Breaking through the inward siege, domestic innovative drugs enter the 2 trillion market!

On April 30, the FDA will announce the review results of two domestic new drugs, Chi-Med's surufatinib and Junshi Bio's toripalimab

Going overseas to explore: listing booms

In March 1959, Fosun Pharma's triamcinolone diacetate was approved (NDA) in the United States, becoming the earliest attempt of China's innovative drugs to go overseas

Before BeiGene's zanubrutinib, there were very few domestic innovative drugs that could successfully go overseas

ICH can realize the gradual mutual recognition of standard guidelines including data, eliminate many import and export re-registration procedures, and accelerate drug innovation and marketing

FDA listing applications for domestic innovative drugs (partial)

Source: Minenet finishing

Levoamlodipine maleate is an improved innovative drug of CSPC and will be launched in the United States in 2019

There were also times when domestic innovative drugs were blocked from going overseas.

Wanchun Pharmaceutical’s plinabulin was also stuck in the results of a single clinical trial.

In addition, the epidemic environment has also caused certain obstacles for local innovative drugs to go overseas.

It is worth noting that on a global scale, innovative drugs such as PD-1/L1 have problems of over-development, and the FDA has gradually tightened the market threshold for such innovative drugs

License-out: Accelerate technology clearance globally

For most of the domestic innovative drug companies, there are still a few companies that can fully own their own overseas sales teams.

With the release of the drug device review and approval reform system and the continuous introduction of overseas talents, the import and export environment for innovative drugs has been further opened, and the number of license-outs has increased sharply.

In recent years, the license-out project of domestic innovative drugs exceeding 1 billion US dollars (part)

Source: Minenet finishing

At the beginning of 2021, BeiGene announced that it had reached a cooperation and licensing agreement with Novartis on the development, production and commercialization of tililizumab in multiple countries.

In addition to BeiGene, companies such as Rongchang Biology and Tianyan Biology also performed well

From the perspective of overseas development experience, the license-out model mainly focuses on emerging Biotech companies.

Riding the Waves: No Shortcut to Landing

From a long-term perspective, it is not realistic for China to follow the development of American Biotech.

Secondly, after China joined the ICH, the domestic innovative drug review and approval guidelines are also closely measured by international standards.

For innovative pharmaceutical companies, there is no shortcut to internationalization
.
If an innovative drug is to successfully "go to sea", excellent technology, strong team, and strong capital are only the necessary hard conditions for innovative pharmaceutical companies
.
On this basis, companies need to have a forward-looking vision in terms of clinical needs, drug therapy, etc.
, tap their core competitiveness and unique advantages according to their own optimization, and achieve differentiated layout centered on clinical value
.
In addition, every step of the process from R&D project establishment, clinical design to clinical trial must be strictly implemented in accordance with international standards.
During this period, sufficient communication with the FDA is maintained to minimize risks.
This is also the reason why major international pharmaceutical companies are currently working in the FDA.
The reason for the location of the office near Maryland
.

Epilogue

In general, in the "post-ICH" era, China's innovative drugs are more vigorous in going overseas, and companies such as BeiGene and Junshi, the first companies to explore overseas, have shown outstanding results in overseas commercialization in 2021
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From the perspective of macro orientation, the internationalization of domestic innovative drugs will become a fixed trend in the future, which will further guide innovative pharmaceutical companies to return to the essence of clinical needs and seek breakthroughs in new targets and new therapies
.
At present, domestic innovative drugs are mainly focused on the two fields of small molecules and biological drugs, but it is difficult to make breakthroughs in Chinese patent medicines with domestic characteristics.
So far, no domestic Chinese patent medicines have been listed in the United States
.
Some experts believe that Chinese patent medicines need to focus on two aspects: quality control and clinical practice, and the market should also give Chinese patent medicines more patience.
It still takes time to verify in the future
.