-75% of all women will develop vulvovaginal candidiasis (VVC) at least once in their lifetime

-75%的女性在一生中至少会患上一次外阴阴道念珠菌病（VVC）

-VIVJOA is now included in the National Reimbursement Drug List for treating severe VVC in

-VIVJOA 现已纳入国家医保药品目录，用于治疗重度 VVC

China

中国

DURHAM, N.C.

北卡罗来纳州达勒姆

,

，

April 2, 2025

2025年4月2日

/PRNewswire/ --

/PRNewswire/ --

Mycovia Pharmaceuticals, Inc.

Mycovia制药公司

('Mycovia'), an emerging biopharmaceutical company, today announced that Jiangsu Hengrui Pharmaceuticals Co., Ltd ('Hengrui Pharma') held a recent conference in

('迈科维亚')，一家新兴的生物制药公司，今天宣布江苏恒瑞医药股份有限公司('恒瑞医药')近期举行了一场会议

Shanghai, China

中国上海

to recognize the listing of VIVJOA

承认VIVJOA上市

®

®

(oteseconazole) in the recent National Reimbursement Drug List (NRDL) by

（奥特赛康唑）在最近的国家报销药品目录（NRDL）中被

China's

中国的

National Healthcare Security Administration, expanding patient accessibility to VIVJOA for the treatment of severe vulvovaginal candidiasis (VVC) in post-menopausal women and women not of reproductive potential. The 2024 NRDL listing process emphasized support for first-in-class therapies and innovative drugs.

国家医疗保障局扩大了绝经后女性及无生殖潜力的女性患者使用VIVJOA治疗重度外阴阴道念珠菌病（VVC）的可及性。2024年国家医保药品目录调整过程强调了对首创疗法和创新药物的支持。

VIVJOA was among a small group of drugs selected..

VIVJOA 是被选中的少数药物之一。

'Hengrui Pharma is committed to national health and has been deeply cultivating and expanding its presence in the field of gynecological infections including the introduction of VIVJOA,' said Mr.

“恒瑞医药致力于国民健康，一直在深耕并拓展其在妇科感染领域的布局，包括引入VIVJOA，”该先生表示。

Hongbin Dai

戴洪斌

, President of Hengrui Pharma. 'Inclusion of VIVJOA in the NRDL highlights the clinical significance of this innovative drug and will allow more people to benefit from this treatment. Hengrui Pharma is continuing to actively explore research in the treatment of multiple women's diseases, bringing more hope to patients.'.

恒瑞医药总裁表示：“VIVJOA被纳入国家医保药品目录，凸显了这款创新药物的临床意义，将使更多人从该治疗中受益。恒瑞医药正在继续积极探索多种女性疾病治疗的研究，为患者带来更多的希望。”

The conference was attended by over 200 experts in gynecological infections and healthcare providers from across

会议有200多位妇科感染和医疗保健方面的专家出席

China

中国

, with presentations by Dr.

，由博士进行演示。

Jack Sobel

杰克·索贝尔

, distinguished professor of Internal Medicine, Division of Infectious Diseases, and dean emeritus at

，内科医学杰出教授，传染病科，兼名誉院长 tại

Wayne State University

韦恩州立大学

, recognized as a global key opinion leader on vulvovaginal candidiasis, and Dr.

，被公认为全球关于外阴阴道念珠菌病的关键意见领袖，以及 Dr.

Stephen Brand

斯蒂芬·布兰德

, Chief Development Officer of Mycovia.

，Mycovia的首席发展官。

'In a Phase 3 clinical study, VIVJOA demonstrated statistically significant and clinically meaningful superiority to fluconazole at Day 14 and 28, the current standard-of-care, in treating severe VVC. The new listing for VIVJOA will provide improved access to many more women suffering with VVC in

“在一项 III 期临床研究中，VIVJOA 在治疗严重的 VVC 方面，于第 14 天和第 28 天显示出统计学上显著且临床意义上优于氟康唑（当前的标准治疗）。VIVJOA 的新上市将为更多患有 VVC 的女性提供更好的治疗选择。

China

中国

, including those with fluconazole-resistant infections,' said

`, 包括那些感染对氟康唑有抗药性的患者，`说。

Stephen Brand

斯蒂芬·布兰德

. 'Also, we are excited that Hengrui Pharma plans to evaluate the potential clinical utility for oteseconazole in multiple indications including and beyond women's health.'

