MabionCD20 (rituximab biosimilar) / HB Human BioSci, Mabion - LARVOL DELTA

MABRIDGE: MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: Mabion SA | N=280 ➔ 0 | Trial completion date: May 2023 ➔ Aug 2023 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Oct 2022 ➔ Aug 2023

Enrollment change • Trial completion date • Trial primary completion date • Trial withdrawal • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CD20 • CRP

MABRIDGE: MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P3; N=280; Not yet recruiting; Sponsor: Mabion SA; N=210 ➔ 280; Trial completion date: Aug 2022 ➔ Apr 2023; Initiation date: Mar 2021 ➔ Oct 2021; Trial primary completion date: Jun 2022 ➔ Oct 2022

Clinical • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • CD19 • CD20 • CRP

MABRIDGE: MabionCD20® Compared to MabThera® and Rituxan® in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P3; N=210; Not yet recruiting; Sponsor: Mabion SA

Clinical • New P3 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Mabion: Parexel will conduct the latest clinical trials of MabionCD20 (Money.Pl) - "Mabion has signed contracts with Parelex to conduct the last clinical trial before submitting an application to the European Medicines Agency (EMA) for marketing authorization for the MabionCD20 product, the company said....The contract provides for a clinical bridge trial (phase I / II) of the company's leading product - the drug MabionCD20. Its implementation includes obtaining additional data necessary to register the drug on the European market and start production on a commercial scale. This will enable registration of the drug used in the treatment of lymphoma and RA in Europe. Data obtained from clinical trials may also be used in the registration process for the US market."

New P1/2 trial • Hematological Malignancies • Rheumatoid Arthritis

Mabion has a preliminary cooperation agreement with Taxon Therapeutics [Google translation] (Strefa Inwestorów) - "Mabion has signed a preliminary 'Memorandum of Understanding' agreement with the Israeli company Taxon Therapeutics Ltd. regarding cooperation in research, development and then commercialization of MabionCD20 antibodies in specific clinical indications in the field of rare diseases..."

Licensing / partnership • Immunology • Oncology

Mabion has received confirmation from the FDA about the possibility of using Mabion CD20 in the registration process [Google translation] (Strefa Inwestorów) - "The company Mabion, after holding a Type 2 meeting with the US Food and Drug Administration (FDA, Agency) on August 11, 2020, received a summary of the meeting on August 28, in which it received confirmation from the FDA about the possibility of using it in the registration process Mabion CD20 on the American market of a significant package of data from research on the MabionCD20 product obtained for the purposes of registration in the European Union."

FDA event • Immunology • Oncology

MabionCD20® Compared to MabThera® in Lymphoma Patients (clinicaltrials.gov) - P3; N=140; Not yet recruiting; Sponsor: Mabion SA

New P3 trial • New trial • Biosimilar

MabionCD20: “The CHMP noted the withdrawal of the marketing authorisation application [NHL, CLL and Rheumatoid arthritis]“ (EMEA) - CHMP Final Minutes of the meeting on 23-26 March 2020

European regulatory • Chronic Lymphocytic Leukemia • Non-Hodgkin’s Lymphoma • Rheumatoid Arthritis

The race to create a biosimilar of rituximab (Pharmaceutical Processing) - "The race for the global rituximab market is approaching the finishing line. Mabion S.A...is among the leaders of the race...the last administration of the drug to a patient in the RA trial will be in June 2016, and in the case of the lymphoma trail [sic], in August 2016. After the trials have been completed, we [Mabion S.A.] will be ready to submit all documents needed for the registration of a drug..."

Anticipated regulatory • Anticipated trial primary completion date • Biosimilar • Rheumatoid Arthritis

Rituximab biosimilar submitted to EMA and Rituxan gains extra indication (GaBI) - "Poland-based Mabion announced...that its candidate rituximab biosimilar (MabionCD20) had been accepted for regulatory review by the European Medicines Agency (EMA)."

European regulatory • Biosimilar

Mabion is allowed to study medicine in Ukraine MabionCD20 (Wyborcza) - "Mabion obtained the consent of the Ukrainian Ministry of Health clinical trial of the drug MabionCD20, the company said in a statement. Ukraine is the sixth country where Mabion open research and begin actively recruiting patients."

New trial • Biosimilar • Rheumatoid Arthritis

MabionCD20: MAA filing in Q1 2018 (Mabion) - Clinical Trial Update

European regulatory • Biosimilar

MabionCD20® Compared to MabThera® in Lymphoma Patients (clinicaltrials.gov) - P3; N=143; Completed; Sponsor: Mabion SA; Recruiting ➔ Completed

Clinical • Trial completion • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

MabionCD20® Compared to MabThera® in Patients With Rheumatoid Arthritis (clinicaltrials.gov) - P3; N=709; Completed; Sponsor: Mabion SA; Recruiting ➔ Completed

Clinical • Trial completion • Immunology • Inflammation • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology • TNFA

Mylan partner Mabion withdraws rituximab In EU (Generics Bulletin - Informa) - "Mabion’s European applications for biosimilar rituximab have been withdrawn, shortly after partner Mylan indicated it was hopeful of potential market entry this year, with a change of strategy necessitating a new application be filed with the EMA."

European regulatory

Mabion changes the regulatory strategy of MabionCD20, the shareholders recapitalize the company (Bankier) - "Mabion has decided to change the regulatory strategy of MabionCD20 in EMA and intends to obtain the marketing authorization of the drug directly on a large commercial scale as opposed to the planned 2-step strategy so far - the company said in a press release. In a separate message, Mabion stated that the company's shareholders declared its recapitalization with an amount not lower than PLN 15 million in 2020."

Commercial • European regulatory

Mabion has obtained the GMP certificate for the production of the active substance [Google Translation] (Bankier) - "Mabion obtained...GMP certificate for the Scientific and Industrial Complex of Medical Biotechnology in Konstantynów Łódzki in the scope of production of the active substance (Rytuksymab) - the company said in a press release. The GIF inspection has been commissioned by the European Medicines Agency (EMA) as part of the evaluation of the company's application for the marketing of MabionCD20....The company said, stating that obtaining a certificate does not guarantee the product's approval by EMA."

European regulatory

Mabion submitted a second registration application for the MabionCD20 medicine at EMA [Google Translation] (Bankier) - "Mabion has submitted a second registration application for MabionCD20 to the European Medicines Agency (EMA), the company said in a press release....According to the company, the positive results of the study...and the consent of EMA to submit a second registration application do not guarantee product approval by the European Medicines Agency....'The registration procedure goes according to the schedule...We believe that we will get a final EMA opinion this year,' said Sławomir Jaros."

European regulatory

Mabion may sign several partnering agreements in '19 [Google Translation] (Bankier) - "The company maintains that the decision regarding the registration of MabionCD20 in the European Medicines Agency (EMA) should be taken by the end of this year. Mabion gave in the presentation that he plans to sign further partnership agreements, among others on MabionCD20...The management announced that the first sales revenues of MabionCD20 can be expected in 2020, but the decision on the date of marketing the drug belongs to the partner -the Mylan group....MabionCD20 may be the first drug that Mabion will launch."

Biosimilar launch • Commercial • European regulatory • Licensing / partnership