{"id":829,"date":"2024-06-30T21:38:36","date_gmt":"2024-06-30T12:38:36","guid":{"rendered":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/?p=829"},"modified":"2024-08-07T21:54:29","modified_gmt":"2024-08-07T12:54:29","slug":"new-drug-approvals-by-the-nmpa-june-2024","status":"publish","type":"post","link":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/829\/","title":{"rendered":"New Drug Approvals by the NMPA - June 2024"},"content":{"rendered":"

 
\nImported drugs:<\/strong>
\n 
\n\u25a1\u3000Alecensa (alectinib) - new indication - marketed by Roche Registration GmbH
\n\u25a1\u3000Awiqli (insulin icodec) - marketed by Novo Nordisk A\/S
\n\u25a1\u3000Budesonide, glycopyrronium bromide and formoterol fumarate inhalation aerosol - marketed by AstraZeneca AB
\n\u25a1\u3000DOPTELET (avatrombopag maleate) - new indication - marketed by AkaRx Inc.
\n\u25a1\u3000Esperoct (turoctocog alfa pegol) - marketed by Novo Nordisk A\/S
\n\u25a1\u3000Glucagon nasal powder - marketed by Amphastar Pharmaceuticals, Inc.
\n\u25a1\u3000Icosapent ethyl soft capsules - marketed by Amarin Pharmaceuticals Ireland Ltd.
\n\u25a1\u3000Jakavi (ruxolitinib) - new indication - marketed by Novartis Pharma Schweiz AG
\n\u25a1\u3000Keytruda (pembrolizumab) - new indication - marketed by Merck Sharp & Dohme LLC
\n\u25a1\u3000Methylthioninium chloride enteric-coated sustained-release tablets - marketed by Alfasigma S.p.A.
\n\u25a1\u3000ORKEDIA (eocalcet) - marketed by Kyowa Kirin Co., Ltd.
\n\u25a1\u3000Ozempic (semaglutide) - new indication - marketed by Novo Nordisk Pharma AG
\n\u25a1\u3000REXULTI (brexpiprazole) - marketed by Otsuka Pharmaceutical Co.\uff0cLtd.
\n\u25a1\u3000Tabrecta (capmatinib) - marketed by Novartis Pharma Schweiz AG
\n\u25a1\u3000TAGRISSO (osimertinib mesylate) - new indication - marketed by AstraZeneca AB
\n\u25a1\u3000Tarlige (mirogabalin besilate) - marketed by DAIICHI SANKYO CO., LTD.
\n\u25a1\u3000TECVAYLI (teclistamab) - marketed by Janssen-Cilag International NV
\n\u25a1\u3000XPOVIO (selinexor) - new indication - marketed by Karyopharm Therapeutics Inc.
\n\u25a1\u3000XTANDI (enzalutamide) - new indication - marketed by Astellas Pharma Europe B.V.<\/p>\n

