Morning,這里是《21健訊Daily》,歡迎與21世紀經濟報道新健康團隊共同關注醫藥健康行業最新事件!
一(yi)、政策動向
●上海10部門聯合發文:深入開展醫療領域亂象治理
近日,上海市(shi)(shi)衛生健(jian)康委員會、財政局(ju)等(deng)十部門聯合發(fa)布(bu)《關(guan)于印發(fa)上海市(shi)(shi)2022年(nian)糾(jiu)正醫(yi)藥購銷領域和醫(yi)療(liao)服務中不正之風工作(zuo)要點(dian)(dian)的(de)通知》(以下(xia)簡稱《通知》),要求深入開(kai)展(zhan)醫(yi)療(liao)領域亂象治(zhi)理。將持續(xu)加強醫(yi)保(bao)(bao)基(ji)金監(jian)管,持續(xu)開(kai)展(zhan)醫(yi)保(bao)(bao)定點(dian)(dian)醫(yi)療(liao)機(ji)構規范使用醫(yi)保(bao)(bao)基(ji)金行(xing)為專項治(zhi)理,持續(xu)推進打擊(ji)欺詐騙保(bao)(bao)專項整治(zhi)行(xing)動(dong),加大重(zhong)點(dian)(dian)領域打擊(ji)欺詐騙保(bao)(bao)工作(zuo)力(li)度。以有效線索、重(zhong)點(dian)(dian)專案(an)作(zuo)為切(qie)入點(dian)(dian),精準打擊(ji)篡改腫瘤(liu)患者基(ji)因檢測結果、串(chuan)換高值醫(yi)用耗材、血液透析(xi)騙取醫(yi)保(bao)(bao)基(ji)金以及(ji)醫(yi)保(bao)(bao)卡(ka)違(wei)規兌(dui)付現金等(deng)違(wei)法違(wei)規行(xing)為。
二、藥械審(shen)批
●東陽光藥糖尿病產品獲批上市
11月7日,中國國家藥(yao)監局(NMPA)官網最(zui)新公示,東陽光藥(yao)申(shen)報的門冬(dong)胰島(dao)素(su)30注(zhu)射(she)液(ye)上市申(shen)請已獲得批準(zhun)。根據東陽光藥(yao)早前發(fa)布的新聞稿(gao),其門冬(dong)胰島(dao)素(su)30注(zhu)射(she)液(ye)是一(yi)款預(yu)混胰島(dao)素(su),含30%可溶性(xing)門冬(dong)胰島(dao)素(su)和(he)70%精蛋白(bai)門冬(dong)胰島(dao)素(su),適(shi)用于糖尿病的治療,可臨(lin)餐注(zhu)射(she),其糖化血紅(hong)蛋白(bai)(HbA1c)達(da)標率更高,可更好地(di)控制餐后血糖。
三(san)、資本(ben)市場
●帕母醫療完成新一輪數千萬美元融資
11月4日,帕(pa)母醫(yi)療(liao)(Pulnovo Medical)宣布完(wan)成新一輪數千萬美(mei)元融(rong)(rong)資。本輪融(rong)(rong)資由元生(sheng)創投領投,奧(ao)博資本(OrbiMed)、千驥資本、禮來亞(ya)洲基金(LAV)、高榕資本、惠合(he)資本、GC&H Investments共同(tong)參與(yu),其中原股東全部(bu)超(chao)額認(ren)購。帕(pa)母醫(yi)療(liao)成立(li)于2013年,該公(gong)司選擇(ze)肺(fei)動(dong)脈(mo)高壓作為探索(suo)的(de)(de)首個疾病領域,開發(fa)了創新的(de)(de)肺(fei)動(dong)脈(mo)去神經(jing)術(shu)。針對該手術(shu)的(de)(de)產品肺(fei)動(dong)脈(mo)高壓射頻消融(rong)(rong)導管(guan)已(yi)經(jing)于2021年獲得美(mei)國FDA突破(po)性(xing)醫(yi)療(liao)器械(xie)認(ren)定(ding),并已(yi)經(jing)在(zai)中國完(wan)成注(zhu)冊臨床(chuang)試驗患者隨訪。
●華廈眼科在創業板正式IPO
7日,華廈眼科在創業板(ban)正(zheng)式(shi)上(shang)市,發行價50.88元/股(gu)(gu)(gu),發行6000萬股(gu)(gu)(gu),發行后總股(gu)(gu)(gu)數5.6億股(gu)(gu)(gu)。
華廈眼(yan)科醫(yi)(yi)院集團(tuan)股(gu)份有限公司成(cheng)立于2004年,是一家專(zhuan)注于眼(yan)科專(zhuan)科醫(yi)(yi)療(liao)服務的大型民(min)營醫(yi)(yi)療(liao)連鎖(suo)集團(tuan),目前已(yi)在國內開設(she)57家眼(yan)科專(zhuan)科醫(yi)(yi)院,核定床位數(shu)為3603張,實際開放床位數(shu)為2951張,覆蓋17個(ge)省(sheng)及46個(ge)城(cheng)市,輻射國內華東、華中、華南、西南、華北等(deng)廣大地(di)區。
●科弈藥業完成首輪近五億元融資
科弈(浙(zhe)江(jiang))藥(yao)(yao)業科技(ji)有限公司近日宣(xuan)布(bu)完成首輪(lun)規模(mo)近五億(yi)元人民幣(bi)融資(zi),由浙(zhe)江(jiang)安吉開發(fa)區(qu)設(she)立(li)的(de)科泉基金投資(zi)。資(zi)金將主要用(yong)(yong)于核(he)(he)心產(chan)品(pin)的(de)臨床(chuang)試驗、核(he)(he)心管線(xian)IND申報和(he)(he)GMP廠房建設(she)。科弈(浙(zhe)江(jiang))藥(yao)(yao)業科技(ji)有限公司成立(li)于2018年,是(shi)專注于腫(zhong)瘤免疫治療(liao)創新藥(yao)(yao)研發(fa)和(he)(he)臨床(chuang)應(ying)用(yong)(yong)生(sheng)物醫藥(yao)(yao)科技(ji)型(xing)企業,全資(zi)控股上海科棋藥(yao)(yao)業科技(ji)有限公司(專注新一代CAR-T研發(fa)和(he)(he)臨床(chuang)應(ying)用(yong)(yong)),已布(bu)局(ju)雙功能抗體、ADC、實體瘤CAR-T、血液瘤CAR-T等研發(fa)平臺,開發(fa)近8款(kuan)FIC/BIC產(chan)品(pin)。
