2017q1: inventory of class 1 new drugs approved by CDE

Hl-085 and its capsule were developed by Shanghai Kezhou pharmaceutical R & D Co., Ltd and Tianjin Binjiang pharmaceutical R & D Co., Ltd It is speculated that this product is a mitogen activated extracellular signal regulated kinase (MEK) inhibitor for the treatment of melanoma Related patents: heterocyclic compounds as protein kinase inhibitors and their preparation methods and applications, cn105384738a; cn103204825a, etc Some data show that the comprehensive pharmaceutical index of hl085 is much better than that of trimetinib, and the efficacy is much higher than azd6244, mek162, etc The founder of Shanghai Kezhou is Dr Tian Hongqi The company's investors include Lilly Asia Fund, Chenxing venture capital, etc 2 the raw materials and tablets of tpn672 maleate are jointly declared by Shanghai Institute of medicine, Chinese Academy of Sciences, Suzhou wangshanwangshui and Shandong tepharman This product is developed by researcher Shen Jingshan It is an innovative anti schizophrenia drug It is optimized by berberine 3 yzj-0318 maleate and tablets This product was developed by Yangzijiang Pharmaceutical Group (Haiyan) as the third representative skin growth factor receptor inhibitor (EGFR-TKI) Official information shows that the candidate drug can selectively inhibit T790M resistant mutation In the h1975 lung cancer transplant model with T790M mutation and the lung cancer transplant model with T790M and L858R double mutation from patient source, it can effectively inhibit tumor growth, At the same time, it has a weak effect on wild-type EGFR, and does not inhibit tumor growth in the wild-type A431 tumor model of EGFR, suggesting that yzj-0318 may have a small clinical side effect of rash, diarrhea and interstitial pneumonia Yzj-1139 and tablet are a kind of dual orexin receptor inhibitor jointly developed by Yangzi Jiangyan and yaomingkant It can inhibit orexin receptor type 1 and type 2 at the same time, accelerate sleep speed and prolong deep sleep time It is the first clinical innovative drug approved by Yangzijiang Pharmaceutical Group Another potential drug for solid tumors developed by Yangzijiang and Sichuan University was also approved in the first quarter Hmpl-689 and capsule are from Hutchison Whampoa They are a new and highly selective PI3K δ inhibitor According to Hutchison Whampoa, hmpl-689 has higher selectivity, better pharmacokinetic characteristics and higher safety than the world's first listing of idelalisib As early as last April, he Huang launched the Australian clinical study Hy-021068 and tablet are from Hefei medical industry pharmaceutical Co., Ltd., which are new antiplatelet aggregation drugs This is the third class 1 new drug approved by Hefei medical industry after piragrex sodium and ceftazidime hydrochloride Related patents of this product may be: tetramethylpyrazine aromatic ether derivatives, preparation method, pharmaceutical composition and application, cn101143851a 7 imp4297 and its capsule were developed by Shanghai Yingpai Pharmaceutical Co., Ltd on April 5, the first clinical trial of this product was recorded in the clinical trial registration center (chinadrugtrials Org CN) I Stage clinical trial (ctr20170271), indications: Patients with advanced solid tumors that are not effective in standard treatment, breast cancer, ovarian cancer and prostate cancer with BRCA gene mutation are preferred 8 cbp-307 and capsule are developed by Conrad biology and are a S1P1 receptor agonist Previously, gilenya (fengomod) of Novartis was listed in the world In this quarter, it was approved in China and completed phase I clinical treatment overseas Conrad said it will be used in a variety of autoimmune diseases, including multiple sclerosis, psoriasis and inflammatory bowel disease Compared with fengomod, the first generation of S1P1 modulator in the treatment of RRMS, cbp-307 has a good improvement in the selectivity of S1P1 receptor subtype and a good efficacy The EC50 of its S1P1 effect is only 0.09nm (10% of the target s1p3 related to the side effects of fibrosis, Cbp-307 has no effect on the potassium channel of ERG Related patent of this product: an immunomodulatory compound, its use and pharmaceutical composition, cn103450171b The pipeline of the company is as follows: 9 bpi-7711 and capsule are from Beida pharmaceutical Bpi-7711 may be a new drug for NSCLC Before that, Beida had bpi-15086, a TKI with T790M mutation of the third generation, which was in phase I clinical practice Below is the existing R & D pipeline of Beida pharmaceutical 10 acc007 and tablet are from Jiangsu Aidi Pharmaceutical Co., Ltd On March 10, Aidi pharmaceutical's new anti AIDS drug, acc007, officially obtained the approval for clinical trials of drugs issued by CFDA Acc007 is the second innovative drug independently developed and approved by the company It is a non nucleoside reverse transcriptase inhibitor The following figure shows the product line of the company Among them, acc006, a new anti-tumor drug, was approved in 2016 The company has previously introduced strategic investors such as Jiangsu high investment, Huatai Securities, Starr, etc Aidi started in the research and development of human urinary protein products 11 vericiguat tablet was approved again in March 2017 A clinical trial has been registered before Study on pharmacokinetics, pharmacodynamics, safety and tolerance of bay1021189 (veriguiat coated tablets) in Chinese healthy male subjects under eating state (ctr20150863) The indication is: malignant heart failure This product is jointly developed by Bayer and mosadon The indication of chronic heart failure is in the third stage Ref: http://adisinsight.springer.com/drugs/800035639 12 aslan001 this product is from Aslan pharmaceuticals (Chinese Name: asiacom), which is jointly declared in China with Charles River Laboratories and Northrop Grumman Aslan001 varitinib is a pan her inhibitor Clinical trials of cholangiocarcinoma, breast cancer and gastric cancer are being carried out at the same time in foreign countries It was approved again in March in China The following figure shows the product line of the company, and the project is basically the introduction and development Ref: http://aslanpharma.com/drug/aslan001/13 heisco-149 and its tablets were developed by HISCO pharmaceutical industry In March, we received the approval for clinical trials of drugs issued by CFDA Heisco-149 is a new nucleoside reverse transcriptase inhibitor, which is intended to be used in anti hepatitis B virus (HBV) or HIV Preclinical studies showed that the product had high antiviral activity, no drug resistance and good safety TDF of tenofovir fumarate was over US $1 billion in 2015, RMB 100 million in Chinese market in 2015, and over RMB 300 million in the first three quarters of 2016 At present, there are Zhengda Tianqing, hausen pharmaceutical, Changzheng Xinkai, etc developing TDF upgrading products in China 14 brivanib alanine was developed by BMS, and Zai Lab (zaiding medicine) obtained the development rights and interests in China, and was approved for clinical use in March in China Some previous clinical trial status of this product: termination / suspension Ref: https://clinicaltrials.gov/15 other clinical products (incomplete version) approved in China in the first quarter are sorted out by heroiv according to the public information If there is any error, please correct it.