Zero breakthrough: China's innovative drug Zanubrutinib enters the door of FDA!

2019Year11Month14Day (US time), US Food and Drug Administration (FDA) officially approvedZanubrutinib(English trade name:BUSINESS™), for the treatment of adult mantle cell lymphoma with at least one prior therapy (MCL) Patients.

ZanubrutinibIt is an oral product independently developed by Baiji Shenzhou CompanyBTKsmall molecule inhibitors, which are characterized by maximizing the impact onBTKThe specific binding of the target, thereby minimizing the toxic side effects of off-target effects. A number of basic studies have shown that Bruton's tyrosine protein kinase (Bruton's tyrosine kinase,BTK) to malignantBplays an important role in cell survival and development, if can inhibitBTKThe activity can kill a lot.BCell lymphoma cells in turn benefit patients. in the treatment of manyBin clinical trials for cell cancer,Zanubrutinibhave shown good efficacy and safety, have become“best-in-class”The potential of drugs. It was also the first to getFDAFour special channel qualification of China's independent research and development of new anti-cancer drugs, the strength can be seen.

In terms of patents,Baiji Shenzhou in2014submitted inZanubrutinibThe compound patent application and in.2017years authorized. This patent isCN104884458B, with a number of authorized or in-process patents in multiple countries and regions, as follows:

Lymphoma is a group of malignant tumors originating from the lymphoid hematopoietic system, and is one of the fastest growing malignant tumors in the world. In the currently known lymphoma70In multiple subtypes, mantle cell lymphoma (MCL)Originated“Set area”ofBcells,more aggressive,The prognosis is very poor,Median survival was only3To4Year. According to statistics, the number of new cases of mantle cell lymphoma worldwide exceeds3.510,000 cases, China about more6000Example. Majoritymantle cell lymphomaAt the time of diagnosis, the patient is in the late stage of the disease, facing the dilemma of limited treatment and poor prognosis.

Based onZanubrutinibEfficacy data in two mantle cell lymphoma clinical trials, U.FDAThis approval was made. InZanubrutinibFor the treatment of relapse/RefractoryMCLmulticenter patientsIIPhase Clinical TrialsBGB-3111-206(clinicaltrials.govRegistration Number:NCT03206970), the overall response rate (combined complete and partial response;ORR)84%, including59%of complete remission (CR) and24%The median duration of remission in this trial (DOR)19.5months, with a median follow-up18.4Months. in the globalI/IIPhase Clinical TrialsBGB-3111-AU-003(clinicaltrials.govRegistration Number:NCT02343120),ORRFor84%, including22%of complete remission as well62%of partial remission, the medianDORFor18.5months, with a median follow-up18.8Months.

as far as the chinese market is concerned,2018Year8month and10In January, Baiji Shenzhou reported to the State Drug Administration (NMPA) submittedZanubrutinibTreatment of recurrence/refractory mantle cell lymphoma (MCL) And chronic lymphocytic leukemia/Small lymphocytic lymphoma (CLL/SLL) of listing applications. Both applications were approved by the Drug Evaluation Center (CDE) has been included in the priority review channel and is believed to be approved soon. By then, it will benefit more domestic patients with mantle cell lymphoma and bring new hope for treatment. In addition,ZanubrutinibAlso in multiple clinical trials, as monotherapy or combination therapy, treating multiple typesBCellular blood cancer. We expect it to have more in the future, for the benefit of more patients.

According to Reuters, Baekje Shenzhou15The anti-cancer drug was announced.ZanubrutinibPricing in the United States, the specific price is, a period.30Days of treatment will cost12935S. dollars, about RMB90642Yuan.An American investment bank expects that,ZanubrutinibFuture sales are expected to reach8.36Billion US dollars, about RMB58.58billion, sales of drugs for mantle cell lymphoma will reach9000Ten thousand dollars, about RMB6.31Billions of dollars. Reuters pointed out that with the help of new drugsZanubrutinib, Chinese pharmaceutical company Baiji Shenzhou will compete with Johnson & Johnson, AbbVie, AstraZeneca and other international pharmaceutical companies for related products.

From once a big country of generic drugs, to now the first local original research anti-cancer drug.ZanubrutinibIntoFDAThe gate was approved for listing,is the Chinese pharmaceutical industry from“Made in China”To“Made in China”The gorgeous turn..ThisIt is a major step forward for Chinese innovative drugs in the process of going global,China's original research and development of new drugs to sea“Zero Breakthrough”.In the process of China's innovative pharmaceutical companies going global, Baiji Shenzhou will leave a strong mark on history.In the future pattern of the world pharmaceutical market, China's innovative pharmaceutical companies will have a greater voice.