R & D investment of 12.16 million yuan! Tenofovir disoproxil tablets obtained from sea Cisco fumarate were approved

On April 10th, the medical network issued a corporate announcement that the wholly-owned subsidiary Sichuan Haisi Pharmaceutical Co., Ltd. recently received the tenofovir dipyridyl fumarate approved by the State Drug Administration. Drug Registration Approval for Fur Ester Tablets.

According to the announcement, on January 25, 2018, Sichuan Haisu submitted the application for the production of the product to the Sichuan Food and Drug Administration and was accepted. It officially approved the production and obtained the “Approval of Drug Registration ”.

Tenofovir disoproxil fumarate tablets are the first nucleotide analogues to treat AIDS, inhibiting viral replication by blocking reverse transcriptase involved in HIV replication. Clinical studies have shown that its antiviral effect and low incidence of drug resistance can inhibit the replication of hepatitis B virus by interfering with the function of hepatitis B virus DNA polymerase in human body, and it has broad application prospects in the treatment of chronic hepatitis B.

Tenofovir disoproxil fumarate tablets were originally developed by Gilead in the United States and approved in the United States in 2001 for use in combination with other antiretroviral drugs for the treatment of HIV-1 infection; It is approved for the treatment of chronic hepatitis B (HBV) in the United States in dosage forms for tablets and oral powders.

Tenofovir disoproxil fumarate tablets are currently available in China, except for the tenofovir disoproxil fumarate tablets (trade name "Wei Rui De") produced by Gilead Pharmaceuticals. Chengdu Bite Pharmaceutical Co., Ltd., Zhengda Tianqing Pharmaceutical Group Co., Ltd., Anhui Baker Biopharmaceutical Co., Ltd., Qilu Pharmaceutical Co., Ltd., Hangzhou Supor Nanyang Pharmaceutical Co., Ltd., Shijiazhuang Longze Pharmaceutical Co., Ltd., Anhui Ankeheng A total of 9 domestic enterprises of Yi Pharmaceutical Co., Ltd., GlaxoSmithKline (Tianjin) Co., Ltd. and Sichuan Haisike Pharmaceutical Co., Ltd. obtained the production approval of the drug .

According to IMS data, the global sales of tenofovir disoproxil fumarate tablets in 2017 was US$1.52 billion; according to the intranet data, the domestic sales of this variety in 2017 was 620 million yuan. The variety of Chengdu Bite Pharmaceutical Co., Ltd. was selected in the 418 4+7 city drug centralized procurement , with a median price of 17.72 yuan/box (specification: 300mg*10 pieces/plate*3 board).

Up to now, the company's research and development investment in tenofovir disoproxil fumarate tablets was about 12.16 million yuan.