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LONDON, May 22, 2025 /PRNewswire/ -- Smart, public 'parent pods' located in central community spaces such as markets or parks could soon become a reality around the world as a result of the Good Start Challenge: a €2.6 million global challenge launching today with a call for innovations that improve the wellbeing of parents of young children in underserved communities in Southeast Asia. The Good Start Challenge, which is also launching in Sub-Saharan Africa and Latin America, was initiated by Van Leer Foundation and is supported by FEMSA Foundation, Fundaçāo Maria Cecilia Souto Vidigal, and LEGO Foundation. It is designed and delivered by global challenge prize expert, Challenge Works. While becoming a parent is a time of joy, it is also a period of significant change and vulnerability, where many need support for their mental, social and physical wellbeing. Despite this, communities across Southeast Asia lack access to effective interventions that champion their wellbeing. Research by Milieu has found that 60% of working mothers across the region struggle to balance their professional and personal commitments, and 31% report difficulties in prioritising their own wellbeing. Similarly, a small study conducted by the Foundation for Mother and Child Health Indonesia found that approximately 35% of pregnant and nursing mothers surveyed in Indonesia exhibited symptoms of depression or anxiety. Just 6% of breastfeeding mothers were found to have stable mental health, and many stated that they had little to no time to rest or care for their emotional wellbeing. Rushda Majeed, Chief Programme Officer at Van Leer Foundation, said: " When a child is born, a parent is also born. We know that a good start for children shapes the rest of their lives. This challenge is asking society to think about a good start for parents. At Van Leer we believe it's critical to listen to their voices, and work together to shape a powerful and purposeful evolution in the way in which parents and other caregivers are supported. Advancing a global conversation about the importance of parental wellbeing will have a clear, transformative knock-on effect, as healthy and happy parents lay the foundations for their children to lead fulfilling lives and make positive contributions to society." While initiatives for supporting parental wellbeing have started to emerge across the globe, more are needed. According to WHO, just a quarter (26%) of governments rate their funding of parent support programmes as sufficient to reach all those in need, despite there being an estimated 500 million parents of children under the age of five worldwide. Growing evidence also indicates that new parents experience vast biological and neurological changes, which, combined with increasing pressures such as work and childcare commitments, present challenges – especially for those already living in vulnerable circumstances. The Good Start Challenge is therefore a call for simple yet radical ideas that support the wellbeing of parents and caregivers faced with pre-existing obstacles that make it even harder to access resources. Investing in these ideas will not only bolster parent wellbeing, but society as a whole. Innovations such as 'parent pods' would offer welcoming spaces for new parents to take a moment while accessing amenities and forming connections with other local parents, as well as tapping into an AI-powered network of local support services such as counselling and other benefits. This is one example of a creative solution that could act as a lifeline for parents, enabling them to feel welcomed by society rather than just having to fit in. Kathy Nothstine, Director of Cities and Societies, Challenge Works, said: "This challenge is about accelerating innovation to reimagine how we can care for parents – something that has been overlooked in the past. This need is particularly acute in underserved communities. Given that parents come into contact with so many services and individuals on a daily basis, this challenge invites creative and impactful solutions from any sector. "Society is on the brink of a vital and meaningful shift in how we understand, support and prioritise parents, and this challenge will identify innovations that can put this into practice." With specific focus on nine countries in Southeast Asia, Sub-Saharan Africa and Latin America, the challenge is designed to address common difficulties experienced by parents in those communities. In November 2025, up to 22 finalists will be chosen and awarded €50,000 each, alongside support for scaling. In July 2026, up to six winners will each be awarded €200,000. To find out more about the Good Start Challenge, please visit the website. Applications close on 17 September 2025.
