Delving into the Latest Updates on Recombinant Human Papillomavirus Trivalent (Types16, 18, 58) Vaccine (Escherichia coli) (Health Guard) with Synapse

Overview

Basic Info

Drug Type

Prophylactic vaccine

Synonyms

Recombinant HPV-III(16/18/58) Vaccine (Health Guard), 重组三价人乳头瘤病毒(16/18/58型)疫苗(大肠杆菌) (康乐卫士)

Target-

Action

stimulants

Mechanism

Immunostimulants

Therapeutic Areas

NeoplasmsInfectious DiseasesUrogenital Diseases+ [1]

Active Indication

Human Papillomavirus InfectionHuman Papillomavirus-Related Cervical CarcinomaCarcinoma in situ of uterine cervix+ [7]

Inactive Indication

HPV16 Infectionhuman papilloma virus infection type 18

Originator Organization

Beijing Health Guard Biotechnology, Inc.

Active Organization

Beijing Health Guard Biotechnology, Inc.

Aihui Import and Export Process For Russia Heihe City HeilongjiangKangle Weishi (Kunming) Biotechnology Co., Ltd.

Inactive Organization

Taizhou Tiande Pharmaceutical Co., Ltd.

License Organization-

Drug Highest PhaseApproved

First Approval Date

China (28 Jul 2026),

Human Papillomavirus InfectionHuman Papillomavirus-Related Cervical Carcinoma

RegulationPriority Review (China)

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评价重组三价 HPV 疫苗（16/18/58 型）接种于 18-45 岁中国女性人群的保护效力。在 18-45 岁女性中接种三剂重组三价 HPV 疫苗（16/18/58 型）后可有效预防 HPV16、18 和 58 型别感染相关的高度宫颈异常（CIN 2/3）、原位腺癌（AIS）、浸润性宫颈癌、高级外阴上皮内瘤样病变（VIN 2/3）、高级阴道上皮内瘤样病变（VaIN 2/3）、外阴癌或阴道癌病变的发生。在 18-45 岁女性中接种三剂重组三价 HPV 疫苗（16/18/58 型）后可有效预防 HPV16、18 和 58 型别相关的 12 个月持续感染（PI12）。

[Translation]

To evaluate the protective efficacy of recombinant trivalent HPV vaccine (type 16/18/58) in Chinese females aged 18-45 years. Three doses of recombinant trivalent HPV vaccine (type 16/18/58) in females aged 18-45 years can effectively prevent the occurrence of high-grade cervical abnormalities (CIN 2/3), adenocarcinoma in situ (AIS), invasive cervical cancer, high-grade vulvar intraepithelial neoplasia (VIN 2/3), high-grade vaginal intraepithelial neoplasia (VaIN 2/3), vulvar cancer or vaginal cancer lesions associated with HPV16, 18 and 58 infection. Three doses of recombinant trivalent HPV vaccine (type 16/18/58) in females aged 18-45 years can effectively prevent 12-month persistent infection (PI12) associated with HPV16, 18 and 58.

Start Date17 Oct 2020

Sponsor / Collaborator

Taizhou Tiande Pharmaceutical Co., Ltd.

[+2]

CTR20180525

/ CompletedPhase 2

在18-45岁健康女性受试者中进行的重组三价人乳头瘤病毒（16/18/58型）疫苗（大肠杆菌）单中心I/II期临床试验（第二部分）

[Translation] A single-center phase I/II clinical trial of a recombinant trivalent human papillomavirus (type 16/18/58) vaccine (Escherichia coli) in healthy female subjects aged 18-45 years (Part II)

在中国18-45岁健康女性中，评价不同剂量的重组三价人乳头瘤病毒16/18/58型疫苗（大肠杆菌）的安全性、耐受性和免疫原性

[Translation]

To evaluate the safety, tolerability, and immunogenicity of different doses of a recombinant trivalent human papillomavirus 16/18/58 vaccine (Escherichia coli) in healthy Chinese women aged 18-45 years

Start Date20 Oct 2018

Sponsor / Collaborator

Taizhou Tiande Pharmaceutical Co., Ltd.

[+2]

100 Clinical Results associated with Recombinant Human Papillomavirus Trivalent (Types16, 18, 58) Vaccine (Escherichia coli) (Health Guard)

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100 Translational Medicine associated with Recombinant Human Papillomavirus Trivalent (Types16, 18, 58) Vaccine (Escherichia coli) (Health Guard)

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100 Patents (Medical) associated with Recombinant Human Papillomavirus Trivalent (Types16, 18, 58) Vaccine (Escherichia coli) (Health Guard)

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100 Deals associated with Recombinant Human Papillomavirus Trivalent (Types16, 18, 58) Vaccine (Escherichia coli) (Health Guard)

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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Human Papillomavirus Infection	China	Kangle Weishi (Kunming) Biotechnology Co., Ltd.	28 Jul 2026
Human Papillomavirus-Related Cervical Carcinoma	China	Kangle Weishi (Kunming) Biotechnology Co., Ltd.	28 Jul 2026

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Carcinoma in situ of uterine cervix	Phase 3	China	Aihui Import and Export Process For Russia Heihe City Heilongjiang	11 Oct 2021
Carcinoma in situ of uterine cervix	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	11 Oct 2021
Invasive Carcinoma	Phase 3	China	Aihui Import and Export Process For Russia Heihe City Heilongjiang	11 Oct 2021
Invasive Carcinoma	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	11 Oct 2021
Persistent Infection	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	11 Oct 2021
Persistent Infection	Phase 3	China	Aihui Import and Export Process For Russia Heihe City Heilongjiang	11 Oct 2021
Uterine Cervical Dysplasia	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	11 Oct 2021
Uterine Cervical Dysplasia	Phase 3	China	Aihui Import and Export Process For Russia Heihe City Heilongjiang	11 Oct 2021
Hyperplasia of cervix	Phase 3	China	Aihui Import and Export Process For Russia Heihe City Heilongjiang	17 Oct 2020
Hyperplasia of cervix	Phase 3	China	Beijing Health Guard Biotechnology, Inc.	17 Oct 2020