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ON DECEMBER 29, THE NEW ENGENG JOURNAL OF MEDICINE (NEJM) PUBLISHED THE RESULTS
OF THE PHASE 3 CLINICAL TRIAL OF JUNSHI VV116 "HEAD-TO-HEAD PFIZER POXLOVID" ONLINE.
The results showed that VV116 was non-inferior to PAXLOVID in terms of duration of clinical recovery and fewer
adverse events in adult patients with mild to moderate COVID-19 with high-risk factors.
A week later, Junshi Biologics' VV116 once again "appeared" in the New England Journal of Medicine (NEJM), giving the global market a more comprehensive understanding
of the domestic new crown drug VV116.
of the domestic new crown drug VV116.
On January 5, the New England Journal of Medicine (NEJM) published another special interview: Expanding the Expanding Arsenal for the treatment of the new crown
of Oral Agents to Treat Covid-19）
。
。
The main points of this interview lie in 4 areas (distilled points after translation):
The main points of this interview lie in 4 areas (distilled points after translation):1) P drug has limitations: Paxlovid has been successful in reducing the number of severe new crown cases in the past, but the body's absorption of it is very limited, and ritonavir in the P drug combination can interfere with the metabolism of many drugs and limit the use of
some people.
At the same time, some people taking P drug also experienced virus rebound (relapse) and repeated symptoms, resulting in some people reluctant to use the drug
.
2) Advantages of VV116 over remdesivir: The launch of VV116 may change the current global pattern of new crown drug use
.
Although remdesivir significantly reduces hospitalization rates in outpatient treatment, the injectable dosage form severely limits its outpatient use, and VV116, as a remdesivir derivative, changes the basic molecular structure of remdesivir to change its absorption and metabolism, breaking the limitations of its dosage form, and has demonstrated its efficacy and safety
in clinical trials.
3) VV116 has confirmed its efficacy and safety, and there are challenges at the clinical level: In the completed phase III non-inferior trial, divided into VV116 group and Paxlovid group, there is no comparison of the (placebo) efficacy level in this population in a natural state, and the placebo group is very helpful in better defining the absolute efficacy of VV116 new drugs, which brings great challenges
.
(In fact, the article also recognizes the value of VV116 on the side)
4) Ideas for recommending P drugs and VV116 combinations: In the interview, the editor-in-chief of NEJM proposed an idea that for some chronically infected/immunocompromised patients, if the combination of these two drugs (VV116 + Paxlovid) is started early in the course of the disease, considering the synergy of the two drugs (both against viral polymerase), the effect will be better
.
The endorsement of the top journal NEJM represents that VV116 has been recognized by the international academic community, and has also caused a wave of public opinion in China, but whether it can be listed in China as soon as possible still depends on the communication between Junshi Biologics and CDE and subsequent data supplementation
.
At present, VV116 is still undergoing phase III clinical research in Ruijin Hospital, the study has been carried out for 2 weeks, and the enrollment of infected patients is expected to end by the end
of January 2023.
In addition, there are also rumors in the market that VV116 is about to be approved, one of which is widely regarded as a precursor is: on January 9, under the unified arrangement of relevant local organizations, Junshi Biologics' new crown oral drug VV116 began to be used in the form of "sympathetic medicine" in 7 hospitals in Shanghai to treat new crown patients
.
(The seven hospitals include: Shanghai Ruijin, Shuguang, Huashan, Renji, Shanghai Public Health Center, Xinhua Hospital and Pudong Hospital
.
) ）
.
(The seven hospitals include: Shanghai Ruijin, Shuguang, Huashan, Renji, Shanghai Public Health Center, Xinhua Hospital and Pudong Hospital
.
) ）
"Compassionate medicine" refers to drugs that are being used in clinical trials for the treatment of serious life-threatening diseases for which there is no effective treatment, which may benefit from medical observation and are ethical, and can be used in other patients
with the same condition in the institution conducting clinical trials after review and informed consent.
There are also other market rumors that the company's management has done its best to communicate with the regulator to obtain emergency authorization
.
It is worth noting that Junshi Biologics does not only have the pipeline reserve
of new crown drugs.
of new crown drugs.
Although the FDA review results of PD-1 teripulimab have been repeatedly postponed due to travel restrictions in the early stage, based on the small incidence of nasopharyngeal carcinoma patients in Europe and the United States and the large unmet clinical demand in the United States, if there is no problem with the inspection of the production base, it is a high probability event
to be approved in the first half of this year.
After obtaining FDA approval in the United States, Junshi Biologics can use this dimensionality reduction to hit Southeast Asia, the Middle East and Africa and other regions, and achieve another way to break the internal roll-up to the sea, and the company has granted the rights and interests of more than 20 countries such as the Middle East and North Africa to Hikma
, a company listed on the London Stock Exchange.
In China, PD-1 teripulimab first-line liver cancer, liver cancer postoperative adjuvant, non-small cell lung cancer (neoadjuvant therapy) and other heavy indications are expected to be declared for marketing in 2023, which is expected to accelerate the commercialization process
of its sales volume.
At present, the commercialization team of Junshi Biologics has more than 1,100 employees, and teripulimab has been sold
in more than 4,000 medical institutions nationwide.
Judging from the trend of A-shares in early December, the trend of Junshi Biologics is significantly weaker than that of BeiGene and Remegen Biologics among biopharmaceutical companies, and has certain supplementary potential
.
.
According to Guanlan of Medicine, at the just-concluded JPM conference, Dr.
Li Ning, CEO of the company, also showed the market the blueprint for the future and the guidance
of important milestones.
From 2022 to 2023, Junshi Biologics will have 3 new molecular entities approved for marketing, including two biosimilars (adalimumab biosimilars UBP1211, JS501 bevacizumab) and Senaparib
, a PARP inhibitor jointly developed with Yingpai Pharmaceutical.
From 2024 to 2025, Junshi expects five new molecular entities to be approved for marketing, including anti-PCSK9 monoclonal antibody, anti-BTLA monoclonal antibody, anti-IL-17A monoclonal antibody, and targeted EGFR
The exon 20's JS111, etc
.
After 2025, more than 10 new molecular entities will be approved for listing
.
It is foreseeable that the overseas expansion of PD-1 and the approval of VV116 will contribute sufficient cash flow to Junshi in 2023 (coupled with the recently completed fixed increase blood transfusion), which will provide sufficient capacity
for the company's new molecule outbreak in 2024 and beyond.
