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License-out, that is, "external authorization" or "authorized export", refers to the transfer of R&D, commercialization or marketing rights of drugs or product portfolios by pharmaceutical companies to other units, which is a fairly common cooperation model in the industry
.
In recent years, with the continuous improvement of the research and development capabilities of domestic innovative pharmaceutical companies, the number of new drug license-out transactions in China has been increasing, and the transaction volume has also begun to hit new highs
.
According to data, in 2021, the overseas authorization transaction of domestic innovative pharmaceutical companies, namely License out, will hit another climax
.
According to incomplete statistics, there will be 53 license outs to overseas companies in China's pharmaceutical industry in 2021, far exceeding the 24 in 2020
.
In this regard, the industry believes that this is due to the release of a series of national reform policies, as well as the improvement of the research and development capabilities of domestic innovative pharmaceutical companies, and our innovation has gradually been recognized by the international market
.
In recent years, under the background of the continuous acceleration of domestic drug exports, a large number of enterprises have successfully shipped many drugs to the sea, and achieved outstanding results
.
For example, Huiyu Pharmaceutical has more than 10 injections approved for marketing in the UK, including irinotecan hydrochloride injection, doxorubicin injection, zoledronic acid injection, docetaxel injection, aza for injection Since 2015, cytidine has won bids for bulk procurement by public medical institutions in the UK region for many times.
At the same time, it has achieved sales in about 40 countries, and its product quality has been recognized by the international market
.
In addition, the company has more than 100 product approval documents independently approved and authorized overseas, and the approval documents have covered more than 40 countries including Europe and Canada
.
On the whole, the industry predicts that with the improvement of the strength of China's innovative drug companies in the future, the layout of more companies will no longer be limited to the domestic market, and more innovative drugs will bravely go overseas
.
In fact, at the beginning of 2022, the trend of this domestic drug accelerating overseas has begun to appear
.
Recently, Junshi Bio announced that Coherus BioSciences, Inc.
(“Coherus”) has initiated the process of exercising the license option of TIGIT monoclonal antibody JS006 in the United States and Canada
.
At the same time, Coherus will pay Junshi Biotechnology an upfront payment of $35 million, development, filing and sales milestone payments of up to $255 million, as well as an 18% sales share of net product sales
.
It is understood that as early as February 1, 2021, Junshi Bio has signed an "Exclusive License and Commercialization Agreement" with Coherus
.
Under the License and Commercialization Agreement, the Company will grant Coherus an exclusive license to Toripalimab and two optional programs (if executed) in the United States and Canada (the "Coherus Regions"), as well as two early-stage checkpoint inhibition The company has priority negotiating rights for the antibody drug, and can receive up to $1.
11 billion in upfront payments, optional program execution fees and milestone payments
.
However, under the background of the promising prospects of domestic drugs going overseas, some people in the industry also pointed out that the difficulty of going overseas for new drugs is also increasing
.
If someone from overseas has published a document saying that there are related problems such as over-development of PD-1 at present, so in 2021, 7 of the 10 PD-1 monoclonal antibody indications in the US FDA's accelerated approval channel will take the initiative.
or withdrawn
.
In this regard, the industry believes that there are still many challenges for domestic new drugs to go overseas, including the innovation of targets, the uniqueness of assets, and the quality of clinical data (especially overseas)
.
In the future, how to find suitable partners, fully understand the market, regulatory regulations, transaction rules, etc.
, will be important considerations and planning for local pharmaceutical companies before going overseas
.
.
In recent years, with the continuous improvement of the research and development capabilities of domestic innovative pharmaceutical companies, the number of new drug license-out transactions in China has been increasing, and the transaction volume has also begun to hit new highs
.
According to data, in 2021, the overseas authorization transaction of domestic innovative pharmaceutical companies, namely License out, will hit another climax
.
According to incomplete statistics, there will be 53 license outs to overseas companies in China's pharmaceutical industry in 2021, far exceeding the 24 in 2020
.
In this regard, the industry believes that this is due to the release of a series of national reform policies, as well as the improvement of the research and development capabilities of domestic innovative pharmaceutical companies, and our innovation has gradually been recognized by the international market
.
In recent years, under the background of the continuous acceleration of domestic drug exports, a large number of enterprises have successfully shipped many drugs to the sea, and achieved outstanding results
.
For example, Huiyu Pharmaceutical has more than 10 injections approved for marketing in the UK, including irinotecan hydrochloride injection, doxorubicin injection, zoledronic acid injection, docetaxel injection, aza for injection Since 2015, cytidine has won bids for bulk procurement by public medical institutions in the UK region for many times.
At the same time, it has achieved sales in about 40 countries, and its product quality has been recognized by the international market
.
In addition, the company has more than 100 product approval documents independently approved and authorized overseas, and the approval documents have covered more than 40 countries including Europe and Canada
.
On the whole, the industry predicts that with the improvement of the strength of China's innovative drug companies in the future, the layout of more companies will no longer be limited to the domestic market, and more innovative drugs will bravely go overseas
.
In fact, at the beginning of 2022, the trend of this domestic drug accelerating overseas has begun to appear
.
Recently, Junshi Bio announced that Coherus BioSciences, Inc.
(“Coherus”) has initiated the process of exercising the license option of TIGIT monoclonal antibody JS006 in the United States and Canada
.
At the same time, Coherus will pay Junshi Biotechnology an upfront payment of $35 million, development, filing and sales milestone payments of up to $255 million, as well as an 18% sales share of net product sales
.
It is understood that as early as February 1, 2021, Junshi Bio has signed an "Exclusive License and Commercialization Agreement" with Coherus
.
Under the License and Commercialization Agreement, the Company will grant Coherus an exclusive license to Toripalimab and two optional programs (if executed) in the United States and Canada (the "Coherus Regions"), as well as two early-stage checkpoint inhibition The company has priority negotiating rights for the antibody drug, and can receive up to $1.
11 billion in upfront payments, optional program execution fees and milestone payments
.
However, under the background of the promising prospects of domestic drugs going overseas, some people in the industry also pointed out that the difficulty of going overseas for new drugs is also increasing
.
If someone from overseas has published a document saying that there are related problems such as over-development of PD-1 at present, so in 2021, 7 of the 10 PD-1 monoclonal antibody indications in the US FDA's accelerated approval channel will take the initiative.
or withdrawn
.
In this regard, the industry believes that there are still many challenges for domestic new drugs to go overseas, including the innovation of targets, the uniqueness of assets, and the quality of clinical data (especially overseas)
.
In the future, how to find suitable partners, fully understand the market, regulatory regulations, transaction rules, etc.
, will be important considerations and planning for local pharmaceutical companies before going overseas
.
