Author: Lin Zhiyin

  In order to improve the early identification and standard diagnosis and treatment of monkeypox by clinicians, on the morning of June 15, the National Health and Health Commission officially released the "Guidelines for the Diagnosis and Treatment of Monkeypox (2022 Edition)" (hereinafter referred to as the "Guidelines for Diagnosis and Treatment"), which mentioned Nucleic acid testing is one of the laboratory tests.

However, no monkeypox nucleic acid detection reagent has been approved for marketing in my country. How should relevant reagent companies respond?

  Monkeypox is a zoonotic viral disease caused by Monkeypox virus (MPXV) infection, and its clinical manifestations are fever, rash, and lymphadenopathy.

The disease is mainly endemic in Central and West Africa, and since May 2022, monkeypox cases and community transmission have also been reported in some non-endemic countries.

  The diagnosis and treatment guidelines show that the laboratory examination of monkeypox includes general examination and etiological examination. Among them, the etiological examination includes nucleic acid detection and virus culture. Monkeypox virus nucleic acid can be detected in nasopharyngeal secretions and other specimens; the latter can be isolated from monkeypox virus by collecting the above-mentioned specimens for virus culture, and virus culture should be carried out in a biosafety laboratory of level 3 or above.

  Diagnosis and treatment guidelines show that the diagnostic criteria for confirmed cases of monkeypox are suspected cases and positive monkeypox virus nucleic acid test or cultured isolation of monkeypox virus.

For cases that meet the criteria for suspected or confirmed cases, infectious disease reporting should be made in accordance with relevant requirements.

  Up to now, including Wanfu Bio (300482.SZ), Zhijiang Bio (688317.SH), Shengxiang Bio (688289.SH), Daan Gene (002030.SZ), Antu Bio (603658.SH), Companies such as Lepu Diagnostics announced that they have developed monkeypox nucleic acid reagents, but the products of these companies are mainly registered and listed overseas, and many companies have obtained EU CE access.

The choice of these companies to take the lead in listing overseas is also related to the local spread of monkeypox virus.

  No imported cases of monkeypox have been found in my country, but many researchers have called for more attention to monitoring and early warning of the virus.

  At the recent 14th China Bio-Industry Conference, Zheng Haifa, vice chairman of Shenzhen Kangtai Biological Products Co., Ltd., told the first financial reporter and other people present that the monkeypox virus is in the process of mutation, and some mutations found so far suggest that the virus It may be developing in the direction of higher infectivity. From the perspective of the basic infection number RO, in the 1980s, due to the smallpox vaccine immunity, the population immunity was greater than 80%, and the RO of the monkeypox virus was much less than 1; in 2012, the smallpox vaccine was immune. The degree of immunity is about 60%, and the RO of monkeypox virus is slightly less than 1; at present, the degree of immunity of smallpox vaccine is about 20%, and the RO of monkeypox virus is greater than 1, which also indicates that monkeypox still has a trend of large-scale epidemics.

In general, monkeypox is still relatively harmful, and some preventive measures should be taken as soon as possible.

  On June 15, the relevant person in charge of Shengxiang Bio told the first financial reporter that there is currently no registration channel for monkeypox nucleic acid detection reagents in China. If the registration channel is opened, the company does not rule out applying for relevant nucleic acid reagents to be listed in China .

  At the same time, Wanfu Bio’s board secretary Hu Hong also replied to the first financial reporter, saying that since the monkeypox diagnosis and treatment guidelines have just been released, the company has not yet promoted the progress of the monkeypox nucleic acid detection reagent in the domestic market, but it does not rule out that it will be promoted in the future. .