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Global Registrational Phase III Study of Olverembatinib for the Treatment of Patients with SDH-Deficient GIST Approved by the China CDE

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SUZHOU, China, and ROCKVILLE, Md., June 10, 2024 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that the Center for Drug Evaluation (CDE) of China’s National Medical Product Administration (NMPA) has approved a global registrational Phase III study of the company’s novel drug candidate olverembatinib (HQP1351), in patients with succinate dehydrogenase (SDH)-deficient gastrointestinal stromal tumor (GIST) who had failed prior systemic treatment. This approval marks a major milestone in Ascentage Pharma’s clinical development in solid tumors.

This global, multicenter, single-arm, open-label, pivotal registrational Phase III study is designed to evaluate the efficacy and safety of olverembatinib in patients with SDH-deficient GIST. The CDE has agreed that results from the study can be used to support a future New Drug Application (NDA) for olverembatinib in SDH-GIST.

GIST is the most common type of soft tissue sarcoma that arises in the gastrointestinal track, with a global incidence of 1-1.5/100,000 per year.1 KIT and PDGFRA are key genetic drivers of GIST, and 85% – 90% of all patients with GIST harbor KIT or PDGFRA mutations. The introduction of tyrosine kinase inhibitors (TKIs) has improved the prognosis of patients with this subset of GIST. However, 85% of pediatric patients and 10%-15% of adult patients with GIST do not harbor KIT or PDGFRA mutations, thus belong to a subtype dubbed wild-type GIST. Depending on whether the SDH expression is lost in the patient, wide-type GIST can be further categorized into SDH-deficient and non-SDH-deficient GISTs.2-3

SDH-deficient GIST has unique clinical and pathological characteristics. According to existing literatures, SDH-deficient GIST has a median age of diagnosis of 21 years and is more common in women. SDH-deficient GIST, primarily arises in the gastric area with a high propensity to metastasize, is characterized in immunohistochemistry essays by the loss of SDHB protein expression. Patients with early-stage localized SDH-deficient GIST can be treated with surgeries, although most patients eventually relapse. At present, there is no standard treatment option for relapsed and advanced SDH-deficient GISTs. Imatinib is generally considered ineffective for the condition and other TKIs have also failed to demonstrate satisfactory efficacy2-5, offering a five-year event-free survival (EFS) rate of just 24%.4 Being commonly diagnosed at young ages, patients with SDH-deficient GIST endure significant impact on their quality of life and survival, therefore have urgent unmet medical needs for new treatment options.

Olverembatinib is an orally-available novel third-generation TKI developed by Ascentage Pharma. The drug has been granted a Breakthrough Therapy Designation by the China CDE for the treatment of patients with SDH-deficient GIST who had received first-line treatment. As a multi-targeted TKI, olverembatinib has shown excellent efficacy and manageable safety in patients with SDH-deficient GIST. Since 2022, the clinical study evaluating olverembatinib in SDH-deficient GIST has been selected for presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting for three consecutive years, including an oral report at the 60th ASCO Annual Meeting just took place this month. According to the latest results, olverembatinib has achieved a clinical benefit rate (CBR) of 92.3% in patients with SDH-deficient GIST.

Olverembatinib is the first China-approved third-generation BCR-ABL inhibitor. To date, the drug has been approved for two indications in China, including adult patients with TKI-resistant chronic-phase chronic myeloid leukemia (CML-CP) or accelerated-phase CML (CML-AP) harboring the T315I mutation; and adult patients with CML-CP resistant to and/or intolerant of first-and second-generation TKIs. Olverembatinib is jointly commercialized in China by Ascentage Pharma and Innovent Biologics.

“In earlier studies, olverembatinib has already shown encouraging efficacy and favorable safety in patients with SDH-deficient GIST,” said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. “We are excited by the approval for this global registrational Phase III study because it could potentially lead to a clinical breakthrough for another indication that currently lacks approved treatment options while marking a major milestone for Ascentage Pharma’s clinical development in solid tumors. Remaining steadfastly committed to the mission of addressing unmet clinical needs in China and around the world, we will expeditiously advance this clinical development program for the benefit of more patients.”

