The general situation in 2004-2015

 

As of January 6, 2016, the state food and drug administration and drug examination and approval center (CDE) for examination and approval of special varieties released list, according to the accept order of 1156, the time span of 2004 ~ 2015. Since 2004, special examination and approval of related to accept order quantity increased year by year, after peak value of 291 in 2013. By statistics, in 2015, a total of 235 special examination and approval to accept order, reduce 8.6% compared with 2014.

 

 

(note: all data from CDE website, statistical time ended on January 6, 2016)

 

In the special varieties of examination and approval of calendar year, to accept order plan the domestic enterprises to declare the number is more, accounted for 68.1%. In 2015, domestic and imported varieties declare ratio is 2.45:1. From the point of application category, the domestic enterprises and foreign enterprises are concentrated in basic medicine new medicine on the clinical application of clinical application of medicine accounted for 86.3% of the total application. Among them, the domestic enterprise combined with 53 medicine new drug application for production, 10 to apply for production of new drug of TCM, five biological products production new drug application. Applications for enterprise only eight in medicine production, the rest are clinical and the supplement.

 

 

 

 

To encourage the development of new drugs, "about 2009 issued by the drug registration for examination and approval of special provisions on the administration of notice. Enjoy special examination and approval of special treatment of drug has four kinds of situations: one is not listed in the domestic sales of extracted from plant, animal, mineral substances such as the effective component and its preparation, the medicinal materials and preparation of new findings; The second is not approed for sale in the domestic and foreign chemical drug substances and their preparations, biological products; Three is for treating other disorders such as AIDS, malignant tumor, a rare disease and clinical treatment has obvious advantages of new drugs; Fourth, new drugs for the treatment of there is no effective treatment of the disease. Lord cure certificate not in attending proprietary Chinese medicine approved by the state function contains a new drug, can be regarded as there is no effective treatment of the new drug of the disease. Belong to one or two drug registration applicant may submit an application for new drug clinical trials when apply for special approval. Belongs to three or four applicants when filing in production can apply for special approval. Special examination and approval administration rules set special examination and approval to separate channels, special preference to the examination and approval for examination and approval of the review process for new drug registration, and according to the time limit stipulated by the drug registration management measures "to complete.

 

2015 varieties

 

In 2015, a total of 235 special examination and approval of drugs to accept order, according to the varieties of 93, which is basic for the medicine application, only two species is Chinese traditional medicine application. Only seven varieties showed that the review has been completed, the rest 86 varieties are in a state in the review.

 

From the declaration enterprise category analysis, domestic enterprises to declare has 167 number, involving 64 varieties; Imports, there are 68 to accept order involves 29 varieties. Declare varieties to achieve the four companies of Beijing novartis, bayer, respectively, and the local pharmaceutical companies zhengda shine. Xi 'an yeung sum and astrazeneca declare three varieties, such as Beijing Kang Chen 9 companies declare two varieties respectively, the rest of the enterprise 1 varieties.

 

 

 

(note: declare varieties in 2 or more enterprises)

 

From the declaration of varieties of indications analysis, a total of 38 antitumor drugs, accounting for 40.9% of the total varieties. Diabetes has seven, is the second categories to declare fields.

 

 

(note: there are eight drugs in all varieties of indications enterprise not released, summarized in the rest of the varieties of category)

 

Antitumor drugs

 

Domestic antitumor drugs to declare on the number of species and varieties of import declaration number close, 18 and 20 respectively. For there are seven classes of drugs, including chongqing after gen medicine of succinic acid after rui, shandong hin for bamboo maleic acid in medicine, rose for Kang Chen, Beijing pharmaceutical Connie for, etc., and imports of boehringer ingelheim afar for Nepal, as well as eisai for his music. For his class of drugs, repeated declaration are mainly involved in the ripe targets for drugs, the market space is limited, can try to find the unpopular targets for domestic enterprises, new drug research and development opportunities.

