Domestic enterprises have more than 10 new crowned oral pills. Can Shenzhen Research Shen26 capsules be up later?

The 21st Century Business Herald reporter Wei Xiao reported that recently, the Shenzhen Municipal People's Government held a 2022 Shenzhen Biomedical Industry Special Investment Council in the floor of the national biological industry base. At the meeting, Zhang Xumu, Dean of the Pingshan Institute of Biomedicine and the Russian Academy of Science and Technology, released the research progress report of the "Anti -New Crown Small Molecular Oral Medicine Shen26 Capsule Project", and announced that the clinical trial of the new crown small molecule oral drug SHEN26 capsule was approved Essence

At present, the project's clinical trial research was jointly developed by the Pingshan Institute of Biomedical at the University of Science and Technology of China, Shenzhen Antaiwei Biological Pharmaceutical Co., Ltd. and Shenzhen Kexing Pharmaceutical Co., Ltd.

It is worth noting that there are more companies in the domestic layout of new crown oral medicines. It is worth noting that Azf, a real creature, who belongs to the RDRP inhibitor with Shen26, is approved to be listed in the country in China; and the current SHEN26 capsule clinical trial has just been approved.

In addition, there are currently more than 10 new crown and oral medications under domestic enterprises, including SIM0417 of Xianyin Pharmaceutical, VV116 of Junshi Bio / Wangshan Wangshui, Puklunamide of Pharmaceuticals, RAY1216 of all beings Pharmaceutical Industry Wait, involve a variety of technical routes such as 3CL protease, RDRP inhibitor.

At present, SHEN26 does not seem to have the market's first -mover advantage and will face more fierce market competition.

Shen26 has obvious advantages

SHEN26 is a broad -spectrum, powerful new -type coronary virus RNA polymerase (RDRP) inhibitor. It was jointly discovered by Professor Zhang Xumu of Southern University of Science and Technology and Professor Guo Dexin from Sun Yat -sen University. Related research results have been published in Science Translational Medicine and J. Med. Chem. Authoritative international academic journals.

Compared with antibody drugs, small molecular drugs have many advantages. For example, it is aimed at the process of virus replication, which is not vulnerable to virus mutation. In addition, small molecular drugs also have the advantages of convenient administration, low price, and high production capacity expansion.

As an oral drug of anti -new crown small molecules, the antiviral effect can be achieved by inhibiting virus nucleic acid synthesis, and the virus variable strains (wild strains, Alpha, Beta, Delta, Omitron) have efficient in vitro inhibitory activity.

It is worth noting that SHEN26 is the same as RDRP inhibitor as RDRP inhibitors. Redsovir was developed by Gilead Technology Company in the United States. It is currently the only drug that is officially approved for COVID-19 infection. On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved Rydecow to treat the new crown hospitalization patients and became the first new crown therapy drug in the United States. On December 3, 2021, Geelyd Science reported that Redsovir was still active in Omikon's mutant strains.

The National Institute of Health (NIH) updated the new crown treatment guide on April 1, 2022. For mild patients, the priority recommended drugs include Reidi Weisovir, followed by the new monoclonal COV-1404 of Lilly, and finally Molnupiravir in Merhadodo; for intensive patients, the use of Reidsiwei priority, then Lili Lili JAK inhibitor Baricitinib.

The above -mentioned guidelines have shown that Redsie has included severe and mildness. Global clinical use cases have exceeded 20 million cases, and there are none of the severe toxic and side effects. It is the first to be approved for children's medication. It is better. Clinical treatment effect and safety. However, Raydivir's injection also had insufficient administration methods and insufficient costs.

The early experiments show that SHEN26 is consistent with the active ingredients (NTP) in the body (NTP) of Rydeci, and the mechanism of action is clear. In addition to all the advantages of the above -mentioned Reedsie, preclinical research results also show multiple advantages.

SHEN26's in vitro antiviral experiment data shows that Shen26 has a 13nm of the Omikon mutant EC50, which has increased by 103 times higher than Redsovir. Experimental experiments in the body show that 50 mg/kg shen 26 and 200mg/kg molnupiravir The effect of anti-new coronal virus is equivalent. In the K18-HCE2 mouse model infected by the new coronal virus, Shen26 can significantly reduce the titer of the lung tissue virus, improve the lung disease, and has a significant improvement in tissue damage caused by the new crown virus. At the same time, SHEN26 is oral capsules, with good oral use and convenient administration.

Safety results suggest that SHEN26 has a low risk of off -target side effects. The research results such as terators and mutations are negative, and have high treatment indexes and good security.

In addition, the synthesis process of raw materials is simple, which can achieve rapid production and meet the needs of temporary emergency and large -scale needs. It is one of the most economical drugs that have been listed and other similar drugs that are currently listed and other -intended to be listed.

