"Pharmaceutical Express" level three hospital evaluation standards revised Novarce new drugs approved in China

December 29, 2020 / Medical Information List: Level 3 Hospital Review Standards Revised; Redding Pharmaceuticals and Cullinan Oncology reach exclusive licensing partnership for Greater China; AstraZeneca and Mercado receive 3 approvals in Japan; Shishi Mesquibo Zeposia applys for new adaptations; Novartis announces that new allergic conjunctivitis drugs have been officially approved in China... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief 9 years after the three-level hospital evaluation standards ushered in a re-revision of the 28th, the National Health and Health Commission issued the three-level hospital evaluation standards (2020 version), while announcing the 2011 version of the "three-level general hospital evaluation standards", cardiovascular diseases and other three-level specialist hospital evaluation standards" immediately abolished.
this is also the first major overhaul of level 3 hospital assessment standards in nine years.
(National Health Council) Part 2 watched Pfizer enter into a partnership with Myovant to develop innovative oncology and women's health therapies Today, Myovant Sciences and Pfizer jointly announced that they have reached an agreement to develop and promote oral gontagogen-releasing hormone-releasing hormone antagonist reluix, used to treat oncology and women's health diseases.
will also have exclusive options to promote the use of relugolix in oncology in other parts of the world outside the United States and Canada, except in some Asian countries.
Pharmaceuticals and Cullinan Oncology have reached an exclusive licensing partnership for Greater China, and Cullinan Oncology has announced that it has reached an exclusive licensing partnership to advance the development, production and commercialization of CLN-081 in Greater China.
under the terms of the agreement, Cullinan Oncology subsidiary Cullinan Pearl will receive an advance payment of $20 million and will be eligible for development, registration and sales-based milestone payments of up to $211 million.
addition, Reding Pharmaceuticals will pay Cullinan royalties based on clN-081's annual net sales in Greater China, including Chinese mainland, Hong Kong, Macau and Taiwan.
(Agency) Part 3 drug news first three total treatment of spinal cord injury after the central nervous pathological pain 3 clinical success! Japanese pharmaceutical company No. 13 recently announced that the evaluation of Tarlig's treatment of spinal cord injury (SCI) after the central nervous pathological pain (CNP) phase 3 study reached the main end.
the study was conducted in 274 patients with post-spinal cord injury in Asia (Japan, South Korea, Taiwan, China) with central neuropathic pain, using a double-blind approach to assess the efficacy and safety of mirogabalin and placebo.
(Bio Valley) AstraZenecom/Merca East Targeted Anti-Cancer Drug received 3 approvals in Japan Recently, AstraZeneum and Merca announced that the targeted anti-cancer drug Lynparza has been approved in Japan to treat 3 advanced cancers: ovarian cancer, prostate cancer, pancreatic cancer.
Specific adaptive disorders are: combined beva monoantigen, used to treat adult patients with ovarian cancer who are positive for ovarian defects after receiving first-line chemotherapy, for treating patients with despotic resistance prostate cancer with far-stage metastasis and BRCA gene mutations, and for treating non-excisive BRCAm pancreatic cancer patients who have no progress after receiving first-line chemotherapy.
(Bio Valley) and Yellow Pharma submitted Sovantinie's listing application to the FDA on the 28th, and Huang Pharma announced that it has begun rolling the submission to the FDA of the first part of Sovantini's new drug listing application (NDA) for the treatment of pancreatic and non-pancreatic neuroendocrine tumors (NDA), and plans to complete the new drug listing application in the first half of 2021, which will be the first U.S. drug listing application.
(Medical Rubik's Cube) Korsuva Injection Seeking Priority Review Cara Therapeutics announced today that it has submitted a new drug application for Korsuva injections to the FDA to treat severe itching in hemodialysis patients.
Korsuva is a small molecular inhibitor that selectively targets exosome opioids.
it has been recognized as a breakthrough therapy awarded by the FDA.
(Pharmaceutical Mingkangde) Novartis announced the official approval of a new drug for allergic conjunctivitis in China on the 29th, Novartis announced that Pataday was approved by the China Drug Administration for the treatment of allergic conjunctivitis-related itching eyes.
, according to a press release, Pataday is an upgraded version of olotta hydrochloride.
it increased the concentration of olotatin hydrochloric acid to 0.2%, not only to continue to maintain the dual-effect anti-sensitivity mechanism, but also to reduce the frequency of use, for China's allergic conjunctivitis patients to bring more convenient treatment options.
(Pharmaceutical Mingkangde) Lilly Abersili tablets to China again submitted the new adaptive drug listing application CDE website latest publicity, Lilly in China submitted three CDK 4/6 inhibitor Abesili tablets of the new adaptive drug listing application, and was accepted on December 28.
it is worth noting that in China, the first adaptive application for female breast cancer patients is in the approval stage.
the acceptance of the new adaptation application means that the Abesili tablet is expected to benefit more Chinese breast cancer patients.
(Pharmaceutical Mingkangde) Johnson and Johnson amivatamab EU application listed Johnson and Johnson's Janssen Pharmaceuticals recently announced that it has submitted a marketing authorization application to the EMA, seeking approval for amivantamab, for the treatment of patients with metastasis non-small cell lung cancer who are progressing after the failure of platinum-containing chemotherapy, exosome No. 20 of the dermis growth factor gene.
month, Janssen Pharmaceuticals also filed a biopharmaceutical license application for the amivantamab.
(Bio Valley) Shishi Shiguibao Zeposia in the European Union formally applied for the new adaptive Shimi shiguibo recently announced that the EMA has accepted Zeposia's marketing authorization application for the treatment of moderate to severe ulcerative colitis adult patients.
now, the EMA has initiated a centralized review process.
if approved, Zeposia will be the first oral arginol-1-phosphate-subject regulator to treat ulcerative colitis.
(Bio Valley) Sanofi "Du Puliyu mono-anti" new adaptive disease was approved clinical 29, Sanofi according to class 2.2 submitted a clinical application for duplyo single anti-injection new adaptive clinical application by CDE default license, intended to develop for the treatment of chronic sinusitis not accompanied by nasal pyridoxal (CRSsNP).
biological products in category 2.2 means to increase the number of new adaptive disorders and/or changes in drug use that have not been approved at home or a foreign country.
(Medical Rubik's Cube) 3rd! Zhengda Tianqing "Malay acid afatini tablets" approved for listing Is Day Qing according to the new 4 categories of submitted Malay acid afatini tablets generic drug listing applications approved by the State Drug Administration, becoming the third domestic product approved for listing enterprises, approved as follows through a consistent evaluation.
(Pharmaceutical Rubik's Cube) is the first fda-approved constipation drug Ruby protone Nanjing Zhengda Qing to copy the 3 categories of submitted Ruby protruding ketone capsule listing application to obtain CDE acceptance, the product is currently in a blank state in the domestic market, Nanjing Zhengda Tianqing first reported production.
is the first FDA-approved chemical to treat constipation, with global sales of 28.1 billion yen in 2019.
the first review in the World Wide Office (Minanet)! Stone drug Euro-Italian "Dasatini tablets" will soon be approved for the market of stone-drug European-Italian according to category 4 submitted Dasatini tablets listing applications in the "in-approval" state, is expected to be approved in the near future, becoming the first variety through the consistent evaluation of manufacturers.
(Medical Rubik's Cube)