7month25On the same day, the National Medical Products Administration conditionally approved the registration application for adding the indication of treating COVID-19 to Zanubrutinib Tablets produced by Real Biotech. This is also the first domestically approved small molecule oral drug for COVID-19.
What is the significance of the launch of China's first domestically developed small molecule COVID-19 oral drug? What is the demand for small molecule oral drugs? What is the supply situation of COVID-19 small molecule drugs in China? Frost & SullivanFrost & Sullivan,Li Qian, Senior Consulting Director for Healthcare in Greater China at Frost & Sullivan (hereinafter referred to as 'Frost & Sullivan'), was interviewed by CBN to discuss the future direction of China's small molecule drug market after the approval of the first domestically produced COVID-19 oral medication.
CBN
7month25On the same day, the National Medical Products Administration conditionally approved the registration application for adding the indication of treating COVID-19 to Zanubrutinib Tablets produced by Real Biotech. This is also the first domestically approved small molecule oral drug for COVID-19.
There is no officially announced manufacturer for the real biological product. However, according to information disclosed by listed companies in the past, including Aoxiang Pharmaceutical, Tuoxin Pharmaceutical, and China Resources Shuanghe, these enterprises have stated that they have signed framework agreements for entrusted production with Real Biological.
As of7month26At the close of trading on the day, Aoxiang Pharmaceutical603229), China Resources Shuanghe600062The stock price has tumbled all the way to a one-character limit down, Tuo Xin Pharmaceutical301089) Stock price fell6.3%.
7month25On the evening of the same day, Fosun Pharma announced a long-term strategic cooperation with Zhenre Biology for the exclusive commercialization of azvudine. A reporter from CBN learned that Fosun Pharma's upfront payment amount has reached1100 million yuan. Fosun Pharma7month26dayAshare600196) and Hong Kong stocks2196The stock price has also fallen3%left and right.
The key lies in market demand
Market analysis suggests that the actual demand for Azvudine is still unclear, and the stock prices of related companies have been significantly pushed up in the early stages, which is also a reason for the significant market decline.
Since the beginning of this year, the cumulative increase in the stock price of China Resources Double Crane has been close to80%Oxbridge Pharmaceuticals also saw an increase of more than two-thirds.
Image source: CBN
Azvudine is a broad-spectrum antiviralRNAdependencyRNApolymeraseRdRpNucleoside analogues that can also specifically act against the novel coronavirusRdRpThe drug inhibits viral replication by targeting specific sites, making it highly targeted. It was originally marketed as an anti-AIDS medication and shares the same mechanism of action with remdesivir.
"Multiple companies can produce Azvudine, but the key lies in future demand, which depends on the development of the pandemic and the effectiveness of the drug during actual use," a pharmaceutical expert told CBN reporters.
According to the previously submitted pivotal Phase III registration clinical trial by Zhejiang Bio-Tech Co., Ltd., the results showed that azvudine has activity in inhibiting the novel coronavirus, with a virus clearance time of5days; after the first administration7Among the subjects whose clinical symptoms improved, the proportion in the azvudine group was40.43%Proportion in placebo group10.87%.
"Judging from the current situation, if it cannot be proven that taking antiviral drugs can prevent severe illness and only shorten the time to virus clearance, then even with very strict clinical trials, their importance would be greatly reduced," said the above-mentioned drug expert to CBN reporters.
Li Qian
Senior Healthcare Industry Consultant, Frost & Sullivan Greater China
Compared to other COVID-19 therapies such as neutralizing antibodies, the advantage of COVID-19 small molecule oral medications lies in their convenience of use and their ability to tolerate mutations to a certain extent. They have significant advantages such as high patient compliance, ease of storage and transportation, and convenient distribution. "As the pandemic becomes normalized, small molecule drugs can play a role in inhibiting viral replication at an early stage of infection, reducing the likelihood of developing into severe illness. They can be used as part of daily preventive measures, adding an important layer to epidemic control efforts." Li Qian, Senior Consulting Director for Healthcare Industry in Greater China at Frost & Sullivan, told CBN reporters.
