공시 • Mar 11
Jacobio Pharmaceuticals Group Co., Ltd., Annual General Meeting, Jun 05, 2026 Jacobio Pharmaceuticals Group Co., Ltd., Annual General Meeting, Jun 05, 2026. 공시 • Feb 26
Jacobio Pharmaceuticals Group Co., Ltd. to Report Fiscal Year 2025 Results on Mar 10, 2026 Jacobio Pharmaceuticals Group Co., Ltd. announced that they will report fiscal year 2025 results on Mar 10, 2026 공시 • Oct 24
Jacobio Pharma Presents Pre-Clinical Data of Pan-KRAS Inhibitor (JAB-23E73) at AACR-NCI-EORTC International Conference Jacobio Pharma announced that it presented the pre-clinical data of its internally discovered pan-KRAS inhibitor JAB-23E73 in a poster presentation at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics. The pre-clinical results demonstrated that JAB-23E73 is a highly potent pan-KRAS (ON/OFF) inhibitor with strong selectivity that spares HRAS and NRAS inhibition. The compound exhibits superior antitumor activity across multiple cancer types harboring different KRAS driver mutations or amplification. In KRAS-driven mouse tumor models, JAB-23E73 induced tumor regression without causing significant body weight loss, indicating good tolerability and a wide therapeutic window. The compound also showed a favorable pharmacokinetic profile for oral administration and exhibited plasma drug concentration-dependent intratumoral p-ERK inhibition. Phase I clinical trials of JAB-23E73 are currently ongoing in both China and the United States for patients with advanced solid tumors harboring KRAS gene alterations. 공시 • Aug 19
Jacobio Pharmaceuticals Group Co., Ltd. to Report First Half, 2025 Results on Aug 29, 2025 Jacobio Pharmaceuticals Group Co., Ltd. announced that they will report first half, 2025 results on Aug 29, 2025 공시 • Jul 15
Jacobio Pharmaceuticals Group Co., Ltd. (SEHK:1167) commences an Equity Buyback for 78,873,528 shares, representing 10% of its issued share capital, under the authorization approved on June 10, 2025. Jacobio Pharmaceuticals Group Co., Ltd. (SEHK:1167) commences share repurchases on July 15, 2025, under the program mandated by the shareholders in the Annual General Meeting held on June 10, 2025. As per the mandate, the company is authorized to repurchase up to 78,873,528 shares, representing 10% of its issued share capital. The repurchases will lead to an enhancement of the net asset value per share and/or earnings per share for the company. The repurchases will be made out of the funds legally available for such purpose in accordance with the Articles of Association and the applicable laws of the Cayman Islands and the Listing Rules. The company may cancel such repurchased shares or hold them as treasury shares on or after the Rule Amendment Effective Date. The authority shall expire at the earliest of the next Annual General Meeting, the date on which the next Annual General Meeting is required to be held or the date on which the authority is varied or revoked in a General Meeting. As of June 10, 2025, the company has 791,755,080 shares in issue.
On July 14, 2025, the company announces a share repurchase program. Under the program, the company will repurchase up to HKD 100 million worth of its shares. The repurchase price of each share shall be no more than 5% higher than the average closing market price for the shares over the five trading days immediately preceding each repurchase. The company intends to fund the program from its own financial resources. 공시 • Jul 03
Jacobio Pharma Submits Phase I/II Investigational New Drug Application for its Bet Inhibitor JAB-8263 for the Treatment of Autoimmune Diseases to the Center for Drug Evaluation in China Jacobio Pharma announced that it has submitted the Phase I/II Investigational New Drug (IND) application for its BET inhibitor JAB-8263 for the treatment of autoimmune diseases to the Center for Drug Evaluation (CDE) in China and has been accepted. According to new regulatory guidelines, the review of JAB-8263's IND application is expected to be completed within 30 working days. Previously, Jacobio has completed phase I clinical trials of JAB-8263 for solid tumor and hematological malignancies in both China and the United States. Data presented at the 2024 American Society of Hematology (ASH) Annual Meeting showed that JAB-8263 demonstrated good tolerability. 공시 • Jul 02
