Mitsubishi Chemical : Announcement of Approval Submission and Marketing Alliance in Japan for Tirzepatide as a Drug for Obesity DiseaseNEW

Press Release

May 8, 2024

Eli Lilly Japan K.K.

Mitsubishi Tanabe Pharma Corporation

Announcement of Approval Submission and

Marketing Alliance in Japan

for Tirzepatide as a Drug for Obesity Disease

Eli Lilly Japan K.K. (head office: Kobe, Hyogo; Representative Director and President: Simone Thomsen; hereinafter referred to as "Eli Lilly Japan") and Mitsubishi Tanabe Pharma Corporation (head office: Osaka, Osaka; Representative Director: Akihiro Tsujimura; hereinafter referred to as "MTPC") announced that Eli Lilly Japan had applied for approval of tirzepatide (hereinafter referred to as "the product") from the Ministry of Health, Labour and Welfare and the two companies will form a marketing alliance in Japan.

Based on the marketing alliance between the two companies, Eli Lilly Japan will obtain the manufacturing and marketing approval for the product, and Mitsubishi Tanabe Pharma will distribute and market the product after obtaining the approval, similar to the long-actingGIP/GLP-1 receptor agonist "Mounjaro® Subcutaneous Injection" (generic name: tirzepatide, hereinafter referred to as "Mounjaro"), which is the same compound and for which both companies tied up for sales in 2023. Activities to provide information to healthcare professionals will be conducted jointly by the two companies.

Eli Lilly Japan and Mitsubishi Tanabe Pharma will work more closely than ever before through the marketing alliance of Mounjaro and this product to contribute to the further advancement of medical care for more fulfilling lives of people living with type 2 diabetes and obesity disease in Japan.

About Tirzepatide

Tirzepatide is the world's first long-actingGIP/GLP-1 receptor agonist that acts as a single molecule on two receptors, glucose-dependent insulinotropic polypeptide (GIP) and glucagon-likepeptide-1(GLP-1). Although the structure of this product is a single molecule based on the natural GIP peptide sequence, it has been modified to also bind to the GLP-1 receptor and acts selectively for a long time. Mounjaro® Subcutaneous Injection, a new product for type 2 diabetes, was launched in Japan in April 2023, and six doses ranging from 2.5 mg to 15 mg are available. It was approved in the U.S. for the treatment of obesity disease in November 2023 and is marketed under the brand name ZepboundTM.

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Obesity disease

In Japan, obesity is defined as excessive accumulation of fat in adipose tissue, with body mass index (BMI) of 25 or higher. On the other hand, obesity disease is defined as a condition in which one is obese and has or is expected to have complicated health problems caused by or related to obesity, requiring medical weight loss. Obesity and obesity disease are caused by not only lifestyle but also various factors such as heredity and environment, and said to be closely related to various other health disorders.

About Eli Lilly Japan

Eli Lilly Japan K.K. is a subsidiary of US-based Eli Lilly and Company. It contributes to medical treatment in Japan through the development, manufacture, import and sale of innovative pharmaceutical products that enable people to live longer, healthier, and more fulfilling lives, focusing on the therapeutic areas such as cancer, diabetes, musculoskeletal diseases, central nervous system diseases, autoimmune diseases, growth disorder, and pain. For more information, visit http://www.lilly.co.jp

About Mitsubishi Tanabe Pharma Corporation

Mitsubishi Tanabe Pharma Corporation (MTPC), the pharma arm of Mitsubishi Chemical Group (MCG), is one of the oldest pharmaceutical companies in the world, founded in 1678, and focusing on ethical pharmaceuticals. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MCG has positioned health care as its strategic focus in its management policy, "Forging the future". MTPC sets the MISSION of "Creating hope for all facing illness". To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction by identifying patient populations with high potential for efficacy and safety. In addition, MTPC is working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.mt-pharma.co.jp/e/

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