RemeGen grabs one of the world's largest ever biotech IPOs

RemeGen has raised $515 million on the Hong Kong exchange in one of the largest biotech IPOs ever produced.

The largest to date in 2020, and one of the biggest after Moderna’s $600 million-plus IPO a few years back, the Yantai-based biotech in China will use its major cash haul toward its healthy pipeline of mid- to late-stage efforts.

RemeGen Co., Ltd. ("RemeGen") is a leading biopharmaceutical company in China dedicated to fulfilling unmet medical needs for patients with life-threatening conditions. RemeGen's main focus is research and development, manufacturing and commercialization of novel biologics, most notably monoclonal antibodies (mAb) and antibody-drug conjugates (ADCs). Headquartered in Yantai, Shandong Province, China, RemeGen has labs/offices in Beijing, Shanghai, California and Maryland. Since its inception in 2008, RemeGen has created more than 10 novel drug molecules that are in various stages of development. Currently, there are two products in late stage clinical development in China to treat autoimmune and oncology indications.

In September, U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for disitamab vedotin (RC48), a novel humanized anti-HER2 antibody drug conjugate (ADC), for the second-line treatment of patients with HER2 positive locally advanced or metastatic urothelial cancer (UC) who have also previously received platinum-containing chemotherapy treatment. Earlier this year, RemeGen announced the FDA's clearance of an Investigational New Drug (IND) application for a Phase II clinical study in the United States and the grant of Fast Track designation for disitamab vedotin.

A drug development program with Breakthrough Therapy designation is eligible for all Fast Track designation features, intensive guidance on an efficient drug development program beginning as early as Phase I, and organizational commitment involving senior managers. This process is designed to expedite the development and review process.

Further back in the pipeline, it also has a series of early-stage drugs working on fusion protein VEGFR/FGF in eye conditions including wet age-related macular degeneration and diabetic macular edema.