UB-621

DUBLIN, Aug. 8, 2022 /PRNewswire/ -- The "Genital Herpes Treatment Market - Global Outlook and Forecast 2022-2027" report has been added to ResearchAndMarkets.com's offering. The global genital herpes treatment market is expected to grow at a CAGR of 3.76% during 2022-2028 The global genital herpes treatment market is segmented based on drug type, distribution channel, virus type, route of administration, and geography. The Acyclovir segment reported a significant share of around 50.44% among all drug types. The Acyclovir is the leading segment due to availability in all three major routes of administration. The key player in the genital herpes treatment GSK has the branded drug Zovirax. Acyclovir is the oldest drug in the antiviral category and has many generic versions of Zovirax available on the market. The Retail pharmacies segment reported a significant share of around 49.79% among all distribution channels. The retail pharmacy segment is showing the highest share due to the availability of branded and generic versions of all antiviral drugs in retail pharmacies. People who have genital herpes is most referred to go to nearby retail pharmacy outlet for anti-genital herpes treatment because of the stigma related to sexually transmitted diseases. The HSV-2 segment reported a major share of around 84.10% among all virus types. HSV-2 is the leading virus type segment as HSV-2 is the leading cause of genital herpes. According to WHO data published in 2022, an estimated 491 million (13%) aged 15-49 years were suffering from infections worldwide in 2016. More women than men are infected with HSV-2. Among all routes of administration, the oral segment reported a major share of around 64.03%. Mostly all the anti-genital herpes drugs are available in an oral formulation. Chronic suppressive doses of oral antivirals, including Acyclovir (Zovirax), valacyclovir (Valtrex), and famciclovir, have significantly reduced the incidence of clinical recurrence and the rate of asymptomatic excretion. Oral administration of Acyclovir effectively suppresses recurrent genital herpes. Daily administration of Acyclovir reduces the recurrence rate by up to 80%, and 25-30% of patients have no further recurrence while taking the drug. North America is the major revenue contributor to the global genital herpes treatment market, with a share of more than 40%. In North America, the US is the key revenue contributor mainly due to an increase in the demand for genital herpes drugs reflecting the growing awareness of various antiviral drugs and their benefits against different STIs, including genital herpes. Europe is the second-largest regional market and is witnessing steady growth owing to increasing acceptance of both branded and OTC antiviral drugs for treating genital herpes. However, APAC is likely to see faster growth than all other regions. Around 1 in every ten people in APAC are infected with HSV-2, which majorly causes genital herpes. The APAC region is witnessing high demand for off-label, generic, and OTC drugs for treating genital herpes. The region has many regional and local vendors offering generic and OTC antiviral drugs, which are majorly used for treating genital herpes. Promising Investigational Therapies for Treating Genital Herpes Researchers have been working on the development of herpes vaccines for decades. Several clinical trials have been conducted to test therapeutic (to reduce recurrence and viral shedding in people already infected with HSV) and prophylactic (to prevent infection) drug candidates. mRNA-1608 a Moderna's HSV vaccine candidate is a vaccine candidate against HSV-2 infection. Moderna believes that an HSV-2 vaccine could provide cross-protection against HSV-1. With mRNA-1608, the Company intends to bring a strong antibody reaction with neutralizing and effector functionality shared with cell-mediated immunity. HSV 2 Vaccines, RVx-201, NE HSV-2 Vaccine, HDIT 101, Pritelivir, UB-621, and other critical Genital Herpes pipeline medicines are in various stages of clinical trials for the treatment of Genital Herpes. Sanofi, Rational Vaccines, BlueWillow Biologics, Heidelberg ImmunoTherapeutics, AiCuris, and United Biopharma are some of the most well-known pharmaceutical companies active in the field. X-Vax Technology announced in May 2021 that it is preparing to submit an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for its experimental herpes simplex virus 1 and 2 vaccines (HSV-1 and -2). The FDA granted AiCuris Breakthrough Therapy Designation for Pritelivir to treat HSV infections in immunocompromised patients in June 2020. Increasing Demand for Genital Herpes Treatment by Homosexuals Homosexual acceptance increased by double digits between 2002 and 2019. This includes a 21-point increase in South Africa since 2002 and a 19-point increase in South Korea over the same period. India has also seen a rise of 22 points since 2014. MSM groups are at increased risk of HIV and other STIs due to sexual networks, the number of concurrent partners, and behavioral or biological factors such as condom-less sex, anal sex, drug use, etc. MSM are vulnerable demographics to spreading STIs. While anyone having sex can get an STD, the sexually active LGBT population, including gay, bisexual, and MSM, are at greater risk. In addition to getting higher rates of HSV, more than half of all new HIV infections happen among MSM. Many aspects contribute to the higher rates of STIs among MSM. Growing Burden of Sexually Transmitted Diseases As the latest data from WHO, an expected 3.7 billion individuals younger than 50, or 67% of the populace, in 2016 had HSV-1 contamination (oral or genital). The assessed predominance of the contamination was most elevated in Africa (88%) and least in the Americas (45%). Genital herpes caused by HSV-2 is a global problem. According to WHO data published in 2022, an estimated 491 million (13%) aged 15-49 years suffered from infections worldwide in 2016. More women than men are infected with HSV-2. In 2016, an estimated 313 million women and 178 million men lived with the infection. This is because male-to-female sexually transmitted HSV is more efficient than female-to-male sexual transmission. Genital herpes is a worldwide issue, and an expected 491 million (around 13%) individuals between 15 and 49 years suffer from this STD. In 2016, around 313 million women and 178 million men had genital herpes. This is because sexual transmission of HSV is more proficient from men to ladies than from ladies to men. The pervasiveness of HSV-2 disease was assessed to be most noteworthy in Africa (44% in ladies and 25% in men), trailed by the Americas (24% in ladies and 12% in men). Key Vendors GlaxoSmithKline Glenmark pharmaceuticals Viatris Novartis Teva Pharmaceuticals Bausch Health Companies Other Prominent Vendors Reddy's