Yichang Renfu Pharmaceutical’s sixth China-U.S. dual-regulatory product, memantine hydrochloride sustained-release capsules, has been approved for market launch.

Release time:

2022-03-09 08:46

Source:

Recently, Yichang Renfu Pharmaceutical’s memantine hydrochloride sustained-release capsules have received approval from the National Medical Products Administration for market launch. The product was approved under the new registration classification and is considered to have passed the consistency evaluation.

In December 2017, Yichang Renfu Pharmaceutical submitted an application to the U.S. FDA for its memantine hydrochloride extended-release capsules, which received approval in April 2021. In April 2020, the company submitted a registration application to China’s National Medical Products Administration and recently obtained approval. This marks the sixth product from Yichang Renfu Pharmaceutical—following naproxen sodium tablets—that has been approved for both domestic and U.S. markets. Currently, the company has three additional products that have been submitted for domestic marketing authorization and are now undergoing review.

Memantine hydrochloride is the first drug approved for the treatment of moderate to severe Alzheimer's disease. It is a low-to-moderate affinity, non-competitive (open-channel) NMDA receptor antagonist that improves symptoms of Alzheimer's disease by continuously activating central nervous system N-methyl-D-aspartate (NMDA) receptors through glutamate excitation. It preferentially binds to NMDA receptors and exerts its therapeutic effect by modulating cation channels.

Patients with Alzheimer’s disease dementia require long-term medication, and adherence to the treatment regimen is critical to determining therapeutic outcomes. Memantine hydrochloride extended-release capsules offer a more prolonged therapeutic effect compared to conventional immediate-release formulations, requiring only once-daily administration. This can improve patient adherence and further enhance clinical efficacy.

In the future, Renfu Pharmaceutical Group will accelerate the approval process for products seeking dual FDA and NMPA registration, based on market demand, and forge ahead on the path of internationalization.

Yichang Renfu Pharmaceutical’s sixth China-U.S. dual-regulatory product, memantine hydrochloride sustained-release capsules, has been approved for market launch.

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