Fractures, Spontaneous

Denosumab marks Accord's sixth biosimilar approval in Europe. The CHMP has issued a positive opinion for Denosumab, to be marketed as Osvyrti® and Jubereq®. Osvyrti® is Accord's second osteoporosis biosimilar, following Sondelbay®. The CHMP's endorsement paves the way for market authorization, with Accord set to launch Denosumab following patent expiry in November 2025 of the brand originator Prolia and Xgeva (Amgen denosumab brands). LONDON, April 2, 2025 /PRNewswire/ -- Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Denosumab, including its branded formulations Osvyrti® and Jubereq®, across its autoimmune and oncology therapy areas. Product Indications Osvyrti® – Bone / Osteoporosis (60mg Pre-Filled Syringe) Indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Denosumab has been shown to significantly reduce the risk of vertebral, non-vertebral, and hip fractures. Indicated for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, reducing the likelihood of vertebral fractures. Indicated for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. Jubereq® – Oncology (120mg Vial) Indicated for the prevention of skeletal-related events (including pathological fractures, radiation to bone, spinal cord compression, or bone surgery) in adults with advanced malignancies involving bone. Indicated for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection would likely result in severe morbidity. Joe Dunford, Accord's Vice President of Specialty Brands, commented: "At Accord, we are dedicated to transforming patients' lives, and the recent CHMP approval of these vital medicines is a significant milestone. Osvyrti® enhances our bone health portfolio, joining Sondelbay®, our previously launched teriparatide biosimilar. Additionally, Jubereq® expands our oncology product portfolio and underscores our commitment to advancing our specialty business and driving innovation in oncology - a field in which we have a rich heritage. As a market leader in oncology, we offer over 54 oncology and oncology-related treatments, including small molecule generics, biosimilars, and new chemical entities. This makes us one of the largest suppliers of chemotherapy products in Europe." About Accord Healthcare Headquartered in the United Kingdom (UK), Accord Healthcare, Ltd. is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints among European companies in its category ensuring that over 95% of European patients get access to vital medicines. Accord has over 54 oncology and oncology-related treatments making it one of the largest suppliers of chemotherapy products in Europe with an additional 20 treatments which are currently in development and scheduled for launch over the next 5 years. Our approach is agile and inventive, always seeking to improve our products and patients' access to them. We're driven to think differently and deliver more for the benefit of patients worldwide. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

CHENGDU, China I March 25, 2025 I Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the “Company”) announced that the Company has received a clinical trial notice approving the investigational new drug application for a radionuclide-drug conjugate (RDC) drug SKB107 (formerly TBM-001) from the Center for Drug Evaluation of the National Medical Products Administration. SKB107 is the first company RDC drug clinical project. SKB107 is jointly developed by the Company and Professor Chen Yue’s team of the Affiliated Hospital of Southwest Medical University (the “Affiliated Hospital of SMU”). It utilizes a small molecule as the targeting ligand, combined with a suitable conjugation technology, chelator, and therapeutic radionuclide, and is intended to be used for treatment of bone metastases in solid tumors. Compared with traditional external radiation therapy, the RDC drug SKB107 can benefit patients with systemic multiple bone metastases and is highly targeted, which can reduce the damage to normal tissues, and is expected to show good safety; and compared with traditional bone-modifying drugs, it can effectively kill tumor cells with bone metastases, and is expected to have potential for the treatment of bone metastases efficacy. The Company entered into an exclusive license agreement with the Affiliated Hospital of SMU for a RDC drug SKB107 on Sept. 14, 2023. About Bone Metastasis of Malignant Tumors Bone is the most common site of metastasis in advanced malignant tumors, and about 70%~80% of patients with advanced malignant tumors will eventually develop bone metastasis. Among common tumors, prostate cancer, breast cancer, thyroid cancer, lung cancer and kidney cancer have a higher incidence of bone metastasis, accounting for more than 80% of all bone metastatic tumors [1] . Bone metastasis can lead to serious complications such as severe bone pain and bone-related events, such as pathologic fracture and spinal cord compression, which can seriously reduce patients’ quality of life and increase the risk of death. Currently, treatments for bone metastases of malignant tumors mainly include comprehensive treatments such as analgesic therapy, radiation therapy, bone-modifying drug therapy, and surgery. However, these treatments are still limited in improving patients’ quality of life, delaying or avoiding the occurrence of SREs, and prolonging patients’ survival, and the development of new mechanisms of action and safer and more effective drugs is imminent. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world’s leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit https://kelun-biotech.com/ . Reference [1] [Bone Tumour Group of the Chinese Orthopaedic Association（2009）] Expert consensus on the surgical treatment of bone metastases. Chinese Journal of Orthopaedics;29(12):1177-1184. SOURCE: Sichuan Kelun-Biotech Biopharmaceutical Co.

