[year end inventory] application for class 1 new drugs of domestic chemicals in 2016

The year-end message is coming to the end of 2016 In this year, various policies such as "new drug rapid review and approval system", "clinical data specification", "generic drug consistency evaluation" drive the development of innovative drugs At the same time, a large number of innovative drugs are emerging On the afternoon of December 30, 2016, President Xi Jinping chaired the thirty-first meeting of the central leading group for deepening reform and delivered an important speech He stressed that: strict drug market review and approval system, accelerate the promotion of drug quality and efficacy consistency evaluation, and orderly promote the pilot drug market license holder system! In 2017, we look forward to the best opportunity period for innovative drugs to be more stable! 1 Zhengda Tianqing Pharmaceutical Group and its raw material pharmaceutical factory, Runzhong pharmaceutical, have submitted 5 applications for raw materials and tablets (capsules) of class 1 chemicals, namely tq-f3083, tq-b3203, tq-b3233, tq-a3334 and tq-b3525 In addition, four new drugs of category 1 have been approved for clinical use this year, all of which were declared last year The fields to be treated may be diabetes, hepatitis B, anti-tumor, rheumatoid arthritis, etc 2 AIDS drugs Jiangsu Aidi Pharmaceutical Co., Ltd.: acc007 raw materials and tablets As a non nucleoside reverse transcriptase inhibitor, it is intended to be used in the treatment of AIDS In 2015, acc007 completed the first phase of sad and mad clinical research in healthy volunteers in South Korea 3 Zhongsheng Pharmaceutical (1) on September 12, 2016, Zhongsheng pharmaceutical announced that the application for clinical trial registration of zsp1602, a class 1 innovative drug for small cell lung cancer (SCLC), for raw materials and capsules was accepted by CFDA Zsp1602 is the first innovative drug for tumor treatment applied by Zhongsheng pharmaceutical (2) Zsp1601 is a new class 1 drug for the treatment of nonalcoholic steatohepatitis (NASH) Related compounds and their uses have been applied for domestic patent and international PCT patent, which is the first domestic application for NASH innovative drug in clinical trials (3) In July 2015, Zhongsheng pharmaceutical signed a strategic cooperation agreement with Wuxi apptec The first stage of cooperation is 2015-2019, in which the R & D of class 1.1 small molecule chemical innovative drugs is jointly carried out At present, Zhongsheng Pharmaceutical Co., Ltd and Wuxi Pharmaceutical Co., Ltd jointly carry out the cooperative research and development projects of new drug zsym003, new drug zsym004, new drug zsym005, new drug zsym006, new drug zsym007, new drug zsym008 and new drug zsym009 for non-alcoholic fatty hepatitis 4 The clinical application of shenggliptin phosphate tablets and shengshityco's shenggliptin phosphate raw materials and tablets was accepted by CDE in October this year The drug is a DPP-IV inhibitor and is intended to be used in the treatment of type 2 diabetes The project is a major national special project during the 12th Five Year Plan period According to the official website, shenggliptin phosphate has better in vitro and in vivo activity, stability, bioavailability, pharmacokinetics, toxicity and other data than Merck's siggliptin 5 Nl-101 for injection is a double inhibitor of DNA damage and histone deacetylase (HDAC), which is intended to be used in the treatment of blood cancer, solid tumor and other cancers The results showed that nl-101, different from bendamostine and Saha (vironastat), has a new mechanism of action and may not be cross resistant to traditional drugs Nl-101 was developed by Mundi In July 2011, Hangzhou Minsheng Pharmaceutical Co., Ltd obtained the patent right, R & D, production and sales right of the product in China 6 Guangdong dongyangguang (1) cliflotinib besylate tablet: it may be an inhibitor of FLT3 target, and the indication is AML; (2) iffenidone hydrochloride capsule: the indication is pulmonary fibrosis Before that, ningetinib p-toluenesulfonate capsule, lelotinib mesylate capsule, boxitinib hydrochloride capsule and iritinib maleate capsule declared by dongyangguang were all approved for clinical use 7 Shandong Danhong pharmaceutical bc0335 granules is the second project declared by Shandong Danhong pharmaceutical, the first new drug