VISEN PHARMA-B (02561) announced its annual results for the period ending December 31, 2025. During the period, the company recorded revenue of 16,500 yuan (Renminbi, same below) and other income of 11.941 million yuan. Research and development costs amounted to 93.484 million yuan, representing an increase of 3.27% compared to the previous year. Throughout the reporting period, the Group continued to advance its drug pipeline and business operations, achieving several milestones. Lonapegsomatropin is the only long-acting growth hormone that has demonstrated superior height growth efficacy and comparable safety versus a daily injection of human growth hormone in a positive-controlled, parallel-group trial for the treatment of pediatric growth hormone deficiency. The import medical device registration application for the needle was approved on April 23, 2025, while the auto-injector received approval in April 2024. On June 12, 2025, the company entered into a Commercial Supply Framework Agreement with Ascendis Pharma to further strengthen the supply arrangements for its core product. Regarding technology transfer and localization, the company successfully completed the small-scale pilot R&D for technology transfer in December 2025. It also developed Dual Chamber Device (DCD) technology as a drug delivery platform for its self-developed formulations. This technology has been implemented as a dual-chamber cartridge within an auto-injector pen, serving as the delivery system for the core product formulation. Concurrently with the technology transfer and localization efforts, the company signed a strategic cooperation agreement with Dongfulong Technology Group Co., Ltd. (Dongfulong) on November 6, 2025, to jointly advance the development and industrial application of dual-chamber lyophilized formulation technology. On January 26, 2026, the National Medical Products Administration approved the Biologics License Application for Lonapegsomatropin for Injection (brand name in China: Weizhen Gao®, international brand name: SKYTROFA®) for the treatment of growth disturbance due to growth hormone deficiency in children and adolescents aged 3 years and older in China. The approved product label in China includes features such as superior height growth efficacy compared to daily growth hormone injections, confirmed in both international and Chinese Phase 3 clinical trials, a released human growth hormone molecular weight of approximately 22kDa (identical to endogenous growth hormone), the absence of preservatives, and a shelf life of 6 months at room temperature (≤30°C). As of the date of this announcement, the company has established a lean but highly specialized internal commercial team, fully equipped with core academic promotion and medical-related functions. The company plans to fully launch the commercialization of Lonapegsomatropin in 2026.
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