Innovative Drugs of Chinese Pharmaceutical Companies have Obtained Overseas Authorization and Developed Rapidly

In March 2007, Chipscreen licensed the global development rights of chidamide, a product under research, to HUYA of the United States at a price of USD 28 million. This transaction represents that Chinese local pharmaceutical companies have embarked on a new jurney to authorize innovative drugs in overseas markets. 

In recent years, with the continuous improvement of the overall R&D environment of innovative drugs in China and the constant improvement of the innovation capability of local pharmaceutical companies, innovative drugs independently developed by China have gained increasing attraction and recognition in the international market. After years of accumulation, the pipelines of Chinese innovative drugs under research are gradually abundant, and the products under research are maturing gradually. The number and overall amount of innovative drug projects authorized in overseas market are increasing. According to statistics, before 2014, there were 4 innovative drugs authorized in overseas markets, and the number has increased to 65 up to now. 

Participation of many local pharmaceutical companies and the multi-target distribution of overseas authorized innovative drugs 

There are 37 local pharmaceutical enterprises that are overseas licensors of innovative drugs in China, including innovative biopharmaceutical companies represented by Innovent and BeiGene; large Chinese pharmaceutical companies that have been internationalized for many years, such as Hengrui Medicine; and traditional pharmaceutical companies that have transformed into making innovative drugs, represented by I-Mab Biopharma and Luye Pharma. 

The innovative drug types authorized in overseas markets include small-molecule, monoclonal-antibody and double-antibody drugs. From the target distribution of authorized innovative drugs overseas, broad-spectrum targets such as VEGF and PD-1/PD-L1 occupy a dominant position. The external authorized enterprises of these innovative drugs involve Bio-Thera, Betta Pharmaceuticals, Innovent, Hengrui Medicine, etc. In terms of targets for specific disease fields such as BTK, EGFR and HER2, pharmaceutical companies including Allist, BeiGene and Remegen have authorized relevant innovative drug varieties. 

From the current development trend, the innovative drug targets authorized by Chinese pharmaceutical companies are gradually laid out and extended in many disease fields, and the types of innovative drugs under research are becoming increasingly rich. 

In 2020, the number of overseas authorizations by Chinese local pharmaceutical companies reached a new high. 

Thanks to the support of Chinese pharmaceutical policies, and help of financing fields for the R&D of innovative drug, Chinese local pharmaceutical companies have put greater focus on their R&D and innovation in recent years. Since 2017, the number and average amount of innovative drugs authorized by Chinese local pharmaceutical companies have gradually increased. 

In 2020, 18 Chinese local pharmaceutical companies have finished their authorizations in overseas markets of 23 innovative drug projects, which has reached a new high. Such therapeutic fields as anti-tumor, ophthalmology, psychiatry, non-alcoholic steatohepatitis, diabetes and COVID-19 are incorporated. There is a historical record in terms of the number of authorizations. The targets of innovative drugs include VEGF, PD-1, BTK, EGFR, CD47, etc. and there are such types of small-molecule, monoclonal-antibody, ADC, double-antibody drugs etc. 

It is worth noting that in 2020, the transaction volume of two overseas authorizations exceeds USD 1 billion. The total transaction amount of PD-1 monoclonal antibody CS1001 authorized by Cstone Pharmaceuticals to EQRx reached USD 1.3 billion, and the total transaction amount of monoclonal antibody antitumor drug Lemzoparlimab authorized by I-Mab Biopharma to Abbvie reached USD 2 billion. 

In 2021, the transaction of authorization is active and the amount of single transaction hit a new record. 

In 2021, Chinese local pharmaceutical companies were still active in external authorization transactions, maintaining the good development momentum in 2020. According to the authorization transactions disclosed by bio pharmaceuticals companies, the total transaction amount was as high as RMB 29.5 billion. Certain therapeutic fields, such as tumors, rare diseases, immune diseases, COVID-19 and multiple sclerosis, are incorporated. 

At the same time, the transaction amount reached a new high, and the performance of Chinese licensors was great. In January 2021, BeiGene and Novartis entered into a cooperation agreement on the development rights of PD-1 monoclonal antibody tislelizumab in many countries, with a total transaction amount of USD 2.2 billion. In September, Remegen reached a cooperation agreement with Seagen on its ADC drug - disitamab vedotin, which is intended to be used for the treatment of gastric cancer. The total transaction amount of USD 2.6 billion, including the down payment of 200 million US dollars and a milestone payment of USD 2.4 billion, sets a new record for overseas authorization of Chinese pharmaceutical companies in innovative drug. 

In addition to the above two transactions exceeding USD 2 billion, the authorized transaction amount of Junshi Biosciences in February and Innocare Pharma in July both exceeded USD 1 billion.

With the further improvement of Chinese innovation strength, Chinese local innovative pharmaceutical companies will gradually integrate into the global market of innovative drug, and their R&D capabilities will gradually be recognized by the international market. In the future, the transaction on overseas authorization of innovative drugs will be more active and frequent, and the transaction amount of projects is expected to reach new heights. The hard power to participate in international competition will become much stronger. 

About  the Author:    

Xiaoyaowan, a pharmaceutical industry practitioner, a word carrier in the We-media era focusing on changes of the pharma industry.