China's briGHt Trial Published in Hormone Research in Paediatrics Further Confirms Once-Weekly Lonapegsomatropin as the Only Long-Acting Growth Hormone with Demonstrated Superiority Over Daily Somatropin

April 21 st , 2026, Shanghai – Results from the briGHt Trial - the pivotal Phase 3 trial in China of once-weekly lonapegsomatropin for pediatric growth hormone deficiency (GHD) conducted by VISEN Pharmaceuticals (2561.HK) have been published in Hormone Research in Paediatrics , the official journal of European Society for Paediatric Endocrinology (ESPE). The trial showed that weekly lonapegsomatropin demonstrated non-inferiority and superiority over daily somatropin in annualized height velocity (AHV) among treatment-naive Chinese children with GHD. Weekly lonapegsomatropin is the only long-acting growth hormone (LAGH) demonstrated superior to daily somatropin in two pivotal Phase 3 trials (the global heiGHt Trial and the China briGHt Trial). Core Data from the briGHt Study: New Evidence Reinforces the Only LAGH with Superiority The briGHt Trial was a Phase 3, randomized, open-label, active-controlled trial conducted across 17 sites in China. Treatment-naive, prepubertal children with GHD were enrolled and randomized 2:1 to either lonapegsomatropin 0.24 mg hGH/kg/week or equivalent weekly dose of daily somatropin 0.034 mg/kg/day. 153 participants received treatment. Key findings include: - Primary Endpoint: The primary endpoint was annualized height velocity (AHV) at week 52. At week 52, participants who received weekly lonapegsomatropin had an LS mean ± SE AHV of 10.66 ± 0.22 cm/year compared with 9.75 ± 0.26 cm/year in the daily somatropin group. LS mean ± SE difference was 0.91 ± 0.28 cm/year (95% CI: 0.37–1.45; p = 0.0010), demonstrating non-inferiority and superiority of weekly lonapegsomatropin over daily somatropin. - Secondary Endpoints: Secondary endpoints included change in height standard deviation score (ΔHT SDS) from baseline, insulin-like growth factor 1, and safety. At week 52, LS mean ± SE of ∆HT SDS was 1.01 ± 0.04 and 0.83 ± 0.05 for the weekly lonapegsomatropin and daily somatropin groups, respectively, with a difference of 0.18 ± 0.06 (95% CI: 0.07–0.29; p = 0.0015). LS mean difference in ∆HT SDS in favour of weekly lonapegsomatropin was statistically significant starting at week 13 and this continued through week 52, meeting the criteria for superiority. - Safety: The overall incidence of treatment-emergent adverse events (TEAEs) between treatment groups was similar (98.0% vs. 94.3%). Injection site reactions were reported as TEAEs in 9 participants (5 [5.0%] in the weekly lonapegsomatropin group and 4 [7.5%] in the daily somatropin group). Glucose metabolism parameters, lipid parameters, and hormone levels were generally stable, remained within the normal range, and were similar between the weekly lonapegsomatropin and daily somatropin groups throughout the trial. Lonapegsomatropin Design: The Dual Advantage of Long-Acting Duration and a Native GH Structure Lonapegsomatropin is a prodrug of somatropin administered once weekly, designed to provide sustained release of active, unmodified somatropin. Leveraging TransCon technology platform, which enables transient conjugation of an inert carrier to a parent drug with known biology to achieve sustained release, lonapegsomatropin consists of 3 components: the parent drug, somatropin; an inert methoxy polyethylene glycol carrier (mPEG, 4 x 10 kDa), and a proprietary TransCon linker that transiently binds them. While bound in the prodrug form, the carrier inactivates somatropin and shields it from receptor uptake, renal clearance, and enzymatic degradation. Following administration, the linker autocleaves under physiological conditions, providing sustained release of active, unmodified somatropin with the identical 191 amino acid sequence and size (22 kDa) as endogenous GH, enabling sustained exposure to unmodified somatropin on growth hormone receptors in target tissues throughout the body. This enables lonapegsomatropin to fully exert the essential physiological effects of GH, stimulating longitudinal growth not only through insulin-like growth factor 1 (IGF-1) induced by somatropin, but also directly through interaction with GH receptors in the growth plate. Professor Xiaoping Luo, Chief Principal Investigator of the briGHt Trial and Director of the Department of Pediatrics at Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology , stated: "The briGHt Trial is the first long-acting growth hormone (LAGH) trial in China to employ a non-inferiority to superiority sequential design, covering 153 children across 17 centers, providing robust and representative data. The results confirm that after 52 weeks of treatment, weekly lonapegsomatropin is superior to daily somatropin in AHV, with no difference in bone age advancement and a favorable safety profile. These findings fill a critical gap in Chinese evidence for the superiority LAGH, offering a new treatment option characterized by stable efficacy, strong adherence, and suitability for long-term therapy." Prof. Stefano Cianfarani, Editor-in-Chief of Hormone Research in Paediatrics , commented: As Editor-in-Chief of Hormone Research in Pediatrics, “I am delighted to see the publication of the briGHt Trial in our journal. The briGHt Trial is characterized by rigorous scientific design and robust, reliable data. Importantly, this trial confirms that the benefits of weekly lonapegsomatropin previously observed in global studies extend to prepubertal Chinese children with GHD, providing clinicians in China with robust evidence to support the development of individualized therapeutic strategies for children with this condition.” Mr. Lu An-Bang, Executive Director and Chief Executive Officer of VISEN Pharmaceuticals, stated: "The publication of the briGHt Trial in this international journal reaffirms VISEN's 'clinical-value-driven' R&D philosophy and marks a significant milestone, demonstrating that China's pediatric endocrinology clinical research has achieved global standards. With solid Chinese data, lonapegsomatropin has gained authoritative validation from both an international peer-reviewed journal and key opinion leaders. As an innovative biopharmaceutical company focused on endocrinology, we are not only providing a once-weekly treatment option for children and their families but are also committed to in China and fulfilling our strategic promise of 'best-in-class' to physicians, patients, and the capital market." Approval NO.:COMU20260417/EN/PR About lonapegsomatropin Lonapegsomatropin was developed and is owned by Ascendis Pharma A/S as TransCon hGH, who markets it as SKYTROFA® for pediatric and adult GHD in markets outside of Greater China. VISEN Pharmaceuticals has exclusive rights to develop, manufacture and commercialize three of Ascendis Pharma’s endocrine disease products (lonapegsomatropin, palopegteriparatide, and navepegritide) in Greater China. About TransCon Technology TransCon is Ascendis Pharma’s innovative platform for drug development. The TransCon name derives from transient conjugation, the technology’s unique ability to transiently link an inert carrier to a parent drug with known biology to achieve sustained release. TransCon prodrugs have up to three components: the parent drug, an inert TransCon carrier, and a TransCon linker that temporarily binds the two. These components allow Ascendis to design TransCon prodrugs with predictable release of the parent drug to achieve the desired dosing frequency and pharmacological effect. When bound in the prodrug form, the TransCon carrier inactivates the parent drug and shields it from receptor uptake, renal clearance, and enzymatic degradation. Following injection, autocleavage of the linker occurs under physiologic conditions, allowing sustained release of the active, unmodified parent drug at a predictable rate. Ascendis Pharma designs TransCon prodrugs with the goal of improving treatment safety, efficacy, tolerability, and convenience. About VISEN Pharmaceuticals (2561.HK) VISEN Pharmaceuticals is an innovative biopharmaceutical company focused on endocrine diseases. We are dedicated to providing innovative therapies and compassionate, patient-centric care, because we believe that achieving better treatment processes and outcomes results in living better lives. Putting patients' needs first, VISEN is committed to providing first-in-class or best-in-class products and treatments for endocrine diseases. Our therapeutic areas cover endocrine diseases in adults and children, and rare endocrine diseases. VISEN comprises seasoned professionals with multinational pharmaceutical experiences and leverages cutting-edge technologies and leading resources across the world. We are focused on the Chinese market, headquartered in Suzhou, and have established offices in Shanghai, Beijing, Hong Kong and Taipei. Our goal is to enable Chinese endocrine patients to benefit from the world's most advanced and reliable treatment solutions earlier. On March 21st, 2025, VISEN officially listed on the Main Board of The Stock Exchange of Hong Kong (HKEX). For more information, please visit our website: www.visenpharma.com Contact us: [email protected]

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