Medical network - on February 21, due to the chemical medicine classification of new registered a formal announcement and supporting documents in mid - 2016 have been issued, the registration regulations of unclear cause enterprise for drug registration in 2016 basic in a wait state.
According to salty reach V3.2 observation data in 2016, the first chemical medicine registration classification for new 3 class (that is, the application of generic listing abroad but not listed in the original medicine) and the new four categories (i.e., application of generic listed in the original drugs) accepted number is the earliest start to undertake in August 2016. New number 3 class accepts the declaration clinical acceptance number four letters for "CYHL", declare production acceptance number is "CYHS" four letters. Records of the new number 4 class to accept the four letters "CYHS". In 2016, the new class 3 and class 4 in 2016 as a whole, including clinical and public declaration, declare to accept the number more than 50. Compared with CDE "2015 annual drug approval report" released by chemical generics listed declare 157, clinical report 1741, 2016, chemical medicine generic declaration is cliff fall.
Salty data V3.2 found, a new class 3 and class 4 registration ShenBaoLiang decreases, accordingly, also reduce product corresponds to the manufacturer's registered competition. New 3 class only hydrochloride for injection benzene da mo SiTing, declare the drug product has 2 manufacturers, precede the nanjing east yuan pharmaceutical and respectively zhengda pharmaceutical group, the weather is fine, the rest are exclusive to declare.
To declare general concrete number calculation, saint pharmaceutical group filed for three new products, most of glycerin fructose sodium chloride injection and sodium potassium magnesium, calcium and glucose injection. New 4 classes declare more is guangdong jia bo pharmaceutical and chongqing st cfna pharmaceutical co., guangdong jia bo pharmaceutical declare long-chain fat emulsion injection (OO) and medium/long-chain fat emulsion injection (C8-24 ve); Chongqing st cfna pharmaceutical declare iodine beauty & injection and left b raschig oral liquid.
Consistency evaluation under impact, declaration of oral solid preparation, injection of the declaration is relatively more, for external use and registration of the oral solution also gradually increase. In product of generic terms, new registered declaration accounted for 77% of the three kinds of injection and oral medications only 8%; 4 kinds of injection of new registered declare accounted for 42%, 32% than oral solid preparations.
Since 2015, the CFDA approved a batch chemical clinical approval of generic drugs, salty reach data V3.2 analysis approved clinical acceptance number top schedule, found the actual start clinical project is still very limited.
Old three kinds of chemical medicine classification (corresponding to the new 3 classes)
BE test prices, assessment of clinical inspection check strictly, consistency, and multiple factors, the first copy after the drug approval documents received oral willing to conduct clinical trials is mainly jiangsu hengrui, jiangsu howson and nanjing, jiangsu zhengda shine at Warwick these enterprises.
Archie, sand temple films
Since 2015, the temple, sand sheet approved clinical acceptance number 73. Temple, sand piece approved clinical corresponding domestic listed companies is jiangsu hengrui medicine (SH600276), nanjing huawei pharmaceutical (SH600721), jiangsu lianhuan pharmaceutical (SH600513), zhejiang jinhua kahn biological (SH600572) and hainan jin rui pharmaceutical (Victoria towers medicine, SZ000908).
However, currently the only generic drugs in clinical hengrui, nanjing, jiangsu huawei pharmaceutical industry cooperation (with sign). The original takeda TAK - 491 (40 mg) in 2015 to launch clinical.
Ibuprofen injection
Ibuprofen injection approved clinical acceptance number since 2015 to 56. Now declare listed only chengdu YuanDong pharmaceutical industry.
Has been declared clinical but no bad memory.didn pharmaceutical manufacturers have mastery in pharmaceutical group, hainan split pharmaceutical, rui pharmaceutical, the joint pharmaceutical/shijiazhuang hebei union pharmaceutical/grace 'pharmaceutical drugs joint, Yangtze river pharmaceutical group nanjing pharmaceutical, tianjin and chengdu are green han kang medicine, biological technology, sichuan direction pharmaceutical co., nanjing rui year balance medicine science and technology/constant dao medicine joint, Beijing love beautiful huawei pharmaceutical medicine, nanjing, jiangsu dragon pharmaceutical co., a total of 12 groups.
And lot fluorine forrest
Since 2015, luo fluorine forrest piece of approved clinical acceptance number 51. At present hefei cubic pharmaceutical/nanjing pharmaceutical group, jiangsu Warwick medical joint, zhengda shine zhiheng/jiangsu hengrui medicine, shijiazhuang he ping pharmaceutical joint Qin Kun, xi 'an days, a total of 5 groups are conducting clinical research. No manufacturer production.
