Chinese Vaccine Firm Walvax Biotech Secures Gates Foundation Grant for 9-Valent HPV Vaccine and Makes Inroads into U.S. Market

VCBeat (WeChat ID: vcbeat) has learned that on the evening of November 6, Walvax Biotechnology (Stock Code: 300142) announced that its controlling subsidiary, Shanghai Zerun Biotechnology Co., Ltd., recently signed the “Funding Agreement for the Development of Walvax’s 9-Valent HPV Vaccine” with the Bill & Melinda Gates Foundation. This marks the second time one of Walvax’s products has received recognition and funding from the organization, following the $5 million in direct financial support provided by the Gates Foundation in 2015 for the research, development, and industrialization of Walvax’s bivalent HPV vaccine.

The funding agreement reveals that Shanghai Zerun has received a $2.5 million project grant from the Bill & Melinda Gates Foundation to accelerate the clinical development and industrialization of its recombinant human papillomavirus (HPV) nonavalent virus-like particle vaccine (Pichia pastoris), and to prepare for World Health Organization prequalification to facilitate bulk procurement by international organizations.

Currently, the four global vaccine production giants—GSK, Merck & Co., Sanofi, and Pfizer—collectively account for 90% of the global market. Among them, GSK holds approximately 24%, followed closely by Merck & Co. at 23%, while Sanofi and Pfizer hold 20% and 21.7%, respectively. The recent support from the Bill & Melinda Gates Foundation will significantly enhance the overseas visibility of Walvax Biotechnology’s products. Coupled with Walvax’s strong R&D and industrialization capabilities in the vaccine sector, industry experts believe that the company is poised to compete on the international stage alongside leading European and American vaccine enterprises.

The Bill & Melinda Gates Foundation’s first collaboration with a Chinese vaccine enterprise dates back to 2007.

Prior to 2007, China produced over one billion vaccine doses annually, yet none had received prequalification from the World Health Organization (WHO). In 2005, to gain WHO recognition, China National Biotec Group (CNBG) began preparing for the prequalification of its Japanese encephalitis vaccine. Starting in 2007, the Bill & Melinda Gates Foundation actively intervened to promote the certification of this vaccine, investing approximately US$40 million in total.

The Bill & Melinda Gates Foundation supports Chinese vaccine products primarily because comparable Japanese encephalitis vaccines produced abroad are prohibitively expensive, costing approximately USD 300 per dose. The Japanese encephalitis vaccine developed in China not only has a lower production cost but also demonstrates high efficacy, making it highly suitable for widespread use in developing countries. By obtaining WHO prequalification, the product has gained access to the international market, enabling procurement by United Nations agencies and other developing nations, thereby benefiting children in more low- and middle-income countries.

According to China Philanthropy Times, the Bill & Melinda Gates Foundation’s support for China’s vaccine industry is comprehensive.

First, in collaboration with drug regulatory authorities, we are working to improve the pharmaceutical regulatory system, elevate regulatory standards, and align norms and management practices with international standards. Second, against the backdrop of increasing product innovation in China, the Bill & Melinda Gates Foundation is helping to enhance the technical capabilities of the regulatory system and facilitate international exchanges, thereby accelerating the assessment of innovative products. Third, the Foundation has made substantial efforts in promoting regulatory cooperation between China and Africa as well as fostering international dialogue. In addition, the Foundation actively promotes domestic product innovation by guiding Chinese enterprises’ R&D and manufacturing capacities toward areas such as the fight against tuberculosis, HIV/AIDS, malaria, and neglected tropical diseases.

As a global philanthropic force, in addition to collaborating with CNBG and its subsidiaries, the Bill & Melinda Gates Foundation has partnered with Walvax, making it the second Chinese enterprise and the only private Chinese vaccine manufacturer to work with the Foundation. The Gates Foundation’s support for Walvax extends beyond vaccine procurement, accelerating and enhancing Walvax’s capacity to obtain World Health Organization prequalification.

The so-called WHO Prequalification (PQ) is a United Nations initiative launched in 2001. In simple terms, the World Health Organization’s prequalification is a system that evaluates pharmaceuticals and diagnostic products against international standards for quality, safety, and performance. Once a product receives WHO prequalification, UN agencies, relevant countries, and international organizations can use this certification as a basis for procurement. Therefore, obtaining WHO prequalification is a crucial step for pharmaceutical products to access the global market. The Bill & Melinda Gates Foundation has played an instrumental role in helping Chinese vaccines achieve WHO prequalification.

To date, China has successfully passed two consecutive WHO evaluations in 2011 and 2014. Four Chinese vaccine products have obtained WHO prequalification, been included in the international procurement list, and are exported to more than ten countries and regions. These include the live attenuated Japanese encephalitis vaccine produced by Chengdu Institute of Biological Products under China National Biotec Group (CNBG), the influenza vaccine produced by Hualan Biological Engineering Inc., the inactivated hepatitis A vaccine “Healive” produced by Sinovac Biotech Ltd., and the bivalent oral polio vaccine (bOPV) produced by Beijing Institute of Biological Products under CNBG. In addition, more than 20 Chinese vaccine products are currently undergoing or intend to apply for WHO prequalification.

Certainly, for China’s vaccine industry to expand globally, the financial cost of obtaining WHO prequalification represents a significant barrier. Previously, a Chinese Japanese encephalitis vaccine required nine years and an investment of up to $40 million to secure WHO prequalification and enter the international market. The Bill & Melinda Gates Foundation provided funding to Walvax Biotechnology to help its vaccine achieve WHO prequalification, thereby sharing part of the certification costs with the company.

On the policy front, at the press conference held by the Standing Committee of the National People’s Congress on June 29, Jiao Hong, Commissioner of the National Medical Products Administration (NMPA), stated that certain Chinese vaccine products have been included in international procurement lists and exported to countries along the Belt and Road Initiative, thereby contributing to safeguarding global public health. Article 98 of the Vaccine Administration Law stipulates that the state encourages vaccine manufacturers to produce and export vaccines in accordance with international procurement requirements. The inclusion of the term “encourage” in the Vaccine Administration Law may signal that future fiscal allocations will provide subsidies for products that have already obtained WHO prequalification.

In 2018, Walvax had already secured procurement contracts from eight countries, including the United States, Indonesia, Egypt, Bangladesh, the Philippines, Kyrgyzstan, Guinea, and Nigeria. From 2016 to 2018, its international sales achieved a compound annual growth rate (CAGR) of 372.65%. In Egypt alone, Walvax obtained import approval from the Ministry of Health for 7.8 million doses of Group A and Group C Meningococcal Polysaccharide Vaccine, along with corresponding purchase orders.

It is worth noting that Walvax is currently the only Chinese enterprise exporting vaccine bulk drug substances to the United States, and the first private company in China’s vaccine industry whose products have been included in foreign governments’ national immunization programs. As the saying goes, “Courtesy demands reciprocity.” While we have previously imported a large volume of vaccines from the United States, Chinese-made vaccine bulk drug substances are now being exported to the U.S., signaling that the day when Americans will use Chinese vaccines is not far off. Walvax has quietly served as a footnote to the vision of “strengthening the nation through science and technology.”

It is understood that Yuxi Walvax is likely to become a long-term cooperative supplier for the bulk vaccine procurement, and may receive more purchase orders in the future, or both parties may engage in deeper cooperation across multiple areas.

As Walvax accelerates its internationalization, more of its vaccine products are expected to obtain WHO prequalification, gradually unlocking vast international markets, including the United States. Walvax vaccines are poised to become a hallmark of Chinese vaccines and even Chinese biological products on the global stage.