Jacobio Completes the First Patient Dage in the Phase I/IIa Clinical Trial of Pan-KRAS Inhibitor JAB-23E73 in U.S The board of directors of JACOBIO PHARMACEUTICALS Group CO., LTD. announced that the Company has completed the first patient dosage in the phase I/IIa clinical trial of its in-house developed pan-KRAS inhibitor JAB-23E73 in U.S. In parallel, the dose-escalation study in China is progressing as planned. KRAS mutations represent one of the most common oncogenic alterations in tumors, occurring in approximately 23%-25% of cancer patients. The mutation frequency is particularly high in pancreatic cancer (90%), colorectal cancer (40%), and non-small cell lung cancer (30%). An estimated 2.7 million newly diagnosed cancer patients worldwide are found to have tumor with KRAS mutations, underscoring the significant unmet need and the potential benefit of pan-KRAS inhibitors for this patient population. JAB-23E73 demonstrates high selectivity for KRAS, effectively inhibiting both the active ("On") and inactive ("Off") states of KRAS, with no inhibition to HRAS or NRAS. As an oral KRAS inhibitor, JAB-23E73 has shown a favorable pharmacokinetic profile and promising anti-tumor activity in preclinical models. 공시 • Mar 07
Jacobio Pharmaceuticals Group Co., Ltd. to Report Fiscal Year 2024 Results on Mar 19, 2025 Jacobio Pharmaceuticals Group Co., Ltd. announced that they will report fiscal year 2024 results on Mar 19, 2025 공시 • Jan 07
Jacobio Pharma Announces the Registrational Clinical Data of Glecirasib Was Published in Nature Medicine Jacobio Pharma announced that the data from a registrational clinical trial of its independently developed KRAS G12C inhibitor glecirasib has been published in Nature Medicine (impact factor 58.7). In the article, Jaocbio disclosed, for the first time, the complete dataset of glecirasib in KRAS G12C mutant non-small cell lung cancer patients in the second line or above setting. The pivotal phase II trial of glecirasib monotherapy demonstrated impressive efficacy, including the confirmed objective response rate of 47.9% (56/117), a median progression-free survival of 8.2 months, and a median overall survival of 13.6 months. Glecirasib has a manageable safety profile. Gleciasib has a favorable gastrointestinal safety profile compared with other KRAS G12C inhibitors. The new drug application of glecirasib is currently under evaluation by the Center for Drug Evaluation of the National Medical Products Administration of China, and has been granted Priority Review Designation. 공시 • Dec 09
Jacobio Pharma Presents preliminary Data on BET Inhibitor for Myelofibrosis at 2024 ASH Jacobio Pharmaceuticals Group Co., Ltd. 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 October 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. 공시 • Nov 27
Jacobio Pharmaceuticals Group Co., Ltd. Completes First Patient Dose in the Phase I/IIa Clinical Trial of Pan-Kras Inhibitor Jab-23E73 in China The board of directors of JACOBIO PHARMACEUTICALS Group CO., LTD. announced that the Company has completed the first patient dosage in the phase I/IIa clinical trial of its in-house developed pan-KRAS Inhibitor JAB-23E73 in China. KRAS is widely present in a variety of tumor mutations. About 23%-25% of cancer patients have KRAS mutations. About 2.7 million tumor patients with KRAS-related mutations are added each year worldwide and are expected to benefit from pan-KRAS inhibitor. JAB-23E73 can inhibit both the active ("On") and inactive ("Off") states of KRAS and with no obvious inhibition to HRAS or NRAS. As an oral KRAS inhibitor, JAB-23E73's preclinical data has shown a good pharmacokinetic profile. 공시 • Oct 09
Jacobio Pharmaceuticals Group Co., Ltd. Presents the Pre-Clinical Data of Shp2 Inhibitorjab-3312 in Combination with Kras G12c Inhibitor Glecirasibat the Fifth Ras Initiative Symposium 2024 Jacobio Pharmaceuticals Group Co., Ltd. announced that the company presented the pre-clinical data of SHP2 inhibitor JAB-3312 in combo with KRAS G12C inhibitor Glecirasib as form of poster at the Fifth RAS Initiative Symposium 2024. The data showed that Glecirasib and JAB-3312 demonstrate potent anti-tumor effect both in vitro and in vivo, and JAB-3312 enhances the anti-tumor effect of Glecirasib. Representative patient cases were also included in the poster. The clinical data of the combination of JAB-3312 and Glecirasib also verified the above preclinical conclusions. The poster released by Jacobio at 2024 European Society for Medical Oncology (ESMO) Congress (ESMO 2024) showed that the confirmed objective response rate (cORR) of Glecirasib and JAB-3312 as first-line treatment for non-small cell lung cancer (NSCLC) was 70.6% (N=102), and the median progression-free survival (mPFS) remained stable at 12.2 months. Currently, a phase III registration clinical trial of JAB-3312 and Glecirasib for the treatment of first-line NSCLC harboring KRAS G12C mutation has been initiated in China. The Fifth RAS Initiative Symposium was held by Frederick National Laboratory which is affiliated with National Cancer Institute of the United States. Glecirasib (JAB-21822) is a KRAS G12C inhibitor developed by Jacobio. A number of clinical trials of Glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with cetuximab in colorectal cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China. JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with Glecirasib and other agents in China, the United States and Europe. The phase III study in combination with KRAS G12C inhibitor Glecirasib has been approved by the Center for Drug Evaluation of the National Medical Products Administration of China in February 2024. 공시 • Sep 23
