Walvax BioTech

Walvax Biotechnology announced on the evening of September 10 that its wholly owned subsidiary, Yuxi Walvax Biotechnology, received the Drug Registration Certificate for the COVID-19 mRNA Vaccine approved and issued by the National Medical Products Administration that day. The vaccine is the company's third-generation COVID-19 mRNA vaccine iteratively developed on its mRNA platform technology, with the antigen sequence designed based on the S protein of the Omicron JN.1 strain, for use in people aged 18 and above to prevent disease caused by SARS-CoV-2 infection. The announcement showed that the company's previously developed first-generation COVID-19 variant vaccine with an S protein chimera and the second-generation iterative vaccine targeting the Omicron XBB.1.5 variant jointly validated the mRNA platform technology. Following the approval of this vaccine, research and development and drug registration work related to the first- and second-generation vaccines concluded simultaneously. Citing data, the announcement said global sales of mRNA COVID-19 vaccines exceeded 6 billion US dollars in 2025, and the company stated that the approval of this vaccine is not expected to have a significant impact on this year's performance.

Moderna and Merck announced preliminary positive results from the Phase III clinical trial of their mRNA personalized cancer vaccine, intismeran autogene, igniting the A-share pharmaceutical sector. On the morning of August 20, multiple vaccine stocks including Baike Biotech, Walvax Biotechnology, CanSino Biologics, Kanghua Biologics, Laimei Pharmaceutical, and Novoprotein hit the 20% daily limit, while Hong Kong-listed CanSino Biologics and Everest Medicines surged over 50% intraday. The vaccine, combined with Keytruda, was used as adjuvant therapy in more than 1,100 high-risk melanoma patients after complete surgical resection, achieving key endpoints of recurrence-free survival and reduced risk of distant metastasis. Following the announcement, Moderna's stock price soared nearly 180%, while Merck's rose over 12%.

Walvax Biotechnology has released a revised draft of its 2026 A-share private placement plan, proposing to raise up to 2.203 billion yuan from Beijing Tengyun Xinwo Biotechnology Partnership. The proceeds will be used entirely to replenish working capital. Upon completion of the issuance, Tengyun Xinwo will hold an 11.51% stake in the company, and together with parties acting in concert with its ultimate controller, the combined shareholding will reach 14.46%. Tengyun Xinwo will nominate more than half of the board members, becoming the controlling shareholder, and its ultimate controller Huang Tao will become the company's ultimate controller. Previously, the company had a dispersed ownership structure with no controlling shareholder. Tengyun Xinwo was established on February 12, 2026, and has not yet commenced business operations. The company's cumulative cash dividends from 2023 to 2025 amounted to 352 million yuan, representing 142.87% of the average annual net profit attributable to the parent over the past three years. In 2025, the company reported revenue of 2.418 billion yuan, down 14.29% year-on-year, while net profit attributable to the parent rose 25.03% to 177.7 million yuan. As of the end of 2025, the company's cash and cash equivalents stood at 1.353 billion yuan, a significant decrease from 4.365 billion yuan at the end of 2023.

The bivalent human papillomavirus vaccine produced by Walvax Biotechnology subsidiary Yuxi Zerun Biotechnology has recently obtained a Drug Registration Certificate from the Tanzania Medicines and Medical Devices Authority, marking the vaccine's marketing authorization in Tanzania. This bivalent HPV vaccine is primarily used to prevent diseases caused by high-risk HPV types 16 and 18, such as cervical cancer. In the first quarter of 2026, Walvax Biotechnology achieved revenue of 444 million yuan and a net profit attributable to the parent company of 111 million yuan.

The global HPV vaccines market is projected to grow from $8.9 billion in 2025 to $18.4 billion by 2034, at a compound annual growth rate of approximately 8%, according to a report by DelveInsight. North America held the largest share in 2025, contributing about 41% of total market revenue, driven by strong awareness, CDC recommendations, and widespread use of advanced vaccines like Gardasil 9. Key companies in the market include GlaxoSmithKline, Xiamen Innovax, Walvax Biotechnology, Merck & Co., and Serum Institute of India. Growth is fueled by rising HPV-related cancer prevalence, expanding national immunization programs, the WHO’s cervical cancer elimination strategy, and the introduction of nonavalent vaccines offering broader protection. Recent developments include Merck presenting long-term effectiveness data for GARDASIL 9 and GARDASIL at the EUROGIN 2026 congress, and China’s NMPA approving Cecolin 9, the first HPV 9-valent vaccine from a developing country.