RegulationOrphan Drug (United States), Orphan Drug (European Union), Breakthrough Therapy (China), Conditional marketing approval (China), Priority Review (China)

Structure/Sequence

Molecular FormulaC31H26ClF4N7O2

InChIKeyQRRJEUIQLZNPIO-UHFFFAOYSA-N

CAS Registry2657613-87-9

Clinical Trials associated with Glecirasib

NCT07339839

/ Not yet recruitingPhase 1/2IIT

Glecirasib Combined With Ivonescimab for First-line Treatment of KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer: A Prospective, Multi-center, Phase I/II Clinical Study

This study evaluates the safety, tolerability, maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), and recommended phase II dose (RP2D) of Glecirasib in combination with Ivonescimab in patients with previously untreated, KRAS G12C-mutated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with PD-L1 TPS ≥1%. The study includes a Phase I 3+3 dose-escalation stage followed by a Phase II Simon two-stage design to assess preliminary antitumor efficacy.

Start Date01 Mar 2026

Sponsor / Collaborator

Cancer Hospital Chinese Academy of Medical Sciences

NCT07164170

/ Not yet recruitingPhase 2

An Open-label Phase II Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ABSK043 in Combination With Glecirasib in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Harboring a KRAS G12C Mutation

This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.

Start Date25 Oct 2025

Sponsor / Collaborator

Abbisko Therapeutics Co., Ltd.

NCT06838338

/ Active, not recruitingPhase 1IIT

A Phase Ib, Open Lable, Clinical Trial of JAB-21822 Combined With Second Line Chemotherapy and Bevacizumab for Metastatic Colorectal Cancer With KRAS G12C Mutation

KRAS is a common genetic mutation in tumors, and CRC is one of the tumors with a high KRAS mutation rate. The anti-tumor activity of KRAS G12C inhibitors combined with anti-EGFR anti-bodies have been proven in patients with advanced colorectal cancer, and one of them was approved for patients who have previously received standard treatment. However, Chinese patients still do not have access to these drugs. This study is to determine the efficacy and safety of KRAS G12C inhibitor JAB-21822 in combination with the second-line standard chemotherapy and bevacizumab in advanced colorectal cancer failed to standard therapy in Chinese population.

Start Date20 Mar 2025

Sponsor / Collaborator-

100 Clinical Results associated with Glecirasib

100 Translational Medicine associated with Glecirasib

100 Patents (Medical) associated with Glecirasib

Literatures (Medical) associated with Glecirasib

01 Feb 2026·Lancet Respiratory Medicine

Glecirasib plus sitneprotafib in patients with KRASG12C-mutated non-small-cell lung cancer in China: an open-label, multicentre, single-arm, phase 1/2a trial

Article

Author: Yu, Yan ; Duan, Jianchun ; Xing, Ligang ; Ye, Feng ; Li, Xiaoyan ; Wang-Gillam, Andrea ; Cao, Baoshan ; Liu, Zhe ; Zhao, Yanqiu ; Xu, Jiachen ; Tang, Kejing ; Bi, Chao ; Zhong, Jia ; Wu, Lin ; Jin, Bo ; Liu, Lian ; Wan, Rui ; Fang, Xuefeng ; Song, Qibin ; Zhao, Jun ; Dong, Xiaorong ; Chen, Jiayan ; Li, Xingya ; Pang, Jiaohui ; Wang, Zhijie ; Chang, Jianhua ; Shi, Jianhua ; Zhuang, Wu ; Wang, Jie ; Fei, Kailun ; Pan, Yueyin ; Fang, Jian ; Sun, Boyang ; Chu, Qian ; Zhang, Li ; Pan, Pinhua ; Bai, Chunmei ; Ding, Yuli ; Shao, Yang

BACKGROUND:

Monotherapy with KRAS^G12C (ie, KRAS Gly12Cys) inhibitors has emerged as a mainstream treatment for patients with KRAS^G12C -mutated non-small-cell lung cancer (NSCLC). Synergistic effects have been observed with the combination of a KRAS^G12C inhibitor and a SHP2 inhibitor in multiple xenograft models. We aimed to evaluate the safety and efficacy of the KRAS^G12C inhibitor glecirasib combined with the SHP2 inhibitor sitneprotafib (JAB-3312; Jacobio Pharmaceuticals, Beijing, China) in patients with KRAS^G12C -mutated solid tumours.

