I-Mab has concluded subject enrolment in the Phase III TALLER clinical trial to analyse eftansomatropin alfa (TJ101) a weekly therapy to treat pediatric growth hormone deficiency (PGHD) in China. 

The company expects final results from the trial next year and will submit an application seeking a Biologics License Application (BLA).

The multicentre, randomised, open-label, active-controlled trial enrolled 168 participants in China. 

It will analyse the safety, efficacy and pharmacokinetics (PK) of eftansomatropin alfa in PGHD patients versus Norditropin, a daily rhGH available in the Chinese market.

The annual height velocity is the primary endpoint of the trial.

A highly differentiated long-acting recombinant human growth hormone, eftansomatropin alfa elicits the production of insulin-like growth factor 1 (IGF-1) in the liver.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

IGF-1 has growth-stimulating effects on various tissues, including osteoblast and chondrocyte activities that induce bone growth. 

I-Mab president Dr Andrew Zhu said: “We are excited by having achieved this important milestone as we are now so close to offering this differentiated therapy to patients. 

“Eftansomatropin alfa provides a convenient weekly treatment option in the current growth hormone market that is dominated by daily injectables. 

“We look forward to advancing this study at full speed towards registration.”

In various priorly concluded clinical trials, the safety, tolerability and efficacy of eftansomatropin alfa were well demonstrated. 

In November last year, the company entered a strategic partnership with Jumpcan Pharmaceutical to expedite the development, production and marketing of eftansomatropin alfa in mainland China.