今日晚间，长春高新发布公告，公司子公司金赛药业的聚乙二醇重组人生长激素注射液（以下简称“长效生长激素”）新适应症上市申请获得国家药监局批准。On the 5th, Changchun High-Tech Industries announced that its long-acting growth hormone was approved for the indication of ISS, and in August of this year, this variety was also approved for the growth retardation of girls with gonadal dysgenesis (Turner syndrome). In the first three quarters of this year, Changchun High-Tech Industries' performance saw a decline in both revenue and profits, and whether the main products that have been on the market for 10 years can attract new attention is widely anticipated.
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Caifinance News November 5th (Reporter Lu A Feng) The former "pharmaceutical grass" Changchun High-Tech Industries (000661.SZ) has made a new breakthrough in the "treasure trove" of growth hormone.
Tonight, Changchun High-Tech Industries issued an announcement that its subsidiary, Jinsai Pharmaceutical, obtained approval from the National Medical Products Administration for the new indication of polyethylene glycol recombinant human growth hormone injection (hereinafter referred to as "long-acting growth hormone") for listing.
According to the announcement, the new indication approved for the long-acting growth hormone is "used for idiopathic short stature (ISS)", idiopathic short stature is a collective term for a group of short stature diseases that are highly heterogeneous and of uncertain etiology, defined as a height below 2 standard deviations (SD) of the average height for the same age, gender, and race, or below the 3rd percentile (P3, -1.88 SD), with normal birth length, weight, and body proportions and no evidence of systemic, endocrine, nutritional, chromosomal abnormalities or genetic variations in short children.
Currently, multiple short-acting recombinant human growth hormones have been approved for this indication globally. In 2003, the U.S. Food and Drug Administration (FDA) first approved recombinant human growth hormone for idiopathic short stature. Since 2021, the China Medical Products Administration has successively approved recombinant human growth hormone injection for idiopathic short stature.
It is reported that children using short-acting growth hormones for treatment need daily injections. The long-term frequent injections not only bring suffering to the children and burden to the parents, but also decrease the children's medication compliance, thereby affecting the treatment effect.
Changchun High-Tech Industries stated that Jinsai Pharmaceutical's long-acting growth hormone is the world's first long-acting growth hormone approved for this indication, filling the clinical demand that has not been met in the field of idiopathic short stature treatment. The results of the clinical trials conducted by the company confirm that using long-acting growth hormone therapy significantly improves the standard deviation scores of the children's height and has good safety and tolerability.
Public information shows that in August this year, the variety was also approved for the treatment of growth disorders in girls with gonadal dysgenesis (Turner Syndrome).
Jinsai Pharmaceutical's long-acting growth hormone has been on the market for 10 years, previously indicated for children with slow growth due to endogenous growth hormone deficiency. According to the semi-annual report of Changchun High-tech Industries in 2024, the indication for small-for-gestational-age (SGA) has completed Phase II clinical trials; the indication for adult growth hormone deficiency has started Phase III clinical trials, with patient enrollment in progress.
Genetically engineered drugs and biopharmaceuticals attributed to growth hormones have always been the 'main force' of Changchun High-tech Industries' performance. In the first half of this year, they contributed 86.94% of the total revenue for the company. In the same period last year, genetically engineered drugs and biopharmaceuticals accounted for 92.39% of total revenue.
Whether long-acting growth hormone can become a new growth point for the company's performance remains to be seen. In the first three quarters of this year, Changchun High-tech Industries saw a decrease in revenue and net income, with a 2.75% year-on-year decrease in operating income and a 22.80% year-on-year decrease in net income attributable to shareholders of the listed company.