METHODS:

We conducted an open-label, multicentre, single-arm, phase 1/2a trial at 26 hospitals across China. Patients (aged ≥18 years) with locally advanced or metastatic solid tumours harbouring a KRAS^G12C mutation, an Eastern Cooperative Oncology Group performance status score of 0-1, and measurable disease according to Response Evaluation Criteria in Solid Tumours (RECIST; version 1.1) were eligible for inclusion in both phases. Patients received oral glecirasib (400 mg or 800 mg once daily) in combination with oral sitneprotafib (2 mg or 3 mg once daily) in seven cohorts evaluating various dose levels and schedules of the two drugs. In phase 1, the primary endpoint was safety assessed by investigators according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0) from first treatment dose to 30 days after the last dose of both agents. In phase 2a, the primary endpoint was objective response rate (ORR) between baseline and disease progression or initiation of anticancer therapy, whichever occurred first, based on the comprehensive assessment of all tumour evaluations by investigators following RECIST (version 1.1). All patients who received at least one dose of combination therapy were included in the safety and efficacy analyses. This trial is registered with ClinicalTrials.gov (NCT05288205) and is currently recruiting.

FINDINGS:

Between May 7, 2022, and Aug 20, 2024, a total of 194 patients with advanced solid tumours were enrolled, of whom 171 (88%) had NSCLC (50 [29%] in phase 1 and 121 [71%] in phase 2a). Median participant age was 65 years (IQR 59-70); 140 (82%) were men and 31 (18%) were women. At data cutoff on Aug 20, 2024, the median follow-up duration was 14·5 months (IQR 11·9-17·1), and 106 (62%) patients had discontinued treatment. Phase 1 concluded with one dose-limiting toxicity (DLT; grade 3 pneumonitis) at the highest dose level (glecirasib 800 mg plus sitneprotafib 3 mg once daily, 1 week on and 1 week off); no DLTs were observed at other dose levels. Across phase 1 and 2a, 167 patients (98%) had at least one treatment-related adverse event, which were grade 3-4 in 78 (46%) patients. The most common treatment-related adverse events (occurring in ≥20% of all 171 patients) were anaemia (105 [61%]), hypertriglyceridaemia (103 [60%]), increased aspartate aminotransferase (95 [56%]), increased alanine aminotransferase (83 [49%]), increased blood bilirubin (78 [46%]), oedema (62 [36%]), increased blood creatine phosphokinase (60 [35%]), neutropenia (54 [32%]), decreased white blood cell count (50 [29%]), and increased bodyweight (44 [26%]). Three (2%) patients discontinued glecirasib and sitneprotafib due to treatment-related adverse events. No grade 5 treatment-related adverse event was reported. The ORR was 71% (72 patients [95% CI 61-79]) in the subgroup of 102 patients with previously untreated NSCLC; 49% (19 patients [32-65]) in the 39 patients previously treated with systemic therapy but naive to KRAS^G12C inhibitors; and 10% (three patients [2-27]) in the 30 patients previously treated with KRAS^G12C inhibitor therapy.

INTERPRETATION:

Glecirasib combined with sitneprotafib showed promising efficacy and manageable safety in patients with advanced KRAS^G12C -mutated NSCLC, particularly among those who had not received previous treatment. These findings support the evaluation of this combination in a phase 3 trial comparing this chemotherapy-free regimen to current standard of care in this patient group.

