Inventory: 15 T790M "EGFR-TKI" under study in China

T790M mutation, is one of the important direction of EGFR-TKI, and has been a number of drugs on the market;
, what about the domestic EGFR-TKI competitive track for the T790M mutation in this direction? To what extent has it been developed? Is the future predictable? This article will provide you with a comprehensive interpretation.
01NDA stage varieties - 2 domestic for T790M development, and 3 generations of EGFR-TKI innovative drugs, parallel development with Amethini, there are still 2 varieties into the NDA stage, namely, Shanghai Ailes aphedrinic acid efutinib and Eisen medicine of Malay acid avitinib.
01 Aefluentini (Shanghai Alistocrine Pharmaceuticals) Development Co., Ltd. for Shanghai Allis Pharmaceutical Technology Co., Ltd., for irreversible, selective EGFR inhibitors, EGFR T790M and EGFR sensitive mutations have significant inhibitory activity, has been China's "major new drug creation" national science and technology major special support for the treatment of advanced non-small cell lung cancer.
January 25, 2016, Shanghai Alice Pharmaceutical Technology Co., Ltd. submitted a clinical trial application (Class 1.1) to CDE, and obtained clinical approval in September 2016.
december 17, 2019, the drug's application for listing was included in the priority review process by CDE.
02 Malay acid Avitini (Eisen Pharmaceuticals) development company for Eisen Pharmaceuticals, was the first developed in China's 3rd generation EGFR-TKI, can simultaneously inhibit EGFR-L858R, Exon19del and T790M mutations, for the treatment of non-small cell lung cancer with EGFR mutation or drug-resistant mutation, is currently in the NDA application stage in China, intended for second-line treatment of advanced or metastasis small cell lung cancer.
August 2013, Avetini's clinical trial application (Chemical Class 1) was accepted by CDE.
June 2018, Eisen Bio submitted an application for the listing of Evigny Marais in China and in August 2018 was included in the CDE's 31st priority review process.
02III clinical varieties - 4 domestic into the clinical phase III T790M EGFR-TKI mainly has 4 models, respectively, Shanghai Timesa Pharmaceuticals BPI-7711, Dongsian pharmaceutical methulphate Lylotini, Shanghai Pharmaceutical Institute / Jiangsu Osaikang ASK120067, and Suzhou Runxin bio-RX-518.
01BPI-7711 (Shanghai Pista) Development Co., Ltd. for Shanghai Times Pharmaceutical Co., Ltd., is intended to be used in the early EGFR-TKI targeted drug treatment due to T790M mutation failure of non-small cell lung cancer patients, but also for non-small cell lung cancer patients with EGFR-positive mutation to provide first-line treatment.
April 2016, the drug's clinical trial application (Class 1) was accepted by CDE and approved for clinical trial in February 2017.
August 2017, an open, one-arm Phase I study evaluating the safety, tolerance, pharmacodynamics and anti-tumor activity of BPI-7711 in patients with advanced non-small cell lung cancer began in China.
February 2019, the BPI-7711 capsule treated EGFR mutation T790M-positive patients with metastasis or recurrence of non-small cell lung cancer in the effectiveness and safety of open, one-arm II.b clinical studies began to recruit patients in China.
March 2019, the effectiveness and safety of BPI-7711 capsule therapy for patients with local late stage or recurring metastasis metastasis of non-small cell lung cancer with EGFR mutation phase III. Clinical studies began in China.
02 Methulphate Lelotini (East Sun Medicine) Development Company for The East Sunshine Drug, can target a number of targets including EGFR (wild type, sensitive mutation, T790M mutation), Her2, Her4, RIPK2, IRAK1, BTK and BLK, intended for the treatment of esophageal cancer, as well as the treatment of pancreatic cancer, head and neck cancer and non-small cell lung cancer and other advanced malignant solid tumor patients.
is currently at the highest clinical stage in Phase III.
January 2014, a clinical trial application (Class 1) submitted by Guangdong Dongsi Pharmaceuticals in China was accepted and approved for clinical trial on March 26, 2015.
