Source of this article: time Finance author: Li Aohua

Wuxi Biologics (02269.HK) and AstraZeneca PLC reached a strategic cooperation on the local production of COVID-19 's neutralizing antibody combination drug Evusheld. Wuxi Biologics announced the above information on August 4.

Enshi is a combined therapy composed of two kinds of McAbs, namely, tetracycline and cigavir, which can bind to different sites on novel coronavirus's spike protein by simulating the natural antibody defense mechanism of the human body. reduce the ability of the virus to enter and infect human cells, so as to achieve the preventive effect.

In 2021, Enshi obtained the Emergency use Authorization (EUA) of the US Food and Drug Administration (FDA), and in 2022 it was approved to be listed in the European Union, Canada and other places.

On July 4 this year, the Boao Le City International Medical Tourism pilot Zone in Hainan (hereinafter referred to as "Boao Le City") announced that Enshi has passed special import approval in Boao Le City, which is suitable for pre-exposure prevention of novel coronavirus in adults and teenagers (age ≥ 12 years old and weight ≥ 40 kg). The next day, Haikou Customs said that Boao Airport Customs, which belongs to Haikou Customs, had completed the examination and approval of entry special items for the first time imported from the mainland, with a total value of 21.9802 million yuan.

After Enshi landed in Boao Le City, related concept stocks rose one after another, and the market was eager to dig out Enshi's partners in China, but before Wuxi Biologics, AstraZeneca PLC had never disclosed Enshi's agents or manufacturers in China. Companies that have been boosted by Enshi news, including 002589.SZ and 002793.SZ, have also clarified one after another that they have not signed cooperation with AstraZeneca PLC.

After all parties' speculation was dashed one after another, Wuxi Biologics became the first gracious Chinese partner in AstraZeneca PLC's "official declaration", a genuine "Enshi concept stock". On August 4, Wuxi Biologics closed at HK $74.85 per share, up 4.32%, with a total market capitalization of HK $319.1 billion.

The appointment is hot when it is suitable.

According to the results of the phase 3 prevention clinical trial of Enshi, when the median follow-up days was 83 days, compared with the placebo group, Enshi reduced the risk of symptomatic COVID-19 infection by 76.7%; when the median follow-up days was 196 days, compared with placebo, Enshi reduced the risk of symptomatic infection by 82.8%.

After being approved for import, Enshi landed at Ruijin Hainan Hospital and Boao Super Hospital. The drug requires an one-time intramuscular injection in two different parts, which is priced at 13300 yuan and cannot be reimbursed by health insurance.

Although the price is not cheap, Enshi still made a hot reservation after landing in Boao Le City. According to China Business report, three weeks after it was put into use, more than 100 people received Enshi medicine, mainly young people and the elderly, especially young people with the need to study abroad.

Time Finance, as a consultant, called Boao Super Hospital and Ruijin Hainan Hospital respectively. The relevant staff of Boao Super Hospital said that at present, the reservation for Enshi is full, and the reservation can not be reopened until the next batch of injections arrives, but it is impossible to predict the arrival date of the next batch. On the other hand, Ruijin Hainan Hospital told time Finance that recently, you can make an appointment with Enshi, and "you can play tomorrow at the earliest."

Although it also has preventive effect, it does not mean that the new crown neutralizing antibody drug can replace COVID-19 vaccine.

Luo Yongqing, president and general manager of 02137.HK and CEO of Tengsheng Huachuang, once told time Finance that COVID-19 neutralizing antibody can not replace the role of COVID-19 vaccine, the two are complementary. Vaccination is active immunity, but no vaccine in the world can 100% prevent the invasion of the virus. for people who are older or have weak immunity such as underlying diseases, the immune response may be weak. the antibodies produced are not enough to protect them from the virus, so direct injection of antibodies can provide better protection for them. Tengsheng Huachuang's long-acting neutralizing antibody combination therapy of ambavirin and romisovir is the first domestic new crown neutralizing antibody therapy, which was commercialized in China in July this year.

The above staff of Ruijin Hainan Hospital told time Finance: "the first choice for healthy people is vaccination, but if you need to go abroad and other reasons, you can also make an appointment here."

Some people in the industry have pointed out to time Finance that the cost is also one of the reasons why the new crown neutralization antibody therapy can not replace the COVID-19 vaccine, and the high price makes it difficult for it to become a means of large-scale prevention.

COVID-19 's battle for preventive indications

Enshi is the only COVID-19 drug that has been approved for COVID-19 's preventive indications so far. Previously, the new crown neutralization antibody Casirivimab/imdevimab developed by Regenerative Yuan and the Bamlanivimab/Etesevimab developed by Eli Lilly and Co have also been approved for post-exposure prevention indications, but the above two new crown neutralization antibodies have been suspended because they are ineffective to Omicron.

However, the research and development enterprises of COVID-19 neutralization antibody therapy have not stopped exploring the indications of prevention.

"many neutralizing antibody research enterprises are also conducting research on the use of neutralizing antibodies for prevention. If this research is successful, the market scale of neutralizing antibodies is expected to further expand." Zhao Bing, head of Huaxing Securities Research Institute and chief analyst of the pharmaceutical industry, said in an interview with the media.

Luo Yongqing once told time that the combination therapy of ambavirin and romisovir developed by Tengshengbo also has plans to develop indications for pre-exposure prevention or post-exposure prevention in the future.

Small molecular oral drugs also regard preventive indications as the next hot spot for research and development.

On April 29th, Pfizer Inc announced that a post-exposure prevention study of COVID-19 small molecule oral drug Paxlovid developed by novel coronavirus failed. The results showed that the effect of Paxlovid in preventing novel coronavirus infection was not statistically significant.

As the "big brother" of COVID-19 's oral medicine industry, Paxlovid's failure in the research and development of preventive indications can not stop the R & D enthusiasm of other enterprises.

On May 13th, 02096.HK announced that SIM0417, a candidate drug against novel coronavirus in cooperation with Shanghai Institute of Medicine and Wuhan Institute of virus of the Chinese Academy of Sciences, has obtained a notice of clinical trial approval issued by the Drug Administration, which is intended to be used for post-exposure prevention and treatment of people who have been exposed to COVID-19-positive people. This is the first new crown candidate for post-exposure prophylaxis that has officially entered the clinical trial stage in China.