FUNDING:

Jacobio Pharmaceuticals.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

01 Feb 2026·Lancet Gastroenterology & Hepatology

Glecirasib with or without cetuximab in previously treated locally advanced or metastatic colorectal cancer with KRASG12C mutation (JAB-21822-1002 and JAB-21822-1007): two open-label, non-randomised phase 1/2 trials

Article

Author: Cao, Baoshan ; Li, Xiaoyan ; Ba, Yi ; Shi, Huaqiu ; Shen, Lin ; Wang-Gillam, Andrea ; Sun, Xin ; Liu, Lian ; Li, Wenhua ; Lu, Shuang ; Yin, Xianli ; Liang, Rong ; Hu, Changlu ; Li, Yongsheng ; Li, Zhen ; Wang, Zhenghang ; Zhang, Yanqiao ; Liang, Xinjun ; Li, Jian ; Luo, Suxia ; Li, Zhihua ; Li, Xingya ; Xiong, Jianping ; Zhu, Liangjun ; Song, Zhengbo ; Xia, Guohao ; Bai, Chunmei ; Zhong, Diansheng ; Fu, Qihan ; Huang, Jing ; Huang, Chenghui ; An, Guangyu ; Ding, Yuli ; Wang, Zhen ; Wang, Feng ; Pan, Wenhui ; Rao, Zhiyue ; Gu, Yanhong

BACKGROUND:

KRAS^G12C mutations are present in around 4% of patients with colorectal cancer and are associated with lower treatment response rates and overall survival. EGFR signalling has been identified as a primary mechanism of resistance to KRAS^G12C inhibitors. We aimed to evaluate the efficacy and safety of a novel, covalent, small molecule KRAS^G12C inhibitor, glecirasib (JAB-21822), as monotherapy or in combination with the anti-EGFR cetuximab, in patients with KRAS^G12C-mutated colorectal cancer.

METHODS:

JAB-21822-1002 was an open-label, non-randomised, dose escalation (phase 1) and expansion (phase 2a) trial evaluating glecirasib monotherapy in KRAS^G12C-mutated solid tumours. JAB-21822-1007 was an open-label, non-randomised, dose escalation (phase 1b) and expansion (phase 2) study evaluating glecirasib plus cetuximab in KRAS^G12C-mutated colorectal, small intestine, and appendiceal cancer. Adult participants (aged ≥18 years) were recruited in China from 17 hospitals for the monotherapy trial and 16 hospitals for the combination trial. Here, we report only on patients with colorectal cancer treated with oral glecirasib at the recommended phase 2 dose (800 mg once daily in 21-day treatment cycles [until disease progression, intolerable toxicity, investigator's discretion, or withdrawal of consent]), pooling phase 1 and 2 data together. In the combination trial, cetuximab was administered intravenously with an initial loading dose of 400 mg/m² in the first week, followed by 250 mg/m² every week or 500 mg/m² every 2 weeks. For this analysis, key eligibility criteria were histologically or cytologically confirmed locally advanced or metastatic colorectal cancer with KRAS^G12C mutation; Eastern Cooperative Oncology Group performance status of 0 or 1; and at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST). For phase 1 of both trials, patients must not have responded to, were not suitable for, or refused standard of care. For phase 2 of both trials, patients must have received at least first-line standard of care and had disease progression or intolerance. Primary endpoints for the monotherapy trial were safety (treatment-emergent adverse events, serious adverse events, treatment-related adverse events, dose-limiting toxicity, and clinically significant changes in vital signs, physical examination, and electrocardiography, and clinically significant unexpected laboratory values of grade ≥3) for phase 1 and objective response rate (complete and partial response) for phase 2a. Primary endpoints for the combination trial were dose-limiting toxicities, maximum tolerated dose, and recommended phase 2 dose for phase 1b and objective response rate for phase 2. The full analysis set was defined as patients with at least one measurable lesion at baseline who received at least one dose of glecirasib in the monotherapy trial, or at least one dose of glecirasib plus cetuximab in the combination trial. The safety analysis set was defined as patients who received at least one dose of glecirasib in the monotherapy trial, or at least one dose of glecirasib or cetuximab in the combination trial. The trials are registered with ClinicalTrials.gov (NCT05009329 and NCT05194995), and are active but no longer recruiting.

