Nine-valent HPV "one seedling is difficult to find" spawned scalpers with a monthly income of tens of thousands, and when domestic production can be replaced

On December 28, some media reported that the import of nine-valent HPV "one seedling is difficult to find" gave birth to rampant scalpers, and there are technical agents to grab tens of thousands of yuan per month. Since the imported nine-valent HPV vaccine was approved for listing in China in April 2018, it has been in short supply for a long time, and when can the domestic nine-valent vaccine be replaced?

Human papillomavirus (i.e., "HPV") is the most common pathogen of diseases of the reproductive system, and although most HPV infections may disappear within a few months without any intervention, some infections may persist and develop into cervical cancer. According to the different pathogenic risks of HPV subtypes, it can be divided into two categories: low-risk type and high-risk type, high-risk HPV infection is mainly caused by type 16, type 18, type 31, type 33, type 45, type 52 and type 58 HPV, which leads to about 90% of cervical cancer cases worldwide, of which HPV 16 and 18 cause 70% of cervical cancer cases worldwide.

At present, there are four HPV vaccines approved for marketing in China, namely two bivalent, one quadrivalent and one nine-valent, which can prevent the diseases caused by HPV16 and 18 subtypes of HPV infection.

However, the higher the price of HPV vaccines, the more diseases caused by subtypes of HPV infection can be covered, of which the nine-valent HPV vaccine generally provides comprehensive protection against about 90% of cervical cancer cases and is widely considered to be the most effective vaccine against HPV. The approved nine-valent HPV vaccine in China is suitable for women aged 16 to 26, the manufacturer of the vaccine is the multinational pharmaceutical company Merck, and the agent is the Chinese company Zhifei Bio (300122.SZ).

As for the reasons why the nine-valent vaccine has not expanded production for a short time, Merck has said that the company's HPV vaccine supply is affected by factors such as the complexity of production, the four-year production cycle, the indispensable strict quality control, and major infrastructure investment.

Frost & Sullivan believes that China's HPV vaccine market has great potential and is expected to grow rapidly in the next few years, the vaccine market size will increase to 13.1 billion yuan in 2020, and it is expected to reach 69 billion yuan by 2030, with a compound annual growth rate of 18.0% from 2020 to 2030, of which HPV nine-valent vaccine will have the largest market share in the HPV vaccine market in 2030.

In the face of the considerable market prospects of the nine-valent HPV vaccine, a number of local companies in China are working intensively to develop related HPV vaccines.

According to the incomplete statistics of the first financial reporter, at least Beijing Kangle Guardian Biotechnology Co., Ltd., Wantai Biological (603392.SH), Shanghai Runze Biotechnology Co., Ltd., Shanghai Bowei Biotechnology Co., Ltd., Jiangsu Ruike Biotechnology Co., Ltd. these five enterprises are developing nine-valent HPV vaccines, of which, Beijing KangleGus Biotechnology Co., Ltd., Wantai Biological, Shanghai Bowei Biotechnology Co., Ltd., The nine-valent HPV vaccine candidate vaccine of Jiangsu Ruike Biotechnology Co., Ltd. of these four companies has entered the clinical phase III research and development stage.

Jiangsu Ruike Biotechnology Co., Ltd. said in a listing prospectus submitted to the Hong Kong Stock Exchange in July this year that the company is undergoing a phase III clinical trial of reconstituting the HPV nine-valent candidate vaccine REC603, which is expected to recruit more than 15,000 subjects, plans to complete the recruitment of subjects in 2021, and plans to complete three injections of drug vaccination in the first half of 2022. The company also said it plans to submit a marketing application for the vaccine to the State Food and Drug Administration in 2025.

At the same time, some companies have been preparing for the industrial production of nine-valent HPV vaccines in advance, such as Wantai Bio issued a refinancing plan in October this year, planning to raise 3.5 billion yuan, with the purpose of building four major projects such as the second phase of the nine-valent HPV vaccine expansion.