On November 15th the Chinese company BeiGene announced that its self-developed BTK inhibitor zanubrutinib (b)™, the English generic name zanubrutinib, had been approved by the U.S. Food and Drug Administration (FDA). Used to treat patients with Mantlecelllymphoma (MCL) who have received at least one treatment in the past.
On November 15th, a new generation of BTK inhibitor zanubrutinib was approved by the FDA, becoming the first new anti-cancer drug developed by a Chinese company and approved for listing in the FDA.
This marks the first new anti-cancer drug developed by a Chinese company and approved by the FDA to date, and achieves a “zero breakthrough” in China’s original anti-cancer drug.
Lymphoma is a group of malignant tumors originating from the lymphoma system, and is one of the fastest growing malignant tumors in the world, with a median survival of only three to four years. Most patients are in the advanced stage of the disease at the time of diagnosis and face the dilemma of limited treatment and poor prognosis.
On November 15th, a set of data presented by BeiGene at a media conference approved by the FDA showed that zanubrutinib had shown better efficacy than its peers in both Phase II clinical trials and final registered clinical trials.
Dr. Wu Xiaobin, General Manager and President of BeiGene China, said, “China’s original research of new drugs to achieve a ‘zero breakthrough’ going overrsea, indicating that our country not only in the large manufacturing equipment, high-speed rail, IT industry goes to the forefront of the world, our biopharmaceuticals are now beginning to emerge.”
The following is a dialogue between the Beijing News reporter and one of the main leaders in zanubrutinib’s research and development, Dr. Wang Lai, Head of Global Research, Clinical Operations and Biostatistics and Asia-Pacific Clinical Development in BeiGene.
On November 15, Dr. Wang Lai shared with the media the development of zanubrutinib. Respondent’s Map
How it works: Inhibiting the faulty protein
Beijing News: How does zanubrutinib work?
Wang Lai: Simply put, cancer is mainly due to the abnormal function of certain proteins in the human body, resulting in some cells not controlled by the human body desperately crazy, or should die cells no longer die, proliferation, become what we often say about the tumor, and these problematic proteins are the target. zanubrutinib works by suppressing BTK targets associated with set cell lymphoma.
Beijing News: Compared to the rest of the BTK inhibitors, what is zanubrutinib’s core breakthrough point?
Wang Lai: First of all, zanubrutinib only inhibits THE BTK protein, avoiding affecting the function of other proteins in the human body. The second is that the inhibition effect is adequate, zanubrutinib inhibits the BTK target is 100% and long-lasting.
Beijing News: In addition to set cell lymphoma (MCL), zanubrutinib is also suitable for other blood tumors?
Wang Lai: As long as the inhibition of BTK has a inhibitory effect on the tumor, Zanubrutinib will be effective. such as chronic lymphocytic leukemia (CLL) and Fahrenheit cyloproteinemia (WM). In addition, zanubrutinib has an inhibitory effect on many B-cell lymphomas, such as marginal B-cell lymphoma, pervadal-type lymphoma, diffuse large B lymphoma, and a total of 16 clinical trials are under way.
FDA Priority Review, Early Approval
Beijing News: Why is Zanubrutinib getting FDA approval?
Wang Lai: Security data based on the validity data of two major trials and many other tests. Among them, the validity data proved that zanubrutinib is very effective in the treatment of set cell lymphoma, and a trial in Australia proved that the drug is not only effective in Chinese patients, but also in Western patients.
Beijing News: Is the approval process going well?
Wang Lai: We got the FDA’s four “passes” – “orphan drug identification,” “fast track”, “breakthrough therapy identification”, “priority review”, the highest gold content is the January 2019 FDA award of “breakthrough therapy recognition”, which brings a lot of special treatment to zanubrutinib , such as the middle of this year, We submitted a new drug marketing application to the FDA and were confirmed in August to accept and be eligible for “priority review”.
According to FDA rules, it should be six months later, that is, the results of February next year. The FDA itself is a very efficient institution, and it tends to give results earlier than Deadline, but three and a half months early is very rare.
I think the main reason is that we submitted the information is very complete, there is no lack of clinical data, the data is also very beautiful, the quality of the FDA has no doubt, so the approval faster.
Independent research and development by Chinese enterprises
Beijing News: How was the zanubrutinib project born?
Wang Lai: In April 2012, I went to the annual meeting of the American Association for Cancer Research (AACR) when I looked at imbruvica’s data as a first-generation BTK inhibitor and thought imbruvica was good, but couldn’t completely suppress BTK targets. And in addition to suppressing BTK targets will also inhibit other targets, there is room for improvement.
Back in China, we discussed the construction of the BTK inhibitor project in BeiGene, in July 2012, the research team officially established a project, after more than half a year of screening, testing, and finally in more than 500 compounds selected zanubrutinib as the final candidate molecule.
Beijing News: Is zanubrutinib developed by Chinese companies?
Wang Lai: Yes. BeiGene has 1,000 clinical research and development staff worldwide, with China accounting for 600 people. zanubrutinib was developed at the research and development center at Changping Life Sciences Park in Beijing, and the early research and development work was all done in China, with most of the research and development teams Chinese.
Beijing News: What difficulties have been encountered in the research and development process?
Wang Lai: Clinical trials can only draw effective scientific conclusions through sufficient lye sample data, which means a huge investment.
Take our global Phase III head-to-head clinical trial against imbruvica, for example, buying imbruvica alone, a patient would cost $100,000 a year, and patients would take drugs for 3-4 years, which is equivalent to a patient’s cost of $300,000-400,000, and we had 400 patients in one of the trials alone. This is a very large number. The company has also faced financial difficulties before, and I don’t know how many times I’ve told investors about this project.
Beijing News: Finally, a breakthrough can be made, what are the policy reasons?
Wang Lai: China’s research and development of new drugs was too slow ahead of the 2015 drug reform. Drugs can already be prepared to go to the clinic, but to the pharmaceutical department to apply, small molecular compounds to be approved for ten months, macromolecule compounds even more than two years, too slow.
In 2015, the state began to strongly support the development of new drugs, some of which include “encouraging clinical value-oriented drug innovation, optimizing the review and approval process for innovative drugs, accelerating the review of innovative drugs urgently needed in the clinic”, and so on, to bring about a dramatic change in the country’s pharmaceutical innovation, the soil will naturally blossom. The country has good policies, we have talent, capital and ideal aspirations, we can do a good job of China’s innovative medicine. It can be said that without China’s pharmaceutical reform, there would be no breakthrough in the FDA zero today.
Beijing News: To achieve China’s original research new drugs out to sea “zero breakthrough”, you and the research and development team how do you feel?
Wang Lai: In the past, Chinese pharmaceutical companies, like “made in China”, gave a low-cost, low-quality feeling. It is not easy for Chinese pharmaceutical companies to hit their products into the world, and to prove that your drug is better than existing ones depends on the support of high-end high-quality scientific research. But today everything is worth, I am particularly proud, I believe that this is only a small step forward in China Pharmaceuticals, the days ahead will be more brilliant.