On October 11, the NMPA website showed that GSK's recombinant zoster vaccine(GSK1437173A, Shingrix)New indication approved for marketing, forPrevention of Herpes Zoster in High-Risk Adults Aged 18 Years and Above(Application No.: JXSS2400007)。Screenshot source: NMPA official websiteThis new indication approval is based on positive results from six clinical trials, with participants being those who recently underwent hematopoietic cell(Stem Cells)Transplant, kidney transplant, or patients aged 18 and above with blood cancer, solid tumors, or HIV. The results showed,Shingrix in these patientsIt has good tolerability and immunogenicity.Shingrix is a recombinant subunit adjuvanted vaccine, dividedTwo doses of intramuscular injection. This vaccine combines the antigen glycoprotein E with the AS01B adjuvant system, aiming to elicit a strong and long-lasting immune response to help counteract the decline in immune function that occurs with aging.ShingrixInFirst approved by the FDA for marketing in 2017, used to prevent shingles in adults aged 50 and above. In 2021, the indication was further expanded and received FDA approval for preventing shingles in individuals aged 18 and above who are at high risk or will soon be at high risk of shingles due to known diseases or treatments causing immunodeficiency or immunosuppression.
In China, 2May 2019The vaccineFor the first timeObtainNMPA ApprovalLaunched in China to prevent shingles in adults aged 50 and above.According to GSK's disclosed performance, Shingrix performed well, with sales reaching£3.364 billion(Approximately USD 4.298 billion)，Is GSK's top-selling single product.Screenshot source: Corporate earnings reportIt is worth mentioning that,In October 2023, GSK and Zhifei BiologicalSign an exclusive distribution and co-promotion agreement.According to the agreement, GSK will exclusively supply Zhifei Biological.Shingrix, and grant ZF Bio the rights to market, promote, import, and distribute the product in mainland China, whileZhiFei Bio 2024, 2025, 2026 Herpes Zoster VaccineThe minimum annual procurement amounts are 3.44 billion yuan, 6.88 billion yuan, and 10.32 billion yuan, respectively.。
Insight database shows that currently in China, there are 2 approved shingles vaccines on the market, respectively.Ganwei(Baike Biotech)AndShingrix（GSK）. In addition to this, in ChinaGreen Bamboo BiotechTheRecombinant Zoster Vaccine - LZ901The fastest-progressing research is already in the application stage for market launch and is proposed to be used forPrevention of herpes zoster caused by the varicella-zoster virus in adults aged 40 years and above.RecoBio, Maikang Bio,Zhonghui Yuantong, Huanuotai BiotechnologyThe recombinant herpes zoster vaccine has also entered Phase III clinical trials.
Screenshot source: Insight database
Note: This article is reprinted from "DXY Insight Database”，Original Title:GSK Blockbuster Approved for New Indication in China。
