Kambani yeJapan yemishonga Otsuka (Otsuka) ichangobva kugamuchira nhau dzakanaka muUS regulatory zvinhu, FDA yakabvumidza anti-cancer komputa mushonga mutsva Lo 3 mwedzi pamberi.surf (trifluridine / tipiracil, FTD / TPI) inoshandiswa kurapa varwere vane refractory metastatic colorectal cancer (mCRC) vasingachapindure kune mamwe marapirwo (chemotherapy uye biotherapy).
Lonsurf (development code TAS-102) is an new antimetabolite compound drug, iyo inoumbwa ne anti-tumor nucleoside analog FTD (trifluridine) uye thymidine phosphorylase inhibitor TPI (tipiracil). Pakati pavo, FTD inogona kutsiva thymine zvakananga muDNA kaviri-strand panguva DNA replication, izvo zvinotungamirira DNA kusashanda uye kunokanganisa synthesis kenza cell DNA; TPI inogona inhibit thymus phosphorylase ine chekuita neFTD decomposition uye kuderedza FTD degradation, Chengetedza kuwedzera kweropa kweFTD.
Lonsurf’s approval was based on positive data from an international, randomized, double-blind phase III study RECOURSE. The study involved 800 patients with previously treated metastatic kenza yakajeka (mCRC). In the study, patients were randomized to receive Lonsurf + best supportive therapy (BSC) or placebo + BSC until the condition deteriorated or the side effects became unbearable. The data showed that the overall survival of the Lonsurf treatment group was significantly longer than that of the placebo group (OS: 7.1 months vs 5.3 months), while progression-free survival was also significantly longer (PFS: 2 months vs 1.7 months) , Reached the primary and secondary endpoints of the study. In terms of safety, the most common side effects of the Lonsurf treatment group include anemia, weakness, extreme fatigue, nausea, decreased appetite, diarrhea, vomiting, abdominal pain, and fever.
Pakutanga, Lonsurf yakatenderwa nevakuru veJapan vanoona nezvekutonga munaKurume 2014; muEurope, Otsuka akaendesa chikumbiro chekunyorera Lonsurf kuEuropean Union munaKurume gore rino, uye kambani yakasaina chibvumirano nemumwe wayo Servier Kune chibvumirano chemamiriyoni zana nemakumi matatu emadhora, Servier achange achitarisira kutengeswa kweLonsurf mukondinendi yeEurope. .
Global colorectal cancer (CRC) musika wekurapa unosvika $ 9.4 bhiriyoni mu2020.
Sekureva kweshumo rekutsvagurudza rakaburitswa nekambani yepasirese yekutsvagisa misika GBI Research, musika wekurapa wekenza wepasi rose (CRC) unochengetedza kukura kudiki uye kwakagadzikana mumakore mashoma anotevera (2014-2020), ichisvika 9.4 bhiriyoni emadhora ekuAmerica na2020 Mune nguva yekufungidzira, mukomboni wegore rekukura (CAGR) yaive 1.8%, uye kukosha kwemusika mumusika muna 2013 waive $ 8.3 bhiriyoni.
Mushumo wacho wakataura kuti kukura uku kuchanyanya kuitika munyika huru sere dzakabudirira, kusanganisira United States, Japan, Canada, uye nyika shanu dzeEurope (United Kingdom, France, Germany, Spain, and Italy). Muna 2013, United States yaive nechikamu chikuru chemusika wepasi rose colorectal cancer (CRC) kurapwa, ichiverengera 44.1%, ichiteverwa neJapan (14.7%) neGermany (11.9%), neSpain (4.1%) ine musika wakaderera. share. Nyika idzi dzinotarisirwa kukura zvishoma nezvishoma, kunze kweJapan, iyo ichakura nekukurumidza (CAGR ye5%).
Chirevo chakaratidza kuti munguva yekufungidzira, iyo Roche blockbuster drug Avastin (zita regeneral: bevacizumab, bevacizumab) uye Merck (Merck KGaA) blockbuster drug Erbitux (zita regeneral: cetuximab), Cetuximab) patent mumisika mikuru inopera, ichasimudzira kugamuchirwa kwemusika kwezvishoma-mutengo biosimilars, izvo zvinodzora kukura kweiyo yepasi rose colorectal kenza yekurapa musika. Iyo Roche chemotherapeutic drug Xeloda (Xeloda, generic name: capecitabine, capecitabine) generic zvinodhaka zvakanyorwa mumisika mikuru zvinotarisirwa kudzikamisawo kukura kweyepasi rose colorectal cancer musika wekurapa.
Zvisinei, muongorori weGBI Saurabh Sharma akaratidza kuti kunyange kana Avastin patent yapera, mushonga wacho uchachengetedza nzvimbo yayo inotungamirira mumusika wepasi rose colorectal cancer (CRC) kusvika 2020. Saurabh akatsanangura kuti Avastin ikozvino inoshandiswa zvakanyanya mumutsara wekutanga uye wechipiri. -mutsara wekurapa cancer colorectal, zvisinei neK-Ras mamiriro emurwere. Kunyangwe yakabatana epidermal kukura factor receptor (EGFR) inhibitors yakatengeswa kurapwa kweK-Ras yemusango-rudzi. tumor ; Avastin anoenderera mberi kutonga musika wayo mukurapa metastatic K-Ras yemusango-mhando uye mutant mamota mamiriro.
The report points out that Bayer ‘s new oral anti-cancer drug Stivarga (regorafenib) is expected to be one of the biggest drivers of growth in the global colorectal cancer (CRC) treatment market. This is mainly due to the expected clinical treatment expansion of the drug as a maintenance treatment The drug is used for the first-line treatment of metastatic colorectal cancer (mCRC) that has had liver metastases removed. Stivarga is an oral multi-kinase inhibitor currently listed in major markets such as the US, EU, and Japan. In addition, Japan ‘s Dapeng Pharmaceutical ‘s anticancer drug Lonsurf (TAS-102) was approved for third- and fourth-line treatment in Japan in 2014, and Amgen ‘s monoclonal antibody Vectibix (panitumumab) was also approved by the United States. And EU approved for first-line treatment. The market acceptance of these new drugs will promote the growth of the global therapeutic market.
Chirevo chakaratidzawo kuti munguva yekufungidzira (2014-2020), mishonga mitsva yemapaipi inotarisirwa kumhara pamusika, kusanganisira Lilly's monoclonal antibody Cyramza (ramucirumab), Boehringer Ingelheim's katatu angiokinase inhibitor nintedanib, XBiotech Iyo kambani monoclonal antibody Xilonix . Nekudaro, iyi mishonga inopinda yekurwira yechipiri-mutsara uye wechitatu- uye wechina-mutsara marapirwo uye haizokanganisa zvakanyanya pamusika wese. Mishonga yakakwenenzverwa iyo iriko pamusika icharamba ichifarira kutonga kwemusika sezvo ichisanganisirwa mune yekutanga uye inobatsira mutero yekurapa kwekutanga.