category 1 project At present, most of the patents applied by the company are related to Danhong injection, and no information about this product has been found Previously, doripenem for injection was declared in 2012 According to the public information, Shandong step holds 75% of Shandong Danhong 8 At the end of November 2016, Kangyuan pharmaceutical submitted the company's first chemical medicine class 1 application, code: ky0467 granules Previously, the author speculated that it was an EGFR / erbB2 inhibitor and lapatinib improved drug according to the patent application of the company (as early as 2008, Kangyuan set up an American team dedicated to new drug development.) However, before receiving the manuscript, a person familiar with the matter said that this is not an anti-tumor drug, nor is it developed by overseas new drug teams, so the announcement was made as follows? 9 HISCO Pharmaceutical (1) hesco-149 and hesco-149 tablets: it is a new liver disease class 1 drug This is one of the few chemicals declared by Hisilicon (2) In March 2016, HISCO obtained the clinical approval of its own product, hsk3486 emulsion injection Hsk3486 is a general anaesthetic for injection (anesthesia to be used in outpatient surgery, painless gastroscopy and induction of general anesthesia) It has completed phase I clinical trial in Australia, involving 92 subjects 10 Xinlitaxel for injection: in August 2016, xinlitaxel applied for a new class 1.1 drug every ten years, which is supposed to be an improved drug of docetaxel 11 Chenxin pharmaceutical mefurepiride hydrochloride tablet was developed by Dr Miao Zehong of Shanghai Institute of pharmaceutical research, Chinese Academy of Sciences, and jointly developed by Shandong Chenxin It is a kind of PARP inhibitor anti-tumor drug, and was selected into the major project of "major new drug creation" It was approved by the end of November 2016 12 Luoxin pharmaceutical scc-31 capsule: the scc-31 capsule jointly developed by Luoxin pharmaceutical, Shanghai Pharmaceutical Institute of Chinese Academy of Sciences and Fudan University submitted a clinical application to CFDA in February 2016 and was approved in September The drug is a selective inhibitor of ATP competitive mTOR and is intended to be used in anti-tumor This drug is the first new drug of class 1.1 declared by Luoxin pharmaceutical Previously, it was reported that Shanghai Institute of medicine and Fudan University would transfer to Luoxin pharmaceutical with 130 million yuan plus sales commission 13 EGFR T790M mutation third generation small molecule targeted drug (1) hausen pharmaceutical: hs-10296 tablets, has carried out international multi center clinical research in the United States, Taiwan and South Korea (2) Zaiding medicine: zl-2303 tablets were introduced from South Korea and the United States in November 2015, and clinical application was submitted to CFDA in May this year (3) Hangzhou Hongyun Huaning Pharmaceutical Co., Ltd.: gma204 capsule: a new generation of tyrosine kinase inhibitor, with small molecular weight, can pass through the blood-brain barrier, and other TKIs with higher drug distribution proportion in the animal brain than EGFR provide new hope and choice for the advanced patients who are ineffective in chemotherapy or the first generation of EGFR inhibitors produce drug resistance and new T790M variation Clinical application was submitted in July 2016 (4) Other domestic manufacturers of T790M similar drugs are Eisen Biology (ivetinib), Huadong medicine (mehuatinib), Beida pharmaceutical, Baiji Shenzhou, etc 14 Tianjin Shangde YaoYuan act001 capsule: a new anti glioma drug Act001 is a derivative of steviolide, which overcomes the disadvantages of steviolide, such as instability, low water solubility and so on Act001 can pass through the blood-brain barrier In the animal model experiment, it has a good effect on glioblastoma In September 2016, act001 was administered safely to the first cancer patient in Australia 15 Kananji CM082 is a double target inhibitor of VEGF / PDGF, which has a similar skeleton structure to sunitinib At present, the indications developed overseas include wet macular disease (Wamd), non-small cell lung cancer, renal cancer, etc In August, September and November this year, we obtained three domestic clinical approval documents for indications 16 In September 2016, amxetine hydrochloride enteric coated tablets obtained the clinical