Jacobio Pharmaceuticals Group Co., Ltd. Receives Investigational New Drug (IND) Approval from the U.S. FDA for Pan-KRAS Inhibitor JAB-23E73 JACOBIO PHARMACEUTICALS GROUP CO., LTD. announced that, the Food and Drug Administration of the United States has approved the Investigational New Drug application of its self-developed drug JAB-23E73 (Pan-KRAS Inhibitor), and plans to initiate phase I/IIa clinical trial in advanced solid tumor patients. The IND in China has been submitted to the Center for Drug Evaluation of the National Medical Product Administration of the PRC, and the clinical trial in China will be conducted after China IND approval. KRAS is widely present in a variety of tumor mutations. About 23%-25% of cancer patients have KRAS mutations. About 2.7 million tumor patients with KRAS-related mutations are added each year worldwide and are expected to benefit from pan-KRAS inhibitor. JAB-23E73 can inhibit both the active ("On") and inactive ("Off") states of KRAS and with no obvious inhibition to HRAS or NRAS. As an oral KRAS inhibitor, JAB-23E73's preclinical data has showed a good pharmacokinetic profile. 공시 • Aug 30
Jacobio Pharmaceuticals Group Co., Ltd. Announces Board Changes Jacobio Pharmaceuticals Group Co., Ltd. announced that Ms. Yanmin TANG (" Ms. Tang ") has tendered her resignation from the position as a non-executive Director with effect from August 30, 2024 due to her pursuit of other personal affairs. Accordingly, Ms. Tang will cease to be a member of the nomination committee of the Company (the "Nomination Committee") and the remuneration committee of the Company (the "Remuneration Committee") with effect from August 30, 2024. Ms. Tang confirmed that she The Board further announces that, Dr. Te-li CHEN, a non-executive Director, has been appointed as a member of the Nomination Committee and the Remuneration Committee in place of Ms. Tang with effect from August 30, 2024, respectively. 공시 • Aug 20
Jacobio Pharmaceuticals Group Co., Ltd. to Report First Half, 2024 Results on Aug 30, 2024 Jacobio Pharmaceuticals Group Co., Ltd. announced that they will report first half, 2024 results on Aug 30, 2024 공시 • Aug 07
Jacobio Pharmaceuticals Group Co., Ltd. Completes First Patient Dosing in the Phase III Clinical Trial of Glecirasib in Combination with Glecirasib The board of directors of Jacobio Pharmaceuticals Group Co., Ltd. announced that the Company has completed the first patient dosage in the Phase III clinical trial of KRAS G12C inhibitor Glecirasib in combination with the SHP2 inhibitor JAB-3312 versus standard care (chemotherapy plus anti-PD-1 antibody) in front-line KRAS G12C mutant non-small cell lung cancer (NSCLC). JAB-3312 is the first SHP2 inhibitor that entered a registration clinical trial globally. The new drug application (NDA) of Glecirasib monotherapy for the second-line and beyond NSCLC with KRAS G12C mutation was granted Priority Review designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China on May 21, 2024. According to data presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in June 2024, Glecirasib in combined with JAB-3312 resulted confirmed objective response rate (cORR) of 64.7% (66/102) and preliminary median progression-free survival (mPFS) of 12.2 months in the front-line NSCLC. The optimal dosing schedule Glecirasib at 800mg daily combined with JAB-33 12 at 2mg daily one week on and one week off resulted a cORR of 77.4% (24/31), and 54.8% (17/31) of patients achieved a deep response with tumors shrinking by more than 50%. Regarding on the safety data from all study patients the incidence of grade 3 or 4 treatment-related adverse events (TRAE) was 43.8%, and there was no treatment-related death. The overall safety is manageable. Glecirasib (JAB-21822) is a KRAS G12C inhibitor independently developed by Jacobio. A number of Phase I/II clinical trials of Glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include a pivotal clinical trial in NSCLC in China, combination therapy trials with SHP2 inhibitor JAB -3312 in NSCLC and with cetuximab in colorectal cancer, and a registrational pivotal clinical trial of single agent for pancreatic cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China. JAB-3312 is a highly selective SHP2 allosteric inhibitor with the best-in-class potential. Jacobio is currently conducting multiple clinical trials of JAB-3312 in China, the United States, the United States and Europe, including the combination therapy trial with Glecirasib. The Phase III study in combination with KRAS G12C inhibitorlecirasib has been approved in China in February 2024. 공시 • Jun 14