FINDINGS:

Between Oct 12, 2021, and Dec 4, 2023, 44 patients with colorectal cancer (27 male and 17 female) in the monotherapy trial received glecirasib 800 mg once daily and comprised the full analysis and safety analysis sets. Between Feb 17, 2022, and Feb 28, 2023, 47 patients with colorectal cancer (22 male and 25 female) in the combination trial received glecirasib 800 mg once daily plus cetuximab and comprised the safety analysis set. One patient was excluded from the full analysis set as they received glecirasib only. Data cutoff was June 30, 2024. Median follow-up was 21·9 months (IQR 20·0-25·5) in the monotherapy trial and 18·7 months (15·9-20·6) in the combination trial. In the monotherapy trial phase 1, 15 patients with colorectal cancer were enrolled. No dose-limiting toxicities, unexpected grade 3 or worse laboratory values, or changes in vital signs, physical examinations, or electrocardiography were observed. 15 (100%) patients had treatment-emergent adverse events (n=8 [53%] grade ≥3), 13 (87%) of 15 reported treatment-related adverse events (n=4 (27%) grade ≥3); five (33%) of 15 patients had serious treatment-emergent adverse events, none were treatment-related. In the combination trial phase 1b, six patients with colorectal cancer were enrolled. No dose-limiting toxicities were observed and the maximum tolerated dose was not reached. The recommended phase 2 dose was chosen as glecirasib 800 mg once daily. Objective response rate was 23% (95% CI 11-38; ten of 44 patients [ten partial responses]) in the monotherapy trial and 50% (35-65; 23 of 46 patients [23 partial responses]) in the combination trial. The most common treatment-related adverse events were anaemia (24 [55%]), blood bilirubin increased (23 [52%]), and conjugated bilirubin increased (17 [39%]) in the monotherapy trial, and rash (39 [83%]), blood bilirubin increased (29 [62%]), conjugated bilirubin increased (17 [36%]), alanine aminotransferase increased (16 [34%]), and anaemia (15 [32%]) in the combination trial. The incidence of grade 3 or 4 treatment-related adverse events was 20% (nine of 44) in the monotherapy trial and 19% (nine of 47) in the combination trial. Two (5%) of 44 patients in the monotherapy trial (febrile neutropenia, n=2) and four (9%) of 47 patients in the combination trial (interstitial lung disease [n=1], pleural effusion and pericardial effusion [n=1], pyrexia [n=1], and rash [n=1]) reported serious treatment-related adverse events. No treatment-related deaths were observed in either trial.

INTERPRETATION:

Glecirasib monotherapy and its combination with cetuximab represent potential treatment options for patients with advanced, refractory colorectal cancer harbouring KRAS^G12C mutations. The promising efficacy and safety support further exploration of glecirasib-based combinations in earlier lines of treatment.

FUNDING:

Jacobio.

TRANSLATION:

For the Mandarin translation of the abstract see Supplementary Materials section.

01 Nov 2025·Cancer Communications

Efficacy and safety of glecirasib in solid tumors with KRAS G12C mutation: A pooled analysis of two phase I/II trials

Article

Author: Jon Zugazagoitia ; Ayala Hubert ; Jian Li ; Diansheng Zhong ; Wenming Wu ; Julia Martínez-Pérez ; Ting Deng ; Zhengbo Song ; Zhiyue Rao ; Ligang Xing ; Jian Zhang ; Xueqin Chen ; Lian Liu ; Zhihua Li ; Guohao Xia ; Andrea Wang-Gillam ; Guilan Wen ; Antonio Calles Blanco ; Xinghu Liu ; Jing Huang ; Yanqiu Zhao ; Lin Wu ; Yanhong Gu ; Yu Yao ; Yuli Ding ; Yongsheng Wang ; Sumei Liu ; Yongsheng Li ; Xingya Li ; Chunmei Bai ; Kuirong Jiang ; Lin Shen

Abstract:

Background:

Glecirasib, an inhibitor of Kirsten rat sarcoma viral oncogene homolog glycine‐to‐cysteine substitution at codon 12 ( KRAS G12C), has exhibited clinical activity in non‐small‐cell lung cancer (NSCLC) and colorectal cancer (CRC). Here, we investigated the efficacy and safety of glecirasib in patients with pancreatic ductal adenocarcinoma (PDAC) and other solid tumors (excluding NSCLC and CRC) that rarely harbor the KRAS G12C mutation but for which effective treatment options remain limited.

