From R&D to Value Realization: VISEN Pharmaceuticals Reaches a Pivotal Milestone as Lonapegsomatropin Gains Approval to Capture 80% of the Long-Acting hGH Market

On January 26, the National Medical Products Administration (NMPA) officially approved the market launch of Ascendis Pharma’s (2561.HK) core product, lonapegsomatropin injection, for the treatment of pediatric growth hormone deficiency (PGHD). This approval marks the commercial debut of the company’s first innovative product, successfully achieving a critical transition from research and development to commercialization. As the first and currently only long-acting growth hormone in China whose superiority over daily formulations has been confirmed by Phase III clinical trials, this product not only fills a technological gap in the mid-to-high-end market but also reshapes the competitive landscape of the multi-billion-yuan growth hormone market.

Pediatric Growth Hormone Deficiency (PGHD) is a disorder of growth and development in children caused by insufficient secretion of growth hormone from the pituitary gland. For a long time, short-acting formulations administered via daily subcutaneous injection have been the standard treatment; however, nearly two-thirds of patients experience missed doses, which directly compromises therapeutic efficacy. Consequently, there is an urgent need for treatment regimens with less frequent dosing and greater peace of mind for patients.

The core breakthrough of Longpei Growth Hormone lies in the dual innovation of “superior efficacy + convenience.” As a long-acting formulation requiring only once-weekly injections, its value resides not only in the significant reduction in injection frequency compared to daily formulations but also in substantial therapeutic advancements. Clinical data demonstrate that Longpei Growth Hormone achieves statistically superior efficacy over traditional daily formulations in terms of annualized growth velocity, making it the only long-acting growth hormone in China whose superiority over daily formulations has been confirmed by Phase III clinical trials. This means that, within the same treatment duration, pediatric patients can gain approximately 1 centimeter more in height per year. While this difference may appear marginal to adults, it holds significant clinical importance for children whose treatment window is limited to just 1–2 years.

Behind the breakthrough in efficacy lies the TransCon transient linkage technology underpinning Lonpeghumab growth hormone. This technology enables the slow release of growth hormone in the body that is structurally identical to endogenously secreted human growth hormone. This mechanism fundamentally differs from products that require permanent chemical modifications (such as PEGylation) to extend their half-life, thereby establishing a theoretical advantage in long-term safety. Data from the six-year enliGHten study show that nearly 60% of participants achieved or exceeded their genetic height potential upon completion of treatment. Approved for four years, this product is the first long-acting growth hormone therapy to receive approval in both the United States and the European Union for the treatment of Pediatric Growth Hormone Deficiency (PGHD). It has become the best-selling long-acting growth hormone in the U.S., with its global quality thoroughly validated by real-world evidence.

Beyond efficacy and safety, Longpei Growth Hormone has also achieved breakthroughs in patient experience. Its innovative integrated drug-device design, featuring a specialized injection pen, aligns with the future trend of chronic disease management—particularly for pediatric patients. This synergistic innovation between medication and delivery device not only reduces operational complexity and alleviates psychological burden but also enhances the sustainability of long-term treatment. Furthermore, without containing preservatives, Longpei Growth Hormone remains stable for up to six months at room temperature (below 30°C), completely overcoming the traditional limitation that growth hormone requires refrigeration. This frees patients’ families from reliance on refrigerators and ice packs, fundamentally liberating them from logistical constraints and truly integrating medication into daily life, thereby significantly improving convenience and treatment adherence.

According to Frost & Sullivan data, the market size of growth hormone in China has surged from RMB 4 billion in 2018 to RMB 11.6 billion in 2023, with a compound annual growth rate (CAGR) of 23.9%, and is projected to reach RMB 28.6 billion by 2030. A more critical change lies in the iteration of dosage form structures: the domestic market for long-acting growth hormone is expected to surpass that of short-acting products within two years and account for 80% of the total market share by 2030. This indicates that the long-acting segment itself is an emerging, high-certainty blue-ocean market worth tens of billions of yuan.

Meanwhile, the market’s payment structure and competitive dynamics are also shifting. As GenSci’s and Amoytop Biotech’s long-acting products enter the preliminary formal review for the 2025 National Reimbursement Drug List (NRDL) adjustment, the industry widely anticipates price adjustments for long-acting growth hormones. While this trend enhances overall drug accessibility, it is also driving the market to gradually bifurcate into two segments: “NRDL-inclusive universal access” and “premium quality.” Leveraging its differentiated positioning as the “only superior-efficacy” option, Ascendis Pharma’s Lonapegsomatropin precisely targets the “demand gap” in the mid-to-high-end market.

Viseon Therapeutics has precisely targeted this niche segment, with its commercialization logic centered on building a closed-loop ecosystem that delivers mutual benefits to physicians, patients, and the enterprise. From a clinical treatment perspective, the “2024 International Consensus on Long-Acting Growth Hormone” clearly states that among the long-acting growth hormone (LAGH) products currently widely approved, Paltusomatide is the only LAGH proven to demonstrate superior efficacy over daily formulations in Phase 3 trials. This provides physicians with clear prescribing rationale and an optimized therapeutic option. For patients, it offers a treatment choice with improved efficacy and convenience. Meanwhile, the company has successfully secured a position in a higher-barrier, more competitive market segment.

Facing substantial market opportunities, Ascendis Pharma has joined forces with industry partners to build an efficient commercialization closed loop. In terms of supply chain, collaboration with Shanghai Pharmaceuticals Holding ensures professionalism and efficiency from importation to distribution. For hospital channels, partnership with Anke Biotechnology leverages its mature network covering over 90% of potential hospitals nationwide to achieve rapid market access. Regarding end-user reach, collaborations with high-end private medical institutions such as United Family Healthcare enable precise targeting of the desired customer base.

The approval of Longpei growth hormone represents a deep implementation of Ascendis Pharma’s “Global Innovation, Accelerated in China” strategy and marks the company’s entry into a critical transition phase from R&D-driven development to market value realization. As the product continues to deepen its presence at the terminal level and penetrate the market, Ascendis Pharma is not only poised to reshape the competitive landscape of the growth hormone industry but also to drive the sector’s upgrade from “scale expansion” to “value-based competition.” By leveraging the localized translation of cutting-edge global technologies, the company enables Chinese patients to simultaneously benefit from global innovative achievements while establishing an industry paradigm of “global innovation empowering local needs,” thereby laying a solid foundation for accelerating the accessibility of more high-quality innovative drugs to the Chinese population.