Cecolin (recombinant human papillomavirus bivalent (types 16, 18) vaccine (Escherichia coli)) / Wantai BioPharm - LARVOL DELTA

Post-Marketing Safety Surveillance of Autoimmune Diseases Following Bivalent Human Papillomavirus Vaccination in China. (PubMed, Vaccines (Basel)) - "Consistent with prior evidence, this study provides real-world evidence further confirming that Cecolin vaccination does not increase the risk of ADs. It adds the first large-scale post-marketing safety evidence for this Chinese domestic bivalent HPV vaccine, filling a critical evidence gap. These results may inform vaccination policy and guide post-licensure safety monitoring in China and other countries that have introduced this vaccine."

Journal • P4 data • Immunology • Oncology

Innovations in HPV vaccination and their role in global cervical cancer control: a review. (PubMed, Ther Adv Vaccines Immunother) - "To address persistent global health disparities, regionally produced, cost-effective alternatives such as Cecolin and Cervavac have been introduced to enhance accessibility within low- and middle-income countries. However, achieving the WHO's 2030 cervical cancer elimination targets remains contingent upon overcoming infrastructural, cultural, and informational barriers that hinder vaccine uptake. This review synthesizes the molecular composition and immunological mechanisms of current and emerging HPV vaccines, evaluating their clinical efficacy and the systemic strategies required to ensure equitable global access."

Journal • Review • Cervical Cancer • CNS Disorders • Gynecologic Cancers • Infectious Disease • Oncology • Solid Tumor

Efficacy, safety, and immunogenicity of an Escherichia coli-produced nine-valent human papillomavirus vaccine: a multicentre, double-blind, randomised, controlled, phase 3 trial. (PubMed, Lancet Infect Dis) - P3 | "The E coli-produced 9vHPV vaccine was well tolerated, immunogenic, and highly protective against vaccine-targeted HPV types. Given its low production cost, this vaccine has the potential to improve global access to high-valency HPV vaccination."

Journal • P3 data • Infectious Disease • Oncology

Lot-to-Lot Consistency Clinical Trial of Recombinant Human Papillomavirus 9-valent (Types 6/11/16/18/31/33/45/52/58) Vaccine (Escherichia Coli) (clinicaltrials.gov) - P4 | N=720 | Recruiting | Sponsor: Xiamen Innovax Biotech Co., Ltd

New P4 trial • Infectious Disease • Oncology

COST-EFFECTIVENESS OF SINGLE-DOSE HPV VACCINATION IN NEPAL:AN ECONOMIC EVALUATION (ISPOR 2026) - "In 2025, Nepal implemented a nationwide single-dose human papillomavirus (HPV) vaccination campaign using Cecolin, achieving 93.7% coverage among 1.56 million girls aged 9-14 years... Single-dose HPV vaccination campaign delivers substantial health gains and strong economic value in Nepal, supporting its integration into the national immunization schedule and sustained domestic financing."

Cost effectiveness • HEOR • Cervical Cancer • Solid Tumor

Cost-effectiveness of human papillomavirus vaccination in Jordan: A modelling study. (PubMed, Vaccine) - "A single dose of Cecolin® could prevent more than half of the expected lifetime cervical cancer cases and deaths in Jordan and is very likely to be cost saving. Cervarix™ may be more impactful than Cecolin® but this depends on cross-protection assumptions. Continued multi-sectoral engagement and donor collaboration will be essential to ensure sustainable integration into the national immunization programme."

HEOR • Journal • Cervical Cancer • Oncology • Solid Tumor

New HPV Vaccines on the Market and Future Trends: A State-of-the-Art Review. (PubMed, Vaccines (Basel)) - "This review aggregates current clinical, immunological, and programme-related evidence on newly licensed vaccines, including the World Health Organization (WHO)-prequalified bivalent formulations (Cecolin® and Walrinvax®), the quadrivalent Cervavac®, and the Escherichia coli-derived nonavalent Cecolin 9®, which received national licensure in 2025. Economic evaluations demonstrating favorable cost-effectiveness emphasize the essential role of next-generation vaccines in improving access and reducing inequity. Overall, innovations in valency, technology, and delivery strategies have the potential to significantly expand global HPV prevention coverage and accelerate progress toward cervical cancer elimination."

