SHANGHAI - Having received approval from China's State FDA for Januvia (sitagliptin), Merck Sharp & Dohme announced March 21 that it has launched the dipeptidyl peptidase-4 inhibitor for Type 2 diabetes and joined the race to compete in China's $300 million oral diabetes drug market.

Januvia enhances the body's ability to lower blood sugar when it is elevated by blocking the DPP-4 enzyme to increase levels of glucagon-like peptide-1, which stimulates insulin release and inhibits glucagon release.

According to SFDA's Internet database, the agency approved the 100 mg dosage of Januvia on Sept. 29, 2009 and the 25mg and 50mg dosages on Jan. 15.

Sales in China of oral anti-diabetic drugs and GLP-1 agonists reached $324.12 million in 2009, according to IMS Health. That number will increase roughly 17.2 percent to $379.73 million in 2010, sales will top more than $600 million in five years and could reach $707.18 million in 2018, IMS said.

Competition Heats Up As More Diabetes Products Enter The Ring

China has the second largest patient population of diabetics in the world with 39.8 million patients, which is expected to increase to 59 million by 2025, according to Merck. There are 1.01 million new incidences of diabetes annually in the country.

In Q4 2009, Bayer's Glucobay [acarbose] was the leading oral diabetes drug in China with 28.16 percent of the market share, according to IMS. Novo Nordisk's Novonorm (repaglinide) controlled 11.92 percent of the market, followed by Bristol-Myers Squibb's Glucophage (metformin) with7.52 percent of the market. The top 10 products own 75.66 percent of the total oral diabetes market.

Eli Lilly, Novo Nordisk and Sanofi-Aventis control roughly 90 percent of the sales of diabetes drugs in China's top hospitals.

Lilly started to market its GLP-1 agonist Byetta (exenatide) in first-tier cities in China last September (Also see "Lilly Launches Byetta In China To Target World's Second Largest Diabetes Market" - Scrip, 31 August, 2009.). The company already has insulins Humulin and Humalog on the market in China.

Diabetes-focused Novo Nordisk announced it would market its long-acting insulin detemir Levemir in China this year and said that China is a key growth market for the company ('The Pink Sheet', Aug. 7, 2009).

Novo Nordisk's GLP-1 agonist Victoza (liraglutide), which was just approved in the U.S. for Type 2 diabetes in January, is expected to be approved and marketed in China by the end of this year or early 2011. Novo Nordisk filed its NDA with SFDA last August. The company said the Chinese diabetes market could even triple its current sales of RMB 8.52 billion ($1.25 billion) in 2012.

Sanofi-Aventis also expanded its production capability in Beijing for leading diabetes drug Lantus , the world's second-largest insulin brand and major competitor of Levemir (Also see "Sanofi-Aventis Sees Diversifying In China As Key To Success; Expands Capacity For Diabetes Treatment Lantus" - Scrip, 26 April, 2009.).

Competing against these existing drugs, comes a product from Shanghai-listed company Jiangsu Hengrui. Its Retagliptin , which it believes is an improved version of Januvia, has been approved to start Phase I clinical trials in the U.S. (Also see "Chinese Pharmaceutical R&D Takes A Great Leap Forward With FDA Approved Clinical Trials In The U.S." - Scrip, 10 September, 2009.).

- Dai Jialing (j.dai@elsevier.com)

Merck Sharp & Dohme Launches Januvia In China To Join Race In Second-largest Diabetes Market

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