 
\n 
\nDomestic drugs:<\/strong>
\n 
\n\u25a1\u3000\u5b89\u6d1b\u6674-An Luo Qing (envonalkib citrate) - marketed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
\n\u25a1\u3000\u767e\u65af\u9510\u660e-Bai Si Rui Ming (ropeginterferon alfa-2b) \u2013 marketed by PharmaEssentia Corporation
\n\u25a1\u3000\u767e\u6cfd\u5b89-Bai ze An (tislelizumab) \u2013 new indication - marketed by BeiGene Ltd.
\n\u25a1\u3000\u500d\u957f\u5e73-Bei Chang Ping (cofrogliptin) - marketed by Haisco Pharmaceutical Group Co., Ltd.
\n\u25a1\u3000\u8d1d\u5854\u5b81-BETAGRIN (bevifibatide citrate) - marketed by Bio-Thera Solutions Inc.
\n\u25a1\u3000Brivaracetam tablets - marketed by Qingfeng Pharmaceutical Group Co. Ltd.
\n\u25a1\u3000Calcipotriol scalp solution - marketed by Sinomune Pharmaceutical Co., Ltd.
\n\u25a1\u3000Calcitriol injection - marketed by Chengdu Gowell Biopharmaceutical Co., Ltd.
\n\u25a1\u3000Carbidopa and levodopa sustained-release tablets - marketed by SJZ No.4 Pharmaceutical Co., Ltd.
\n\u25a1\u3000Cetirizine hydrochloride injection - marketed by Shandong Cosci Med-tech Co., Ltd.
\n\u25a1\u3000\u6069\u7acb\u59a5-En Li Tuo (cetuximab beta) \u2013 marketed by Taizhou Mabtech Pharmaceutical Co. Ltd.
\n\u25a1\u3000\u6069\u8212\u5e78-En Shu Xing (enlonstobart) - marketed by CSPC Megalith Biopharmaceutial Co., Ltd.
\n\u25a1\u3000Estradiol valerate tablets - marketed by Zhejiang Xianju Pharmaceutical Co., Ltd.
\n\u25a1\u3000Fexofenadine hydrochloride for suspension - marketed by Jumpcan Pharmaceutical Group Co., Ltd.
\n\u25a1\u3000\u9ad8\u745e\u54f2-Gao Rui Zhe (golidocitinib) - marketed by Dizal Pharmaceutical Co.,Ltd.
\n\u25a1\u3000\u514b\u745e\u6bd5-Ke Ru Bi (zamerovimab and mazorelvimab) - marketed by Synermore Biologics (Suzhou) Co., Ltd.
\n\u25a1\u3000Levofloxacin oral solution - marketed by Hubei Jinluo Silk Cloth Co., Ltd.
\n\u25a1\u3000Metformin hydrochloride and empagliflozin tablets (VI) - marketed by Qilu Pharmaceutical Co., Ltd.
\n\u25a1\u3000Naltrexone hydrochloride implants - marketed by SciencienCare Pharmaceutical Technology Co.,Ltd.
\n\u25a1\u3000Olmesartan medoxomil orally disintegrating tablets - marketed by ApicHope Pharmaceutical Co., Ltd.
\n\u25a1\u3000Oxycodone hydrochloride and naloxone hydrochloride sustained-release tablets - marketed by Shandong Luye Pharmaceutical Co., Ltd.
\n\u25a1\u3000Palbociclib tablets - marketed by CSPC Ouyi Pharmaceutical Co., Ltd.
\n\u25a1 Perfluoropropane-albumin microspheres for injection - marketed by Xiamen Lizhuo Pharmaceutical Co., Ltd.
\n\u25a1\u3000Phloroglucinol orally disintegrating tablets - marketed by Renhe Yikang Group Co., Ltd.
\n\u25a1\u3000Pregabalin orally disintegrating tablets - marketed by DiQi Pharmaceuticals Co.,Ltd.
\n\u25a1\u3000Progesterone injection (II) - marketed by Changchun GeneScience Pharmaceutical Co., Ltd.
\n\u25a1\u3000Rivastigmine bitartrate oral solution - marketed by Shandong Loncom Pharmaceutical Co., Ltd.
\n\u25a1\u3000Rotigotine microspheres for injection - marketed by Luye Jiaao (Shijiazhuang) Pharmaceutical Co., Ltd.
\n\u25a1\u3000\u745e\u6c81-Rui Qin (henagliflozin proline) \u2013 new indication - marketed by Jiangsu Hengrui Pharmaceuticals Co., Ltd.
\n\u25a1\u3000Salmeterol xinafoate and fluticasone propionate powder for inhalation - marketed by Joincare Pharmaceutical Group Industry Co., Ltd.
\n\u25a1\u3000\u5723\u745e\u6c99-Sheng Rui Sha (rilertinib mesylate) - marketed by Nanjing Sanhome Pharmaceutical Co., Ltd.
\n\u25a1\u3000Sodium dihydrogen phosphate and disodium hydrogen phosphate granules - marketed by Harvest(Hunan) Pharmaceuticals Co.,Ltd.
\n\u25a1\u3000Tafamidis meglumine soft capsules - marketed by Qilu Pharmaceutical Co., Ltd.
\n\u25a1\u3000Technetium [\u2079\u2079\u1d50Tc] tetrofosmin injection - marketed by Nanjing JYAMS Electronic Research & Development Co., Ltd.
\n\u25a1\u3000Telmisartan and amlodipine tablets - marketed by Jiangxi Shimei Pharmaceutical Co., Ltd.
\n\u25a1\u3000Ticagrelor dispersible tablets - marketed by Honghe Pharmaceutical Co., Ltd.
\n\u25a1\u3000\u62d3\u76ca-Tuo Yi (toripalimab) \u2013 new indication - marketed by Shanghai Junshi Biosciences Co., Ltd.
\n\u25a1\u3000Valganciclovir hydrochloride tablets - marketed by Shanghai Zhongxi Sunve Pharmaceutical Co.,Ltd.
\n\u25a1\u3000\u4fe1\u7acb\u6c40-Xin Li Ting (fultagliptin benzoate) - marketed by Shenzhen Salubris Pharmaceuticals Co., Ltd.
\n 
\n(Source: BaiPharm)<\/p>\n","protected":false},"excerpt":{"rendered":"

  Imported drugs:   \u25a1\u3000Alecensa (alectinib) - new indication - marketed by Roche Registration GmbH \u25a1\u3000Awiqli (insulin icodec) - marketed by Novo Nordisk A\/S \u25a1\u3000Budesonide, glycopyrronium bromide and formoterol fumarate inhalation aerosol - marketed by AstraZeneca AB \u25a1\u3000DOPTELET (avatrombopag maleate) - new indication - marketed by AkaRx Inc. \u25a1\u3000Esperoct (turoctocog alfa pegol) - marketed by Novo Nordisk A\/S \u25a1\u3000Glucagon nasal powder - marketed by Amphastar Pharmaceuticals, Inc. \u25a1\u3000Icosapent ethyl soft capsules - marketed by Amarin Pharmaceuticals Ireland Ltd. \u25a1\u3000Jakavi (ruxolitinib) - new indication - marketed by Novartis Pharma Schweiz AG \u25a1\u3000Keytruda (pembrolizumab) - new indication - marketed by Merck Sharp & Dohme LLC \u25a1\u3000Methylthioninium chloride enteric-coated sustained-release tablets - marketed... Read more »<\/a><\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-829","post","type-post","status-publish","format-standard","hentry","category-medicalnews"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/posts\/829","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/comments?post=829"}],"version-history":[{"count":10,"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/posts\/829\/revisions"}],"predecessor-version":[{"id":839,"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/posts\/829\/revisions\/839"}],"wp:attachment":[{"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/media?parent=829"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/categories?post=829"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.ssri.com\/china\/e\/medicalnews\/wp-json\/wp\/v2\/tags?post=829"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}