February 17, 2025
Source: drugdu
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On February 11, 2025, Anko Bio (stock code: 300009.SZ), a well-known A-share listed company, issued an announcement, announcing that it will use its own funds of no more than US$31 million (including brokerage commissions and related fees such as levies) to participate in the subscription of Weisheng Pharmaceutical's initial public offering of shares on the Hong Kong stock market. The announcement clearly stated: "This investment is based on Anko Bio's strategic development plan and aims to promote in-depth strategic cooperation between the two parties and further enhance Anko Bio's risk resistance, core competitiveness and capital market influence."
On the evening of February 9, information from the Hong Kong Stock Exchange showed that Weisheng Pharmaceuticals had officially passed the Hong Kong Stock Exchange hearing. As of now, the company has established a product pipeline consisting of three candidate drugs, including lonapegsomatropin, navepegritide, and palopegteriparatide, which are used to treat childhood growth hormone deficiency, achondroplasia, and hypoparathyroidism, respectively.
Among them, the core product closest to commercialization, Longpe Somatropin, is a once-weekly long-acting growth hormone preparation (LAGH). It has been approved by the FDA and EMA worldwide. Its Phase 3 key trial in China has been completed, and its BLA was accepted by the National Medical Products Administration in March 2024.
China becomes the world's largest growth hormone market, driven by unmet clinical needs
According to Frost & Sullivan, the scale of the Chinese growth hormone market has increased rapidly, from RMB 4 billion in 2018 to RMB 11.6 billion in 2023, with a compound growth rate of about 23.9%, surpassing the United States to become the world's largest drug user in this field. Among them, the market size of long-acting growth hormone has shown a growth trend from scratch. By 2023, the market size has rapidly climbed to RMB 2.9 billion, with a compound growth rate of 57.4%. According to Frost & Sullivan's forecast, China's growth hormone market will increase to RMB 28.6 billion by 2030, of which the market size of long-acting growth hormone will reach RMB 21.1 billion in 2030, accounting for 73.8% of the sales share of the growth hormone market.
According to the Sullivan report, there will be as many as 3.4 million children with growth hormone deficiency in my country in 2023, but the penetration rate of growth hormone treatment is only 5.3%. This figure has reached 10% in Europe and the United States in the early years, so there is still a lot of room for improvement in my country. In recent years, with the improvement of patients' disease awareness and the enhancement of treatment accessibility, the treatment penetration rate is gradually increasing. It is expected that the penetration rate of growth hormone treatment will reach 10.7% in 2030.
In addition, compared with developed countries, the application of growth hormone in China is not sufficient. According to Frost & Sullivan statistics, children with GHD in developed countries start growth hormone treatment earlier than Chinese patients, and the average treatment time is 3.5 years, which is longer than the treatment time of Chinese patients of about 1.7 years. Therefore, the Chinese growth hormone market has a lot of room for growth in terms of the time of starting treatment for children and the treatment cycle.
Looking back at the history of treatment for short stature, technological innovation promotes diagnosis and treatment upgrades
Short stature has always been one of the most common symptoms in pediatric endocrinology outpatient clinics, and growth hormone is currently the most effective means of clinical treatment of short stature. The earliest human pituitary GH extracted from the pituitary glands of cadavers can be traced back to the 1950s, but due to limited sources, scarce production and susceptibility to viral contamination, this method was quickly eliminated.
After entering the 1980s, with the development of genetic engineering technology, recombinant human growth hormone (rhGH) was synthesized and began to be used to treat childhood growth hormone deficiency. This genetically recombinant human growth hormone has the same amino acid sequence and structure as the natural growth hormone secreted by the human body, with high biological activity and low immunogenicity. It has been widely used in childhood growth hormone deficiency and other diseases related to dwarfism.
Like many drugs, growth hormone has also gone through many upgrades. It can be said that each change is accompanied by years of dedicated exploration by the researchers, such as the transition from powder to liquid, and the revolutionary progress from short-acting to long-acting. After nearly 40 years of development, in the era of comfort treatment, the birth of long-acting growth hormone also meets the actual needs of parents and children. From once a day injection to once a week injection, while greatly reducing the pain of children and improving compliance, it also ensures that the treatment goals are better achieved.
At the same time, despite the continued growth of the market size and the increasing demand from patients, most of the growth hormone products approved for marketing in China are short-acting growth hormone. According to a white paper released by Ernst & Young [1] , there is a direct positive correlation between patient compliance and treatment efficacy. However, the inconvenience of frequent administration of short-acting growth hormone and many force majeure factors have led to a serious and widespread phenomenon of missed injections, which in turn has led to irregular medication or insufficient dosage, affecting the treatment effect. At present, only one long-acting product has been approved in China, and there is still a huge unmet clinical demand.
Leading a new era of treatment for children's growth and development, core products are recognized by the international market
Lompex Somatotropin is the only long-acting preparation in the world that has good safety and efficacy as confirmed by clinical data, and is expected to become China's first long-acting growth hormone that can release unmodified growth hormone molecules and thus has a "natural" mechanism of action, with BIC potential. Unlike other long-acting growth hormones that form growth hormone analogs based on permanent protein modification to achieve long-term effects, Lompex Somatotropin's long-term effect technology - "TransCon (temporary connection)" technology is an innovative technology platform for new drug development. Its core advantage is that while achieving long-term effects, the active drug molecules released in the human body are completely consistent with the structure of growth hormone secreted by the human body itself, and can play a physiological role based on the model of endogenous growth hormone. This long-term effect technology with a "natural" mechanism of action ensures its effectiveness and safety.
The advantage of the "natural" mechanism of action of Lompezil somatotropin has been further confirmed in its Phase 3 clinical trial in China: the results of the completed Phase 3 clinical trial in China in which the two products were compared head to head showed that after 52 weeks of treatment of Chinese children with growth hormone deficiency with Lompezil somatotropin and daily somatotropin, the primary endpoint - annualized growth rate (AVH) was 10.66 cm/year and 9.75 cm/year, respectively, with a difference of 22.75cm/year (p=0.0010). Lompezil somatotropin was significantly more effective in promoting growth than daily somatotropin, and its safety was comparable.
Romper growth hormone has been approved for marketing in the United States and the European Union under the trade name Skytrofa. After its launch overseas, the product has gained high recognition in clinical treatment and its sales have increased rapidly. According to public information, Ascendis expects the sales of Lompezil somatropin to reach 202 million euros in 2024, a year-on-year sales increase of 84%.
According to public information, Weisheng Pharmaceutical is the only biotech company in Hong Kong that focuses on the endocrinology field and develops long-acting growth hormone. It focuses on a large number of unmet medical needs and is committed to providing first-in-class or best-in-class endocrine disease products and treatment solutions. Anko Bio said, "This overseas investment reflects the company's recognition of the future development potential of Weisheng Pharmaceutical. In addition, through this investment, the company will promote the establishment of a close long-term cooperative relationship with Weisheng Pharmaceutical, promote in-depth strategic cooperation between the two parties in their respective areas of strength, and help achieve resource integration and complementary advantages." In the future, the cooperation between the two parties may become a benchmark case of the "capital + innovation" dual-wheel drive.
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