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In recent years, with the rapid development of Chinese pharmaceutical companies and the improvement of their innovation strength, the upsurge of domestic innovative drugs has begun to emerge, but at the same time, the FDA's supervision has become more stringent
.
Recently, the FDA Oncology Drugs Advisory Committee (ODAC) voted on the BLA application of Eli Lilly and Innovent's sintilimab for non-squamous non-small cell lung cancer, and the result was a 1:14 vote that failed
.
The news quickly aroused heated discussions in the industry
.
According to industry insiders, in May 2021, Innovent Bio's PD-1 monoclonal antibody submitted a marketing application to the FDA for the non-squamous non-small cell carcinoma indication.
Bristol-Myers Squibb's O drug and Roche's T drug have been approved, so if Innovent wants to continue to promote PD-1 monoclonal antibody overseas, it needs to do head-to-head trials with O drug and K drug to prove its superiority
.
In this regard, Innovent also stated that the company and Eli Lilly will continue to cooperate with the FDA to complete the review of new drug marketing applications
.
"The FDA is indeed tightening the approval of PD-1 monoclonal antibody, and the setback encountered by Innovent is actually a step that all domestic innovative drugs need to experience and take
.
" The industry believes that through this ODAC meeting, it has also allowed In the future, the path for domestic innovative drugs to go overseas will become clearer
.
For example: domestic innovative drugs approved for marketing overseas must conduct global multi-center clinical trials, including different patient groups to account for differences between different races; when designing clinical trial protocols, attention must be paid to the current standard therapy in the United States; related companies It is also necessary to pay attention to the communication with regulatory agencies during the whole process from the IND stage to the listing
.
These requirements also mean that in the future, domestic innovative drugs will require companies to be more familiar with the FDA's "rules of the game"
.
On the whole, with the rise of the strength of domestic innovative drugs and the intensification of competition in the domestic market, the industry is still optimistic about the prospect of domestic innovative drugs going overseas, but the way for innovative drugs to go overseas is long and difficult
.
Facing the vast unexplored overseas market, many institutions have recently published several types of innovative drug companies that they are optimistic about
.
For example, Essence Securities believes that in the future, there are three types of companies that are expected to realize products going overseas, digging into the European and American pharmaceutical markets..
First, companies with strong funds, sufficient courage and confidence to promote Phase 3 clinical trials overseas, mainly in the European and American markets, such as BeiGene, Hengrui Medicine, etc.
; Companies that have the potential to license varieties to MNC, such as Legend Bio (BCMA CAR-T), Kangfang Bio (PD-1/CTLA-4 double antibody, PD-1/VEGF double antibody, CD73 monoclonal antibody, CD47 monoclonal antibody) , Innovent Bio (LAG-3 monoclonal antibody), etc.
; thirdly, it is optimistic that the product can supplement the unmet clinical needs of European and American companies: such as Junshi Bio (PD-1 monoclonal antibody for nasopharyngeal cancer indications), Chi-Med Pharmaceuticals (so Vantinib for pancreatic and extrapancreatic neuroendocrine tumors)
.
CITIC Securities is also optimistic about leading innovative drug companies with international layout capabilities
.
The agency believes that the ODAC meeting has clarified two new paths for domestic innovative drugs to go overseas in the future: first, the global multi-center clinical trial layout; second, targeting unmet clinical needs in Europe and the United States, or therapies with high scarcity
.
The agency said that with the clarification of FDA's attitude and the implementation of new standards, the market is optimistic about innovative drug companies with strong R&D strength and international layout capabilities
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
Recently, the FDA Oncology Drugs Advisory Committee (ODAC) voted on the BLA application of Eli Lilly and Innovent's sintilimab for non-squamous non-small cell lung cancer, and the result was a 1:14 vote that failed
.
The news quickly aroused heated discussions in the industry
.
According to industry insiders, in May 2021, Innovent Bio's PD-1 monoclonal antibody submitted a marketing application to the FDA for the non-squamous non-small cell carcinoma indication.
Bristol-Myers Squibb's O drug and Roche's T drug have been approved, so if Innovent wants to continue to promote PD-1 monoclonal antibody overseas, it needs to do head-to-head trials with O drug and K drug to prove its superiority
.
In this regard, Innovent also stated that the company and Eli Lilly will continue to cooperate with the FDA to complete the review of new drug marketing applications
.
"The FDA is indeed tightening the approval of PD-1 monoclonal antibody, and the setback encountered by Innovent is actually a step that all domestic innovative drugs need to experience and take
.
" The industry believes that through this ODAC meeting, it has also allowed In the future, the path for domestic innovative drugs to go overseas will become clearer
.
For example: domestic innovative drugs approved for marketing overseas must conduct global multi-center clinical trials, including different patient groups to account for differences between different races; when designing clinical trial protocols, attention must be paid to the current standard therapy in the United States; related companies It is also necessary to pay attention to the communication with regulatory agencies during the whole process from the IND stage to the listing
.
These requirements also mean that in the future, domestic innovative drugs will require companies to be more familiar with the FDA's "rules of the game"
.
On the whole, with the rise of the strength of domestic innovative drugs and the intensification of competition in the domestic market, the industry is still optimistic about the prospect of domestic innovative drugs going overseas, but the way for innovative drugs to go overseas is long and difficult
.
Facing the vast unexplored overseas market, many institutions have recently published several types of innovative drug companies that they are optimistic about
.
For example, Essence Securities believes that in the future, there are three types of companies that are expected to realize products going overseas, digging into the European and American pharmaceutical markets..
First, companies with strong funds, sufficient courage and confidence to promote Phase 3 clinical trials overseas, mainly in the European and American markets, such as BeiGene, Hengrui Medicine, etc.
; Companies that have the potential to license varieties to MNC, such as Legend Bio (BCMA CAR-T), Kangfang Bio (PD-1/CTLA-4 double antibody, PD-1/VEGF double antibody, CD73 monoclonal antibody, CD47 monoclonal antibody) , Innovent Bio (LAG-3 monoclonal antibody), etc.
; thirdly, it is optimistic that the product can supplement the unmet clinical needs of European and American companies: such as Junshi Bio (PD-1 monoclonal antibody for nasopharyngeal cancer indications), Chi-Med Pharmaceuticals (so Vantinib for pancreatic and extrapancreatic neuroendocrine tumors)
.
CITIC Securities is also optimistic about leading innovative drug companies with international layout capabilities
.
The agency believes that the ODAC meeting has clarified two new paths for domestic innovative drugs to go overseas in the future: first, the global multi-center clinical trial layout; second, targeting unmet clinical needs in Europe and the United States, or therapies with high scarcity
.
The agency said that with the clarification of FDA's attitude and the implementation of new standards, the market is optimistic about innovative drug companies with strong R&D strength and international layout capabilities
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
