A big discussion about the special medicine for the new crown brought Shanghai’s top three top Huashan Hospital into the water.
On May 18, the public account “Huashan Infection” of Huashan Hospital affiliated to Fudan University published the clinical data of Junshi Bio’s new crown specific drug VV116, which aroused public doubts. The data in the article shows that the time for nucleic acid to turn negative after taking VV116 is 8.56 days, although it is shorter than the 11.13 days of the control group, but it seems that the difference in effect is not big.
“Huashan Infection” quickly deleted the original text, and released updated data at 0:00 on the 19th: “Anti-New Coronavirus Small Molecule Oral Drug VV116″ Published the results of the first clinical study in Omicron infected patients in China”.
According to the new data published by Huashan Hospital, the conclusion of this clinical study is: VV116 is ok. The results of the research have been published in the journal Emerging Microbes & Infections.
Average 3 days and a half nucleic acid turn negative
Judging from the information disclosed by “Huashan Infection”, the clinical trial of VV116 was mainly conducted during the current round of Shanghai epidemic.
From March 8 to March 24 this year, 136 adult patients who were hospitalized due to infection with the new crown Omicron strain were enrolled, of which 60 patients were included in the experimental group. received treatment with VV116; the other 76 patients served as a control group and received standard care alone.
The average age of the 136 subjects was 33.9 years, and a few had underlying diseases. 11% of them had not received the vaccine, 0.7% had received one dose of the vaccine, 45.6% had received two doses, and 42.6% had received the third booster shot.
The test data released late at night by “Huashan Infection” showed that the “average time” for the nucleic acid to turn negative in the experimental group and the control group was 9.92 days and 11.13 days, respectively.
This is the most controversial part of the initial release of “Huashan Infection”. According to the version that was deleted after the first disclosure of “Huashan Infection”, the two figures were 8.56 days and 11.13 days, respectively.
Regardless of which version of the data, it was shown that:The time to negative for the experimental group was not significantly different from that of the control group.
But in the updated version of the data, “Huashan Infection” also disclosed: The average time from the first day of taking VV116 to the time when the nucleic acid test turned negative in the experimental group was 3.52 days . This data is more critical.
Not every subject can take medicine immediately after testing positive for nucleic acid. The experiment took 5 days after the detection of nucleic acid positive as the dividing line, and divided the experimental group into two categories. Those who took the specific drug for 5 days after the positive detection had an average time of 8.56 days for the nucleic acid to turn negative; those who took the drug after 5 days, the nucleic acid The average time to turn negative was 11.46 days. That is to say, after receiving VV116 treatment, the speed of turning negative is faster than that without taking medicine.
In a word, take medicine as soon as possible.
It is worth noting that this study is not a “head-to-head” study, and all subjects have not received hormones, monoclonal antibodies and antiviral drugs other than VV116; secondly, the experiment is not double-blind , the subject’s consent was obtained before the drug was administered; thirdly, no severe patients participated in the trial. Neither the experimental group nor the control group had severe cases, so the efficacy of VV116 in preventing severe cases could not be estimated.
Head to head is the final battle
Huashan Hospital re-released the trial data because at first public opinion believed that mild patients did not take special medicines, and the problem was not serious. The advantages of VV116 are not reflected.
But judging from the updated data, VV116 can still help COVID-19 patients to be discharged from hospital faster, and it is comparable to Pfizer’s new crown-specific drug Paxlovid.
At present, the approval of Pfizer Paxlovid from the State Food and Drug Administration of China is “for mild to moderate new crown patients with severe risk”, but for mild and ordinary patients without underlying diseases , and there is no corresponding oral chemical drugs, patients can only choose Chinese patent medicines such as Lianhua Qingwen.
But this is also the biggest problem facing VV116: Pfizer’s oral specific drug does not have a replacement for the time being, but patients with mild symptoms have a choice, They can If you choose not to take special drugs and only accept conventional treatment, the nucleic acid can also be turned negative.
According to the clinical research results disclosed by Pfizer: on the 5th day of treatment with Paxlovid, the viral load of patients was reduced by 10 times compared with the control group; the relative incidence of hospitalization or death in related cases can be caused by taking Paxlovid The risk was reduced by 89.1%.
Strictly speaking, Jushi’s VV116 and Pfizer’s specific drugs are not targeted at the same type of patients, it is difficult to directly compare.
Health Knowledge Bureau was informed that Junshi Biosciences has designed a head-to-head clinical trial with Paxlovid. On April 19, a clinical study conducted by Ruijin Hospital was approved to directly compare the efficacy of VV116 and Paxlovid. According to the trial design , the advantages and disadvantages of the two can be seen within 28 days at the earliest.
The results of the head-to-head trials are unknown, but have summoned market confidence.
On May 16th, Junshi Biosciences issued an announcement related to fixed increase, and planned to refinance nearly 4 billion yuan. In March of this year, Junshi disclosed this financing plan. The company told the media at the time that the approval process could be completed first, and the subsequent issuance could be selected at a later time.
What Junshi is waiting for may be the time to announce that it will be head-to-head with Pfizer.
As of the close of May 19, the total market value of Junshi Biotechnology reached 104.8 billion, approaching BeiGene’s 112.3 billion. Despite the unfavorable sales of its own PD-1, Junshi’s stock price has not fallen, and it dares to ask the capital market for money again.
In any case, the world is looking forward to a good outcome during the current epidemic.