四、行業大事
●浙江省藥監局:25批次藥品抽檢不合格
11月7日,浙江(jiang)省(sheng)藥(yao)監(jian)局發(fa)布(bu)了2022年第(di)2期藥(yao)品質量抽檢公告。
公(gong)告內(nei)容顯示:為(wei)加強藥品(pin)質(zhi)量監管,保障公(gong)眾用藥安(an)全,浙江省藥品(pin)監督管理局組(zu)織(zhi)開展(zhan)了對轄區內(nei)藥品(pin)生產、經營和使(shi)用單位的相關藥品(pin)質(zhi)量監督抽檢(jian)。經檢(jian)驗,發現不合(he)格藥品(pin)25批次,分(fen)別為(wei)益母草顆粒、三黃(huang)片、大黃(huang)通便片、異(yi)維A酸凝膠、藿香正氣水(shui)、六味地黃(huang)膠囊(nang)、雞骨草、浙貝母、醋(cu)五味子、野葡萄根、紅(hong)花、五加皮、當(dang)歸(gui)。
不合格(ge)產品標示的生產企業(ye)(ye)(ye)(ye)(ye)有(you)(you)(you):江西品信藥(yao)(yao)(yao)業(ye)(ye)(ye)(ye)(ye)股(gu)(gu)份有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、愛民(min)藥(yao)(yao)(yao)業(ye)(ye)(ye)(ye)(ye)集(ji)團股(gu)(gu)份有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、江西德上制藥(yao)(yao)(yao)股(gu)(gu)份有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、哈爾濱大中(zhong)(zhong)(zhong)制藥(yao)(yao)(yao)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、四(si)川天府康達藥(yao)(yao)(yao)業(ye)(ye)(ye)(ye)(ye)集(ji)團府慶制藥(yao)(yao)(yao)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、四(si)川恩威制藥(yao)(yao)(yao)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、安(an)徽(hui)(hui)省(sheng)(sheng)萬生中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲片(pian)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、安(an)徽(hui)(hui)省(sheng)(sheng)萬生中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲片(pian)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、安(an)徽(hui)(hui)九州(zhou)(zhou)方圓制藥(yao)(yao)(yao)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、安(an)徽(hui)(hui)國宏藥(yao)(yao)(yao)業(ye)(ye)(ye)(ye)(ye)股(gu)(gu)份有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、杭州(zhou)(zhou)桐閣堂中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲片(pian)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、江蘇仟(qian)草堂藥(yao)(yao)(yao)業(ye)(ye)(ye)(ye)(ye)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、黑龍江省(sheng)(sheng)亳鑫中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲片(pian)廠(chang)、安(an)徽(hui)(hui)人民(min)中(zhong)(zhong)(zhong)藥(yao)(yao)(yao)飲片(pian)有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)、安(an)徽(hui)(hui)源和堂藥(yao)(yao)(yao)業(ye)(ye)(ye)(ye)(ye)股(gu)(gu)份有(you)(you)(you)限(xian)(xian)(xian)(xian)(xian)公(gong)(gong)(gong)(gong)司(si)(si)(si)(si)。
對抽檢發(fa)現(xian)的不合(he)格藥品,省藥品監督管(guan)理局(ju)已要求各相關(guan)地市(shi)(shi)市(shi)(shi)場監督管(guan)理部門依法處置。特此公告。


