Mitsubishi Tanabe Pharma : NMPA accepts our filing for TENELIA, a treatment agent for type 2 diabetes mellitus in China

September 24th, 2019

NMPA accepts our filing for TENELIA,

a treatment agent for type 2 diabetes mellitus in China

Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Chuo-ku, Osaka;

President & Representative Director, CEO: Masayuki Mitsuka), announced today that the National Medical Products Administration (NMPA) accepted MTPC's filing through Mitsubishi Tanabe Pharma Development (Beijing) Co., Ltd., which is MTPC's R&D subsidiary in China for TENELIA (generic name: teneligliptin hydrobromide hydrate; Japan name: TENELIA® 20 mg tablets), a treatment agent for type 2 diabetes mellitus.

TENELIA®, originating in Japan, is a dipeptidyl peptidase-4(DPP-4) inhibitor discovered by MTPC. TENELIA® has made it highly effective in lowering each of the postprandial blood glucose levels, as well as fasting blood glucose levels, with once-a-day administration. TENELIA® needs no dose adjustments according to the levels of renal or hepatic dysfunction, so that TENELIA® can be used to treat a wide range of patients with diabetes.

China has about 120 million people with diabetes* (as of 2017), the largest in the world, and China accounts for approximately 30% of the total number of worldwide patients with diabetes. This proportion is expected to continue increasing.

Tianjin Tanabe Seiyaku Co., Ltd. (Tianjin Tanabe), MTPC's manufacturing and sales subsidiary in China, has concluded a strategic agreement to promote TENELIA® with Servier (Tianjin) Pharmaceutical Co., Ltd. (Servier Tianjin) in February 2019. In collaboration with Servier Tianjin, which in China has approximately 700 medical representatives (MRs) specializing in diabetes, Tianjin Tanabe will contribute to early market penetration and product value maximization of TENELIA®.

By providing a new option for the treatment of diabetes in China, the second largest pharmaceutical market in the world, MTPC shows its continued resolve to help patients in China.

*Source: International Diabetes Federation (IDF)

Mitsubishi Tanabe Pharma Corporation

Corporate Communications Department

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■ About TENELIA

In Japan, approval for TENELIA (generic name: teneligliptin hydrobromide hydrate,

Japan name: TENELIA® 20 mg tablets), a treatment agent for type 2 diabetes mellitus, was received in June 2012, with approval for a partial change in its indication received in December 2013. In Korea, approval for use of TENELIA in combination with biguanide agents was received in April 2014. Development of TENELIA is being promoted not only in China, where application has just been filed, but also in other ASEAN countries.

■ 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 in self-promoted clinical development aimed at receiving marketing approval of pharmaceuticals 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 the country, 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 is engaged in the manufacture and sales of pharmaceuticals in China. As a core company 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, and anti-allergic agents for patients in China.

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