FB704A / Microbio - LARVOL DELTA

Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Oneness Biotech Co., Ltd. | N=40 ➔ 20 | Trial completion date: Sep 2025 ➔ May 2026 | Trial primary completion date: Sep 2025 ➔ Feb 2026

Enrollment change • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Oneness Biotech Co., Ltd. | Phase classification: P2a ➔ P2 | Trial completion date: Jun 2024 ➔ Sep 2025 | Trial primary completion date: Feb 2024 ➔ Sep 2025

Phase classification • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • IL6

Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma (clinicaltrials.gov) - P2a | N=40 | Recruiting | Sponsor: Oneness Biotech Co., Ltd. | Trial completion date: Dec 2022 ➔ Jun 2024 | Trial primary completion date: Jul 2022 ➔ Feb 2024

Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

Heyi: Announcement that the new anti-IL6 fully human monoclonal antibody drug FB704A independently developed by the company has obtained an invention patent in India [Google translation] (Anue Juheng) - "The company received a notification from the patent office today that the new drug FB704A, a fully human monoclonal antibody developed by itself, has obtained the Indian invention patent. The patent name is 'Interleukin-6 antibody and its use', and the patent certificate number is 389592."

Patent • Asthma • Immunology • Respiratory Diseases • Rheumatoid Arthritis

Heyi's self-developed Anti-IL6 fully human monoclonal antibody new drug FB704A obtained a Korean invention patent [Google translation] (Yahoo News) - "...The company received a notification from the patent office today that the new drug FB704A, a fully human monoclonal antibody developed by itself, has won the Korean National invention patent. The patent name is "Interleukin-6 antibody and its use", and the patent certificate number is 10-2321372."

Patent • Asthma • Immunology • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Rheumatoid Arthritis

Evaluate the Efficacy and Safety of FB704A in Adult With Severe Asthma (clinicaltrials.gov) - P2a; N=40; Recruiting; Sponsor: Oneness Biotech Co., Ltd.

Clinical • New P2a trial • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

New crown and new drug animal challenge test reveals light to start human clinical trials as soon as next year [Google translation] (Anue.com) - "After the second phase trial of the new severe asthma drug FB704A started and accepted in July, it is scheduled to be completed in the second half of the year and the trial report will be completed in the first half of next year."

Trial completion date • Asthma • Immunology • Respiratory Diseases

New Monoclonal Antibody Drug Proposes Phase II Clinical Severe Coronary Pneumonia to the U.S. FDA (money.udn.com) - "Heyi (4743) announced today (8) that the company has submitted an application for review of the Phase II clinical trial of severe new coronary pneumonia to the US Food and Drug Administration (FDA) for the development of a new Chinese drug FB704A (Anti-IL6 fully human monoclonal antibody)."

New P2 trial • Infectious Disease • Novel Coronavirus Disease

Shenghuake's COVID-19 new drug reports good news and gaps in the daily limit [Google translation] (money.udn.com) - "The self-developed Anti-IL6 fully human monoclonal antibody new drug FB704A has been approved by the US Food and Drug Administration (FDA) for the treatment of severe asthma in the second phase of clinical trials."

New P2 trial • Asthma • Respiratory Diseases

Evaluate the Safety, Tolerability, Pharmacokinetics,and Clinical Activity of FB704A (clinicaltrials.gov) - P1; N=31; Completed; Sponsor: Fountain Biopharma Inc.; Recruiting ➔ Completed; Trial completion date: Nov 2019 ➔ May 2020; Trial primary completion date: Nov 2019 ➔ May 2020

Clinical • Trial completion • Trial completion date • Trial primary completion date • Immunology • Rheumatoid Arthritis • Rheumatology

A Placebo-controlled Study to Evaluate the Safety, Movement Through, and Reaction of the Body to Single and Multiple Increasing Doses of FB704A (clinicaltrials.gov) - P1; N=41; Recruiting; Sponsor: Fountain Biopharma Inc.

Clinical • New P1 trial