SHANGHAI, October 23, 2026—Hansoh Pharmaceutical Group Company Limited ("Hansoh Pharma," 03692.HK) today announced that the company presented data from a pivotal Phase Ⅲ clinical study and a Phase Ⅱ long-term safety study of gosicalcetide hydrochloride in patients with CKD receiving hemodialysis complicated by SHPT at the American Society of Nephrology (ASN) Kidney Week 2026, held on October 21–25, 2026, in Denver, Colorado, USA.

Gosicalcetide hydrochloride is an intravenous calcimimetic intended for SHPT in adult patients with CKD receiving hemodialysis. Both studies were featured as Late-Breaking Research Posters. The Phase Ⅲ study was a pivotal, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group clinical study to confirm the efficacy and safety of gosicalcetide hydrochloride in patients with CKD receiving hemodialysis complicated by SHPT. A total of 498 participants were enrolled at 81 sites across China, with a 26-week treatment period. The Phase Ⅱ study was a multicenter, open-label, long-term safety and tolerability clinical study of gosicalcetide hydrochloride in patients with CKD receiving hemodialysis complicated by SHPT. A total of 303 participants were enrolled at 47 sites across China, with a median treatment duration of 74.7 weeks.

The pivotal Phase Ⅲ study showed that, compared with cinacalcet (a first-line treatment for SHPT [1]), gosicalcetide hydrochloride demonstrated significantly higher proportions of patients achieving >30% and >50% reductions from baseline in iPTH among CKD patients receiving hemodialysis complicated by SHPT, and was significantly superior to cinacalcet in reducing iPTH, with a significantly lower incidence of gastrointestinal adverse events. In the long-term Phase Ⅱ study, it also demonstrated a favorable safety profile and sustained reductions in iPTH level. The data from these two studies confirm the efficacy and long-term safety of the intravenous calcimimetic gosicalcetide hydrochloride in adult patients with CKD receiving hemodialysis complicated by SHPT.

Details of the poster presentations are as follows:

No. 1

● Poster Title: Efficacy and safety of gosicalcetide hydrochloride versus cinacalcet in patients with CKD on hemodialysis complicated by SHPT

● Session: Late-Breaking Research Posters

● Abstract No.: 4581975

● Date/Time: October 22, 2026, 10:00 AM to 12:00 PM (MDT)

● Presenter: Xueqing Yu; Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, China

The study results showed:

Efficacy: At Weeks 20–27, 90.2% of participants in the gosicalcetide hydrochloride group achieved >30% iPTH reduction from baseline (primary endpoint), versus 74.7% in the cinacalcet group, with a difference of 15.5% (P<0.0001); 77.9% of participants in the gosicalcetide hydrochloride group achieved >50% iPTH reduction from baseline (key secondary endpoint), versus 50.5% in the cinacalcet group, with a difference of 27.3% (P<0.0001). Both endpoints confirmed the superiority of gosicalcetide hydrochloride over cinacalcet.

Safety: The incidence of GI adverse events (AEs) was 20.2% in the gosicalcetide hydrochloride group, significantly lower than 28.8% in the cinacalcet group (P=0.0251).

No. 2

● Poster Title: Long-term safety of gosicalcetide hydrochloride in patients with CKD on hemodialysis complicated by SHPT

● Session: Late-Breaking Research Posters

● Abstract No.: 4581967

● Date/Time: October 22, 2026, 10:00 AM to 12:00 PM (MDT)

● Presenter: Li Zuo; Peking University People’s Hospital, Beijing, China

The study results showed:

The median treatment duration was 74.7 weeks. Among participants receiving gosicalcetide hydrochloride, only 17 cases (5.6%) reported hypocalcemia AEs (defined as serum calcium < 2.1 mmol/L within 1 hour before dialysis, accompanied by hypocalcemia-related symptoms and/or signs), mostly mild to moderate. During each efficacy assessment period, at least 71% of participants successfully reduced their iPTH level to below 300 pg/mL.

About Gosicalcetide Hydrochloride Injection

Gosicalcetide hydrochloride injection is an intravenous calcimimetic that inhibits parathyroid hormone (PTH) secretion by acting on the calcium-sensing receptor (CaSR), and it is intended for the treatment of patients with CKD on hemodialysis complicated by SHPT. A drug marketing authorization application for gosicalcetide hydrochloride injection has been submitted to the National Medical Products Administration (NMPA) of China and was accepted on June 9, 2026. The proposed indication is for secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) receiving hemodialysis.

About Secondary Hyperparathyroidism (SHPT)

Secondary hyperparathyroidism (SHPT) is one of the important clinical manifestations of chronic kidney disease–mineral and bone disorder (CKD-MBD). SHPT refers to elevated serum PTH levels, secondary hyperplasia of the parathyroid glands, and even the formation of parathyroid adenomas, all caused by CKD. SHPT can cause multi-system disorders involving the skin, bones, and cardiovascular system in patients with CKD. If it progresses to severe SHPT, it may lead to severe pruritus, skeletal deformities, and cardiovascular calcification, increasing the risk of fractures, cardiovascular events, and death ^[1]. For CKD patients in stage G5 who are on dialysis (CKD-G5D) and require PTH reduction, the Chinese CKD-MBD guidelines and the KDIGO guidelines recommend calcimimetics as one of the monotherapy options or for use in combination with other therapies ^[2-3].

References

1. Expert Consensus Working Group on Calcimimetic Therapy for SHPT in Patients Receiving Maintenance Hemodialysis. Chinese expert consensus on calcimimetic therapy for secondary hyperparathyroidism in patients receiving maintenance hemodialysis (2024 edition) [J]. Chin J Blood Purif, 2024, 23(10): 721–735.

2. National Clinical Research Center for Kidney Diseases. Summary of the Chinese guidelines for the diagnosis and treatment of chronic kidney disease–mineral and bone disorder [J]. Chin J Nephrol Dial Transplant, 2019, 28(1): 52–57.

3. Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease–Mineral and Bone Disorder (CKD-MBD) [J]. Kidney Int Suppl, 2017, 7(1): 1–59.