Journal • Review • Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

Cost-effectiveness of HPV catch-up vaccination program in women aged 13-24 years in a middle income country. (PubMed, J Gynecol Oncol) - "All catch-up vaccination programs for women aged 13 to 24 years produce additional health benefits and reduce healthcare costs. Vaccination with 9vHPV was considered the most cost-effective option."

HEOR • Journal • Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Oncology • Solid Tumor

Adverse reaction surveillance analysis of domestic human papillomavirus vaccines with different production processes (PubMed, Zhonghua Yu Fang Yi Xue Za Zhi) - "Participants were randomly assigned to receive either of two domestically produced HPV vaccines (Walrinvax or Cecolin)...In conclusion, both domestic HPV vaccines demonstrated a favorable safety profile in the 9-30 years age group, with mostly mild adverse reactions. Compared to the three-dose schedule (15-30 years group), the two-dose HPV vaccination schedule (9-14 years group) significantly reduced the incidence of adverse reactions and improved vaccination compliance."

Clinical • Journal • Oncology • Pain

Human papillomavirus (HPV) vaccination for the prevention of cervical cancer and other HPV-related diseases: a network meta-analysis. (PubMed, Cochrane Database Syst Rev) - "The evidence in this network meta-analysis of HPV vaccines is based on extensive searches and analyses. There is evidence from randomised controlled trials that HPV vaccination reduces the risk of pre-cancerous outcomes such as CIN2+ and anogenital warts. No data were available for cervical cancer or other cancer outcomes, and no data on pre-cancer outcomes were available for vaccination under age 15 years. There were no safety concerns noted in the studies."

Clinical • Journal • Retrospective data • Review • Cervical Cancer • Dermatology • Human Papillomavirus Infection • Infectious Disease • Oncology • Penile Cancer • Solid Tumor

HUMAN PAPILLOMAVIRUS VACCINE LANDSCAPE (IPVC 2025) - " Since 2006, WHO has approved five HPV vaccines: three bivalent vaccines (Cervarix, Cecolin, and Walrinvax); one quadrivalent vaccine (Gardasil); and one nonavalent vaccine (Gardasil 9). Two domestically licensed vaccines are available in Bangladesh (HPvax) and India (Cervavac)... Global vaccine introduction has made good progress in recent years. Countries that have introduced the vaccine subnationally—such as China, Russia, and India—have large populations and wide geographical areas. The vaccine landscape in China is changing rapidly with more low-cost vaccines becoming available, that will likely further influence global vaccine availability."

Cervical Cancer • Genito-urinary Cancer • Penile Cancer • Solid Tumor

ADDRESSING CERVICAL CANCER IN GUINEA: THE URGENT NEED FOR HPV VACCINE INTRODUCTION (IPVC 2025) - "Given the high disease burden and inequitable access to prevention and treatment, introducing HPV vaccination is urgent. Guinea plans to apply to Gavi for vaccine introduction by 2026."

Cervical Cancer • Oncology • Solid Tumor

PREVALENCE OF HPV INFECTIONS AMONG FEMALES AGED 9–50 YEARS IN NEPAL: A NATIONALLY REPRESENTATIVE STUDY (GLOBE-HPV) (IPVC 2025) - "Introduction: In February 2025, Nepal launched its first national HPV vaccination campaign targeting girls aged 10–14 years with a single dose of the Cecolin® vaccine (HPV16/18)... This study reveals a substantial burden of HPV among Nepalese females, with variation by age, geography, and urbanicity. These findings offer a critical baseline for monitoring trends and guiding targeted cervical cancer prevention and screening strategies."