Methods:

We conducted and analyzed two open‐label, phase I/II trials in adult patients with KRAS G12C mutant solid tumors, in which glecirasib was administered orally. The two trials had similar eligibility criteria and endpoints but differed in the regions of patient recruitment. We performed a pooled analysis of all patients, excluding NSCLC and CRC, from both trials. The primary endpoint in the pooled population was objective response rate (ORR). Efficacy and safety were assessed in patients who received at least one dose of glecirasib.

Results:

As of June 30, 2024, the pooled analysis included 54 patients who were treated with glecirasib: 32 PDACs, 8 biliary tract cancers (BTCs), 4 small intestinal cancers, 3 gastric cancers, 2 appendiceal cancers, and 5 other tumors. At baseline, 24 received ≥ two prior lines of systemic therapy. Of the 53 efficacy‐evaluable patients, the confirmed ORR was 50.9% (95% confidence interval [CI], 36.8%‐64.9%), with an ORR of 46.9% (95% CI, 29.1%‐65.3%) in PDAC patients. Among other solid tumors, ORR was 71.4% (5/7) in BTC, 100% (4/4) in small intestinal cancer, and 66.7% (2/3) in gastric cancer. Median progression‐free survival and median overall survival were 6.9 and 10.8 months, respectively, in the overall population, and 5.5 and 10.8 months, respectively, in patients with PDAC. Treatment‐related adverse events (TRAEs) of any grade occurred in 94.4% patients, with grade ≥ 3 TRAEs in 27.8%. No fatal TRAEs or TRAEs leading to treatment discontinuation occurred.

Conclusions:

Glecirasib showed promising efficacy and was well tolerated in patients with PDAC and other advanced solid tumors (beyond NSCLC and CRC), warranting further expedited clinical development in this patient population.

Trial registration:

ClinicalTrials.gov identifier: NCT05009329 and NCT05002270.

News (Medical) associated with Glecirasib

22 Dec 2025

·www.fiercebiotech.com

AstraZeneca fronts $100M for Jacobio\'s clinical-stage pan-KRAS inhibitor

KRAS has been an area of interest for AstraZeneca since 2012.\n AstraZeneca has fronted $100 million to head deeper into the KRAS space, securing the rights to a clinical-stage, multitarget asset from China’s Jacobio Pharma.U.K.-based AstraZeneca has scored the exclusive rights to develop and commercialize the pan-KRAS inhibitor, dubbed JAB-23E73, outside China. On Jacobio’s home territory, the Beijing-headquartered biopharma will jointly work on the therapy with AstraZeneca.JAB-23E73 was developed with Jacobio\'s induced allosteric drug discovery platform, which the company has designed to target multiple KRAS mutation subtypes. So far, the biopharma has been evaluating JAB-23E73 in phase 1 studies in both China and the U.S., with Jacobio pointing to “early signs of anti-tumor activity.”That activity appears to have been enough to attract AstraZeneca, which—beyond the $100 million upfront payment—is also liable to make development and commercial milestone payments of up to $1.91 billion as well as distribute tiered royalties on net sales outside of China.KRAS has been an area of interest for AstraZeneca since 2012, when the pharma licensed an anti-KRAS antisense oligonucleotide, AZD4785, from Ionis Pharmaceuticals. That candidate never progressed past phase 1, with AstraZeneca pulling the plug after wrapping up a trial in 2019, but the company’s research teams continued to work on the target.After discovering the KRAS G12C inhibitor AZD4625, AstraZeneca tweaked the molecule to generate the clinical candidate AZD4747. Then, in 2023, the drugmaker headed to China to license a preclinical KRAS G12D asset from Usynova.“KRAS is one of the most important oncogenes in cancer, with KRAS-mutated tumours driving profound unmet need for patients with pancreatic, colorectal and lung cancers,” Matt Hellmann, M.D., senior vice president, early oncology and precision medicine, oncology R&D, AstraZeneca, said in yesterday’s release.“By advancing KRAS inhibitors like JAB-23E73, and in combination with our diverse oncology portfolio, we aim to accelerate the development of new treatment regimens that have the potential to transform outcomes for patients,” Hellmann added. AstraZeneca isn’t the first pharma to see potential in Jacobio’s pipeline. AbbVie secured the rights to Jacobio’s SHP2 portfolio in 2020 before handing back the assets as part of a portfolio review two years later.More recently, Allist Pharmaceuticals paid about $21 million last year for the rights to one of those SHP2 inhibitors as well as a KRAS G12C inhibitor called glecirasib. Glecirasib demonstrated an overall response rate of 47.9% in a Chinese trial of 119 patients with locally advanced or metastatic KRAS G12C mutated non-small cell lung cancer last year and went on to secure approval in China in May 2025.Jacobio’s co-CEO Yinxiang Wang, Ph.D., said yesterday’s deal with AstraZeneca “marks a significant step forward as we bring our world-class programs to the global stage and maximize the value of our R&D innovation.”“This agreement strengthens Jacobio\'s financial position, accelerates the global development efforts, and expands our presence in the global oncology innovation ecosystem,” added the company, which also has an R&D presence in Boston.

