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In recent years, benefiting from policies, talents, and capital increase, the domestic innovative drug industry has developed rapidly, and going overseas has also become an important part of international pharmaceutical companies to build overseas markets
.
However, there are many uncertainties in going overseas.
The recent news of FDA's refusal to approve Cinda PD-1 has brought a trace of concern to the industry, and it has also caused a certain blow to the confidence of other innovative drugs going overseas
.
However, from the perspective of the industry, although the road for Chinese innovative drugs to go overseas is difficult, the decision and courage of pharmaceutical companies to break through the FDA has not diminished the momentum of going overseas
.
On April 1, Yifan Pharmaceutical announced that its holding subsidiary, Yiyi Bio, received an email notification from the FDA that due to travel restrictions, the FDA would postpone the use of its research product, albegrastim α injection, for the prevention and treatment of tumors.
Marketing application approval for patient with neutropenia during chemotherapy
.
Public information shows that ebeggravstim α injection is an innovative biological drug product developed based on the existing Di-KineTM bi-molecular technology platform of Yiyi Biotechnology, which is based on Fc fusion protein technology and expressed by CHO cells.
-CSF dimer with long-acting and potent biological properties
.
The product has successfully achieved the pre-set goals of clinical trials in Phase I, Phase II and Phase III clinical trials conducted at home and abroad
.
Clinical data show that elbergrostim α injection shows non-inferiority in the main indicators such as immunogenicity and overall infection rate
.
On March 30, 2021, Yiyi Bio submitted a Biologics License Application (BLA) for F-627 to the FDA for the prevention and treatment of neutropenia in cancer patients during chemotherapy
.
About 2 months later, Yiyi Bio received an acceptance letter from the FDA, stipulating that the target date for approval of the drug was March 30, 2022
.
In response to the approval of this extension of the product's marketing application, the FDA said that until on-site inspections are completed; once safe travel resumes, and when public health and other factors permit, it will actively identify a way to complete the unfinished on-site an examination
.
It is reported that the drug is Yiyi Bio’s first innovative drug product.
In addition to sprinting to the FDA, the drug’s marketing application was accepted by the European EMA in 2021
.
In addition, the domestic listing application has also been accepted recently
.
From the perspective of the commercialization process, Chia Tai Tianqing has reached a cooperation with Yiyi Biotech to obtain the exclusive commercialization rights of the product in China, and Yifan Pharmaceutical has also received a license fee of no more than 210 million yuan and graded net sales.
Amount of commission fee
.
After the start of the year in 2022, Yifan Pharmaceutical has successively signed exclusive license agreements with KALTQ, APOGEPHA and other companies, and is expected to gradually open the European market in the future
.
It is worth mentioning that, unlike China's market expansion strategy, Yifan Pharmaceuticals currently adopts a cooperative sales model in three European countries including Germany, that is, KALTEQ and APOGEPHA are only albegrastim α injection in Greece, Exclusive distributor in Cyprus and Germany, and charges exclusive distributorship fees and milestone payments
.
The industry believes that the acceptance of this model by European companies means that the clinical and market value of the product has been recognized, which will help to accelerate the internationalization of Yifan Pharmaceuticals, and also provide some confidence and expectations for China's innovative drugs to go overseas
.
Yifan Pharmaceutical stated that at present, the company has responded to all questions raised by the FDA during the technical review of F-627
.
The inability to conduct production site inspections this time due to travel restrictions is not a delay caused by the F-627 program itself
.
The company will actively prepare for the on-site inspection of production, meet the on-site inspection of the FDA at any time, and strive to promote the listing of F-627 as soon as possible
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
.
However, there are many uncertainties in going overseas.
The recent news of FDA's refusal to approve Cinda PD-1 has brought a trace of concern to the industry, and it has also caused a certain blow to the confidence of other innovative drugs going overseas
.
However, from the perspective of the industry, although the road for Chinese innovative drugs to go overseas is difficult, the decision and courage of pharmaceutical companies to break through the FDA has not diminished the momentum of going overseas
.
On April 1, Yifan Pharmaceutical announced that its holding subsidiary, Yiyi Bio, received an email notification from the FDA that due to travel restrictions, the FDA would postpone the use of its research product, albegrastim α injection, for the prevention and treatment of tumors.
Marketing application approval for patient with neutropenia during chemotherapy
.
Public information shows that ebeggravstim α injection is an innovative biological drug product developed based on the existing Di-KineTM bi-molecular technology platform of Yiyi Biotechnology, which is based on Fc fusion protein technology and expressed by CHO cells.
-CSF dimer with long-acting and potent biological properties
.
The product has successfully achieved the pre-set goals of clinical trials in Phase I, Phase II and Phase III clinical trials conducted at home and abroad
.
Clinical data show that elbergrostim α injection shows non-inferiority in the main indicators such as immunogenicity and overall infection rate
.
On March 30, 2021, Yiyi Bio submitted a Biologics License Application (BLA) for F-627 to the FDA for the prevention and treatment of neutropenia in cancer patients during chemotherapy
.
About 2 months later, Yiyi Bio received an acceptance letter from the FDA, stipulating that the target date for approval of the drug was March 30, 2022
.
In response to the approval of this extension of the product's marketing application, the FDA said that until on-site inspections are completed; once safe travel resumes, and when public health and other factors permit, it will actively identify a way to complete the unfinished on-site an examination
.
It is reported that the drug is Yiyi Bio’s first innovative drug product.
In addition to sprinting to the FDA, the drug’s marketing application was accepted by the European EMA in 2021
.
In addition, the domestic listing application has also been accepted recently
.
From the perspective of the commercialization process, Chia Tai Tianqing has reached a cooperation with Yiyi Biotech to obtain the exclusive commercialization rights of the product in China, and Yifan Pharmaceutical has also received a license fee of no more than 210 million yuan and graded net sales.
Amount of commission fee
.
After the start of the year in 2022, Yifan Pharmaceutical has successively signed exclusive license agreements with KALTQ, APOGEPHA and other companies, and is expected to gradually open the European market in the future
.
It is worth mentioning that, unlike China's market expansion strategy, Yifan Pharmaceuticals currently adopts a cooperative sales model in three European countries including Germany, that is, KALTEQ and APOGEPHA are only albegrastim α injection in Greece, Exclusive distributor in Cyprus and Germany, and charges exclusive distributorship fees and milestone payments
.
The industry believes that the acceptance of this model by European companies means that the clinical and market value of the product has been recognized, which will help to accelerate the internationalization of Yifan Pharmaceuticals, and also provide some confidence and expectations for China's innovative drugs to go overseas
.
Yifan Pharmaceutical stated that at present, the company has responded to all questions raised by the FDA during the technical review of F-627
.
The inability to conduct production site inspections this time due to travel restrictions is not a delay caused by the F-627 program itself
.
The company will actively prepare for the on-site inspection of production, meet the on-site inspection of the FDA at any time, and strive to promote the listing of F-627 as soon as possible
.
Disclaimer: Under no circumstances does the information or opinions expressed in this article constitute investment advice to anyone
.