D every methadone hydrochloride
Since 2015, d every methadone hydrochloride approved clinical acceptance number 38, but only the jiangsu howson pharmaceutical industry began to efficacy and safety of treating depression patients multicenter, randomized, double blind and double simulation and positive controlled clinical studies.
Lu geodon hydrochloride
Since 2015, the shandong geodon hydrochloride approved clinical acceptance number 36, only 2015 jiangsu howson pharmaceutical, pharmaceutical group/Shanghai zhengda shine joint in the pharmaceutical industry research institute, a total of two groups in clinical.
Old chemical medicine classification 6 class 4 class) (corresponding to the new
Domestic existing product class generic drugs were not as popular varieties in clinical, many manufacturers are expected to fill consistency evaluation process forward consistent homework.
Atorvastatin calcium tablets
Atorvastatin calcium tablet approved clinical acceptance number since 2015, 77. Since 2015 in order to declare a registration of conducting clinical trials to utilize modern pharmaceutical enterprise and jiangsu hengrui medicine. Beijing jia Lin pharmaceutical initiated by 20 mg bioequivalence test more is for the sake of consistency.
Clopidogrel bisulfate tablet
Since 2015, clopidogrel bisulfate tablet approved clinical classification of old six kind of chemical medicine registration acceptance number 51. Since 2015, in order to declare a registration for the optimal clinical trial enterprise for Shanghai pharmaceutical, pharmaceutical factory, henan purui pharmaceutical and hainan date zhongtian pharmaceutical. Shenzhen xinli Thai pharmaceutical launched 75 mg of bioequivalence test is also for the sake of consistency.
Ziggy column nai piece
Ziggy column nai piece since 2015 approved clinical acceptance number 44, but there is no factory to conduct clinical trials. Has listed the Beijing hokuriku Wan Sheng pharmaceutical pharmaceutical co., tianjin Conrad pharmaceutical, Beijing and jiangsu, pharmaceutical industry, the above manufacturer temporarily not to carry out the bioequivalence test, namely no consistency evaluation tests.
For it, hydrochloride
Ziggy column nai piece since 2015 approved clinical acceptance number 41. No domestic manufacturer listed on the product, the Shanghai novartis pharmaceutical, pharmaceutical group, jiangsu zhengda shine than high pharmaceutical and chongqing winbond pharmaceutical in rob the first position in imitation of a drug, including Shanghai novartis pharmaceutical finished it for his hydrochloride bioequivalence study.
Celecoxib capsules
Since 2015, celecoxib capsules new approved clinical acceptance number 39, but none to conduct clinical trials. Jiangsu zhengda qingjiang pharmaceutical registration declaration in 1622 clinical inspection check list, once the withdrawal, restart the clinical trial in 2016. Also withdraw jiangsu hengrui has yet to start clinical trials.
For the sand for piece
Since 2015, for the sand for approved clinical acceptance number 39. Since 2015 for generics listed on registration and clinical in nanjing in SAN pharmaceutical and shiyao group the pharmaceutical. Zhengda sunny pharmaceutical group is carried out in 2017 Ⅲ period clinical, mainly for the evaluation of sand, pieces of treatment of always contain imatinib resistant or intolerance of adult Ph + ALL efficacy and safety.
conclusion
Due to regulations temporarily unclear, chemical medicine generics declare the overall decline in 2016. Salty V3.2 extraction of data since 2015 have been approved for clinical acceptance number approved the quantity of product analysis clinical trials found that progress in addition to ibuprofen injection competitive manufacturer of more than 10, 2015 years after oral solid preparations started clinical trials on the number of manufacturers generally within 10.
This with the sharp rise in the costs of clinical trials have certain relevance, BE test if costs between 3 million ~ 6 million yuan, the manufacturer must choose bigger sales potential products to guarantee profits. This means more manufacturers will take following strategy choice foreign enterprises have to foster good market products, there is clinical demand but smaller products manufacturers may not be willing to invest. Drug prices to refer to the price of the neighboring countries, so the costs of clinical trials in China also want to return to the perimeter of the international average level or the level of Japan, China Taiwan, Hong Kong, China, to help Chinese generic drug supply of accessibility.
Mostly CRO companies declare in the past to accept order, can be seen from the recent number of clinical, ultimately failed to find manufacturers to undertake many projects, manufacturers from the requirement of consistency evaluation, more and more attention to the quality of the project.
CRO company evolution ultimately to pass the consistency of the evaluation the project is completed, a preliminary results, is expected to 2018 individual CRO company will form their own brand. |