Jacobio Pharmaceuticals Group Co., Ltd. (SEHK:1167) commences an Equity Buyback Plan for 79,175,508 shares, representing 10% of its issued share capital, under the authorization approved on June 7, 2024. Jacobio Pharmaceuticals Group Co., Ltd. (SEHK:1167) commences share repurchases on June 13, 2024, under the program mandated by the shareholders in the Annual General Meeting held on June 7, 2024. As per the mandate, the company is authorized to repurchase up to 79,175,508 shares, representing 10% of its issued share capital. The repurchases will lead to an enhancement of the net asset value per share and/or earnings per share for the company. The repurchases will be made out of the funds legally available for such purpose in accordance with the Articles of Association and the applicable laws of the Cayman Islands and the Listing Rules. The company may cancel such repurchased shares or hold them as treasury shares on or after the Rule Amendment Effective Date. The authority shall expire at the earliest of the next Annual General Meeting, the date on which the next Annual General Meeting is required to be held or the date on which the authority is varied or revoked in a General Meeting. As of June 7, 2024, the company has 791,755,080 shares in issue.
On June 11, 2024, the company announces a share repurchase program. Under the program, the company will repurchase up to HKD 100 million worth of its shares. The repurchase price of each share shall be no more than 5% higher than the average closing market price for the shares over the five trading days immediately preceding each repurchase. The company intends to fund the program from its own financial resources. 공시 • May 11
Jacobio Pharmaceuticals Group Co., Ltd. Receives Approval of Registrational Phase III Clinical Trial of Glecirasib (Jab-21822) and Epidermal Growth Factor Receptor Inhibitor Erbitux in Patients with Colorectal Cancer The board of directors of JACOBIO PHARMACEUTICALS Group CO., Ltd. announced that, the Company received approval of registrational phase III clinical trial of the combination therapy between its independently developed novel KRAS G12C inhibitor Glecirasib (JAB-21822) and epidermal growth factor receptor (anti-EGFR antibody) inhibitor ERBITUX® (cetuximab) in patients with KRAS G12C-mutated colorectal cancer. This approved registrational phase III trial in China aims to evaluate the efficacy and safety of Glecirasib in combo with cetuximab versus positive control treatment in colorectal cancer patients with unresectable or metastatic KRAS G12C mutations. In October 2022, Jacobio entered into a clinical trial collaboration agreement with Merck on clinical study of combination therapy between Jacobio's KRAS G12C inhibitor Lecirasib and Merck's epidermal growth factor receptor ("anti-EGFR antibody") inhibitor ERBITUX® ("cetuximab). Merck will provide cetuximab for combimation trials in China and Europe under the collaboration agreement. In June 2023, Jacobio announced clinical results of Glecirasib In combination therapy with cetuximab to treat KRAS G12C mutant advanced colorectal cancer at the Second JCA - AACR Precision Cancer Medicine International Conference. In a trial of Glecirasib with cetuximab, the overall response rate (ORR) is 62.8% (27/43), the disease control rate (DCR) is 93% (40/43). The majority of treatment related adverse events (TRAEs) in monotherapies and combinations are grades 1-2. Colorectal cancer is the second most common cancer in China, with about 550,000 new cases per year, of which about 3% of colorectal cancer patients have KRAS G12C mutation. Glecirasib (J AB-21822) is a KRAS G12C inhibitor independently developed by Jacobio. A number of Phase I/II clinical trials of Glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation". These include a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting, combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with cetuximab in colorectal cancer, and a registrational pivotal clinical trial of single drug