Global and Domestic Pharma Companies Vie for China's Height Enhancement Market with Recombinant Human Growth Hormone Therapies

As people’s expectations for height become increasingly stringent, some individuals resort to extreme measures such as limb-lengthening surgery to achieve greater stature, while a larger number of patients with dwarfism eagerly await effective pharmacological treatments to address their short stature.

Recently, the National Medical Products Administration (NMPA) approved Novo Nordisk’s application to expand the indications for its recombinant human growth hormone injection, Norditropin®, to include “short stature in children caused by Noonan syndrome.” Meanwhile, GenSci Pharmaceutical, a subsidiary of Changchun High-Tech (000661.SZ), Anke Biotechnology (300009.SZ), and other companies have all launched recombinant human growth hormone drugs for the treatment of dwarfism. Why has recombinant human growth hormone attracted such intense competition among numerous Chinese and foreign pharmaceutical companies?

It is reported that dwarfism refers to children whose height is more than two standard deviations below the average height of children of the same sex, age, and ethnicity, with an annual growth rate of less than 5 centimeters. As of now, the incidence of dwarfism among children in China is approximately 3%, meaning that out of China's total population of 1.4 billion, 42 million people suffer from dwarfism. This represents a vast market for related medications, with recombinant human growth hormone drugs being one of the most advanced treatment options currently available, making it a highly competitive area for both domestic and international pharmaceutical companies.

The Overlooked “Dwarfism”

Why does short stature occur?

According to Pan Jiayan, Chief Physician of the Department of Pediatric Endocrinology at Wuhu No. 1 People’s Hospital, “Common causes of short stature include: endocrine short stature due to growth hormone deficiency, familial short stature, nutritional short stature, intrauterine growth retardation, chromosomal disorders, inherited metabolic diseases, constitutional delay of puberty, and skeletal system disorders. Among these, endocrine short stature caused by growth hormone deficiency responds well to treatment.”

Data indicate that the primary physiological function of growth hormone (GH) is to promote protein synthesis and stimulate the proliferation and differentiation of articular cartilage and epiphyseal chondrocytes, thereby increasing body height.

Growth Hormone Deficiency is a disorder of growth and development caused by partial or complete deficiency in the synthesis and secretion of growth hormone by the anterior pituitary, or by structural abnormalities of growth hormone, receptor defects, and other factors.

A deficiency in growth hormone (GH) in the human body leads to growth arrest. GH is primarily indicated for the treatment of pediatric growth hormone deficiency, idiopathic short stature (ISS), children born small for gestational age (SGA), adult growth hormone deficiency (AGHD), Prader-Willi syndrome (PWS), Turner syndrome, Noonan syndrome, other chromosomal abnormalities, and inherited metabolic disorders.

“A representative from the Board of Directors’ Office of Changchun High-Tech stated, ‘With the advancement of modern medical science and technology, the production and modification of proteins using genetic engineering has become a reality. Human growth hormone manufactured through recombinant DNA technology is recombinant human growth hormone (rhGH), an effective medication for improving final adult height in children.’”

According to statistics, the prevalence of short stature among children in China is currently approximately 3%. Among the entire population with short stature, there are about 5.37 million children aged 4–15 years who require treatment; of these, approximately 51.6% have growth hormone deficiency or idiopathic short stature, conditions amenable to growth hormone therapy. Although market demand is substantial, Guosheng Securities estimates that the overall market penetration rate for growth hormone in China is less than 4%, compared to 28% in the United States. This indicates significant room for improvement in the market penetration of recombinant human growth hormone, suggesting that its market potential remains to be further explored.