In September 2015, the evaluation of the safety, tolerance, pharmacodynamic and preliminary pharmacological properties of lelotini capsules in patients with advanced malignant solid tumors began in China; Clinical Phase I trials of pharmacodynamic properties began in China;
03ASK120067 (Shanghai Pharmaceutical Institute / Jiangsu Osaikang) development unit for the Chinese Academy of Sciences Shanghai Institute of Pharmacy, the Chinese Academy of Sciences Guangzhou Institute of Biomedicine and Health and Jiangsu Osaikang Pharmaceutical Co., Ltd. jointly developed, intended for the treatment of T790M mutation of non-small cell lung cancer, is currently in clinical phase III.
March 2017, the drug's clinical trial application (Class 1) was accepted by CDE and approved for clinical trial in September 2017.
January 2018, ASK120067 patients with local late stage or metastasis non-small cell lung cancer were admitted to the first phase I/II study in China.
04RX-518 (Suzhou Runxin Bio) Development Company for Suzhou Runxin Bio, is currently in Clinical Phase III, for the treatment of non-small cell lung cancer.
the FDA accepted THED applications for this variety in August 2016, and the dose-increment open-label open-label clinical phase I/II trial for patients treating NSCLC and other advanced solid tumors in September 2016 began in New Zealand, Australia, Thailand, and the United States to assess the safety of the species in this patient group, pharmacodynamics and Efficacy: Obtained FDA orphan drug qualification in September 2017 for the treatment of NSCLC patients with EGFR mutation positive, January 2018 Suzhou Runxin Biotech Co., Ltd. submitted a clinical trial application to the General Administration of Food and Drug Administration of China (Class 1), and obtained clinical trial approval in June 2018.
03II / I clinical varieties - 9 in addition to the above-mentioned NDA, Phase III clinical varieties, domestic pharmaceutical companies developed T790M EGFR-TKI has nearly 9 varieties into clinical phase II, phase I;
01D-0316 (Yifang Bio/Beda Pharmaceuticals) was developed by Yifang Bio (formerly known as Shale Technology) to treat non-small cell lung cancer that produces T790M mutations using EGFR-TKI resistance and is currently in clinical Phase II.
February 2017, Shanghai Shale Technology Co., Ltd.'s clinical trial application (Class 1) submitted in China was accepted and clinical approval was obtained in August 2017.
January 2018, the phase I clinical study of D-0316 in patients with advanced non-small cell lung cancer with EGFR mutation was launched in China and sponsored by Yifang Bio.
July 2018, the D-0316 capsule was launched in China on an empty stomach in healthy men and in post-meal drug generational dynamics characteristics Phase I study, sponsored by Yifang Bio.
2018, Beda Pharmaceuticals and Yifang Bio cooperated on the D-0316 project.
Under the agreement, Beda Pharmaceuticals will pay a down payment of a total of 23 million yuan to Yifang Bio and subsequent research and development milestones, after the product is listed plus a sales credit, Yifang Bio transfers its D-0316-related Patents and patent applications and know-how in the Cooperation Area (including Chinese mainland, Hong Kong and Taiwan) and joint patents are exclusively enforced by Beda Pharmaceuticals in the Cooperation Area to develop, manufacture and commercialize D-0316 and products.
February 2019, phase II clinical trials of D-0316 in patients with local late stage or metastasis non-small cell lung cancer with EGFR mutations began in China.
December 2019, phase II/III clinical trials of D-0316 in patients with localized late stage or metastasis non-small cell lung cancer with EGFR mutations began in China.
02 g Nitini (Jiangsu Meito) Development Co., Ltd. for Jiangsu Medi Pharmaceutical Research and Development Co., Ltd., is currently in clinical Phase II, intended for the treatment of T790M mutation of non-small cell lung cancer.
July 2017, Jiangsu Meido Pharmaceutical Research and Development Co., Ltd. submitted a clinical trial application (Class 1) to CDE and obtained clinical implied permission in December 2017;
03ES-072 (Bosheng Pharmaceuticals) Development Company for Bosheng Pharmaceuticals, EGFR (L858R, ex19del) and EGFR T790M has a namor-level inhibition effect, intended to be used to treat EGFR T790M drug-resistant mutation non-small cell lung cancer patients.
preclinical data show that ES-072 can penetrate the blood-brain barrier.
June 2017, a clinical trial application (Class 1) submitted by Zhejiang Bosheng Pharmaceutical Co., Ltd. in China was accepted by CDE and approved for clinical trial in December 2017.
July 2017, ES-072 was approved by the FDA to enter the clinical trial phase.
