– 維奧莎®（非唑奈坦）是一種同類首創 的新型非激素藥物，可緩解絕經相關中重度血管舒縮症狀（VMS）
-血管舒縮症狀正影響著全球50% 以及中國80% , 的女性
香港，2025年5月9日–香港安斯泰來製藥有限公司（以下簡稱“安斯泰來香港”）今日宣佈，香港藥劑業及毒藥管理局已批准維奧莎®（非唑奈坦）45毫克用於緩解與停經相關的中度至重度血管舒縮症狀。該批准是基於BRIGHT SKY™項目的結果，該項目包括三項三期臨床試驗，在歐洲、美國和加拿大招募了超過3000名患者。
血管舒縮症（VMS,又稱潮熱和/或盜汗）是女性更年期常見的臨床表現,。在絕經前，女性體內雌激素（主要由卵巢分泌的性激素）與神經激肽 B（一種由中樞神經系統產生的神經遞質）之間維持著相對平衡，該平衡對大腦中調控體溫的中樞區域至關重要。隨著女性進入更年期，卵巢功能逐漸衰退，雌激素水準顯著下降，導致這種調節機制失衡，從而觸發體溫調節異常，最終表現為血管舒縮症狀。
“此次獲批標誌著安斯泰來香港、非唑奈坦及女性健康領域的又一重要里程碑，”安斯泰來香港總經理Aurelie Partouche表示，“在安斯泰來，我們始終致力於在尚未滿足的醫療需求領域提供創新療法。此次獲批正是這一承諾的體現，我們很高興能夠為受絕經相關中重度血管舒縮症狀（VMS）困擾的香港女性提供全新的選擇。”
非唑奈坦於2023年5月獲得美國食品藥物管理局 (FDA)批准，2023 年 12 月獲得歐盟委員會批准，2024年2月獲得澳大利亞藥品管理局 (TGA) 批准，用於緩解絕經相關中重度血管舒縮症狀 (VMS)。
關於 非唑奈坦
非唑奈坦是一款口服、非激素類藥物，用於緩解絕經相關中重度血管舒縮症狀（VMS）。VMS也被稱為潮熱或盜汗。非唑奈坦作用原理是通過阻斷神經激肽B（NKB）與kisspeptin/神經激肽/強啡肽（KNDy）神經元的結合來調節大腦溫度控制中心（下丘腦）的神經元活動，從而減少潮熱和盜汗的頻率和嚴重程度。,,
關於絕經相關血管舒縮症狀（VMS）
血管舒縮症狀（VMS），是更年期常見症狀，表現為潮熱（亦稱潮紅）和/或盜汗。6，7在全球範圍內，40至64歲的女性中有50%以上會受到VMS的影響，歐洲的發生率在56%到97%之間不等2,,。在歐洲絕經後女性中，有40%出現中重度VMS。VMS可能對女性的日常活動和整體生活品質產生破壞性影響。6
關於BRIGHT SKY™第三階段專案
BRIGHT SKY關鍵試驗SKYLIGHT 1™（NCT04003155）和SKYLIGHT 2™（NCT04003142）招募了1000多名患有中度至重度VMS的絕經女性。試驗在前12周採用雙盲、安慰劑對照，然後接受40周的擴展期治療。入組患者來自美國、加拿大和歐洲的180多個研究中心。SKYLIGHT 4™（NCT04003389）是一項為期52周的雙盲安慰劑對照研究，旨在研究非唑奈坦的長期安全性。對於SKYLIGHT 4，在美國、加拿大和歐洲的180多個研究中心招募了超過1800多名患有VMS的絕經女性。
關於安斯泰來香港
香港安斯泰來製藥有限公司在香港製藥業扮演著重要角色。作為香港科研製藥聯會之基本會員，我們著重香港和澳門市場的產品銷售與市場推廣，並專注於五大治療範疇，包括免疫抑制科、感染科、泌尿科、腫瘤科及代謝科。
警示說明
本新聞稿中，有關當前計畫、估計、戰略和信念以及其他非歷史事實的陳述，均為關於安斯泰來未來表現的前瞻性陳述。這些陳述是根據管理層結合當前可獲得的資訊而形成的當前假設和信念得出的，並涉及已知和未知的風險與不確定性。許多因素可能導致實際結果與前瞻性陳述中討論的結果產生重大差異。這些因素包括但不限於：（i）與製藥市場有關的一般經濟條件和法律法規的變化，（ii）貨幣匯率波動，（iii）新產品上市的延遲，（iv）安斯泰來無法有效地銷售現有產品和新產品，（v）安斯泰來無法繼續有效地研究和開發在競爭激烈的市場中被客戶接受的產品，以及（vi）協力廠商侵犯安斯泰來的智慧財產權。
本新聞稿中包含的有關藥品（包括當前正在開發的產品）的資訊不構成廣告或醫療建議。
Astellas’ VEOZA®(fezolinetant) Approved by Pharmacy and Poisons Board of Hong Kongfor ReducingMenopause RelatedSymptoms
Fezolinenetant is a first-in-class1 nonhormonal option to reduce moderate to severe VMS associated with menopause.
