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SEOUL, South Korea, April 30, 2025 /PRNewswire/ -- J INTS BIO, a company specializing in anticancer and orphan drugs, announced its research findings for the next-generation EGFR-TKI therapeutic 'JIN-A02' (clinical Phase 1/2 results) and the ovarian cancer treatment candidate 'JIN-001' (preclinical results) at the American Association for Cancer Research (AACR) 2025, held in Chicago from April 25 to 30. In this presentation, J INTS BIO demonstrated its innovative drug development capabilities on a global stage, attracting significant attention from both academia and the industry. Continue Reading Professor Byoung Chul Cho from Yonsei Cancer Center is presenting a poster at AACR on the phase 1/2 clinical trial of ‘JIN-A02’, a next-generation oral EGFR-TKI. (Photo = J INTS BIO) 'JIN-A02': New Hope for Overcoming Resistance – 4th Generation EGFR-TKI Clinical Results Non-small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases worldwide, and among these, EGFR mutations are considered a major therapeutic target. JIN-A02, introduced at AACR 2025, showed outstanding therapeutic efficacy in patients who developed resistance to existing third-generation EGFR-TKIs. In particular, JIN-A02 demonstrated remarkable antitumor activity in patients with EGFR C797S mutation—currently a mutation for which no approved targeted therapies exist—thus opening a new avenue for treatment options. In the clinical trial, a patient in the 300 mg cohort showed complete clearance of circulating tumor DNA (ctDNA) harboring either the C797S or Ex19del mutation, and ctDNA carrying the T790M mutation was reduced by over 90%. Clinically, a partial response (PR) was observed, with tumor size reductions of up to 39.7%, and notable shrinkage of intracranial metastatic lesions. These findings are particularly important for NSCLC patients, in whom brain metastases are common. Furthermore, no dose-limiting toxicities (DLTs) or serious adverse events were observed up to the 300 mg dose, highlighting the excellent safety profile of JIN-A02. This safety profile is expected to be particularly beneficial for patients requiring long-term treatment and combination therapies. Currently, JIN-A02 is undergoing multinational clinical trials in Korea, the United States, Thailand, and other countries, and it is being closely watched as a potential groundbreaking treatment option for EGFR-mutant NSCLC patients. 'JIN-001': An Innovative New Drug Targeting Refractory Ovarian Cancer Also presented was 'JIN-001,' J INTS BIO's second-generation synthetic HSP90 inhibitor, developed as a new strategy to overcome resistance to existing ovarian cancer treatments. Ovarian cancer remains one of the deadliest gynecological malignancies, as it is often diagnosed at an advanced stage when effective treatment options are extremely limited. The preclinical study demonstrated that JIN-001, when combined with the chemotherapeutic agent cisplatin, significantly enhanced tumor suppression compared to cisplatin alone. Notably, even at low concentrations (≤0.1 μM), JIN-001 enhanced the antitumor activity of cisplatin against both cisplatin-sensitive and cisplatin-resistant ovarian cancer cells, compared to cisplatin alone. Moreover, the combination therapy significantly reduced the expression of key signaling proteins related to cisplatin resistance, contributing to a sustained antitumor effect. Based on these promising results, J INTS BIO is planning additional preclinical studies and aims to rapidly advance JIN-001 into clinical trials, with the goal of establishing a new standard of care for the treatment of refractory and multidrug-resistant ovarian cancer. Led by the presentation at AACR 2025, J INTS BIO aims to further strengthen its competitiveness in the global oncology market and solidify its position as a frontrunner in next-generation anticancer drug development. The company also outlined its vision to continue delivering innovative therapies through ongoing research and development efforts, offering new hope to cancer patients worldwide. SOURCE J INTS BIO WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China, April 24, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (6990.HK) announced that it will present results from six Kelun-led clinical studies at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, held in Chicago from May 30 to June 3. Results include data from its TROP2 antibody-drug conjugate (ADC) sacituzumab tirumotecan (sac-TMT), anti-PD-L1 