I-Mab's IND Application Accepted By China NMPA; Shares Up

Author: Binwei Wang   

I-Mab (Nasdaq: IMAB) announced Tuesday that the China National Medical Products Administration has accepted its pivotal trial application for eftansomatropin (also known as TJ101) as a weekly treatment for growth hormone deficiency in pediatric patients (PGHD), sending its shares up 3%, trading at $31.25 today in New York.

The clinical-stage biopharmaceutical company said eftansomatropin is an innovative long-acting recombinant human growth hormone (rhGH) with a novel molecular format utilizing Genexine's patented half-life extension hyFc® fusion technology, which stimulates the production of insulin-like growth factor 1 (IGF-1) in the liver, alongside growth-stimulating effects on a variety of tissues, including osteoblast and chondrocyte activities that stimulate bone growth.

Joan Shen, the chief executive officer of I-Mab stated, "The China NMPA's acceptance of this pivotal IND for eftansomatropin represents an important step towards bringing this innovative product to the Chinese market as planned." 

She added,  "With eftansomatropin, we will be able to potentially address a substantial unmet medical need with a safer, highly differentiated, and convenient therapy for pediatric patients suffering from the growth hormone deficiency."

According to Frost & Sullivan, PGHD affected approximately 3.4 million patients in Greater China, but only 3.7% of all PGHD patients were receiving growth hormone replacement therapy, which primarily consists of daily injections of rhGH. Recombinant human growth hormone therapy has been included in the National Reimbursement Drug List in China.

I-Mab has offices in Beijing, Shanghai, Hong Kong and Maryland, United States.

The company raised $103.7 million in its IPO on January 17.

I-Mab has over 10 drug candidates in the pipeline in the therapeutic areas of immuno-oncology and autoimmune diseases. 

Shares in I-Mab are up over 148% since the close of its first trading day on Jan. 17 as of midday Tuesday.