Domestic Hepatocellular Carcinoma Drugs Line Up for Market Entry, Potentially Breaking Bayer's Originator Monopoly

　　【Pharmaceutical Network Industry News】Recent reports indicate that Nanjing Chia-TaiTianqing's application for the marketing approval of Regorafenib Tablets under the Class 4 generic drug pathway has been accepted. Regorafenib blocks multiple enzymes that promote tumor growth and inhibits tumorigenesis, angiogenesis, and tumor microenvironment formation by targeting multiple kinases in tumor cells, endothelial cells, and peripheral cells.
 

Regorafenib, developed by Bayer, is primarily indicated for the treatment of colorectal cancer, hepatocellular carcinoma, and gastrointestinal stromal tumors. In March 2017, regorafenib received marketing approval in China and is commonly used as a second-line treatment for liver cancer.
 

China has a high incidence of liver cancer, with approximately 466,000 new cases diagnosed annually, alongside 376,000 new cases of colorectal cancer each year. Due to their continuously rising patient populations, these two major malignancies have become critical malignant diseases that severely threaten public health and lives. In the field of liver cancer treatment, regorafenib has ushered in an era of comprehensive, full-course pharmacological management. Data from Asian populations indicate an overall survival of up to 16.3 months for the monotherapy cohort, while Chinese data demonstrate that a sequential sorafenib-to-regorafenib regimen extends overall survival to up to 35.3 months. In the treatment of metastatic colorectal cancer, Chinese real-world studies show that a 120 mg regorafenib dose provides a survival benefit of up to 16.7 months.
 

Regorafenib's sales have been steadily rising in recent years. According to the Insight database, Regorafenib's sales reached $458 million in 2019. Data from Menet indicates that sales of Regorafenib in China exceeded RMB 30 million in 2018. Following its inclusion in the national medical insurance catalog, its sales volume surged rapidly, reaching RMB 387 million in 2019. Sales continued to grow in 2020, surpassing RMB 600 million, with the first half alone reaching RMB 342 million. It is understood that the market for this drug is primarily concentrated in urban public hospitals. However, with the advancement of the tiered diagnosis and treatment policy in recent years, pharmaceutical companies are increasingly focusing on lower-tier markets, and the market for this product in county-level public hospitals is gradually expanding.
 

From a market landscape perspective, currently, in China, the originator Bayer is the sole manufacturer of Regorafenib tablets. However, generics produced in China are racing to secure market approval. In addition to Chia-Tai Tianqing, Yangzijiang submitted a marketing authorization application for its Regorafenib tablets in April 2021, which is currently under regulatory review. Furthermore, more than 20 pharmaceutical companies have established pipelines for Regorafenib, involving enterprises such as CSPC, Qilu, Kelun, and Shuanglu. Among them, five companies are conducting bioequivalence (BE) studies, while 15 have filed applications for clinical trials. In the future, with the market launch of these domestically produced drugs, Bayer's monopoly on the originator product is expected to be broken, allowing these companies to capture a share of this multi-hundred-million-yuan market.
 

It is understood that shortly after its launch in China, Regorafenib was priced at over 10,000 RMB per box. Following its inclusion in the national medical insurance in 2018, the price was reduced to approximately 5,400 RMB per box. However, with a monthly consumption of three boxes, patients still faced medication costs exceeding 16,000 RMB. In December 2020, Regorafenib successfully renewed its national medical insurance coverage and will undergo another price reduction, continuing to benefit Chinese patients with hepatocellular carcinoma, colorectal cancer, and gastrointestinal stromal tumors. For patients, the successful market launch of domestically produced alternatives that are more affordable than the originator drug would represent another significant positive development, further helping to alleviate the financial burden of medication costs.
 

According to available data, Nanjing Chia Tai Tianqing's product portfolio spans five major therapeutic areas: cardiovascular and cerebrovascular, oncology, surgical, anesthesiology, and anti-infectives. Since 2018, the company has launched an average of five new products annually. From 2021 to the present, Nanjing Chia Tai Tianqing has received marketing approval for six products. Additionally, three products, including tedizolid phosphate tablets and tedizolid phosphate for injection, are currently under regulatory review for marketing approval.