treatment for pancreatic cancer. The pancreatic cancer indication has obtained orphan drug designation in the United States and breakthrough therapy designation in China. ERBITUX is an IgG1 monoclonal antibody targeting the epidermal growth factor receptor. As a monoclonal antibody, the mode of action of ERBITUX is distinct from standard non-selective chemotherapy treatments in that it specifically targets and binds to the EGFR. To date, ERBITUX has obtained market authorization in over 100 countries worldwide for the treatment of RAS wild-type metastatic colorectal cancer and for the treatment of RAS Wild-type metastatic coloreCTal cancer and for the treatment the treatment of squamous cell carcinoma of the head and neck (SCCHCHC). 공시 • May 03
Jacobio Pharma Announces Its KRAS G12C Inhibitor Reached the Primary Endpoint Jacobio Pharma announced that the data from the Phase II registrational study of the KRAS G12C inhibitor glecirasib were offically reported at the April ASCO Plenary Series, which was held online. Prof. Yuankai Shi, chief physician of Cancer Hospital Chinese Academy of Medical Sciences, the lead principal investigator of this clinical trial, presented the data in the form of an online oral presentation (Abstract 468214). The efficacy data showed that among second-line non-small cell lung cancer patients receiving monotherapy treatment, the confirmed objective response rate (cORR) was 47.9% (56/117), including 4 patients achieved a complete response (CR) and 36 patients with tumor reduction exceeding 50%. Disease control rate (DCR) was 86.3%. The median progression-free survival (mPFS) was 8.2 months, and median overall survival (mOS) was 13.6 months. The median duration of response (mDoR) has not been reached:6-month and 12-month DOR rates were 73.6% and 56.6%, respectively. Safety data showed that glecirasib has a manageable safety profile. No grade 5 treatment related adverse event (TRAE) was observed, and only 5.0% of patients discontinued the treatment due to TRAEs. Gleciasib has a favorable gastrointestinal (GI) profile compared to other KRAS G12C inhibitors. 공시 • Apr 09
Jacobio Pharma to Present Data of PARP7 Inhibitor and P53 Reactivator at the 2024 AACR Annual Meeting Jacobin Pharma announced that the company will present the results of two preclinical evaluation of PARP7 inhibitor JAB-26766 and p53 Y220C reactivator JAB-30355 in form of the abstract during the American Association for Cancer Research (AACR) Annual Meeting 2024 (the "AACR 2024") from April 5 to 10, 2024. Details for the 2024 AACR abstracts are as follows: JAB-26766: a small-molecule, orally bioavailable PARP7 inhibitor with high potency and selectivity Poster Presentation: April 9, 2024, 9:00 AM - 12:30 PM (GMT-7) Session: PO.ET09.01 - DNA Reactive Agents. JAB-26766 is a potent, orally bioavailable PARP7 inhibitor with >1800-fold selectivity on PARP7 over PARP2. JAB-26766 as a single agent shows potent in vivo anti-tumor activities, which can be further enhanced through combination with STING agonist or anti-PD-1 mAb. JAB-30355: A highly potent, orally bioavailable p53 Y220C reactivator Poster Presentation: April 9, 2024, 1:30 PM - 5:00 PM (GMT-7) Session: PO.ET09.09 - Novel Antitumor Agents 4. JAB-30355 is a potent and selective p53 Y220C reactivator. JAB-30355 exhibited dose-dependent anti-tumor activity, inducing tumor stasis or regression in multiple CDX and PDX models of ovarian cancer, pancreatic cancer, gastric cancer, and small cell lung cancer, with overall good tolerability. A phase I/IIa clinical trial to evaluate the safety and efficacy of JAB-30355 in patients with advanced solid tumor is ongoing in U.S. The 2024 AACR Annual Meeting will be held in San Diego, California, U.S. from April 5th to April 10th, 2024. 공시 • Mar 29
Jacobio Pharmaceuticals Group Co., Ltd., Annual General Meeting, Jun 07, 2024 Jacobio Pharmaceuticals Group Co., Ltd., Annual General Meeting, Jun 07, 2024. 공시 • Mar 19
Jacobio Pharmaceuticals Group Co., Ltd. to Report Fiscal Year 2023 Results on Mar 28, 2024 Jacobio Pharmaceuticals Group Co., Ltd. announced that they will report fiscal year 2023 results on Mar 28, 2024 공시 • Feb 19