approval from the Institute of toxicants and drugs (1) of the Academy of Military Sciences: amxetine hydrochloride is a brand-new 5-HT and NE reuptake inhibitor drug, which is intended to be used in the treatment of antidepressant Apply for the joint declaration of Sinology and the Academy of Military Sciences (2) The clinical application was submitted in February 2016 It is an improved new drug of phenacyronyl hydrochloride for the treatment of motion sickness 17 Beijing salintai ct-1530 capsule: a Btk kinase inhibitor, intended to be used in the treatment of chronic lymphoblastic leukemia, small lymphoid lymphoma, etc After 7-month review, the clinical approval document was obtained in September this year 18 Kangnaide biological cbp-307 capsule: accepted by CDE in May this year This product is a S1P1 agonist, intended for the treatment of autoimmune diseases, such as multiple sclerosis, psoriasis and inflammatory bowel disease In January 2016, phase 1b clinical study of cbp-307 in Australia was completed Other projects under research include cbp-174, cbp-201 and cbp-104 19 The tp-168 tablet declared by Shanghai Tangrun pharmaceutical in August this year is a hepatitis C drug (HCV protease inhibitor) Tangrun pharmaceutical development focuses on anti hepatitis C, anti infection and anti-tumor fields 20 Zhejiang Jianfeng Pharmaceutical Co., Ltd (1) deoxypodophyllotoxin for injection: it belongs to microtubule combined drug and is used for anti-tumor treatment Submitted the ind application to CFDA in August 2016 (2) In April 2012, Jianfeng pharmaceutical and China Pharmaceutical University signed a cooperative development agreement on a new anticancer drug, deoxypodophyllotoxin (DPT), with a contract amount of 30 million yuan 21 Shenzhen mingsairuilin Pharmaceutical Co., Ltd silektorin tablet: a drug for anti diabetic retinopathy Founded in 1996, Shenzhen Ruilin is a general agent with ophthalmology as the dominant field Through international cooperation, ms-553 has been declared in China and the United States at the same time At present, it has completed the first phase of clinical treatment in the United States and started the second phase in 2016 22 Yangzijiang Pharmaceutical (1) yzj-0318 maleate tablets: an anti-tumor drug comes from Yangzijiang sea geese Yangzijianghaiyan is located in Zhangjiang High Tech, focusing on the research and development of class 1 innovative drugs, biomacromolecule drugs and accompanying diagnostic reagents (2) Ifetinib tosilate tablets: an anti-tumor drug from Hairong, Sichuan Province Hairong is also responsible for four major new drug development projects during the 12th Five Year Plan period (3) Yzj-1139: no relevant information found 23 HUYUN Cancer Research Center (1) spt-07a injection: the drug is a small molecule monomer compound extracted from natural medicine, which is intended to be used in the neuroprotective treatment of acute ischemic stroke (2) The company focuses on acute ischemic stroke, psoriasis and lupus erythematosus, Sanyin breast cancer and prostate cancer The new third board was listed in September 2015 24 Hubei biomedical research institute: Hubei Biomedical Industry Technology Research Institute Co., Ltd is a wholly-owned subsidiary of Wuhan Optics Valley humanwell biomedical Co., Ltd (1) Wxfl10040340 capsule: wxfl10040340 capsule, a class 1 new drug, was jointly declared with Wuhan kemeide biological Co., Ltd This product may be a PARP inhibitor for the treatment of malignant solid tumors (2) Wxfl10230486 capsule: developed jointly with humanwell Pharmaceutical Group, it is a Btk inhibitor, intended for rheumatoid arthritis treatment 25 Description of Shanghai Xingtai pharmaceutical: Shanghai Xingtai pharmaceutical is a subsidiary of Fosun Pharmaceutical PA-824 tablets: declared in April this year, and obtained clinical approval in November The announcement shows that PA-824 tablet can inhibit Mycobacterium tuberculosis mainly through the double action mechanism of inhibiting bacterial protein synthesis and mycotic acid synthesis in cell wall The antibacterial activity is better than isoniazid, and it has better activity to sensitive TB and rifampicin resistant TB; it has potential efficacy to isolated MDR-TB, and may shorten the treatment cycle, and has no cross resistance with the anti TB drugs currently used in clinical At the time of the announcement in February, about 14 million yuan had been invested in R & D.