-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
[Pharmaceutical Network Industry News] In the context of the hot research and development of innovative drugs in China, the fierce competition on the track, and the downward trend of drug prices forced by centralized procurement, domestic new drugs have challenged to go overseas in order to seek a way of valuation premi.
Although it is a general trend for innovative drugs to "go overseas", it is not easy for domestic new drugs to go overse.
At present, many pharmaceutical companies including Innovent Bio, Junshi Bio, and Chi-Med Pharmaceutical have experienced setbacks in going overse.
It is not easy for domestic new drugs to go overseas In March this year, Innovent announced that the “going overseas” had failed, and the marketing application of its core product sintilimab was not approved by the US F.
In May, Innovent Bio’s overseas cooperation regenerated wav.
The company announced that the authorized cooperation with the American pharmaceutical company Coherus (CH.
US) was terminated, and the second largest product, bevacizumab biosimilar (IBI-305), was recovered in the United Stat.
and Canadian interes.
On May 2, Junshi Bio announced that the marketing application of the PD-1 antibody toripalimab received a complete response letter (CRL) from the FDA, requiring a quality control process chan.
Also in May, Chi-Med's surufatinib application in the.
was reject.
In its response letter, the FDA noted that “data are insufficient” and that “more international multicenter clinical trials (MRCTs) representative of the.
patient population are needed to support approv.
”On July 14, BeiGene announced that due to the travel restrictions related to the epidemic, the US FDA could not complete the required on-site inspection work in China as scheduled, so it will extend BeiGene (Tislelizumab) for unresectable or Target approval completion time for a New Drug Authorization Application (BLA) for second-line (2L) therapy in patients with metastatic esophageal squamous cell carcinoma (ESC.
There is a long way to go for innovative drugs to go overse.
Judging from the accumulated experience of these pharmaceutical companies' failure to break through the barriers, Chinese innovative pharmaceutical companies need to consider the rationality of clinical trial design, the clinical value of drugs, and registration strategies if they want to "go overseas" successful.
In addition, some analysts believe that it is necessary to comprehensively consider the selection of target countries, including disease spectrum, registration supervision, competition landscape/availability of existing treatments, unmet needs, patient population/epidemiology, tax environment, e.
, combined with the product itself Features Choose the right mark.
For access to the global market, it is necessary to formulate access strategies and sequences based on the international reference pricing of drugs, time to market, reimbursement time, access barriers, the number of eligible patients, and income trade-of.
Recently, Junshi Biotech, which failed to pass the test, once again challenged to go overse.
The company announced that the.
Food and Drug Administration (FDA) accepted its resubmitted Biologics License Application (BLA) for its PD-1 monoclonal antibody toripalimab in combination with gemcitabine/cisplat.
The FDA has now set a target review date for the Prescription Drug User Fee Act (PDUFA) of December 23, 202The results of the "breakthrough" FDA are expected to be announced before the end of this ye.
Nasopharyngeal carcinoma is a highly aggressive malignant tum.
Due to the high incidence in Asia, the development of innovative treatments for nasopharyngeal carcinoma in Europe and the United States is relatively sl.
At present, there is still a huge unmet need for the treatment of NPC patients in Europe and the United Stat.
It is reported that in March 2021, Junshi Bio became the first domestic PD-1 monoclonal antibody drug company to submit a marketing application to the FDA, and then the FDA required a BLA for the indication of toripalimab in nasopharyngeal canc.
Quality control process chang.
Now that the company is challenging to go overseas again, whether it can succeed is worth the expectations of the indust.
In China, in 2021, two new indications of toripalimab for nasopharyngeal carcinoma have been approved by the National Medical Products Administration (NMPA), becoming the world's first immune checkpoint inhibitor approved for the treatment of nasopharyngeal carcino.
Not long ago, the product (for the treatment of nasopharyngeal cancer) was also granted orphan drug designation by the European Commission (E.