Jacobio Pharma Announces China CDE Clearance for Phase III Clinical Trial of SHP2 Inhibitor Plus KRAS G12C Inhibitor Jacobio Pharma announced it received approval of registrational phase III clinical trial of the combination therapy between its novel KRAS G12C inhibitor Glecirasib and novel SHP2 inhibitor JAB-3312. JAB-3312 is the first SHP2 inhibitor entered into phase III study globally in combination with KRAS G12C inhibitor. This approved study in China is a randomized active controlled phase III trial design to evaluate the efficacy and safety of JAB-3312 in combination with Glecirasib for first-line non-small cell lung cancer patients with KRAS G12C mutations. The control arm is the current standard treatment for first-line non- small cell lung cancer, which is the combination therapy of PD-1 antibody and chemotherapy. Jacobio initiated clinical trials of SHP2 inhibitors in 2018. Data presented by Jacobio in an oral presentation at the 2023 European Society for Medical Oncology Annual Meeting (ESMO 2023) showed that among 129 patients with non-small cell lung cancer, 58 patients were first-line treatment patients (including 7 dose groups), ORR (objective response rate) was 65.5% (38/58), and the DCR (disease control rate) was 100%. Among them, in the dose group of 800 mg (once daily) Glecirasib and 2 mg JAB-3312 (once daily for 1 week on, then 1 week off), the ORR was 86.7% (13/15). This clinical study is continuing to enroll patients. The KRAS G12C inhibitors currently on the market have not been approved as first-line non-small cells lung cancer treatments for KRAS G12C mutations; Jacobio's JAB-3312 and Glecirasib are both oral formulations, and the combination therapy is also the first approved Phase III registration clinical trial for dual oral inhibitors in the first-line treatment of non-small cell lung cancer worldwide. JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glecirasib and other agents in China, the United States and Europe. The phase III study in combination with KRAS G12C inhibitor Glecirasib has been approved by China CDE in Feb. 2024. 공시 • Jan 20
Jacobio Pharma Presents Data of Glecirasib in Patients with Pancreatic Cancer and Other Solid Tumors At the 2024 ASCO GI Jacobio Pharmaceuticals announced data of glecirasib in patients with pancreatic cancer and other solid tumors in the oral abstract session at the American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium ("2024 ASCO GI"). As of December 6, 2023, the monotherapy global study of glecirasib enrolled 52 patients with pancreatic cancer and other solid tumors harboring KRAS G12C mutation in China, the United States, Europe, Israel and other regions, including 31 patients with pancreatic cancer, and 21 patients with other solid tumors (8 with biliary tract tumors, 3 with gastric cancer, 3 with small bowel cancer, 2 with appendix cancer, and 5 with other solid tumors). Among 50 patients with evaluable solid tumors, the confirmed objective response rate (cORR) was 48% (24/50) and the disease control rate (DCR) was 90% (45/50). For second-line and above KRAS G12C mutated pancreatic cancer patients, 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, and the median overall survival (mOS) was 10.7 months. In other solid tumor patients, the cORR was 57.9% (11/19), DCR was 84.2% (16/19), the mPFS was 7.0 months, and the mOS has not yet matured. The above safety and efficacy data are better than the published data of similar studies. Glecirasib has good tolerability and safety characteristics, the majority of treatment-related adverse events (TRAEs)are grades 1-2, and grade 3 or above TRAEs occurred in 25% of patients. No patient has permanently withdrawn from the study due to TRAE. Jacobio continues to explore the application of glecirasib in pancreatic cancer. Glecirasib's registrational pivotal study for pancreatic cancer was approved by CDE in July 2023, which became the first global pancreatic cancer KRAS G12C registrational clinical study. The study results will be used to submit NDA (New Drug Application) for pancreatic cancer. Based on the clinical efficacy and safety data from ongoing clinical trials, glecirasib was granted breakthrough therapy designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for the pancreatic cancer patients with a KRAS G12C mutation who have progressed after frontline standard care treatment. Pancreatic cancer is a malignant tumor and there is a lack of effective treatment currently. The five-year overall survival rate is only 5%-10%. The BTD will expedite the clinical development of glecirasib and accelerate its early access to the patients. 공시 • Dec 07
