On January 4, Jimin Credible announced that its subsidiary Shanghai Jiyu's Class 1 new drug JYB1907 new drug clinical trial application (IND) for injection has been approved
by the US FDA.
According to the data, JYB1907 is a humanized monoclonal antibody targeting GARP/TGF-β1 recombinant monoclonal antibody independently developed by Shanghai Jiyu Macromolecular Innovation Institute, which is intended to be used for the treatment of locally advanced or metastatic solid tumors
.
It is understood that with the improvement of the innovation and research and development capabilities of domestic pharmaceutical companies, the overseas expansion of domestic innovative drugs is accelerating
.
In the past month, in addition to Shanghai Jiyu's JYB1907 for injection, many new drugs have been approved by the FDA for clinical trials
.
Not long ago, Remegen Biopharmaceutical (Yantai) Co.
, Ltd.
announced that the company's self-developed innovative antibody conjugate drug (ADC) RC108 for injection has obtained the clinical trial approval of the US Food and Drug Administration (FDA) to carry out clinical research
in patients with solid tumors with positive c-Met expression.
RC108 is an ADC independently developed by Remegen for the treatment of patients
with c-Met positive solid tumors.
In November 2020, Remegen was approved by the NMPA to conduct a Phase I clinical trial
of RC108 for c-Met-positive advanced solid tumors in China.
At present, the test is progressing
smoothly.
On December 27, Ingchem and Shijian Biologics jointly announced that INES103, a new antibody drug jointly developed by the two companies, has obtained the approval of the US FDA New Drug Clinical Trial (IND) and will conduct clinical trials
in the United States for advanced or metastatic solid tumors.
INES103 is a humanized single-domain antibody (VHH)-Fc fusion protein that targets tumor immunity-related targets and is intended for the treatment
of a variety of solid tumors.
According to the data, INES103 is an important achievement
of the new drug development strategy guided by translational medicine research.
Since the molecular weight of VHH-Fc fusion protein is only half that of classical IgG, the molecule retains a long plasma half-life while having good tumor tissue penetration, so the unique molecular design will bring certain advantages
to INES103 for the treatment of solid tumors.
It is worth mentioning that Yingshi Biotech and Shijian Biotech have jointly completed the process and preclinical research and development
of INES103.
In addition, on December 21, Hitron Pharmaceutical also announced that the clinical trial application of the company's self-developed PROTAC drug HP518 for the treatment of metastatic castration-resistant prostate cancer (mCRPC) was officially accepted
by the FDA.
According to the announcement, HP518 is an androgen receptor (AR) PROTAC molecule
independently developed by the company using its PROTAC core technology platform to treat drug-resistant advanced prostate cancer.
As a novel PROTAC oral drug, preclinical studies have shown that HP518 has high activity, selectivity and potential to solve drug resistance, good oral exposure and bioavailability, high degradable activity against wild-type androgen receptors and enzalutamide-resistant variant androgen receptors, and excellent tumor suppressive activity
against androgen receptor-dependent prostate cancer cell lines.
Industry analysts believe that more and more domestic innovative drugs have been approved by the FDA for clinical trials and marketing, which on the one hand will help pharmaceutical companies open up a broader market in Europe and the United States, on the other hand, it also fully proves that the clinical development capabilities and application capabilities of Chinese innovative pharmaceutical companies are constantly improving
.
In the future, with the rapid development of China's innovative drug industry, the internationalization of domestic innovative drugs will become a general trend
.
={"common":{"bdSnsKey":{},"bdText":"","bdMini":"1","bdMiniList":false,"bdPic":"","bdStyle":"0","bdSize":"32"},"share":{},"image":{"viewList":[" weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"],"viewText":"share:","viewSize":"24"},"selectShare":{" bdContainerClass":null,"bdSelectMiniList":["weixin","sqq","qzone","tsina","tqq","tsohu","tieba","renren","youdao","fx","ty","fbook","twi","copy","print"]}}; with(document)0[(getElementsByTagName('head')[0]|| body).
appendChild(createElement('script')).
src='http://bdimg.
share.
baidu.
com/static/api/js/share.
js?v=89860593.
js?cdnversion='+~(-new Date()/36e5)]; 
