The first CTA and clinical study of EnliTISA Pharmaceuticals TISA-818 for treating idiopathic pulmonary fibrosis has been approved by the MPA
On November 27, 2023, EnliTISA Pharmaceuticals TISA-818, a Class I innovative drug for the treatment of idiopathic pulmonary fibrosis, was approved by the MPA.
The approval of this clinical trial is the first step for EnliTISA Pharmaceuticals to carry out international clinical trials and the overall layout of innovative drug registration. The company's efforts in preclinical study, phase I clinical study, manufacture of drug products in Sweden, preparation of clinical study protocol, submission of clinical trial applications (CTAs), and overall quality of research and development have been recognized by the European regulatory system.
The essence of innovative drug development is to meet the most profound clinical needs. EnliTISA Pharmaceuticals focuses on the fields of inflammation and fibrosis, and focuses on promoting the TISA-818 projects in the treatment of idiopathic pulmonary fibrosis and acute respiratory distress syndrome. EnliTISA always adhered to an internationalized strategy, from intellectual property application, technical team building, clinical key opinion leader (KOL) invitation, clinical study operation, new drug registration to business promotion.
Completion of first patient first visit in phase II clinical trial of TISA-818-Inj for the treatment of acute respiratory distress syndrome
The Phase II clinical trial of TISA-818-Inj for the treatment of acute respiratory distress syndrome (ARDS) recently completed first patient first visit (FPFV), which was led by Professor Zhan Qingyuan of the China-Japan Friendship Hospital and sponsored by EnliTISA (Shang Hai) Pharmaceutical Co., Ltd (Abbreviated as EnliTISA).