Four new domestic anti-tumor drugs to be included in the national priority review is expected to accelerate the approval of the market.

According to the recent information on the website of the National Drug Administration (NMPA) Drug Review Center (CDE), five applications for the listing of innovative drugs have been included in the list of priority review stakes, of which four are anti-tumor drugs: Volitinib, Avapriitinib, Triprisadna and Parmipale capsules.
Volitinib volitinib is a powerful and highly selective oral small molecule MET inhibitor, MET is a receptor tyrosine kinase that exhibits abnormal functionality in many types of solid tumors.
may, in May this year, Volitinib's new drug listing application has been submitted to NMPA and accepted for the treatment of MET 14 exoon-on-the-micro-jumping non-small cell lung cancer (NSCLC), the first new drug application submitted globally by Volitinib.
MET mutation is one of the rare mutations common in lung cancer patients.
about 1% to 3% of non-small cell lung cancer patients in the clinic had MET mutations.
, however, even rare mutations, such as EGFR20, RET, ROS1, HER2, have the corresponding targeted drugs, only MET mutations, in the clinical has not been effective target drugs until the success of the Volitinib clinical trial.
Volitinib is a highly selective, powerful, oral MET receptor tyrosine kinase inhibitor developed by Hutchison Whampoa Pharmaceuticals.
clinical design as follows: Sample size: This clinical total of 41 patients.
16 cases were lung sarcoma-like cancer patients and 25 were patients with other types of non-small cell lung cancer.
of these cases, 17 patients received first-line treatment in Volitinib.
Clinical Efficacy: After evaluation, the best efficacy of 31 patients whose efficacy could be evaluated was as follows: That is, in clinical studies, the patient control rate of MET exoon 14 jumpwas over 90%, and the objective mitigation rate was 54.8%.
this figure is already very good for lung cancer patients.
side effects: in clinical trials, most of the participants had side effects of 1-2, mainly in areas such as nausea, elevated transaminase, edema, vomiting, etc. the incidence of severe side effects of
and above was 31.7%, which was under control.
for all patients with met14 exosome stoic-jumping lung cancer, The clinical success of Volitini is tantamount to catching the last straw.
Aperinib Avapritinib is a powerful high-specific KIT and PDGFRA mutantkinase inhibitor developed by Blueprint Medicines, which is licensed exclusively for development and commercialization in Chinese mainland and in Hong Kong, Macau, And Taiwan, China.
early 2020, avapritinib was approved by the U.S. FDA for the treatment of non-surgical excision or metastatic gastrointestinal interstitial (GIST) adult patients carrying PDGFRA exon 18 mutations, including PDGFRA D842V mutations, the first FDA-approved precision therapy for patients with specific genomic giST. According
to data recently published in The Lancety, Avapritinib was used in patients with PDGFRA D842V mutant advanced gastrointestinal interstitial tumors with a total survival rate of 81% for 24 months and good tolerance.
the therapeutic effect sourcing population included 56 patients with PDGFRA D842V mutant GIST. The
safety analysis group included 82 patients, including 26 non-PDGFRA D842V mutant GIST patients during the dose-increasing study phase.
all data due on 16 November 2018.
data show that the overall remission rate (ORR) reached 88% in patients with PDGFRA D842V mutant GIST treated with avapritinib, and 9% of patients achieved complete remission.
Avapritinib treatment showed lasting clinical benefits in this patient population: 70% for 12 months of continuous remission, 81% for 12 months of progression less than progression (PFS), and 81% for 24 months.
and avapritinib has good overall tolerance, and most of the adverse therapeutic events (AE) reported in the study were level 1 or 2.
Tripri monoto-ret, a PD-1 monoab, developed by Junshi Bio, was approved for sale in China at the end of 2018 for the treatment of advanced melanoma after previous standard treatment failures.
this year, Junshi Bio submitted to NMPA two new applications for the listing of Triprimonostatis: one for patients with advanced nasopharyngeal cancer (NPC), who have previously undergone failed treatment with the second-line and above systems, and the other for patients with advanced urinary tract cancer who have previously been treated.
nasopharyngeal cancer belongs to the high incidence of tumors in China, with more than 60,000 new cases each year, accounting for more than 40% of the world's new NPC patients.
although the effect of simple radiotherapy in early patients is more than ideal, the 5-year survival rate is more than 90%.
because NPC symptoms are not specific and the anatomical site is special, nearly 70% of patients have developed to a local late stage, even if the use of standard same-period chemotherapy methods, its 5-year survival rate is only about 60%, equal to about 30% of patients will eventually relapse or metastasis.