Regarding the question of why China has a large patient population but low market penetration, a representative from the Board Office of Changchun High-Tech provided an explanation: “Based on current preliminary statistical data, there are over 7 million children with short stature in China who meet strict medical criteria. In the past, among patients with short stature, those diagnosed with growth hormone deficiency (GHD) accounted for a relatively large proportion; many of these children had a history of dystocia or suffered from hunger and malnutrition due to family poverty. However, with the general improvement in economic standards and education levels, late marriage and late childbearing have become increasingly common, leading to a significant rise in the incidence of small for gestational age (SGA) and central precocious puberty (CPP). This indicates that the factors influencing short stature in China are shifting from being poverty-related in the past to being lifestyle-related.”

Meanwhile, the extremely low public awareness that short stature is treatable is also one of the main reasons for the low market penetration rate.

“A significant number of parents are unaware that short stature can be treated through standardized medical care at hospitals, instead blindly using certain health supplements, thereby missing the optimal window for treatment. Furthermore, among parents who do seek medical attention, there are concerns regarding growth hormone therapy, particularly about the safety of hormones; even when recommended by physicians, they remain hesitant to proceed with treatment. According to preliminary statistics, the current public awareness rate that short stature in children is treatable is only 1%, and the treatment rate for children with short stature is merely 2%. Therefore, there is substantial potential for future growth, which is why GenSci Pharmaceutical has strategically positioned itself in the field of recombinant human growth hormone,” added the person in charge.

Intensifying Competition

In addition to GeneScience Pharmaceuticals, other pharmaceutical companies have also launched recombinant human growth hormone (rhGH) drugs for the treatment of endocrine short stature caused by growth hormone deficiency, aiming to supplement the body’s deficient growth hormone to promote height increase.

From the perspective of the overall competitive landscape, the major domestic players in the growth hormone sector are currently GeneScience Pharmaceuticals, Anke Biotechnology, and United Cell. With the approval and market launch of liquid formulations by major companies and the development of long-acting drugs, liquid growth hormone has become the mainstream dosage form on the market. Three of the four leading growth hormone enterprises have already launched liquid products, indicating that competition in the recombinant human growth hormone (rhGH) field will intensify.

It is understood that GenSci Pharmaceutical currently offers the most comprehensive range of growth hormone formulations, including powder, liquid, and long-acting preparations. Among these, the long-acting growth hormone is the world’s first PEGylated long-acting growth hormone and remains the only long-acting growth hormone available on the Chinese market, holding a significant market share.

Following closely, according to Li Kun, Board Secretary of Anke Biotechnology, the company’s long-acting product has also completed clinical trials.

To address intensifying competition, GenSci Pharmaceutical is developing an oral growth hormone product, striving to optimize the patient medication experience and enhance treatment adherence.

Regarding future development trends in the field of recombinant human growth hormone (rhGH), a reporter from Blue Whale Finance interviewed Zhang Deshen, Board Secretary of Changchun High-Tech. He stated, “In terms of product indications, the indications for growth hormone currently approved by the China Food and Drug Administration (CFDA) mainly include: pediatric growth hormone deficiency, growth hormone deficiency caused by severe burns and hypothalamic-pituitary disorders, Turner syndrome, and idiopathic short stature in children. Applications for adult growth hormone deficiency (GHD) replacement therapy and persistent postnatal short stature due to intrauterine growth retardation are currently under review. In addition to the above-mentioned indications, the U.S. Food and Drug Administration (FDA) has also approved growth hormone for several other conditions, such as short bowel syndrome and HIV-associated wasting syndrome. Furthermore, according to statistics published in the Journal of the American Medical Association (JAMA), growth hormone in the United States is used not only for therapeutic purposes but also for anti-aging and muscle enhancement. China may follow a similar trajectory in the future.”

“From the perspective of product dosage forms, marketed recombinant human growth hormone (rhGH) formulations are primarily categorized into short-acting and long-acting types, with short-acting formulations further divided into powder injections and liquid injections. The advent of long-acting growth hormone has reduced the dosing frequency from once daily to once weekly, alleviating injection-related discomfort and fundamentally improving medication adherence. Therefore, long-acting growth hormone is expected to be one of the prevailing trends in the near future,” added Zhang Deshen.

(Editor:Wang Xing）

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