January 16, 2018

Reinforcing Our Pharmaceutical Development and Sales in China,
the World's Second Largest Pharmaceutical Market

Approval in China Received for Additional Novastan®
Indication for Acute Cerebral Infarction
Mitsubishi Tanabe Pharma Corporation (hereafter "MTPC"; Head Office: Osaka;
President & Representative Director: Masayuki Mitsuka) announced today that MTPC
received approval on December 20, 2017 from the China Food and Drug
Administration (hereafter "CFDA") for injectable argatroban (Product Name:Novastan®) for the indication of “Improvement of neurological abnormalities (motorparalysis) and activities of daily living (ADL) disabilities (ADL includes walking,standing, sustaining the sitting position, and eating) associated with the following
disease Acute cerebral infarction within 48 hours after the onset of symptoms”.
In Japan in 1990, MTPC received approval for Novastan® for the indication of"Improvement of ulcers of extremities, pain while resting, and cold extremities
associated with chronic arterial occlusion (Burger’s disease and arteriosclerosis
obliterans)" and the indication of "Improvement of neurological abnormalities(motor paralysis) and activities of daily living (ADL) disabilities (ADL includes
walking, standing, sustaining the sitting position, and eating) “ associated with thefollowing disease “Acute cerebral thrombosis within 48 hours after the onset ofsymptoms (Excluding type of lacunar)” in 1996.
In China, MTPC submitted an application for an import drug license for Novastan® tothe CFDA and received approval for the indication of "Improvement of ulcers ofextremities, pain while resting, and cold extremities associated with chronic arterial
occlusion (Burger’s disease and arteriosclerosis obliterans)" in May 1999.
After fully examining related drug management systems in China, we submitted anapplication for approval of Novastan® for an additional indication of “Acute cerebralinfarction” to the CFDA on February 23, 2017. The CFDA reviewed the efficacy ofNovastan® via an ordinary technical review and a review by specialists in this field.
This led to the approval of our application for the additional indication of Acutecerebral infarction without requiring clinical trials in China.
In collaboration with MTPC group companies, including Mitsubishi Tanabe Pharma
Development (Beijing) Co., Ltd. in charge of self-promoted clinical development
aimed at receiving marketing approval of pharmaceuticals in China, the world'ssecond largest pharmaceutical market, and Tianjin Tanabe Seiyaku Co., Ltd.,
engaging in the manufacture and sale of pharmaceuticals in China.
MTPC will strive to contribute to the acceleration of its pharmaceutical business inChina, a market with a high potential for future growth.
Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119
Investor contacts: TEL:+81 6 6205 5110
1/2◆Reference◆About Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma, which was founded in 1678, has its headquarters inDoshomachi, Osaka, which is the birthplace of Japan’s pharmaceutical industry. Withbusiness centered on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is awell-established company and has the longest history of any listed company inJapan. In accordance with the corporate philosophy of “contributing to the healthierlives of people around the world through the creation of pharmaceuticals,” theCompany formulated the key concept of Open Up the Future under theMedium-Term Management Plan 2016-2020. Through the discovery of drugs thataddress unmet medical needs, centered on its priority disease areas — autoimmune
diseases, diabetes and kidney diseases, central nervous system diseases, andvaccines — Mitsubishi Tanabe Pharma will strive to contribute to the health ofpatients around the world. MTPC is the parent company of MTPA and the license
holder of RADICAVA.
https://www.mt-pharma.co.jp/
About Mitsubishi Tanabe Pharma Development (Beijing) Co., Ltd.
Mitsubishi Tanabe Pharma Development (Beijing) Co., Ltd. is a wholly-owned
subsidiary founded by MTPC in Beijing, China, in 2006. The company is engaged inself-promoted clinical development aimed at receiving marketing approval ofpharmaceuticals in China. As a key base of the MTPC group in China, it promotes
business in China by developing new drugs and receiving their approval in thecountry, thereby seeking to enhance MTPC's corporate value.
About Tianjin Tanabe Seiyaku Co., Ltd.
Tianjin Tanabe Seiyaku Co., Ltd. was founded in Tianjin, China, in 1993 through joint
financing from Tianjin Lisheng Pharmaceutical Co., Ltd. and MTPC. The company isengaged in the manufacture and sales of pharmaceuticals in China. As a corecompany of the MTPC group in China, the company seeks to contribute to medical
needs in China through the manufacture and sales of high quality pharmaceuticals
with the MTPC brand, particularly cardiovascular drugs, gastrointestinal drugs, andanti-allergic agents for patients in China.

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