Published Date:2021-04-05 Original Link:https://www.onenessbio.com/en/news_detail35_4.htm No 1 Date of announcement   2021/03/31 Time of announcement 20:49:25 Subject An Indian patent on the Anti-CεmX (FB825) antibody was granted.      To which item it meets paragraph 53 Date of events 2021/03/31 Statement 1.Date of occurrence of the event:2021/04/03 2.Company name:ONENESS BIOTECH CO., LTD. 3.Relationship to the Company (please...Read More

Published Date:2021-03-31 Original Link:https://www.onenessbio.com/en/news_detail34_4.htm No 1 Date of announcement   2021/03/31 Time of announcement 20:49:25 Subject 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.      To which item it meets paragraph 53 Date of...Read More

Published Date:2021-03-28 Original Link:https://www.onenessbio.com/en/news_detail33_4.htm No 2 Date of announcement      2021/03/28 Time of announcement 10:01:57 Subject Oneness has received the letter from MOHW with regards to collection the drug license of DFU new drug: Fespixon cream.      To which item it meets paragraph 10 Date of events  2021/03/26 Statement 1.Product:The diabetic foot ulcer...Read More

Published Date:2021-03-26 Original Link:https://www.onenessbio.com/en/news_detail32_4.htm No 1 Date of announcement  2021/03/26 Time of announcement 18:21:40 Subject Oneness Biotech Co., LTD receives a European patent on OB318, a new drug in development for liver cancer.      To which item it meets paragraph 53 Date of events  2021/03/26 Statement 1.Date of occurrence of the event:2021/03/26 2.Company name:ONENESS...Read More

Published Date:2021-03-23 Original Link:https://www.onenessbio.com/en/news_detail31_4.htm No 1 Date of announcement  2021/03/23 Time of announcement 18:17:00 Subject Oneness Biotech Co.,LTD receives a Taiwan patent on antagonistic PDL1 aptamers.      To which item it meets paragraph 53 Date of events  2021/03/23 Statement      1.Date of occurrence of the event:2021/03/23 2.Company name:ONENESS BIOTECH CO., LTD. 3.Relationship to...Read More

Published Date:2021-03-13 Original Link:https://www.onenessbio.com/en/news_detail30_4.htm No 1 Date of announcement   2021/03/13 Time of announcement  20:52:32 Subject Oneness has been notified by Microbio Shanghai Co., Ltd. that CDE under NMPA accepted NDA application by writing for, the DFU new drug: ON101      To which item it meets paragraph 10 Date of events  2021/03/13 Statement 1.Product:ON101 Diabetic...Read More

Published Date:2021-03-13 Original Link:https://www.onenessbio.com/en/news_detail29_4.htm No 1 Date of announcement   2021/03/13 Time of announcement  17:05:18 Subject 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      To which item it meets paragraph 10 Date of...Read More

Published Date:2021-02-24 Original Link:https://www.onenessbio.com/en/news_detail28_4.htm No 1 Date of announcement   2021/02/24 Time of announcement  08:42:18 Subject 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.      To which item it meets paragraph 10 Date of events  2021/02/24 Statement...Read More

Published Date:2021-02-15 Original Link:https://www.onenessbio.com/en/news_detail27_4.htm No 1 Date of announcement   2021/02/15 Time of announcement  08:42:18 Subject 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.      To which item it meets paragraph 10 Date of events  2021/02/13 Statement 1.Product:FB704A...Read More

Published Date:2021-02-09 Original Link:https://www.onenessbio.com/en/news_detail26_4.htm No 1 Date of announcement  2021/02/09 Time of announcement  17:10:57 Subject Oneness will not proceed with the ON101 Phase3 clinical trial (ON101CLCT04) application with BfArM of Germany based on strategic consideration.      To which item it meets paragraph 10 Date of events 2021/02/09 Statement 1.Product:ON101 2.Mass production date:NA 3.Effect on...Read More