VV116, long overdue, what does it mean to be on top magazine

On December 29, the New England Journal of Medicine (NEJM) published online the results of Phase 3 clinical trial VV116 "head-to-head Pfizer PAXLOVID". The results show that VV116 is not inferior to PAXLOVID and has fewer adverse events in terms of time to sustained clinical recovery in adults with mild to moderate COVID-19 with high risk factors.

This is the first clinical trial of novel coronavirus innovative drug independently developed in China published by NEJM. The clinical results show that for adult patients with mild to moderate Covid-19 with high risk factors, VV116 made in China is not inferior to Paxlovid in terms of duration of clinical recovery time (4 days vs.5 days; Hazard ratio, 1.17; 95% confidence interval, 1.02 to 1.36) with fewer adverse events.

Some investors wonder: "If clinical data has been approved by top academic journals, why not in China?"

Near the end of the Hong Kong stock market, 21 financial reporters telephoned the company, and a person in charge of investor relations said, "VV116 has not yet submitted an application for listing. I am in constant communication with the drug regulatory authorities. The current Phase III trial results, the regulatory authorities believe that more data support, so do not support us to use the Phase III clinical study to submit a marketing application."

A message, also led to Jun real biological Hong Kong stocks late trend of Hong Kong stocks "insert water".

Industry insiders point out: Junshi biological this clinical trial probability is not set placebo control group and criticized by experts, Junshi Biological VV116 is currently conducting two phase III clinical studies, are control placebo, if there is a follow-up of one of the phase III success, then the probability can communicate with CDE to submit an application.

This also shows that regulators have a very careful consideration and a high standard for the approval of domestic novel coronavirus drugs.

Although VV116 has not been approved by NMPA domestically, its clinical trial has been published by the New England Journal of Medicine, which plays a very important role in promoting VV116's future internationalization and market recognition.

The academic journals most revered by surgeons and physicians are the New England Journal of Medicine and the Lancet. (Nature and Science are basic science journals)

The above two are one of the authoritative journals in the world medical community. According to the description of the "Journal Citation report" in 2010, the impact factor of the New England Journal of Medicine was 53.48, while that of the Lancet was 33.63, and the influence of the former was stronger than that of the latter.

As one of the medical journals with the highest impact factor in the world, the New England Journal of Medicine enjoys a high reputation in the global medical community. The NEJM publication of the results of VV116 study confirms the full recognition of the design, quality control and clinical value of the study by the international academic community.

"What kind of study gets published in the New England Journal of Medicine? There are four main criteria: thefirst, thebest, thelast, and thebiggest.

In the past, China's drug research and clinical teams were not regular visitors to the top academic journals.

Statistics show that from 2014 to 2016, China ranked ninth among 12 major pharmaceutical innovation countries in terms of the number of articles published in clinical research journals The Lancet, the New England Journal of Medicine and the Journal of the American Medical Association. It ranks fourth in the number of papers published in top basic research journals such as Nature, Science and Cell. Clinical research has significantly slowed down the pace of transformation of basic innovation results.

According to the data of 2019, in the past five years, the journal published only six clinical research results of Chinese teams in one year, only two in 2018, and a total of four papers in the first seven months of 2019.

In 2019, the New England Journal of Medicine published a research paper with Chinese doctors as thefirst author and corresponding author for thefirst time. Rosalsitat was included in the NEJM Phase III clinical study, which has two characteristics: thefirst and thebest. First of all, Rosallistat is the first targeted HIFpathway (hypoxy-inducing factor pathway) in the world, and also the first clinical study of a new drug completed by China in the world. At the same time, the design and data of the study show a very high level and quality.

Developed and commercialized by Farbotin/Astrazeneca, its first market is China (approved in December 2018), the European Union, Japan, Chile, South Korea and many other places approved. In the first half of 2021, the domestic sales of Rosalxtar exceeded 700 million yuan, and according to the forecast of Rui Wei, the sales of Rosalxtar in 2022 will reach 2 billion dollars. EvalutePharma predicts peak sales of $5.8 billion to $8.1 billion.

Although the publication in the New England Journal of Medicine does not mean that a certain drug will be successfully commercialized in the future, it will undoubtedly play a positive role in the subsequent approval, marketing and education of new drugs.

In recent years, except for the launch of NEJM in the head-to-head Phase III clinical trial of VV116, only BTK inhibitor Zebtinib of Beigene has "defeated" ibutinib on NEJM due to the dual superior effect of ORR and PFS in the head-to-head phase III. However, the number of domestic innovative drugs on NEJM should not exceed five digits in history.

Because of scarcity, innovative drugs that make it to the NEJM have higher potential to become "big drugs" than other drugs.

In 2019, Tu Youyou's team proposed a feasible treatment plan to deal with the problem of "artemisinin resistance", which was published by NEJM. Up to now, artemisinin combination therapies have cured billions of malaria patients, and artemisinin-based products have generated annual sales of US $1.5 billion to US $2 billion in the global market. If they are not patented, then they will be very profitable for the drug companies that commercialize them.

At the just-concluded annual meeting of the American Society of Hematology (ASH), Beigene announced data from the Phase III APLINE trial of Zebutinib head-to-head with Ibutinib in the CLL/SLL indication and presented at NEJM, cementing Zebutinib's position as Bestinclass (best inclass) in the BTK inhibitor category. The FDA approved Zbrutinib for CLL/SLL in January 2023. With the future approval of CLL/SLL as a large indication, Zbrutinib will be rapidly increased in the next three years, which has already shown a clear trend (Q1 to Q3 2022: $679 million. $88.4 billion. $108 million). Even Wall Street analysts estimate that annual sales could peak at $15 billion, or about 100 billion yuan.

Conclusion: The VV116 study can obtain the inclusion of NEJM, at least the "endorsement" for its efficacy and safety, as for the rapid launch to seize the domestic and global market, it needs to test the ability of the company's team.