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Oneness Biotech Co., Ltd., has been granted the Brazil Good Manufacturing Practice (B-GMP) certification for Bonvadis from Brazil ANVISA.

2021

Date

Title

2021-04-05

An Indian patent on the Anti-CεmX (FB825) antibody was granted.

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2021-03-31

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.

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2021-03-28

Oneness has received the letter from MOHW with regards to collection the drug license of DFU new drug: Fespixon cream.

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2021-03-26

Oneness Biotech Co., LTD receives a European patent on OB318, a new drug in development for liver cancer.

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2021-03-23

Oneness Biotech Co.,LTD receives a Taiwan patent on antagonistic PDL1 aptamers.

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2021-03-13

Oneness has been notified by Microbio Shanghai Co., Ltd. that CDE under NMPA accepted NDA application by writing for, the DFU new drug: ON101

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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

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2021-02-24

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.

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2021-02-15

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.

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2021-02-09

Oneness will not proceed with the ON101 Phase3 clinical trial (ON101CLCT04) application with BfArM of Germany based on strategic consideration.

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2021-02-02

Oneness Biotech Co.,LTD receives a U.S. patent titled “TOPICAL FORMULATION FOR PROMOTING WOUND HEALING” on the developing new drug: ON101 Cream.

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2021-01-29

Oneness Biotech Co.,LTD receives a European patent on antagonistic PDL1 aptamers.

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2021-01-29

Oneness Biotech Co.,LTD receives a European patent on antagonistic CTLA-4 aptamers.

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2021-01-14

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.

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2021-01-04

Oneness Biotech to Present at the 39th Annual J.P. Morgan Healthcare Conference

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