CHENGDU, China, March 25, 2025 /PRNewswire/ -- Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (the "Company") announced that the Company has received a clinical trial notice approving the investigational new drug application for a radionuclide-drug conjugate (RDC) drug SKB107 (formerly TBM-001) from the Center for Drug Evaluation of the National Medical Products Administration. SKB107 is the first company RDC drug clinical project. SKB107 is jointly developed by the Company and Professor Chen Yue's team of the Affiliated Hospital of Southwest Medical University (the "Affiliated Hospital of SMU"). It utilizes a small molecule as the targeting ligand, combined with a suitable conjugation technology, chelator, and therapeutic radionuclide, and is intended to be used for treatment of bone metastases in solid tumors. Compared with traditional external radiation therapy, the RDC drug SKB107 can benefit patients with systemic multiple bone metastases and is highly targeted, which can reduce the damage to normal tissues, and is expected to show good safety; and compared with traditional bone-modifying drugs, it can effectively kill tumor cells with bone metastases, and is expected to have potential for the treatment of bone metastases efficacy. The Company entered into an exclusive license agreement with the Affiliated Hospital of SMU for a RDC drug SKB107 on Sept. 14, 2023. About Bone Metastasis of Malignant Tumors Bone is the most common site of metastasis in advanced malignant tumors, and about 70%~80% of patients with advanced malignant tumors will eventually develop bone metastasis. Among common tumors, prostate cancer, breast cancer, thyroid cancer, lung cancer and kidney cancer have a higher incidence of bone metastasis, accounting for more than 80% of all bone metastatic tumors[1]. Bone metastasis can lead to serious complications such as severe bone pain and bone-related events, such as pathologic fracture and spinal cord compression, which can seriously reduce patients' quality of life and increase the risk of death. Currently, treatments for bone metastases of malignant tumors mainly include comprehensive treatments such as analgesic therapy, radiation therapy, bone-modifying drug therapy, and surgery. However, these treatments are still limited in improving patients' quality of life, delaying or avoiding the occurrence of SREs, and prolonging patients' survival, and the development of new mechanisms of action and safer and more effective drugs is imminent. About Kelun-Biotech Kelun-Biotech (6990.HK) is a holding subsidiary of Kelun Pharmaceutical (002422.SZ), which focuses on the R&D, manufacturing, commercialization and global collaboration of innovative biological drugs and small molecule drugs. The company focuses on major disease areas such as solid tumors, autoimmune, inflammatory, and metabolic diseases, and in establishing a globalized drug development and industrialization platform to address the unmet medical needs in China and the rest of world. The Company is committed to becoming a leading global enterprise in the field of innovative drugs. At present, the Company has more than 30 ongoing key innovative drug projects, of which 3 projects have been approved for marketing, 1 project is in the NDA stage, and more than 10 projects are in the clinical stage. The company has established one of the world's leading proprietary ADC platforms, OptiDC™, and has 1 ADC project approved for marketing, 1 ADC project in NDA stage, and multiple ADC or novel ADC projects in clinical or preclinical research stage. For more information, please visit . SOURCE Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED