Under the background of the domestic PD-1 track has overheated and the medical insurance control fee is superimposed, the domestic PD-1 market has shrunk compared with the past
.
Under this circumstance, many pharmaceutical companies have begun to go to sea to find a new blue ocean
.
It is understood that in foreign countries, the PD-1 market is still in the blue ocean
.
According to Research and Markets' forecast, global PD-1/PD-L1 sales will maintain a compound annual growth rate of 23.
4% in the future, and are expected to reach $50 billion
by 2025.
At present, a large number of enterprises are successively applying to overseas markets for PD-1 products
.
On November 15, Junshi Biologics announced that it has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for teripulimab (anti-PD-1 monoclonal antibody) for the first-line treatment of patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) in combination with cisplatin and gemcitabine, respectively; Teripulimab in combination with paclitaxel and cisplatin is used first-line therapy
in patients with unresectable locally advanced/recurrent or metastatic esophageal squamous cell carcinoma (ESCC).
Teripulimab is an anti-PD-1 monoclonal antibody drug independently developed by Junshi Biologics, and the submission of the marketing authorization application (MAA) to EMA means that after China and the United States, the global commercialization of teripulimab has begun to expand
to Europe.
In addition to Junshi Biologics, in May this year, Hengrui Pharmaceutical announced the launch of a wholly-owned subsidiary, Luzsana Biotechnology (Luzsana), which will be dedicated to the development and commercialization of Hengrui's drugs in markets outside China, currently involving more than 250 clinical studies, covering unmet clinical needs such as oncology, cardiovascular, metabolic/diabetes, pain management, immunity, liver and kidney diseases.
.
.
The industry believes that under the involution of PD-1 products, going overseas has become a key breakthrough path
for Chinese pharmaceutical companies to seek valuation premiums.
However, it is worth noting that the current Chinese innovative drugs going overseas is still very complicated and difficult, since the beginning of this year, there is no shortage of
cases of domestic PD-1 failure.
For example, on February 11, Innovent disclosed that its PD-1 drug was frustrated
at sea.
The U.
S.
Food and Drug Administration's (FDA) Tumor Drug Advisory Committee (ODAC) asked Innovent to supplement additional clinical trials to eliminate the two shortcomings
of the current product "no international multi-center clinical studies and no head-to-head trials" in clinical trials.
In May, Hutchison also announced that the FDA had issued a full response letter
to the new drug application for sulfatinib for the treatment of pancreatic and non-pancreatic neuroendocrine tumors.
FDA believes that the current data package based on two successful China Phase III studies and one US bridging study is not sufficient to support the current approval
of the drug in the United States.
In this regard, analysts said that for pharmaceutical companies, if they want their products to go abroad smoothly, they must undoubtedly always pay attention to the changes in the clinical pattern, and maintain communication with the FDA, EMA, etc.
for clinical design
.
It is necessary to improve the technical content
of its products from multiple dimensions such as reflecting product innovation, meeting unmet clinical needs, improving drug accessibility, improving processes, indications selection, and improving safety and efficacy.
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