In recent years, the trend of "long-acting replacement" in the domestic growth hormone market has entered an accelerated phase: the market share of long-acting growth hormones has consistently climbed from less than 10% in 2018 to over 35% in 2023, driven by dual market demands for "therapeutic efficacy certainty" and "treatment experience." As the shift towards long-acting growth hormones becomes an established trend, the critical question remains: who will seize the "best-in-class" position in this lucrative segment? On January 26, Hong Kong-listed innovative biopharmaceutical company VISEN PHARMA-B (02561) provided an answer: its core product, LongPei growth hormone, has recently received formal marketing approval from the National Medical Products Administration (NMPA). As the first domestic product boasting the dual advantages of being both "long-acting" and having a "natural structure," it is a "potentially best-in-class" candidate that not only precisely addresses unmet clinical needs but also signifies VISEN PHARMA's crucial leap into becoming a dual-driven enterprise focused on both "R&D and commercialization," injecting a rare dose of certainty into the Hong Kong stock market's innovative drug sector.
The product's breakthrough lies in its technological innovation addressing core pain points, forging a Best-in-Class (BIC) advantage. Pediatric Growth Hormone Deficiency (PGHD) is a condition where children have significantly short stature due to insufficient growth hormone; early diagnosis and treatment with growth hormone can reduce long-term complications. The central challenge in the growth hormone field has long revolved around balancing "efficacy stability" and "medication adherence." Previously, PGHD treatment in China relied predominantly on short-acting formulations, with daily subcutaneous injections leading to high clinical missed-dose rates—statistics indicate an annual missed-dose rate often exceeding 30% among pediatric patients. This is linked to children's physiological resistance and the caregiving burden on parents, directly impacting treatment continuity and final outcomes. The approval of LongPei growth hormone, with its leading edge as "China's first weekly long-acting formulation with a natural growth hormone structure," provides a targeted solution for this pain point, backed by substantial clinical data validation.
It is understood that the core product approved for VISEN PHARMA is the long-acting growth hormone LongPei growth hormone (lonapegsomatropin, TransCon hGH), developed based on the TransCon prodrug technology from its major shareholder, Ascendis Pharma. Notably, as of November 2025, LongPei growth hormone is the only Long-Acting Growth Hormone (LAGH) proven superior to daily growth hormone formulations in clinical trials, demonstrating clear BIC attributes. Developed using TransCon technology, LongPei temporarily links natural growth hormone to an inert carrier, fundamentally allowing for the release of a recombinant growth hormone identical to endogenous growth hormone. It works through direct and indirect stimulation of chondrocytes and the liver, thereby reducing risks and exhibiting a lower incidence of adverse reactions, providing crucial assurance for long-term treatment safety. The fundamental reason the prodrug technology enables LongPei's clinical superiority over daily formulations likely lies in its preservation of both direct and indirect actions; if the molecule were too large, its direct stimulatory effect on chondrocytes would be ineffective.
VISEN PHARMA has already completed its Phase 3 pivotal trial in China for treating PGHD in children aged 3 to 17 years. This trial verified that LongPei growth hormone is the only LAGH to demonstrate both superiority and comparable safety compared to an active control (daily injected human growth hormone) in a parallel-group study. The published results from this trial are consistent with the completed global Phase 3 pivotal trial (which supported its FDA and EMA approvals for PGHD) and confirm LongPei's superiority and comparable safety versus daily growth hormone. Furthermore, LongPei growth hormone has undergone multiple pivotal Phase 3 trials globally, including the heiGHt, fliGHt, enliGHten extension trials, and the China pivotal Phase 3 briGHt trial. These trials provide robust evidence supporting LongPei's use in initial treatment, switching therapy, and long-term administration.
This product profile—"technological breakthrough meeting clinical needs supported by effective data"—not only fills a gap in the domestic long-acting growth hormone category but also promotes a shift in pediatric growth hormone treatment towards "active adaptation to life scenarios." It is poised to become a key variable driving the upgrade of the growth hormone sector towards "high efficiency, safety, and high adherence."
