12 "China class 1" NDA applications worthy of attention in China

The research and development of domestic innovative drugs can not only improve the competitiveness of China's pharmaceutical industry in the global scope, but also solve the drug shortage or even "drug free" situation in many disease areas in China, so as to comprehensively improve the protection of Chinese people's pursuit of a better and happy life At the same time, the research and development of innovative drugs, as a long-lasting battle from the past, to the present and in the future, the birth of each variety can be described as experiencing "ninety-one difficulties" So when an NDA application is submitted to CFDA's drug Audit Center, what kind of feelings will it be mixed with Now, Xiaobian has sorted out 12 "in progress" China class 1 "NDA applications worthy of attention in China in recent years We hope that we can learn from each other, and each small partner can further explore products of interest according to their scientific research needs At present, the "in progress" NDA applications in China are inquired through drug delivery data (12772 drug data have been published up to now) Currently, 162 NDA applications are in the research and development stage (global), while 26 NDA applications belong to "China class 1" Of the 26 messages, 12 were in progress, 11 were not in progress, and 3 were terminated The following focuses on 12 NDA application drugs in the "ongoing" clinical state See Table 1 for brief information Each "in progress" NDA application will be introduced separately ☆ androtinib dihydrochloride hydrochloride, which is considered to be the anticancer drug with the most investment so far Advenhen Laboratory and Zhengda Tianqing have reached an agreement to jointly develop the clinical treatment for a variety of cancers, including advanced gastric adenocarcinoma, non-small cell lung cancer, advanced renal cell cancer, medullary thyroid cancer, soft tissue sarcoma, metastatic colorectal cancer and ovarian cancer The administration mode of "taking two stops and one stop" of androtinib hydrochloride is quite unique, which can keep the blood concentration stable within the treatment window after stopping for one week for two weeks In July 2010, androtinib hydrochloride began to apply for clinical application In April 2011, it was officially approved for clinical application Until March 2017, it formally applied for production Shortly after the delivery, it obtained the CDE priority evaluation qualification in China at the end of April (PS: in 2015, the compound obtained the orphan drug qualification in the United States for its treatment of ovarian cancer) Peg loxenatide, a long-acting GLP-1 receptor agonist, is independently developed by Haosen, Jiangsu Province It is intended to be used as a single drug or combined with metformin in the treatment of type 2 diabetes The product only needs to be injected once a week In terms of registration, in March 2007, Jiangsu Haosen applied for class 1.1 clinical research of Sinochem, obtained clinical approval in October 2008, completed two important phase III clinical trials in January and July 2015, registered and accepted in October 2017, and entered CDE of evaluation center on December 6, 2017 With the continuous progress of the project, it has also won many honors, such as being selected into the "863 Plan" of the state in 2008, being supported by major national science and technology projects twice in 2010 and 2012, etc [bencycloquinium bromide] bencycloquinium bromide is a new anticholinergic drug synthesized on the basis of penehyclidine It is developed by Gu'an Shiqiao Pharmaceutical (Beijing Shiqiao biopharmaceutical subsidiary) and Yingu pharmaceutical It is clinically used to treat asthma, allergic rhinitis and chronic obstructive pulmonary disease, with few adverse reactions and strong anticholinergic effect In June 2006, Beijing Shiqiao biology submitted a new drug application to CFDA and was approved for clinical application in August 2007 Among them, in January 2016, the R & D enterprise withdrew the application, and in November 2017, it again submitted the drug registration application NDA to CFDA, which is currently in the process of acceptance Roxadustat, an inhibitor of hypoxia inducible factor prolyl hydroxylase (hif-ph), can inhibit the ubiquitination and degradation of HIF It was jointly developed by fibrogen / AstraZeneca / Astaire It is intended to be used in the treatment of anemia in patients with dialysis dependent chronic kidney disease (dd-ckd) and non dialysis dependent chronic kidney disease (ndd-ckd) Originally developed by fibrogen, Rosas was granted development rights in Asia, Europe and South Africa in 2006 Development rights granted to AstraZeneca in the United States, China and other major regions except Japan and Europe in 2013 In April 2014, Beijing fabojin pharmaceutical technology applied for class 1.1 clinical research of Chinese chemical medicine, and obtained the clinical approval document in August 2015 In October 2017, it submitted a new drug listing application (Class 1 Chemical Medicine) in China The action target is β - AR, which is β - adrenergic receptor agonist It is proposed to be used in the treatment of coronary heart disease It took 7 years to complete the phase I, II and III clinical trials On September 17, 2011, a summary meeting of clinical trials was held in Zhuhai City It was pointed out that the drug had a good diagnostic effect on myocardial ischemia of coronary heart disease in the heart load test, which could significantly improve the heart rate, have a strong positive inotropic function, and have a small impact on blood pressure, with a slight adverse reaction In August 2012, Zhuhai Rundu Pharmaceutical Co., Ltd., Guangdong South China new drug development center and Institute of medicine of Chinese Academy of Medical Sciences jointly applied for the review of class 1.1 