The first new chemical entity of small cell lung cancer in 20 years! Green leaf pharmaceutical partner Pharma Mar innovative medicine lubinectedin US entered the priority review!

Pharma, partner of Luye Pharma, is a leading global biopharmaceutical company in the discovery and development of innovative marine derived anticancer drugs Recently, pharmapar announced that the U.S Food and Drug Administration (FDA) has accepted the new drug application (NDA) of lubinectedin (zepsyre ®) and granted priority review The NDA seeks to accelerate the approval of lurbinecteden for the treatment of small cell lung cancer (SCLC) patients undergoing platinum based chemotherapy FDA has set the target date of PDUFA as August 16, 2020 In the United States, pharmamar and jazz pharmaceuticals signed an exclusive license agreement in December 2019, which came into effect in January 2020, granting jazz the right to commercialize lurbinectedin in the U.S market Lurbinectedin (zepsyre ®) is a derivative of ascidian developed by pharmamar, a Spanish biopharmaceutical company It is an innovative tumor drug At present, LVYE pharmaceutical and pharma Mar cooperate to develop the drug in China LVYE pharmaceutical has the exclusive right to develop and commercialize the drug in China, including all indications of small cell lung cancer; and can require pharmar to transfer the technology of the drug, which is produced in China by LVYE pharmaceutical This NDA is based on the data of stage II single drug treatment basket study of lurbinectdin (zepsyre ®) in the treatment of small cell lung cancer A total of 105 patients were enrolled in the study The results showed that the overall response rate (ORR) of the second-line single drug treatment for small cell lung cancer was 35.2%, and the median overall survival time (OS) was 9.3 months According to the results of researcher evaluation and independent review committee, the trial reached the main end point of total efficiency (ORR) The efficacy of lurbinectdin (zepsyre ®) was better in patients with sensitive relapse (the interval between discontinuation of treatment ≥ 90 days), with orr of 45% and OS of 11.9 months The activity of lurbinectedin (zepsyre ®) in patients with drug-resistant relapse (the interval between discontinuation of treatment < 90 days) was 22.2% and OS was 5 months For this kind of patients, there is no approved drug on the market at present Lurbinectedin (zepsyre ®) has good and controllable security The results were also presented at the June meeting of the American Society for Clinical Oncology (ASCO) Molecular structure formula of lurbinectedi (picture source: medchemexpress Com) Lurbinectdin (zepsyre ®) is a derivative of ascidian It is an inhibitor of RNA polymerase II It can covalently bind with the small groove on the double helix structure of DNA By blocking the binding of RNA polymerase II with DNA and degrading the catalytic subunit rpb1 of RNA polymerase II, it can inhibit the transcription activity from the beginning of transcription to the extension stage, so as to make tumors In the process of mitosis, cell distortion, apoptosis, and ultimately reduce cell proliferation Small cell lung cancer accounts for about 10% - 15% of all lung cancer patients It is more aggressive and more difficult to treat than non-small cell lung cancer The 5-year survival rate is only 5% - 10% Although small cell lung cancer has high sensitivity to initial chemotherapy and radiotherapy, most of the patients died of recurrence and metastasis after initial treatment failure, with poor prognosis According to the announcement released by Pharma Mar in December last year, the progress of new drugs for small cell lung cancer is slow, and there has been no substantial change in this field in the past 20 years Topotecan (Hycamtin), which was approved in 1996 to treat recurrent small cell lung cancer, is the last New chemical entity approved by FDA in the past 20 years If approved, lurbinectedi (zepsyre ®) would be the first new chemical entity to treat small cell lung cancer in the past 20 years However, according to foreign biotech website fierce biotech, Pharma Mar's description of drug innovation in small cell lung cancer is wrong In recent years, Bristol Myers Squibb and mosadon's two PD-1 tumor immunotherapies, opdivo (Chinese trade name: odivo, common name: nivolumab, nevulizumab) and keytruda (Chinese trade name: coreda, common name: pembrolizumab, and pabolizumab), have respectively obtained the US FDA Approved for treatment: small cell lung cancer patients who have progressed after receiving platinum containing chemotherapy and at least one other treatment Therefore, patients with small cell lung cancer can choose to receive checkpoint inhibitors However, the overall remission rate of opdivo and keytruda in the treatment of small cell lung cancer was less than 35% achieved by lurbinectdin (zepsyre ®) Although the unreliability of cross test comparison makes the significance of this difference unclear But pharmamar also has early evidence that lurbinectdin (zepsyre ®) is effective in patients who have previously been treated with immunooncology LVYE pharmaceutical has previously said that it hopes to further expand its R & D product line in the field of cancer through cooperation with Pharma Mar, and also hopes to provide new treatment options for doctors and patients in China through the innovative drug Tumor field is one of the core treatment fields focused by green leaf pharmaceutical Relying on the way of independent R & D and cooperative R & D, the company has deeply distributed the global product line in this treatment field At present, it has more than ten innovative preparations and innovative drugs, which are at different clinical stages in China and overseas.