For VISEN PHARMA, the approval of LongPei growth hormone marks a critical inflection point in the company's development. To facilitate the product's commercial launch, the company has completed full-chain preparatory work, establishing a comprehensive commercial system encompassing production and sales. By collaborating with numerous partners, it aims to accelerate the commercial process, enabling rapid multi-tiered coverage across hospitals at various levels post-launch to benefit a wider range of Chinese patients. Regarding channel partnerships, in July of last year, the company signed a strategic cooperation framework agreement with its shareholder, Anke Biotech (300009.SZ), authorizing the latter to exclusively promote LongPei growth hormone in specific regions within China. As a leading player in the domestic growth hormone field with over 30 years of biopharmaceutical experience, a 20-year clinical promotion team for growth hormone, and a nationwide pediatric outpatient network, Anke Biotech holds a 44% market share in the short-acting powder segment, ranking first domestically. Its terminal resources can directly help VISEN bypass the "protracted cycle" of channel building, enabling rapid access to target physician and patient groups. This collaboration creates synergies in promotion resources and market education, potentially accelerating the adoption of long-acting growth hormones in the domestic market.
From a global perspective, LongPei growth hormone has already undergone commercial validation: it received approvals from the US FDA and EU EMA in 2021 and 2022, respectively (marketed overseas as Skytrofa), for treating pediatric GHD. After its overseas launch, the product gained significant market recognition due to its excellent profile, becoming the top-selling growth hormone brand in the US by Q4 2023. Its overseas sales have shown a steady upward trend, growing from €179 million in 2023 to an estimated €206 million in 2025. In July 2025, the FDA further approved its adult GHD indication, and preparations are underway to expand into more indications, aiming for full population coverage ("pediatric + adult"), which could drive sales to new heights.
Concurrently, a significant supply-demand gap persists in domestic PGHD treatment. According to Frost & Sullivan data, the number of PGHD patients in China was approximately 3.4 million in 2023, with an estimated treatment rate of only 5.3%, indicating substantial room for penetration growth. Frost & Sullivan predicts that the domestic long-acting growth hormone market will account for about 80% of the total growth hormone market by 2030. If VISEN leverages its leading advantage to capture 15%-20% of the long-acting market share, this single product alone could generate billions in revenue, painting a highly imaginative long-term growth picture for the company.
Beyond its core product, VISEN PHARMA's pipeline further strengthens its long-term growth narrative, forming a structure of "core product foundation supported by potential pipeline expansion": Palopegteriparatide for treating hypoparathyroidism has completed its domestic Phase III clinical trial and is preparing for regulatory submission, having already been introduced in China synchronously with the international product via the Boao Lecheng Pilot Zone. Navpegotide for treating achondroplasia has completed its domestic Phase II trial with excellent data and is communicating for priority review based on its orphan drug designation. These pipeline assets are highly promising drugs that will continuously expand the company's coverage in the endocrine therapy field. The commercialization of LongPei growth hormone will provide sustained cash flow, accumulate clinical resources, and build brand recognition, thereby supporting the subsequent launch of its pipeline and helping the company enter a new stage driven by both R&D and commercialization.
In summary, backed by years of accumulated differentiated innovation and commercial advantages, the market has sufficiently validated VISEN PHARMA's capability to introduce globally excellent research outcomes and translate them into commercial value for innovative drugs in China. With the impending market launch of LongPei growth hormone and the advancement of other R&D pipelines, the company is entering a new phase of comprehensive acceleration and is approaching a harvest period.
From a capital markets perspective, the Hong Kong-listed innovative biopharma sector is undergoing a cyclical shift from "R&D-driven valuation" to "profit realization-driven valuation." VISEN PHARMA's value reassessment logic aligns perfectly with this trend: as one of the few domestic innovative drug companies with an approved long-acting growth hormone product, the launch of LongPei growth hormone makes it a rare entity possessing both "innovation attributes" and a "mature commercial product." It retains the growth potential typical of biotech pipelines while offering near-term profit realization certainty. Compared industry-wide, the competitive landscape in the domestic long-acting growth hormone market is relatively clear. Leveraging its differentiated technological advantages, LongPei growth hormone is expected to achieve steady market share gains over the next 3-5 years, and this earnings growth expectation will gradually be reflected in the company's valuation system.
As the flagship product in VISEN PHARMA's pipeline, LongPei growth hormone carries high expectations and arrives well-prepared. With the sounding of the commercial launch horn, capital markets are destined to focus on this leading long-acting BIC drug. As the drug's sales gradually ramp up post-launch, it will further demonstrate the company's sustained industrial development capabilities to the market. This is likely to create a "Davis Double Play" effect on its overall valuation and earnings, further driving the company's valuation back to its appropriate level, forming a long-term sustainable upward trend, and unleashing significant commercial potential.