PROVISION Study, Prospective Randomized Trial Evaluating Clinical Outcomes of FFRangio Versus FFR Guidance, Demonstrates Similar MACE Rates at One Year PARIS, May 22, 2025 /PRNewswire/ -- Today at the annual EuroPCR conference taking place in Paris, France, Dr. Toru Tanigaki of Gifu Heart Center in Gifu, Japan presented the one-year results of the physician-initiated PROVISION1 Study. At TCT 2024, investigators shared that the PROVISION Study met its non-inferiority primary endpoint and revealed economic and resource utilization advantages for the FFRangio technology over traditional invasive FFR. PROVISION Study Which Met Its Primary Endpoint Now Demonstrates Similar Clinical Outcomes for FFRangio and FFR. The PROVISION Study is the first Japanese prospective randomized controlled trial (RCT) comparing the outcomes of an angio-based technology compared to invasive wire-based physiology and enrolled 401 patients across 13 centers in Japan. Patients with intermediate coronary lesions (30-90% diameter stenosis) were randomized 1:1 to either the wire-based FFR arm, in which the treatment decision was determined based on FFR values obtained using an invasive pressure wire, or the FFRangio arm, in which the treatment decision was based on FFRangio values. Based on the functional evaluations, either revascularization (PCI) and optimal medical management (OMT) or OMT alone were selected, and patients were followed clinically for at least one year. During a Hotline / Late-Breaking Trials session at EuroPCR 2025, Dr. Tanigaki presented the rates of major adverse cardiac events (MACE) at one year for patients treated according to FFRangio guidance versus FFR guidance. MACE was defined as a composite of death from any cause, nonfatal myocardial infarction (MI) or unplanned revascularization. MACE at one year was 9.9% for the FFRangio arm versus 12.6% for the FFR arm [HR 0.80 (0.42 to 1.51), p = 0.489]. MACE excluding periprocedural MI was 3.5% for the FFRangio arm versus 6.0% for the FFR arm [HR 0.58 (0.13 to 1.42), p = 0.167]. The rates of all-cause death, myocardial infarction and target vessel revascularization at one year were all similar in the FFRangio arm and FFR arm. "The CathWorks FFRangio® System has already demonstrated the highest diagnostic accuracy compared to wire-based FFR among non-hyperemic indices and angio-based technologies. The FFRangio System not only eliminates the drawbacks of invasive wire-based technologies that have limited the overall adoption of physiology but also provides tools that optimize clinical decision making. With the addition of this new body of clinical evidence demonstrating patients treated according to FFRangio guidance have similar outcomes to those treated based on invasive FFR guidance while potentially reducing procedural resources and costs, we are truly embarking on a new era in physiology, transforming FFRangio into the new standard of care," said Ramin Mousavi, CathWorks President & CEO. ABOUT CATHWORKS CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio® System combines artificial intelligence and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit www.cath.works and follow @CathWorks on LinkedIn. 1. Prospective Randomized trial of clinical Outcomes of angiography-based fractional flow reserve guidance Versus wIre-baSed fractIOnal flow reserve guidance (PROVISION) study is an investigation of the Utility of Coronary Angiography (FFRangio) in Comparison to Coronary Fractional Flow Reserve (FFR) in the Determination of Treatment Planning and the Clinical Prognosis in Patients with Chronic Phase Coronary Artery Disease Investors:Mike Fehermike.feher@cath.works Media:Sarita Monicosarita.monico@cath.works
Global eye experts reunite in Jakarta for JECIM 2025, after five-year hiatus JEC showcases 41 years of ophthalmology leadership and innovation Launch of Matapedia marks new chapter in eye health education JAKARTA, Indonesia, May 22, 2025 /PRNewswire/ -- JEC Eye Hospitals and Clinics, Indonesia's leading eye care providerwith more than four decades of clinical excellence, hosts the fifth edition of JEC International Meeting (JECIM) 2025 and launches the nation's first AI-powered digital eye health encyclopedia, Matapedia. Dr. Referano Agustiawan, Sp.M(K), Director of JEC @ Menteng and Chair of JECIM 2025, delivers remarks at the opening ceremony of the JEC International Meeting (JECIM) 2025 in Jakarta (25/4). This year’s event features 17 international speakers and over 1,200 participants from across the ophthalmology and eye health community. The return of JECIM, after its last edition in 2020, marks a significant moment for global eye care collaboration. Under the theme "Shaping the Future of Vision," the three-day scientific forum features pioneering discussions on AI-assisted retinal diagnostics, semi-robotic surgical tools, hospital management for practitioners managing hospitals and eye clinics to meet global standards, a 3D surgery experience—the first of its kind in Indonesia—which allows participants to feel as if they are directly involved in an eye surgery through special glasses, and innovative approaches to combat vision impairment in high-prevalence regions. The forum attracts over 1,200 eye care professionals from 17 countries for groundbreaking discussions on cutting-edge diagnostic tools, surgical innovations, and global strategies to improve vision care. The participants include ophthalmologists—among them young ophthalmologists and members of the ophthalmology community—eye care nurses, optometrists/refractionists-opticians, and other eye health industry practitioners. DR. Dr. Johan Hutauruk, Sp.M(K), CEO of JEC Corporation said, "At JEC, our mission is rooted in the belief that a clear vision is fundamental to a better quality of life. Every step we take is driven by a commitment to help people see better—because when people see better, they live better. That belief drives everything we do—especially through platforms like the JEC International Meeting, which we are proud to host as part of our commitment to elevating eye care in Indonesia and beyond. JECIM is more than just a medical symposium—it is a vital convergence of knowledge, innovation, and collaboration. We bring together world-class ophthalmologists, researchers, and professionals to exchange ideas, share the latest breakthroughs, and empower one another." JEC International Meeting (JECIM) 2025 is the most comprehensive ophthalmology scientific forum in Indonesia, initiated by JEC and held every two years. JECIM has become the most comprehensive ophthalmology scientific forum in Indonesia— reinforcing JEC's ongoing contribution to advancing eye health not only domestically but also internationally. Founded in 1984, JEC's legacy as Indonesia's most advanced and comprehensive eye hospital network is well-established, both nationally and internationally. In terms of reach, JEC now operates five state-of-the-art eye hospitals: JEC @ Menteng, JEC @ Kedoya, JEC PRIMASANA @Tj. Priok, JEC CANDI @Semarang, and JEC ORBITA @Makassar. It also runs eleven leading eye clinics in major Indonesian cities, including JEC @ Cibubur, JEC @ Tambora, JEC @ Cinere, JEC @ Bekasi, Candi Eye Center @ Semarang, JEC ANWARI @Purwokerto, JEC JAVA @Surabaya, JEC ORBITA @Makassar, JEC BALI @Denpasar, JEC JAVA @Pasuruan, and the newly opened JEC ORBITA @Kendari. Later this year, JEC will add a few other branches to bring access to trusted, international-standard eye care services closer to not only for local communities, but also for international visitors and even residents of neighboring countries. Its flagship facility, JEC @ Kedoya, has earned four consecutive accreditations from the Joint Commission International (JCI)—in 2014, 2017, 2020, and 2023—cementing its status as a global-standard institution in patient safety and clinical excellence. This achievement serves as a benchmark for the standardization of JEC's services across all its branches. A pioneer in vision correction, JEC made history by being the first hospital in Indonesia to introduce LASIK surgery and launch the country's first Laser Vision Correction Center (LVC). For this groundbreaking achievement, JEC was awarded a record by the Indonesian World Records Museum (MURI) for its contributions to LASIK services. Domestically, JEC has achieved the highest level of accreditation from the Hospital Accreditation Commission (KARS) and received numerous accolades, including the title of Most Brand Reputable Eye Hospital in Greater Jakarta and seven other major cities across Indonesia by SWA Magazine, as well as Best in Building and Managing Corporate Image in the Eye Hospital category from the Corporate Image Award. In addition, JEC was recognized for its excellence in Omnichannel Branding in 2023 and as the winner of the Digital Customer Engagement category at the 2024 Marketeers OMNI Awards. On the international stage, JEC is a founding member of the ASEAN Association of Eye Hospitals (AAEH) and an active member of the World Association of Eye Hospitals (WAEH), further reinforcing its role as a regional leader in ophthalmic care. As the most complete eye care provider in Indonesia, JEC offers a full spectrum of advanced treatments, including cataract surgery (Phacoemulsification and FLACS), refractive procedures like SMILE PRO, SMILE, and LASIK, as well as specialized care for corneal diseases, vitreoretinal disorders, glaucoma, and neuro-ophthalmology. JEC also leads in oculoplasty (eye plastic surgery and ocular tumors), ocular infections and immunology, and provides services, namely general eye exams, tele-ophthalmology, dry eye care, contact lens services, and myopia control. For pediatric and specific cases, JEC offers specialized clinics including