ABVC BioPharma, Inc. (ABVC) stock soared 75.59% in the pre-market trading session at the price of $4.46 despite no fundamental reason. ABVC is a clinical-stage biopharmaceutical company. It has one medical kit (ABV-1701/Vitargus) and an ongoing pipeline of six drugs under progress.
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CIRB Granted Approval for ABV-1505 Phase II
On 27th October 2021, ABVC published that it had received approval for the Phase II study of its ABV-1505 Attention-Deficit Hyperactivity Disorder drug. The approval had granted by Taiwan Central Institutional Review Board for Taiwan medical centers only. The Phase II study is a placebo-controlled, double-blind, and randomized study that comprises 100 victims in Taiwan sites.
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Part 1 of ABV-1505 study was conducted from January 2020 to July 2020 at UCSF and approved by the US Food & Drug Administration (FDA) in October 2020. The Part 2 ABV-1505 study will start in the first quarter of 2022 and be complete by the end of 2022. BioPharma is also expecting approval to conduct the study at the University of California, San Francisco (UCSF) Medical Center in the United States.
Management Comments
Dr. Howard Doong, Chief executive officer of ABVC BioPharma, remarked that they are happy that CIRB approved their ABV-1505 ADHD Phase II Part II study. ABVC’s clinical trials demonstrate that drugs originating from plants and administered in proper doses have vital therapeutic benefits to treat severe medical conditions. The company expects to get CIRB approval for UCSF later this year. It will start the clinical study of ADHD in Taiwan and the United States in the first quarter of 2022, he added.
ABVC Announced Joint Venture Agreement with Lucidam
Previously on 12th October 2021, ABVC published the execution of a joint venture deal with Lucidam, a Tokyo-based private investment company. The agreement aims to expand business collaboration to identify opportunities in drug development and medical technology.
Under the joint venture deal, ABVC BioPharma will preserve equity ownership of 49%, while Lucidam will retain equity ownership of 51% in BioLite Japan. As per the terms, BioLite Japan will identify and approve New Biological Entities (NBEs), New Chemical Entities (NCEs), biomarkers, diagnostic tools, and medical devices in the early stages of development all around the world.
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Dr. Toru J. Seo will lead the Tokyo-based joint venture agreement. He has extensive pharma industry experience in research and development from his prior roles with GSK, Taisho, and Merck.
