Genexine, after two decades of unconventional drug development, is on the cusp of its first commercial product launch. The leading contenders for this ground-breaking debut are the sustained-release growth hormone, GX-H9, and the sustained-release erythropoietin (EPO) known as GX-E4. The imminent release of these innovative drugs has generated significant anticipation and could potentially remove the disheartening 'NDA・BLA 0 cases' label. As they gear up for market entry, the growth hormone sector finds itself under a cloud of uncertainty, attracting substantial attention.

On August 30th, Genexine announced a significant milestone: GX-H9 successfully met the phase 3 clinical trial criteria in China. The clinical results demonstrated superior efficacy and safety in comparison to the control group, 'Norditropin,' particularly in pediatric growth hormone deficiency (PGHD) patients. A notable differentiator is that while Norditropin necessitates daily administration, GX-H9 only requires a once-a-week dosage. Consequently, GX-H9 showcases the potential to enhance patients' quality of life, a highlight of its phase 3 clinical trial findings.

Nevertheless, GX-H9 is entering a growth hormone market that is already saturated with competitors offering weekly dosing regimens. 'Skytrofa' by Ascendis, 'Sogroya' by Novo Nordisk, and 'Ngenla' by Pfizer received FDA approvals in August 2021, April 2023, and June 2023, respectively.

It's worth noting that even in China, where GX-H9 is expected to debut first, there are already once-a-week growth hormone options available, such as 'Jintrolong' by Changchun GeneScience. Furthermore, Skytrofa, through Ascendis' partnership with Visen, completed phase 3 clinical trials in China in January 2023. Sogroya is also expected to conclude its phase 3 clinical trials in China in January 2024, indicating its intent to vie for a share of the once-a-week growth hormone market within China.

In a competitive landscape with three similar drugs, it appears that for GX-H9 to gain a market advantage, it must demonstrate superior efficacy and safety compared to its competitors or offer a competitive price. Jintrolong, Skytrofa, and Sogroya have not shown a significantly higher average annual growth rate in their respective once-a-day growth hormone regimens in completed phase 3 clinical trials. Furthermore, all three have not exhibited any notable safety issues. Therefore, it is expected that GX-H9's competitive edge will likely be determined in terms of product pricing.

Another formidable challenge facing Genexine is determining the next market after China for GX-H9. Presently, GX-H9 has only completed phase 3 clinical trials in China. In the absence of data from multi-country trials, Genexine must make a choice between conducting additional trials in different regions or seeking countries willing to accept the Chinese phase 3 clinical data for product approval.

The first option, involving further trials, would demand extra time and resources, potentially causing delays in the product launch. Therefore, industry experts recommend that to expand beyond China, Genexine should leverage the Chinese phase 3 clinical data.

One industry insider commented, "The competitive landscape for GX-H9 in China remains uncertain until developments unfold. Predicting Jintrolong's current sales trends and pinpointing the precise timing of Skytrofa and Sogroya’s launches in China presents a formidable challenge."

They added, "For GX-H9 to venture into markets beyond China, Genexine may need to explore international partnerships, given their limited overseas presence. It appears crucial to seek partnerships that can facilitate entry into non-Chinese markets."