Suspected of being the first domestic covid-19 oral drug, the A-share "mysterious partner" was finally unveiled.
On the afternoon of April 26, Shandong Xinhua Pharmaceutical Company Limited(000756) rapidly increased the limit, and the information of heavy cooperation with Henan real Biotechnology Co., Ltd. (hereinafter referred to as "real biology") was released on that day.
Shandong Xinhua Pharmaceutical Company Limited(000756) announced that the company signed the strategic cooperation agreement with real life, and real life agreed that Shandong Xinhua Pharmaceutical Company Limited(000756) is the manufacturer and distributor of azvudine and other products in China and other countries agreed by both parties, that is, both parties will carry out production and sales cooperation on drugs including azvudine
The reason why real creatures have attracted so much attention from the capital market is that azvudine in its hand is a covid-19 oral drug that has attracted much public attention recently, and it is also one of many covid-19 oral drugs under development in China.
On April 2, real creatures applied for three types of communication and exchange meeting. This is regarded by many people in the industry as a signal that "the listing of the first domestic covid-19 specific drug is getting closer and closer".
Previously, the share prices of several A-share companies rose due to market rumors and signed agreements with real organisms to produce and sell the antiviral drug azvudine.
what's the origin of real creatures
Real biology, founded in 2012, is an innovative drug R & D enterprise integrating independent R & D, production and sales. It is mainly engaged in the R & D of innovative drugs such as antiviral, antitumor, cardiovascular and cerebrovascular diseases and liver diseases.
In July 2021, azvudine tablets, a class 1.1 innovative drug developed and produced by real organisms and with independent intellectual property rights, passed the priority review and approval procedure of the State Drug Administration and was officially approved for listing.
Public information shows that azivudine, as a nucleoside reverse transcriptase inhibitor, was first used for AIDS indications. In fact, as early as last July, azvudine, as a new therapy for adult HIV-1 patients with high viral load, obtained the conditional marketing approval of the State Food and drug administration. At present, it is still developing hepatitis B and tumor indications.
However, originally used for the treatment of AIDS, is azivudine useful for the treatment of covid-19?
real life official wechat "real biotechnology" published several articles that mentioned: "the phase III clinical trial of azvudine in the treatment of covid-19 pneumonia is being fully promoted in China, Brazil and Russia."
Source: real biology official wechat "real biotechnology"
2021 August, real biology official wechat "real biotechnology" announced the completion of round B financing, referring to the latest progress of azivudine in the treatment of covid-19 viral pneumonia published in nature in October 2020. The preliminary clinical results showed that azvudine was effective in the treatment of covid-19 virus, and could significantly shorten the time of nucleic acid negative conversion, treatment time and hospital stay p align = "center" source: real biology official wechat "real biotechnology"
At the China Medical Development Conference on April 16, academician Jiang Jiandong introduced the clinical efficacy of azvudine, saying that the patients' nucleic acid turned negative after oral medication for 3-4 days, with an average medication time of 6-7 days and an average discharge of 9 days. Among them, azvudine is also effective for patients who are ineffective with other drugs for many days, and different from other covid-19 drugs, azvudine has similar therapeutic effects on patients with severe and mild diseases.
Azvudine for the treatment of covid-19 virus was conducted by Academician Wang Chen, President of the Chinese Academy of Medical Sciences. In April 2020, it was approved by SFDA for the phase III clinical trial of anti covid-19; At present, the phase III clinical trial has been completed, and the results of Russia and Brazil have been submitted for approval.
Shandong Xinhua Pharmaceutical Company Limited(000756) "surface"
According to the strategic cooperation agreement signed between Shandong Xinhua Pharmaceutical Company Limited(000756) and real life, real life agrees that Shandong Xinhua Pharmaceutical Company Limited(000756) is its product manufacturer and distributor in China and other countries agreed by both parties. This is based on real organisms, which are committed to the research and development and registration of drugs, and have the drug registration certificate and / or patent right of azvudine and other products, as well as relevant valuable and proprietary information and data.
Shandong Xinhua Pharmaceutical Company Limited(000756) has cGMP drug production capacity and agrees to produce relevant products for real organisms in accordance with the relevant requirements specified in the registration documents to meet the registration and sales needs of real organisms in China and potential international markets.
