(Yicai Global) Nov. 4 -- Green Valley Pharmaceuticals, one of the main developers of a new treatment for Alzheimer's disease, is pushing forward with applying for US clinical trials with the aim of selling the drug in the US and other markets.

"Our first communication round with the US Food and Drug Administration has ended, and I hope that we can finish the medicine's clinical trials and gain approvals in the US and the world as soon as possible so as to benefit patients worldwide," Chairman Lu Songtao told Yicai Global.

A team lead by Geng Meiyu, a researcher at the Shanghai Institute of Materia Medica under the Chinese Academy of Sciences, together with Shanghai-based Green Valley and the Ocean University of China developed Oligomannate, or GV-971. In trials, this first new Alzheimer's drug in 17 years has been proven to improve cognitive function in patients suffering from mild to moderate Alzheimer's.

It was recently given the green light by China's drug regulator, the National Medical Products Association, for use as a treatment for mild to moderate cases of Alzheimer's, Green Valley said in a statement on Nov. 2. Mass production of the drug will begin on Nov. 7 and it should be available nationwide by Dec. 29, Lu said.

More experiments are needed for the drug to be globally recognized, Li Shuai, founder of bio-pharmaceutical research and development firm Shanghai SIMR Biotech, told Yicai Global. It would be amazing if the drug's future results are good and it gains worldwide approval, he added.

A 161,000-square-meter production plant will start being built in Shanghai's Pudong new district this year. It should be in operation in three years' time, supplying medicines to two million patients, Lu said.

The plant will be built according to US good manufacturing practice standards, he added. Hopefully by the time it is completed, the firm's application for clinical trials in the US will be approved, so that the drugs produced in Pudong can be exported to the world, he said.

Lower Cost

Pricing has not yet been announced. Existing medicines are extremely expensive antibody drugs costing patients at least USD60,000 a year. Oligomannate is a carbohydrate-based drug that has relatively high production costs, but its price will definitely be much lower than that, Lu said.

The company will work to include the drug in medical insurance, he added. The aim is to not only make the medicine affordable for Chinese patients, but to also be competitive globally.

At around 10 million, China has the most Alzheimer's patients in the word and that is forecast to increase to 40 million by 2050. Parkinson's disease is generally regarded as a precursor to Alzheimer's and 30 percent of Parkinson's sufferers will eventually develop Alzheimer's.

"We'll focus on patients with Alzheimer's disease to see if this drug is equally effective against other neurological diseases such as Parkinson's and depression once the drug hits the market," Geng said. "These have yet to be verified."

Geriatric diseases such as Alzheimer's have placed a significant burden on public health care services around the world. Alzheimer's affected almost 50 million people worldwide last year and this is expected to rise to 152 million by 2050, according to the latest statistics. Global treatment and care costs for Alzheimer's patients was in the trillions of dollars last year.