Tislelizumab

TAIPEI and SAN DIEGO, Dec. 10, 2025 /PRNewswire/ -- Senhwa Biosciences, Inc. (TPEx: 6492), a clinical-stage biopharmaceutical company developing first-in-class therapies for difficult-to-treat cancers, today announced a clinical supply agreement with BeOne Medicines, a global oncology company. This agreement will supply a global, multi-center Phase 1b/2a clinical trial to evaluate Senhwa's lead compound Pidnarulex (CX-5461) in combination with BeOne's tislelizumab, a PD-1 inhibitor, in patients with advanced solid tumors, including pancreatic ductal adenocarcinoma (PDAC) and immune checkpoint inhibitor (ICI)-refractory melanoma. This agreement represents a significant milestone for Senhwa as CX-5461 enters the immuno-oncology field, and it also underscores the company's commitment to advancing strategic combination therapies that break through the limitations of immunotherapy —bringing new hope to cancer patients worldwide. Senhwa Biosciences: Driving a New Era in Immuno-Oncology "This agreement represents a major step forward for Senhwa as we expand into the heart of immuno-oncology," said Benny T. Hu, Chairman of Senhwa Biosciences. "By leveraging the unique mechanism of action of CX-5461 in modulating the tumor microenvironment, we hope to discover and confirm new treatment options for patients who do not currently benefit from existing treatment options, while increasing international recognition and building long-term strategic value for the company," added by Chairman Hu. Under the terms of the agreement, BeOne Medicines will provide tislelizumab for the combination study, while Senhwa will supply CX-5461 and lead clinical and regulatory operations. The study will enroll patients at multiple sites in the United States and Taiwan, assessing safety, tolerability, and preliminary efficacy of the CX-5461 plus tislelizumab combination. By modulating the tumor microenvironment, CX-5461 breaks through the barriers of immunotherapy, opening new possibilities for cancer treatment Discovered and developed by Senhwa, CX-5461 is the world's first G-quadruplex stabilizer with significant clinical data—a novel therapeutic class designed to selectively disrupt genomic stability in tumor cells through replication stress induction. Recent preclinical and clinical findings suggest that CX-5461 not only exerts direct cytotoxic activity but also modulates the tumor microenvironment, enhancing immune recognition and response. By converting immunologically "cold" tumors into "hot" ones, CX-5461 may sensitize previously resistant tumors to checkpoint blockade and broaden the clinical utility of immunotherapy. The "cold-to-hot" tumor concept represents one of the most promising frontiers in cancer immunology. CX-5461's differentiated mechanism positions Senhwa to play a leading role in improving the efficacy of the immune checkpoint inhibitors approved by FDA with only 20-30% response rates. Global Immunotherapy Market: Expanding Horizons According to Precedence Research, the global cancer immunotherapy market is expected to grow from USD 136.4 billion in 2025 to USD 338.4 billion by 2034, representing a compound annual growth rate (CAGR) of 10.65%. Similarly, Grand View Research projects that the broader immunotherapy market will exceed USD 486 billion by 2030. As major pharmaceutical companies approach a looming patent cliff—most notably with the immune checkpoint inhibitor blockbuster KEYTRUDA®, which is expected to lose its exclusivity in 2028—the industry is ramping up efforts to secure next-generation immuno-oncology assets through strategic partnerships, mergers, and acquisitions. With its differentiated pipeline, established collaboration with the U.S. National Cancer Institute (NCI), and now entering the supply agreement with BeOne Medicines, Senhwa Biosciences is uniquely positioned at the intersection of scientific innovation and global capital markets. The company aims to play a pivotal role in the next wave of expansion and innovation in precision medicine and immuno-oncology by partnering with global pharmaceutical companies and to drive sustainable growth and long-term value creation for its stakeholders. About Senhwa Biosciences, Inc. Senhwa Biosciences, Inc. (TPEx: 6492) is a Taiwan-based clinical-stage biopharmaceutical company focused on developing novel therapeutics in oncology and rare diseases. The company's lead asset, CX-5461 (Pidnarulex), is a first-in-class G-quadruplex stabilizer currently in clinical development across North America and Asia. Senhwa is committed to translating scientific innovation into transformative therapies that improve treatment outcomes for the patients worldwide. Website: SOURCE Senhwa Biosciences, Inc. 21% more press release views with Request a Demo

