China has a large patient base with significant unmet clinical needs, which has promoted the rapid development of the pharmaceutical market in recent years.
Imports of pharmaceutical products grew 383% in the last decade (from 2010 to 2020), reaching 34,010 million dollars.
Conversely, China’s pharmaceutical exports were US$13.214 billion in 2020, up 195% from 2010, according to data from the China General Administration of Customs.
Since 2016, according to the company Simcere Pharmaceutical Group, the acceleration of the review and approval of pharmaceutical products in China, the expanded coverage of the National Reimbursement Drug List, and increased investment from the capital market fueled the flourishing development of R& D of innovative pharmaceutical products.
In 2021, regulatory authorities issued the Guiding Principles for Clinical Research and Development for Antitumor Drugs of Clinical Value, which set out strict requirements for differentiated innovation as a source of evaluation to guide innovative pharmaceutical companies to avoid duplication of low level and develop products with the practical value of clinical innovation based on actual needs.
Both pharmaceutical companies and innovative biotech corporations will need to further demonstrate their own ability in the two critical elements of registration for marketing and commercialization if they are to demonstrate the value of innovation.
Pharmaceutical market
As the development of innovative pharmaceutical products in China has entered the 2.0 era, innovative companies must adhere to being patient-oriented, keep in line with forward-looking differentiation in the pursuit of high-quality development, in order to to develop professional and mature innovative medicine R&D and marketing ability.
In particular, Simcere has achieved remarkable results in innovation-oriented transformation and has become a pharmaceutical company focused on innovative pharmaceutical business.
The company focuses on three therapeutic areas including oncology, nervous system and autoimmunity with a prospective design of disease areas with significant clinical needs in the future.
In these three main areas, the company has five innovative pharmaceutical products approved for marketing and sale (including one imported innovative pharmaceutical product).