Jacobio Pharmaceuticals Group Co., Ltd. Announces Clinical Results in the Oral Abstract Session of Clinical Oncology Gastrointestinal Cancers Symposium The board of directors of Jacobio Pharmaceuticals Group Co., Ltd. announced that, the Company will present its clinical results in the oral abstract session at 2024 American Society of Clinical Oncology (ASCO) Gastrointestinal Cancers Symposium. The Company continues to explore the application of Glecirasib in pancreatic cancer and other solid tumor harboring KRAS G12C mutation. The registrational pivotal clinical study for pancreatic cancer of Glecirasib was approved by Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China in July 2023, which became the first global pancreatic cancer KRAS G12C registrational clinical study. The study results will be used to submit New Drug Application (NDA) for pancreatic cancer. In August 2023, based on the clinical efficacy and safety data from ongoing Phase I/II clinical trials, Glecirasib was granted breakthrough therapy designation (BTD) by the CDE for the pancreatic cancer patients with a KRAS G12C mutation who have progressed after frontline standard care treatment. Pancreatic cancer is a malignant tumor and there is a lack of effective treatment currently. The five-year overall survival rate is only 5%. The BTD will expedite the clinical development of Glecirasib and accelerate its early access to the patients. 공시 • Oct 23
Jacobio Pharma Presents Clinical Results of Glecirasib in Combination with Jab-3312 At Esmo Jacobio Pharma announced that the clinical data of Glecirasib in combination with JAB-3312 was published in the form of a proffered paper presentation at the 2023 European Society for Medical Oncology Congress (ESMO 2023). Jacobio presented results of a Phase I/IIa study of glecirasib in combination With JAB-3312. The trial consisted of seven dose groups, including Glecirasib of 400 mg and 800 mg in combination with JAB- 3312 at different doses and dosing intervals, aiming to explore the safety, efficacy, and tolerability through different dose groups, and to provide a basis for a subsequent registrational clinical trial. As of August 4, 2023, a total of 144 KRAS G12C mutant patients were enrolled, including 129 NSCLC patients, 14 patients with colorectal cancer, and 1 patient with pancreatic cancer. Among the 129 NSCLC (non-small cell lung cancer) patients involved in the trial, 107 patients had undergone at least one tumor assessment using RECIST1.1 criteria, and 58 of them were first-line therapy patients (spread across the seven dose groups), with an ORR of 65.5% (38/58) and a DCR of 100%. The ORR was 86.7% (13/15) in the dose group of 800 mg glcirasib in combinationwith 2 mg JAB-3312. Glecirasib is a KRAS G12C inhibitor developed by Jacobio. A number of Phase I/II clinical trials of Glecirasib are currently ongoing in China, the United States and Europe for patients with advanced solid tumors harboring KRAS G12C mutation. These include a pivotal clinical trial in NSCLC in China; a monotherapy study for STK11co-mutated NSCLC in the front-line setting, and combination therapy trials with SHP2 inhibitor JAB-3312 in NSCLC and with Cetuximab in colorectal cancer. JAB-3312 is a highly selective SHP2 allosteric inhibitor with best-in-class potential. Jacobio is currently conducting clinical trials of JAB-3312 in monotherapy and combination therapies with glorectal cancer and other agents in China. 공시 • Aug 19
Jacobio Pharmaceuticals Group Co., Ltd. to Report First Half, 2023 Results on Aug 30, 2023 Jacobio Pharmaceuticals Group Co., Ltd. announced that they will report first half, 2023 results on Aug 30, 2023 공시 • Aug 08
Jacobio Pharmaceuticals Group Co., Ltd.'S In-House KRAS G12C Inhibitor Jab-21822 (Glecirasib) Granted Breakthrough Therapy Designation for Pancreatic Cancer Patients The board of directors of Jacobio Pharmaceuticals Group Co., Ltd. announced that the Company's in-house KRAS G12C inhibitor JAB-21822 (Glecirasib) was granted breakthrough therapy designation for KRAS G12C-mutated pancreatic cancer patients who have progressed on frontline standard care treatment by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA). The designation was granted based on the solid clinical efficacy and safety data of JAB-21822. It will expedite the clinical development of JAB-21822 and accelerate its early access to the patients. JAB-21822's pivotal study for pancreatic cancer has been approved by CDE, which became the first global pancreatic cancer registrational clinical study for KRAS G12C. The approved pivotal clinical trial will evaluate the efficacy and safety of single agent Glecirasib in KRAS G12C- mutated locally advanced or metastatic pancreatic cancer patients who have advanced on frontline standard care treatment. This is a multi-center, single-arm, open-label study. pancreatic cancer is a highly malignancy and there is a limited effective treatment currently. The five-year overall survival rate is only 5%. The breakthrough therapy designation will help accelerate the clinical study. pancreatic cancer is JAB-21822's second indication that was granted breakthrough