Nine-Valent HPV Vaccine Added to Hainan's Supplementary Procurement List for Category II Vaccines with Price Negotiation Underway

VCBeat (WeChat ID: vcbeat) reported that on May 10, the Hainan Provincial Public Resource Trading Service Center announced that, in accordance with the requirements of the Hainan Provincial Center for Disease Control and Prevention, the 9-valent human papillomavirus vaccine (9-valent cervical cancer vaccine) (manufacturer: MSD Ireland, Merck Sharp & Dohme Corp.; Chinese distributor: Chongqing Zhifei Biological Products Co., Ltd.) has been added to the supplementary procurement list for Category II vaccines in Hainan Province.

The vaccine distributor is requested to bring the price negotiation authorization documents to the Hainan Provincial Public Resource Trading Service Center at 10:00 a.m. on May 11, 2018, for online listing price negotiations.

According to data from the World Health Organization (WHO), cervical cancer is one of the most common gynecological tumors worldwide. In China, it ranks as the second most common malignant tumor among women aged 15 to 44.

It is well established that persistent infection with high-risk human papillomavirus (HPV) types is the primary cause of cervical cancer. Among these, seven high-risk HPV types (16, 18, 31, 33, 45, 52, and 58) are responsible for approximately 90% of cervical cancers and 80% of high-grade cervical precancerous lesions worldwide. These same seven HPV types also account for 85%–90% of HPV-related vulvar cancers, 80%–85% of HPV-related vaginal cancers, and 90%–95% of HPV-related anal cancers.

The 2017 WHO position paper states that HPV vaccines should be used as part of a comprehensive, coordinated strategy for the prevention of cervical cancer and other HPV-related diseases.

Merck & Co., Inc. (known as MSD outside the United States and Canada) announced on April 29, 2018, that its nine-valent HPV vaccine had received conditional marketing approval from the National Medical Products Administration (formerly the China Food and Drug Administration). The vaccine is indicated for females aged 16 to 26 years and is administered in a three-dose regimen. According to the approval granted by the National Medical Products Administration, the nine-valent HPV vaccine is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN 1/2/3) and adenocarcinoma in situ (AIS) caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.

The HPV vaccine is the first vaccine globally to include cancer as an indication in its package insert. The nine-valent HPV vaccine approved in China is composed of virus-like particles (VLPs) made from the major capsid proteins of HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, which are highly purified and blended. This vaccine is indicated for females aged 16 to 26 years for the prevention of cervical cancer, vulvar cancer, vaginal cancer, anal cancer, genital warts, persistent infection, precancerous lesions, or dysplastic lesions caused by HPV. Currently, the nine-valent HPV vaccine has been introduced in 71 countries and regions. Since 2015, more than 34 million doses have been distributed worldwide.

On May 1, 2018, Chongqing Zhifei Biological Products Co., Ltd. signed a cooperation agreement with Merck & Co., Inc. Under the agreement, Zhifei Biological continues to serve as Merck’s market service provider in the Chinese mainland market (excluding Hong Kong, Macao, and Taiwan regions; hereinafter referred to as the “Chinese mainland”), responsible for the importation, distribution, and promotion of Merck’s 9-valent Human Papillomavirus Vaccine (Recombinant Saccharomyces cerevisiae) (hereinafter referred to as the “9-valent HPV vaccine”) in the Chinese mainland market.