The detailed difference between brigatinib (Brigatinib) and whether it is a domestic drug or an imported drug

Brigatinib, also known as brigatinib, is a new, highly selective anaplastic lymphoma kinase (ALK) inhibitor, mainly used to treat ALKpositive non-small cell lung cancer (NSCLC), especially those who are resistant to crizotinib (Crizotinib). The question of whether it is a "domestic drug" or an "imported drug" involves multiple dimensions such as drug research and development background, production sources, marketing status in China, and availability of generic drugs. The following will be analyzed in detail from these aspects.

1. Drug sources and research and development background

Brigatinib is an original drug developed by the American biopharmaceutical company Ariad Pharmaceuticals and later acquired by Japan's Takeda Pharmaceuticals (Takeda). Therefore, from the perspective of research and development and patent ownership, brigatinib is an imported original drug, not a domestic drug developed in my country.

This drug was first approved by the FDA in the United States in 2017 for the treatment of patients with ALK-positive metastatic non-small cell lung cancer who have developed resistance or disease progression after taking crizotinib. Brigatinib was quickly included in international lung cancer treatment guidelines due to its high efficiency in inhibiting ALK, broad-spectrum effect on drug-resistant mutations (such as G1202R mutation), and strong central nervous system penetration.

2. China’s marketing situation and drug properties

Brigatinib was launched relatively late in China. China's National Medical Products Administration (NMPA) approved the marketing of brigatinib in 2022 for the treatment of patients with ALK-positive metastatic non-small cell lung cancer. In the early stages of its launch, since there were no domestic generic drugs, all brigatinib sold on the market were imported original drugs, which were imported and distributed by Takeda China.

Domestic drugs generally refer to drugs independently developed or copied by domestic companies in China. Currently, no domestic version of brigatinib has been officially launched. Although several Chinese companies have applied for or are conducting consistency evaluation or clinical studies of generic brigatinib drugs, as of now (mid-2025), the brigatinib products circulating in the Chinese market are still mainly imported drugs, and no domestic generic version has yet been officially approved.

三、价格对比与医保情况

As an imported original drug, brigatinib had a relatively high price when it first entered the Chinese market. Depending on the specifications (such as 90mg or 180mg), the price of each box can reach RMB2-3yuan. However, the good news is that with the Chinese government’s active promotion of negotiations and centralized procurement policies, brigatinib has been included in the national medical insurance directory in 2022. After medical insurance reimbursement, the patient’s out-of-pocket payment has been greatly reduced, greatly reducing the financial burden.

In contrast, once domestic generic drugs are on the market, they will theoretically be cheaper than original drugs, and are expected to further reduce costs through centralized procurement, thereby expanding drug accessibility. However, in the case of brigatinib, domestic generic drugs are still in the research and development or approval stage and have not yet been put on the market. Therefore, patients in China can still only purchase the original version imported by Takeda through regular hospitals or pharmacies.

4. Differences in drug quality and indications

The imported original drug brigatinib has mature global clinical data and support from multiple large-scale III clinical studies. It has clear indications, complete and transparent drug safety and efficacy data. In contrast, even if domestic generic drugs are launched in the future, their bioequivalence must be verified by the National Food and Drug Administration (NMPA) to ensure that they are consistent with the original drugs in terms of efficacy and safety.

Original drugs usually have all the indications and usage and dosage marked in the instructions, but domestic generic drugs may be restricted when they are first launched on the market. They are only approved for the most basic indications and need to supplement clinical data to expand the label. In addition, original drugs usually have a long history of drug use abroad and are more trustworthy to doctors; domestic drugs require time to accumulate clinical experience.

In summary, brigatinib is an imported original drug, developed by overseas pharmaceutical companies and marketed in China. Currently, there is no domestic generic version officially launched. For patients, the currently available brigatinib is basically provided by Takeda Pharmaceutical China. The price has dropped after it has been included in medical insurance, ensuring the accessibility and compliance of the drug. If domestic generic drugs are launched in the future, they are expected to further reduce prices and improve the inclusiveness of treatment, but they still need to be gradually accumulated and verified in terms of quality, indications and physician awareness. Therefore, when choosing medication, patients should weigh it based on doctor's recommendations, treatment needs and economic conditions to ensure both safety and efficacy.

Reference materials:https://www.drugs.com