FB825 / Microbio, LEO Pharma - LARVOL DELTA

Evaluate Efficacy and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Oneness Biotech Co., Ltd. | Trial completion date: Dec 2026 ➔ Dec 2025 | Trial primary completion date: Dec 2026 ➔ Dec 2025

Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=90 | Recruiting | Sponsor: Oneness Biotech Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis (clinicaltrials.gov) - P2 | N=90 | Not yet recruiting | Sponsor: Oneness Biotech Co., Ltd.

New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

A Study to Evaluate the Safety and Bridging PK Profile of FB825 for Single Subcutaneous Administration in Healthy Adults (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Oneness Biotech Co., Ltd. | Trial primary completion date: Dec 2023 ➔ Mar 2024

Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

[Announcement] The patent of Heyi FB825 applied to the treatment of IgE-mediated allergic diseases has obtained the Russian patent certificate [Google translation] (stock.yahoo) - "The patent of Heyi FB825 applied to the treatment of IgE-mediated allergic diseases has obtained the Russian patent certificate....The company received a notice from the patent office today that the Anti-CεmX humanized monoclonal antibody (FB825) was obtained. Russian patent certificate...number is 2800765." "

Patent • Allergy • Food Hypersensitivity • Immunology

A Study to Evaluate the Safety and Bridging PK Profile of FB825 for Single Subcutaneous Administration in Healthy Adults (clinicaltrials.gov) - P1 | N=22 | Active, not recruiting | Sponsor: Oneness Biotech Co., Ltd.

New P1 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Evaluate the Efficacy and Safety of FB825 in Adult With Allergic Asthma (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Oneness Biotech Co., Ltd. | Trial completion date: Dec 2022 ➔ Jun 2024 | Trial primary completion date: Oct 2022 ➔ Jun 2024

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

Evaluate Efficacy of FB825 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2 | N=20 | Completed | Sponsor: Oneness Biotech Co., Ltd. | Trial completion date: Jun 2021 ➔ Mar 2022

Trial completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

FB825 monoclonal antibody new drug Phase IIa clinical trial of atopic dermatitis in the United States performs part of the efficacy indicators during the period of analysis. [Google translation] (Yahoo News) - "A total of 99 patients with moderate to severe atopic dermatitis were enrolled in this trial, and they were given a dose every four weeks FB825, a total of four doses of 16 weeks of treatment. This phase IIa trial is ongoing. All curative effects, blood Chemical index, sample analysis, pharmacokinetics, safety data, etc., it is scheduled to be completed in the first half of 2022..."

Trial status • Atopic Dermatitis • Immunology

One Anti-CεmX Monoclonal Antibody (FB825) Obtained Malaysian Invention Patent [Google translation] (Yahoo News) - "The company received a notice from the patent office that Anti-CεmX monoclonal antibody (FB825) obtained a Malaysian patent certificate."

Patent • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Food Hypersensitivity • Immunology • Respiratory Diseases

Evaluate Efficacy of FB825 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2; N=20; Completed; Sponsor: Oneness Biotech Co., Ltd.

Clinical • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Heyi DFU new drug first uses medical material card slot, Q4 enters FDA review, AD new drug first authorization fee will be credited to Q2 next year [Google translation] (Yahoo News) - "The new Chinese medicine FB825 is developed for the treatment of atopic dermatitis (AD), and the 2a full trial was reached in June. The target of the case is 99. It is expected that the main efficacy analysis will be completed in the fourth quarter. The trial report (CSR) will be completed in Q2 next year. At that time, the first authorization will be credited; the authorized partner Leo Pharmam will take over the start of 2b, and there will be a second The authorization fee is credited to the account."

Enrollment closed • New P2b trial • P2a data • Trial completion date • Atopic Dermatitis • Immunology

Evaluate Efficacy, PK, and Safety of FB825 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2; N=99; Active, not recruiting; Sponsor: Oneness Biotech Co., Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Jul 2021 ➔ Jun 2022; Trial primary completion date: May 2021 ➔ Dec 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

"Biomedicine stocks" new diabetic foot drugs are sold in Taiwan [Google translation] (China Times) - "Heyi's other product FB825-AD, the IIa clinical trial conducted in the United States completed the acceptance target in June, the analysis of the main efficacy indicators will be completed in November, and the trial blindness will be completed in March 2022. It is expected to be the second in 2022 quarterly completion of the test report (CSR)....LEO Pharma will take over the follow-up international IIb clinical trials in 2022."