$AstraZeneca fronts $100M for Jacobio\'s clinical-stage pan-KRAS inhibitor$

Phase 1License out/inClinical ResultDrug ApprovalAcquisition

22 Dec 2025

·www.biospace.com

AstraZeneca Finds Another Jewel in China With Up To $2B For KRAS Inhibitor

iStock, ValleraTo Jacobio discovered JAB-23E73, which is designed to treat several KRAS mutation subtypes, and is testing the therapy in multiple Phase I trials. AstraZeneca has found another potential gold nugget in China, this time offering as much as $2 billion to Jacobio Pharma to work on an early-stage pan-KRAS inhibitor. The focus of the deal is JAB-23E73, which is designed to treat multiple KRAS mutation subtypes, according to a Sunday press release . The therapy is already being tested in Phase I trials in China and the U.S. and has exhibited antitumor behavior. The U.K. pharma is offering Jacobio $100 million upfront, with $1.9 billion worth of milestones plus royalties down the line. AstraZeneca will lead clinical development, regulatory submissions and commercialization outside of China. The companies will jointly develop the therapy in China, where AstraZeneca has a large presence. KRAS was long considered an undruggable target until Mirati Therapeutics and Amgen finally broke it in 2021. Amgen’s Lumakras is now approved for lung cancer and colorectal cancer. Mirati, meanwhile, secured approval for Krazati in 2022 and was bought by Bristol Myers Squibb in 2024. China With Chinese Assets in Hand, Pharma Is Wondering What Else Can Be Learned What China is accomplishing in R&D “has implications for everyone playing in the R&D or innovation world,” McKinsey’s Fangning Zhang says. December 9, 2025 · 3 min read · Annalee Armstrong Read More Jacobio discovered JAB-23E73 using its induced allosteric drug discovery platform, which targets undruggable proteins. In addition to JAB-23E73, the company has a KRAS G12C inhibitor called glecirasib that’s been approved in China for pancreatic cancer. The biotech signed an agreement with AbbVie in 2020 to develop SHP2 inhibitors, and has deals with both Merck KGaA and Merck & Co. AstraZeneca has been on a deal spree in China. The company offered up to $5.3 billion to CSPC Pharmaceutical in June to work on small molecule drugs for chronic disease. Beyond deals, AstraZeneca plans to invest billions in China over the next five years, including a new global strategic R&D center. That March announcement came amid political pressure from the U.S. to bring manufacturing back, and an insurance fraud probe into one of AstraZeneca’s former China executives.