Cervical Cancer • Human Papillomavirus Infection • Infectious Disease • Solid Tumor

ADVERSE PREGNANCY OUTCOMES AMONG FEMALES RECEIVING BIVALENT HUMAN PAPILLOMAVIRUS VACCINE IN XIAMEN, CHINA (IPVC 2025) - "Real-world evidence supports that CecolinⓇ did not increase the risk of the studied APOs."

Adverse events

HEALTH AND ECONOMIC IMPACT OF DOMESTICALLY MANUFACTURED BIVALENT HPV VACCINES IN CHINA: STAKEHOLDER ENGAGEMENT AND MODELLING STUDY (IPVC 2025) - "Introduction: China has two recently domestically manufactured bivalent HPV vaccines (Cecolin and Walrinvax), but such a vaccine is not yet included in China's National Immunisation Programme... A domestic bivalent HPV vaccination programme would be cost-effective in China. Under short-term supply or budget constraints, adopting a one-dose schedule or prioritising high-burden regions would be optimal."

HEOR • Cervical Cancer • Solid Tumor

ACTIVELY PROMOTE THE VACCINATION OF HUMAN PAPILLOMAVIRUS VACCINE IN CHINA (IPVC 2025) - " At present, there are 5 HPV vaccines in China, including bivalent vaccine (Cervarix, Cecolin and Wozehui), 4-valent and 9-valent vaccine (Gardasil 4 and 9), for women aged 9 to 45 ys,and for men aged 9 to 26y (4-valent), and 16 to 26ys(9-valent ). Now we have face big challenges to eliminate cervical cancer, With the combination of HPV vaccination and cervical cancer screening, China is accelerating the elimination of cervical cancer."

Cervical Cancer • Infectious Disease • Solid Tumor

HPV VACCINE IN CHINA: PROGRESS AND CHALLENGES TOWARD THE NATIONAL IMMUNIZATION PROGRAM (IPVC 2025) - " At present, five HPV vaccines are commercially available in China, including three bivalent vaccines (Cervarix, Cecolin, and Walrinvax), one quadrivalent vaccine (Gardasil), and one nonavalent vaccine (Gardasil-9). Despite the increasing availability of HPV vaccines in China and the gradual expansion of provincial-level vaccination programs, national coverage remains critically low, particularly among the target age group of 9–14 years. Accelerating the integration of HPV vaccination into the national program, alongside strategies to improve affordability, accessibility, and public awareness, will be essential for China to close the gap with global progress and to advance toward cervical cancer elimination."

Cervical Cancer • Solid Tumor

POTENTIAL IMMUNE-MEDIATED DISORDERS AMONG FEMALES RECEIVING BIVALENT HUMAN PAPILLOMAVIRUS VACCINE IN XIAMEN, CHINA (IPVC 2025) - "The incidence of pIMDs in females who received the CecolinⓇ was comparable to that in HPV-vaccine unexposed females. The CecolinⓇ administered to females aged 9-45 years did not show an increase risk of developing the studied pIMDs."

Ankylosing Spondylitis • Hematological Disorders • Idiopathic Arthritis • Immune Thrombocytopenic Purpura • Immunology • Inflammatory Arthritis • Lupus • Ocular Inflammation • Ophthalmology • Optic Neuritis • Rheumatoid Arthritis • Rheumatology • Seronegative Spondyloarthropathies • Systemic Lupus Erythematosus • Thrombocytopenic Purpura

CHINA'S DOMESTIC HPV VACCINES: CLINICAL TRIAL EVIDENCE AND POST-APPROVAL PROGRESS (IPVC 2025) - "Two domestic bivalent HPV vaccines (Cecolin® and Walrinvax®) have been approved... China has made significant progress in developing and implementing domestic HPV vaccines, contributing to improved coverage and self-reliance in cervical cancer prevention. However, regional policy variation and implementation challenges highlight the need for strengthened national coordination and long-term sustainability planning."

