Zero breakthrough! A new anti-cancer drug, zebutini, developed by baek China, has been approved for

   Date:2019-11-16     Browse:41    
Core tips:On November 15, the us food and drug administration (FDA) announced that the new anti-cancer drug "zepitinib" independently developed by beiji shenzhou, a biomedical enterprise from Beijing yizhuang, has been approved for the market with "p
 On November 15, the us food and drug administration (FDA) announced that the new anti-cancer drug "zepitinib" independently developed by beiji shenzhou, a biomedical enterprise from Beijing yizhuang, has been approved for the market with "priority review" as a "breakthrough therapy". This is good news for cancer patients all over the world, but also a milestone in the development of new drugs in China!
As a result, zepitinib became the first Chinese indigenous anti-cancer drug to be approved for market listing in the United States, rewriting the embarrassing history of "only in but not out" of China's anti-cancer drugs.

R&d background:

Developed independently by a team of Chinese scientists at baekje China, this new BTK inhibitor is designed to maximize the specific binding rate to the BTK target while minimizing the off-target effect. With its in a series of clinical trial show the curative effect and security, including the set of B cell lymphoma, and other research data obtained in malignant tumor cells, in January 2019, the jersey fabric for, get the United States food and drug administration (FDA) awarded the "Breakthrough treatments that" (Breakthrough Therapy Designation), is used to treat the previously receiving at least one Therapy adult cell lymphoma (MCL), set to become the first in the FDA to receive the recognition of the local development of anti-cancer drugs.

The complete response rate of zebutini to mantle cell lymphoma was 78%

Mantle cell lymphoma (MCL) is an aggressive non-hodgkin's lymphoma. Due to insidious early symptoms, relatively rare and difficult to diagnose, most patients are usually in the advanced stage of diagnosis, and patients often face poor prognosis due to high disease recurrence rate, and the median survival time is only 3-4 years.

The results showed that in 85 patients with evaluable efficacy, objective response rate (ORR) and complete response rate (CR) were 84 percent and 78 percent, respectively, after treatment with zebinib. Professor song yuqin, deputy director and chief physician of lymphoma department of Peking University tumor hospital, said that zepitinib showed high activity in patients with tunica cell lymphoma, with 84 percent achieving objective remission and more than half achieving complete remission and overall tolerance.

A second global phase I/II trial enrolled 53 patients with various b-cell malignancies, including mantle cell lymphoma. Results of this updated trial showed that in 43 evaluable mantle cell lymphoma patients treated with zebinib alone, the objective response rate was 85.4%, the complete response rate was 29.2%, and the partial response rate PR was 56.3%.

In addition, zepitinib also showed a high remission rate for chronic lymphoblastic leukemia (CLL)/small lymphoblastic lymphoma (SLL). Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) is a type of mature B lymphocytic tumor that occurs in middle-aged and elderly people. The course of chronic lymphocytic leukemia is relatively slow, but some patients can transform into juvenile lymphocytic leukemia, diffuse large B, Hodgkin's lymphoma, acute disease and other malignant lymphoproliferative diseases. In a single arm, multi-center key phase II clinical study in China, 91 patients, including 82 patients with chronic lymphocytic leukemia and 9 patients with small lymphocytic lymphoma, were enrolled. The data showed that the objective response rate was 85%, and the estimated 12-month progression-free survival rate was 87.2%.

The objective response rate of treatment for Fahrenheit megaglobulinemia was 92%

Giant globulinemia (WM), a rare type of lymphoplasma cell lymphoma, is an inert b-cell lymphoma that accounts for only 2% of all non-hodgkin's lymphomas and is most common in middle-aged and elderly people, with a median age of about 64 at diagnosis.

According to the summary and analysis of 2 studies on zebutini in huaglioglobulinemia and safety data of treatment of b-cell malignant tumor published by parkine China, the objective response rate of zebutini treatment was 80.8%, the main response rate was 54%, including 23% very good partial response (VGPR). Meanwhile, the patient was generally well tolerated, with only 7.7% of patients interrupted treatment due to adverse events and no fatal adverse events or atrial fibrillation. The study also included 26 MYD88 wild genotype patients, including five governance and at the beginning of 21 patients with relapse/refractory, all accept the jersey fabric for treatment, MYD88 wild genotype patients' response rate in the past in other BTK inhibitors are generally lower, prognostic effect is not very ideal, but the data show that jersey fabric for, in this type of patients with refractory can still achieve depth.

Another study showed that in 73 evaluable patients, zepitinib had an objective response rate of 92% and was well tolerated for treatment of Fahrenheit's megagglutinemia.

Currently, baekje China is conducting a total of 14 clinical studies on zebutini worldwide, including 8 registered clinical trials, 2 of which are phase III head to head clinical studies worldwide. In August and October 2018, the drug evaluation center of the national food and drug administration successively accepted the new drug market application of zepitinib for R/R MCL and R/R CLL/SLL, both of which were included in the priority evaluation. In January 2019, zepitinib was awarded the "breakthrough therapy" designation by the us food and drug administration (FDA) for the treatment of adult patients with R/R MCL, becoming the first independently developed anti-cancer new drug in China to receive the designation. Zepitinib has previously been approved by the FDA as a "fast-track" agent for the treatment of Fahrenheit's macroglobulinemia. According to the currently announced plan, paikechini will submit the application for the new drug to the us FDA in 2019 or early 2020.

On November 15, bakeji shenzhou ( opened 2.3% higher, opening at 120.1 Hong Kong dollars, a new high on the market, pre-market turnover of 2.93004 million Hong Kong dollars, the latest total market value of 94.3 billion Hong Kong dollars.

"We are committed to improving the treatment of cancer patients around the world, and this approval brings us closer to our mission of bringing the highest quality drugs to patients around the world. The FDA approval of BRUKINSA today confirms its importance as a treatment for relapsed or refractory MCL, in addition to the previous breakthrough treatment in this indication. We will continue to develop BRUKINSA in other blood tumors and hope that this approval is the first of many that will follow."

Yan xiaojun, senior vice President of baji shenzhou and head of global pharmaceutical affairs, commented, "BRUKINSA, as a BTK inhibitor, is designed to maximize targeted occupancy while avoiding off-target binding. BRUKINSA has enrolled more than 1,600 patients since it began an extensive clinical program in 2014. Today's accelerated approval is the result of many years of work by the baekje shenzhou team and the clinical trial researchers, but it is even more important to thank every patient who participated in the trial. We are honored to have the opportunity to participate in the development of this therapy, making it the first cancer drug developed by paikche China and approved by the FDA."

Zhu jun, md, director of the department of internal medicine and lymphoma department of Peking University cancer hospital, China, said, "as a Chinese cancer clinician, I am very excited to witness the historic breakthrough of the first FDA approval of an innovative anticancer drug independently developed by a local biomedical company. This breakthrough is an important milestone for China's local biomedical industry and clinical oncology research, marking that we can not only develop new drugs for Chinese patients, but also benefit patients in more countries, providing Chinese solutions and contributing Chinese wisdom to the world."

ghanGutierrez, CEO of the lymphoma research foundation of the United States, commented, "the approval of zepitinib as a second-line treatment for MCL is a major advance in this indication. Expanding treatment options could improve the patient experience and offer hope to patients diagnosed with MCL."

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