"Pong Shang" new crown oral drugs, China Resources Shuanghe, Xinhua Pharmaceutical and other collective daily limit!

China Resources Shuanghe and Xinhua Pharma have daily limit after winning the new crown oral drug

The rumors are tr.

On the evening of May 8, China Resources Shuanghe announced that the company and Real Biology signed the "Strategic Cooperation Agreement" and "Azvudine Tablet Entrusted Processing and Production Framework Agreement" in Beiji.

This news confirms the rumors of previous performan.

On May 10, China Resources Pharma also announced that China Resources Double-Crane signed a 10-year strategic cooperation agreement with Real Biology to expand cooperation in product research and development, production, distribution and various aspects and fields directly related to distribution; the two parties have signed According to the entrusted processing framework agreement, Real Bio owns the ownership of Azvudine tablets, applies for and obtains the drug registration certificate of the drug, is the holder of the marketing license, and has the right to produce (self-manufacture or commissioned production), release and se.

It is worth noting that on the evening of April 26, Xinhua Pharma issued an announcement stating that the company signed a "Strategic Cooperation Agreement" with Real Bio, and Real Bio agreed that the Azvudine and other products owned by Xinhua Pharmaceutical would be sold in China and by both parti.

On May 10, China Resources Shuanghe and Xinhua Pharmaceutical once again hit the daily lim.

Real Bio's new crown oral drugs were popular before approv.

On May 10, Tuoxin Pharmaceutical stated on the investor interaction platform that the construction of the Azvudine API project has received great attention from governments at all levels and relevant authorities, giving important guidance and strong support; the new production line At present, it has started operation and is gradually developing producti.

Relevant data show that Azvudine was originally a drug for the treatment of AI.

In July 2021, Azvudine received conditional marketing approval from the State Food and Drug Administration for use in combination with nucleoside reverse transcriptase inhibitors and non-nucleoside reverse transcriptase inhibitors to treat adults with high viral load HIV- 1 infected patien.

A randomized single-arm clinical trial showed that oral azvudine (5mg) cured patients with COVID-19 through its anti-SARS-CoV-2 activity concentrated in the thym.

According to the information on the conference call of real biological experts held by Pacific Medicine on March 24, the daily dosage of azvudine is 5 mg, and a course of treatment is 35 .

If listed, Azvudine's price would be significantly lower than Pfizer's Paxlov.

The market size may reach tens of billions of dollars! Merck, Pfizer lead the way

The outbreak of the new crown pneumonia epidemic in early 2020 has been more than two years, and the epidemic has not completely disappear.

The pathogen new coronavirus SAR-COV-2 continues to evolve and muta.

On November 24, 2021, South Africa reported the first case of Omicron variant infection to W.

After that, the original strain of Omicron (21K, .

1) gradually replaced Delta within 2 months to become the main circulating strain in the world, attracting global attenti.

Most confirmed cases of Omicron variant infection are asymptomatic or mild cas.

According to Northeast Securities, at present, the treatment drugs for new coronary pneumonia are mainly small-molecule oral drugs and neutralizing antibodi.

Neutralizing antibodies mainly target the S protein to function, while the mutations produced by the Omicron strain are mainly located in the S protein, so they can significantly escape the treatment of neutralizing antibodi.

It is worth noting that the neutralizing antibody products of many pharmaceutical companies such as Eli Lilly, Regeneron, and GlaxoSmithKline have been suspended or restricted for regional use due to their ineffectiveness against mutant strai.

New crown oral antiviral drugs generally function against viral enzyme structures (RdRp, 3CLpro, PLpro, e.

), and the probability of mutation at this position is low, so new crown oral drugs are less affected by new coronavirus mutatio.

A variety of new crown oral drugs have shown inhibitory activity against Omicron strains in vit.

Up to now, four anti-COVID-19 oral drugs have been approved for marketing/emergency use authorization in the world, namely Paxlovid from Pfizer, Molnupiravir from Merck & .

, VV116 from Junshi Bio/Suzhou Wangshan Wangshui, and Proclutamide from Kint.

Several drugs are in preclinical and clinical research stag.

Note: Northeast Securities 2022-03-29 Research Report

Globally, Merck's Molnupiravir and Pfizer's Paxlovid lead the first echelon of new crown oral dru.

On November 4, 2021, Merck's Molnupiravir was approved in the UK for the treatment of adults with mild to moderate COVID-19, becoming the world's first approved oral drug for COVID-1 However, clinical trial results show that Molnupiravir is not effective in treating patients with severe new crown infecti.

The drug is continuing to conduct two clinical trials in patients with mild to moderate new coronary infection and post-exposure prophylax.

After the.


approval, Merck's sales reached $952 million in the quart.

Both Merck and Pfizer’s two new crown oral drugs received emergency use authorization from the.


FDA in December 202

Among them, Pfizer's Paxlovid is currently the only approved new crown specific drug in China, and the Phase III clinical trial results are remarkab.

