JAB-8263

BEIJING, SHANGHAI and BOSTON, March 19, 2025 /PRNewswire/ -- Jacobio Pharma (1167.HK) released its 2024 annual results, with revenue of RMB160 million, R&D expense of RMB330 million. Major operating and financing activities generated RMB320 million cash inflows. By the end of 2024, cash and bank balances and bank credit balances amounted to RMB1.45 billion. Jacobio also announced recent business progress and expected milestones. "2024 is a transforatmive year for Jacobio. We have submitted a New Drug Application (NDA) for the KRAS G12C inhibitor glecirasib and have licensed out the China rights of glecirasib and the SHP2 inhibitor sitneprotafib to our partner. This marks Jacobio's successful transformation from the early R&D stage to an innovation-driven value realization stage," said Dr.Yinxiang Wang, the Chairman and CEO of Jacobio Pharma. "Looking ahead to 2025, glecirasib is expected to receive the official approval for marking, which will continuously generate cash flow to invest in Jacobio' subsequent pipeline." Development of core clinical stage products Glecirasib (JAB-21822, KRAS G12C inhibitor) and sitneprotafib (JAB-3312, SHP2 inhibitor) The commercialization and further clinical development in China of glecirasib and sitneprotafib were licensed to Allist on August 30, 2024. Non-small cell lung cancer (NSCLC) The NDA application of glecirasib monotherapy in second-line and above NSCLC was submitted to the CDE (China Drug Evaluation Center) in May 2024 and the priority review designation was granted in the same month. Glecirasib is expected to be approved in the first half of 2025. The Phase III pivotal trial of glecirasib combined with sitneprotafib in front-line NSCLC enrolled the first patient in China on August 7, 2024. Multi-tumor basket The multi-tumor basket registration phase II trial of glecirasib for the treatment of pancreatic cancer, biliary tract cancer, gastric cancer, small bowel cancer, appendiceal cancer and other indications has been initiated in China. Glecirasib has received orphan drug designation (ODD) from FDA and EMA for pancreatic cancer. Colorectal cancer The Phase III trial of glecirasib mono or in combination with cetuximab in third line was approved by the CDE in May 2024 JAB-23E73 (pan-KRAS inhibitor) The IND (Investigational New Drug) applications were approved in China and the United States in September 2024 The first patient was enrolled in November 2024 The dose escalation phase is expected to be completed in the second half of 2025 JAB-30355 (p53 Y220C activator) The IND application of FIH (first-in-human) global trial of JAB-30355 was approved by the FDA in March 2024 and by the CDE in June 2024. The first patient was enrolled in July 2024 The dose escalation is expected to be completed in the second half of 2025 JAB-8263 (BET inhibitor) The dose escalation for JAB-8263 in solid tumors and hematologic malignancy were completed in the U.S. and China, respectively. The RP2D (phase II recommended doses) was obtained. Dose expansion in patients with myelofibrosis is ongoing. Solid tumor portion with specific biomarkers is being explored. . JAB-2485 (Aurora A inhibitor) A Phase I/IIa global trial of JAB-2485 is ongoing in the U.S. and China. Dose escalation phase is expected to be completed in the first half of 2025 The expansion of monotherapy and combination with chemotherapy are being planned. Development of pre-clinical pipelines JAB-BX467 (HER2-STING iADC) Clinical candidate of HER2-STING iADC has been nominated in the second half of 2024. The IND application is being planned to be submitted in 2026. JAB-BX600 (KRAS G12D ADC) The clinical candidate is expected to be nominated in the second half of 2025. As of December 31, 2024, Jacobio has filed more than 360 patent applications worldwide, including 126 authorized patents. Conference call information Jacobio Pharma will hold a conference call at 9:30 AM (Beijing time) on March 20, 2024. Participants, please register in advance through this link: About Jacobio Pharma Jacobio Pharma (1167.HK) is committed to providing breakthrough treatments for patients. With an induced allosteric drug discovery platform, the company's core projects focus on the KRAS pathway. The company envisions becoming a global leader in research and development, fostering strategic partnerships to drive innovation. Jacobio's R&D centers are located in Beijing, Shanghai (China), and Boston (USA). Clinical trials are conducted at over 180 sites in China, more than 30 sites in the USA, and over 10 sites across several European countries. For more information, please visit: SOURCE Jacobio Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BEIJING, SHANGHAI and BOSTON, Dec. 8, 2024 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company dedicated to developing therapies toward undruggable targets, today presented preliminary Phase I data of BET inhibitor JAB-8263 to treat myelofibrosis (MF) at the 2024 ASH (American Society of Hematology) Annual Meeting in San Diego, California. The data showed that JAB-8263 was well tolerated with Recommended Phase 2 Dose (RP2D) being 0.3mg QD. The preliminary efficacy data for JAB-8263 monotherapy in MF are promising, as most patients demonstrated spleen volume reduction (SVR) and total symptom score (TSS) reduction. As of the data cutoff date of Oct 17, 2024, 16 patients with intermediate-/high-risk MF have been enrolled, and 13 patients have undergone at least one post-treatment efficacy assessment. All patients showed a mean SVR-19.95%at week 24 and -26.16% at best response. Two patients achieved ≥35% SVR, and an SVR of -34.9% was observed in one patient. Six of ten (60%) patients experienced a ≥50% reduction in TSS at week 24. The best response of SVR in 2 of 8 patients (JAK inhibitors-treated) was -41.2% and -34.9%, respectively. At week 24, 3 of 6 (50%) patients (JAK inhibitors-treated) achieved TSS50. The monotherapy of JAB-8263 expansion in MF and solid tumor is ongoing. Andrea Wang-Gillam M.D., Ph.D., Chief Medical Officer and Global Head of R&D at Jacobio said, "The preliminary data demonstrated the promising clinical value of our potent BET inhibitor in MF. We will continue exploring for broader indications for JAB-8263, hoping to bring hope to more cancer patients." About Jacobio Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions. Our pipeline revolves around novel molecular targets on six major signaling pathways: KRAS, immune checkpoints, tumor metabolism, P53, RB and MYC. We aim for our key projects to be among the top three in the world. Our vision is to become a global leader recognized for our impact in drug R&D together with our partners. Jacobio has R&D centers in Beijing, Shanghai and Boston with our Induced Allosteric Drug Discovery Platform (IADDP) and our iADC Platform. SOURCE Jacobio Pharma WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED