VISEN Receives China NMPA Approval for Once-Weekly Lonapegsomatropin for Pediatric Growth Hormone Deficiency

January 26 th , 2026, Shanghai, China — VISEN Pharmaceuticals (2561.HK), an innovative biopharmaceutical company focused on endocrine diseases, today announces that its core product, lonapegsomatropin, has been officially approved by the China National Medical Products Administration (NMPA) for the treatment of pediatric growth hormone deficiency (PGHD). Mr. Pony Lu, CEO and Executive Director of VISEN Pharmaceuticals, said: “The statistical analysis of the 52-week results demonstrated both non-inferiority and superiority in annualized height velocity (AHV) compared to daily treatment in the Chinese Phase 3 clinical trial. Its approval marks a major milestone in VISEN’s transition from R&D to commercialization and reflects our commitment to ‘Global Innovation, China Activation’. We believe that by continuously focusing on providing first-in-class or best-in-class products and treatments, we can provide Chinese endocrine patients with innovative therapies that achieve better treatment processes and outcomes.” Jan Mikkelsen, President and CEO of Ascendis Pharma, said: “We congratulate VISEN on this important milestone. Our collaboration expands availability of our once-weekly growth hormone product to patients in China and supports our shared goal of bringing innovative treatment options to patients.” Lonapegsomatropin, developed by our partner Ascendis Pharma using its innovative TransCon technology platform, was the first once-weekly growth hormone approved by the U.S. Food & Drug Administration (FDA) for the treatment of PGHD and was also approved by European Commission (EC) and other regulatory authorities. Professor Luo Xiaoping, lead investigator of the China Phase 3 pivotal clinical trial, stated: “Lonapegsomatropin leverages the TransCon technology platform, which enables sustained release of unmodified somatropin with the same amino acid sequence and size as endogenous growth hormone that binds to growth hormone receptors throughout the body. In the China Phase 3 trial, lonapegsomatropin treatment demonstrated significantly higher mean AHV compared with daily somatropin at week 52 (10.66 cm/year vs. 9.75 cm/year), with a comparable safety profile.” PGHD is a serious disease caused when the pituitary gland does not produce enough growth hormone. Children with GHD are not only characterized by short stature, but they also may experience metabolic abnormalities, psychosocial challenges and poor quality of life. The current standard of care for the treatment of GHD requires patients to receive daily injections of somatropin over many years. The administrative burden of daily injections often results in poor patient compliance and can lead to suboptimal treatment outcomes. Lonapegsomatropin sets the standard as a premium, imported long-acting growth hormone, adhering to rigorous international GMP standards, including those set by the FDA and European Medicines Agency (EMA). The long-term safety and efficacy profile of this therapy was demonstrated in the China and global Phase 3 clinical trials with children receiving up to 6 years of lonapegsomatropin treatment in the global Phase 3 clinical trial program. Lonapegsomatropin was developed as TransCon hGH and is marketed as SKYTROFA ® for pediatric and adult GHD by Ascendis Pharma. VISEN Pharmaceuticals has exclusive rights to develop, manufacture and commercialize Ascendis Pharma’s lonapegsomatropin, palopegteriparatide, and navepegritide in Greater China. Approval NO.:COMU20260121/EN/PR About Ascendis Pharma A/S Ascendis Pharma is a global biopharmaceutical company focused on applying its innovative TransCon technology platform to make a meaningful difference for patients. Guided by their core values of Patients, Science, and Passion, and following their algorithm for product innovation, Ascendis applies TransCon to develop new therapies that demonstrate best-in-class potential to address unmet medical needs. Ascendis is headquartered in Copenhagen, Denmark and has additional facilities in Europe and the United States. Please visit ascendispharma.com to learn more. 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 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' need 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 - have set up headquarters in Suzhou and 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 HKEX main board. For more information, please visit our website: http://www.visenpharma.com/ Contact us [email protected]

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