Drugs approved for marketing in China in 2015: first imitation, new dosage form and new compound!

CFDA announced the approval of Chinese drugs for listing in 2015 on February 22 According to statistics, in 2015, CFDA approved 241 chemical drugs, 25 biological products, and 76 traditional Chinese medicine and natural drugs According to the degree of innovation (new drug or new dosage form or new compound?) 44 key varieties were selected from the market first mover advantage (first or second or third) The specific data are as follows Note: "new drug" refers to the first drug in China, tafluprost eye drops (towering pharmaceutical), in the treatment of glaucoma, prostaglandin drugs have been in a high proportion The sales volume of Pfizer's latanoprost and its compound reached US $1.749 billion in 2010, that of Elgin's bemeprost and its compound reached US $762 million in 2014, and that of towering tafluprost in Japan was about 7 billion yen, which was approved to enter the Chinese market in 2015 Acitinib (Pfizer) is a new generation of renal cancer targeting drug (tyrosine kinase inhibitor TKI), which is used in adult patients with advanced renal cell carcinoma (RCC) who have previously received a tyrosine kinase inhibitor or cytokine treatment failure Among renal cancer drugs, sunitinib and acitinib had sales of US $1120 million and US $430 million respectively in 2015 The domestic price of acitinib is about 40000 / month, slightly lower than that of sunitini The CYP17 inhibitor of abiolone acetate tablet (Johnson and Johnson) is suitable for the combination of prednisone and abiolone acetate in the treatment of patients who have received chemotherapy containing docetaxel for metastatic castration resistance to prostate cancer The drug was launched in the United States in 2011, with a sales volume of $2237 million in 2014 It is currently the best-selling prostate cancer drug The incidence rate of incidence of prostate cancer is high in the United States, but the incidence rate is low in China The market may not be large, but patients are still desperate for life-saving drugs Acarbose chewable tablets (East China Medicine) acarbose is not outstanding in the global diabetes market, but because it is especially suitable for Chinese patients, it has become the best-selling oral hypoglycemic drug in China In recent years, East China medicine gradually eroded the market share of Bayer, the original manufacturer, but other domestic manufacturers are also eyeing the market Acarbose chewable tablets as an exclusive dosage form help East China medicine keep its own victory fruit Mingfule (Mingkang Biology) mingfule is the third generation of recombinant t-PA thrombolytic drugs independently developed by Mingkang biology It is the only thrombolytic drug that can be injected intravenously at a single time, which is more suitable for emergency treatment Linezolid glucose injection (hausen pharmaceutical) hausen pharmaceutical successfully won the first imitation of linezolid, which is the original zodiacone antibiotic researched by Pfizer In 2013, it reached a sales peak of $1.353 billion, and the sales began to decline after the expiration of the patent Hausen is expected to grow this product in China Daptomycin for injection (East China pharmaceutical, Haizheng pharmaceutical) and daptomycin for injection of East China Pharmaceutical and Haizheng pharmaceutical were approved at the same time The drug is a heavy-duty antibiotic originally researched by Cubist pharmaceuticals (purchased by MSD) Its sales reached US $1127 million in 2015, and the global market is still growing Xinruibai (pegylated recombinant human granulocyte stimulating factor injection) (Qilu pharmaceutical) granulocyte stimulating factor is one of the most commonly used adjuvants in cancer chemotherapy, and the sales volume of pefigetine, which was originally developed by Anjin, reached 4.715 billion US dollars in 2015 The domestic market is mainly short-term granulocyte stimulating factor Xinruibai of Qilu pharmaceutical was approved after jinyouli of Shiyao group However, the most concerned may be Hengrui 's upcoming 19K, which is said to be superior to the existing 19K Guipaizite maleate injection (Jinshan biology, Qilu pharmaceutical) guipaizite is a well-known best-selling drug in China, which can be used for more than n indications in the field of cardio cerebral blood vessels Sihuan pharmaceutical has achieved its market of 2 billion yuan CFDA approved guipeizite of Jinshan biology and Qilu pharmaceutical, and the era of Sihuan pharmaceutical monopolizing the market is over Ambano (recombinant human type II tumor necrosis factor receptor antibody fusion protein for injection) (Haizheng pharmaceutical) 2015 is a nightmare for fans of Haizheng The main product, special treatment star, is in short supply and the company's performance is terrible However, in 2015, CFDA approved two major varieties of Haizheng, datomomycin and ambroxol, which gave a little hope of full blood revival Ambano's original research is anacept of Amgen and Pfizer In 2015, its sales reached US $8.538 billion Yisaipu of CITIC Guojian and qiangke of SAIJIN biology have been listed, and Haizheng is the third in China As the rheumatoid arthritis patients in China are generally not rich, ambano's large-scale sales may take a while The concept of the second child has finally been released by the state, and everyone has begun to cajole the fierce human creation movement The concept of the second child is also in a share In 2015, CFDA approved two first generic drugs related to fertility, one is atoxicpan, a fertility drug for neutralizing the pharmaceutical industry, and the other is the follicle stimulating hormone for treating infertility by Kinsey pharmaceutical.