BeiGene recently announced that Tevimbra, a monoclonal antibody, has been launched for sale in the United States for the treatment of unresectable or metastatic esophageal squamous cell carcinoma (ESCC) in adult patients who have not previously received systemic chemotherapy with PD - (L) 1 inhibitors. This is the first indication approved for the drug in the United States.
BeiGene North America General Manager Matt Shaulis said, "BeiGene has lowered the pricing of Trastuzumab by 10% compared to other approved PD-1 therapies for this indication to improve drug accessibility." According to foreign media Fierce Pharma, a spokesperson for BeiGene revealed that the average wholesale purchase price of Trastuzumab is estimated to be $15075 per month (approximately RMB 106300).
The other PD-1 therapies approved for this indication include Merck's Keytruda (pembrolizumab, commonly known as "K-drug") and Bristol Myers Squibb's Opdivo (nivolumab, commonly known as "O-drug"). The 100mg/4ml specification of K-drug is priced at $4800 (approximately RMB 33000) in the United States; The price of the 240mg specification of O drug in the United States is approximately $6500 (about 46000 RMB).
The price of Trastuzumab in the United States is 10% lower than that of K drug, which means that the price of Trastuzumab of the same specification is approximately $4320 (about RMB 30500). At the beginning of its launch in China in 2019, the price of Trastuzumab was 10688 yuan/100mg per vial; After negotiations with medical insurance, the price has now been adjusted to 1253.53 yuan per unit, and only about 376 yuan per unit is required after medical insurance payment. Even though the price of Trastuzumab monoclonal antibody has decreased compared to similar products, if calculated based on the above results, it still exceeds the domestic price by 20 times.
Due to differences in pricing systems for innovative drugs in different countries, an innovative drug entering different markets will be priced according to the local market system. Industry media, Medicine Magic Cube, has pointed out that existing public information shows that, in the context of different drug pricing systems in various countries around the world, Chinese drug prices are about 39% lower than the median reference price of the same drug in other countries, making it a "depression" in global prices.
On the contrary, the United States is the high ground for global drug prices. A research report by China Galaxy Securities Research Institute pointed out that the drug pricing system in the United States is mainly determined by market mechanisms, and the government does not directly intervene. Under this system, pharmaceutical companies are responsible for producing drugs and independently pricing them based on production costs and commercialization strategies, determining the nominal ex factory price as the basis for drug price negotiations, which is the wholesale procurement cost. Afterwards, multiple payment parties such as distributors, pharmacies, and pharmaceutical benefit management companies (PBMs) that represent insurance companies and sign contracts with pharmacies will also participate. Under the free pricing mechanism of the market, American pharmaceutical companies and intermediaries such as PBMs push drug prices to the global high through negotiation games, cultivating the most commercially valuable innovative drug market. The vast majority of global pharmaceutical companies regard entering the US market as a benchmark for measuring the commercial value of drugs.
The pricing of Trastuzumab in the United States is lower than that of similar products, possibly with the aim of competing for the market at a low price. The competitors of Trastuzumab in the United States are K-drug and O-drug. K Medicine achieved a revenue of $25.011 billion for the whole year of 2023, a year-on-year increase of 19%, and won the title of "Medicine King" in 2023; The global sales of O drug in 2023 will be 10.031 billion US dollars.
Moreover, the approval of Trastuzumab for marketing in the United States is based on the results of the RATIONALE 302 trial, which achieved the primary endpoint in the intention to treat (ITT) population. Compared with chemotherapy, Trastuzumab demonstrated statistically significant and clinically significant survival benefits.
In addition, the degree of clinical benefit is also one of the factors determining the pricing of new drugs. In the above experiment, the reference group for Trastuzumab was chemotherapy, and its clinical efficacy was not superior to similar drugs. Only by entering the market at a low price can we gain a glimmer of hope, given that K and O drugs have long dominated the market and Trastuzumab has not shown any superiority over its competitors.
If the clinical benefits of a new drug exceed those of existing drugs, even if the pricing is too high, the market will still buy it. Taking Zebutinib, another BTK inhibitor from BeiGene, as an example, in 2022, Zebutinib outperformed Ibrutinib in head to head trials, confirming its potential as the "best in class" BTK inhibitor globally. After opening in the United States, Zebutinib is priced at $12935 (120 pills/bottle) for a 30 day course, which is higher than Ibrutinib; In China, the negotiated price of Zebutinib for medical insurance is 5440 yuan per box (80mg, 64 pills), which is only about 1/16 of the price in the United States. Although Zebutinib is priced higher in the United States than the former "BTK leader" Ibutinib, it is still gradually eroding Ibutinib's market share with its "best in class" strength.
In addition, there are already multiple innovative drugs going abroad in China, and overseas pricing is much higher than in China. At the end of 2023, Junshi Biotech's PD-1 Terizumab was priced 30 times higher in the United States than in China, sparking industry discussions. Coherus, the American partner of Junshi Biotechnology, has disclosed that the selling price of Triprolizumab, which has been determined to be used for the treatment of nasopharyngeal carcinoma, is $8892.03 per bottle (approximately 63600 yuan) in the United States. In China, the medical insurance price for products of the same specification from Junshi Biology is 1912.96 yuan per bottle.
Coincidentally, at the end of 2023, Takeda Pharmaceuticals announced the price of its collaboration with Hwanghae Pharmaceuticals for Fruquintinib. Fruquintinib comes in two specifications, 1mg and 5mg, with each box containing 21 pills. The unit prices of the two specifications of products are 6300 US dollars (approximately 45100 RMB) and 25200 US dollars (approximately 180300 RMB), respectively. In China, the latest medical insurance pricing for Fruquintinib is 1885.38 yuan per box (1mg * 21 pills) and 2513.70 yuan per box (5mg * 7 pills).