Pharmaceutical Network, May 29 News As of now, the number of drug varieties that have passed the consistency evaluation of generic drugs announced by the State Food and Drug Administration this year has reached 41, including entecavir, atorvastatin and other categories.

The latest announcement by the State Food and Drug Administration was on May 22. In 2018, the fourth batch of approved generic drug quality and efficacy consistency evaluation categories included Chia Tai Tianqing, Dongting Pharmaceutical, and CSPC.

So far, the number of drugs that have passed the consistency evaluation of generic drugs announced by the Food and Drug Administration this year has risen from 29 to 41.

According to the "Catalogue of Generic Drug Consistency Evaluations to be Completed by the End of 2018" published by the former Food and Drug Administration in 2016, China must complete the consistency evaluation of 289 generic drugs by the end of 2018. At the same time, the China Listed Drug Catalogue Database was officially launched on December 29, 2017. The included drugs include the first batch of generic drugs of 13 varieties and 17 specifications that have passed the consistency evaluation of quality and efficacy. In the future, all generic drugs that are included in the list of drugs that are interchangeable with the original research drugs, that is, the "List of Listed Drugs in China", can use the "passed the consistency evaluation" mark.

In the list announced this time, Entecavir dispersible tablets (Runzhong) developed by Chia Tai Tianqing were approved. China Biopharmaceuticals disclosed in its announcement: Entecavir dispersible tablets (Runzhong) are a class of drugs for hepatitis B virus, mainly used for the treatment of adults with active viral replication and continuous increase in serum transaminases, or active liver histology. hepatitis. From its launch in 2010 to 2017, the sales revenue of entecavir dispersible tablets exceeded RMB 3.1 billion.

Entecavir is a new generation of oral guanosine analogs for the treatment of hepatitis B virus infection. It is mainly used for the treatment of chronic hepatitis B with active viral replication and persistently elevated serum transaminases, or active liver histology in adults. Hepatitis; also indicated for the treatment of nucleoside-naïve pediatric patients aged 2 to <18 years with chronic HBV infection and compensated liver disease.

It is understood that tenofovir disoproxil fumarate tablets (Qingzhong) developed by Chia Tai Tianqing have also been included in the "China List of Drugs Listed", and the "Pass Consistency Evaluation" mark can also be used. So far, Chia Tai Tianqing's two major anti-HBV drugs have all passed the "consistency evaluation", and will receive greater support in the aspects of drug bidding and medical insurance payment in the future, accelerating the process of replacing original research with high-quality generic drugs. Behind this replacement, Chia Tai Tianqing, known as the leader in the field of liver health in China, will rapidly increase its market share and market share in the hepatitis B market.

According to the statistics of related diseases of the National Health and Medical Commission, there are about 93 million people with chronic HBV infection in China. The national level hopes to solve the problem of drug accessibility for hepatitis B patients. Chia Tai Tianqing's entecavir dispersible tablets were developed 10 years ago under the support of national special projects such as the "Major New Drug Creation".

According to Zhang Xiquan, vice president of Chia Tai Tianqing and dean of the research institute, Chia Tai Tianqing has created a completely different synthesis route, formulation and formulation process from the original entecavir "guanine glycoside method", completely breaking the technical barriers of foreign companies. It is the first company to market Entecavir Dispersible Tablets (Runzhong). The drug has achieved many innovations in synthesis technology, preparation technology, and excipients, and has 9 authorized invention patents.

According to IMS data, Chia Tai Tianqing's entecavir dispersible tablets have been on the market since 2010, and by 2017, they have accounted for nearly 50% of the entecavir market share.

The consistent evaluation of the quality and efficacy of generic drugs is in full swing, which reflects the country's attitude towards the active development of generic drugs. In April this year, the General Office of the State Council issued a document in promoting the research and development of generic drugs, pointing out that it will accelerate the evaluation of the quality and efficacy of generic drugs, and that generic drugs that are consistent with the quality and efficacy of the original drug will be included in the list of drugs that are interchangeable with the original drug. And in the medical insurance, it is paid according to the same standard as the original research drug, which will strongly promote the widespread use of generic drugs that have passed the consistency test in the market.

Also on the list is escitalopram oxalate tablets developed by Hunan Dongting Pharmaceutical Co., Ltd., a subsidiary of Fosun Pharma. Fosun Pharma disclosed in the announcement: As of May 22, escitalopram oxalate tablets that have been listed in China include Lexapro from Xi'an Janssen Pharmaceutical Co., Ltd. Data shows that in 2017, the sales of escitalopram oxalate tablets in China were approximately RMB 1.09 billion.

There is no doubt that generic drugs are playing an increasingly important role in the Chinese pharmaceutical market. The China Pharmaceutical Industry Information Center estimates that the size of China's generic drug market in 2016 was about 916.7 billion yuan. Affected by factors such as population aging and medical insurance cost control, the size of China's generic drug market will continue to grow. By 2020, its market size may reach 1,411.6 billion yuan.

Faced with this trend, the government is promoting pharmaceutical companies to conduct R&D and innovation in generic drug projects through a series of favorable policies. The State Council stipulates that if there are more than three production enterprises that pass the consistency evaluation of the same variety of drugs, the varieties that have not passed the consistency evaluation will no longer be used in the centralized procurement of drugs. At the same time, the R&D expenses incurred by qualified generic drug companies for the development of new products will be deducted before corporate income tax in accordance with relevant regulations, and corporate income tax will be levied at a reduced rate of 15% for those identified as high-tech enterprises.

Comprehensive policy factors and the development status of the domestic drug market, the research and development and production of generic drugs in China will enter a new climax in the future.