Phase 1Drug ApprovalLicense out/inAcquisition

16 Oct 2025

·www.pharmaceutical-technology.com

Oceanpine Capital to acquire 80% equity stake in Beijing Jacoray

The approach aims to implement a risk-sharing model, optimise capital allocation and improve efficiency to preserve project value. Credit: PanuShot/Shutterstock.com. Oceanpine Capital is to acquire an 80% equity stake in Beijing Jacoray Pharmaceutical Technology for a total consideration of 200m yuan ($28m). The move is part of Jacobio Pharma’s subsidiary Beijing Jacobio Pharmaceuticals’ capital increase and equity transfer agreement signed with Oceanpine Capital and an industry partner. The deal value is an upfront payment of 125m yuan, with an additional 75m yuan to be paid as a milestone payment in a second instalment. Upon completion, Oceanpine Capital will hold an 80% stake in Jacoray, while the industry partner and Beijing Jacobio will each own 10%. Jacoray serves as the project company for Jacobio’s cardiovascular research programme, currently in its early stages. This transaction is in line with Jacobio’s focus on advancing oncology therapies such as iADC and Kirsten rat sarcoma viral oncogene homolog (KRAS). GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence The approach aims to implement a risk-sharing model, optimise capital allocation, and improve operational efficiency to preserve long-term project value. The transaction’s proceeds will predominantly be allocated to research and development, production and the commercialisation of Jacobio’s Pan-KRAS inhibitor and other oncology assets. Oceanpine Capital founder, CEO and managing partner Dave Chenn stated: “Jacobio demonstrates outstanding scientific strength and strategic focus in oncology innovation. Oceanpine Capital looks forward to partnering with Jacobio to advance the globalisation of China’s biotech innovation.” Jacobio chairman Dr Yinxiang Wang stated: “This partnership with Oceanpine Capital strengthens our strategic focus on oncology innovation and reinforces our commitment to advancing next-generation cancer therapies.” In October 2024, Jacobio Pharma’s internally developed KRAS glycine-to-cysteine mutation at codon 12 (G12C) inhibitor, glecirasib, received orphan drug designation from the European Medicines Agency. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now

Orphan Drug

100 Deals associated with Glecirasib

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
KRAS G12C mutant Non-small Cell Lung Cancer	China	Shanghai Allist Pharmaceuticals Co., Ltd.	20 May 2025

