As oncology is increasingly moving toward a personalized treatment approach, the use of biomarkers may enable patients to receive more efficacious treatment.  At the same time, biomarkers may actually limit the uptake of their respective targeted therapies. How has this biomarker “double-edged sword” shaped the China oncology drug market?

Multiple oncology biomarkers, such as EGFR, RAS, HER2, BRCA, have been discovered and have led to development and approvals of biomarker-targeted therapies. In 2002, Herceptin was approved in China for HER2-positive breast cancer, and became the first biomarker-driven oncology therapy in this market. Currently, there are seven total biomarker-driven agents across multiple oncology indications launched in China, including a local product Conmana, an EGFR inhibitor for NSCLC. Multiple emerging therapies with companion biomarker tests, such as Novartis’s Zykadia (ceritinib) and AstraZeneca’s Lynparza (olaparib), are expected to gain approvals in the Chinese market through 2020.

Biomarkers are found to increase the likelihood of approval (LOA) for clinical studies of related treatments. In an analysis from Biomedtracker, 512 phase transitions out of 9,985 (5%) were identified that incorporated a selection biomarker for patient stratification. The benefit from selection biomarker use raises the LOA from Phase I to 25% compared to less than 10% when no selection biomarker was used. A study by Jardim DL, et al a reported that a biomarker-based approach was associated with improved efficacy outcomes for FDA-approved anticancer agents. In another analysis for NSCLC clinical trials b, 676 trials were analyzed and biomarker targeted therapies were found to have a much higher (62%) approval rating compared to 11% for all trials. After the drugs launch, the companion biomarker tests are used to identify patient subpopulations for treatment. One of the Chinese payers we interviewed commented, “Through biomarker tests, physicians can choose the most suitable drug so that we will not waste money and also guarantee the drugs have good efficacy in those patients.”

On the other side, biomarker use can also limit the uptake of respective targeted therapies. Firstly, the treatable patient population is limited by the biomarker selection. Secondly, most of these biomarker tests are not reimbursable in China and patients currently have to pay for such tests out-of-pocket (OOP). In China, because of limited insurance funding, not only the high-cost therapies but also the biomarker tests are not fully covered and the tests are normally only provided by large Tier 3A hospitals. According to one of Decision Resources Group’s physician surveys, only around one-third of NSCLC, breast cancer and CRC patients are tested for biomarkers in China. Lack of reimbursement, alongside high patient OOP costs, are often the important restrictive factors to the uptake of biomarker tests and also the targeted therapies.  As well, lack of tissue availability due to the difficulty of biopsy, insufficient tissue and poor tissue quality also become problems in accessing to biomarker tests or getting definitive results for the tests. Therefore, testing is restricted and this acts as a major barrier for the uptake of biomarker-driven therapies.

There is no doubt that Chinese oncologists are embracing biomarker-driven targeted therapies. Nevertheless, expanding the uptake of these therapies in China is still an important issue that the pharmaceutical industry needs to tackle by:

  • designing proper pricing strategies;
  • providing effective funding support for biomarker tests if necessary;
  • providing adequate education and technical support for the pathology laboratories conducting these tests to overcome technical difficulties they encounter.

Mastering the biomarker “double-edged sword” would definitely be a competitive advantage for any biopharma company competing in the China oncology market.

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a. Jardim DL, Schwaederle M, Wei C, et al. Impact of a biomarker-based strategy on oncology drug development: a meta-analysis of clinical trials leading to FDA approval. J Natl Cancer Inst. 2015 Sep 15; 107(11).

b. Falconi A, Lopes G, Parker JL. Biomarker and receptor targeted therapies reduce clinical trial risk in non-small-cell lung cancer. J Thorac Oncol. 2014 Feb; 9(2):163-9.

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