2020/7/27 Centus Biotherapeutics Ltd. (hereinafter “Centus”)

July 27, 2020
Centus Biotherapeutics

Centus Biotherapeutics Ltd. (hereinafter "Centus"), a joint venture between AstraZeneca and Fujifilm Kyowa Kirin Biologics, today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the Marketing Authorization Application of Equidacent^TM (Product Code: FKB238), the companies' biosimilar to Avastin^® (bevacizumab), for indications including metastatic carcinoma of the colon or rectum, metastatic breast cancer, unresectable advanced, metastatic or recurrent non-small cell lung cancer, advanced and/or metastatic renal cell cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer, persistent, recurrent, or metastatic carcinoma of the cervix. The decision of the European Commission (EC) on the approval is expected in September 2020, which would grant marketing authorization in the 27 European Union (EU) member countries, United Kingdom (UK) and European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein.

Centus President and Product Development Team Lead, Dr. Hiroshi Ohashi from Fujifilm Kyowa Kirin Biologics commented, "We are very happy receiving a positive CHMP opinion toward approval of Equidacent^TM, our bevacizumab biosimilar. We will continue with every effort to bring Equidacent^TM to patients and healthcare professionals."

Centus Product Development Team Co-lead, Mr. Kelvin Tsang from AstraZeneca, also commented that "This represents a great collaborative effort between our shareholders to bring high quality and affordable medicines to our patients worldwide."

Data submitted as part of the Marketing Authorization Application for Equidacent^TM included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the bevacizumab reference product, Avastin^®. The phase 3 clinical study, study named AVANA, demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity compared with the reference product, Avastin^®, in non-small cell lung cancer patients.

About Bevacizumab
Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A). It reduces growth and metastasis of several solid tumors.

2016/9/6 Centus Biotherapeutics enrolls first patient in global efficacy equivalence trial (AVANA)

Sept 6, 2016
Centus Biotherapeutics

CENTUS BIOTHERAPEUTICS Co., Ltd. (hereinafter “CENTUS”), a joint venture between AstraZeneca plc (hereinafter “AstraZeneca”) and Fujifilm Kyowa Kirin Biologics (hereafter “FKB”), today announced the enrolment of the first patient into its AVANA study, a new global efficacy equivalence study trial for patients with non-small cell lung cancer.

AVANA Study is a global multi-centre phase III double blinded study, to compare the efficacy and safety of FKB238 to Avastin® in first line treatment for patients with advanced/recurrent non squamous non-small cell lung cancer (NSCLC) in combination of paclitaxel and carboplatin. Targeting to recruit 730 subjects from more than 20 countries, the primary objective of the study is to demonstrate the efficacy equivalence of FKB238 and EU approved Avastin® when used in combination with paclitaxel/carboplatin as measured by overall response rate (ORR).

“This is a great accomplishment for Centus and our stakeholders as this demonstrates tangible progress in our aim to provide additional treatments for patients around the world” said Yoshifumi Torii, President of Centus, General Manager of FKB EU. “Centus was able to accomplish so much so quickly largely because of the great support from our stakeholders - the deep biosimilar expertise from FKB, high quality manufacturing capability from KHK and the global platform and biological capabilities from AstraZeneca” mentioned by Hideaki Nomura, Board member of Centus, FKB President & CEO. “AVANA study remains our highest priority and will receive our full support. In the meantime, we look to the future and prepare for the next regulatory and commercial milestones to ensure getting FKB238 to patients as soon as possible.” Said Shou-Bai Chao, Board member of Centus, Senior VP, BioVentures, AstraZeneca/MedImmune.

About FKB238
FKB238 is a biosimilar version of bevacizumab, an anti-VEGF¹ humanized monoclonal antibody with established efficacy across a range of cancers including colorectal and non-small cell lung cancer².

Additional explanation is as follows.

• *1 VEGF is an abbreviation for Vascular Endothelial Growth Factor. VEGF is a glycoprotein which promotes mitogenic activity in vascular endothelial cells, which in turn stimulates angiogenesis.

• *2 Lung cancer can be broadly divided into small cell lung cancer and non-small cell lung cancer, with 85% of lung cancers falling into the latter category. Non-small cell lung cancers include squamous cell cancer, adenocarcinoma and large cell carcinoma.

FKB238 has successfully completed its Phase I clinical trial for FKB238.

About Centus Biotherapeutics
Founded in 2015, Centus Biotherapeutics is a leading biosimilar developer joint venture between AstraZeneca, a global pharmaceutical leader, and Fujifilm Kyowa Kirin Biologics (FKB), a Japanese biopharmaceutical company focused on biosimilar development. With the unique coupling of world class biologics expertise, global commercial infrastructure and deep biosimilar development experience from its stakeholders, Centus Biotherapeutics is well positioned to win the trust of doctors and serve the needs of patients worldwide. VEGF is an abbreviation for Vascular Endothelial Growth Factor. VEGF is a glycoprotein which promotes mitogenic activity in vascular endothelial cells, which in turn stimulates angiogenesis.

Lung cancer can be broadly divided into small cell lung cancer and non-small cell lung cancer, with 85% of lung cancers falling into the latter category. Non-small cell lung cancers include squamous cell cancer, adenocarcinoma and large cell carcinoma.