Priority introduction and price exposure, the new crown neutralizing antibody welcomes the highlight moment?

In 2021, the annual revenue of Regeneron and Eli Lilly's new crown neutralizing antibodies will reach 574 billion US dollars and 239 billion US dollars respective.

Recently, the new crown neutralizing antibody therapy has received good news one after anoth.

1

New crown neutralizing antibody landing application

The domestic price is around 10,000 yuan

On July 8, 2022, the price of the neutralizing antibody Evusheld (Enshide) developed by AstraZeneca was exposed in Chi.

The drug is not currently on the market in China, but according to the relevant policies of the "Nine Articles of the State", Evusheld can be used in the Hainan Boao Lecheng International Medical Tourism Pilot Zo.

According to relevant regulations, the approved products are limited to the use of relevant hospitals in the Boao area, and are not equivalent to "imported listings" that can be sold nationwi.

The data shows that Evusheld consists of two fully human long-acting monoclonal antibodies (tixagevimab + cilgavimab), which can mimic the human body's natural antibody defense mechanism and reduce virus entry and infection by binding to different sites on the new coronavirus spike prote.

The two antibodies were first discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 202 In December 2021, Evusheld's emergency use authorization application was approved by the FDA for pre-exposure prophylaxis against SARS-CoV-2, becoming the first FDA-approved antibody therapy for pre-exposure prophylaxis against the novel coronavir.

After AstraZeneca Evusheld was used in China, it was revealed in the industry that Ruikang Pharmaceutical had obtained Evusheld's agent in mainland China, but it was not the only age.

Coincidentally, on July 7, Tengsheng Biopharma announced that its holding company Tengsheng Huachuang’s long-acting new crown neutralizing antibody, the combination therapy of ambavirumab and romisevirumab, was commercialized in Chi.

As early as December 2021, the combination therapy of ambavirumab and romisevirumab was approved by the State Food and Drug Administration for the treatment of mild and common types with progression to severe (including hospitalization or death) high Risk factors for adults and adolescents (12-17 years, weighing ≥40 kg) with novel coronavirus infection (COVID-1

In March 2022, the combination therapy was approved by the National Health Commission to be included in the "New Coronary Virus Pneumonia Diagnosis and Treatment Program (Trial Version 9)"; The scope of payment of the provincial medical insurance fu.

On July 8, Tengsheng Biopharma held an online media communication meeti.

Affected by the good news, the share price of Tengsheng Boyao has risen for two consecutive days, with a cumulative increase of 22% on the 2nd, closing at HK$100 per share, with a total market value of HK$95 billi.

       It is worth noting that at this stage, the price of neutralizing antibodies for the new crown in the United States is about 2,000 US dollars per course of treatment, and the price of neutralizing antibody therapy for the new crown in China is relatively l.

       2

       New crown neutralizing antibodies that were once "restricted" are about to become popular again?

       As the strains of COVID-19 continue to mutate, the prospects for COVID-19 antibody therapies are also ble.

       Moreover, the neutralizing antibody products of many pharmaceutical companies such as Eli Lilly, Regeneron, and GlaxoSmithKline that have already been on the market have been suspended or restricted for regional use due to their ineffectiveness against mutant strains——

       In January 2022, the FDA announced emergency use authorizations for Junshi and Eli Lilly's etesevimab and bamlanivimab diabodies, and Regeneron's casirivimab and imdevimab diabodies Modifications were made to restrict use only to mutant strains susceptible to these neutralizing antibodi.

       In April 2022, the FDA announced the cancellation of the authorization of sotrovimab in the United States due to data showing that GlaxoSmithKline and Vir Biotechnology's new crown antibody therapy sotrovimab is unlikely to be effective against the main US variant Omicron .

       Before a lot of new crown oral drugs have been approved, what are the advantages behind the use of the two neutralizing antibodies?

       According to preclinical real "live" virus data at the University of Washington School of Medicine, Evusheld has potent neutralizing activity against major epidemic strains, including Omicr.

According to the Boao Lecheng Pioneer District, Evusheld is preferentially suitable for the prevention of new coronavirus infection in people with impaired immune function or low immunity, such as tumor patients undergoing chemotherapy, organ transplant patients, and dialysis patien.

At the same time, Evusheld can also be used for people who are ineffective in using the new crown vaccine and need additional protection outside the vacci.

