BEIJING, SHANGHAI, AND BOSTON, March 29, 2024/PRNewswire/ -- Gacos Pharmaceuticals (1167.HK) released its 2023 annual results report. During the performance period, revenue was 63.5 million yuan, R&D investment was 372 million yuan, and a capital balance of 1.2 billion yuan at the end of 2023. Gacos also announced recent business developments and expected milestones.
Dr. Wang Yinxiang, Chairman and CEO of Gacos Pharmaceuticals, said, “In the past year, several Gacos projects have progressed. The combination of the SHP2 inhibitor JAB-3312 and Golerese was approved to conduct phase III registered clinical trials in China. Gacos became the first company to promote SHP2 into registered clinical trials. This is a phased result of our layout of difficult drug targets. The core product Golerese has completed registration clinical trials and will submit a new drug marketing application in the first half of 2024, which marks that Gacos will enter the commercialization stage.”
Accelerating core projects
KRAS G12C inhibitor golirese (JAB-21822)
Non-small cell lung cancer:
- The second-line single-agent non-small cell lung cancer phase II registered clinical trial has been completed and a new drug marketing application will be submitted to CDE (National Drug Administration Drug Evaluation Center) in the second quarter of 2024 according to the original plan
- First-line Phase III registered clinical trial with SHP2 inhibitor JAB-3312 approved in China
Pancreatic cancer:
- Second-line single-agent treatment of pancreatic cancer has initiated phase II registered clinical trials in China
- Data were released at the 2024 American Society of Clinical Oncology Gastrointestinal Cancer Symposium Annual Meeting (2024 ASCO GI), confirming that the objective response rate was 41.9% (13/31), the disease control rate was 93.5% (29/31), and the median progression-free survival (mPFs) was 5.6 months
Colorectal cancer:
- Clinical data on the treatment of advanced KRAS G12C mutant colorectal cancer with goleside monotherapy and cetuximab have been published at AACR-JCA
- Phase III registered clinical trials for monotherapy and combination with cetuximab are expected to be approved by CDE in the second quarter of 2024
Pancreatic tumors:
- Common tumors include biliary tract tumors, stomach cancer, small intestine cancer, appendix cancer, etc.
- Data were released at the 2024 American Society of Clinical Oncology Gastrointestinal Cancer Symposium Annual Meeting (2024 ASCO GI), confirming that the objective response rate was 57.9% (11/19), the disease control rate was 84.2% (16/19), and the median progression-free survival was 7.0 months
- Phase II single-arm registration clinical trial is communicating with CDE
SHP2 inhibitor JAB-3312
- The combined use of JAB-3312 first-line and golerese has been approved by the CDE to conduct a phase III registered clinical trial, which is scheduled to commence in the third quarter of 2024. JAB-3312 is the world's first SHP2 inhibitor to enter phase 3 registered clinical trials
- Data have been published at the 2023 European Society of Medical Oncology Annual Meeting (ESMO 2023). The objective response rate (ORR) was 86.7% (13/15) and the disease control rate was 100% (15/15) in the 800 mg (once daily) golese and 2 mg SHP2 (once daily, 1 week interval) dose group
- Long-term safety and efficacy data of combined drugs have been submitted to the American Society of Clinical Oncology (ASCO) in 2024
Other clinical project developments
- P53 Y220C activator JAB-30355: IND has been approved in the US and clinical trials are scheduled to be carried out in the second half of 2024; preclinical data will be released at the American Association for Cancer Research (AACR) in 2024
- BET inhibitor JAB-8263: A single drug or combination phase II trial is scheduled to be initiated in the second half of 2024; data has been submitted to the 2024 European Hematology Association Conference (EHA)
- Aurora A inhibitor JAB-2485: The recommended dose for phase 2 is scheduled to be determined in the second quarter of 2024; pre-clinical data was announced at the 2023 American Association for Research on Cancer (AACR) Annual Meeting
- CD73 monoclonal antibody JAB-BX102: The recommended dose for phase 2 is scheduled to be determined in the second quarter of 2024; pre-clinical data was announced at the 2023 American Association for Research on Cancer (AACR) Annual Meeting
- PARP7 inhibitor JAB-26766: Preclinical data will be released by the American Association for Research on Cancer (AACR) in 2024
- PARP7 inhibitor JAB-26766, GUE (glutamine substrate related metabolic enzyme) inhibitor JAB-24114, and LIF monoclonal antibody JAB-BX300 will optimize clinical development strategies based on relevant research progress and resource allocation
Pre-clinical project progress
- KRASMultiThe inhibitor JAB-23E73 will submit a new drug clinical trial application in the second quarter of 2024
- HER2-STING iADC JAB-BX400 will confirm clinical candidate molecules in the second half of 2024
As of December 31, 2023, Gacos has applied for more than 340 invention patents worldwide, including 82 authorized invention patents. During the performance period, Gacos raised HK$159 million through a Hong Kong stock placement and received financial support of 150 million yuan from Yizhuang SDIC. The balance of funds was 1.2 billion yuan, and there were sufficient cash reserves for R&D investment over the next 30-36 months. At the same time, 1.807 million shares were repurchased and cancelled, continuing to increase shareholder value.
Conference call related information
Gacos Pharmaceuticals will hold a 2023 annual results conference call on March 29, 2024, Beijing time. To participate, please register in advance using this link:
About Garcos
Gacos Pharmaceuticals (1167.HK) is committed to providing patients with breakthrough treatment solutions. The company's research projects focus on the six major tumor signaling pathways: KRAS, tumor immunity, tumor metabolism, P53, RB, and MYC. The core projects target the top three in the world. The company's vision is to work hand in hand with partners to become a globally recognized leader in drug development. Gacos's laboratories are located in Beijing, China, Shanghai, and Boston, USA, and have an inducible allosteric drug discovery platform and an iADC drug development platform. To learn more, visit:.