This article is organized by HEROIV based on publicly available information.
1, bendamustine
Domestic imports of products by the Israeli tycoon to declare.
Bendamustine hydrochloride, developed by Cephalon, was approved by the U.S. FDA for treatment of chronic lymphocytic leukemia (CLL) in March 2008. TEVA acquired Cephalon in May 2011. The results for 2014 were $ 767 million (peak ), Which dropped to 661 million U.S. dollars in 2016.
This product is a bifunctional alkylating agent, can lead to DNA single-stranded and double-stranded cross-linked by alkylation, disrupt the DNA function and DNA synthesis, DNA and protein, and between protein and protein Produce cross-linking, thus exert anti-tumor effect.
Domestic CTT and Simcere have filed applications for the listing of generic drugs and obtained the priority review.
2, Dramani
Delamanid from Japan Otsuka Pharmaceutical declaration.
This product is a drug for the treatment of drug-resistant tuberculosis (MDR-TB) and was first reviewed in 2017. This product is a bactericidal drug with a novel mechanism of action that interferes with the metabolism of the cell wall of M. tuberculosis (MTB) The drug has a high bactericidal activity in vitro against a wide range of MTB strains, including strains of first-line anti-TB drugs such as isoniazid and rifampin and was approved for marketing in May 2014 by EMA.
The WHO Global Tuberculosis Report 2016 shows that the number of new tuberculosis cases in the world is about 10.4 million in 2015, when 1.4 million people died of tuberculosis in that year, but the number of first-line first-line anti-tuberculosis drugs and eight second-line Anti-TB drugs were found during the 1940s and 1970s of the last century, and no new anti-TB drugs emerged after 40 years.
Otsuka is currently one of the largest backers of anti-TB drug development in the world.
3, Luvartinib (Levignine)
This product declaration by the Eisai, as the priority review varieties.
Lentivatin is a multi-target kinase inhibitor that inhibits regulatory factors such as VEGFR1-3, FGFR1-4, PDGFRα, KIT, RET etc. It was approved by the US FDA and EMA in 2015 for aggressive, locally advanced or metastatic differentiation Type thyroid cancer treatment, and in 2016 have received FDA and EMA approved lombinide combined with everolimus treatment of advanced renal cell carcinoma.
At the CSCO 2017, the results of a Phase III clinical trial (REFLECT study) of Lentivatinib versus sorafenib in the treatment of unresectable hepatocellular carcinoma (HCC) were published. Patients in mainland China, Taiwan, and Hong Kong In the cohort, the overall survival (OS) of lonivantenic met the non-inferiority criteria and the OS was significantly prolonged by 4.8 months (15.0 months vs 10.2 months, HR 0.73, P = 0.02620) Compared with the efficacy of lombatinib for Chinese patients is more significant.
HCC is the second leading cause of cancer death in the world and can cause an estimated 745,000 deaths each year.According to the data of China Cancer Registry, the incidence of primary liver cancer in China has been the fourth most common malignant tumor with the highest mortality rate 3 digits.
4, according to Luo Yu monoclonal antibody
This product from Amgen's declaration.
In some databases, there are disagreements, some think this is migraine drug Erenumab-AMG334 (CGPR), and some think it is lipid-lowering drug Evolocumab-AMG145 (PCSK9) .In the English and Chinese translation and query information, not difficult to find : A Double-blind, Randomized, Placebo-controlled, Multicenter, Phase III Study Enrollment Enrollment Appears Ended by a Double-blind, Randomized, Placebo-controlled Study Evaluating the Effect of Additional LDL-cholesterol Drops in AMG145 in Combination with Statins for the Treatment of Cardiovascular Disease Others.) And AMG334 and no related clinical registration, there is no clinical application. This is the PCSK9 monoclonal antibody domestic listing application.
Amgen's Repatha PCSK9 revenue rose 126% to $ 319 million in FY 2017. Repatha, which received FDA approval in December 2017, became the first heart disease, stroke, and coronary artery in adults with cardiovascular disease PCSK9 inhibitors of revascularization.
5, rotavirus live pentavalent vaccine
The goods from Merck East declared.
RotaTeq (US Trade Name) is a 3-dose, prophylactic oral pentavalent rotavirus live vaccine developed by MSD that consists of 5 human-bovine recombinant live rotavirus strains.
In China, Zhifei Bio signed a "Development, Promotion and Distribution Agreement" with Merck on live pentavalent live rotavirus vaccine in June 2012. At present rotavirus vaccines have been classified as a type of vaccine in the United States and all Children will be funded by the state for free vaccination currently still belongs to the second category of vaccines in our country, vaccinated by consumers at their own expense.
Rotavirus is the leading cause of severe acute gastroenteritis in infants and young children. In China, more than 10 million infants and young children suffer from rotavirus gastroenteritis each year, accounting for about 1/4 of infants under 2 years of age. The most important source of diarrhea.
6, other imported and imported drugs to declare the market
Other imported innovative drugs listed on the market include: tiotropium oxydale (BI), moxifloxacin eye drops (Alcon), ceritinib - ceritinib (Novartis), Rosas FibroGen, butanamide naloxone, Nivolumab, Pembrolizumab-Peibloizumab and the like.
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