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Multiple pharmaceutical companies disclose progress in clinical trials of innovative drugs


Time:2024-09-23 10:44:12  Source:  Author:

 

In the past three days, several pharmaceutical companies have disclosed the progress of clinical trials for innovative drugs, including Baili Tianheng, Jiakesi, Dezhan Health, and Shiyao Group.

 
 
 
On September 23rd, Gakos announced that its independently developed Pan KRAS inhibitor JAB-23E73 has obtained approval from the US Food and Drug Administration (FDA) for its new drug clinical trial application (IND), and will conduct Phase I/IIa clinical trials for advanced solid tumors in the United States. The IND application in China has been submitted to the Drug Evaluation Center of the China National Medical Products Administration, and clinical trials will be conducted simultaneously in China after approval.
 
 
 
Data shows that KRAS is widely present in various tumor mutations, with approximately 23% -25% of cancer patients carrying KRAS mutations. Approximately 2.7 million new cancer patients worldwide with KRAS related mutations are expected to benefit from Pan KRAS inhibitors each year. JAB-23E73 can simultaneously inhibit the activity and inactive state of KRAS, and has no significant inhibition on HRAS and NRAS. As an oral KRAS inhibitor, JAB-23E73 has demonstrated good pharmacokinetic properties in preclinical data.
 
 
 
Baili Tianheng announced on September 22 that its self-developed innovative biopharmaceutical multispecific antibody GNC-077 has been approved by the National Medical Products Administration for clinical trials and is used to treat advanced solid tumors.
 
 
 
The announcement shows that GNC-077 is an innovative multispecific antibody molecule independently developed by Baili Tianheng through an innovative multispecific antibody drug development platform. Its molecular structure includes antibody domains targeting T cell CD3 and T cell immune checkpoint, as well as antibody domains targeting tumor antigens. It is reported that GNC-077 can effectively induce the activation, differentiation, and proliferation of T cells, and mediate the specific targeted killing of tumor antigen positive tumor cells by activated T cells. In in vivo studies, GNC-077 has shown strong anti-tumor efficacy in various solid tumors.
 
 
 
On September 22, Dezhan Health also announced that Dezhan Big Health Co., Ltd. had received a notice from its joint venture company Beijing Dongfang Lue Biomedical Technology Co., Ltd. Dongfang Lue recently received the "Drug Clinical Trial Approval Notice" approved by the National Medical Products Administration (NMPA), approving its Phase II clinical trial application for the VGX-3100 project developed in collaboration with Inovio Pharmaceuticals Inc. in the United States for HPV-16/18 related anal precancerous lesions.
 
 
 
Data shows that VGX-3100 is a key collaborative development project between Dongfang Lue and Inovio in the field of DNA immunotherapy, used to treat precancerous lesions caused by human papillomavirus (HPV). The newly approved Phase II clinical trial of VGX-3100 is aimed at anal precancerous lesions and is a domestic drug for the treatment of anal precancerous lesions that has entered Phase II clinical trials. However, the research and development of original drugs have the characteristics of high investment, long cycle, and high risk. There is uncertainty in the time required for subsequent clinical trials, trial results, approval results from authorized departments, and whether they can ultimately be successfully launched.
 
 
 
In addition, on September 21st, according to a new announcement on the website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration, the clinical research application for the biosimilar drug of Shilao Group's daratumumab injection was accepted.
 
 
 
According to the data, DARZALEX, a single antigen research product developed by Johnson&Johnson, has been approved for marketing by the US FDA since 2015. It has been approved for marketing in multiple countries worldwide and is used in combination therapy with various products to treat multiple myeloma patients with different treatment backgrounds. In China, this product was first approved for market in 2019 and has since been approved for multiple new indications, covering various types of multiple myeloma.

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