此外，我们很高兴恒瑞制药计划评估奥特赛康唑在包括女性健康在内的多种适应症中的潜在临床效用。

Vulvovaginal candidiasis is an exceedingly common mucosal infection usually caused by

外阴阴道念珠菌病是一种非常常见的黏膜感染，通常由

Candida albicans

白色念珠菌

but can occasionally be caused by other

但偶尔也可能由其他原因造成

Candida

念珠菌

species or yeasts. Typical symptoms include vulvovaginal itching, irritation, burning, soreness, fissuring, redness, vaginal discharge, and dyspareunia. Approximately 70% to 75% of women in all strata of the society will experience at least one episode during their lifetime.

种类或酵母。典型症状包括外阴阴道瘙痒、刺激、灼烧感、酸痛、裂口、发红、阴道分泌物和性交困难。大约70%到75%的女性在社会各阶层中会在其一生中至少经历一次发作。

In April 2022, the U.S. Food and Drug Administration (FDA) approved VIVJOA (oteseconazole) capsules as the first prescription medication for recurrent vulvovaginal candidiasis (RVVC, or chronic yeast infection). VIVJOA is currently available in the US at over 200 Walgreens Specialty Pharmacies located throughout the U.S.

2022年4月，美国食品和药物管理局（FDA）批准VIVJOA（奥特赛康唑）胶囊作为首个用于治疗复发性外阴阴道念珠菌病（RVVC，或慢性酵母菌感染）的处方药。VIVJOA目前已在美国超过200家分布于全美的Walgreens专科药房上市。

In .

在。

June 2023

2023年6月

, VIVJOA received approval in

，VIVJOA获得批准在

China

中国

from the National Medical Products Administration and is indicated for the treatment of severe VVC.

来自国家药品监督管理局，用于治疗重度VVC。

About Recurrent Vulvovaginal Candidiasis

关于复发性外阴阴道念珠菌病

RVVC is a debilitating, chronic infectious condition that affects 138 million women worldwide each year. RVVC, also known as chronic yeast infection, is a distinct condition from vulvovaginal candidiasis (VVC) and defined by the Centers for Disease Control and Prevention as three or more symptomatic acute episodes of yeast infection in 12 months.

复发性外阴阴道念珠菌病（RVVC）是一种使人衰弱的慢性感染性疾病，全球每年有1.38亿女性受其影响。RVVC，也被称为慢性酵母菌感染，与外阴阴道念珠菌病（VVC）不同，美国疾病控制与预防中心将其定义为12个月内出现三次或更多次伴有症状的急性酵母菌感染发作。

Primary symptoms include vaginal itching, burning, irritation and inflammation. Some women may experience abnormal vaginal discharge and painful sexual intercourse or urination, causing variable but often severe discomfort and pain..

主要症状包括阴道瘙痒、灼热感、刺激和炎症。一些女性可能会出现异常的阴道分泌物以及性交或排尿疼痛，导致不同程度但通常较为严重的不适和疼痛。

About VIVJOA®

关于VIVJOA®

VIVJOA® (oteseconazole) is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential. VIVJOA is the first FDA-approved medication that provides sustained efficacy demonstrated by significant long-term reduction of RVVC recurrence through 50 weeks versus comparators..

