Obesity research and development stalemate has a solution from diabetes treatment drugs to diet pills

Medical Network November 28th The crisis caused by obesity to global health is self-evident. According to a survey conducted by the McKinsey Global Institute, more than 2.1 billion people are overweight or obese on a global scale, resulting in annual global economic losses of up to $2 trillion. The amount of damage caused by obesity ranks second with tobacco (2012: 71 billion euros). By 2030, nearly half of the world's population will be overweight.

Many pharmaceutical companies are in the market for diet pills. However, with respect to cancer and other diseases market, the development of diet pills market is not so smooth. The market demand for weight-loss drugs can be described as rising, even zero tolerance for side effects, which also makes the development of such drugs more tortuous.

New drugs are expected to break the deadlock

At present, diet pills mainly include pancreatic lipase inhibitors and appetite suppressants acting on the central nervous system. The weight-loss drugs approved by the US FDA include Xenical (orlistat) from Genentech, Belviq developed by Japan Eisai and Arena, and Qsymia (phentermine/topiramate) developed by Vivus. Compound sustained-release drug), compound drug Contrave (Naltrexone/Bupropionone compound preparation) developed by Takeda and Orexigen. Diet pills have been blamed for safety problems, and the above-mentioned drugs have performed poorly in recent years.

However, the industry still believes that Novo Nordisk's Saxenda (Lilaglutide 3mg) will be a "black horse." Because many types of diabetes in the clinic are complicated by obesity, Saxenda is different from other diet pills. In fact, as early as September 2014, the US FDA Endocrine and Metabolic Drugs Specialist recommended Saxenda for weight control, including for non-diabetics.

For Chinese patients, the Novo Nordisk brand is directly linked to diabetes drugs. There is a very close relationship between obesity and diabetes. About 80% of patients with type 2 diabetes have obesity problems, so obesity drug development is also the direction that Novo Nordisk has been working hard to develop. Ke Zesi, senior vice president and head of global R&D at Novo Nordisk, pointed out that in the development of medicine , the cost of failure is very high, so more joint treatment should be adopted for the problem of obesity. "Combination treatments are common in areas such as cancer, infectious diseases and AIDS. In the treatment of obesity, we also expect to improve basal metabolism on the basis of diet control."

The reporter learned that as early as 2014, Novo Nordisk Company planned to open a separate obesity research department, and even the company had initially selected the research and development center of the department in Seattle, USA. In 2015, the glucagon-like peptide-1 (GLP-1) receptor agonist Saxenda for weight management was approved by the United States, the European Union, and Canada.

At the commemoration of the 20th anniversary of the Novo Nordisk China Research and Development Center, Zhang Kezhou, vice president of Novo Nordisk China Medical Department, told reporters that the company's newly developed long-acting GLP-1 receptor agonist will be launched globally. In the phase III clinical trial, the drug will also be submitted to the clinical trial application in China.

R&D center opportunities and challenges coexist

Since the second half of this year, the R&D centers of some multinational pharmaceutical companies have announced the closure and partial withdrawal. For example, in September 2017, Lilly Pharmaceuticals announced the closure of its China R&D center in Zhangjiang, Shanghai; in the same month, GE China R&D Center partially withdrew and returned to the company. Some domestic business practitioners even bluntly stated that the inefficiency of large multinational pharmaceutical companies in China's R&D centers is the main reason for their closure.

In this regard, Ke Zesi said: "For many reasons, many large pharmaceutical companies have set up R&D centers and management R&D centers in China, but I don't think (partial centers are closed) related to China, Novo Nordisk's R&D centers in China. The investment will continue. At present, the way we organize the structure is to increase the internationalization trend of R&D. In addition to the R&D centers in China and Denmark, we have also established R&D facilities in Seattle, USA and Oxford, UK, and hope to have talent pools around the world. We have access to outstanding talents and gradually increase the globalization of research and development."

In fact, as far as China's current R&D environment is concerned, it is more inclined to foreign pharmaceutical companies in the short term. Zhang Keyzhou also said: "The reforms on overseas data in the 36 articles of the two offices are actually the demands of pharmaceutical companies, especially foreign-funded enterprises. For the most part, if more than a dozen clinical trials have been invested in global research. Funding, which is going to be re-launched in China, is almost impossible from the aspect of input-output ratio. This is especially true in the approval of new indications, and there is an urgent need for global synchronization."

He further added: "In the long run, China's R&D will truly become a part of the world, and the company's investment, strategy and process in new drug research and development will become clearer."

The reporter learned that in 1997, Novo Nordisk established a research and development center in China and was the first multinational biopharmaceutical company to set up a research and development center in China. At present, the R&D Center has four departments: New Drug Research and Development Biology Department, New Drug Research and Development Technology Department, Microbial Protein Engineering Research Department and Pilot China Research Department, which undertakes dozens of R&D projects every year.

When talking about the problems that foreign R&D institutions may encounter, Zhang Kezhou said: "We may compete with domestic enterprises in the institutional resources of clinical trials. Although the country is now gradually moving to the specific policy of GCP certification to record change, but The bigger problem facing domestic clinical institutions is probably the problem of doctor resources with relevant capabilities."