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BreStem is a clinical stage biotech company working to fight deadly lung diseases through stem cell and exosome therapies. The company’s lead candidate BRS101(autologous lung spheroid cells) has gained FDA approval as the world’s first IND using intrinsic lung-derived cells to treat pulmonary conditions. The company’s second candidate BRS201 (lung spheroid secretome/exosome) is currently at the preIND development stage.


BreStem is at the forefront of a revolution in lung regeneration therapy. Lung Spheroid Cells (LSCs) therapy have shown to be effective in preclinical studies of pulmonary fibrosis and may have wide applications as an anti-inflammatory and anti-fibrotic treatment, with the potential to cure pulmonary fibrosis. In addition, we are developing cell-free strategies (using secertome and exosome) derived from lung stem cells for off-the-shelf and non-invasive regenerative therapies.


June 2017

BreStem Therapeutics was formed at the Research Triangle Area of North Carolina and obtained a global exclusive license from NC State University to develop the lung stem cell therapy invented in Dr. Ke Cheng’s lab

October 2017

BreStem closed a 2 million Seed Round funding from a VC

April 2018

BreStem completed key preclinical safety and efficacy data on the lead candidate BRS101, autologous lung spheroid cells

May 2018

The IND on autologous lung spheroid cells (BRS101) to treat patients with idiopathic pulmonary fibrosis was submitted to the FDA

August 2018

The FDA granted a go-ahead for the IND to test autologous lung spheroid cells in patients with idiopathic pulmonary fibrosis

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