Centus Biotherapeutics Announces Positive CHMP Opinionfor FKB238, Biosimilar Bevacizumab

LONDON and TOKYO, July 27, 2020― Centus Biotherapeutics Ltd., a joint venture betweenFujifilm Kyowa Kirin Biologics Co., Ltd. and AstraZeneca PLC (LSE/STO/NYSE: AZN), today
announced that the European Medicines Agency's Committee for Medicinal Products for HumanUse (CHMP) has adopted a positive opinion for the Marketing Authorization Application ofEquidacentTM (Product Code: FKB238), the company’s biosimilar to Avastin® (bevacizumab), forindications 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 Centus the marketing authorization in 27 European Union (EU)member states, the United Kingdom (UK) and the European Economic Area (EEA) member
states of Norway, Iceland and Liechtenstein.
Centus President Hiroshi Ohashi, Ph. D. commented, “We are happy to receive a positive
CHMP opinion toward the approval of EquidacentTM, our bevacizumab biosimilar. We willcontinue to make every effort to obtain the approval for EquidacentTM, which could help patientsand healthcare professionals.”
Fujifilm Kyowa Kirin Biologics President and CEO Atsushi Matsumoto, Ph. D. said, “I amdelighted that CHMP decided to recommend the approval of the proposed biosimilar
bevacizumab. We will continue our efforts to bring high quality and affordable biosimilars topatients throughout European countries.”
Centus was established in 2015 as a joint venture between Fujifilm Kyowa Kirin Biologics andAstraZeneca. Fujifilm Kyowa Kirin Biologics has granted an exclusive license to Centus for thedevelopment, manufacture and commercialization of EquidacentTM on a worldwide basis.
Centus has been promoting clinical development of EquidacentTM.
Data submitted as part of the Marketing Authorization Application for EquidacentTM included
similarity assessment in analytical testing, preclinical and clinical studies that demonstratedbiosimilarity to the bevacizumab reference product, Avastin®. The phase 3 clinical study,
AVANA, conducted by Centus, demonstrated no clinically meaningful differences in terms ofsafety, efficacy and immunogenicity compared with the reference product, Avastin®, in nonsmall cell lung cancer patients.

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

About Centus
Centus Biotherapeutics (Centus) founded in 2015 is a joint venture between AstraZeneca, a
global pharmaceutical leader, and Fujifilm Kyowa Kirin Biologics, a Japanese biopharmaceuticalcompany focused on biosimilar development.
With the unique coupling of world class biologics expertise, global commercial infrastructure anddeep biosimilar development experience, Centus is well positioned to win the trust of doctors
and serve the needs of patients worldwide.
For more information please visit: https://www.centusbiotherapeutics.com
About Fujifilm Kyowa Kirin Biologics
Fujifilm Kyowa Kirin Biologics was established by FUJIFILM Corporation (President: Kenji
Sukeno; “Fujifilm”) and Kyowa Kirin Co., Ltd. (President and CEO: Masashi Miyamoto, “KyowaKirin”) on March 27, 2012 as a company for developing, manufacturing, and marketingbiosimilars. Its pipeline includes EquidacentTM and Hulio®, an adalimumab biosimilar (ProductCode: FKB327), a drug used to treat a range of inflammatory diseases.
By merging the technologies in advanced production, quality control and analysis which Fujifilm
has developed over many years through its photographic film business, with the proprietary
technologies and know-how which Kyowa Kirin has accumulated through its biopharmaceutical
R&D and manufacturing, Fujifilm Kyowa Kirin Biologics creates revolutionary production
processes and reduces costs for the production of biosimilars. Through this partnership, thecompany will develop and manufacture reliable, high quality, cost-competitive biosimilar
products and commercialize these products in a timely manner. With this strategy, Fujifilm
Kyowa Kirin Biologics aims to hold a leading position in the expanding biosimilar market.
You can learn more about the business at: fujifilmkyowakirin-biologics.com

For inquiries on information in this media release, contact:
Fujifilm Kyowa Kirin Biologics
Ryohei Kawai
Kyowa Kirin Co., Ltd (for Fujifilm KyowaKirin Biologics)+81-3-5205-7205
Email: media@kyowa-kirin.co.jp
Takuro Nishijima
FUJIFILM Holdings Corporation (for Fujifilm
Kyowa Kirin Biologics)+81-3-6271-2000