VMS affects more than 50% of women globally2 and 80%3 4within China
[Hong Kong],[May 9, 2025] –Astellas Pharma Hong Kong Co., Limited. ( “AstellasHong Kong”) today announced thePharmacyandPoisonsBoardof Hong Konghas approved VEOZA®(fezolinetant) 45 mg for the reductionof moderate to severe vasomotor symptoms (VMS) associated with menopause.The approval is based on the results from the BRIGHT SKY™ program, which included three Phase 3 clinical trials that collectively enrolled over 3,000 individuals across Europe, the U.S., and Canada.5
VMS, also known as hot flushes and/or night sweats, is a common symptom of menopause.67Before menopause, there is a balance between oestrogens (hormones made by a woman’s ovaries) and neurokinin B (NKB), a brain chemical. This balance regulates the body’s temperature control center located in a specific area of the brain. As the body goes through menopause, oestrogens decline and this balance is disrupted. This imbalance can lead to VMS.8
“This approval marks yet another significant milestone for our company, fezolinetant and women’s health,” said Aurelie Partouche, General Manager, Astellas Pharma Hong Kong Co.,Ltd.,“At Astellas, we are committed to delivering innovative therapies in areas of unmet need and are pleased to be delivering on that commitment by providing women in Hong Kong experiencing moderate to severe VMS associated with menopause with a novel option.”
Fezolinetanthas beenapproved by the US Food and Drug Administration (FDA) in May 2023, by European Commission in December 2023, and by Australian Therapeutic Goods Administration (TGA) in February 2024for the reductionof moderate to severe vasomotor symptoms (VMS) associated with menopause.
About Fezolinetant
Fezolinetantis oral, nonhormonal medicine indicated for the reductionof moderate to severe VMS associated with menopause. VMS are also known as hot flushes or night sweats. VEOZA works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy), helping restore the balance in the brain’s temperature control center (the hypothalamus) to reduce the number and intensity of hot flushes and night sweats.91011
About VMS Associated with Menopause
VMS, characterised by hot flushes (also called hot flashes) and/or night sweats, is a common symptom of menopause.6,7Worldwide, more than half of women 40 to 64 years of age experience VMS with rates in Europe ranging from 56% to 97%.2,1213The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%.14VMS can have a disruptive impact on women’s daily activities and overall quality of life. 6
About the BRIGHT SKY Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1 (NCT04003155) and SKYLIGHT 2 (NCT04003142), enrolled over 1,000 women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within Europe, the U.S., and Canada. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 women with VMS were enrolled at over 180 sites within Europe, the U.S., and Canada.
About AstellasHong Kong
Astellas Pharma Hong Kong Company Limited plays an important role in the Hong Kong Pharmaceutical Industry. Being a full member of The Hong Kong Association of the Pharmaceutical Industry, we focus on sales and marketing of our products in both Hong Kong and Macau markets for the treatment of five major therapeutic areas – Immunology, Anti-infective, Urology, Oncology and Metabolic.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