References

Mantese G. Gastrointestinal stromal tumor: epidemiology, diagnosis, and treatment. Curr Opin Gastroenterol. 2019; 35(6): 555-559.Call JW, Wang Y, Rothschild S, et al. Treatment responses in SDH-deficient GIST. LRG Science, https://liferaftgroup.org/2019/08/treatmentresponses-in-sdh-deficient-gist-2/(2019, accessed 4 May 2022).Nannini M, Rizzo A, Indio V, et al. Targeted therapy in SDH-deficient GIST. Ther Adv Med Oncol. 2021; 13: 17588359211023278.Weldon CB, Madenci AL, Boikos SA, et al. Surgical Management of Wild-Type Gastrointestinal Stromal Tumors: A Report From the National Institutes of Health Pediatric and Wildtype GIST Clinic. J Clin Oncol. 2017; 35(5): 523-528.Mullassery D, Weldon CB. Pediatric/”Wildtype” gastrointestinal stromal tumors. Semin Pediatr Surg. 2016; 25(5): 305-310.

*Olverembatinib is an investigational drug that has not been approved for any indication outside the Chinese mainland.

About Ascentage Pharma
Ascentage Pharma (6855.HK) is a globally focused biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B, and age-related diseases. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

Ascentage Pharma focuses on developing therapeutics that inhibit protein-protein interactions to restore apoptosis, or programmed cell death. The company has built a pipeline of 9 clinical drug candidates, including novel, highly potent Bcl-2, and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation tyrosine kinase inhibitors (TKIs). Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company is conducting more than 40 Phase I/II clinical trials, including 6 global registrational phase III studies, in the US, Australia, Europe, and China. Ascentage Pharma has been designated for multiple Major National R&D Projects, including five Major New Drug Projects, one New Drug Incubator status, four Innovative Drug Programs, and one Major Project for the Prevention and Treatment of Infectious Diseases.

Olverembatinib, the company’s core drug candidate developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China 2022 National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted an Orphan Drug Designation (ODD) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU. To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates.

Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships with numerous renowned biotechnology and pharmaceutical companies and research institutes such as UNITY Biotechnology, MD Anderson Cancer Center, Mayo Clinic, Dana-Farber Cancer Institute, MSD, and AstraZeneca. The company has built a talented team with global experience in the discovery and development of innovative drugs and is setting up its world-class commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

Forward-Looking Statements
The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, Ascentage Pharma undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events, or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

 

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SOURCE Ascentage Pharma

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HelloNation Article Explains Deferred Maintenance, Featuring Commercial Property Management Expert Courtenay Brack

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November 2, 2026

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The article explains why addressing repairs early helps commercial property owners reduce long-term costs and protect property value.

CHARLESTON, S.C., Nov. 2, 2026 /PRNewswire/ — What happens when commercial property owners delay needed repairs? HelloNation answers that question in an article featuring insights from Commercial Property Management Expert Courtenay Brack of Charleston Green Commercial, LLC in Charleston, South Carolina.

The article explains that postponing repairs may appear to reduce expenses in the short term, but deferred maintenance often results in substantially higher costs over time. According to the HelloNation article, delaying repairs can lead to larger construction projects, operational disruptions, and declining property value that consistent upkeep could have avoided.

Commercial buildings depend on numerous systems that are designed to perform reliably for decades when properly maintained. The article notes that roofs, HVAC systems, parking lots, plumbing infrastructure, elevators, and exterior finishes all require routine inspections and scheduled servicing. Small maintenance issues rarely remain isolated when they are left unresolved. Instead, they often spread to surrounding building components, increasing both the complexity and the cost of future repairs.

The HelloNation article highlights roof leaks as one example of how deferred maintenance can escalate. A small leak may initially appear insignificant, but over time it can damage insulation, ceilings, electrical systems, and tenant improvements. Likewise, aging HVAC components that could have been repaired during routine service may eventually fail completely, requiring costly system replacements instead of relatively inexpensive repairs. The article explains that these situations demonstrate why preventive maintenance consistently provides greater value than emergency response.

Commercial Property Management Expert Courtenay Brack’s featured insights also highlight how maintenance affects tenant satisfaction. Businesses rely on safe, comfortable, and dependable spaces to serve customers and operate efficiently. The article explains that recurring equipment failures, poor climate control, water intrusion, or deteriorating common areas can affect tenant confidence and increase the likelihood of lease turnover. Stable occupancy supports reliable income and helps owners avoid the additional costs of vacant space.

Emergency repairs often involve expenses beyond the construction work itself. According to the article, after-hours labor, expedited material delivery, temporary tenant accommodations, and interruptions to business operations all contribute to higher overall costs. The article explains that planning routine maintenance helps commercial property owners avoid many of these unexpected financial burdens while allowing repairs to be completed under more favorable conditions.

