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With the improvement of the strength of China's innovative drug enterprises, the layout of enterprises is no longer limited to the domestic market, and more innovative drugs are bravely going overseas
.
On the one hand, in recent years, many innovative drug companies have chosen to license-out domestically produced innovative drugs to increase their international influence and to supplement their cash flow.
Makes the "Sino-US double newspaper" boom
.
According to incomplete statistics, in 2021, there will be 8 domestic innovative drugs accepted by the FDA, and the number has reached a new high
.
These 8 domestic innovative drugs involve BCMA-CART, PD-1 monoclonal antibody, long-acting G-CSF, and VEGFR, FGFR1 inhibitors and other categories, of which monoclonal antibody products account for half, including Innovent's sintilimab , Junshi Bio's Toripalimab, BeiGene's Tislelizumab, and Kangfang Bio's Piamprimab 4 products
.
Judging from the FDA's acceptance time, the indication of Junshi Bio's toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma was accepted by the FDA in March 2021, which was the earlier product among the four products.
; Innovent's sintilimab for the treatment of non-squamous non-small cell lung cancer, and Acupuncture's piamplimumab for the treatment of metastatic nasopharyngeal carcinoma will be accepted in May 2021
.
In addition, BeiGene's tislelizumab for the treatment of esophageal squamous cell carcinoma was accepted in September in the second half of 2021
.
From BeiGene's zanubrutinib being approved by the US FDA, becoming the first new anti-cancer drug independently developed and approved by the FDA, and now a number of domestic monoclonal antibodies sprinting to the FDA, it can be seen that domestic PD-1/ L1 has entered the second half of the global competition, and the war will gradually burn from the domestic market to the overseas market
.
It is worth mentioning that Pharmaco's piamplimumab was newly launched in August 2021 for the treatment of relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) after at least second-line systemic chemotherapy patients
.
This product is also the fifth approved domestic PD-1 in China
.
Now that it has been less than half a year since it was approved, Piamprimab is ready to sprint to the FDA, which shows the fierce competition in the PD-1/L1 market in the future
.
It should be noted that the difficulty of going overseas for PD-1 mAb is also increasing
.
According to media reports, the recent overseas posting said that at present there is excessive development of PD-1 and other related issues, the drug into the market quickly channel tend to adopt a "single-arm experiment", and hope that drugs can be studied "head to head" and so on
.
It said that in 2021, 7 of the 10 PD-1 monoclonal antibody indications entered into the accelerated approval channel by the US FDA were voluntarily or withdrawn
.
It can be seen that it is not easy for domestic innovative drugs to go overseas
.
Looking back at 2021, there will also be many domestic innovative drugs that have had twists and turns and have not successfully obtained the FDA "pass"
.
For example, on December 1, 2021, Wanchun Pharmaceutical announced that it had received a complete response letter (CRL) from the US FDA on the new drug application (NDA) of plinabulin
.
The NDA is indicated for the combination of plinabulin and granulocyte-colony stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN)
.
Wanchun Pharmaceutical said in the announcement that the company remains confident in the efficacy and safety data of plinabulin combined with G-CSF in the prevention of CIN, and will discuss the next steps with the FDA, including the possibility of conducting a second trial
.
In this regard, the industry believes that in addition to courage, domestic innovative drug companies need to withstand the test of capital, manpower, and clinical capabilities on the road to the sea
.
"But in the long run, with the continuous improvement of research and development capabilities, the internationalization of China's innovative drugs will be an inevitable process
.
"
.
On the one hand, in recent years, many innovative drug companies have chosen to license-out domestically produced innovative drugs to increase their international influence and to supplement their cash flow.
Makes the "Sino-US double newspaper" boom
.
According to incomplete statistics, in 2021, there will be 8 domestic innovative drugs accepted by the FDA, and the number has reached a new high
.
These 8 domestic innovative drugs involve BCMA-CART, PD-1 monoclonal antibody, long-acting G-CSF, and VEGFR, FGFR1 inhibitors and other categories, of which monoclonal antibody products account for half, including Innovent's sintilimab , Junshi Bio's Toripalimab, BeiGene's Tislelizumab, and Kangfang Bio's Piamprimab 4 products
.
Judging from the FDA's acceptance time, the indication of Junshi Bio's toripalimab for the treatment of recurrent or metastatic nasopharyngeal carcinoma was accepted by the FDA in March 2021, which was the earlier product among the four products.
; Innovent's sintilimab for the treatment of non-squamous non-small cell lung cancer, and Acupuncture's piamplimumab for the treatment of metastatic nasopharyngeal carcinoma will be accepted in May 2021
.
In addition, BeiGene's tislelizumab for the treatment of esophageal squamous cell carcinoma was accepted in September in the second half of 2021
.
From BeiGene's zanubrutinib being approved by the US FDA, becoming the first new anti-cancer drug independently developed and approved by the FDA, and now a number of domestic monoclonal antibodies sprinting to the FDA, it can be seen that domestic PD-1/ L1 has entered the second half of the global competition, and the war will gradually burn from the domestic market to the overseas market
.
It is worth mentioning that Pharmaco's piamplimumab was newly launched in August 2021 for the treatment of relapsed or refractory classical Hodgkin's lymphoma (r/r cHL) after at least second-line systemic chemotherapy patients
.
This product is also the fifth approved domestic PD-1 in China
.
Now that it has been less than half a year since it was approved, Piamprimab is ready to sprint to the FDA, which shows the fierce competition in the PD-1/L1 market in the future
.
It should be noted that the difficulty of going overseas for PD-1 mAb is also increasing
.
According to media reports, the recent overseas posting said that at present there is excessive development of PD-1 and other related issues, the drug into the market quickly channel tend to adopt a "single-arm experiment", and hope that drugs can be studied "head to head" and so on
.
It said that in 2021, 7 of the 10 PD-1 monoclonal antibody indications entered into the accelerated approval channel by the US FDA were voluntarily or withdrawn
.
It can be seen that it is not easy for domestic innovative drugs to go overseas
.
Looking back at 2021, there will also be many domestic innovative drugs that have had twists and turns and have not successfully obtained the FDA "pass"
.
For example, on December 1, 2021, Wanchun Pharmaceutical announced that it had received a complete response letter (CRL) from the US FDA on the new drug application (NDA) of plinabulin
.
The NDA is indicated for the combination of plinabulin and granulocyte-colony stimulating factor (G-CSF) for the prevention of chemotherapy-induced neutropenia (CIN)
.
Wanchun Pharmaceutical said in the announcement that the company remains confident in the efficacy and safety data of plinabulin combined with G-CSF in the prevention of CIN, and will discuss the next steps with the FDA, including the possibility of conducting a second trial
.
In this regard, the industry believes that in addition to courage, domestic innovative drug companies need to withstand the test of capital, manpower, and clinical capabilities on the road to the sea
.
"But in the long run, with the continuous improvement of research and development capabilities, the internationalization of China's innovative drugs will be an inevitable process
.
"
