By Fineline Cube 
Changchun High & New Technology Industries (Group) Inc. (SHE: 000661) on Aug 27, 2025 disclosed that its wholly‑owned subsidiary, Changchun GeneScience Pharmaceutical Co., Ltd., has filed for a domestic clinical‑trial application for GenSci134, a novel injection aimed at treating growth retardation caused by endogenous growth hormone deficiency (GHD) and idiopathic short stature (ISS) in children.
What is GenSci134?
- Class 1 Therapeutic Biological – independently developed by GeneScience.
- Target Indications –
— Growth Hormone Deficiency (GHD): adult (AGHD) and pediatric (PGHD).
— Non‑GHD Conditions – idiopathic short stature (ISS). - Mechanism – Provides exogenous growth hormone to compensate for pituitary insufficiency.
Clinical Need
| Condition | Prevalence | Current Treatment | Unmet Need |
|---|---|---|---|
| Pediatric GHD (PGHD) | ~1–2 % of children | Long‑term GH replacement | Requires extended therapy, high cost |
| Idiopathic Short Stature (ISS) | 60–80 % of short‑staturey children | Variable GH therapy | Heterogeneous response, limited evidence |
Persistent, untreated GHD can lead to metabolic disorders and cardiovascular disease in adulthood, underscoring the urgency of effective, long‑term therapies.
Strategic Impact
- First‑In‑Class Position – GenSci134 is the only Class 1 biologic in China targeting both GHD and ISS.
- Pipeline Diversification – Strengthens Changchun High’s focus on high‑tech pharmaceuticals and biotherapeutics.
- Market Opportunity – China’s pediatric endocrinology market is projected to reach USD 3.2 bn by 2030, with a growing demand for GH therapies.
Next Steps
- Regulatory Review – The China Food and Drug Administration (CFDA) will evaluate the application.
- Phase II/III Studies – Upon approval, the company plans to initiate multinational trials.
- Manufacturing Scale‑Up – GeneScience will leverage its GMP facilities to meet demand.-Fineline Info & Tech