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Friday, November 1, 2019

In a bid to get to Chinese patients faster, Shanghai’s I-Mab plans $100M Nasdaq IPO

Aiming to be the next Chinese company to list on Nasdaq after Zai Lab’s debut two years ago, the Shanghai drug developer I-Mab is gunning for a $100 million IPO.
The company — which has raised more than $400 million in the last three years — has a shrewd strategy for biologic development: it first conducts its proof-of-concept trials in the United States and works towards getting FDA clearance for in-human studies.  The data generated are then used to advance clinical development in China. Eventually, after the experimental drug has been clinically validated in the United States, the company retains Chinese rights for further development and commercialization — while retaining the option to out-license globally.
I-Mab’s approach could allow Chinese patients to access treatments concurrently or soon after their market approvals elsewhere, particularly since Chinese officials have carved out a pathway for the fast-track approval of drugs supported by solid overseas clinical data and granted priority reviews. Zai Lab, which has acquired a slate of late-stage and commercial products to quickly build its portfolio, has benefited from these Chinese reforms.
I-Mab, meanwhile, has a slate of ten clinical and preclinical biologics for autoimmune disease and cancer, which is on the rise in China due to pollution and lofty rates of smoking. Growth in China’s biologics market has surpassed the global biologics market and is expected to reach $189.4 billion in sales by 2030, I-Mab said, citing a Frost & Sullivan report.
The company’s global portfolio houses monoclonal antibodies and bi-specific antibodies. Three drugs: TJM2, TJC4 and TJD5 are in phase 1 trials in the United States — and applications to test TJC4 and TJD5 in humans was granted by China’s National Medical Products Administration (NMPA) earlier this year.
In its China portfolio, the company has five home-grown investigational drugs that are in or ready for phase II or phase III trials in China, having met the related pre-set safety and preliminary efficacy endpoints in early or mid-stage studies in Europe or the United States. TJ202 is in two pivotal trials testing its use in multiple myeloma in Taiwan, while the NMPA has endorsed testing the drug for the same indications in humans in China. Data on TJ101 is being compiled for an application to test in a registrational trial in China. For enoblituzumab, an IND is being prepped for 2020 for a mid-stage trial or a pivotal trial. Altogether, the company is vying to submit a slate of marketing applications come 2021.
The company was established in June 2016 and has inked a number of collaborations, including MorphoSys, Genexine, MacroGenics, and Ferring. It intends to list on the Nasdaq with the symbol IMAB.

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