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
KRAS G12C mutant non-squamous non-small cell lung cancer	Phase 3	China	Beijing Jiakesi New Drug Development Co. Ltd.	18 Jul 2024
KRAS p.G12C mutant pancreatic cancer	Phase 2	China	Beijing Jiakesi New Drug Development Co. Ltd.	16 Oct 2023
KRAS G12C mutation Solid Tumors	Phase 2	United States	Jacobio Pharmaceuticals Group Co., Ltd.	04 May 2022
KRAS G12C mutation Solid Tumors	Phase 2	Israel	Jacobio Pharmaceuticals Group Co., Ltd.	04 May 2022
KRAS G12C mutation Solid Tumors	Phase 2	Spain	Jacobio Pharmaceuticals Group Co., Ltd.	04 May 2022
Pancreatic Ductal Carcinoma	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	14 Apr 2022
Advanced Colorectal Adenocarcinoma	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	17 Feb 2022
KRAS p.G12C mutant colorectal cancer	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	17 Feb 2022
Small intestine carcinoma recurrent	Phase 2	China	Shanghai Allist Pharmaceuticals Co., Ltd.	17 Feb 2022
Appendiceal Neoplasms	Phase 2	China	Beijing Jiakesi New Drug Development Co. Ltd.	07 Feb 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05009329 \| NCT05194995 (Pubmed \| Lancet Gastroenterol Hepatol) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer KRAS G12C	91	Glecirasib 800 mg once daily	ztnzicqcaw(smowqdnopz) = qbbgrmlyhw nuybrbeixp (cdmkmumuxp, 11 - 38) View more	Positive	01 Dec 2025
				Glecirasib 800 mg once daily + Cetuximab	ztnzicqcaw(smowqdnopz) = panfjuunqc nuybrbeixp (cdmkmumuxp, 35 - 65) View more
NCT05009329 \| NCT05194995 (JAB-21822-1002, Pubmed \| Lancet Gastroenterol Hepatol)	Phase 1/2	KRASG12C mutation	91	Glecirasib 800 mg once daily	quuhwlrcle(hycaptxbnw) = hnzoqqygvn ixdescebhb (nfrkyugvpk, 11 - 38) View more	Positive	01 Dec 2025
				Glecirasib 800 mg once daily + cetuximab	quuhwlrcle(hycaptxbnw) = yrcngavsrw ixdescebhb (nfrkyugvpk, 35 - 65) View more
NCT05009329 \| NCT05002270 (Pubmed \| Cancer Commun (Lond))	Phase 1/2	KRAS G12C mutation Solid Tumors KRAS G12C mutation	54	Glecirasib	xukvcawabb(kywakcorzi) = fpxlioopqo imrcexsvqz (fstggskjsb, 36.8 - 64.9) View more	Positive	01 Nov 2025
				Glecirasib (PDAC)	xukvcawabb(kywakcorzi) = iezkkceeuc imrcexsvqz (fstggskjsb, 29.1 - 65.3) View more
NEWS Manual	Phase 2	KRAS G12C mutant Non-small Cell Lung Cancer First line KRAS G12C	-	Glecirasib	othfqnnxob(aualyupnfd) = sxowprhklp cvrtzzmcnm (wldcaxjvpi ) View more	Positive	16 Jul 2025
				Sotorasib	othfqnnxob(aualyupnfd) = zdblcvappu cvrtzzmcnm (wldcaxjvpi ) View more
NCT05009329 \| NCT05194995 (ASCO_GI2025) Manual	Phase 1/2	KRAS G12C mutant Colorectal Cancer KRAS G12C	44	Glecirasib 800mg QD	guitahiklt(fnhuziffdx) = dteuktkvpq awpaqfcexx (estlxqmjpw ) View more	Positive	23 Jan 2025
				Glecirasib 800mg QD + Cetuximab	guitahiklt(fnhuziffdx) = kfuboysrca awpaqfcexx (estlxqmjpw ) View more
NCT05009329 (Pubmed) Manual	Phase 2	KRAS G12C mutant Non-small Cell Lung Cancer KRAS G12C	119	Glecirasib 800 mg daily	hjtovjrwmo(nldvdfxden) = ozuguykspu kxofphovxe (zsznoparnx, 38.5 - 57.3) View more	Positive	06 Jan 2025
NCT05288205 (ESMO2024) Manual	Phase 1/2	KRAS G12C mutant Non-small Cell Lung Cancer First line KRAS G12C \| PD-L1	102	Glecirasib plus JAB-3312	yjlffghvyw(ytcbrpfwca) = jlyxlnnzsu qiwbwuujup (txefrfdtxo ) View more	Positive	14 Sep 2024
				Glecirasib plus JAB-3312 (PD-L1 TPS≥50%)	yjlffghvyw(ytcbrpfwca) = adyvjijall qiwbwuujup (txefrfdtxo ) View more
NCT05288205 (PRNewswire) Manual	Phase 1/2	KRAS G12C mutant Non-small Cell Lung Cancer First line KRAS G12C	194	JAB-21822+JAB-3312	mtzifqggpi(ziwkrwlbwr) = ausgjnylfb pknokuobxd (syafaamxwc )	Positive	01 Jun 2024
				JAB-21822+JAB-3312 (frontline)	paxigczesw(vybszlblem) = upgufrdknf ooefvlxuwz (hparxoqcbx ) View more
NCT05288205 (ASCO2024) Manual	Phase 1/2	KRAS G12C mutation Solid Tumors KRAS G12C	179	Glecirasib 800 mg	lplbemuqze(heecozbbaq) = beqxtrxuwm wjzptjlshn (kpytiolaib ) View more	Positive	24 May 2024
NCT05009329 (ASCO2024) Manual	Phase 2	Non-Small Cell Lung Cancer Second line KRAS G12C	119	Glecirasib 800mg daily	upmfxnjmvk(dsjkzuzkxz) = ynxamgzmwo gxzffblkdh (cjjxzrekpc ) Met View more	Positive	30 Apr 2024

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