2020 Tumor New Drug Data Card - Zebtinib

In 2020, the State Drug Administration (NMPA) approved a total of 16 new cancer drugs.
Based on the Pharmaceutical Rubik's Cube NextPharma database, NextMed database, 2020 version of the new anti-tumor drug clinical application guidelines and public information, the pharmaceutical Rubik's Cube Med specially launched "oncology new drug data card", for you to introduce some key information on the domestic market of new cancer drugs for your reference.
Zebtini Q1 Basic Information Zebutini (Brukinsa, Parkinze) is a BTK inhibitor developed by Baiji, the treatment of MCL's adaptation as early as November 14, 2019 has been approved by the FDA accelerated, is the third batch of Ibdini (Johnson/Abevie) and Acatini (AstraZeneca) approved BTK inhibitors.
June 2020, Zebtini was approved by NMPA for listing through priority review and special approval, becoming the second BTK inhibitor approved in China.
Zebutini is designed with the drug design strategy driven by the relationship between structure and effect, and has high potency, selectivity, introphysics characteristics, as well as good pharmacodynamic research in the OCI-LY10 DLBCL xenogenous transplant model.
Zebutini was the first BTK inhibitor to achieve 100% domination of the external perennia blood cells, and the only BTK inhibitor to be taken once a day, twice a day.
Q2 listed background B-cell malignancies include non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukemia (CLL), the most common subtypes are chronic lymphocytic leukemia/small lymphocyte lymphoma (CLL/SLL), diffuse large B Cell lymphoma (DLBCL), flotular lymphoma (FL), multiple myeloma (MM), marginal lymphoma (MZL), clergy lymphoma (MCL) and Fahrenheit globulinemia (WM).
notable is that the NHL was the third-largest Chinese mainland trials of new drugs from 2009 to 2018.
B-cell malignancies are among the most successful clinical trials in cancer.
BTK inhibitor is a promising new drug for the treatment of B-cell malignancies and autoimmune diseases.
Ibtini is a BTK inhibitor of first-in-class and has been approved in more than 80 countries.
FDA has approved its treatment for CLL/SLL, WM, R/R MCL, R/R MZL, and R/R chronic grafts against host disease.
, the second-generation BTK inhibitor Acatini was approved by the FDA for CLL/SLL and R/R-MCL.
BTK adaptive research and development layout Zebtini to treat MCL adaptation as early as 2019/11/14 has been approved by the FDA accelerated, the product is called Brukinsa.
, Zebtini's adaptation has also filed a listing application in Israel, and Zebtini's commercial interest in Israel has been authorized to Madison.
Q3-adaptive Brukinsa's FDA-approved adaptation is to treat patients with block cell lymphoma (MCL) who have received at least one treatment in the past.
Brukinsa's approved adaptations in China are: 1) treatment of patients with relapsed/recurring (R/R) set of cell lymphoma (MCL) and 2) treatment of patients with R/R chronic lymphocytic leukemia (CLL) or small lymphocyte lymphoma (SLL).
the above-mentioned adaptations are conditional approval based on objective mitigation rate results from one-arm clinical trials.
approval will depend on the results of an on-the-go, verifiable randomized controlled clinical trial.
new adaptation listing application for Brukinsa for the treatment of patients with relapsed/resuscable Fahrenheit globulinemia (WM) has been accepted by the NMPA Drug Review Centre (CDE) and included in the priority review process.
Brukinsa Global Progress Q4 treatment costs are currently 176.56 yuan per capsule for Zebutini capsules.
recommended doses of MRL and CLL/SLL are 160 mg and are given oral twice daily until the disease progresses or there is unacceptable toxicity.
a box of 64 grains, the price per bottle / box is 11,300 yuan, the monthly treatment cost of 22,600 yuan.
On 28 December, the State Health Insurance Administration and the Ministry of Human Resources and Social Security officially published the National List of Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drugs (2020), which Zebtini has included, and the standard of payment for medical insurance has not yet been officially announced, with an agreement until 31 December 2022.
is understood to be on sale in the U.S. in 2019 at a low price of $12,935 (120 capsules/bottle), or about 91,472 yuan (120 pills/bottle).
first three quarters of 2020, Zebtini's global sales were $720,000, $6.97 million and $15.66 million, respectively, according to the company's financial results.
Q5 evidence-based data and core clinical BRUKINSA obtained FDA approval for R/R MCL patients based on validity data from two one-arm clinical trials.
in the global Phase 1/2 clinical trial BGB-3111-AU-003, the medium follow-up time was 84% at 18.8 months, including 22% full remission (CR) and 62% partial remission (PR).
another one-arm, critical 2 clinical trial (BGB-3111-206) conducted in 86 patients in China is also the basis for Brukinsa's NMPA approval.
18.4 months, the results of the IRC's evaluation based on Lugano (2014) classification criteria showed that the ORR was 83.7%, with a full mitigation rate of 68.6% and a partial mitigation rate of 15.1%.
Brukinsa is NMPA approved for the treatment of R/R CLL/SLL patients and is based on a single-arm, critical Phase 2 clinical trial in China (BGB-3111-205).
the trial included 91 patients (82 of whom were R/R CLL patients and 9 were R/R SLL patients).
the medium follow-up time of 15.1 months, the ORR was 62.6%, including 3.3% full remission (CR) and 59.3% partial remission (PR), and 22% of patients received partial remission (PR-L) with increased lymphocytes.
the efficacy and safety of Zebutinib in patients with primary treatment of 17p chromosome loss in group CLL/SLL was also explored in the study group C data of Phase III SEQUOIA.
the medium follow-up time was 18.2 months, the ORR was 94.5%, the partial remission (PR) rate was 87.2%, the PR rate with lymphocyte growth was 3.7%, and the total remission (CR) rate was 3.7%.
, adverse events are mainly 1-2, and the occurrence rate is low, and the rate of treatment discontinuation due to adverse events is low.
, Zebtinib can be used as a treatment option for patients with CLL/SLL who have del (17p) in the first treatment.
Brukinsa is currently conducting a wide range of critical clinical trials around the world as a single drug and in combination with other therapies to treat a variety of B-cell malignancies.
includes first-line treatment of chronic lymphocytic leukemia/small lymphocyte lymphoma (Global Multi-Center PHASE II. Phase Clinical Study AU003, Global Multi-Center III.Phase SEQUOIA Study 17p-Subgroup); Fahrenheit globulin hemoglobinemia lymphoma (Phase III.) Relapse/Difficult To Treat Marginal Lymphoma (I.-II. Phase Study), Recurrence/Refractic Foam Lymphoma (I.-II. Phase Study), etc.
note that ASPEN is the first Phase III clinic to compare two BTK inhibitors head-to-head, and is also the largest Phase III clinic for Fahrenheit globulinemia.
the trial failed to reach the main clinical endpoint (VGPR/CR, 28.9% vs 19.8%, p-0.116), Zebtini has proven to be superior to Erutinib's safety.
Brukinsa Core Clinical Layout Data Source: NextClinTrial Database, which retains only key clinical trials for drug registration or change of guidelines; In the CSCO Lymphoma Guidelines (2020 edition) 2020 edition of the CSCO Lymphoma Guidelines, Zebtini is officially included as a Level I recommended program for recurring incurable sleeve lymphoma (MCL), a level II recommendation for primary treatment or recurring recurring resusable chronic lymphoblastic leukemia (CLL).
The treatment of relapsed refractically difficult-to-treat cytoblastoma (MCL) primary treatment or recurrence of refractic chronic lymphoblastic leukemia (CLL) Q7 reasonable medication point 1. Zebutini for CLL treatment, should be strictly clinically evaluated, if the patient has a clear del (17p), choose BTK inhibitor treatment.
2. Baseline assessment should be done before treatment in accordance with the relevant disease guidelines, treatment response and toxicity should be monitored regularly during treatment, and attention should be paid to tumor dissolution syndrome (especially in CLL patients).
3. There is no need to adjust the dose in patients with mild and moderate liver impairment (Child-Pugh A and B).
recommended dose for patients with severe liver damage (Child-Pugh B and C) is 80 mg twice a day.
4. Oral dosing, the daily medication time is approximately fixed.
the whole capsule with water, which can be taken before or after the meal.
the opening, breaking or chewing of capsules is prohibited.
if this product is not taken at the scheduled time, the patient should take it as soon as possible on the basis of at least 8 hours between adjacent medications, and resume the normal medication plan in the follow-up.
do not take this product additionally to compensate for missed doses.
recommended dose is 160 mg or oral at a time, twice daily, until the disease progresses or insulable toxicity occurs.
5. Granulocyte reduction, plate reduction, anemia is a common adverse reaction.
blood routines need to be monitored during medication.
level 3 hematological toxicity and above to pay attention to dose adjustment.
6. Dose adjustment should be made when combined with CYP3A inhibitors or inducers.
7. Risk of reactivation of HBV: The risk of HBV activation needs to be noted during the use of Zebtinib.
The status of hepatitis B virus should be clarified before use, and for patients who are or have been infected with hepatitis B virus, a hepatitis specialist should be consulted before starting treatment and monitored during treatment.
. Dose adjustment is not recommended in patients with renal impairment.
severe renal impairment (creatinine removal rate <30 ml/min) or dialysis patients need to pay attention to monitor adverse reactions.