The institution has significantly lowered its sales forecast for Pfizer's oral medications
The only small molecule drug currently in clinical use for treating COVID-19 in China is Pfizer's antiviral drug against the novel coronavirus.PaxlovidThis drug is also currently the leading medication in the global COVID-19 treatment market. However, according to the latest research predictions from data analytics companies,PaxlovidSales for the next six months are likely to fall short of market expectations.
Health data organizationAirfinityIt is reported that the latest data confirm that the order volume and quotes recently signed by Pfizer have begun to slow down gradually. The institution expects that by the end of this year, there could be as many as7000Ten thousand coursesPaxlovidExcess.
AirfinityAnalysis suggests that this small molecule drug may interact with other drugs, which could limit its use.AirfinityanalystHarry CheeldIt is stated that Pfizer may re-examine its bullish outlook for the drug demand and address the issue of oversupply.
Pfizer earlier said it plans to provide this year1.2Hundreds of millions of coursesPaxlovidSince the beginning of this year, Pfizer's stock price has fallen by more than12%Pfizer is about to7month28Announces the financial report for the latest quarter.
According toAirfinityAccording to the forecast, another company providing COVID-19 oral medications, Merck & Co., expects this year's supply to be only1500Ten thousand treatment courses.
Looking at overall sales,AirfinityIt is expected that PfizerPaxlovidThe total sales volume will reach232billion US dollars, lower than the forecast for the past three months236billion US dollars; Merck's total oral drug sales are estimated to be58billions, lower than previously estimated64billion US dollars; the sales of the COVID-19 oral drug approved at a later date by the Japanese pharmaceutical company Ono Pharmaceutical are estimated to be5billion US dollars, lower than previously estimated25billion dollars.
In China, in addition to the real-life biological AZVUDINE tablets, there are also Junshi Biotech's COVID-19 oral medicationVV116The film has also entered clinical trialsIIIPhase. This year5month23Today, Junshi Biology announced thatVV116The film in a comparison with PfizerPAXLOVIDFor the early treatment of mild to moderate COVID-19IIIThe phase-registered clinical study has achieved the primary endpoint preset in the protocol and is indicated to submit an application for marketing approval in the near future.
*This article is reprinted from 'CBN'. , author Qian Tongxin , Original title: After the approval of the first domestically produced COVID-19 oral medication, why did the manufacturer's stock plummet by one percentage point? ">
Frost & Sullivan Insight & Extended Readings
Q: What does the launch of China's first domestically developed small molecule COVID-19 oral drug indicate?
A: As of June this year, overseas2Several COVID-19 small molecule drugs have been approved for marketing and commercialization in multiple countries around the world, including Pfizer'sPaxlovidand Merck Sharp & DohmemolnupiravirBefore the launch of the first self-developed drug, the only available oral small molecule drug in China wasPaxlovidAzvudine, as the first domestically approved small molecule oral drug for treating COVID-19, further builds upon our country's 'vaccine+neutralizing antibody+Integrated prevention and control system for small molecule drugs."
Q: Globally, is there currently an oversupply of Pfizer's small molecule drugs?
A: PaxlovidApplied to preventing high-risk populations from developing into severe cases, as the spread of the real epidemic continues unabated and the number of infections remains high, the demand for medication is still there. Although sales in the first quarter of this year were lower than market forecasts, overall sales are still considerable. In the global field of COVID-19 small molecule oral medications, PfizerPaxlovidDominating the field.
Q:What is the supply situation of COVID-19 small molecule drugs in our country?
A: Fosun Pharma at7month25Announcements released on the evening of the same day disclosed that a strategic cooperation has been reached with True Biotech to advance joint development between both parties and for the exclusive commercialization of Azvudine by Fosun Pharma Industries. The commercialization layout of Azvudine will be carried out after the full industrial chain is established, aiming to meet current clinical medication needs through increased production.
Q:Which other companies are expected to receive approval?
A: In China, in addition to the real-life biological AZVUDINE tablets, there are also2The development of this drug has progressed relatively rapidly in the research and development of COVID-19 oral medications, including one jointly developed by Junshi Biosciences and Wangshan Wangshui.VV116Developing the pharmaceutical industry with Pukrulam, which is currently in clinical trialsIIIDuring the Phase I trial stage, it is expected to be launched in the near future, and the progress of research and development is worthy of continuous attention.
