In recent years, the development of new anticancer drugs has embraced a flourishing period. From 2014 to 2018, the U.S. Food and Drug Administration (FDA) had approved 57 new anticancer drugs to launch, covering 23 kinds of cancers and 89 indications.

However, none of them was developed by China. Now China has made progress in this domain.

On November 15, FDA accelerated the approval of BRUKINSA™ (generic name: Zanubrutinib) for its launch. BRUKINSA™ is a BTK inhibitor developed by BeiGene to treat adult patients with MCL who have received at least one therapy in the past. It is expected to sell BRUKINSA™ in the US market in the next few weeks.

BRUKINSA™ is China’s first self-developed anticancer drug approved by FDA and also the first one winning FDA’s qualification of “breakthrough therapy” and “priority review”. It fills China’s gap in new anticancer drug and becomes an absolute milestone event in the history of drug research and development in China.

 

Source/FDA

In 2017, the sales of the global anti-tumor drug market achieved USD 111 billion. This figure will reach USD 406.8 billion by 2030, accounting for 16.6% of the global drug market. Innovative drugs with intellectual property patents occupy a dominant position in the list of the world’s bestselling drugs.

As the global center of biomedical development, European and American countries have been taking the world’s leading position in the drug innovation industry. Meanwhile, the Chinese patent drugs and generic drugs with Chinese characteristics account for nearly 90% in the Chinese drug market.

Most new anticancer drugs launched in China in recent years were imported from multinational pharmaceutical companies. In 2017, for example, China approved the launch of 5 new anticancer drugs from foreign pharmaceutical companies, including Osimertinib (for lung cancer), Votrient (for kidney cancer), Afatinib (for lung cancer), Vemurafenib (for melanoma) and Regorafenib (for intestinal cancer and liver cancer). Without exception, all of them are manufactured by foreign pharmaceutical companies.

In this context, imported drugs are able to monopolize the domestic market, which leads to high price and even sky-high price of some anticancer drugs and life-saving drugs.

But the situation has begun to change in the past ten years. BeiGene, Jiangsu Hengrui Medicine Co., Ltd. and other companies start to invest heavily in R&D of drugs. In 2018, BeiGene alone invested over RMB 4 billion in R&D of drugs, which was amazing. The continuous investment began to yield fruitful results recently.

In the past few years, the biomedicine industry of China has forged ahead to pave a path for innovation. It shows that China has transformed from a powerful country of generic drugs into a country capable of developing anticancer drug approved by FDA. Therefore, the launch of Zanubrutinib in the US is a joyful milestone.

 

Zanubrutinib is a BTK small-molecule inhibitor independently developed by scientists from BeiGene. Currently, Zanubrutinib is being tested in key clinical trial projects worldwide. It is used jointly with other therapies to treat numerous B-cell malignancies.

BTK is an important part of BCR’s signaling pathway. Since BCR’s signaling pathway is often abnormally activated in cancer cells in patients suffering from leukemia and lymphoma, the R&D of new anticancer drugs aims to develop the inhibitor of BTK to treat cancers.

Zanubrutinib has shown good efficacy and safety in clinical trials for treating B-cell cancers of various kinds, and it has the potential to become a “best-in-class” drug. It is also China’s first self-developed new anticancer drug approved by FDA through four special tracks.

 

As a BTK inhibitor, Zanubrutinib is not a simple “ME-TOO” or “ME-BETTER”, but a drug independently developed by a Chinese pharmaceutical company and following the international standards from discovery, development, test to declaration.

Through decades of scientific research, scientists have begun to focus on BTK. BTK plays a significant role in the functioning of B cells. As the core switch of the growth of B cells, it controls the expansion, differentiation, apoptosis and migration of cells.

In order to maintain rapid growth, malignant B cells will kidnap and continuously activate BTK to promote the growth and proliferation of cancer cells.

On this basis, scientists naturally think that if a drug is developed to inhibit the activity of BTK, will the growth of malignant B cells be controlled and the relevant cancers treated?

The answer is “Yes”!

Ibrutinib, the first BTK inhibitor launched in the world, was launched in the US in 2013 and China in 2017. Ibrutinib performed well in clinical trials. For example, it was better than chemotherapy for treating chronic lymphocytic leukemia, enabling more than 98% of patients to survive for over two years.

 

Efficacy of Ibrutinib and Chemotherapy in Treating Chronic Lymphocytic Leukemia

Zanubrutinib is the representative of the new-generation BTK inhibitor.

Although the first-generation BTK inhibitors performed well, they need to be improved in efficacy, absorbency and safety. Scientists hoped to strengthen efficacy and reduce the side effects by improving the drug’s structure.

Zanubrutinib was developed by Chinese scientists under this background.

 

 

Zanubrutinib performed very well in clinical trials.

For instance, a phase II key research on Chinese patients shows that the overall remission rate of patients with relapsed and refractory MCL reached 84% after they used Zanubrutinib, among which 78% achieved complete remission.

It was based on this research that FDA awarded Zanubrutinib “breakthrough therapy accreditation” early this year and accepted the application of launching Zanubrutinib. It is the first time for FDA to award “breakthrough therapy accreditation” to a drug and accept the application for its launch based on China’s clinical research.

In clinical trials of chronic lymphocytic leukemia, Zanubrutinib still had good performance with an objective remission rate of 94%. The following curve graph shows the amazing performance of Zanubrutinib. It can be seen that the cancer of most patients has been controlled successfully for more than two years and a half.

 

Curve Graph for Progression-free Survival Rate of Patients Using Zanubrutinib in Clinical Trials of Chronic Lymphocytic Leukemia

 

It is worth mentioning that the clinical researches of Zanubrutinib are international. The recruited patients for researches come from more than 20 countries, which is one of reasons why Zanubrutinib can go international and be approved by FDA. All of these experiences can provide directions for other Chinese anti-cancer drugs to go overseas in the future.

 

We are fortunate to have recently seen the emergence of a number of new Chinese pharmaceutical companies like BeiGene, which can develop the new drug that can compete internationally. The development of a new drug needs great efforts of an R&D team.

 

In the project of Zanubrutinib, BeiGene has made full use of its advantages as an innovative biotechnology company, conducted decision-making communication efficiently, and rapidly pushed forward the progress of the project. It took Zanubrutinib only 2 years from being approved to be initiated to the first dosing, which has fully demonstrated the professionalism and efficiency of the R&D team of Zanubrutinib. This is the glorious achievement of Chinese medicine researchers.

 

Recently, there was good news about BeiGene. In addition to bringing Zanubrutinib to market, BeiGene has also established strategic cooperation relations with the famous multinational pharmaceutical company–Amgen. BeiGene and Amgen have jointly developed 20 drugs, which is the largest and most lucrative deal ever between Chinese biopharmaceutical company and leading multinational pharmaceutical company.

 

We congratulate BeiGene on this innovative treatment being approved to be available soon for the benefit of patients. We also expect BeiGene to make further breakthroughs in the future, go global from China, meet the unfulfilled medical needs of the global patients, and truly realize “Innovative drugs of BeiGene benefit the society and mankind”.