I-Mab (NASDAQ: IMAB) Gets China CDE Approval To Start Phase 3 Clinical Trial Of Eftansomatropin

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I-Mab (NASDAQ: IMAB), a biotechnology company announced Wednesday that it has got the green signal from China Center for Drug Evaluation (CDE) to commence the Phase 3 clinical trial Eftansomatropin. Eftansomatropin is a  long-acting recombinant human growth hormone (rhGH) used to treat the deficiency of growth hormone in pediatric patients.

In Phase 1 and 2 clinical studies, Eftansomatropin has shown encouraging results as compared to the daily injected rhGH (Genotropin). This is not only the greatest achievement of I-Mab but also for pediatric patients. The company aimed to bring new innovative therapy that is safe for the patients and convenient for pediatric patients once proven.

Eftansomatropin is proven to be very useful and has some long-term safety advantages over conventional pegylated rhGH drugs. Frost & Sullivan, a market research company revealed that only 3.7% of 3.4 million pediatric patients in Greater China with growth hormone deficiency get growth hormone therapies, which primarily consist of daily injections of rhGH.

Shares of I-Mab traded up 22.54% as it gained +8.65 at $47.03 on Wednesday. In the past 52-weeks of trading, this company’s stock has fluctuated between the low of $9.30 and a high of $42.30. IMAB has moved up 405.70% and 11.18% from its 52-weeks low and 52-weeks high, respectively. Looking at its liquidity, it has a current ratio of $1.50. I-Mab market capitalization has remained high, hitting $41.07 million at the time of writing.

The company has earlier disclosed that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) gave the green signal for the Investigational New Drug (IND) application for lemzoparlimab.

lemzoparlimab is also known as TJC4 to start a phase 1 clinical trial in patients. Phase 1 clinical trial in the US has shown positive results. It is the highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab.

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