(Yicai) June 9 -- Green Valley Pharmaceutical’s production of sodium oligomannate capsules, its flagship Alzheimer’s drug approved in China in late 2019, has been halted because the innovative drugmaker failed to renew the license in time, according to an insider.

Green Valley said in an internal notice at the end of last month that it was suspending sodium oligomannate production and closing related offices and production areas, a source at the Shanghai-based company told Yicai. The firm is waiting for the National Medical Products Administration to approve its application for the license to be renewed, the person added.

Pharmaceutical companies typically apply to renew drug permits six months before they expire, so it is rare that an expiring license forces a firm to shut down production, Yicai found.

The insider noted that Green Valley has been under severe operational strain and is experiencing very tight cash flow.

The NMPA conditionally approved sodium oligomannate as a new treatment for mild to moderate Alzheimer's in November 2019, making it the first such drug approved worldwide since 2003. The capsule was included in the National Medical Insurance Drug List on Jan. 1, 2022, with its price cut to CNY296 from CNY895 (USD41.15 to USD124.50) per box.

Sodium oligomannate's hospital and retail sales topped CNY326 million (USD45.4 million) in 2022, according to data from the national hospital sales database Pharnexcloud.

But questions have arisen in the industry about sodium oligomannate's efficacy, action mechanism, and clinical trial protocol. According to Green Valley, the drug is a low molecular weight acidic oligosaccharide compound prepared from brown marine algae extract, which can improve the cognitive function of patients with mild to moderate Alzheimer's.

In April 2020, the US Food and Drug Administration said it approved the international multi-center phase-III clinical trial of sodium oligomannate, with plans to recruit 2,046 people in China, the United States, and Europe for the trials. 

Green Valley ended the studies in May 2022, citing pandemic disruptions, funding shortfalls, and insufficient cash flow to sustain large-scale international trials.

Alzheimer’s disease is a degenerative disorder of the central nervous system that is very hard to treat. There is no cure, but early diagnosis and treatment can help slow its progression. In the past two decades, there have been very few new Alzheimer's drugs approved worldwide, with most mainly focused on improving clinical symptoms.

Green Valley previously conducted post-marketing clinical studies on around 3,300 patients on sodium oligomannate in China and planned to present the results at an international academic conference later this year.

Editors: Tang Shihua, Martin Kadiev