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Recently, the research interest of institutions in the pharmaceutical and biological industry has not diminished, and Junshi Bio has received frequent attention from institutions
.
According to statistics, since February 1, Junshi Bio has received more than 1,000 research institutions within a month, including many large institutions such as Hillhouse, Aobo, Gao Yi, and Ruiyuan
.
As for the reason why Junshi Bio has received frequent attention from institutions, the analysis believes that on the one hand, it may be related to the company's layout and achievements in blockbuster vaccines.
At present, the company has two neutralizing antibodies (JS016, JS026) and two small molecule oral drugs.
Drugs (VV116, VV993); on the other hand, the company's self-developed toripalimab will be tested by the FDA in April 2022.
If it is successfully approved, it is expected to become the first domestic PD-1 marketed in the United States
.
On March 1, Junshi Bio released the company's investor relations activity record sheet, February 12, 2022, February 15, 2022, February 16, 2022, February 17, 2022, February 18, 2022 On February 21, 2022, February 22, 2022, and February 23, 2022, the company has received more than 1,000 investors
.
From the perspective of the communication link, the institutions mainly focus on the progress and production capacity layout of oral drug VV116, related drug pipelines, and overseas listing progress of toripalimab
.
Among them, in response to the progress of toripalimab's overseas listing, Junshi Bio said that the company has always maintained communication with the US FDA at the critical time node of the application of drugs.
First-line treatment of patients with metastatic nasopharyngeal carcinoma and two indications of single drug for second-line and above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing therapy, the company has successfully completed the FDA's interim review in mid-December 2021 (mid-cycle review), as of now the FDA's Biologics License Application (BLA) review is progressing as planned
.
There is currently no PD-1 product approved for nasopharyngeal cancer indications in overseas markets.
The BLA of toripalimab for nasopharyngeal cancer indications meets "unmet clinical needs", and the overall clinical trial program has also been approved by the FDA before.
Accredited and awarded two "Breakthrough Therapy" designations
.
The company expressed confidence in this overseas declaration and expected good results
.
In terms of the commercialization of toripalimab in the domestic market and the North American market, Junshi Bio said that in the domestic aspect, the company has withdrawn the promotion rights agreed in the agreement with AstraZeneca, and the toripalimab injection in mainland China All regional promotions will be handled by the company's own commercialization team
.
At present, the adjustment of the company's commercialization team has been completed
.
In the North American market, Coherus will be responsible for the commercialization of toripalimab after the launch
.
The drug access in the United States is different from the domestic situation, mainly requiring the deployment of commercial medical insurance and pharmacies
.
Coherus will base its pricing on the overall U.
S.
market
.
Coherus has shown the company a follow-up promotion plan for toripalimab in stages, and the company believes that the plan is feasible
.
In addition, as to the question raised by the agency, "Will PD-1, BTLA and other varieties be commercialized in other countries after they are approved in China and the United States? Do additional clinical data need to be supplemented?" Junshi Bio mentioned that most of the The drug supervision system of non-ICH countries is not very perfect.
If the company's pipeline drugs are approved in China and the United States, they can basically cross the entry threshold of most other countries without special circumstances
.
In addition to North America and China, the cooperation of Toripalimab does not rule out the possibility of negotiating cooperation with other multinational pharmaceutical companies in different countries and regions
.
If toripalimab is approved by the FDA, it will be of great help to the company's overseas commercialization cooperation negotiations in other regions
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
According to statistics, since February 1, Junshi Bio has received more than 1,000 research institutions within a month, including many large institutions such as Hillhouse, Aobo, Gao Yi, and Ruiyuan
.
As for the reason why Junshi Bio has received frequent attention from institutions, the analysis believes that on the one hand, it may be related to the company's layout and achievements in blockbuster vaccines.
At present, the company has two neutralizing antibodies (JS016, JS026) and two small molecule oral drugs.
Drugs (VV116, VV993); on the other hand, the company's self-developed toripalimab will be tested by the FDA in April 2022.
If it is successfully approved, it is expected to become the first domestic PD-1 marketed in the United States
.
On March 1, Junshi Bio released the company's investor relations activity record sheet, February 12, 2022, February 15, 2022, February 16, 2022, February 17, 2022, February 18, 2022 On February 21, 2022, February 22, 2022, and February 23, 2022, the company has received more than 1,000 investors
.
From the perspective of the communication link, the institutions mainly focus on the progress and production capacity layout of oral drug VV116, related drug pipelines, and overseas listing progress of toripalimab
.
Among them, in response to the progress of toripalimab's overseas listing, Junshi Bio said that the company has always maintained communication with the US FDA at the critical time node of the application of drugs.
First-line treatment of patients with metastatic nasopharyngeal carcinoma and two indications of single drug for second-line and above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing therapy, the company has successfully completed the FDA's interim review in mid-December 2021 (mid-cycle review), as of now the FDA's Biologics License Application (BLA) review is progressing as planned
.
There is currently no PD-1 product approved for nasopharyngeal cancer indications in overseas markets.
The BLA of toripalimab for nasopharyngeal cancer indications meets "unmet clinical needs", and the overall clinical trial program has also been approved by the FDA before.
Accredited and awarded two "Breakthrough Therapy" designations
.
The company expressed confidence in this overseas declaration and expected good results
.
In terms of the commercialization of toripalimab in the domestic market and the North American market, Junshi Bio said that in the domestic aspect, the company has withdrawn the promotion rights agreed in the agreement with AstraZeneca, and the toripalimab injection in mainland China All regional promotions will be handled by the company's own commercialization team
.
At present, the adjustment of the company's commercialization team has been completed
.
In the North American market, Coherus will be responsible for the commercialization of toripalimab after the launch
.
The drug access in the United States is different from the domestic situation, mainly requiring the deployment of commercial medical insurance and pharmacies
.
Coherus will base its pricing on the overall U.
S.
market
.
Coherus has shown the company a follow-up promotion plan for toripalimab in stages, and the company believes that the plan is feasible
.
In addition, as to the question raised by the agency, "Will PD-1, BTLA and other varieties be commercialized in other countries after they are approved in China and the United States? Do additional clinical data need to be supplemented?" Junshi Bio mentioned that most of the The drug supervision system of non-ICH countries is not very perfect.
If the company's pipeline drugs are approved in China and the United States, they can basically cross the entry threshold of most other countries without special circumstances
.
In addition to North America and China, the cooperation of Toripalimab does not rule out the possibility of negotiating cooperation with other multinational pharmaceutical companies in different countries and regions
.
If toripalimab is approved by the FDA, it will be of great help to the company's overseas commercialization cooperation negotiations in other regions
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
