Recently, Changchun High-tech issued the "Announcement on the Approval of New Indications of Recombinant Human Growth Hormone Injection of Holding Subsidiaries" (hereinafter referred to as the "Announcement"), and the approved and increased indication of the drug is prepubertal growth disorder
caused by chronic kidney disease (CKD).
It is reported that human growth hormone (recombinant human growth hormone) is the core variety of Changchun High-tech, and the manufacturer is Kinsey Pharmaceutical
.
Last year, the company announced that the long-acting growth hormone packaged in cartridges has been officially approved by the State Food and Drug Administration, and the long-acting crypto-needle electronic injection pen used with it has been launched, which will further improve the comfort of long-acting growth hormone therapy and provide patients with more convenient treatment methods
.
It is worth mentioning that the marketing application for the new indications of recombinant human growth hormone injection (including Prader-Willi syndrome) declared by Kinsey Pharmaceutical has been officially approved by the National Medical Products Administration, which is the first time that domestic growth hormone products have been approved for Prader-Willi syndrome (PWS) indications
.
In addition, on August 4, 2022, the marketing application for idiopathic short stature (ISS) for a new indication of recombinant human growth hormone injection declared by Kinsey Pharmaceutical has also been officially approved
.
The industry expects that it will become a treatment option
for more and more patients as indications continue to expand.
Growth hormone is a common main treatment for short stature diseases, and in recent years, as growth hormone therapy begins to enter the field of vision of more and more parents, its market size is expanding
.
According to Hengzhou Bozhi survey, the compound annual growth rate of growth hormone in China from 2018 to 2030 can reach 15.
7%, and the market size will exceed 22 billion yuan
by 2030.
At present, many domestic pharmaceutical companies are increasing their layout
in this field.
It is understood that since December last year, a number of pharmaceutical companies have announced the progress of their growth hormone clinical marketing
.
For example, on December 29, 2022, Acro Biotech announced that the company's self-developed "AK2017 injection" (recombinant human growth hormone-Fc fusion protein injection) was approved for drug clinical trials, agreeing to carry out clinical trials
of this product for slow growth in children caused by endogenous growth hormone deficiency.
On December 8, Sinovac also said through the interactive platform that the company's research pipeline includes short-acting growth hormone and long-acting growth hormone projects, which are currently in the preclinical research stage
.
In addition, I-Mab, Tebao Biologics, Weisheng Pharmaceutical, and other growth hormone products are in the Phase III clinical stage, and many pharmaceutical companies such as Fu'an Pharmaceutical, Tonghua Dongbao, Renhe Pharmaceutical, and Yifan Pharmaceutical are also involved in growth hormone research and development
.
The industry believes that compared with the penetration rate of more than 10% in developed countries such as Europe and the United States, there is huge room for improvement in China, that is, recombinant human growth hormone has huge potential space
in the domestic market.
Its broad prospects and excess profits will also support the revenue of related enterprises to maintain a high growth rate
.
It is worth mentioning that in the current growth hormone market in China, Changchun High-tech and Ankor Biotech account for a total of 91%, and the performance of this business is expected to usher in substantial growth
in the future.
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