Clinical • Cervical Cancer • Solid Tumor

IMMUNOPERSISTENCE AND EFFECTIVENESS OF ONE OR TWO DOSES OF THE ESCHERICHIA COLI-PRODUCED HPV-16/18 BIVALENT VACCINE IN WOMEN AGED 18-45 YEARS (IPVC 2025) - P3 | "This study revealed that one or two doses of Cecolin® could establish robust immunity and protection against HPV-16/18 infection in women aged 18-45 years, lasting for up to 5.5 years. In the context of continued HPV vaccine shortages, our data support for the optimizing of immunization strategies for adult women and highlight the necessity for further research to verify the efficacy of one or two dose HPV vaccination in this group."

Clinical • Human Papillomavirus Infection • Infectious Disease

Immunogenicity comparison of an Escherichia coli-produced 9-valent human papillomavirus vaccine and Gardasil9 in Chinese women aged 18-26 years: three-year follow-up data from a randomised clinical trial. (PubMed, Lancet Reg Health West Pac) - P, P3 | "The Cecolin9 cohort demonstrated sustained non-inferior HPV type-specific plateau antibody levels compared to the Gardasil9 cohort, supporting Cecolin9's potential for enduring protection. National Key Research and Development Plan, the National Natural Science Foundation of China, Beijing Natural Science Foundation, Fundamental Research Funds for the Central Universities, the Fieldwork Funds for graduate students of Xiamen University, and Xiamen Innovax."

Journal • Oncology

Long-term efficacy and immunopersistence of an Escherichia coli-produced HPV-16/18 bivalent vaccine: an observational extension study following a randomised, double-blind Phase III clinical trial cohort. (PubMed, Lancet Reg Health West Pac) - P3 | "A safe and highly efficacious Escherichia coli-produced HPV-16/18 bivalent vaccine (Cecolin®) offers a cost-effective cervical cancer prevention measure...The E. coli-produced HPV 16/18 bivalent vaccine elicits sustained antibody responses and confers durable protection against HPV 16/18 associated high-grade cervical, vulvar or vaginal lesions and persistent infections for a minimum of 10 years post-vaccination. National Key Research and Development Program of China (2023YFC2307602), National Natural Science Foundation of China (823B2086, 82273640), Beijing Natural Science Foundation (L244091), and Fundamental Research Funds for the Central Universities (20720220005)."

Journal • P3 data • Cervical Cancer • Infectious Disease • Oncology • Solid Tumor

Immunogenicity and safety of an Escherichia coli-produced bivalent human papillomavirus vaccine (Cecolin) in girls aged 9-14 years in Ghana and Bangladesh: a randomised, controlled, open-label, non-inferiority, phase 3 trial. (PubMed, Lancet Infect Dis) - P3 | "Non-inferior immune responses for extended two-dose regimens of 2vHPV support dosing flexibility. For up to 24 months, one dose of 2vHPV elicited immunogenicity that was similar to one dose of 4vHPV, for which single-dose efficacy has been shown, supporting a single-dose use of 2vHPV."

Head-to-Head • Journal • P3 data • Cervical Cancer • Oncology • Solid Tumor

HPV-PRO-006-4: Long-term Effectiveness and Immuno-persistence Study of a Recombinant HPV 16/18 Bivalent Vaccine in Preadolescent Girls (clinicaltrials.gov) - P=N/A | N=2188 | Active, not recruiting | Sponsor: Xiamen University | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Cervical Cancer • Gynecology • Infectious Disease • Oncology • Solid Tumor

China approves first domestically produced nine-valent HPV vaccine (XINHUANET.com) - "China approved its first domestically developed nine-valent human papillomavirus (HPV) vaccine on Thursday, according to the National Medical Products Administration...The vaccine, Cecolin 9, was jointly developed by the Xiang An Biomedicine Laboratory, Xiamen University and Wantai BioPharm. Its approval makes China the second country in the world -- after the United States -- with the capability to independently supply high-valency HPV vaccines....Results from these trials showed that the vaccine provides strong protection against HPV types 16 and 18 -- the same strains covered by the two-valent vaccine -- as well as five other HPV types 31, 33, 45, 52 and 58, with a protection rate of over 98 percent against persistent infections lasting more than 12 months and a 100 percent protection rate against cervical infections."

China approval • Human Papillomavirus Infection