JAB-8263

BEIJING, SHANGHAI and BOSTON, March 28, 2024 Jacobio/PRNewswire/ -- Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, today announced its 2023 annual results. The revenue was RMB63.5 million, the R&D investment was RMB372 million, the cash and cash equivalent at the end of 2023 was RMB 1.2 billion. Jacobio Pharma also announced its recent business progress and expected milestones. Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma, said: "In the past year, Jacobio continued to make progress in our projects. We received approval for registrational phase III clinical trial of the combination therapy between our SHP2 inhibitor JAB-3312 and KRAS G12C inhibitor glecirasib. Our JAB-3312 became the first SHP2 inhibitor to enter into registrational trial. This milestone is consistent with our mission of 'drugging the undruggable'. Meanwhile, the patient enrollment for pivotal trial of our core product glecirasib has been completed, and the NDA application expected to be submitted in the first half of 2024. This marks that Jacobio will enter into the commercial stage." Development of core clinical stage products KRAS G12C inhibitor Glecirasib (JAB-21822) Non-small cell lung cancer (NSCLC) The patient enrollment for pivotal trial of glecirasib monotherapy in ≥2L NSCLC patients harboring KRAS G12C mutation was completed. The NDA application is expected to be submitted to CDE (Center for drug evaluation, NMPA) in Q2 2024 as planned. 1L NSCLC is in combination with SHP2 inhibitor JAB-3312. The phase III registrational trial was approved by CDE. Pancreatic cancer (PDAC) The pivotal trial of glecirasib monotherapy in ≥2L PDAC patients was activated in China. The results were presented at the 2024 American Society of Clinical Oncology (ASCO) GI Annual Meeting. The cORR was 41.9% (13/31) and the DCR was 93.5% (29/31). The median progression-free survival (mPFS) was 5.6 months. Colorectal cancer (CRC) The clinical results of glecirasib monotherapy and glecirasib combined with cetuximab in advanced colorectal cancer were presented at the Second JCA- AACR Precision Medicine International Conference. Phase III pivotal trial design of glecirasib monotherapy or glecirasib in combination with cetuximab is expected to be approved by CDE in Q2 2024. Multi-tumors basket Multi-tumors basket includes biliary tract cancer, gastric cancer, small bowel cancer, appendices cancer, etc. The results were presented at the 2024 American Society of Clinical Oncology (ASCO) GI Annual Meeting. The cORR was 57.9%（11/19), DCR was 84.2%（16/19), mPFS was 7.0 months. A phase II single arm pivotal trial is under communication with CDE. SHP2 inhibitor JAB-3312 The Phase III pivotal trial of JAB-3312 in combination with glecirasib to treat 1L NSCLC patients has been approved by CDE, and this study in China is expected to initiated in Q3 2024. JAB-3312 is the very first SHP2 inhibitor entering a phase III registrational trial worldwide. The clinical data of glecirasib in combination with JAB-3312 was published at the 2023 European Society for Medical Oncology Congress (ESMO 2023). Glecirasib (800mg once daily) + JAB-3312 2mg (once daily for 1 week on, then 1 week off) dosage yielded ORR of 86.7% (13/15) and DCR of 100% (15/15). Long term safety and efficacy data have submitted to the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Development of other clinical products P53 Y220C activator JAB-30355: The IND has been approved by U.S. FDA (Food and Drug Administration), and phase I clinical trial is expected to be initiated in the second half of 2024. Preclinical data will be presented at the AACR Annual Meeting 2024. BET inhibitor JAB-8263: A Phase II trial of JAB-8263 monotherapy or combination therapies is planned to be initiated in the second half of 2024. Clinical data will be published at the 2024 European Hematology Association (EHA) Congress. Aurora A inhibitor JAB-2485: RP2D is anticipated to be determined in Q2 2024. The preclinical study of JAB-2485 was presented at the 2023 AACR. Anti-CD73 humanized monoclonal antibody JAB-BX102: RP2D is anticipated to be determined in Q2 2024. The preclinical study of JAB-2485 was presented at the 2023 AACR. PARP7 inhibitor JAB-26766: Preclinical data will be presented at the AACR Annual Meeting 2024. We are optimizing the clinical development strategy for PARP7 inhibitor JAB-26766, GUE (glutamine-utilizing enzyme) inhibitor JAB-24114, and LIF mAb JAB-BX300 considering the current treatment landscape and our resources available. Development of other pre-clinical products KRASmulti inhibitor JAB-23E73: The IND application is expected to be submitted in Q2 2024. Clinical candidate for HER2-STING iADC JAB-BX400 is expected to be nominated in the second half of 2024. As of December 31, 2023, Jacobio owned 340 patents or patent applications that are filed globally, of which 82 patents have been issued or allowed in major markets globally. During the performance period, Jacobio raised HKD159 million through public placing, and obtained RMB150 million from Beijing E-town Capital. As of December 31, 2023, Jacobio has RMB 1.2 billion cash and cash equivalent, providing sufficient cash reserves for R&D investment in the next 30-36 months. Jacobio repurchased and canceled 1.807 million shares, continuing to increase shareholder value. Conference Call Information Jacobio Pharma will hold a live conference call at 10:30 AM March 29 2024 Beijing time. Participants please register in advance through . About Jacobio Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions to improve people's health. 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

