Three new Class 1 drugs are intended to be included in the breakthrough treatment varieties from Keystone, Microcore Biology and Dijon

December 18, China's State Drug Administration Drug Review Center (CDE) recently announced that three new drugs are to be included in the breakthrough treatment varieties, namely: Blueprint Pharmaceuticals / Keystone Pharmaceuticals RET inhibitor BLU-667 capsules, micro-core biological multi-target multi-path selective kinase inhibitor Theo Ronnie capsule, Dizhe Pharmaceutical EGFR inhibitor DZD9008 tablets.
Screenshot Source: CDE Website 1, Blueprint Pharmaceuticals/Keystone Pharmaceuticals: BLU-667 Capsule Action Mechanism: RET Inhibitor Adaptation: Systems for Patients with Advanced or Metastatic Thyroid Myelin Cancer (MTC) Who Are Positive for Reflying Refraction (RET) Mutation The sex therapy BLU-667 (pralsetinib) is a powerful, highly selectively targeted cancer-causing RET variant developed by Blueprints, including predictable drug-resistant mutations, and is a daily oral precision therapy.
Foundation Pharmaceuticals obtained an exclusive development and commercial license for the product in Greater China in June 2018.
July, Blueprint Medicines also launched a global partnership with Roche (in addition to Greater China) to develop and commercialize pralsetinib for the treatment of RET mutation cancer.
the BLU-667 is intended to be included in the breakthrough treatment varieties in China, and is intended to be developed for: systemic treatment for patients with advanced or metastasis MTC who are positive for RET mutation.
Based on the Drug Clinical Trial Registration and Information Disclosure Platform, Keystone Pharmaceuticals is conducting a phase 1 study in China on the treatment of patients with BLUE-667 for thyroid cancer, non-small cell lung cancer (NSCLC) and other advanced solid tumors.
noted that the FDA has awarded pralsetinib breakthrough therapies for treating PATIENT-positive MTC patients who require systematic treatment and do not have an alternative treatment option.
Screenshot Source: In early December, the FDA accelerated approval of pralsetinib extension adaptation for the treatment of patients with thyroid cancer with RET variants, including patients over 12 years of age who require systemic treatment for advanced or metastatic RET mutated thyroid myelinoid cancer MTC.
approval is based on the efficacy and safety results of a Phase 1/2 clinical trial called ARROW.
in 55 treated MTC patients with RET mutations, pralsetinib achieved a total remission rate (ORR) of 60%.
ORR was 66% of the 29 primary MTC patients with RET mutations.
2, Microcore Biology: Theo Ronnie Capsule Action Mechanism: Multi-Target Multi-path Selective Kinase Inhibitor Adaptation: Single-drug Treatment After 2-Line System Chemotherapy Program, Disease Progression or Recurrence of Small Cell Lung Cancer (SCLC) Public Information Shows that Chiauranib is a self-developed The high selective inhibition of Aorora B/VEGFR/PDGFR/c-Kit/CSF1R target can simultaneously play an integrated anti-tumor effect by inhibiting tumor angiogenesis, inhibiting tumor cells with silk division and regulating tumor micro-environment, and has better animal drug ability activity and good safety than similar mechanism drugs.
the Theo Ronnie capsule in China to be included in the breakthrough treatment varieties, to develop adaptive disorders: single-drug treatment after 2-line system chemotherapy treatment after disease progression or recurrence of SCLC.
previously, Microcore Bio has conducted a Phase 1 clinical trial of Theoroni capsule therapy for relapse-resistant SCLC to observe and explore the initial efficacy of the candidate drug therapy for relapse-resistant SCLC- objective mitigation rate.
Screenshot Source: CDE.com Microcore Biology is currently conducting Phase 2 clinical trials of Theroni for ovarian, small cell lung, liver and non-Hodgkin's lymphoma, and the company expects to submit a new drug for the product in 2021.
3, Dijon Medicine: DZD9008 Tablet Mechanism: EGFR Inhibitor Adaptation: Exon Insertion Mutation No. 20 with Skin Growth Factor Recipient (EGFR) who has received at least one systemic chemotherapy in the past Local late stage or metastatic NSCLC disclosure data show that DZD9008 is a potentially anti-cancer egFR inhibitor intended for the treatment of advanced NSCLC and non-Hodgkin B cell lymphoma with EGFR or HER2 mutations.
EGFR is a group of cell surface bodies of the family of skin growth factors with tyrosine kinase activity, whose activation abnormalities activate genes associated with tumor proliferation and differentiation, which in turn induce tumor formation and development.
EGFR inhibitors inhibit the activity of tyrosine kinase by combining EGFR with endogenetic ligation competition, blocking the EGFR signaling path, thus producing a series of biological effects such as inhibiting the proliferation, metastasis and promoting apoptosis of tumor cells.
the DZD9008 is intended to be included in the breakthrough treatment varieties in China, the proposed development of adaptation is: at least once in the past received a systemic chemotherapy with EGFR 20 exon insertion mutation of the local late stage or metastasis NSCLC.
based on the drug clinical trial registration and information disclosure platform, Dijsher Pharmaceuticals is conducting a phase 1 study of DZD9008 in NSCLC Chinese patients with EGFR or HER2 mutations.
screenshot Source: CDE's official website, Dijon Pharmaceuticals, shows that the DZD9008 clinical development has progressed to Phase 2 clinical, the company has global rights.
: 1. Retrieved Dec 18, 2020, Blueprint from Medicines Announces FDA Approval of GAVRETO™ (pralsetinib) for The Treatment of Patients with Advanced or Metastatic RET-Mutant and T Fusion-Positive Thyroid Cancer. Retrieved December 1, 2020, press releases and announcements from various companies Source: Pharmaceutical Mission Hills, follow medicinalcond.com WeChat Public No