therapy designation by CDE in China. In December 2022, JAB-21822 was granted breakthrough therapy designation for the second line setting and beyond of advanced or metastatic non-small cell lung cancer (NSCLC) patients with KRAS G12C mutation by CDE. About CDE's Breakthrough Therapy Designation. CDE's breakthrough therapy designation (BTD) is designed to expedite the clinical development of innovative drugs presenting significant clinical advantages. A breakthrough therapy must provide effective treatment for a seriously debilitating or life-threatening condition that has no effective therapy or demonstrate substantial improvement over available therapies. According to the CDE, the breakthrough therapy designation provides opportunities for more intensive CDE guidance and discussion with respect to clinical trials and development strategy, and for priority review later. JAB-21822 is an oral, small molecule KRAS G12C inhibitor independently developed by the Company. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors harbouring KRAS G12C mutation, including a pivotal clinical trial to treat non-small cell lung cancer in China, a monotherapy study for STK11 co-mutated NSCLC in the front-line setting; combination therapy trials with SHP2 inhibitor JAB-3312, anti-PD-1 monoclonal antibody and Cetuximab. 공시 • Jul 07
Jacobio Pharmaceuticals Group Co., Ltd. announced that it expects to receive CNY 150 million in funding from Beijing E-Town International Investment & Development Co., Ltd. Jacobio Pharmaceuticals Group Co., Ltd. announced that it will receive CNY 150,000,000 in its equity round of funding from new investor, Beijing E-Town International Investment & Development Co., Ltd. on July 6, 2023. The company has signed a capital increase agreement with the investor. 공시 • Jun 30
Jacobio Pharmaceuticals Group Co., Ltd. Presents Clinical Results of Glecirasib in Colorectal Cancer The board of directors of Jacobio Pharmaceuticals Group Co., Ltd. announced that the Company has announced clinical results of in-house novel KRAS G12C inhibitor Glecirasib (JAB-21822) monotherapy and in combination with cetuximab to treat KRAS G12C mutant advanced colorectal cancer(CRC) in Second JCA-AACR Precision Cancer Medicine International Conference. In the monotherapy study, overall response rate (ORR) is 33.3% (11/33), disease control rate (DCR) is 90.9% (30/33), mPFS (median progression-free survival) is 6.9 months. In a clinical trial of Glecirasib with cetuximab, ORR is 62.8% (27/43), DCR is 93% (40/43), mPFS has not reached before the May 23, 2023 data cutoff date. In terms of safety, the majority of treatment-related adverse events (TRAEs) in monotherapies and combinations are grades 1-2. Colorectal cancer is the second most common cancer in China, with about 550,000 new cases per year, of which about 3% of colorectal cancer patients have KRAS G12C mutation. Patients with KRAS G12C mutation are insensitive to existing standard chemotherapies and targeted therapies, have rapid disease progression, short survival, and they have high unmet clinical treatment needs. Glecirasib has the potential to bring effective and less toxic treatment option for patients. 공시 • Jun 09
Jacobio Pharmaceuticals Group Co., Ltd. Receives Investigational New Drug (IND) Approval for PARP7 Inhibitor JAB-26766 in China The board of directors of the Jacobio Pharmaceuticals Group Co., Ltd. announce that the Company has received Investigational New Drug (IND) approval of its self-developed drug JAB-26766 (PARP7 inhibitor) from the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The Group plans to initiate a Phase I/IIa advanced solid tumors clinical trial in China. PARP7 inhibitors target immuno-oncology (I/O) signaling pathway and can be used to treat various solid tumors such as squamous non-small cell ling cancer (NSCLC), and head and neck squamous cell carcinomas (HNSCC). Studies show that PARP7 inhibitors have the potential to directly inhibit tumor growth and enhance the anti-tumor immune response. JAB-26766 is an orally administered small-molecule with significant anti-tumor activity against a variety of tumor models in mice. PARP7 is located downstream of STING signaling pathway, and JAB-26766 has potential to combine with Jacobio's self-developed CD73 STING-iADC. JAB-26766 also has the potential to be used in combination with PD-(L)1 monoclonal antibodies to bring more treatment options to patients. Jacobio is committed to developing global first-in-class drugs, and key programs are targeting the top three worldwide. As of the date of this announcement, there is only one PARP7 inhibitor in Phase I clinical stage globally.