Airmega Mighty (AP-1512HH) feature Coway’s HEPA filter system, which is independently tested to capture 99.97% of ultra-fine particles down to 0.3 microns. This technology effectively removes airborne particulate matter, including pollen, mold spores, and dust mite allergens.

Customized Air Care for Every Home Environment

The featured Airmega models offer tailored solutions for diverse Australian residential layouts. Both models incorporate intuitive technologies, including a Real-Time Air Quality Indicator (AQI) and Smart Auto Mode, which automatically adjusts fan speeds based on real-time pollution levels for continuous pollen defense.

  • Airmega 350: Specifically engineered for expansive spaces up to 182 m² , this flagship model is ideal for typical Australian open-plan living, dining, and kitchen areas. Its aerodynamic high-capacity airflow system rapidly purifies large volumes of indoor air during peak outdoor pollen penetration. Also, an optional Allergen Filter is available for separate purchase.
  • Airmega Mighty (AP-1512HH): Designed for spaces up to 109 m², the Mighty is a global bestseller named “Top Pick Air Purifier” by The New York Times’ Wirecutter for 11 consecutive years (2015–2026). Ideal for master bedrooms and dedicated care spaces, it also offers an optional Allergen Filter(sold separately) for targeted relief during sleep.

During the Amazon Australia Prime Big Deal Days, Coway is offering 30% to 44% off complete air purifier units and 30% off replacement filters.

For more information or to purchase Coway’s Airmega air purifiers, visit the Coway Amazon Australia Brand Store or au.coway.com.

About Coway Co., Ltd.

Established in Korea in 1989, Coway (KRX: 021240), the “Best Life Solution Company,” is a leading global innovator dedicated to enhancing everyday life through state-of-the-art environmental home appliances and premium wellness solutions. Renowned for its industry-leading water purifiers, air purifiers, and bidets, Coway expands its premium sleep and wellness brand, BEREX, to advance the global lifestyle sector with smart mattresses and advanced massage chairs. Driven by intensive research and award-winning engineering, Coway continues to accelerate its business across major markets, including Malaysia, the USA, Thailand, China, Indonesia, Vietnam, and Europe. For more information, please visit http://www.coway.com/ or http://newsroom.coway.com.

 

iRegene Therapeutics’s NouvSight001 Cleared for Clinical Trials in the U.S. and China for Retinitis Pigmentosa

– Following its Parkinson’s disease program, iRegene advances another off-the-shelf cell therapy into clinical development in the U.S. and China.

CHENGDU, China, Sept. 29, 2026 /PRNewswire/ — iRegene Therapeutics Co., Ltd. (“iRegene” or the “Company”), a biotechnology company pioneering chemically induced allogeneic cell therapy, today announced that its investigational cell therapy NouvSight001 has received clearance from China’s National Medical Products Administration (NMPA) for a Phase I/III clinical trial in patients with retinitis pigmentosa (RP) to evaluate its safety, tolerability and preliminary efficacy.

The U.S. Food and Drug Administration (FDA) has also cleared NouvSight001 for a Phase I/II clinical trial for the same indication and granted a special exemption.

NouvSight001 is an allogeneic, off-the-shelf photoreceptor cell therapy developed using iRegene’s proprietary “AI + Chemical Induction” (“AI + Chem”) platform. As a cell replacement therapy, NouvSight001 is not limited to patients with a specific disease-causing genotype. The regulatory clearances in the U.S. and China mark another milestone in iRegene’s global product development.

The company has built a regenerative medicine pipeline focused on major diseases associated with the structural burden of an aging global population, including Parkinson’s disease (PD), multiple system atrophy (MSA), retinal degenerative diseases and ischemic stroke. Its pipeline now spans the central nervous system, visual system and neurovascular system.

From a Single Global Program to a Repeatable Global R&D Model

iRegene’s “AI + Chem” platform is designed to identify and characterize key biological networks that determine cell fate and function, and to precisely regulate these networks using small molecules.

Through this approach, iRegene aims to make complex cell differentiation processes more predictable, controllable, reproducible and scalable for therapeutic manufacturing.

As multiple programs generated from the same platform move into international clinical development, iRegene is beginning to show the platform’s applicability across different cell types and disease areas.

NouvSight001 expands iRegene’s pipeline into retinal regenerative medicine, an area with significant unmet medical need. The program has now been cleared for clinical development in both the U.S. and China. This marks another step toward iRegene’s “one platform, multiple products, global development” model, a key capability for a global platform biotech.

Advancing Global Clinical Execution Across the U.S. and China

Following FDA Orphan Drug Designation in 2024, NouvSight001 has now received clinical trial clearances from both the NMPA and FDA, as well as a special exemption from the FDA. This further demonstrates iRegene’s ability to advance internally developed therapies into U.S. clinical development under global regulatory and development standards.

Although iRegene’s programs address different diseases, target tissues and clinical settings, they share a common set of underlying capabilities: global regulatory strategy; CMC and quality systems established to meet FDA and NMPA requirements; manufacturing capabilities for allogeneic, off-the-shelf cell therapies; cross-border cold-chain and supply-chain capabilities; clinical development capabilities in the U.S. and China; and an R&D platform designed to continuously generate new therapeutic candidates.

For iRegene, globalization is therefore moving beyond regulatory clearance into what it calls “global clinical execution.” This requires coordination across R&D, manufacturing, quality, regulatory affairs, supply chain and clinical operations.

Building a Global Regenerative Medicine Pipeline for Aging-Related Diseases

As populations age worldwide and healthcare needs evolve, iRegene is focused on the fundamental challenge of restoring cells and tissue functions lost to disease and aging.

Rather than developing a single cell therapy, iRegene aims to build a technology platform capable of continuously generating new regenerative medicine products. The company has built a pipeline across several major disease areas. Its programs seek to restore functions lost to disease, including neural circuits and vision, and to repair damaged neural tissue.

Through these programs, iRegene is building a regenerative medicine portfolio around key functions lost to aging and disease. The company aims to move more of these therapies into global development while building toward commercial scalability.

“Globalization has been embedded in our R&D system since the company was founded,” said Tianshi Ruan, Chief Financial Officer of iRegene Therapeutics. “NouvNeu001 has given us hands-on experience advancing an iPSC-derived cell therapy across both the NMPA and FDA regulatory frameworks. NouvSight001 allows us to apply that experience to ophthalmology, a very different disease and tissue setting.”

“The same underlying technology platform allows us to advance our pipeline globally and more efficiently. Going forward, we will continue to advance our core programs in clinical development in the U.S. and China, while actively exploring global multicenter studies and international commercial partnerships.” Ruan added.

About Retinitis Pigmentosa

Retinitis pigmentosa (RP) is a group of inherited retinal degenerative diseases affecting approximately 1.5 million people worldwide. It typically begins with night blindness and progresses to peripheral vision loss and, in some cases, blindness. The only approved therapy is limited to patients with biallelic RPE65 mutations, who represent a small fraction of the RP population. Most patients still have no disease-modifying treatment options.

About iRegene Therapeutics

iRegene Therapeutics is a platform biotechnology company developing regenerative medicines for major aging-related diseases worldwide. At the core of the company is its proprietary “AI + Chem” platform, combining artificial intelligence, systems biology and chemical biology to identify and control key biological networks that determine cell fate and function. iRegene uses this approach to develop allogeneic, off-the-shelf cell therapies designed for standardized, scalable manufacturing.

Media Contact: PR@iregene.com