Connect with us

Technology

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

Published

2 years ago

on

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.

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/global-registrational-phase-iii-study-of-olverembatinib-for-the-treatment-of-patients-with-sdh-deficient-gist-approved-by-the-china-cde-302168859.html

SOURCE Ascentage Pharma

Related Topics:
Continue Reading
Click to comment

Leave a Reply

Your email address will not be published. Required fields are marked *

Technology

TiTE x IHT 2026: The Definitive Hub for Taiwan’s Hardware Manufacturing Excellence

Published

2 hours ago

on

May 6, 2026

By

TAICHUNG, May 6, 2026 /PRNewswire/ — When sourcing from Taiwan, location is the ultimate strategic advantage. Don’t be misled by smaller, general trade shows held in city centers like Taipei. To truly connect with the source, you must go where the products are born. TiTE x IHT (Oct 20-22, 2026) in Taichung is the undisputed largest and most vital hardware industrial expo on the island. Hosted directly in the heart of Taiwan’s precision manufacturing cluster, this event features 1,000+ booths and 500+ top-tier manufacturers, offering a scale and industrial depth that no other exhibition can replicate.

Why Global Buyers Choose the Taichung Source Over Urban Trade Shows:

The Revolutionary “Exhibition as Factory” Model: Taichung is the global epicenter for hardware, home to 70% of Taiwan’s industry output. Our unique location enables the “30-Minute Sourcing Circle.” This allows you to verify high-end samples on the show floor in the morning and audit world-class production lines by the afternoon. By eliminating the travel gap between the booth and the factory, we reduce traditional procurement cycles from weeks to hours, providing unmatched transparency for R&D, capacity assessment, and quality control.ESG & CBAM Compliance for Western Markets: As the EU’s Carbon Border Adjustment Mechanism (CBAM) and global ESG mandates reshape trade, our exhibitors are already ahead of the curve. Discover CBAM-ready solutions and green manufacturing processes specifically designed to meet the strict sustainability requirements of the European and American markets. We provide more than just tools; we provide carbon-footprint-managed resilience for your brand.AI-Driven Smart Manufacturing: Address global labor shortages and rising costs with Taiwan’s latest innovations. The 2026 expo focuses on “AI Empowerment,” showcasing collaborative robotics, automated digital inspection, and data-driven supply chain management. These technologies ensure lead-time stability and high-precision consistency for premium global brand owners.Direct Sourcing & Global Matchmaking: Skip the middlemen and trading agencies. Our “Global Buyer Day” offers exclusive, pre-arranged matchmaking with the actual OEMs/ODMs. This is the primary decision-making platform for major distributors seeking resilient, direct-to-factory partnerships that guarantee the best pricing and priority production slots.

Experience the synergy of smart manufacturing and global trade. Stop at the source—where the world’s hardware is actually built. Secure your competitive edge in the true heart of the industry.

【TiTE x IHT】

Date: October 20-22, 2026Venue: TICEC, Taichung, TaiwanRegister Now: https://accu.ps/g8MZ1SHousing Subsidy: https://forms.gle/34VHVxSrEw7g8GxDAOfficial Website: https://www.hardwareexpotw.com

View original content to download multimedia:https://www.prnewswire.com/news-releases/tite-x-iht-2026-the-definitive-hub-for-taiwans-hardware-manufacturing-excellence-302763625.html

SOURCE TiTE x IHT

Continue Reading

Technology

KIST Accelerates U.S. Expansion of Quantum Deep-Tech Startups Through SelectUSA 2026

Published

2 hours ago

on

May 6, 2026

By

SEOUL, South Korea, May 5, 2026 /PRNewswire/ — The Korea Institute of Science and Technology (KIST) President Oh Sang-rok announced that it will participate in the SelectUSA Investment Summit 2026 as part of a Korean delegation, together with quantum technology startups supported by the Ministry of SMEs and Startups under the Deeptech Project (DIPS).

The initiative, supported by South Korea’s Ministry of SMEs and Startups (MSS), is part of the government’s “Deeptech Incubator Project for Startups” (DIPS) initiative, which aims to nurture globally competitive deep-tech ventures.

KIST, which serves as the lead institution for the quantum technology sector under the program, said it will oversee the global commercialization efforts of participating firms. In particular, the “Global Bridge Program,” jointly developed with the U.S. Embassy in Korea in September 2025, is an official program designed to generate tangible overseas expansion outcomes by linking investment attraction with local market entry through diplomatic channels.

Organized by the U.S. Department of Commerce, the SelectUSA Investment Summit is the largest investment promotion event in the US, connecting international startups with venture capital firms, corporate investors and state-level economic development agencies.

It serves as an execution-oriented platform that extends to investment, corporate establishment, site selection, and tax incentives, and is considered a key entry gateway for deep-tech companies, including those in quantum technology.

KIST said participation in the summit is particularly significant for deep-tech sectors such as quantum technology, where access to the US innovation ecosystem is seen as key to growth.

The program is conducted in two stages. From April 30 to May 1, companies took part in a spin-off program hosted by the State of Maryland, which included visits to research institutions and tours of the regional quantum technology ecosystem.

During this period, the delegation also conducted localized activities with the Maryland state government and its economic development agencies, focusing on investment attraction, corporate collaboration, and joint R&D. In addition, on May 5, the delegation held discussions with U.S. Department of Commerce Deputy Secretary William Kimmitt on potential areas of cooperation.

