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In recent years, with the multiple resonances of policies, capital, and talents, China's domestic innovative drugs have flourished, and the enthusiasm of enterprises in research and development has been high.
Overseas, participate in international competition
.
Undoubtedly, the research and development of local new drugs is different from the past, and the achievements made are also worthy of recognition, but what needs to be seen is that behind the still hot research and development of new drugs, there are still some challenges, such as the problem of homogenization
.
Data show that from 2016 to 2021, 66 domestically produced Class 1 new drugs have been launched in China; the number of Class I new drug applications has been increasing year by year, with a compound annual growth rate (CAGR) as high as 40%
.
But judging from the targets involved in new drugs in the past 6 years, 41% of new drugs focused on the top 6% of popular targets
.
Take PD-1/PD-L1 as an example.
Once, the blue ocean of PD-1/PD-L1 in China was as high as 10 billion yuan, attracting many multinational pharmaceutical companies such as Eli Lilly and AstraZeneca.
Monoclonal antibody and foreign companies work together to develop and promote
.
At present, many cooperations around PD-1 are still in progress
.
For example, Kangfang Biologics licensed Piamprimab to Chia Tai Tianqing with a milestone amount of 345 million yuan, and the latter obtained the right to sell in China; Yuheng Biologics and WuXi Biologics licensed Sepalizumab to Arcus , received an upfront payment of $18.
5 million and milestones of $797.
5 million plus a 10% sales commission
.
However, many multinational pharmaceutical companies have also made a decision to sell
.
For example, Junshi Bio announced on the evening of January 4 that as its self-built commercialization team gradually matured, on December 31, 2021, it signed the "Termination Agreement of Exclusive Promotion Agreement" with AstraZeneca, and decided to withdraw it.
The right to promote Toripalimab injection as stipulated in the original agreement; earlier, Eli Lilly also stated that from 2022, about 15% of the hospital visits that Eli Lilly will be responsible for since 2021 will be transferred to Innovent Bio, Innovent Bio will be responsible for 100% of hospital visits for sintilimab in China
.
After multinational pharmaceutical companies have withdrawn from the domestic PD-1 promotion market, the track has become more and more crowded
.
The data shows that the number of PD-1 clinical trials in the world has grown rapidly since 2012.
As of January 6, 2022, the total number of global clinical trials of PD-1 target drugs has reached 3,471, of which China (CDE registration) is 675.
, accounting for about 19.
5% of the world
.
Another data shows that from 2016 to 2021, the number of new PD-L1 drugs that were only declared and accepted by CDE in China has reached 57, and the number of new PD-1 drugs that have been accepted is approaching 50
.
Up to now, a total of 12 PD-(L)1 products have been approved for marketing in China, of which 8 are domestic new drugs and 4 are imported drugs
.
The industry pointed out that PD-1 has become a representative product of homogenous competition in the domestic innovative drug market.
At present, many domestic monoclonal antibodies have been included in medical insurance, many new indications of monoclonal antibodies have been approved continuously, and many monoclonal antibodies have been released overseas.
On the whole, the commercialization competition of PD-1 products is still fierce, especially for the late runners on the track, they will face huge challenges
.
So, how should pharmaceutical companies take the road of commercialization? From the perspective of the industry, in addition to considering factors such as capital and personnel structure, innovative drug companies need to continuously realize the clinical value of product differentiation, strive to realize the value of innovative drugs in the international market, improve corporate management capabilities, and formulate scientific sales model selection and commercialization promotion strategies
.
Overseas, participate in international competition
.
Undoubtedly, the research and development of local new drugs is different from the past, and the achievements made are also worthy of recognition, but what needs to be seen is that behind the still hot research and development of new drugs, there are still some challenges, such as the problem of homogenization
.
Data show that from 2016 to 2021, 66 domestically produced Class 1 new drugs have been launched in China; the number of Class I new drug applications has been increasing year by year, with a compound annual growth rate (CAGR) as high as 40%
.
But judging from the targets involved in new drugs in the past 6 years, 41% of new drugs focused on the top 6% of popular targets
.
Take PD-1/PD-L1 as an example.
Once, the blue ocean of PD-1/PD-L1 in China was as high as 10 billion yuan, attracting many multinational pharmaceutical companies such as Eli Lilly and AstraZeneca.
Monoclonal antibody and foreign companies work together to develop and promote
.
At present, many cooperations around PD-1 are still in progress
.
For example, Kangfang Biologics licensed Piamprimab to Chia Tai Tianqing with a milestone amount of 345 million yuan, and the latter obtained the right to sell in China; Yuheng Biologics and WuXi Biologics licensed Sepalizumab to Arcus , received an upfront payment of $18.
5 million and milestones of $797.
5 million plus a 10% sales commission
.
However, many multinational pharmaceutical companies have also made a decision to sell
.
For example, Junshi Bio announced on the evening of January 4 that as its self-built commercialization team gradually matured, on December 31, 2021, it signed the "Termination Agreement of Exclusive Promotion Agreement" with AstraZeneca, and decided to withdraw it.
The right to promote Toripalimab injection as stipulated in the original agreement; earlier, Eli Lilly also stated that from 2022, about 15% of the hospital visits that Eli Lilly will be responsible for since 2021 will be transferred to Innovent Bio, Innovent Bio will be responsible for 100% of hospital visits for sintilimab in China
.
After multinational pharmaceutical companies have withdrawn from the domestic PD-1 promotion market, the track has become more and more crowded
.
The data shows that the number of PD-1 clinical trials in the world has grown rapidly since 2012.
As of January 6, 2022, the total number of global clinical trials of PD-1 target drugs has reached 3,471, of which China (CDE registration) is 675.
, accounting for about 19.
5% of the world
.
Another data shows that from 2016 to 2021, the number of new PD-L1 drugs that were only declared and accepted by CDE in China has reached 57, and the number of new PD-1 drugs that have been accepted is approaching 50
.
Up to now, a total of 12 PD-(L)1 products have been approved for marketing in China, of which 8 are domestic new drugs and 4 are imported drugs
.
The industry pointed out that PD-1 has become a representative product of homogenous competition in the domestic innovative drug market.
At present, many domestic monoclonal antibodies have been included in medical insurance, many new indications of monoclonal antibodies have been approved continuously, and many monoclonal antibodies have been released overseas.
On the whole, the commercialization competition of PD-1 products is still fierce, especially for the late runners on the track, they will face huge challenges
.
So, how should pharmaceutical companies take the road of commercialization? From the perspective of the industry, in addition to considering factors such as capital and personnel structure, innovative drug companies need to continuously realize the clinical value of product differentiation, strive to realize the value of innovative drugs in the international market, improve corporate management capabilities, and formulate scientific sales model selection and commercialization promotion strategies
.
