Published Date:2021-04-19 Original Link:https://www.onenessbio.com/en/news_detail38_3.htm No 2 Date of announcement 2021/04/19 Time of announcement 19:32:01 Subject 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. To which item it meets paragraph 10 Date of events 2021/04/19 Statement 1.Product:FB704A 2.Mass production...Read More
Published Date:2021-04-12 Original Link:https://www.onenessbio.com/en/news_detail37_3.htm No 1 Date of announcement 2021/04/12 Time of announcement 20:52:15 Subject Oneness announces that Nanchou manufacturing site has been GMP and GDP certified by MOHW To which item it meets paragraph 53 Date of events 2021/04/12 Statement 1.Date of occurrence of the event:2021/04/12 2.Company name:Oneness Biotech Co., Ltd. 3.Relationship...Read More
Published Date:2021-04-07 Original Link:https://www.onenessbio.com/en/news_detail36_3.htm No 1 Date of announcement 2021/04/07 Time of announcement 19:21:18 Subject 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. To which item it meets paragraph 10 Date of events 2021/04/07 Statement 1.Product:FB704A...Read More
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