"New Viagra" of Tianfang pharmaceutical needs at least 5 years to be listed

On July 10, a news that "tpn729ma, a new drug of Tianfang pharmaceutical industry absorbed and merged by China pharmaceutical, has been prepared and certified by the State Food and drug administration, and will soon send the production approval document" pushed the company's share price to the trading board Tpn729ma is mainly suitable for the prevention and treatment of male erectile dysfunction, and is expected to become a substitute of sildenafil (Viagra) According to an interview with China Securities News, tpn729ma obtained clinical approval rather than production approval Tpn729ma is a class 1.1 innovative drug, but it is difficult to obtain the qualification of green channel for approval It will take at least 5 years to obtain the production license, the technical director of Tianfang pharmaceutical said The absorption and merger of Chinese medicine and Tianfang pharmaceutical industry has finally come to an end On July 11, Tianfang pharmaceutical released a notice that the company will terminate the listing of shares on July 15 after receiving the notice from the exchange Just one day before the termination of listing schedule, Tianfang pharmaceutical industry offered a big gift to absorb the merging party, which directly increased the market value of China's medicine by 488 million yuan "We did get the approval, but it was the clinical approval, not the production approval in the hearsay The SFDA information shows that the approval has been completed " Liu Ningyu, Secretary of the board of directors of Tianfang Pharmaceutical Co., Ltd., is on a business trip in other places, but he has noticed the huge impact of the new drug rumors According to an official from the State Food and drug administration, the code of new drug review has obvious rules Cxhl1100735 is the acceptance number of Tianfang pharmaceutical's new drug, which respectively means: C stands for domestic registration, new drug-x, category is Chemical-H, stage is clinical-l, if the letter is the review of production approval, it is - S A technical director of Tianfang pharmaceutical clearly pointed out that tpn729ma needs at least 5 years to get the production approval "Tpn729ma belongs to class 1.1 new drug, which means that the R & D risk is greater, and the drug regulatory department requires higher clinical research requirements for such drugs, with a relatively longer time, even if it is smooth, it will take at least 2-3 years In addition, it will take another 2-3 years to review the production approval documents " In addition, the above-mentioned person in charge thinks that tpn729ma has no possibility of taking the green channel "From the perspective of approval progress, green channel can save a lot of time, and we can get approval in about half a year, but it is almost impossible for us to get this qualification."