mAb tagitanlimab, and RET inhibitor KL590586 (A400/EP0031). The abstracts for these studies will be published on the ASCO's official website on May 22, 2025, local time. Detailed information on the studies selected for ASCO 2025 are as follows: Title: Sacituzumab tirumotecan (sac-TMT) in patients (pts) with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC): Results from the randomized OptiTROP-Lung03 study. Presentation Type: Oral Abstract Number: 8507 Session Date and Time: 6/1/2025 8:00 AM-11:00 AM CDT Title: Tagitanlimab versus placebo in combination with gemcitabine and cisplatin as first-line treatment for recurrent or metastatic nasopharyngeal carcinoma (R/M NPC): Results from a randomized, double-blind, phase 3 study. Presentation Type: Oral Abstract Number: 6004 Session Date and Time: 5/31/2025 1:15 PM-4:15 PM CDT Title: Sacituzumab tirumotecan (sac-TMT) as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer (a/m TNBC): Initial results from the Phase II OptiTROP-Breast05 study. Presentation Type: Rapid oral Abstract Number: 1019 Session Date and Time: 5/30/2025 2:45 PM-4:15 PM CDT Title: Sacituzumab tirumotecan (sac-TMT) in combination with tagitanlimab (anti-PD-L1) in first-line (1L) advanced non-small-cell lung cancer (NSCLC): Non-squamous cohort from the phase II OptiTROP-Lung01 study. Presentation Type: Poster Abstract Number: 8529 Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT Title: Sacituzumab Tirumotecan (sac-TMT) in patients (pts) with previously treated locally advanced or metastatic (LA/M) non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutations: Preliminary results from a phase 2 study. Presentation Type: Poster Abstract Number: 8615 Session Date and Time: 5/31/2025 1:30 PM-4:30 PM CDT Title: Results from a phase I study of KL590586 in patients with advanced RET-mutant medullary thyroid cancer. Presentation Type: Poster Abstract Number: 6098 Session Date and Time: 6/2/2025 9:00 AM-12:00 PM CDT 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), breast cancer (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, Macau, 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 TNBC who have received at least two prior systemic therapies (at least one of them for advanced or metastatic setting) and EGFR mutation-positive locally advanced or metastatic non-squamous NSCLC following progression on EGFR-TKI therapy and platinum-based chemotherapy. Sac-TMT became the first domestic ADC with global intellectual property rights to be fully approved for marketing. It is also the world's first TROP2 ADC to be approved for marketing in a lung cancer indication. In addition, the NDA 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 National Medical Products Administration (NMPA), and was included in the priority review and approval process. As of today, Kelun-Biotech has initiated 8 registrational clinical studies in China. MSD has initiated 12 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 Tagitanlimab Tagitanlimab is the first PD-L1 monoclonal antibody (mAb) globally to receive authorization for the first-line treatment of NPC. Previously, the National Medical Products Administration (NMPA) has approved the marketing in China of tagitanlimab used in combination with cisplatin and gemcitabine for the first-line treatment of patients with R/M NPC and monotherapy for the treatment of patients with recurrent or metastatic NPC who have failed after prior 2L+ chemotherapy, respectively. About KL590586 ( A400/EP0031) A400, a novel next-generation selective RET inhibitor for NSCLC, MTC and other solid tumors with a high prevalence of RET alterations. We are currently conducting pivotal clinical study for both 1L and 2L+ advanced RET+ NSCLC as well as a phase 1b/2 clinical study for RET+ MTC and solid tumor in China. In March 2021, we granted Ellipses Pharma, a U.K.-based international oncology drug development company, an exclusive license to develop, manufacture and commercialize this agent outside Greater China and certain Asian countries under the code EP0031. In March 2024, it was announced that EP0031/A400 was granted Fast Track designation by the FDA for the treatment of RET-fusion positive NSCLC. In April 2024, EP0031/A400 was cleared by the FDA to progress into Phase 2 clinical development and is now open in the US, UK, EU and UAE. 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 . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. 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