Recently, the Equipment Review Center of the National Medical Products Administration released the results of the priority approval application for medical devices (No. 16 of 2024), and the product of Beijing Wantai Biopharmaceutical Co., Ltd. (hereinafter referred to as Wantai Bio) - Human Immunodeficiency Virus 1+2 Urine Anti physical Examination Test Kit (Colloidal Gold Method) has entered the priority approval green channel.

It is worth mentioning that this product belongs to the category of "medical devices listed in the National Science and Technology Major Special Project".

Layout HIV testing
Since the Joint United Nations Programme on AIDS (UNAIDS) put forward the "90-90-90" HIV prevention and control goal in 2013, it aims to end the AIDS epidemic in the world by 2030. WHO strongly recommends that countries carry out routine HIV testing and promote HIV self inspection as a supplement to routine HIV testing, so as to jointly realize the first 90:90% of HIV infected people will know their HIV status.

Turning to China, according to the 9th National AIDS Academic Conference, by the end of 2023, 1.29 million people living with AIDS virus and AIDS were reported nationwide, and 110500 new AIDS patients were reported in 2023 alone.

According to the IQVIA report, it is expected that the actual number of infections will exceed 2 million by 2027. According to the CDC, only 68% of patients were aware of this in 2018, and only 78.7% of HIV infected individuals were detected in 2021. Based on this situation, the National Health Service clearly proposed the goal of "more than 90% of the infected people who have been diagnosed and know their own infection status", encouraged the promotion of self testing, and specifically proposed in the 13th Five Year Plan to explore ways to carry out AIDS self testing through pharmacies, online sales of testing reagents and other means.

On the occasion of World AIDS Day on December 1, the latest test kit of Wantai Biology - Human Immunodeficiency Virus 1+2 Urine Antibody Test Kit (colloidal gold method) entered the priority approval channel for medical devices.

It is worth mentioning that Wantai Biology's layout for HIV testing began many years ago. In 2000, China's first third-generation HIV antibody testing reagent was launched; In 2008, China's first fourth generation HIV antigen antibody testing reagent was launched; In 2012, China's first HIV RIBA reagent was launched; In 2014, a major project "Research on Early Diagnosis and Treatment of High Risk AIDS Populations" was established; In 2019, the world's first rapid urine test for HIV was launched.

From the third-generation product to the world's first rapid urine based HIV detection reagent product, Wantai Biotechnology's product iteration in this area has covered multiple platforms such as enzyme-linked immunosorbent assay, colloidal gold, and molecular testing, with a complete range of types.

Multi domain research and development at the forefront of the world
In addition to HIV testing, Wantai Biology's diagnosis and prevention in multiple fields are also at the forefront of the world.

The most famous one is also the HPV vaccine from Wantai Biotechnology. In May 2020, Wantai Biotechnology launched the first bivalent HPV vaccine in China, which was extremely popular and its market value exceeded 180 billion yuan in 2021. Although the popularity of HPV vaccines has gradually cooled down, Wantai Biotech is also actively seeking supplements.

On November 18th, Wantai Biotechnology announced that its wholly-owned subsidiary Wantai Canghai Biotechnology had received a "Drug Clinical Trial Notice" issued by the National Medical Products Administration, agreeing to conduct clinical trials of the company's nine valent human papillomavirus vaccine (Escherichia coli) for indications in the male population.

In addition, Wantai Biotechnology has also excelled in the research and development of hepatitis E virus. Hepatitis E virus (HEV) infection is the most common cause of acute viral hepatitis worldwide, and chronic HEV infection can rapidly progress to cirrhosis, ultimately leading to liver failure and severe extrahepatic manifestations. It is worth noting that China is an epidemic area for hepatitis E virus infection. Since 2012, the reported incidence of hepatitis E has exceeded that of hepatitis A for 9 consecutive years, and the mortality rate has exceeded that of hepatitis A for 15 consecutive years. It is one of the main diseases of acute viral hepatitis in adults in China.

In 2012, Wantai Biotechnology developed the recombinant hepatitis E vaccine "Yikening". As the only hepatitis E vaccine on the market worldwide, it has been proven safe, immunogenic, and effective in clinical trials for over 100000 adults.

Moreover, two hepatitis E virus antigen urine detection kits (colloidal gold method and fluorescence immunoassay) from Wantai Biotechnology have also been approved for market by the National Medical Products Administration, becoming the world's first hepatitis E diagnostic kits targeting urine antigens, filling the gap in related products and technologies.

Conclusion
With the support of policies and the promotion of continuous technological development, the "gold content" of domestic medical devices is increasing. Domestic medical devices in more fields in China are also continuously shining, and the degree of independent innovation of local medical devices is also constantly improving.

Source: https://news.yaozh.com/archive/44624.html