At present, a series of policies and regulations have been issued to promote the development of the pharmaceutical industry, and the implementation of these policies has released "positive" signals
to the innovative drug market.
Affected by this, while the R&D strength of local pharmaceutical companies is constantly improving, the willingness of pharmaceutical companies to go overseas is also increasing
.
It is reported that in recent years, the license out incident of innovative drugs in China has been constantly occurring
.
In 2023, the willingness of domestic innovative drugs to go overseas will continue to increase (Image source; Pharma Network)
Domestic innovation strength is increasingly recognized, and going overseas is accelerating
Some time ago, Kelun Pharmaceutical reached an overseas rights authorization with Merck for 7 preclinical ADC drugs, with a total milestone of up to US$9.
3 billion
.
Prior to this, Akeso also announced a "going overseas" licensing agreement for its bispecific antibody Ivosi, with a total transaction value of up to $5 billion
.
It is worth mentioning that on December 27, 2022, Fosun Pharma and Henlius officially reached an authorized cooperation
on anti-PD-1 monoclonal antibody H drugs in the United States.
Analysts believe that this means that Henlius and Fosun Pharma will jointly enter the US market
.
Of course, in addition to the above pharmaceutical companies, a large number of companies such as Lixin Pharmaceutical, Harbour Biologics, WuXi Biologics, Akeso, Pregin Biologics, 3SBio, and Innovent Biologics have also announced the news of authorized cooperation of innovative drugs to go overseas
.
In this regard, the industry said that the frequent license out transactions mean that the innovation ability of domestic new drugs is constantly increasing, and the innovation strength of domestic pharmaceutical companies has been increasingly recognized
by multinational pharmaceutical companies.
According to the current development trend of the industry, the layout and implementation of the globalization strategy of innovative drugs has become the only way
to achieve development and growth and become one of the world's pharmaceutical giants.
Therefore, in the future, with the continuous improvement of the innovation ability of domestic pharmaceutical companies, the willingness of domestic innovative drugs to go overseas is expected to continue to increase
.
Based on the investment logic of internationalization, the industry recommends paying attention to products with real BIC/FIC potential, as well as related companies, such as BeiGene, Remegen, InnoCare, Ditzhe, Keji Pharmaceutical, Conoya, Innovent Biologics, Junshi Biologics, Akeso, etc
.
There are still many difficulties in domestic innovative drugs going overseas
However, it is important to note that having the determination to go to sea does not mean that every step is smooth
.
In fact, there are still many difficulties in the current domestic innovative drugs going overseas
.
For example, from the perspective of disease fields, the current overseas authorized products are mainly concentrated in the field of anti-tumor, followed by the fields
of metabolism, pain and autoimmune diseases.
In addition, the greater difficulty in going to sea is the drug itself
.
In recent years, insufficient clinical data is also becoming the reason for
the frequent setbacks of domestic innovative drugs going overseas.
For example, in May 2022, Junshi Biologics announced that it received a full response letter from the FDA regarding teripulimab BLA requesting a quality control process change
that the company believes is easier to complete.
In addition, Hutchison has been required to include more international multicenter clinical trials representing the U.
S.
patient population to support the approval of sulfatinib in the U.
S.
; Wanchun Pharmaceutical's Plinabulin also requires additional controlled trials to support substantial evidence for its indications.
.
.
So in the context of the increasing willingness of domestic innovative drugs to go overseas, how should pharmaceutical companies solve the above problems? The industry proposes that local innovative drugs should do three things when going overseas: the first point is "new", and the product or treatment plan should be distinctive and differentiated, which is truly new and can meet unmet clinical needs; The second point is "early", starting from the first day of the product project to prepare for going to sea, through preclinical, clinical, CMC (chemical component production and control), production, etc.
; The third point is "compliance", when pharmaceutical companies carry out preclinical and international multi-center clinical trials for the world, they must be very familiar with international standards, trial quality control, international registration, etc.
, and operate
in accordance with regulations.
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