'Tripartite' change 'four countries for hegemony', BTK inhibitor who master ups and downs?

Since the beginning of this year, the development of BTK inhibitors has made frequent progress:

Including accelerated FDA approval of Lilly's third generation BTK inhibitor, Pirtobrutinib; Hengrui Pharmaceutical BTK inhibitor Edralbrutinib tablets for the treatment of optic neuromyelitis spectrum disease indications, has been granted orphan drug status by the US FDA...

After you sing and I come on stage, the hot research and development of BTK inhibitors at the same time, the new market pattern has quietly changed.

Cumulative sales of nearly $50 billion,
BTK inhibitors shine

BTK is a non-receptor tyrosine kinase. By acting on the BCR signaling pathway, BTK inhibitor specifically binds to BTK to inhibit the self-phosphorylation of BTK and prevent the activation of BTK, thus blocking signal transduction and inducing cell apoptosis, so as to control the development of B cell tumors.

Prior to the advent of BTK inhibitors, treatment options in the lymphoma field were limited, typically including chemotherapy, antibody therapy against CD20, and less frequently, radiation therapy. In 2013, the world's first BTK inhibitor, ibrutinib, was launched, bringing revolutionary progress for the treatment of B-cell malignancies and opening the era of no chemotherapy for B-cell malignancies.

Compared with conventional therapies, BTK inhibitors have a much lower rate of discontinuation due to intolerance due to more precise action and fewer toxic side effects.

Ibrutinib quickly became a global bestseller thanks to better treatment. So far, the drug has been approved in more than 80 countries or regions, seven indications have been approved by the FDA.

In its 9 years on the market, Ibrutinib has accumulated sales of nearly 50 billion US dollars, ranking among the TOP10 best-selling drugs in the world for several consecutive years.

With the improvement of the level of new drug research and development and the support of technical strength, the new generation of BTK inhibitors have been approved and marketed successively, and improved in the aspects of targeting, compound optimization, and reduction of drug interaction, etc., the global sales of BTK inhibitors show a rapid growth trend.

The global market for BTK inhibitors is expected to reach US $20 billion by 2025 and US $26.1 billion by 2030 as the number of cancer patients increases and indications for the drug expand, according to Forrester Sullivan's analysis.

Among them, the Chinese market is expected to reach 13.1 billion yuan in 2025 and 22.5 billion yuan in 2030 after Ibrutinib was approved for listing in 2017.

Currently, Phase III clinical trials of Pirtobrutinib have also started in China. Cinda Biology has previously reached a product license agreement with Eli Lilly to obtain the right to negotiate the commercialization rights of Pirtobrutinib in the Chinese mainland in the future.

In addition to Lilly, at least four non-covalent BTK inhibitors have entered clinical trials, with Roche's Fenebrutinib and Merck's MK-1026 (ARQ531) in phase III and II clinical trials the most advanced.

conclusion

The emergence of the first generation of BTK inhibitors, the achievement of 50 billion "medicine king" ibrutinib; The listing of the second generation of BTK inhibitors propped up two domestic "A+H" listed companies...... With the arrival of more third-generation BTK inhibitors and BTKPROTAC, it is worth keeping an eye on what surprises the market will bring.