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InxMed Receives US FDA IND Approval to Initiate Clinical Trial for IN10018

InxMed Receives US FDA IND Approval to Initiate Clinical Trial for IN10018

2019-09-20 09:00

September 20, 2019

Shanghai, China—InxMed (Shanghai) Co., Ltd. (“InxMed” or “Company”), announced that the Company has obtained FDA (Food and Drug Administration) IND clearance for IN10018, a proprietary focal adhesion kinase (FAK) inhibitor. This is InxMed’s first IND opening approved by FDA, which reflects the company's superior R&D capability.


Dr. Zaiqi Wang, InxMed’s Chairman and CEO, said: “We feel very excited about obtaining IND clearance from FDA for IN10018.It only took 8 months  to achieve this significant milestone upon the inception of the company. We feel very proud of the execution excellence of our team. As a clinical-stage biotech company with focus on developing “Best-in-Disease Combination” regimen to provide better treatment option for patients. , InxMed is striving to  become a leading player to accelerate the tranlations of science innovations into clinic and Proof of Concept through our insight of the underlining disease biology and execution efficiency.


IN10018, formerly known as BI853520, is a potent and selective ATP-competitive focal adhesion kinase (FAK) small molecule inhibitor under clinical development stage in both the United States and China. InxMed owns the exclusive global rights for development and commercialization. Early clinical data of IN10018 has demonstrated a favorable safety profile and promising efficacy signals against a number of tumor types. Emerging science also showed that FAKi like IN10018 potentially overcomes fibrotic barrier and immune tolerance, boosting multi-modalities including targeted therapy, chemotherapy, immune-therapy and radiation therapy.


About InxMed

InxMed is a clinical-stage biotech company focusing on developing “Best-in-Disease Combination” medicines to bring novel treatment option for patients. Our innovations are inspired by patients and driven by in-depth understanding of disease biology and pharmacology. InxMed is committed to building a translational platform equipped with global-level top-notch know how and efficient execution capabilities. Established in the end of 2018, InxMed has raised tens of millions of US dollars in series A round financing, established an integrated high caliber research and clinical development team across Shanghai, Beijing, United States, Canada and Australia. We have built a highly differentiated pipeline, and established licensing or co-development partnership with various multinational pharmaceutical companies.

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