Shandong Xinhua Pharmaceutical Company Limited(000756) is mainly engaged in the development, manufacturing and sales of chemical APIs, preparations, pharmaceutical intermediates and other products. In the first quarter of 2022, the net profit attributable to the shareholders of the listed company was 109 million yuan, an increase of 8.20% year-on-yearP align = "center" financial data related to the first quarterly report of Xinhua manufacturing in 2022
On April 3, 2019, the controlling shareholder of Shandong Xinhua Pharmaceutical Company Limited(000756) was changed from Shandong Xinhua Pharmaceutical Group Co., Ltd. to Hualu Holding Group Co., Ltd., and the final controller was still Shandong SASAC.
Shandong Xinhua Pharmaceutical Company Limited(000756) controlling shareholder source: Shandong Xinhua Pharmaceutical Company Limited(000756) annual report of 2021
domestic covid-19 oral drug "three strong competition"
In China, covid-19 therapeutic drugs that have entered phase III clinical practice include prochloramide (the first case of phase III in China was completed on February 10), vv116 of Shanghai Junshi Biosciences Co.Ltd(688180) and azvudine, which is considered to be the earliest real organism approved recently.
Among them, Kaifa pharmaceutical recently announced the key data results of phase III global multicenter clinical trial of lumide in the treatment of mild and moderate disease non hospitalized covid-19 patients: the corresponding protection rate was 100%. The industry was once optimistic that it might become the first domestic covid-19 oral drug.
In terms of commercialization, Shanghai Fosun Pharmaceutical (Group) Co.Ltd(600196) in July 2021, spent 560 million yuan to reach strategic cooperation with Kaifa pharmaceutical, and obtained the exclusive registration and commercial sales rights of prochloramide in India and 28 African countries.
Meanwhile, Shanghai Junshi Biosciences Co.Ltd(688180) and Wangshan wangshui pharmaceutical have launched phase II / III clinical trials for patients with mild to moderate covid-19 infection and phase III clinical trials for patients with severe covid-19 infection respectively.
Previously, Shanghai Junshi Biosciences Co.Ltd(688180) released the latest research results of covid-19 oral drug vv116: in the mouse model, the antiviral effect is significantly better than ribavirin, and can alleviate the pathological damage of lung tissue.
In September 2021, juntuo biology, a subsidiary of Shanghai Junshi Biosciences Co.Ltd(688180) holding company, entered into a cooperative development contract with Wangshan wangshui to jointly undertake the clinical development and industrialization of vv116 in the cooperation area. The cooperation area is a global scope except five Central Asian countries, Russia, North Africa and the Middle East.
However, since late March this year, news about the imminent approval of azvudine has continued to spread. The enterprise of "the first domestic covid-19 oral drug to be listed" has also transitioned from developing the pharmaceutical industry to real organisms.
industrial chain related enterprises are popular with A-share funds
At present, the drugs for covid-19 have not been approved, and the real organism has not yet landed in the capital market, but the relevant concept stocks have been stir fried in the capital market.
Xinxiang Tuoxin Pharmaceutical Co.Ltd(301089) subsidiary Xinxiang pharmaceutical is a manufacturer of azvudine API. At present, the new azvudine production line of Xinxiang pharmaceutical is under construction. From the beginning of this year to April 26, the stock price has increased by 86.82%.
At the same time, Beijing Xiehe pharmaceutical factory is the manufacturer of azvudine tablets. The Zhejiang Ausun Pharmaceutical Co.Ltd(603229) statement shows that Beijing Xiehe Pharmaceutical Co., Ltd. is its top five customers, selling CS acid, entecavir and other products to it, of which CS acid is only sold to Beijing Xiehe Pharmaceutical Co., Ltd. CS acid is an important intermediate for the synthesis of besenol. Entecavir is a guanine nucleoside analogue, which is similar to azvudine in structure.
Therefore, Zhejiang Ausun Pharmaceutical Co.Ltd(603229) and Xinxiang Tuoxin Pharmaceutical Co.Ltd(301089) have become the leading companies of domestic covid-19 specific drugs, which are highly sought after by funds.
However, in the process of funds chasing concept stocks, regulators are also revealing risks for investors.
On March 4, Shenzhen Stock Exchange issued a letter of concern to Xinxiang Tuoxin Pharmaceutical Co.Ltd(301089) requesting the company to explain the R & D and production investment of azvudine related products, current production capacity, current production and sales volume of related products, operating revenue and proportion realized in recent one year and one period, and orders on hand.
On the evening of April 19, the Chinese pharmaceutical enterprise China Resources Double-Crane Pharmaceutical Co.Ltd(600062) issued an announcement to refute the rumor: "up to now, the company has not reached relevant agreements with Henan real biology." As soon as this news came out, China Resources Double-Crane Pharmaceutical Co.Ltd(600062) share price ended the rising trend of the second board and fell to the limit on April 20.
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