Company History

2021

April
OBI-3424, a new precursor chemotherapy drug, has completed the safety evaluation of the first phase of clinical dose increment trial, and plans to launch the second phase of clinical population expansion trial.
February
It signed a global cosmetic medicine licensing agreement with Obigen Pharma, Inc. “OBI-858 new botulinum toxin preparation”.

2020

December
The active immune anticancer drug OBI-822(Adagloxad Simolenin) was approved by National Medical Products Administration, China for the third phase of human clinical trial.
November

We received a reply from the US Food and Drug Administration (FDA) on the application for medical equipment clinical research (IDE) in the first/second stage of population expansion of human clinical trials of a new precursor chemotherapy drug OBI-3424, which can be used in the first/second stage of population expansion of human clinical trials without approval.

September
It increased capital and issued 10,693,000 shares in exchange for 53,466,000 common shares of Amaran Biotechnology Inc. to shareholders of Amaran Biotechnology Inc., and acquired 67% equity of Amaran Biotechnology December 31st, 2020 is the benchmark date of share exchange.
August

– OBI-866, an active immune anticancer drug, was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first phase of human clinical trial.
– The new botulinum toxin preparation OBI-858 was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first phase of human clinical trial.

July
OBI-888, a new passive immune monoclonal antibody, was approved by the Taiwan Food and Drug Administration of the Ministry of Health and Welfare for the first/second phase human clinical trials.
April
OBI-822 (Adagloxad Simolenin) was approved by the Ministry of Food and Drug Safety of South Korea to carry out phase III human clinical trial.
January
In January, Globo H antibody-drug conjugate OBI-999 obtained the qualification as the “orphan drug” for gastric cancer treatment from US Food and Drug Administration (FDA).

2019

December
Globo H antibody-drug conjugate OBI-999 obtained the qualification as the “orphan drug” for pancreatic cancer treatment from US Food and Drug Administration (FDA).
September
The results of Adagloxad Simolenin (OBI-822) ovarian cancer phase II clinical trial cooperated with Taipei Mackay Memorial Hospital were announced, generally speaking, the safety and tolerance of this vaccine were acceptable.
August
The Globo H antibody-drug conjugate OBI-999 was approved by US Food and Drug Administration (FDA) to carry out phase I/II human clinical trial.
June

– Convened annual general meeting, carried out reelection of directors comprehensively, and then Board of Directors Meeting was convened, in which directors elected and reappointed Michael N. Chang, legal representative of Yi Tai Investment Co., Ltd., as the Chairman.
– Passive immunity monoclonal antibody new drug OBI-888 had completed the assessment of major safety indicators for phase I human clinical trial, the safety and tolerance of OBI-888 were good, and there were no major safety concerns.

April
OBI-822 (Adagloxad Simolenin) was approved by Ministry of Health of the Russian Federation to carry out phase III human clinical trial.
March
Poster at the annual meeting of the American association for cancer research (AACR): Obi-888 and obi-999 (a new single antibody drug and a new antibody small molecule drug complex called ADC) are the first to be developed. Their mechanism of action, antineoplastic efficacy, drug metabolism and pharmacokinetic characteristics are also discussed.
February

– Published in the journal of the national academy of sciences (PNAS) in cooperation with academia sinica, the paper proves that the Globo series is closely related to the survival of cancer cells, which provides an important theoretical basis for haoding Globo series to target new anti-cancer drugs.
– OBI-822 (Adagloxad Simolenin) was approved by Ministry of Health of Ukraine to carry out phase III human clinical trial.

January
The 37th J.P. Morgan HealthCare Conference Report was first invited to San Francisco.