the Children's Eye & Strabismus Center, Low Vision Care, and the Thyroid Eye Center for thyroid-related vision conditions. In a groundbreaking move at JECIM 2025, JEC unveiled Matapedia — a comprehensive and accessible digital platform dedicated to eye health. Matapedia serves as a trusted source of accurate, easy-to-understand information about eye conditions, treatments, and preventive care, aiming to empower the public and support medical professionals in enhancing vision and quality of life. All of this information can be accessed free of charge by the general public through the website www.matapedia.id. Dr. Referano Agustiawan, SpM(K), Director of JEC @ Menteng and Chair of JECIM 2025, said the high-profile gathering has become the ideal stage to introduce this groundbreaking digital solution. "JECIM has always been about pushing boundaries in eye care. Matapedia, on the other hand, represents a vital bridge between cutting-edge ophthalmology and public accessibility. While JECIM advances professional knowledge sharing, this digital platform extends our expertise directly to communities facing critical eye care shortages." Developed in response to Indonesia's severe ophthalmologist shortage - with just 3,000 specialists serving 275 million people - Matapedia combats an equally urgent crisis: medical misinformation. Findings from Indonesia's Communications and Digital Ministry (KOMDIGI), which identified 163 health misinformation cases among 1,923 hoaxes circulating in 2024 are concerning. Given that 27.79% of Indonesians look for health information online, Indonesia's 2024 Digital Literacy Index, however, shows a score of 43,34, indicating that while the public is fairly skilled in using digital devices, they tend to buy the information blindly. The platform's "Ask AI" feature provides instant symptom guidance in multiple languages. JEC is also developing a mobile application with full accessibility features for the visually impaired, including screen readers and interactive audio guides. All content undergoes rigorous review by JEC's specialist network, presenting complex medical information through text, audio, and video formats. DR. Dr. Johan Hutauruk, Sp.M(K), added, "Matapedia represents the culmination of our 41-year commitment to advancing eye care. This platform bridges our clinical expertise with digital innovation to address critical gaps in eye health education and literacy. From rural health workers to urban families, Matapedia delivers trustworthy knowledge exactly when and where it's needed." Initial content covers hundreds of conditions and procedures, with plans to expand to 1,000+ articles by 2026. The forthcoming mobile app will incorporate screen reader technology and interactive audio guides, furthering JEC's commitment to inclusive care. With a powerful combination of extensive clinical capacity, decades of experience, and the integration of cutting-edge digital technology, JEC continues to strengthen its position as a leader in eye care services in Southeast Asia. Through JECIM and Matapedia, JEC not only advances professional development in the medical field but also creates a meaningful social impact by expanding public access to accurate, high-quality eye health information. About JEC With 41 years of experience since its establishment in 1984, JEC's contribution to eye care services has been widely recognized through numerous prestigious awards and achievements. These include four consecutive accreditations from the Joint Commission International (JCI), awarded to JEC @ Kedoya in 2014, 2017, 2020, and 2023; recognition as the first LASIK pioneer in Indonesia, granted to "JEC LASIK Center" by MURI (Indonesian World Records Museum) in 2007; and Full Paripurna Accreditation from the Indonesian Ministry of Health. JEC has also received accolades such as "Indonesia Healthcare Most Reputable Brand" in 2014 and 2015 for the eye hospital category in Greater Jakarta and seven major cities in Indonesia from SWA Magazine, and "Best Corporate Image" from 2015 to 2019. JEC is a pioneer in establishing the ASEAN Association of Eye Hospitals (AAEH) and remains an active member, alongside its involvement in the World Association of Eye Hospitals (WAEH). To date, JEC operates five eye hospitals and eleven main eye clinics across major Indonesian cities, including JEC @ Menteng, JEC @ Kedoya, JEC PRIMASANA @Tj. Priok, JEC CANDI @ Semarang, and JEC ORBITA @ Makassar. The clinics include JEC @ Cibubur, JEC @ Tambora, JEC @ Cinere, JEC @ Bekasi, Candi Eye Center @ Semarang, JEC ANWARI @ Purwokerto, JEC JAVA @ Surabaya, JEC ORBITA @ Makassar, JEC BALI @ Denpasar, JEC JAVA @ Pasuruan, and JEC ORBITA @ Kendari. For more information, please visit www.jec.co.id Phone: (021) 2922 1000 / Fax: (021) 390 4601 / www.jec.co.id
