Green Valley Pharmaceutical's "Ninth Phase One" clinical application for new indications was undertaken by CDE

Today (December 29), the official website of the Center for Drug Evaluation (CDE) of the State Drug Administration shows that the clinical application of the new drug category 2.
4 of Mannat Sodium Capsules of Green Valley (Shanghai) Pharmaceutical Technology Co.
, Ltd.
has been undertaken
.
According to the latest "Chemical Drug Registration Classification and Application Data Requirements", Class 2.
4 new drugs are: drugs with new indications containing known active ingredients
.
It was reported earlier that the preclinical study of Phase 1 (Mannat Sodium Capsule, GV-971) for Parkinson's disease (PD) has been basically completed, and it is planned to submit an application for an international multi-center clinical Phase II trial in the second half of 2021; The preclinical studies of 3 new indications including sexual dementia (VD), neuromyelitis optica (NMO) and amyotrophic lateral sclerosis (ALS) are underway, and it is expected to submit a nine-phase one clinical study application for the treatment of neuromyelitis optica by the end of 2021
.
The indications for the clinical application of Green Valley Pharmaceutical may be related to neuromyelitis optica
.
GV-971 was jointly developed by Professor Geng Meiyu of the Shanghai Institute of Materia Medica, Chinese Academy of Sciences and Green Valley Pharmaceuticals, and was approved for conditional marketing by CDE in China in November 2019
.
However, CDE requires the applicant to continue to carry out pharmacological mechanism research and long-term safety and efficacy research after listing, improve the analysis method of oligosaccharides, and submit relevant test data on time
.
In 2020, GV-971 applied to be included in the medical insurance catalog, but failed to pass the assessment of the comprehensive group.
Industry insiders speculated on the reason, "It may be because the drug was relatively controversial when it was first launched, and the time to market was short, and the use data was not enough.
Therefore, in the comprehensive group.
The assessment failed
.
" This year, GV-971 was successfully included in the medical insurance catalog
.
It is reported that previously, the domestic price of GV-971 was 895 yuan per box, and the cost of the "36-week treatment period" was about 32,000 yuan
.
In April 2021, GV-971 launched the "6+3 Donation Drug Program" in China, and patients can receive up to 12 boxes of drugs (about 10,000 yuan worth)
.
This time successfully entered the new list of medical insurance
.
The decrease is from 895 yuan to 296 yuan per box, and patients can pay at least <600 yuan/month in the future
.