The article also discusses the importance of life cycle planning for long-term property performance. Every major building component has an expected service life, and regular condition assessments help owners forecast future replacement needs. Developing reserve funding and budgeting for improvements before systems fail allows owners to spread capital expenses over time instead of responding to emergencies that require immediate funding.

Commercial Property Management Expert Courtenay Brack’s featured article further explains that professional property managers support owners by coordinating inspections, documenting building conditions, prioritizing repairs, and recommending maintenance schedules based on observed performance. This proactive approach gives owners better information for decision-making while helping preserve building systems and manage operating costs more effectively.

The article concludes that building condition also influences insurance considerations, financing opportunities, and marketability. Buyers and lenders often review maintenance history before closing, and well-maintained properties generally perform better operationally with fewer unexpected capital expenses. The article explains that consistent maintenance protects investments by supporting tenant satisfaction, preserving property value, and reducing long-term financial uncertainty for commercial property owners.

Why Delaying Commercial Property Repairs Costs More features insights from Courtenay Brack, a commercial property management expert in Charleston, South Carolina, in HelloNation.

About HelloNation

HelloNation is America’s Good News Network, a premier media platform built on the idea that good news travels faster when real people tell real stories. Through its community-focused publications and innovative “edvertising” approach, HelloNation delivers content that informs, inspires, and spotlights the leaders making a meaningful impact in their communities.

www.hellonation.com

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Drone Nerds Expands Drone Detection Portfolio Through AirSight Partnership

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51 minutes ago

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November 2, 2026

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AirGuard software and compatible detection systems support airspace awareness for public safety agencies, critical infrastructure operators, and enterprise security teams

FORT LAUDERDALE, Fla., Nov. 2, 2026 /PRNewswire/ — XTI Aerospace, Inc. (Nasdaq: XTIA) (“XTI Aerospace,” “XTI,” or the “Company”), an aerospace and advanced technology platform and parent company of Drone Nerds, LLC (“Drone Nerds”), a drone solutions platform serving commercial, enterprise, and government customers, today announced a partnership with AirSight, a drone detection and airspace security software solutions provider, to expand Drone Nerds’ drone detection offerings within its enterprise solutions portfolio.

The partnership broadens the options available to customers seeking greater visibility into drone activity around their facilities and operations. AirSight’s solutions combine compatible detection systems with its AirGuard software platform. Intended applications include law enforcement, critical infrastructure, correctional facilities, higher education campuses, and sports and entertainment venues.

AirGuard brings data from compatible detection sensors into a unified interface, providing security teams with real-time alerts and information to assess detected drone activity. Solutions can be configured for individual facilities, campuses, or multiple locations based on customer requirements.

“AirSight strengthens our drone detection portfolio and enhances our ability to serve the security needs of enterprise and government organizations,” said Jeremy Schneiderman, Interim CEO of XTI Aerospace. “This partnership supports our growth strategy by opening doors to new customers and broadening our role across drone operations and airspace security.”

Expanding Security Awareness into the Airspace

AirSight’s approach allows organizations to add drone detection capabilities alongside their existing security infrastructure. Its hardware-agnostic AirGuard platform integrates compatible detection technologies and can support connections with existing security and command systems, subject to technical compatibility.

The partnership will focus on helping customers evaluate their airspace monitoring needs and identify appropriate solutions, including:

Drone Detection and Alerts: Detection of drone activity within system coverage, with real-time notifications to designated security personnel.

Centralized Monitoring: A unified software interface that brings together information from compatible detection sensors.

Scalable Configurations: Solutions tailored to individual sites or multiple locations, with the ability to expand as requirements evolve.

Integration Support: Evaluation of compatible connections with existing security systems to incorporate drone detection information into operational workflows.

Available information and detection performance depend on the selected sensors, drone characteristics, site conditions, and system configuration.

“Drone detection gives security teams an additional layer of awareness beyond their ground-based perimeter,” said Robert Tabbara, CEO and Founder of AirSight. “Working with Drone Nerds allows us to introduce these capabilities to more enterprise and public safety organizations and help them evaluate solutions suited to their facilities, existing systems, and operational priorities.”

Availability

Customers can contact Drone Nerds’ enterprise team to discuss AirSight drone detection solutions, available configurations, and pricing. Drone Nerds’ team will work with AirSight specialists to evaluate customer requirements and discuss deployment options.

For more information, visit enterprise.dronenerds.com.

About XTI Aerospace, Inc.