The drug is currently undergoing two phase III clinical trials for patients with mild to moderate disease (low-risk groups) and post-exposure prophylaxis, which are expected to be completed in the first half of this ye.

The 2022 Q1 financial report shows that Merck molnupiravi achieved revenue of $2 billion, more than half of the company's full-year expected reven.

In 2022, Merck expects annual sales of molnupiravir to be US$5 billion to US$5 billion; Pfizer’s Paxlovid achieved revenue of US$47 billion, lower than market expectations of US$42 billi.

Pfizer's full-year 2022 sales target for the drug is $22 billion in reven.

In addition, the Geneva Medicines Patent Pool (MPP) announced that there are 5 Chinese companies qualified to produce Molnupiravir APIs or preparations, namely Fosun Pharma, Langhua Pharma, Longze Pharma, Borui Pharma and Desano Pharma; There are a total of 5 companies qualified to produce the raw materials or preparations of nematevir, one of the components of Paxlovid, namely Shanghai Desano, Huahai Pharmaceutical, Pro Pharmaceuticals, Fosun Pharmaceuticals, and Jiuzhou Pharmaceutica.

General Technology China Pharmaceuticals will be responsible for the commercial operations of Pfizer's Paxlovid in the Chinese mainland mark.

According to a forecast by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington at the end of March, it is expected that the growth rate of the global number of new crown infections will accelerate again in the next three months, and the number of newly diagnosed patients worldwide will exceed 100 milli.

The oral drug market will reach tens of billions of dolla.

Three domestic new crown oral drugs are racing, who will win?

On March 15, 2022, the Novel Coronavirus Pneumonia Diagnosis and Treatment Program (Trial Version 9) was announc.

Among them, the etiological characteristics section pointed out that Omicron was the main epidemic strain of the current epidem.

Clonal antibodies were incorporated into antiviral treatment methods, and oral drugs for COVID-19 were recognized by China's diagnosis and treatment plan for the first ti.

However, many brokerages said that the price of foreign new crown oral drug products is high and the quantity is limited, and China urgently needs its own new crown oral drug produc.

At present, Azvudine from Real Bio, VV116 from Junshi Bio, and Prolutamide from Kintor are the fastest-growing domestic oral drugs for COVID-1 Who will get the first domestically-made oral drug for COVID-19 is worthy of attenti.

Today, azvudine is being targeted by many pharmaceutical compani.

China Resources Shuanghe and Xinhua Pharma are rushing to become its production and distributors, which also makes the outside world extremely optimistic about azvudi.

Internationally, however, Junshi Bio's VV116 has been granted emergency use authorization in Uzbekistan, and Kintor's proclutamide has been granted emergency use authorization in Paragu.

Junshi Bio's VV116 is a novel oral nucleoside anti-coronavirus drug jointly developed by the Chinese Academy of Sciences, Wangshan Wangshui and Junshi B.

It is an RdRp inhibitor with a structure similar to Remdesivir, but improved oral bioavailability on the basis of Remdesivir and can be administered oral.

On April 28, Junshi Bio announced that the oral nucleoside anti-SARS-CoV2 drug VV116 jointly developed by the company's holding subsidiary Juntuo Bio and Wangshan Wangshui is in the phase III clinical research stage of an international multi-cent.

A registrational clinical study in patients with mild-to-moderate and moderate-to-severe COVID-19 is ongoi.

Prolukamide was originally a small molecule targeted drug for prostate cancer and breast cancer independently developed by Kint.

After the outbreak of COVID-19, Prokluamide started to explore the path of inhibition in the infection pathway of the new coronavir.

On April 6, Kintor announced positive data from the Phase III clinical trial (n=730) of (Proxalutamide, GT091
In a subgroup analysis (n=693), the company reported that prokalutamide significantly reduced hospitalization/mortality, with 100% protection in patients treated for more than 7 days (p<0

On the other hand, the stock prices of companies with "new crown oral drugs" are soari.

On the evening of May 9, Shanhe Yaofu revealed in a telephone exchange that in terms of new crown oral drug related projects, the company is currently cooperating with Kintor Pharmaceutical's Prokalutamide and Junshi Biopharmaceuticals in researching oral drugs, and 3 mo.

-5 companies that have not yet entered the late clinical stage are also collaborating with .

On May 10, Shanhe Yaofu opened the daily lim.

Among the domestic new crown oral drug R&D companies, in addition to Junshi Bio, Kintor, and Real Bio, Ascletis Pharmaceuticals, Simcere Pharmaceuticals, Guangshengtang, Genting Xinyao, and Kexing Pharmaceuticals are also actively promoting their produc.

into clinical tria.

Among them, Ascletis Pharmaceuticals and Simcere Pharmaceuticals are expected to apply for clinical trials of new crown oral drug products this ye.

At present, the growth rate of patients with new crown infections in the world is accelerating, and the domestic epidemic situation is also repeat.

If the new crown oral drugs are approved for marketing, it will usher in a huge mark.