The delegation will also meet officials from Fairfax County Government to explore collaboration and investment opportunities.

The main summit, currently ongoing from May 3 to May 6, features exhibitions, pitching sessions and meetings with US state representatives, with participating firms expected to engage in discussions on investment and market entry.

The delegation is structured to encompass the entire quantum industry rather than a single technology domain.

The Korean delegation comprises five startups, alongside Kyung Hee University Department of Future Science & Technology Commercialization Policy and Entrepreneurship, with approximately 20 participants forming an integrated ecosystem that combines research institutes, academia, and startups, enabling a full-cycle support system from technology validation to commercialization and global expansion.

One of the firms, OptiQ-Labs, was selected for an official pitching session on May 4, where it presented its laser-based optical modules designed for ion-trap quantum computing systems.

This highly competitive program selects only around 100 companies from more than 20,000 applicants worldwide. If selected as the winner of the pitching session, the company will receive follow-up meetings with U.S. state governments and economic development agencies, access to global investor networks, support for local entity establishment, and connections to site selection and tax incentive programs.

Other participating companies include QUAD, which develops single-photon detection technology; SLEEX, focused on underwater sensing; Elixir (StatUp AI), which works on quantum-classical hybrid algorithms for healthcare; and SQK (QMEDIC), specializing in physics-based imaging solutions.

KIST Project Director, Kang Sunjoon, said, “This program represents a critical milestone for Korean quantum startups to directly connect with global investors and industry ecosystems. Via the DIPS program, we are actively promoting the global commercialization of quantum technologies.”

Through its participation in SelectUSA, KIST has established a package-type global expansion model that integrates technology validation, investment attraction, and U.S. market entry.

The summit serves as a turning point for South Korea’s quantum sector, enabling startups to move into the next phase of validation, investment, and overseas expansion.

For more information, visit https://eng.kist.re.kr/.

About KIST 

KIST was established in 1966 as the first government-funded research institute in South Korea. KIST now strives to solve national and social challenges and secure growth engines through leading and innovative research.

About Participating Quantum Startups

QUAD, led by Chief Executive Officer, Oh Byung-doo, develops quantum sensing technologies based on superconducting nanowire single-photon detectors (SNSPDs), offering high sensitivity and precision with applications spanning quantum communication, quantum computing, semiconductor inspection, and defense.

SLEEX is developing an advanced perception technology that combines quantum LiDAR and electric field sensing to overcome limitations of existing underwater sensors, particularly by eliminating blind zones within the 0–2 meter range, with strong potential in autonomous navigation, maritime security, and defense, with Lee Jeho at the helm as Chief Executive Officer.  (https://www.thesleex.com)

Elixir, headed by Chief Executive Officer Jang Jung-kwon, develops a drug discovery and biomarker analysis platform based on quantum-classical hybrid algorithms, targeting the precision medicine market through the integration of bioinformatics and quantum machine learning. (statupai.com)

SQK develops medical imaging AI based on quantum-physics constraints, addressing the hallucination issues of conventional AI by ensuring physical consistency in CT and MRI reconstruction. Under the leadership of Chief Executive Officer Kim Yoon-hak, SQK is improving reliability and reducing the need for re-scans in clinical settings. (www.sqkcloud.com)

View original content to download multimedia:https://www.prnewswire.com/news-releases/kist-accelerates-us-expansion-of-quantum-deep-tech-startups-through-selectusa-2026-302763636.html

SOURCE The Korea Institute of Science and Technology (KIST)

Continue Reading

Technology

Former Visa Asia Pacific Executive David Tay Joins YeahPay as Global Vice President

Published

2 hours ago

on

May 6, 2026

By

SINGAPORE, May 6, 2026 /PRNewswire/ — YeahPay, the international payment brand under YEAHKA (9923.HK), has appointed David Tay, a former senior executive at Visa Asia Pacific, as Global Vice President, tasking him with overseeing the strategic direction and product ecosystem development of YEAHKA’s overseas payment business. The appointment comes as global digital trade enters a new phase defined by ecosystem integration, with payment infrastructure undergoing a generational shift in acceleration.

David Tay, a Singaporean national, is a rising leader in the payments industry. During his career at Visa, David played a key role in driving business growth across multiple Southeast Asian markets, demonstrating early promise in commercial insight and innovation. He subsequently moved into Visa’s Innovation division, where he rose to serve as Head of Innovation, leading Visa Pacific’s product innovation and new business.

In that capacity, David led the commercialization of cutting-edge payment paradigms including Visa Flex Credential and Pay by Palm. He was also involved in the evaluation and governance of strategic partners across the region, accumulating deep expertise in collaborating with banks, fintechs, and large-scale enterprise merchants.

David’s track record spans the full go-to-market lifecycle, from concept to pilot to scale, as well as deep capabilities in cross-institutional partnerships and ecosystem development. His appointment comes at an inflection point for YEAHKA’s international expansion. According to YEAHKA’s 2025 annual report, its overseas business delivered full-year Gross Payment Volume (GPV) surpassing RMB 5 billion, representing a 323.3% year-on-year surge from RMB 1.1 billion in 2024.

View original content:https://www.prnewswire.com/apac/news-releases/former-visa-asia-pacific-executive-david-tay-joins-yeahpay-as-global-vice-president-302763652.html

SOURCE Yeahka

Continue Reading

Trending