HONG KONG, Dec. 8, 2025 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced that at the 2025 ESMO Asia Congress, updated results from the pivotal Phase III HARMONi-6 study (AK112-306) were shared in an oral presentation by Professor Shun Lu from Shanghai Chest Hospital. The study evaluates ivonescimab (a first-in-class PD-1/VEGF bispecific antibody) combined with chemotherapy versus tislelizumab combined with chemotherapy in first-line treatment for advanced squamous non-small cell lung cancer (sq-NSCLC). Beyond the previously reported efficacy data presented at the ESMO 2025 Presidential Symposium and simultaneously published in The Lancet, this presentation further disclosed patient-reported quality of life outcomes based on the EORTC QLQ-C30 questionnaire. Both prolonging survival and improving quality of life are core indicators for evaluating cancer treatments. The results published at 2025 ESMO Asia demonstrate that, compared to the tislelizumab-based regimen, treatment with ivonescimab plus chemotherapy not only significantly prolongs progression-free survival (PFS) but also offers better tolerability, enables higher treatment adherence, and provides patients to maintain better overall health status and quality of life over a longer period. These findings highlight the comprehensive clinical value of the ivonescimab regimen in delivering both survival and quality-of-life benefits for patients. Quality of life (QoL) assessments from the HARMONi-6 study show that, compared with PD-1 inhibitor plus chemotherapy, ivonescimab plus chemotherapy not only significantly prolongs progression-free survival (PFS) but also helps patients maintain better overall health status. Time to deterioration in "Global Health Status/Quality of Life" was meaningfully delayed in the ivonescimab arm (HR = 0.94), indicating a trend toward reduced risk of QoL worsening versus the control group. The ivonescimab-based regimen met the primary PFS endpoint versus the tislelizumab-based regimen, delivering a decisive, strongly positive outcome with both statistical significance and clear clinical benefit. PFS was substantially prolonged with ivonescimab plus chemotherapy compared with tislelizumab plus chemotherapy. The hazard ratio for PFS between the ivonescimab and tislelizumab arms was 0.60 (P < 0.0001), corresponding to an absolute PFS improvement (ΔPFS) of 4.24 months (11.14 months vs. 6.90 months). This benefit was consistent across all PD-L1 expression subgroups. The HARMONi-6 study enrolled 532 patients with well-balanced baseline characteristics. Among these patients, 92.3% had stage IV disease at enrollment. The squamous histology profile of the patients reflected real-world patterns, with approximately 63% of patients exhibiting the central squamous subtype (66.9% in the ivonescimab arm vs. 59.4% in the control arm). PD-L1 expression levels were also aligned with clinical expectations. The results from the HARMONi-6 study further validate the breakthrough clinical value of the ivonescimab-plus-chemotherapy regimen compared to PD-1-plus chemotherapy regimen. The ivonescimab-plus chemotherapy regimen addresses a critical clinical gap when anti-angiogenic agents such as bevacizumab demonstrated severe safety considerations in the treatment of sq-NSCLC. Since ivonescimab's initial approval in 2024, it has been evaluated in multiple clinical studies and used in real-world settings involving over 40,000 patients, where its transformative clinical benefits have been consistently demonstrated. Across the immuno-oncology landscape, ivonescimab has shown clinical superiority to both PD-1 based treatments, which are currently the optimal standard of care for many cancers, and to also VEGF-targeted therapies in anti-angiogenesis based treatments. In July 2025, based on the HARMONi-6 study results, the supplemental New Drug Application (sNDA) for ivonescimab in combination with chemotherapy as first-line treatment for sq-NSCLC was accepted for review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA). Akeso's partner, Summit Therapeutics, is currently carrying out a global multicenter Phase III HARMONi-3 study, evaluating ivonescimab plus chemotherapy versus pembrolizumab plus chemotherapy as first-line therapy for advanced NSCLC (both squamous and non-squamous subtypes). Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 26 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. 21% more press release views with Request a Demo