VIVJOA®（奥特赛康唑）是一种唑类抗真菌药物，用于降低有复发性外阴阴道念珠菌病（RVVC）病史且不具备生殖潜力的女性中RVVC的发生率。VIVJOA是首个获得FDA批准的药物，通过与对照组相比，在50周内显著减少RVVC复发，证明了其长期有效性。

Oteseconazole is designed to inhibit fungal

奥特赛康唑旨在抑制真菌生长

CYP51

CYP51

, which is required for fungal cell wall integrity, and this selective interaction is also toxic to fungi, resulting in the inhibition of fungal growth. Due to its chemical structure, oteseconazole has a lower affinity for human CYP enzymes as compared to fungal CYP enzymes. The FDA approved VIVJOA based upon the positive results from three phase 3 clinical trials of oteseconazole – two global VIOLET studies and one U.S.-focused ultraVIOLET study, including 875 patients at 232 sites across 11 countries..

，这对于真菌细胞壁的完整性至关重要，而且这种选择性相互作用对真菌也有毒性，导致真菌生长受到抑制。由于其化学结构，奥特赛康唑与人类CYP酶的亲和力相比真菌CYP酶较低。美国食品药品监督管理局（FDA）基于奥特赛康唑的三项三期临床试验的积极结果批准了VIVJOA——两项全球性的VIOLET研究和一项以美国为中心的ultraVIOLET研究，涵盖了11个国家232个地点的875名患者。

Please click

请单击

here

这里

for full Prescribing Information.

完整的处方信息。

IMPORTANT SAFETY INFORMATION

重要安全信息

CONTRAINDICATIONS

禁忌症

VIVJOA is contraindicated in females of reproductive potential. Females who are NOT of reproductive potential are defined as: persons who are biological females who are postmenopausal or have another reason for permanent infertility (e.g., tubal ligation, hysterectomy, salpingo-oophorectomy).

VIVJOA 禁用于有生殖潜力的女性。没有生殖潜力的女性定义为：绝经后或因其他原因导致永久不育（例如输卵管结扎、子宫切除术、输卵管卵巢切除术）的生理女性。

VIVJOA is contraindicated in pregnant and lactating women.

VIVJOA禁用于孕妇和哺乳期妇女。

VIVJOA is contraindicated in patients with known hypersensitivity to oteseconazole.

VIVJOA 禁用于已知对奥特康唑过敏的患者。

WARNINGS AND PRECAUTIONS

警告和注意事项

Based on animal studies, VIVJOA may cause fetal harm. The drug exposure window of approximately 690 days (based on 5 times the half-life of oteseconazole) precludes adequate mitigation of the embryo- fetal toxicity risks. Advise patients that VIVJOA is contraindicated in females of reproductive potential, and in pregnant and lactating women because of potential risks to a fetus or breastfed infant..

基于动物研究，VIVJOA可能会对胎儿造成伤害。该药物的暴露窗口期约为690天（基于奥替康唑5倍半衰期），无法充分减轻胚胎-胎儿毒性风险。请告知患者，由于对胎儿或哺乳婴儿存在潜在风险，VIVJOA禁用于有生育潜力的女性、孕妇及哺乳期妇女。

ADVERSE REACTIONS

不良反应

The most frequently reported adverse reactions among VIVJOA-treated patients in clinical studies included headache (7.4%) and nausea (3.6%).

在临床研究中，接受VIVJOA治疗的患者最常见的不良反应包括头痛（7.4%）和恶心（3.6%）。

DRUG INTERACTIONS

药物相互作用

VIVJOA is a Breast Cancer Resistance Protein (BCRP) inhibitor. Concomitant use of VIVJOA with BCRP substrates (e.g., rosuvastatin) may increase the exposure of BCRP substrates, which may increase the risk of adverse reactions associated with these drugs.

VIVJOA 是一种乳腺癌耐药蛋白 (BCRP) 抑制剂。VIVJOA 与 BCRP 底物（例如，瑞舒伐他汀）同时使用时，可能会增加 BCRP 底物的暴露量，从而可能增加与这些药物相关的不良反应风险。

Please see full

请参阅完整内容

Prescribing Information

处方信息

and

和

Patient Information

患者信息

.