POLARIS-02 is an open, II-phase registration study covering 17 centers nationwide, with 190 patients with advanced STAGE NPC patients recruited from April 2017 to February 2019, of which 165 were evaluated.
its preliminary results show that the patient's objective remission rate of 25.5%, compared with other similar studies, both in terms of the number of cases in the group or effectiveness, both reflectthe the clinical quality of Thepril single resistance comparable to or even surpassing the imported products.
, the efficiency was as high as 31% in PD-L1-positive patients, while the pD-L1-negative patients were 23%.
this brings new options for follow-up treatment in patients with recurrent metastatic NPC patients with platinum-containing chemotherapy failure, and also suggests the feasibility of Tripri sepsal monotomatherapeutic chemotherapy in patients with advanced NPOS treatment in the first line of treatment.
based on polarIS-02 research, the approval of the late-stage NPC for chemotherapy resistance in Treple is worth looking forward to.
POLARIS-03 Study is an open-label, multi-center, phase II-registered clinical study designed to assess the effectiveness and safety of Tripri singous (3 mg/kg, Q2W) in the treatment of urinary skin cancer.
as of October 21, 2019, there were 151 subjects in the group, with 128 cases of therapeutic effect being evaluated.
results: 4 patients with total efficacy evaluation (CR), 25 patients confirmed as partial lysuating (PR), 4 patients as unconfirmed PR, 31 patients with disease stability (SD), orR confirmed in the study was 22.7%, disease control rate (DCR) was 50%.
subgroup analysis showed an ORR of 38.5% in PD-L1 positive populations and 13.4% for PD-L1-positive populations.
results show that Trepri monotodrine showed promising clinical efficacy and manageable safety in locallate or metastatic urethra skin cancer sourcing resistance to chemotherapy.
ParmiPari Parmipale i'm a PARP1 and PARP2 inhibitor in the research of Baiji Shenzhou.
preclinical models show that the drug has pharmacological properties such as penetrating the blood-brain barrier and PARP-DNA complex capture.
the National Drug Administration's Drug Review Center has received applications for new drug marketing (NDA) for patients with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received at least two lines of chemotherapy and have been present with a disease-causing or suspected germbrcon mutation.
submitted this NDA based on a 1/2 clinical trial (NCT03333915) for patients with advanced ovarian cancer, fallopian tube cancer, primary peritoneal cancer, or advanced triciacyn breast cancer.
the critical part of the trial, 113 patients in China who had previously received at least two standard chemotherapy and had a BRCA1/2 mutation with high-level epithelial ovarian cancer (including fallopian tube or primary peritoneal cancer) or high-level endothelial-like cancer.
patients received parmipari twice daily oral medication, each 60 mg.
the primary endpoint of the trial is objective mitigation rate (ORR) based on the solid tumor efficacy evaluation criteria RECIST 1.1.
trial results will be announced at a future medical conference.
compared with imported drugs, domestic drugs will be more price advantage, which means that patients will be greatly more accessible to drugs, helping Chinese cancer patients to reduce the burden of treatment.
we look forward to the successful adoption of these domesticnew drugs and the early benefit of more patients.
Reference Source: 1. Retrieved July 06, 2020, from
2. Recombinant Humanized Anti-PD-1 Monoclonal Antibody Toripalimab (JS001) in patients with redy refract/metastatic nasophyngal carcinoma: Interim results of a phase II clinical study POLARIS-02. 2019 ASCO, abs6017. 3. Recombinant Humanized Anti-PD-1 Monoclonal Antibody toripalimab in patients with meta urothelial carcinoma: preliminary results of the results of an open-label phase II clinical study polaris-03.