AstraZeneca Submits NDA in China for Eplontersen, a $7B+ ASO Therapy for ATTR-CM

Sep 29, 2024 16:18 CST Updated 16:18

AstraZeneca

Biopharmaceutical Manufacturer

On September 29, the CDE website showed that AstraZeneca's Eplontersen Injection had been submitted for marketing authorization in China. Eplontersen isAstraZeneca Strikes Two Collaborations Worth Over $7 Billion, introduced from Ionis companyAAntisense Oligonucleotide (ASO) Therapy. Based on the research progress of this drug in China, it is speculated that the indication for this application may be:For adult patients with transthyretin amyloid cardiomyopathy (ATTR-CM)。

Screenshot source: CDE official website

ATTR amyloidosis is a systemic, progressive, and fatal disease, where patients experience a variety of overlapping clinical manifestations due to the deposition of TTR amyloid in various tissues and organs (Including peripheral nerves, heart, intestines, eyes, kidneys, central nervous system, thyroid, and bone marrow) caused by inappropriate formation and aggregation in China.The gradual accumulation of TTR amyloid deposits in these tissues and organs can lead to organ failure and eventually death.。

Eplontersen isDeveloped by Ionis PharmaceuticalsAn ASO therapy,Aimed at inhibiting the production of transthyretin or TTR protein。The drug was approved for marketing by the U.S. FDA in December last year for the treatment of adult hereditary transthyretin-mediated amyloidosis polyneuropathy (Also known as ATTRv-PN）。

In 2021, Ionis and AstraZeneca entered into a collaboration to jointly develop and commercialize Eplontersen in the United States.And grant AstraZeneca the rights to develop and commercialize the drug in regions outside of Latin America.，The total amount of this cooperation exceeds 3.5 billion US dollars.. In July 2023, the two parties expanded their cooperation again, and AstraZeneca obtained the exclusive rights to commercialize Eplontersen in Latin America.The total amount of this cooperation also exceeds 3.6 billion US dollars.。

In China,AstraZeneca is conducting a Phase III, randomized study, aimed atIn Chinese subjects with transthyretin amyloid cardiomyopathy (ATTR-CM)Evaluate the effect of Eplontersen on transthyretin (TTR) reduction and its long-term safety. The study has now completed patient recruitment.

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