January 2018, ES-072's single-center, open, incremental Phase I clinical studies in patients with localized late-stage or metastasis non-small cell lung cancer have recruited patients in China.
November 27, 2018, CBT Pharmaceuticals (Zhejiang Guanke Meibo) and Zhejiang Bosheng Pharmaceutical Co., Ltd. signed a clinical cooperation and licensing agreement granting CBT ES-072 Exclusive right to develop and commercialize ES-072, a new skin growth factor inhibitor (EGFR) inhibitor of Bosheng Pharmaceuticals, in partnership with CBT's own c-Met inhibitors and anti-PD-1 antibodies.
04BEBT-109 (Guangzhou Bibert) was developed by Guangzhou Bibet Pharmaceutical Technology Co., Ltd., and in May 2019 CDE accepted the clinical trial application for this product (Chemical Class 1).
was approved by default in July 2019 for clinical trials to treat advanced non-small cell lung cancer that relapses after at least one anti-tumor drug and carries EGFR-TKI-sensitive mutations.
BEBT-109 is an innovative drug of the chemical structure of oseltinib, for the low concentration of human peaks and long half-life at the dose of oseltinib treatment and the high rate of drug accumulation, which can easily lead to off-target toxicity characteristics, BEBT-109 in the retention of oxitinib While the advantages of EGFR exon 19 loss or L858R mutation and EGFR T790M mutation selectivity, strong activity and significant anti-tumor effect in the body, improving pharmaconological dynamics by increasing compound peak concentration and shortening half-life may have better safety while increasing drug ability.
05BPI-15086 (Beda Pharmaceuticals) Development Company is Bayda Pharmaceuticals, intended for the treatment of non-small cell lung cancer.
2015, the Chinese chemical drug Class 1.1 clinical studies were declared, and in August 2016, the clinical trial approval was obtained.
December 2016, the first phase I clinical study of BPI-15086 in patients with advanced non-small cell lung cancer with advanced T790M mutations who progressed after treatment with EGFR-TKIs was completed in China.
06C-005 (Nanjing Galaxy Bio) Development Company is Nanjing Galaxy Biopharmaceutical Co., Ltd., intended for use in non-small cell lung cancer caused by EGFR T790M mutations, including brain metastasis lung cancer.
November 2018, CDE accepted applications for clinical trials of this product (Class 1 of Chemical Drugs) and in January 2019, clinical trials were tacitly licensed.
07YZJ-0318 (Yangzijiang Pharmaceuticals) Development Company for Yangzijiang Pharmaceutical Group Co., Ltd., is currently in clinical phase I, intended for the treatment of EGFR-T790M mutation-positive non-small cell lung cancer.
August 2016, Shanghai Haiyan Pharmaceutical Technology Co., Ltd., a subsidiary of Yangzijiang Group, jointly submitted a clinical trial application (Class 1) to CDE and obtained a clinical trial approval on March 7, 2017.
08YK-029A (Hainan Yuekang Bio) Development Company for Hainan Yuekang Biopharmaceutical Co., Ltd., is currently in clinical phase I, intended to be used to treat the past EGFR-TKI treatment by the T790M gene mutation obtained resistance and disease progression of advanced non-small cell lung cancer.
CDE accepted applications for clinical trials of this product (Chemical Class 1) in August 2017 and obtained clinical trial approval in January 2018.
09FHND9041 (Jiangsu Zhengda Fenghai Pharmaceuticals) Development Company for Jiangsu Zhengda Fenghai Pharmaceutical Co., Ltd., through computer simulation and molecular design, and through the pharmaceutical chemistry of structural analysis, structural optimization and in vivo biological activity and DMPK screening found a new structure of 3 representative skin growth factor subject small molecule inhibitors.
CDE accepted clinical trial applications for this product in June 2018 (Chemical Class 1), and in August 2018, Zhengdafenghai announced that FHND9041 had been approved for clinical trials.
the T790M EGFR-TKI's domestic variety competition track above the 04 knot.
can be said that the success of the T790M 3-generation variety Oghitini, so that the fierce competition heats up, Amethini's stand-out, and further aggravated the domestic varieties in the race for time.
Now, the potential varieties in clinical development are at a glance, and in the future, in addition to doing better on the basis of clinically identified indications, how to further make more important clinical characteristics will be T790M EGFR-TKI