BEIJING, SHANGHAI and BOSTON, Aug. 30, 2023 /PRNewswire/ -- Jacobio Pharma (1167.HK), a clinical-stage oncology company focusing on undruggable targets, announced its 2023 interim results. During the period, the company recorded revenue of RMB 40.3 million even as it continued to accelerate multiple R&D projects. R&D investment increased by 5.5% to RMB 230 million. "Jacobio has been continuously developing drugs for undruggable targets since its founding. We have developed more than 10 projects generated by our Induced Allosteric Drug Discovery Platform (IADDP) and iADC Platform. During the first half year of 2023, we remain committed to exploring the full potential of glecirasib and are pleased with the development program, expanding the pivotal trial from non-small cell lung cancer to pancreatic cancer, " said Dr. Wang Yinxiang, Chairman and CEO of Jacobio Pharma. "Following two rounds fundraising, we are well positioned to advance our pipeline." Development of core clinical stage products KRAS G12C inhibitor glecirasib (JAB-21822) - Non-small cell lung cancer (NSCLC): The pivotal trial has been initiated in more than 60 hospitals in China. Enrollment is expected to be completed in September 2023. The pre-NDA application will be submitted by the end of 2023 and an NDA is expected to be submitted in the first half of 2024. - Pancreatic cancer: Glecirasib has been granted Breakthrough Designation (BTD) for second-line or above pancreatic cancer patients with the KRAS G12C mutation. The pivotal trial has been approved in China. This is the first approved global pivotal trial for pancreatic cancer with the KRAS G12C mutation. The pivotal site is expected to be activated in September 2023. - Colorectal Cancer: The clinical results of glecirasib in combination with cetuximab to treat KRAS G12C mutant advanced CRC was released at the JCA- AACR Precision Medicine International Conference. The ORR is 62.8% (27/43) and DCR is 93% (40/43). The pivotal trial of this combination therapy is currently being discussed with the Centre for Drug Evaluation (CDE). SHP2 inhibitors: JAB-3312 - In combination with KRAS G12C inhibitor: JAB-3312 is currently enrolled in the Phase I/IIa clinical trial with glecirasib in China, with over 100 patients enrolled. The Phase IIa dose expansion trial of JAB-3312 in combination with sotorasib is ongoing in Europe and the U.S. The preliminary clinical results will be presented in the form of a Proffered Paper presentation at the 2023 European Society for Medical Oncology (ESMO) Congress in October 2023. - In combination with other products: JAB-3312 is currently being used in combination with drugs such as osimertinib and PD-1 monoclonal antibody. Efficacy signals have been observed in specific tumor types. - Monotherapies: JAB-3312 is a highly active second-generation SHP2 inhibitor, and the monotherapy phase I/IIa trial has been completed. Development of other clinical stage products - JAB-8263 (BET inhibitor): A Phase I trial in solid tumors and hematological malignancies is ongoing in the U.S. and China simultaneously. Efficacy signals in hematological tumors have been observed. The recommended phase II dose (RP2D) is expected to be determined in the second half of 2023. - JAB-2485 (Aurora A inhibitor): Preclinical data was released at the annual meeting of the American Association for Cancer Research (AACR) in April 2023. Phase I/IIa clinical trials are ongoing in the U.S. and China, and efficacy signals have been observed in the first dose group. - JAB-BX102 (CD73 mAb): The Phase I/IIa dose expansion trial is ongoing and it is expected to receive the RP2D in the first half of 2024. In March 2023, Jacobio entered into a clinical collaboration with Merck (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of Jacobio's CD73 mAb JAB-BX102 with Merck's anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). - JAB-26766 (PAPR7 inhibitor): A Phase I/IIa clinical trial was approved in China in June 2023, and it is currently being planned. - JAB-24114 (GUE inhibitor): China's CDE approved the IND application in March 2023. - JAB-BX300 (LIF mAb): China's CDE approved the IND application in April 2023. Development of pre-clinical stage products - JAB-23400 (KRASmulti inhibitor): Preclinical data was released at the annual meeting of the AACR in April 2023. The IND application is expected to be submitted in the first half of 2024. - JAB-30300 (P53 Y220C corrector): JAB-30300 is an orally bioavailable small molecule activator for the treatment of patients with locally advanced or metastatic solid tumors harboring the P53 Y220C mutation. An IND application will be submitted in the second half of 2023. - iADC projects: Relying on the iADC platform, Jacobio has developed JAB-BX400 (HER2 STING iADC) and JAB-X1800 (CD73 STING iADC). Preclinical studies have shown that JAB-BX400 is effective against DS8201 resistant tumor models, and the IND application will be submitted in 2024-2025. While accelerating the progress of R&D projects, Jacobio completed two rounds of financing during the period to maintain sufficient cash reserves to support R&D and company operations. As of June 30, 2023, Jacobio has RMB 1.3 billion in cash and cash equivalents. Conference Call Information Jacobio Pharma will hold a live conference call at 9:00 AM August 31 2023 Beijing time. Participants, please register in advance through About Jacobio Jacobio Pharma (1167.HK) is committed to developing and providing new and innovative products and solutions to improve people's health. 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