13 injections were exported to domestic sales, Hengrui, Qilucheng big winner
According to data from the MED China Drug Evaluation Database 2.0 of Minernet, as of August 16, 2018, there were 59 acceptances for the consistency of chemical generic injections, involving 38 products (with 'generic name' + The production company 'as a statistical standard), of which 13 products have been approved for listing abroad.
The Announcement on Matters Related to the Evaluation of the Quality and Efficacy of Generic Drugs (No. 100, 2017) states that the production of products in China is approved for listing in the European Union, the United States or Japan. drug Listed in China. On May 28 this year, Puli Pharmaceuticals announced that the company's injection of azithromycin was approved by the State Drug Administration for the approval of the drug supplement application through the consistency of the quality and efficacy of generic drugs. It is mentioned that 0.5g of azithromycin for injection (according to C38H72N2O12) is a double-reported company registered by the company to be registered in China and the United States. It has been approved by the FDA in 2015.
Who is going to be the next beneficiary of the export-to-domestic approach like this?
13 injections were exported to domestic sales, Hengrui, Qilucheng big winner
13 applications for conformity assessment of products that have been listed abroad, including Hengrui medicine There are 6 products involved, including sulfonate cis-atracurium injection, docetaxel injection, irinotecan hydrochloride injection, dexmedetomidine hydrochloride injection, oxaliplatin for injection, injection Use cyclophosphamide. Qilu Pharmaceutical has 5 products, including ondansetron hydrochloride injection, irinotecan hydrochloride injection, oxaliplatin for injection, ceftriaxone sodium for injection, cefepime hydrochloride for injection. .
Among them, Hengrui Medicine and Qilu Pharmaceutical have declared products including irinotecan hydrochloride injection, oxaliplatin for injection.
6 billion large varieties, 2 domestically won the original research
Docetaxel injection is an anti-tumor drug with good curative effect on advanced breast cancer, ovarian cancer, non-small cell lung cancer. It also has certain effects on head and neck cancer, pancreatic cancer, small cell lung cancer, gastric cancer, melanoma, and soft tissue sarcoma. The efficacy of the intranet data shows that docetaxel injection in the Chinese city public in 2015-2017 hospital The sales of county-level public hospitals, urban community centers and township health centers (referred to as Chinese public medical institutions) have exceeded 4 billion yuan, and there is a trend of continuous increase. From the perspective of market share, the original research enterprise Sanofi only ranked second, the market share increased from 18.24% in 2013 to 20.89% in 2017, while the market share of Jiangsu Hengrui Pharmaceutical, the leading company, remained above 40% in 2013-2017. In addition, the market Qilu Pharmaceutical is also a domestic company with a share of more than 10%. At present, Qilu Pharmaceutical's docetaxel injection does not have the ANDA symbol.
Gemcitabine hydrochloride for injection is an anti-tumor drug for the treatment of inoperable advanced or metastatic pancreatic cancer and for the treatment of locally advanced or metastatic non-small cell lung cancer, treatment, advanced non-small cell lung cancer, pancreatic cancer, bladder cancer, breast Cancer and other solid tumors. According to the data from the intranet, the sales of gemcitabine hydrochloride for injection in China's public medical institutions in 2013-2017 has exceeded 2 billion yuan. From the market share, the original research company is only ranked second. Position, market share fell from 26.22% in 2013 to 25.67% in 2017, while the market share of the leading company Jiangsu Haosen Pharmaceutical Group in 2013-2017 rose from 59.01% in 2013 to 60.53% in 2017.
Qilu, Tiandao Medicine, after the consistency evaluation, the counterattack is still organic
Ceftriaxone sodium for injection is a systemic antibacterial, used for lower respiratory tract infections caused by sensitive pathogens, urinary tract, biliary tract infection, and abdominal infection, pelvic infection, skin and soft tissue infection, bone and joint infection, sepsis, meninges Inflammation and prevention of infection during surgery. After the implementation of 'Limited Limitation', the ceftriaxone sodium for injection, which is one of the star products of cephalosporin antibiotics, has been hit hard, and it was at the terminal of public medical institutions in China in 2013-2017. Sales fell by roller coaster and then slowly recovered. Sales in 2017 were 2.654 billion yuan. In terms of market share, the original research company Roche ranked first with more than 50% market share, Qilu Pharmaceutical ranked 11th, and occupied in 2017. The market share is 1.57%. If Qiqilu Pharmaceutical's ceftriaxone sodium for injection has successfully passed the consistency evaluation, it has obtained various provinces and cities. Tender The dividend of policy is likely to turn over in adversity.
Enoxaparin sodium injection is an antithrombotic drug that prevents venous thromboembolic disease (prevention of venous thrombosis), especially thrombosis associated with orthopedics or general surgery. It can also be used to treat established deep vein thrombosis. With or without pulmonary embolism. According to the data from the intranet, the sales of enoxaparin sodium injection in China's public medical institutions in 2013-2017 has increased year by year, and successfully broke through one billion yuan since 2016. From market share In view of the fact, the original research company Sanofi fell from 84.85% in 2013 to 68.23% in 2017, and the momentum of domestic products broke out. The market share of Shenzhen Tiandao Pharmaceutical rose to 7.77% in 2017. Consistency evaluation will also be another product that has the opportunity to turn over.
Conclusion
As of August 16, 2018, the chemical generics injection consistency evaluation involved 38 products, in addition to 13 products have been approved for listing abroad, there are 25 injections in the examination and approval. From the current processing status, Qilu Pharmaceutical The irinotecan hydrochloride injection, Hainan Jinrui Pharmaceutical's injection of gemcitabine hydrochloride is in the 'sent condition' state, who can become the next injection through the consistency evaluation?