Up to now, toripalimab has accumulated 6 orphan drug designations granted by the European Union and the United States drug regulatory agencies, involving the treatment of mucosal melanoma, nasopharyngeal cancer, soft tissue sarcoma, esophageal cancer and small cell lung canc.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
Although it is a general trend for innovative drugs to "go overseas", it is not easy for domestic new drugs to go overse.
At present, many pharmaceutical companies including Innovent Bio, Junshi Bio, and Chi-Med Pharmaceutical have experienced setbacks in going overse.
It is not easy for domestic new drugs to go overseas In March this year, Innovent announced that the “going overseas” had failed, and the marketing application of its core product sintilimab was not approved by the US F.
In May, Innovent Bio’s overseas cooperation regenerated wav.
The company announced that the authorized cooperation with the American pharmaceutical company Coherus (CH.
US) was terminated, and the second largest product, bevacizumab biosimilar (IBI-305), was recovered in the United Stat.
and Canadian interes.
On May 2, Junshi Bio announced that the marketing application of the PD-1 antibody toripalimab received a complete response letter (CRL) from the FDA, requiring a quality control process chan.
Also in May, Chi-Med's surufatinib application in the.
was reject.
In its response letter, the FDA noted that “data are insufficient” and that “more international multicenter clinical trials (MRCTs) representative of the.
patient population are needed to support approv.
”On July 14, BeiGene announced that due to the travel restrictions related to the epidemic, the US FDA could not complete the required on-site inspection work in China as scheduled, so it will extend BeiGene (Tislelizumab) for unresectable or Target approval completion time for a New Drug Authorization Application (BLA) for second-line (2L) therapy in patients with metastatic esophageal squamous cell carcinoma (ESC.
There is a long way to go for innovative drugs to go overse.
Judging from the accumulated experience of these pharmaceutical companies' failure to break through the barriers, Chinese innovative pharmaceutical companies need to consider the rationality of clinical trial design, the clinical value of drugs, and registration strategies if they want to "go overseas" successful.
In addition, some analysts believe that it is necessary to comprehensively consider the selection of target countries, including disease spectrum, registration supervision, competition landscape/availability of existing treatments, unmet needs, patient population/epidemiology, tax environment, e.
, combined with the product itself Features Choose the right mark.
For access to the global market, it is necessary to formulate access strategies and sequences based on the international reference pricing of drugs, time to market, reimbursement time, access barriers, the number of eligible patients, and income trade-of.
Recently, Junshi Biotech, which failed to pass the test, once again challenged to go overse.
The company announced that the.
Food and Drug Administration (FDA) accepted its resubmitted Biologics License Application (BLA) for its PD-1 monoclonal antibody toripalimab in combination with gemcitabine/cisplat.
The FDA has now set a target review date for the Prescription Drug User Fee Act (PDUFA) of December 23, 202The results of the "breakthrough" FDA are expected to be announced before the end of this ye.
Nasopharyngeal carcinoma is a highly aggressive malignant tum.
Due to the high incidence in Asia, the development of innovative treatments for nasopharyngeal carcinoma in Europe and the United States is relatively sl.
At present, there is still a huge unmet need for the treatment of NPC patients in Europe and the United Stat.
It is reported that in March 2021, Junshi Bio became the first domestic PD-1 monoclonal antibody drug company to submit a marketing application to the FDA, and then the FDA required a BLA for the indication of toripalimab in nasopharyngeal canc.
Quality control process chang.
Now that the company is challenging to go overseas again, whether it can succeed is worth the expectations of the indust.
In China, in 2021, two new indications of toripalimab for nasopharyngeal carcinoma have been approved by the National Medical Products Administration (NMPA), becoming the world's first immune checkpoint inhibitor approved for the treatment of nasopharyngeal carcino.
Not long ago, the product (for the treatment of nasopharyngeal cancer) was also granted orphan drug designation by the European Commission (E.
Up to now, toripalimab has accumulated 6 orphan drug designations granted by the European Union and the United States drug regulatory agencies, involving the treatment of mucosal melanoma, nasopharyngeal cancer, soft tissue sarcoma, esophageal cancer and small cell lung canc.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyo.
