
不良事件/反应报告
https://www.walvax.com/public_information/?type=5&id=1
不良事件/反应报告
Shanghai Zerun’s wholly-owned subsidiary, Yuxi Zerun Biotech Co., Ltd. (collectively referred to as “Zerun Biotech”), has recently obtained the Marketing Authorization from the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM) for its bivalent human papillomavirus (HPV) vaccine (Pichia pastoris). The vaccine, marketed in Indonesia under the brand name “VACETA”, has been approved in two formulations: pre-filled syringes and vials.
Cervical cancer is one of the most significant public health burdens in Indonesia, with approximately 95% of cases caused by HPV infection. In recent years, the mortality rate has shown an upward trend, making HPV vaccination a critical preventive measure. In December 2023, the Indonesian Ministry of Health officially launched the National Cervical Cancer Elimination Plan for Indonesia 2023-2030. The Indonesian government will conduct tenders for related products based on annual budget allocations and this national strategy.
Zerun Biotech’s bivalent HPV vaccine is designed to prevent diseases caused by high-risk HPV types 16 and 18, including cervical cancer; grade 2/3 cervical intraepithelial neoplasia (CIN2/3); adenocarcinoma in situ (AIS). The vaccine was first launched in 2022 and achieved World Health Organization Prequalification (WHO PQ) in August 2024.
Moving forward, Zerun Biotech will continue to drive innovation in vaccine development, strengthening its R&D capabilities to contribute to global public health initiatives.