Two Vaccine Advances: Yidao Bio's RSV Vaccine Granted Clinical Trial Approval and Abogen's mRNA Zoster Vaccine IND Accepted
Abogen
Nucleic Acid Drug Developer
On January 3, 2025, according to the Center for Drug Evaluation of the National Medical Products Administration,Yidao Biotechnology(Suzhou) Co., Ltd.TheRecombinant Respiratory Syncytial Virus Vaccine (CHO Cells) Receives Clinical Trial Implied Consent, Application No. CXSL2400711;Abogen BiosciencesTheLyophilized Herpes Zoster mRNA Vaccine Submitted for Clinical Trial and Accepted, with the acceptance numbers CXSL2500001, CXSL2500002, and CXSL2500003.
1、RSV Vaccine
RSV is a common respiratory virus, estimated to cause over 3 million hospitalizations and more than 26,000 deaths annually worldwide. Vulnerable populations include children under the age of 5, adults aged 65 and above, immunocompromised patients, and those with lung or heart diseases. It can be said that the core expectations for the RSV vaccine market are supported by two high-risk susceptible groups: infants and the elderly.
Currently, there are three RSV vaccines available on the market globally: GSK's Arexvy, Pfizer's Abrysvo, and Moderna's mRNA-1345. In June 2024, due to the U.S. Centers for Disease Control and Prevention (CDC) adjusting the recommended age group for vaccination — from 60 years old to 75 years old, with the 60-74 age group limited to high-risk populations, it led to...RSV Vaccine Market Faces Some Resistance in Penetrating the Elderly PopulationRecently, the FDA disclosed an "imbalance of severe RSV infections",Moderna Suspends Infant and Toddler Studies for Two mRNA Vaccines, Partially Halts Research on Other Non-Live Attenuated Vaccines for Infants and ToddlersIt can be seen that there are still some challenges in the RSV vaccine research and development and commercialization.
As for the Chinese market, there are currently many players in this track, and the number is increasing.According to incomplete statistics from PharmaTime, more than 30 companies in China have already laid out plans for RSV vaccines, and an increasing number of companies are entering the clinical research stage.. Among them, except forYidao BioIn addition, there areMaikang Bio, Pano Biotech, GenovacIt is also a recombinant Respiratory Syncytial Virus vaccine (CHO cell) developed by Yidao Biotechnology (Suzhou) Co., Ltd.
2. Herpes Zoster Vaccine
The herpes zoster vaccine is a globally significant vaccine product. In 2023, GSK's herpes zoster vaccine Shingrix (recombinant zoster vaccine) achieved global sales of £3.446 billion, approximately US$4.286 billion, representing a 17% year-on-year increase. However, in the third quarter of 2024, Shingrix’s sales fell by 10% to £739 million (US$956 million), which was 13% lower than analysts' expectations. Meanwhile, to address challenges in the Chinese vaccine market, in December 2024, ZF Bio announced an update regarding the optimization and adjustment of its strategic cooperation with GSK. Both parties extended their partnership for the herpes zoster vaccine (Shingrix) — from the end of 2026 to the end of 2034 — albeit with a reduction in supply volume. The estimated procurement amount is approximately 21.6 billion yuan.
According to incomplete statistics from PharmaTime,Currently, nearly 30 companies in China have already laid out plans for the shingles vaccine.. Among them, except forAbogen, LayoutHerpes Zoster mRNAVaccine companies also includeJiachen Xihai,Abogen, Ruiji Biotech, Yidao Biotechnology(Suzhou) Co., Ltd./Hangzhou Tianlong Pharmaceutical, Sinovac Life Sciences, CSPC Pharmaceutical Group, Amgen VaccinesAndKanghua Biotech。
Back to Abogen, it is worth noting that on May 11, 2020, Abogen and Walvax signed respective "Technology Development Cooperation Agreements" for two vaccine products in order to jointly promote the technology, product development, and later commercialization of mRNA-based COVID-19 vaccines and shingles vaccines. According to the agreement, after the approval and market launch of the shingles mRNA vaccine, Walvax would cumulatively pay Abogen a total of RMB 110 million in research and development and clinical milestone fees. However, this cooperation eventually ended in a "breakup." On June 25, 2024, Walvax issued an announcement stating that both parties decided to terminate the technology development cooperation for the COVID-19 mRNA vaccine and the shingles mRNA vaccine, and signed the "Termination Agreement."
