▎WuXi AppTec Content Team Report

Today (July 16), the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) announced,Class 3.1 New DrugRomosozumab InjectionThe listing application has been accepted. Public information shows that Romosozumab (trade name: Evenity) isA Novel Mechanism of Action Drug for Treating Osteoporosis, currently by Amgen（Amgen）Company andUCBJointly developed by the company. Notably,November 2023,Amgen at the 6th China International Import ExpoFirst DisplayRomosozumabThe "debut" of this new drug in China.

Screenshot source:CDE Official Website

With the intensification of population aging,Osteoporosis is becoming an increasingly serious threat to elderly health., becomingOne of the main reasons for disability and death in the elderly。According to data from China's "Guidelines for the Diagnosis and Treatment of Primary Osteoporosis (2022)", the prevalence rate among women aged 65 and above in China is as high as 51.6%, while for men, it is 10.7%. Additionally,Postmenopausal women are also a high-risk group for osteoporosis.One of.

Romosozumab is a monoclonal antibody drug that can inhibitSclerostinPlay a role in the activity.According to Amgen's previousPress Release,Romosozumab is the world's first approved sclerostin inhibitor.HasPromote Bone FormationAndInhibit Bone ResorptionThe dual mechanism of action.The product was onceCleveland ClinicRated as 2020 AnnualTop Ten Medical Innovations#1.

January 2019,Romosozumab for the First TimeApproved in Japan for the treatment of osteoporosis in patients at high risk of fractures. April 2019,Romosozumab Receives U.S. FDA Approval forTherapeutic DeviceOsteoporosis in Postmenopausal Women with High Fracture Risk。According to the earlier press releases from Amgen and UCB,RomosozumabIs the first approvedWith dual effects of promoting bone formation and reducing bone resorptionConstruction of Bone Quality Therapy Mechanism.Compared with previous anti-osteoporosis drugs, RomosozumabRapidly increase bone density and reduce fracture incidence through a dual mechanism of action.

According to previously published clinical trial results, treatment with romosozumab for 12 months increased lumbar spine bone mineral density by 12.7% compared to placebo.`, can quickly reduce the risk of vertebral fractures by 73%`。Compared with oral bisphosphonate alendronate sodium, romosozumab significantly reduced new vertebral fractures after 12 months of treatment.37%。

Screenshot source:China Drug Clinical Trial Registration and Information Disclosure Official Website

According to the official website of China's drug clinical trial registration and information disclosure, in China, Amgen and UCB have completed a Phase 3 clinical study, which aims toChinese Postmenopausal Women with OsteoporosisMedium EvaluationRomosozumabEfficacy, safety, and tolerability. The total number of participants actually enrolled in the study was 327.RomosozumabThe route of administration is subcutaneous injection, with two syringes (210mg) each time, once a month, for a total of 12 months.

References:
[1] Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China.Retrieved July 16，2024, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2]Amgen Debuts New Osteoporosis Treatment Evenity® (Romosozumab) at the 6th CIIE New Products Launch. Retrieved Nov 8，2023, From https://www.prnasia.com/story/425971-1.shtml

[3]Evenity™ (Romosozumab) Approved for Marketing in the United States to Treat Osteoporosis in Postmenopausal Women at High Risk of Fracture. Retrieved Apr 9，2019, From https://www.ucbchina.com/About-UCB/%E5%85%AC%E5%8F%B8%E5%8A%A8%E6%80%81/Evenity%E2%84%A2-Romosozumab