Bildyos (denosumab-nxxp) / Fosun Pharma, Organon, Shanghai Henlius Biotech - LARVOL DELTA

Shanghai Henlius Biotech, Inc. has announced that China’s National Medical Products Administration has accepted a new drug application for a 120 mg strength of its denosumab biosimilar HLX14. (TipRanks) - "The filing covers indications including bone metastases from solid tumors or multiple myeloma and unresectable giant cell tumor of bone in adults and certain adolescents. The submission is backed by analytical, non-clinical and clinical data showing high similarity in quality, safety and efficacy to the reference drug, reinforcing Henlius’s biosimilar credentials."

China filing • Giant Cell Tumor of Bone • Multiple Myeloma • Solid Tumor

Organon Canada and Shanghai Henlius Biotech…announced that BILDYOS (denosumab injection) 60 mg/1 mL and TUZEMTY (denosumab injection) 120 mg/1.7 mL, biosimilars to PROLIA and XGEVA, respectively, are now available in Canada for all indications of reference products (Businesswire) - "Used across several indications, denosumab products treat osteoporosis and bone events associated with cancer by helping to strengthen bones."

Biosimilar launch • Giant Cell Tumor of Bone • Osteoporosis

…denosumab injection (HLX14) secured approval in Canada in March 2026, covering all indications of the reference product approved locally, achieving a global commercialization breakthrough in areas such as osteoporosis, bone metastasis from tumors, and giant cell tumor of bone. (The Manila Times)

Canada approval • Giant Cell Tumor of Bone • Osteoporosis

Product Revenue Reaches New High, Driven by a Synergistic Commercial Portfolio (The Manila Times) - "Pursuant to agreements with its partners, the Company generated RMB 0.6117 billion in sales and licensing revenue from HANLIKANG (rituximab), up 11.1% year-on-year...two dosage strengths of HLX14 (denosumab) were approved in the United States, the European Union, and the UK under the trade names BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL), respectively, and were recently approved in Canada under the trade names BILDYOS and TUZEMTY, becoming the first 'China-developed' denosumab to approved in ex-China markets."

Sales • Chronic Lymphocytic Leukemia • Giant Cell Tumor of Bone • Hodgkin Lymphoma • Osteoporosis

Shanghai Henlius Biotech, Inc….and Organon…announced the European Commission (EC) has granted marketing authorization for BILDYOS (denosumab) injection 60 mg/mL and BILPREVDA (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. (PRNewswire)

EMA approval • Breast Cancer • Giant Cell Tumor of Bone • Inflammatory Arthritis • Multiple Myeloma • Osteoporosis • Prostate Cancer • Rheumatoid Arthritis • Sarcoma

Shanghai Henlius Biotech, Inc…and Organon…announced the US Food and Drug Administration (FDA) has approved BILDYOS (denosumab-nxxp) injection 60 mg/mL and BILPREVDA (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. (Yahoo Finance)

FDA approval • Osteoporosis

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025 (European Medicines Agency) - "On 24 July 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Bildyos,intended for the treatment of osteoporosis in women who have been through menopause and men who are at increased risk of fractures, treatment of bone loss linked to hormone ablation in men with prostate cancer who are at increased risk of fractures or treatment of bone loss in adults linked to long-term treatment with systemic glucocorticoid. The applicant for this medicinal product is Henlius Europe GmbH."

CHMP • Osteoporosis

Interrogation of Structure-Activity Relationships in Charge Variants of Therapeutic IgG2s Enabled by Free-Flow Isoelectric Focusing Fractionation. (PubMed, BioDrugs) - "This study underscores the irreplaceable role of FF-IEF in both biosimilar and innovative therapeutic pipelines, highlighting the importance of monitoring charge heterogeneity and understanding SAR in therapeutic IgG2 antibodies."

Journal

Phase 3 MRCT Results of Denosumab Biosimilar HLX14 Released at ORS 2025 (Firstwordpharma Press Release) - P3 | N=514 | NCT05352516 | Sponsor: Shanghai Henlius Biotech | "Between 17 June, 2022 to 05 June, 2024, a total of 514 subjects were randomized to the HLX14 (n= 256) or EU-denosumab (n=258) group...From baseline to week 52, an increase in LS-BMD was evident in both the HLX14 and EU-denosumab groups; the mean (standard deviation) percent change from baseline to Week 52 as assessed by central imaging were 6.10% (3.95%), and 5.90% (3.83%) for the HLX14, and EU-denosumab group, respectively. The adjusted mean difference between the two groups was 0.23% (90% confidence interval [CI]: −0.36%, 0.83%; 95% CI: −0.48%, 0.95%)....As for the primary PD endpoint, the geomean (CVb%) of AUEC0‑26W for subjects in the HLX14, and EU-denosumab group were 14075.1253 (17.3%) day*% inhibition, and 13883.3613 (17.9%) day*% inhibition, respectively."

P3 data • PK/PD data • Osteoporosis

Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of HLX14 versus reference denosumab in healthy males: A randomized phase I study. (PubMed, Clin Transl Sci) - "No notable difference was observed among treatment groups in pharmacodynamics, safety, or immunogenicity. HLX14 demonstrated highly similar pharmacokinetic characteristics with comparable pharmacodynamics, safety, and immunogenicity to denosumab, supporting its further investigation as a potential denosumab biosimilar."

Clinical • Journal • P1 data • PK/PD data • Osteoporosis • Rheumatology

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture (clinicaltrials.gov) - P3 | N=514 | Completed | Sponsor: Shanghai Henlius Biotech | Active, not recruiting ➔ Completed | Trial primary completion date: Apr 2024 ➔ Dec 2023

Trial completion • Trial primary completion date • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=252 | Completed | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Completed

Trial completion

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture (clinicaltrials.gov) - P3 | N=478 | Active, not recruiting | Sponsor: Shanghai Henlius Biotech | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2024 ➔ Aug 2024

Enrollment closed • Trial completion date • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta (Pertuzumab) and Prolia/Xgeva (Denosumab) Biosimilar Candidates (Businesswire) - "Organon...announced that it has entered into an agreement with Shanghai Henlius Biotech, Inc. (2696.HK), whereby Organon will license commercialization rights for biosimilar candidates referencing Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14). Organon will acquire exclusive global commercialization rights except for China; including Hong Kong, Macau and Taiwan....The agreement also includes an option to negotiate an exclusive license for global commercialization rights for a biosimilar candidate referencing Yervoy® (ipilimumab, HLX13)."

Licensing / partnership • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Giant Cell Tumor of Bone • HER2 Breast Cancer • HER2 Positive Breast Cancer • Melanoma • Microsatellite Instability • Oncology • Renal Cell Carcinoma • Solid Tumor

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture (clinicaltrials.gov) - P3 | N=430 | Recruiting | Sponsor: Shanghai Henlius Biotech | Trial completion date: Dec 2024 ➔ Apr 2024 | Trial primary completion date: Dec 2023 ➔ Apr 2024

Trial completion date • Trial primary completion date • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology

Pharmacokinetic, Safety and Immunogenicity Phase I Study of HLX14 Versus Prolia® in Healthy Male Subjects (clinicaltrials.gov) - P1 | N=228 | Recruiting | Sponsor: Shanghai Henlius Biotech | Not yet recruiting ➔ Recruiting | N=24 ➔ 228 | Trial completion date: Aug 2021 ➔ Aug 2023 | Trial primary completion date: Dec 2020 ➔ Jul 2023

Enrollment change • Enrollment open • Trial completion date • Trial primary completion date

A Study to Evaluate the Efficacy and Safety of HLX14 vs. Denosumab Prolia® in Postmenopausal Women With Osteoporosis at High Risk of Fracture (clinicaltrials.gov) - P3 | N=430 | Recruiting | Sponsor: Shanghai Henlius Biotech

New P3 trial • Musculoskeletal Diseases • Orthopedics • Osteoporosis • Rheumatology