NEWS

 

Title Date
Oneness received approval by TFDA on the phase 2 clinical trial application for FB704A, a fully-human anti-IL6 antibody new drug, in severe asthma. 2021-04-19
Oneness announces that Nanchou manufacturing site has been GMP and GDP certified by MOHW 2021-04-12
Oneness has submitted the phase 2 clinical trial application for FB704A, a fully-human anti-IL6 antibody new drug, in severe asthma to TFDA via fast track. 2021-04-07
An Indian patent on the Anti-CεmX (FB825) antibody was granted. 2021-04-05
Oneness was notified by US FDA today that the DFU new drug (ON101), has been granted the Fast Track Designation, which will facilitate NDA process of ON101 in US. 2021-03-31
Oneness has received the letter from MOHW with regards to collection the drug license of DFU new drug: Fespixon cream. 2021-03-28
Oneness Biotech Co., LTD receives a European patent on OB318, a new drug in development for liver cancer. 2021-03-26
Oneness Biotech Co.,LTD receives a Taiwan patent on antagonistic PDL1 aptamers. 2021-03-23
Oneness has been notified by Microbio Shanghai Co., Ltd. that CDE under NMPA accepted NDA application by writing for, the DFU new drug: ON101 2021-03-13
Oneness has been notified that FB704A, a fully-human anti-IL6 antibody new drug, is safe to proceed with the phase 2 clinical trial in severe asthma under US FDA IND 2021-03-13
Oneness received the letter from MOHW informing that ON101 for DFUs has obtained the new drug approval and its drug certificate will be notified for receipt. 2021-02-24
Oneness submits an IND to US FDA on a phase II clinical trial on severe asthma of FB704A, a mAb developed from its own platform. 2021-02-15
Oneness will not proceed with the ON101 Phase3 clinical trial (ON101CLCT04) application with BfArM of Germany based on strategic consideration. 2021-02-09
Oneness Biotech Co.,LTD receives a U.S. patent titled "TOPICAL FORMULATION FOR PROMOTING WOUND HEALING" on the developing new drug: ON101 Cream. 2021-02-02
Oneness Biotech Co.,LTD receives a European patent on antagonistic PDL1 aptamers. 2021-01-29
Oneness Biotech Co.,LTD receives a European patent on antagonistic CTLA-4 aptamers. 2021-01-29
Oneness announces that LEO PHARMA made the 2nd upfront payment of US$15.12MM according to the agreement. A total of US$33.6MM upfront payments have been received. 2021-01-14
Oneness Biotech to Present at the 39th Annual J.P. Morgan Healthcare Conference 2021-01-04