Chinese authorities did not renew a conditional approval of Green Valley Pharmaceuticals’ controversial Alzheimer’s disease drug sodium oligomannate, also known as GV-971, according to online records from the country’s drug regulator.

As part of its routine disclosure of regulatory activities on Aug. 12, China’s National Medical Products Administration (NMPA) put its responses to Green Valley’s applications to turn GV-971’s conditional nod into a full approval in a group marked “notification delivery” but not the “approval document delivery” list. This move suggests that the drug did not get approval.

A search of the NMPA’s Center for Drug Evaluation database of drugs with conditional approvals returned no results for GV-971.

Without an approval, GV-971, which was touted as a breakthrough for China’s Alzheimer’s disease community when it entered the field in late 2019 despite much controversy, will likely be pulled from the market.

The exact reason for the rejection is unclear. Green Valley has not announced the NMPA’s feedback as of publication time. Fierce Pharma has reached out to the company.

Concerns that Green Valley was struggling to get GV-971’s licensure renewed emerged in May. First, patients reported difficulty finding supplies of the drug. The next month, word came out that the Shanghai biotech had halted production and sales of the drug. At that time, the company cited the need to renew its marketing license, which was under a protracted review that stretched past the expiration date of its existing permit.

“We are in close communications with relevant authorities and believe patients’ treatment needs will be met soon,” the company said in June, as quoted by Bloomberg.

In China, drugmakers must renew marketing licenses for their products every five years.

GV-971 arrived in 2019 ahead of any anti-amyloid antibodies such as Eisai and Biogen’s first-generation Aduhelm or their newer product Leqembi. But the seaweed-derived drug has faced significant skepticism from day one.

In a phase 3 trial in Chinese Alzheimer’s patients, oligomannate significantly outperformed placebo at slowing cognitive decline as measured by a standard clinical scale called ADAS-Cog. However, skeptics have flagged an unusual precipitation of disease worsening in the control arm, suggesting trial misconduct. Besides, the drug only demonstrated a nonsignificant trend for improvement on another widely used cognition score called CIBIC-plus.

Then in 2022, Green Valley canceled a global phase 3 trial, blaming funding challenges and the COVID-19 pandemic.

Despite the controversies, GV-971 has enjoyed national reimbursement coverage since 2022.

Because of the lack of treatment options, GV-971 reportedly sold 2.13 million boxes in 2024. At a reimbursed price of 296 Chinese yuan (about $41), the drug’s sales last year reached about $88 million. A patient needs four boxes of the drug per month.

China’s denial of renewal for GV-971 comes after the country approved Eisai’s Leqembi in early 2024 and Eli Lilly’s rival antibody Kisunla in December, both for patients with mild cognitive impairment and mild dementia stage of Alzheimer’s disease.

Eisai and Lilly see big market potential for their Alzheimer’s drugs in China, which is home to about 17 million patients with early Alzheimer’s disease, according to Eisai.