Significant increases in incidence rates have made cancer a high priority in China. Despite major government reforms to reduce cancer burdens, problems remain. To fulfill its agenda in cancer innovation, China is embracing new frontiers and opportunities.
Assessing the Oncology burden in China
China has the largest number of cancer patients globally - Around 4.3 million new cancer cases were reported in 2018; the numbers are expected to grow to 6.7 million by 2040. There is an urgent and continued demand for better cancer treatment strategies in China.
China has approximately 50% of the global gastric cancer, hepatocellular carcinoma, and esophageal cancer cases. Lung cancer is the major cause of cancer mortality in China, with an overall five-year survival rate of 36%. Late diagnosis is a key factor responsible for exacerbating the disease; approximately 55 % of patients in China are diagnosed with hepatocellular carcinoma in the later stage of the disease. China also exhibits a unique epidemiological and patient profile. For instance, the EGFR mutation frequencies in Chinese patients with lung adenocarcinoma are higher than those reported in USA/European patients.
China’s oncology market represents 37% of all lung cancer, 44% of stomach cancer, and 52% of liver cancer patients globally. Though significant advances have been made in basic research and improved access to care, there are many challenges. Much more needs to be done to accelerate the growth of innovation in cancer therapy. Late diagnosis, low biomarker testing rates, and varying treatment quality are some of the hurdles which China faces. Most patients in China are diagnosed at a later stage of the disease and have limited access to an early screening. Local governments and pharma companies are working on early-screening programs for some cancers. The adoption rate of cancer-biomarker testing varies across different hospital tiers in China. In the top 500 hospitals, the testing rate for mutations such as EGFR and HER2 can reach up to 80 to 95 %; however, due to high costs and constrained availability, the next-generation sequencing testing rate is only 15 %. Treatment capacities, capabilities, and standards also vary across different classes of hospitals.
The hurdles in the road to innovation
1. The lack of new molecular entities
As high expenses and risk are involved in discovering new molecular entities, most Chinese biopharma companies avoid the gamble and focus on follow-on drugs with best-in-class potential. These strategies, although practical, might not promote innovative drug development in the long-term.
There is a severe lack of new molecular entities in phase 1 studies. The majority of the investigational new drugs or type 1 innovative drugs by the National Center for Drug Evaluation are drugs modified from existing molecular entities.
2. Lack of well-equipped study sites and severe inequality in the geographical distribution of studies
Despite the increase in phase 1 studies, there has been a scarcity of fully equipped study sites in China. There is also an imbalance in the geographical distribution of studies done across the country - 73% of the phase I studies were done in Beijing, Shanghai, or Guangzhou, the largest cities in China. Inequality in the distribution of phase 1 study sites also indicates the disparities in medical resources among different regions in China.
3. Repetitive study designs in phase 1 trials
The utilization of repetitive study designs in phase 1 trials is another loophole. The majority of the phase 1 trials in China replicate the studies done abroad and fail to include characteristics of the Chinese population. Also, most of the studies sponsored by multinational companies are pharmacokinetics or pharmacodynamic studies that assess the pharmacokinetics and pharmacodynamics profile of the Chinese population.
The role of China’s drug regulatory reform in reshaping the biopharmaceutical industry
“Drug lag” is recognized as a major issue responsible for the scarcity of innovative drugs in China. A lengthy drug review process, lack of locally developed innovative drugs, strict regulations in the clinical trial application, and import drug registration - all have hampered drug innovation. To tack...
(All Rights Reserved)