HAMBURG, Germany, May 22, 2025 /PRNewswire/ -- MGI Tech Co., Ltd. (MGI), a company dedicated to developing core tools and technologies that drive innovation in life sciences, is proud to unveil its latest innovation, PrepALL, a flexible liquid handling system, along with the latest version of the Smart8 at SLAS Europe 2025, taking place from May 20–22 in Hamburg. Featuring advanced robotics, AI integration, and modular platforms, MGI's automation portfolio addresses critical challenges in genomics, drug discovery, synthetic biology, and molecular diagnostics—empowering labs of all sizes to scale research efficiently. PrepALL: Compact, Affordable Automation for Flexible Pipetting The PrepALL Flexible Liquid Handling Platform simplifies complex laboratory tasks while maintaining enterprise-level performance—without the high costs typically associated with traditional systems. Compact yet powerful, PrepALL is ideal for laboratories adopting automation for the first time or scaling existing research capacity. PrepALL Key Features Include: Space-saving design: Occupies just 0.7 m², with 16 SBS deck positions (expandable to 41). High-precision pipetting: 8 independent channels support 0.5–1200 µL volumes with CVs (coefficients of variation) of less than 3% (1–50 µL) and <1% (50–1200 µL). It supports pLLD/cLLD, liquid level tracking, and anti-dripping, so that it reduces dead volume and improves pipetting accuracy. Plug-and-play setup and easy to use: Integrated with a visual system, it can achieve automatic consumables identification and automatic position calibration Full traceability: Built-in sensors and data logging ensure reproducibility and consistency. Leveraging advanced vision-based AI, PrepALL delivers high-precision performance in critical applications such as nucleic acid extraction, plasmid construction, sample preparation, and NGS library prep. Designed for global accessibility, it addresses cost and complexity barriers with a scalable, modular design and open APIs. Ideal for both entry-level and high-throughput environments, PrepALL empowers smaller labs to scale without costly infrastructure overhauls. "PrepALL represents a major leap in lab automation, giving labs of all sizes the ability to streamline complex workflows with unmatched affordability and reliability. It's a bold step in our mission to democratize cutting-edge tools and accelerate scientific discovery worldwide." said Dr. Christian Zimmerman, VP of Sales at MGI Europe and Africa. Scalable Automation Ecosystem for Every Lab MGI's automation portfolio is among the most versatile in the industry, designed to meet diverse laboratory needs while ensuring scalability and ease of use. At SLAS Europe 2025, MGI also presents Smart 8, a globally recognized solution launched in 2022. Smart 8 features eight-channel pipetting, and smart gripper technology. The new enhancement introduces AI-optimized pipetting for up to 20% faster cycle times, including nucleic acid extraction, microbial screening, and library preparation. This update ensures higher reproducibility and efficiency, making the Smart 8 an ideal partner for labs seeking reliable automation while remaining cost-effective. The enhanced capabilities of the Smart 8 will cater to academic institutions, biotech startups, and clinical labs, offering a competitive edge in high-throughput research. By reducing manual intervention, the system accelerates time-to-results, enabling researchers to focus on data analysis and discovery. Affordable, Scalable, Smart: The MGI Automation Edge MGI stands out in the lab automation market by prioritizing cost-effectiveness, scalability, and global accessibility. Designed to democratize advanced technology, MGI empowers researchers across diverse fields—from precision medicine to agriculture—regardless of budget constraints. MGI provides a comprehensive portfolio that covers the entire workflow, from sample extraction and preparation to sequencing and data analysis. This all-in-one solution enhance chances to meet customers' diversified demand under one system and brand and ensures compatibility among various systems, simplifying the overall experimental workflow. These advantages have positioned MGI as a trusted partner in more than 100 countries, accelerating breakthroughs in genomics, synthetic biology, and beyond. During global health crises, systems like the Platforms like the MGISP-960 and MGISTP-7000 have processed millions of samples, demonstrating MGI's ability to deliver robust solutions under pressure. MGI invites researchers, lab managers, and industry professionals to explore its latest automation solutions at SLAS Europe 2025. Visit MGI's booth#516 to see the enhanced innovations in action.
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.
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 YuAnnJi Pharmaceutical Co., Ltd.(+886) 2-2365-5677anne.yu@ajpharm.com
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