 

Bayer declare three antitumor drug varieties, the largest number. Is used for non-hodgkin's lymphoma Copanlisib respectively, for the treatment of symptomatic uterine fibroids and Vilaprisan are forming in the uterine cancer drugs, and prostate cancer new ODM - 201. Bayer in domestic has the MSD, DianGong pharmaceutical industry as well as white and black three pieces of OTC business, is expected in 2015 will become the OTC market sales leader, but bayer prescription drugs in the domestic business also no less, in 2014, bayer health care prescription drug business growth in China reached 15%, a new declaration of the three antineoplastic drugs will become another blockbuster chip its expanding China market.

 

The lilly drug declare two tumor drugs for breast cancer drug LY2835219 respectively, and can be LY2157299 with tumor immunotherapy of compound. It is worth mentioning that LY2157299 has not been listed in other countries, in China has been approved for clinical, speed and review schedule is relatively fast. But rather than form a compound inhibitor nivolumab PD - 1 Chinese clinical application is not approved, so it seems, from lilly in China to carry out clinical trials of immunotherapy compound still need to wait for a period of time.

 

Novartis's LEE011 used in the treatment of drug-resistant breast cancer and melanoma. Is a kind of CDK4 LEE011/6 (cell cycle insulin-dependent kinase (4/6) of the small molecule inhibitors. Currently CDK4/6 inhibitors is the hotspot in anticancer drugs, pharmaceutical giants such as Pfizer and lilly are in this field have their own research projects.

 

Paekche shenzhou declare two varieties for tumor treatment. The BGB - 3111 is a kind of bruton's tyrosine kinase (BTK) specific inhibitor, is used in the treatment of B cell malignancies. In June 2015 IND application have been granted the FDA's new drug research, will be conducting clinical research in the United States. Another BGB - 290 is a new type of poly adenosine diphosphate ribose transferase (PARP) inhibitor, is a kind of innovative targeted anti-cancer agents. The drug for the independent research and development, and with Germany's Merck snow pock company signed a joint development agreement. There is also another enterprise declare a PARP inhibitor drugs, is the qingfeng-xiangguang fracture pharmaceutical development of jiangxi SC10914 piece to declare. PARP inhibitors inhibit tumor cell DNA damage repair, and promote tumor cell apoptosis, which can strengthen radiation as well as alkylating agent and the curative effect of cisplatin chemotherapy drugs. Currently listed on the main for astrazeneca Lynparza PARP inhibitors (ora). Domestic listed drugs will fill the blank in this field, but with paekche shenzhou and jiangxi qingfeng-xiangguang fracture will also be an intense competition.

 

Diabetes drug

 

Diabetes is the second largest indications, declare there are five diabetes drug, 2 diabetes related disease. From domestic special review in 2015 to declare varieties, mainly glp-1 analogues, SGLT - 2 inhibitor, DPP 4 inhibitors declare gradually return to calm.

 

Diabetes drug in jiangsu hengrui medicine and the DPP 4 inhibitors of jiangsu sdsensor medicine joint declaration raigor column dean to apply phosphate production, the rest 4 for clinical application.

 

There are two glp-1 analogues: beida pharmaceutical BPI - 3016, and dalian emperor's short peptide 1 glucagon sample injection; The other two are SGLT - 2 inhibitor: guangdong east sunshine focal glutamate jung column net, and Shanghai Ellis medicine Edgar column net. SGLT - 2 inhibitor is a new kind of diabetes drugs listed in the past two years, several big drug firms is also a tough battle against the target. But on December 4, 2015, the FDA issued security communications, the SGLT - 2 inhibitor class diabetes drug add black box warnings on the label, suggest that these drugs can cause serious ketoacidosis and urinary tract infection. The FDA's requirements before the conclusion than DPP 4 inhibitors added "may cause serious disabling arthritis pain" boxed warning came harsh, SGLT - 2 inhibitor of market prospects or will face a bleak.

 

Two drugs for diabetes related disease daiichi, DS - 5565, used in the treatment of diabetic peripheral neuropathic pain, and another is shenzhen Ming ceri lam pharmaceutical g - ", and used for diabetic eye disease drugs.

 

Zhengda four drugs were reporting the weather is fine, but not released drug indication, in the stage of secrecy. Zhengda shine after 2011 declaration for comfortable cloth for Nepal, has been relatively quiet, explosion in 2015 to declare the four 1.1 generalization. Zhengda sunny is leading pharmaceutical companies in the field of national generics, but is not yet approved listing 1.1 class of new drugs.