Introduction: Real Bio's Azvudine Tablets have increased the registration application for the treatment of new crown indications for the treatment of common adult patients with new crown.
With the approval of the drug as a new crown drug, it will directly benefit Xinhua Pharma and China Resources Double Crane in the short term.
Author | Lin Zhiyin, China Business News
On July 25, the official website of the State Food and Drug Administration announced: According to the relevant provisions of the "Drug Administration Law", in accordance with the special drug approval procedures, emergency review and approval, and conditional approval of Henan True Biotechnology Co., Ltd. Azvudine Tablets to increase the treatment of new crowns Application for registration of viral pneumonia indications for the treatment of adult patients with common novel coronavirus pneumonia (COVID-19).
This is the first domestically-produced oral small molecule novel coronavirus pneumonia treatment drug on the market in China.
On July 15 this year, Real Bio has just announced that it has recently formally submitted a marketing application for Azvudine Tablets to the State Food and Drug Administration for the treatment of new crown indications.
As the drug is launched as a new crown drug, which companies will it benefit?
For ordinary adult new crown patients
The approved indication of Real Bio-Azvudine Tablets is for the treatment of adult patients with common novel coronavirus pneumonia (COVID-19).
A new crown treatment expert told the first financial reporter that the common type of new crown patient has the characteristics of pneumonia, while the severe type has obvious hypoxia characteristics.
Recently, there have been market rumors that Aziv is priced at 240 yuan for a single course of treatment, with a daily dosage of 5 mg, and one course of treatment is 35 mg.
In this regard, the first financial reporter also asked real creatures to verify the specific pricing, but has not yet received a reply.
Azvudine tablets belong to the new use of old drugs, and this time it is a conditional approval for new indications.
As early as July 20, 2021, the National Medical Products Administration has conditionally approved the drug in combination with other reverse transcriptase inhibitors to treat adult HIV-1 infected patients with high viral load.
According to public information, the price of Azvudine tablets as an AIDS drug is 25.86 yuan/mg (tablets), and it is expected that the price of this new crown indication will not be higher than this price.
Since the beginning of this year, the State Food and Drug Administration has approved another oral small molecule drug for the new crown, namely Pfizer's Paxlovid, which is an imported drug that sells for up to 2,300 boxes.
The market also speculates that the price of Azvudine tablets as a new crown indication drug may be much lower than Pfizer's Paxlovid.
Pfizer's Paxlovid is approved for the treatment of adult patients with mild to moderate novel coronavirus pneumonia (COVID-19) with high risk factors for progression to severe disease, such as advanced age, chronic kidney disease, diabetes, cardiovascular disease patients with severe high-risk factors such as chronic lung disease.
Good for Xinhua Pharma and China Resources Double Crane
Initially, with the launch of real biological new crown drugs, it may benefit companies in the relevant industry chain in the short term.
In April of this year, Real Biology signed an agreement with Xinhua Pharma (000756.SZ), agreeing that Xinhua Pharma will be the manufacturer and distributor of azvudine and other products it owns in China and other countries agreed by both parties.
Then, in May of this year, Real Life and China Resources Double Crane (600062.SH) signed the "Strategic Cooperation Agreement" and "Azvudine Film Entrusted Processing and Production Framework Agreement" in Beijing, entrusting China Resources Double Crane to process and produce Azev. Fudine tablets.
The above-mentioned new crown treatment experts revealed to the first financial reporter that in the treatment of AIDS, Azvudine tablets are used or less, mainly in clinical treatment. It is not clear how the drug is used in combination with other drugs. It cannot be used alone.
"It remains to be seen how the clinical application of Azvudine tablets as a new crown drug will be. The drug is approved for marketing as a conditional, and the approval conditions are very flexible. If the supplementary materials are not ideal, the approval can still be withdrawn."
The State Food and Drug Administration also requires Real Biology to continue to carry out relevant research work, complete the conditional requirements within a time limit, and submit the follow-up research results in a timely manner.