Application for production of ice breaking biological similar drugs of Fosun Pharmaceutical subsidiary was accepted

[China Pharmaceutical network enterprise news] Fosun Pharmaceutical announced in the evening of October 30 that Fuhong Hanlin and Hanlin pharmaceutical, the holding subsidiaries, had received the notice of acceptance of drug registration application This means that the application for production of Fuhong Hanlin HLX01 (rituximab injection), which is closely watched by the majority of investors, has been officially accepted It is understood that this is a new drug reported by Fuhong Hanlin and a similar McAb drug reported by Chinese enterprises According to the reporter of China business daily, the birth of Fuhong Hanlin HLX01 can be described as "a sword in seven years" Rituximab developed by Fuhong Hanlin is a kind of macromolecular biological similar drug, which is mainly suitable for the treatment of non Hodgkin lymphoma and rheumatoid arthritis Fosun Pharmaceutical said to reporters that the company always takes independent innovation as the source power of enterprise development, and will continue to improve the pharmaceutical R & D innovation system of "combination of imitation and innovation" It is reported that biological similar drugs are a kind of biological drugs similar to the original drugs approved for marketing, similar to the original drugs in terms of safety and effectiveness, but with advantages in price Biological analogues have been hot in recent years Many pharmaceutical companies at home and abroad have entered or intend to enter the market of biological similar drugs The world's generic pharmaceutical companies, such as TIWA and Sandoz, have increased their investment in biological similar drugs Many of the world's original research pharmaceutical giants, such as Pfizer, MSD, Amgen and bringer Ingelheim, have also entered biological similar drugs In addition, on October 12, pioneer pharmaceutical, a local Chinese pharmaceutical company, and Amgen, a multinational pharmaceutical company, announced the launch of a strategic alliance of biological similar drugs, introducing four global heavyweight biological drugs of Amgen into China at one time According to the data provided by Fosun Pharma, as of October 30, 2017, the list of rituximab injection in China (excluding Hong Kong, Macao and Taiwan) was only that of Shanghai Roche Pharmaceutical Co., Ltd According to IMS CHPA, in 2016, the sales volume of rituximab injection in China was about 1.5 billion yuan As of September 2017, Fosun Pharmaceutical has invested about 290 million yuan in research and development of the new drug at this stage It's worth mentioning that Liu Shigao, President of Fuhong Hanlin, said in an interview with the media including China Business Daily that Roche's Merlot ® has no indications for rheumatoid arthritis in China, only indications for non Hodgkin's lymphoma, so Fuhong Hanlin's indications for rheumatoid arthritis in China are considered original "What's the benefit of this for the hospital? It's the same variety I have two indications, both departments can use it, one is the oncology department, one is the rheumatology and Immunology Department, and the other variety can only be used in the oncology department Therefore, from the perspective of management, the hospital is more willing to use drugs with two indications, two different departments can use them, which is our differentiation Factors " As a subsidiary of Fosun Pharmaceutical, in February 2010, Fuhong Hanlin was officially registered and established, and its products HLX01 entered the early stage of R & D; in December 2010, HLX01 expanded its production to 200L; in January 2011, it obtained the "12th Five Year" major new drug innovation; in December 2011, HLX01 submitted an ind application to CFDA for non Hodgkin lymphoma indications; In March 2014, HLX01 obtained the clinical approval for non Hodgkin's lymphoma (clinical I / II / III phase approval at the same time); in June 2015, the production was enlarged to 500L, and the pilot test of antibody drugs and the construction of industrial production base were completed in the same year Subsequently, HLX01 took more than 600000 hours from R & D to production, produced more than 20 batches and carried out more than 10000 tests; In September this year, HLX01 obtained the drug production license issued by Shanghai food and drug administration; in October, HLX01 obtained the NDA registration application At the same time, on the evening of October 30, Fosun Pharmaceutical also disclosed its third quarterly report In the first three quarters of 2017, the company realized operating revenue of RMB 12.96 billion, an increase of 21.83% over the same period of last year; net profit attributable to shareholders of the listed company was RMB 2.419 billion, an increase of 11.13% over the same period of last year; net profit attributable to shareholders of the listed company after deducting non recurring profit and loss was RMB 1.856 billion, an increase of 11.70% over the same period of last year Original title: the application for production of domestic biological similar drugs by the subsidiary of Fosun Pharmaceutical Co., Ltd was accepted