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BeiGene announced that the new adaptation of Zebutinib Capsules (Baiyueze) has received conditional approval from the National Medical Products Administration
.
It is used to treat adult patients with Waldenstrom's macroglobulinemia (WM).
BeiGene Official Account
Waldenstrom's macroglobulinemia is a rare indolent lymphoma that accounts for less than 2% of non-Hodgkin's lymphoma (NHL) patients
.
The disease usually occurs in elderly patients and is mainly found in the bone marrow, but it may also involve the lymph nodes and spleen
The NMPA conditional approval of Baiyueze for the treatment of WM patients who have received at least one treatment in the past is based on the safety and efficacy results of a key single-arm phase II clinical trial (NCT03332173)
.
The trial’s median follow-up time was 14.
So far, Baiyueze has been approved for the following indications in the following areas:
So far, Baiyueze has been approved for the following indications in the following areas:In November 2019, Baiyueze® was approved in the United States for the treatment of mantle cell lymphoma (MCL) patients who have received at least one treatment in the past*
In June 2020, Baiyueze® was approved in China for the treatment of adult mantle cell lymphoma (MCL) patients who have received at least one treatment in the past**
In June 2020, Baiyueze® was approved in China for the treatment of adult patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) who have received at least one treatment in the past
In June 2021, Baiyueze® was approved in China for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM) who had received at least one treatment in the past**
In February 2021, Baiyueze® was approved in the United Arab Emirates for the treatment of patients with relapsed or refractory MCL
In March 2021, Baiyueze® was approved in Canada for the treatment of adult patients with Waldenstrom's macroglobulinemia (WM)
*Indicates that the indication is approved for accelerated approval based on the overall response rate (ORR)
.
Full approval for this indication will depend on the verification and description of clinical benefits in confirmatory trials
**This item means that the indication has been conditionally approved
.
Full approval for this indication will depend on the results of ongoing confirmatory randomized, controlled clinical trials
At present, in addition to the United States and China, a total of more than 30 Baiyueze related listing applications for multiple indications have been submitted and submitted, covering the European Union and more than 20 other countries
.
According to BeiGene's financial report, Baiyueze's global sales in 2020 were US$41.
Note: The original text has been deleted
