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On October 8, BeiGene announced that its product Baiyueze® (Zebutinib) was approved in Australia for the treatment of adult patients with Fahrenheit's macroglobulinemia who had previously received at least one therapy, or as a first-line therapy It is used to treat patients who are not suitable for chemoimmunotherapy
.
In addition to being approved in Australia, in May of this year, the U.
S.
Food and Drug Administration (FDA) has also accepted Baiyueze® for the treatment of marginal zone lymphoma (MZL) adults who have previously received at least one CD20-directed therapy The patient’s New Indication Marketing Application (sNDA) and granted priority review qualifications
.
In addition, it has recently been approved by the Singapore Health Sciences Authority (HSA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one treatment in the past
.
It is worth mentioning that on the same day, E-Bio also announced that the European Medicines Agency (EMA) has officially accepted E-Bio’s Ryzneuta™ for the treatment of chemotherapy-induced neutropenia (CIN) for marketing authorization (MAA).
And has started a centralized review process
.
In addition to submitting the MAA to the EMA, Yiyi Biosciences also submitted a new drug marketing application (BLA) to the US FDA earlier this year.
According to the Prescription Drug User Fee Act (PDUFA), the FDA has made a decision on the marketing application of Ryzneuta™.
The date is March 30, 2022
.
In addition, on August 1st, Deck Pharmaceuticals announced that the company's oral XPO1 inhibitor Celinisolone combined with dexamethasone NDA has also passed the priority review process of the Korean Ministry of Food and Drug Safety (MFDS)
.
From the above point of view, industry analysts believe that with the continuous deepening of centralized procurement and medical insurance control fees, and the continuous squeeze of the profit margin of the domestic pharmaceutical market, more and more innovative drug companies and traditional pharmaceutical companies seeking to transform are One after another, they are choosing to go overseas to expand the market
.
Among them, the number of companies that choose Sino-US dual reporting and even global reporting is increasing
.
The industry predicts that with the continuous and vigorous development of Chinese local innovative drug companies, more and more independently developed innovative drugs will be accepted by other countries and overseas pharmaceutical companies
.
In fact, according to incomplete statistics, there were a total of 100 license out transactions from 2007 to 2020, and a total of 67 transactions since 2020, surpassing the sum of previous years and accounting for 67% of the total in 13 years
.
Among them, as of August 31, 2021, the number of transactions is even closer to the total number of 2020
.
In the future, under the background that domestic innovative drugs continue to be exported to the sea, the industry believes that domestic pharmaceutical companies will innovate from the perspective of clinical needs, and will achieve full innovation through the selection of new targets and new mechanisms of action; at the same time, the Market competition may also become more and more overseas
.
However, it should be noted that while Sinopharm’s going global and participating in global competition will become the general trend, “going global” is expected to face a serious lag in the recognition of China’s pharmaceutical industry by relevant national laws and regulations, as well as in terms of talents and capital.
There are also many problems such as urgent need for reinforcement
.
Therefore, the industry suggests that all parties in the society and their companies need to work together to better accelerate China's innovative drugs to the global market
.
.
In addition to being approved in Australia, in May of this year, the U.
S.
Food and Drug Administration (FDA) has also accepted Baiyueze® for the treatment of marginal zone lymphoma (MZL) adults who have previously received at least one CD20-directed therapy The patient’s New Indication Marketing Application (sNDA) and granted priority review qualifications
.
In addition, it has recently been approved by the Singapore Health Sciences Authority (HSA) for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one treatment in the past
.
It is worth mentioning that on the same day, E-Bio also announced that the European Medicines Agency (EMA) has officially accepted E-Bio’s Ryzneuta™ for the treatment of chemotherapy-induced neutropenia (CIN) for marketing authorization (MAA).
And has started a centralized review process
.
In addition to submitting the MAA to the EMA, Yiyi Biosciences also submitted a new drug marketing application (BLA) to the US FDA earlier this year.
According to the Prescription Drug User Fee Act (PDUFA), the FDA has made a decision on the marketing application of Ryzneuta™.
The date is March 30, 2022
.
In addition, on August 1st, Deck Pharmaceuticals announced that the company's oral XPO1 inhibitor Celinisolone combined with dexamethasone NDA has also passed the priority review process of the Korean Ministry of Food and Drug Safety (MFDS)
.
From the above point of view, industry analysts believe that with the continuous deepening of centralized procurement and medical insurance control fees, and the continuous squeeze of the profit margin of the domestic pharmaceutical market, more and more innovative drug companies and traditional pharmaceutical companies seeking to transform are One after another, they are choosing to go overseas to expand the market
.
Among them, the number of companies that choose Sino-US dual reporting and even global reporting is increasing
.
The industry predicts that with the continuous and vigorous development of Chinese local innovative drug companies, more and more independently developed innovative drugs will be accepted by other countries and overseas pharmaceutical companies
.
In fact, according to incomplete statistics, there were a total of 100 license out transactions from 2007 to 2020, and a total of 67 transactions since 2020, surpassing the sum of previous years and accounting for 67% of the total in 13 years
.
Among them, as of August 31, 2021, the number of transactions is even closer to the total number of 2020
.
In the future, under the background that domestic innovative drugs continue to be exported to the sea, the industry believes that domestic pharmaceutical companies will innovate from the perspective of clinical needs, and will achieve full innovation through the selection of new targets and new mechanisms of action; at the same time, the Market competition may also become more and more overseas
.
However, it should be noted that while Sinopharm’s going global and participating in global competition will become the general trend, “going global” is expected to face a serious lag in the recognition of China’s pharmaceutical industry by relevant national laws and regulations, as well as in terms of talents and capital.
There are also many problems such as urgent need for reinforcement
.
Therefore, the industry suggests that all parties in the society and their companies need to work together to better accelerate China's innovative drugs to the global market
.
