February 14, 2019

FDA accepted an Investigational New Drug Application forMT-8633, an ADC Targeting cMet Positive Solid Tumors
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; President &Representative Director: Masayuki Mitsuka, MTPC) announced today that the U.S.
Food and Drug administration (FDA) cleared Tanabe Research Laboratories U.S.A.
(TRL)’s first Investigational New Drug (IND) application to initiate a phase 1 for its
Antibody Drug Conjugate (ADC) MT-8633/TR1801-ADC in patients with cMet
positive solid tumors. TRL is a pharmaceutical research and development
subsidiary of MTPC.
MT-8633 is an extremely potent ADC that combines a non-agonizing anti-c-Met
antibody developed at TRL, with a pyrrolobenzodiazepine dimer (PBD) toxin, andhas demonstrated potent dose dependent anti-tumor activity against Met positive
tumors in preclinical models’. The PBDs were developed by TRL’s collaborative
partner MedImmune Limited (Headquarters: Maryland, U.S.A; Chief Operating
Officer: Matt Bell) and licensed to TRL. PBDs are of an order of magnitude morepotent than other warheads currently used with other ADCs, and in the case ofMT-8633 are linked to the antibody via a site-specific conjugation site.
cMet, also referred to as the hepatic growth factor receptor (HGFR), is a validated
target expressed on a variety of tumor types including colorectal, NSCLC, gastric,
esophageal, pancreatic, bile duct and many other cancers.
Regarding the oncology domain where MTPC’s RD knowledge has not been
accumulated yet, TRL choses the option to utilize open innovation to challengethrough a study of MT-8633. MTPC concluded a licensing agreement between
Open Innovation Partners (OIP) which was established by DCI partners (HeadOffice: Chiyoda-ku, Tokyo; President & Representative Director: Hiroki Narita) of
the Daiwa Securities group in December, 2017. MTPC and OIP will accelerate thedevelopment of MT-8633 in this framework.
MTPC Group will continue challenging to contribute to the patients’ health around theworld through creating innovative antibody drugs that address unmet medical needs.
Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119Investor contacts: TEL:+81 6 6205 5110
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Tanabe Research Laboratories U.S.A. Inc.（TRL）
TRL is an independent subsidiary of MTPC located in San Diego California, whoserole is to discover and develop biological drug candidates for therapy. Currently,
TRL’s efforts are directed towards antibody and antibody-related research totarget tumors and other diseases with high unmet needs.
TRL has established collaborative relationships with other companies andacademic research organizations to develop Antibody Drug Conjugates (ADCs)
and to further its goals of identifying preclinical therapeutic lead compounds fordevelopment. http://trlusa.com
MedImmune Limited
MedImmune is the global biologics research and development arm of AstraZeneca.
MedImmune is pioneering innovative research and exploring novel pathways across
key therapeutic areas, including respiratory, inflammation and autoimmunity;
cardiovascular and metabolic disease; oncology; neuroscience; and infection andvaccines. The MedImmune headquarters is located in Gaithersburg, MD., one of
AstraZeneca’s three global R&D centres.
Open Innovation Partners（OIP）
Open Innovation Partners was established by DCI Partners of the Daiwa Securities
group to specialize the development of MT-8633. OIP will accelerate thedevelopment of MT-8633 by using a fund from Daiwa Taiwan-Japan Biotech Fund
Investment Limited Partnership via DCI Partners.

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