production of Sinochem Corimycin, jointly developed by the Institute of pharmaceutical biotechnology, Peking Union Medical College, Chinese Academy of Medical Sciences / Beijing Shouke group / Shenyang Tonglian Pharmaceutical Group, is a macrolide antibiotic for the treatment of bacterial infection It has three national patents and belongs to the National 863 and the tenth five year key project In September 2010, the Institute of pharmaceutical biotechnology, Chinese Academy of Medical Sciences, Shenyang Tonglian and Beijing Shouke group jointly applied for 1.1 new drug application; in March 2015, Shenyang Tonglian Group Co., Ltd carried out supplementary application; in January 2017, it entered review [albuvirtide] Ibovetai, developed by frontier biopharmaceutical industry (Nanjing), is a fusion inhibitor of human immunodeficiency virus (HIV-1), which belongs to gp41 inhibitor It is the first long-acting AIDS drug in the world It can be injected once a week, and it is effective for the main HIV-1 virus and drug-resistant virus It is planned to be combined with lopinavir / litonavir to treat HIV infection In March 2007, Chongqing frontier biology applied for new drug registration; in June 2012, it completed the supplementary application; in 2014, it carried out two important phase III clinical trials; in July 2016, frontier biology submitted new drug listing application NDA to China's CFDA In addition, ibovetai is also a national major new drug development project Pyrotinib maleate was developed by Jiangsu Hengrui Co., Ltd and its target was EGFR / erbB2 It is intended to be used in the treatment of HER2 positive metastatic breast cancer In May 2011, Jiangsu Hengrui Pharmaceutical Co., Ltd and Shanghai Hengrui Pharmaceutical Co., Ltd jointly submitted the clinical trial application (chemical 1.1) to the State Food and drug administration; in May 2012, obtained the class 1.1 clinical approval document of Chinese chemical; in May 2015, submitted the supplementary application; in July 2016 and March 2017, conducted two important phase III clinical trials; in August 2017, submitted in China It is expected to become a domestic breast cancer small molecule targeted treatment heavyweight variety [buthio nine sulfoximine] is jointly developed by Liaoning Lantian Pharmaceutical Co., Ltd., Fudan University and Shanghai Zhongmin new technology Its target is GCS, which is a tumor chemotherapeutic sensitizer The compound obtained phase I new drug clinical Certificate in 1998, phase II and phase III new drug clinical Certificate in 1999, phase II clinical trial in 2004, phase III clinical trial in 2007, and production application in September 2011 The approval conclusion is that some clinical trials need to be supplemented Fruquintinib, developed by Hutchison Whampoa medicine, is used for the treatment of gastric cancer, advanced or metastatic colorectal cancer and non-small cell lung cancer Fiquitinib is a highly selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) It was originally developed by Hutchison Whampoa and authorized to Lilly in 2013 According to the clinical data, the kinase selectivity of furquitinib has been proved to reduce the Miss target toxicity Under this condition, the drug exposure can completely inhibit VEGFR, and it has the potential to be used in combination with other targeted therapies and chemotherapy in a larger group of patients receiving early treatment In September 2009, new drug application was submitted to CFDA; in November 2014 and December 2015, two important phase III clinical trials were carried out; in June 2017, the new drug market application of furquitinib in the treatment of advanced colorectal cancer was officially accepted by China food and Drug Administration (CFDA) Danoprevir sodium, an inhibitor of HCV protein, combined with pegylated interferon, ribavirin and ritonavir in the treatment of hepatitis C infection The compound was initially developed by intermune and authorized to Roche in 2006 The agreement was terminated in 2010 Roche obtained the R & D right of the drug In 2014, intermune was acquired by Roche In 2013, Roche authorized the R & D right of China and Taiwan to Geli, and filed an NDA application in China in December 2016 Benvitimod is the first new non hormonal immune regulation / anti-inflammatory small molecule compound with independent intellectual property rights, which is intended to be used for the treatment of dermatosis and psoriasis The compound was initially developed by welichem biotech, and then authorized to Stafford (GlaxoSmithKline subsidiary) and Tianji pharmaceutical In March 2008, the application for new drug registration was submitted to CFDA; in April 2013 and September 2013, two important phase III clinical trials were conducted; in December 2016, the application for new drug listing (chemical class 1) was submitted In addition, as a new small molecular compound, benzenomod has been continuously supported by the national "major new drug creation" science and technology major special support during the 11th and 12th Five Year Plan Summary of new drug research and development, from the initial target recognition, compound screening, to the determination of lead compounds, candidate drugs, and then to the ind application, clinical trials, the difficulty of this road is painful and memorable Therefore, to be able to walk the NDA step, is really a zigzag, cold and warm self-knowledge It's just like being close to the door in a football field, where the victory or defeat is at one stroke However, we have already stepped into the step of NDA, and are still "in progress" To some extent, we can see the importance of this NDA application Xiaobian hopes that through the comprehensive collation of the data of Yaodu and CDE, the brief collation of 12 NDA in the recent "China class 1" will be helpful to your daily scientific research If so, it's lucky for Xiaobian! Reference: 1 Drug delivery data 2 Cfda-cde data