。

To report SUSPECTED ADVERSE REACTIONS, contact Mycovia Pharmaceuticals, Inc. at 1-855-299-0637 or FDA at 1-800-FDA-1088 or

要报告疑似不良反应，请联系迈科维亚制药公司，电话：1-855-299-0637，或FDA，电话：1-800-FDA-1088，或

www.fda.gov/medwatch

www.fda.gov/medwatch

.

。

About Mycovia Pharmaceuticals, Inc.

关于Mycovia Pharmaceuticals, Inc.

Mycovia Pharmaceuticals, Inc. is an emerging biopharmaceutical company dedicated to recognizing and empowering those living with unmet medical needs by developing novel therapies. VIVJOA® (oteseconazole) capsules, the first FDA-approved product for Mycovia, is an azole antifungal indicated to reduce the incidence of recurrent vulvovaginal candidiasis (RVVC) in females with a history of RVVC who are NOT of reproductive potential.

Mycovia Pharmaceuticals, Inc.是一家新兴的生物制药公司，致力于通过开发新型疗法来认识和帮助那些存在未满足医疗需求的人群。VIVJOA®（奥特赛康唑）胶囊是Mycovia首个获得FDA批准的产品，是一种唑类抗真菌药物，用于降低有复发性外阴阴道念珠菌病（RVVC）病史且无生殖潜力的女性RVVC的复发频率。

Oteseconazole received FDA Qualified Infectious Disease Product and Fast-Track designations to become the first FDA-approved therapy for RVVC. In 2019, Mycovia licensed oteseconazole to Jiangsu Hengrui Pharmaceuticals Co., Ltd., to develop and commercialize oteseconazole in .

奥特赛康唑获得了FDA合格传染病产品和快速通道资格，成为首个FDA批准的RVVC疗法。2019年，Mycovia公司将奥特赛康唑授权给江苏恒瑞医药股份有限公司，以在中国开发和商业化奥特赛康唑。

China

中国

, including mainland

，包括大陆

China

中国

,

，

Hong Kong

香港特别行政区

,

，

Macau

澳门

and

和

Taiwan

台湾

.

。

Mycovia also recognizes a tremendous potential for its oral fungal inhibitors and a growing need to treat a range of multi-drug resistant fungal pathogens. For more information, please visit

Mycovia还认识到其口服真菌抑制剂的巨大潜力，并且治疗一系列多药耐药真菌病原体的需求日益增长。欲了解更多信息，请访问

www.mycovia.com

www.mycovia.com

.

.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

关于江苏恒瑞医药股份有限公司

Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) is an innovative, global pharmaceutical company dedicated to the research, development and commercialization of high-quality medicines to address unmet clinical needs. With a global R&D team that includes 14 R&D centers and more than 5,500 professionals, Hengrui Pharma's therapeutic areas of focus include oncology, metabolic and cardiovascular diseases, immunological and respiratory diseases, and neuroscience.

江苏恒瑞医药股份有限公司（恒瑞医药）是一家创新的全球制药公司，致力于研究、开发和商业化高质量药物，以满足未被满足的临床需求。恒瑞医药拥有包括14个研发中心和5500多名专业人员的全球研发团队，重点领域涵盖肿瘤学、代谢和心血管疾病、免疫和呼吸系统疾病以及神经科学。

To date, Hengrui Pharma has commercialized 19 new molecular entity drugs and 4 other innovative drugs in .

截至目前，恒瑞医药已上市19款新分子实体药物和4款其他创新药。

China

中国

. Founded in 1970 with the core principle of putting patients first, Hengrui Pharma remains committed to advancing human health by striving to conquer diseases, improve health, and extend lives through the power of science and technology.

成立于1970年，恒瑞医药始终秉持以患者为中心的核心理念，致力于通过科学技术的力量攻克疾病、改善健康、延长生命，推动人类健康事业的发展。

SOURCE Mycovia Pharmaceuticals, Inc.

来源：Mycovia Pharmaceuticals, Inc.

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