Changchun High-Tech's days of "dominating the market" in the field of growth hormone may face significant challenges in the future.

According to Kanjian Finance, since 2024, the National Medical Products Administration has intensively accepted applications for the market approval of three long-acting growth hormone products: Yipei Growth Hormone Injection by Amoytop Biotech, Lonapegsomatropin by VISEN Pharmaceuticals, and Sogroya by Novo Nordisk. Based on the review records published by the Center for Drug Evaluation and the evaluation time for past imported drugs, Lonapegsomatropin by VISEN Pharmaceuticals is expected to be approved for market launch in the second half of 2025.

From the current perspective, the growth hormone sector is similar to the previous HPV vaccine sector, both undergoing a process from nonexistence to existence and from exclusivity to widespread availability.

From this angle, once new long-acting growth hormone products emerge in the market and the highest barrier in the growth hormone field is breached, it is only a matter of time before the growth hormone market heads toward a "price war" direction.

In the past two years, Changchun High-Tech's performance and stock price have not been ideal, especially the stock price. As of the latest closing, Changchun High-Tech's stock price was 99.75 yuan per share, with a total market capitalization of 40.7 billion yuan. Compared to its peak of 515.9 yuan per share, the stock price has dropped by over 80%, and the market capitalization has shrunk by more than 160 billion yuan.

Is the "HPV Moment" Coming?

Before 1998, Changchun High-Tech's subsidiary, GeneScience Pharmaceutical, launched China's first recombinant human growth hormone, filling the gap in China's growth hormone field.

In the following 20-plus years, Changchun High-Tech achieved rapid growth thanks to its first-mover advantage.

Taking the last 10 years as an example, in 2015, Changchun High-Tech's revenue and net profit were 2.402 billion yuan and 384.5 million yuan, respectively. By 2023, revenue and net profit had soared to 14.57 billion yuan and 4.532 billion yuan, respectively. In other words, in just eight years, Changchun High-Tech's revenue increased about sixfold, while net profit grew more than tenfold.

Driven by rapid performance growth, Changchun High-Tech's stock price soared, with its market capitalization once exceeding 200 billion yuan and the stock price reaching a peak of 515.9 yuan per share.

However, in the past two years, Changchun High-Tech has rapidly fallen from grace. As of the latest closing, its stock price was 99.75 yuan per share, with a total market capitalization of 40.7 billion yuan. Compared to its peak, the stock price has dropped by over 80%, and the market capitalization has shrunk by more than 160 billion yuan.

Why has Changchun High-Tech suddenly "lost its magic"?

In the growth hormone field, low-end products are powder injections, mid-range products are liquid injections, and high-end products are long-acting liquid injections. Many companies can produce powder and liquid injections, such as Anke Biotechnology and United Cell for powder injections, and Anke Biotechnology and Novo Nordisk for liquid injections. Only long-acting liquid injections remain dominated by Changchun High-Tech. In fact, the situation of growth hormone is very similar to that of the HPV vaccine sector: many companies can produce low-barrier bivalent and quadrivalent HPV vaccines, while the nine-valent HPV vaccine remains exclusive.

But similar to the nine-valent HPV vaccine, as more pharmaceutical companies begin researching long-acting liquid injections, the days of long-acting liquid injections being "dominated by one company" will not last much longer.

According to media reports, since 2024, the National Medical Products Administration has intensively accepted applications for the market approval of three long-acting growth hormone products: Yipei Growth Hormone Injection by Amoytop Biotech, Lonapegsomatropin by VISEN Pharmaceuticals, and Sogroya by Novo Nordisk. Based on the review records published by the Center for Drug Evaluation and the evaluation time for past imported drugs, Lonapegsomatropin by VISEN Pharmaceuticals is expected to be approved for market launch in the second half of 2025. In other words, in a year, Changchun High-Tech will face competitors in the long-acting liquid injection field.

For Changchun High-Tech, the emergence of competitors in the high-barrier long-acting liquid injection field will not only impact its business but may also push the entire growth hormone market toward a "price war" direction.

Time Is Running Out

From the current perspective, the launch of new long-acting growth hormone products is only a matter of time.

Changchun High-Tech has long recognized this reality.

Previously, Changchun High-Tech's R&D investment was not high, but in recent years, its R&D expenses have increased significantly: from 474 million yuan in 2020 to 1.723 billion yuan in 2023, with growth rates of 28.12%, 86.37%, 53.57%, and 26.85%, respectively.

In terms of existing products, apart from recombinant human growth hormone, before 2020, Changchun High-Tech only had Changchun BCHT Biotechnology's varicella vaccine and two traditional Chinese medicine products, Yinhua Miyanling Tablets and Xueshuan Xinmaining Tablets. Even with the addition of the herpes zoster vaccine GANVAC launched in April 2023, its competitiveness remains weak.

Looking at the financial reports, although Changchun High-Tech has increased R&D efforts, most of its revenue still comes from recombinant human growth hormone. In the first half of this year, the core subsidiary GeneScience Pharmaceutical, which produces growth hormone, generated revenue of 5.15 billion yuan, while Changchun High-Tech's total revenue was 6.639 billion yuan, meaning GeneScience accounted for 77.57% of Changchun High-Tech's revenue.

For Changchun High-Tech, having grown accustomed to "easy money" in the past, it is unrealistic to develop new products to replace growth hormone in the short term. Therefore, Changchun High-Tech has also turned its attention beyond vaccines. In its 2023 annual report, the company explicitly mentioned that it would "continue to improve market-oriented mechanisms, diversify business pipelines, pursue international development paths, and adopt differentiated competitive strategies to concentrate resources on development" and "build a second growth curve with high expectations, high technology, and high barriers to achieve rapid development through multiple products and channels."

According to media reports, in the past two years, Changchun High-Tech has indeed accelerated its expansion into new businesses beyond vaccines. For example, it has entered the tumor treatment field, focusing on gastric cancer and prostate cancer, and secured the commercialization rights for Megace ES (megestrol acetate oral suspension) in mainland China, Hong Kong, Macau, and Singapore. Additionally, Changchun High-Tech has over a dozen oncology R&D pipeline products gradually entering clinical stages, with progress faster for products like Jinsairui, which is about to submit an NDA, and Jintuoxi Monoclonal Antibody Injection, which is in the final stages of Phase III clinical trials.

Based on the aforementioned business proportions, these new ventures have yet to gain traction, and even if they do, they are unlikely to match the scale of the current growth hormone products. While it is undoubtedly positive for Changchun High-Tech to explore new markets beyond vaccines, with the imminent launch of new long-acting growth hormone products, the company truly has little time left for "trial and error."