Laboratories Cipla Pfizer Eli Lilly & Company Avet Pharmaceuticals Aurobindo Pharma Centurion Remedies Abbott Macleods Pharmaceuticals FDC Hetero Zydus Group Torrent Pharma Finecure Pharmaceuticals ADLEY FORMULATIONS Medico Remedies Zeelab Pharmacy Key Topics Covered: 1 Research Methodology 2 Research Objectives 3 Research Process 4 Scope & Coverage 4.1 Market Definition 4.2 Base Year 4.3 Scope of the Study 5 Report Assumptions & Caveats 5.1 Key Caveats 5.2 Currency Conversion 5.3 Market Derivation 6 Market at a Glance 7 Introduction 7.1 Overview 7.1.1 STI Control Health Policy Agenda 7.1.2 Global Prevalence of HSV Infections 7.1.3 Risk of HIV and Genital Herpes Among the LGBTQ+ Community 8 Market Opportunities & Trends 8.1 R&D of Genital Herpes Vaccine Candidates 8.2 Rise in Genital Herpes Cases in LGBTQ+ Community 8.3 Market Growth Potential in Low-Middle-Income Countries 8.4 Increased Online Purchase of Genital Herpes Therapeutics 9 Market Growth Enablers 9.1 Increased Burden of STDs 9.2 Awareness of STIs 9.3 Demand for Topical Genital Herpes Treatment Drugs 10 Market Restraints 10.1 Social Stigma Associated With STDs 10.2 Side Effects & Adverse Reactions to Genital Herpes Medications 10.2.1 Risks Associated With Valacyclovir 10.3 Limitations of Genital Herpes Treatment Medications 11 Market Landscape 11.1 Market Overview 11.2 Market Size & Forecast 11.3 Five Forces Analysis 12 Drug Type 12.1 Market Snapshot & Growth Engine 12.2 Market Overview 12.3 Acyclovir 12.4 Valacyclovir 12.5 Famciclovir 12.6 Other Drugs 13 Distribution Channel 13.1 Market Snapshot & Growth Engine 13.2 Market Overview 13.3 Retail Pharmacies 13.4 Hospital Pharmacies 13.5 Online Pharmacies 14 Virus Type 14.1 Market Snapshot & Growth Engine 14.2 Market Overview 14.3 HSV-2 14.4 HSV-1 15 Route of Administration 15.1 Market Snapshot & Growth Engine 15.2 Market Overview 15.3 Oral 15.4 Topical 15.5 Injection 16 Geography 16.1 Market Snapshot & Growth Engine 16.2 Geographic Overview For more information about this report visit Media Contact: Research and Markets Laura Wood, Senior Manager [email protected] For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Logo: SOURCE Research and Markets

2022年5月29日，台湾联合生物宣布台湾食品药品监督管理局 (TFDA) 已批准新型抗 IgE 单克隆抗体 UB-221 的2 期临床试验。这项 2 期临床试验（双盲、安慰剂对照）旨在评估 UB-221 作为一种长效附加疗法治疗慢性自发性荨麻疹（ CSU ）的疗效，并证明UB-221 两个高剂量组治疗6个月期间的潜力。 UB-221 是一种 IgG1，靶向 IgE 抗体的 Cε3 结构域，通过与B 细胞表面的 FcεRII (CD23) 受体结合来中和可溶性 IgE 并抑制 IgE 合成。临床前研究表明，UB-221 的药理作用优于目前针对 IgE 的治疗性抗体（Xolair ）8倍；体外数据中显示出 2 至 5 倍的 IgE 合成抑制作用，需要 1/10 剂量才能在 huIGHE 敲入小鼠模型中达到相同的效果。1 期临床试验显示，CSU 患者对 UB-221 单次给药后反应迅速，并将其血清游离 IgE 抑制数周至数月，表明 UB-221 可以比 Xolair 更有效地缓解 CSU 症状。UB-221 还可以通过与低亲和力受体 CD23 上已经结合的 IgE 结合来抑制新 IgE 的产生，因此，停药后IgE的反弹速度会变慢。 自发性荨麻疹分为急性（<六周）和慢性（>六周）变体。发病率约为0.5-1%，患者随时可能患上该病。目前，非镇静 H1 抗组胺药是对症治疗的主要药物，使用许可剂量的治疗可有效缓解 <50% 的患者的症状。由于患者从 H1-抗组胺药中获益甚少，因此需要新的治疗策略。 IgE抗体在所有免疫球蛋白中浓度最低、半衰期最短，在自发性荨麻疹等过敏性疾病的发病中起到决定性作用。自第一代IgE抗体Xolair（奥马珠单抗）上市已经历20余年，同为第一代IgE抗体的ligelizumab在2b期临床头对头治疗自发性荨麻疹击败奥马珠单抗。第二代IgE抗体的代表药物FB825，2020年4月，利奥制药、合一生技及中天上海针对FB825的开发签订合作协议，合一生技将负责于美国执行异位性皮肤炎2a期临床试验，中天上海将于中国大陆执行过敏性气喘2a期临床试验，利奥制药将于这两项2a期临床试验后，承担后续药物开发。联合生物的UB-221作为第三代IgE抗体，未来的发展我们拭目以待。 将目前处于临床开发阶段的IgE药物统计如下： 联合生物的创新单抗药物产品线涵盖了传染病、免疫失调疾病和癌症。其中， UB-421是一种可应用于治疗HIV感染的抗CD4抗体，抗HSV抗体UB-621正处于研究治疗复发性生殖器疱疹的2期临床试验。在处于临床前开发阶段的三项抗肿瘤抗体中，UB-925 是一种新型抗VEGFR2单株抗体， UB-923和 UB-926 是以联合生物专有的去岩藻糖技术(defucosylation technology) 开发的抗CD20 和抗HER2 抗体，该技术可提升修饰后单株抗体的抗肿瘤活性。 内容来源于网络，如有侵权，请联系删除，谢谢