The idea that innovative pharmaceuticals independently researched and developed by China could be sold at premium prices in overseas markets used to be a fantasy. Today, that is no longer the case.
According to data from the National Medical Products Administration, the number of applications and approvals for self-developed new drugs in China has continued to rise -- some 402, 448 and 528 applications for Category 1 innovative drugs were accepted in 2017, 2018 and 2019, respectively.
Furthermore, China has witnessed rapid growth in the total number of relevant applications for three consecutive years. Since 2018, a total of 35 Category 1 innovative drugs have been given approval to enter the market, bringing China’s innovative drugs steadily to the forefront of the world level.
Song Ruilin, executive president of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), said that at present, there are two indicators that measure the level of innovative drugs in a country: one is the total number of drugs under study and declaration, and the other is the number of new drugs approved. In the former indicator, China ranks second in the world, and ranks third in the latter.
"Globally, China, as a developing country, has made remarkable progress in the development of innovative drugs," said Song, adding that China now ranks among the top three in the world in this field, the highest in the country's history.
China's innovative drugs have also been making their presence more felt in the overseas market. On Nov. 15, 2019, an innovative drug named BRUKINSA from BeiGene, a Chinese maker of cancer medicines, received accelerated approval from the U.S. Food and Drug Administration (FDA), becoming the first Chinese anti-tumor drug approved for the U.S. market.
Following in the footsteps of BRUKINSA, an increasing number of drugs manufactured by China's major pharmaceutical companies have started to target overseas markets. Almonertinib Mesilate tablets of the third-generation EGFR tyrosine kinase inhibitor (TKI) from Hansoh Pharma and the recombinant mycobacterium tuberculosis fusion protein (EC) Ekear from Zhifei Biological Products Co., Ltd. serve as notable examples.
This achievement can be attributed to years of efforts from China, said Professor Shen Lin, vice president of Peking University Cancer Hospital. From Shen's perspective, the large number of returnees to China and multinational enterprises and their professionals focusing on the China market have greatly promoted the development of innovative drugs in China.