XTI Aerospace, Inc. (“XTI”) (Nasdaq: XTIA) is focused on building a leading platform for commercial and government drone adoption in the growing unmanned aircraft systems (“UAS”) industry. Through its subsidiary, Drone Nerds, LLC, XTI supports enterprise and government customers in sectors including public safety, agriculture, construction, and energy across the drone program lifecycle, from hardware sourcing and deployment to training, service, repair, and the proprietary Always Flying™ program. Its established U.S. customer base and reputation as a trusted solutions provider position the company as a go-to-market partner for drone manufacturers and software developers seeking to scale in the domestic market.

For more information about XTI, please visit xtiaerospace.com and follow XTI on LinkedIn, Instagram, X, and YouTube.

About Drone Nerds

Drone Nerds, LLC, a subsidiary of XTI Aerospace, Inc. (Nasdaq: XTIA), provides comprehensive drone solutions for enterprise, private and recreational needs. Established in 2014, Drone Nerds focuses on helping customers deploy the right UAS solutions for their unique operational requirements. Through its proprietary Always Flying™ program, Drone Nerds focuses on delivering enhanced reliability and assurance for enterprise implementations across industry verticals, including public safety, government, agriculture, construction, insurance, energy, inspection, and more.

For more information, visit enterprise.dronenerds.com.

About AirSight

AirSight provides drone detection and airspace security software solutions. Its AirGuard platform integrates data from compatible detection sensors to provide real-time alerts and visibility into drone activity. Depending on sensor configuration and available data, the platform can provide drone and pilot location information to help security teams assess activity and inform their response.

For more information, visit airsight.com.

Contacts:

General inquiries:
Email: contact@xtiaerospace.com
Web: https://xtiaerospace.com/contact

Investor Relations:
IR@xtiaerospace.com

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SOURCE XTI Aerospace, Inc.

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The Inner Circle acknowledges Andrea E. Neal as a Pinnacle Professional Member Inner Circle of Excellence

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November 2, 2026

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TITUSVILLE, Fla., Nov. 2, 2026 /PRNewswire/ — Prominently featured in The Inner Circle, Andrea E. Neal is acknowledged as a Pinnacle Professional Member Inner Circle of Excellence for her contributions to Reading Education and Literacy Development.

Andrea E. Neal has dedicated her career to helping students overcome reading challenges and achieve academic success through individualized instruction and evidence based literacy interventions. As an intensive reading teacher at Einstein Academy in Cocoa, Florida, she is recognized for her commitment to supporting students with dyslexia, learning disabilities, and other educational needs through targeted reading instruction that builds confidence and long term success.

Since joining Einstein Academy in 2020 and serving as an intensive reading teacher since 2022, Ms. Neal has provided specialized support for students with Individualized Education Programs and 504 plans. Her expertise includes intensive reading instruction, dyslexia support, phonics development, word decoding, and therapeutic literacy interventions designed to meet the unique needs of each student.

Certified in the Lindamood Phoneme Sequencing Program for Reading, Spelling and Speech, Ms. Neal utilizes evidence based strategies and manipulative based activities to strengthen phonemic awareness, decoding skills, and reading comprehension. Through small group instruction, she helps students deepen their understanding of language by exploring idioms, vocabulary, and contextual reading strategies.

Ms. Neal earned a Bachelor of Fine Arts in Fine and Studio Arts from Linfield University in 2000. She also completed the New World of Work externship program for teachers and paraprofessionals, further enhancing her ability to support student growth and development.

Among her most rewarding accomplishments is helping students achieve significant literacy gains. One notable success involved guiding a ninth grade student from a fourth grade reading level to grade level proficiency while fostering a genuine love of reading. Her dedication has helped countless students overcome barriers and develop the skills necessary for academic achievement.

Beyond the classroom, Ms. Neal remains active in volunteer service through tutoring, soup kitchens, Habitat for Humanity International, and church Bible conferences. She is also honored to have been recognized by Marquis Who’s Who Top Educators for her dedication, achievements, and leadership in reading education.

Ms. Neal credits much of her success to the support of her husband, Troy Neal, and the inspiration she draws from her daughter on the autism spectrum. Their experiences have strengthened her commitment to helping students with diverse learning needs reach their full potential.

Looking ahead, she hopes to expand her impact through programs with increased funding and resources that will allow more students to receive the specialized literacy support they need. Guided by a philosophy centered on individualized instruction and student success, Ms. Neal remains dedicated to helping every learner overcome reading obstacles and thrive academically.

Contact: Katherine Green, 516-825-5634, editorialteam@continentalwhoswho.com

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SOURCE The Inner Circle

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