At present, the project's clinical trial research was jointly developed by the Pingshan Institute of Biomedical at the University of Science and Technology of China, Shenzhen Antaiwei Biological Pharmaceutical Co., Ltd. and Shenzhen Kexing Pharmaceutical Co., Ltd. It is worth noting that on July 13, SHEN26 Capsule clinical trial was approved. The three parties unanimously stated that the project is expected to complete clinical trials within 6 to 9 months and was approved to be listed. Regarding Shen26's commercialization, according to the related cooperation between Koh Maxima and Antaivi, Kexing Pharmaceutical enjoys the global rights and interests of "SHEN26". Its marketing network shows that the marketing terminals of Kexing Pharmaceuticals in China cover more than 19,000 hospitals, grass -roots medical institutions, pharmacies, etc., including nearly 7,000 hospitals, 3 terminals with more than 8,000 pharmacies, and 4,000 pharmacies; overseas markets have already been in overseas markets; Through the market access and sales of more than 30 countries and regions such as Brazil, the Philippines, Indonesia, etc.

Can you live up later?

At present, the Shen26 Capsule clinical trial has been approved. Although it is expected to complete clinical trials and obtained listing in 6 months, it does not seem to have the premissions of the market.

Recently, the real creature Azf is scheduled to be approved to be listed in domestic conditions. Related studies have shown that Azfding is also an RDRP inhibitor that suppresses the new coronary virus by blocking virus RNA replication. The new coronal virus is the RNA virus like HIV, so Azfding can also copy the activity of the new coronary virus by blocking the virus RNA.

Kexing Pharmaceutical pointed out in the announcement that in terms of market competition, there are currently a number of new crown therapeutic drugs at home and abroad, and there are many new crown prevention and therapeutic drugs in different R & D stages. Determination.

It is more critical in the fierce market competition, which is reflected in the new crown vaccine market competition.

However, Kexing Pharmaceutical recently pointed out that the need for drug use of the new crown can refer to the national drug reserves of influenza therapy drugs. The national reserves of Dafi and Oshwewei's national reserves are about 26 million people. If the provincial Health and Health Commission and disease control reserves are added, the demand will be greater. Preventive clinical research, densely connected, and sub -dense -connected people will be a large medication group.

Zhou Chaoze, an analyst of Minsheng Securities, said that the core competition point of the new crown oral medication is three factors including efficacy, cost, and toxic and side effects. The first competition point is the curative effect.

Taking the new crown oral medication that has been approved, the Molnupiravir (Monpiravir) and Phard's Paxlovid of Meroshadong as an example, as the world's first approved small molecular oral medication, Molnupiravir of Merhadon was out of stock. The quarterly sales were more than twice the PAXLOVID, but due to the effects of the efficacy, Paxlovid sales soared since May, while Molnupiravir has begun to decline.

The listing application submitted by Azfdin this time is based on the clinical trial of the key III phase registered. This test is a clinical trial design of multi -centered, random, double -blindness, and placebo control. The results show that the Azf fixed tablet can significantly shorten the moderate new type of coronary virus infection with the symptoms of pneumonia, the proportion of patients with improvement of clinical symptoms, and achieve the results of clinical excellent efficiency. On the first 7th day of the administration, the proportion of the subjects of the clinical symptoms improved 40.43%, and the placebo group was 10.87%(P value <0.001). There are very significant statistical differences with the placebo group (P value <0.001).

In terms of suppressing the role of the new coronary virus, Azf's dating virus is about 5 days; in terms of safety, Azf's general tolerance is good, and the incidence of adverse events is not statistical. Learning differences have not increased the risk of subjects.

At present, Azf must be approved to be listed on emergency conditions. The Pharmaceutical Supervision Bureau needs to "continue to carry out relevant research work, complete the requirements for attached conditions within a time limit, and submit subsequent research results in a timely manner."

Therefore, although Azf is scheduled to occupy the first -mover advantage in the domestic new crown and oral medication industry, it is necessary to observe whether it can continue to lead. At present, the clinical trial of SHEN26 capsules has been approved, and its efficacy needs to be further observed. In terms of overseas clinical, Koxing Pharmaceutical stated that it will promote the clinical of SHEN26, focusing on the deployment of Southeast Asia, Central South America. Partners in the Philippines, Peru, Brazil and other countries have expressed their clear intentions for cooperation in clinical research.

It is worth noting that Professor Zhang Xumu of the Shen26 R & D team is carrying out related research work for Shen26 and 3CL targets. It will closely follow up the research progress of Professor Zhang and evaluate the effect of combined use.

In February this year, Paxlovid has been approved by the State Drug Administration to approval. "But for China, it is still very important to achieve autonomous and controllable new crown therapy drugs. We need different drugs to compete with Pfizer and reduce the price of new crown drugs. In addition, considering the problem of resistance to resistance, 3CL proteases are taken with 3CL proteases. Drugs with RDRP polymerase should be advanced at the same time, and multi -pronged approach. "A brokerage pharmaceutical industry analyst said in an interview with the media.

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