       On the other hand, Tengshengbo Pharmaceutical also mentioned in the announcement that ambavirumab/romisevirumab can reduce the risk of hospitalization and death of new crown patients by 8
All mutants of interest retained neutralizing activi.

       Since its approval for listing, the company has donated nearly 3,000 doses of ambavirumab/romisevirumab to 22 hospitals in 21 cities in China for the clinical treatment of patients with COVID-1

       At the online media communication meeting on the 8th, Tengsheng Boyao further disclosed the data conclusion that its new crown neutralizing antibody may still be effective against Omicron variant .

4 and .

       However, the neutralizing antibodies for the new crown that have been approved in China are still used for treatment, and there is no one for pre-exposure prophylax.

In this regard, Tengsheng Boyao said that the company is actively promoting the approval of combination therapy as a preventive dr.

       3

       New crown neutralizing antibody research and development is hot

       More than 30 domestic enterprises are deployed

       According to incomplete statistics, there are 7 types of COVID-19 neutralizing antibody therapies on the market globally, namely Casirizumab + Idezumab from Roche and Regeneron, and Atelizumab + Banivirumab from Eli Lil.

As well as bebtelovimab, GSK/Vir's sotrovimab, AstraZeneca's Evusheld (tixagevimab + cilgavimab), Inhalon Biopharma/Celltrion's regdanvimab, and Tengsheng Biopharma's ambavirumab/romisevirumab combination thera.

       Among them, sotrovimab, casirizumab + idelizumab, eltemirumab + banivirumab, tixagevimab + cilgavimab, and bebtelovimab have been approved by the US E.

       In addition, according to the data of Southwest Securities in January 2022, there are 12 projects in the global new crown neutralizing antibody in Phase III clinical and Phase II/III clinical projec.

In the first three quarters of 2021, COVID-19 neutralizing antibodies generated a total of $6 billion in sal.

The United States quickly brought effective neutralizing antibodies to the market through EUA, and is currently the country with the largest amount of neutralizing antibodies in the wor.

At present, the number of neutralizing antibodies distributed in the United States is about 100,000 per we.

       From mid-September to mid-to-late December, a total of 665 million neutralizing antibodies were distribut.

Regeneron/Roche, Eli Lilly/Junshi, and GSK/Vir share the market, of which Regeneron/Roche has the largest sales volume, accounting for nearly 60% of the overall market, followed by Lilly/Juns.

       Judging from the research and development of COVID-19 neutralizing antibodies by domestic companies, Junshi Bio's ectelizumab lisence out to Eli Lilly has already contributed revenue in 202 In 2021, Junshi's technology license and franchise revenue from Eli Lilly will be approximately 365 billion yuan, exceeding 50% of the total annual sal.

In 2021, Eli Lilly's new crown antibody combination therapy sales will be $239 billi.

       Tengsheng Biopharma's neutralizing antibody cocktail therapy was approved for marketing in China on December 8, 2021, and is the first domestically marketed neutralizing antibody therapy for COVID-1 The new crown neutralizing antibodies of Maiwei Bio and Shenzhou Cell are in Phase II/III clinical tria.

In addition, the BGB-DXP593 of BeiGene and Danxu Biology is in the phase II clinical trial of the international multi-center, and the DXP-604 is in the phase I clinical tri.

       There are about 30 COVID-19 neutralizing antibodies in China that are in the early stage of research before Phase II clinical trials, of which 3 are in Phase II and Phase I/II clinical trials, 4 are in Phase I clinical trials, and the others are all pre-clinic.

From the perspective of antibody technology, most of them are monoclonal antibodies, and 2 are double antibodies, namely 89C8-ACE2 (anti-SARS-CoV-2 S protein/ACE2 bispecific antibody) of Pumis and BAT2022 (anti-SARS-CoV-2) of Bio-Te.

SARS-CoV-2 bispecific antibod.

       It can be seen that the research and development of new crown neutralizing antibody therapy is crowded together, and there are not many companies entering the market around the wor.

The constant mutation of the new coronavirus has also brought many uncertainties to the promising new crown neutralizing antibody therapy, but the market has not yet been filled with needs, such as prevention, as well as the treatment and application of mutants, e.

As one of the effective supplementary measures for the prevention and treatment of new coronary pneumon.