June 8, 2026
Source: drugdu
27

Recently, GenSci155 injection, independently developed by Changchun GenSci Pharmaceutical Co., Ltd. (hereinafter referred to as "GenSci Pharmaceutical"), has been approved by the National Medical Products Administration to conduct clinical trials. It is intended for the prevention of bronchopulmonary dysplasia (BPD) in premature infants and the treatment of acute ischemic stroke (AIS). GenSci Pharmaceutical will subsequently conduct further clinical research in the fields of pediatric health and neuroprotection.
GenSci155 injection is a long-acting fatty acid-conjugated recombinant human insulin-like growth factor-1 (IGF-1) analogue, registered as a Class 1 therapeutic biological product. Developed based on GenSci Pharmaceutical's Duratide™ long-acting sustained-release peptide platform, this product achieves reversible binding to albumin through fatty acid chain modification, prolonging the drug's half-life in vivo. It supports both intravenous and subcutaneous administration, extending dosing intervals and contributing to stable and adequate drug exposure.
Indication 1
Prevention of bronchopulmonary dysplasia (BPD) in premature infants
Bronchopulmonary dysplasia (BPD) is the most common pulmonary complication in preterm infants, with its incidence increasing significantly with decreasing gestational age, and it has a lasting impact on respiratory system and long-term health. Approximately 25,000 newborns with BPD are born annually in China and the United States at gestational age <28 weeks [1,2] . As of June 5, 2026, prior to the publication of this article, there are no approved drugs globally for the prevention of BPD in preterm infants. Short-acting IGF-1 has shown some potential in early clinical trials, but its reliance on continuous intravenous infusion presents challenges in clinical practice and control of drug exposure levels.
GenSci155 is designed to correct the rapidly declining IGF-1 levels in preterm infants after birth, supporting early lung and other organ development. It is a preventative therapy that supports alveolarization and vascularization of the lungs and improves organ maturation and growth through upstream mechanisms. Preclinical studies have shown stable IGF-1 exposure characteristics, and the product can be administered intravenously or subcutaneously, allowing for flexible use at different stages of growth and development in preterm infants.
Indication 2
Treatment of acute ischemic stroke (AIS)
Acute ischemic stroke is one of the leading causes of death and disability in China and around the world. According to statistics released by the Chinese Stroke Association, there were 14.94 million stroke patients in China in 2024, with 3.3 million new stroke cases each year . [3]
Current treatment for acute ischemic stroke has entered an era centered on reperfusion therapy. However, ischemia-reperfusion injury can occur after reperfusion, further aggravating neuronal damage and limiting functional recovery. Neuroprotective therapy holds promise for synergistic effects with reperfusion therapy, improving clinical outcomes by protecting neurons within a time-sensitive window.
Preclinical studies suggest that GenSci155 can alleviate ischemia-reperfusion injury, promote neuronal and glial cell survival, and improve neurovascular function by activating IGF-1R-mediated downstream signaling pathways, thereby exerting neuroprotective and repair effects. Furthermore, this product has the potential for intravenous bolus administration, which may enable neuroprotective intervention in the acute phase of stroke.
In the future, GenSci Pharmaceutical will continue to drive innovation, accelerate global clinical research and product launches, and bring more diverse treatment options to patients.
https://bydrug.pharmcube.com/news/detail/a1683d95645ab6253f87b92a3e4db2a7
By editoryour submission has already been received.
OK
Please enter a valid Email address!
Submit
The most relevant industry news & insight will be sent to you every two weeks.