New P2b trial • Trial completion date • Atopic Dermatitis • Dermatology

Heyi new medicine for diabetic foot wound ulcers in Taiwan is expected to be launched in May [Google translation] (money.udn.com) - "The IIa clinical trial of FB825 allergic asthma under Heyi has been approved by the Food and Drug Administration (TFDA) of the Ministry of Health and Welfare of Taiwan, and the same plan has been sent to the U.S. Food and Drug Administration (FDA) for review; 5 hospitals have been arranged to conduct the trial. Cases will be accepted in the second quarter of this year. It is scheduled to complete patient admissions in the first half of 2022, and the goal is to complete the trial in the second half of 2022."

New P2a trial • Trial completion date • Asthma • Respiratory Diseases

An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2; N=12; Completed; Sponsor: Fountain Biopharma Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Atopic Dermatitis • Dermatitis • Dermatology • Immunology

Zhongtian: Announced that its subsidiary Zhongtian (Shanghai) Biotechnology Co., Ltd. has entrusted Hesheng Technology to apply and received approval from the Ministry of Health and Welfare today to implement the Evaluation of the efficacy and safety of FB825 in adult patients with moderate to severe allergic asthma clinical trial [Google translation] (Anue.com) - "The name or code name of the new drug developed: FB825; Uses: To evaluate the efficacy and safety of adult patients with moderate to severe allergic asthma; All R&D stages expected to be carried out: Phase II human clinical trials....Zhongtian (Shanghai) entrusted Hesheng Technology to apply to the Ministry of Health and Welfare and was approved to implement the 'assessment FB825' in Taiwan Phase II clinical trial..."

New P2 trial • Asthma • Respiratory Diseases

Zhongtian subsidiary received LEO PHARMA A/S to pay the second phase FB825 new drug authorization signing fee of 2.88 million US dollars as agreed [Google translation] (MoneyDJ) - "Zhongtian announced that Zhongtian (Shanghai) Biotechnology Co., Ltd....has received a contract payment of US$ 2.88 million for the second phase of FB825 new drug authorization from a major international pharmaceutical company LEO PHARMA A/S. A total of 6.4 million has been received Full USD signing fee..."

Commercial • Atopic Dermatitis • Dermatology

Evaluate Efficacy, PK, and Safety of FB825 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2; N=90; Recruiting; Sponsor: Oneness Biotech Co., Ltd.

Clinical • New P2 trial • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology

"LEO Pharma pays $40 million upfront to Oneness Biotech to assume development of humanized IgG1 mAb FB-825 for atopic dermatitis and allergic asthma after phase IIa" (@Cortellis)

Financing • P2a data • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Dermatopathology • Immunology • Inflammation • Respiratory Diseases

LEO Pharma enters license agreement with Oneness Biotech and Microbio Shanghai for FB825 a novel atopic dermatitis and asthma drug candidate (Businesswire) - "LEO Pharma...today announced that is has signed a worldwide exclusive licensing agreement with Oneness Biotech...and Microbio Shanghai (China) covering the development and commercialization of the novel Atopic Dermatitis (AD) and Allergic Asthma drug candidate, FB825....Under the terms of the agreement, LEO Pharma will make an upfront payment of USD 40 million and offer milestone payments up to USD 530 million...Oneness will be responsible for executing the Phase 2a study for Atopic Dermatitis in the United States and Microbio Shanghai will execute the Phase 2a study for allergic asthma in China."

Licensing / partnership • New P2a trial • Asthma • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Respiratory Diseases

An Open-Labeled Exploratory Study to Evaluate Safety and Efficacy of FB825 in Adults With Atopic Dermatitis (clinicaltrials.gov) - P2; N=12; Active, not recruiting; Sponsor: Fountain Biopharma Inc.; Trial completion date: Dec 2018 ➔ Apr 2019

Clinical • Trial completion date