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[April 13th, 2021 / Medical Information List] The first domestically produced mRNA COVID-19 vaccine is close to phase III clinical trials; Henlius's new indication for adalimumab has been approved; Guizhou Moutai 1.
[April 13, 2021 / Medical Information List] Cologne medicine fumarate propofol obtain a certificate of registration of drugs tenofovir tablets daily fresh smell drugs Medical News, speed reading club with you attention!
Part1 Policy Brief
Part1 policy briefing Part1 policy briefingThe State Food and Drug Administration revised the drug inserts for tramadol suppositories and compound preparations
The State Food and Drug Administration revised the drug inserts for tramadol suppositories and compound preparationsOn April 13, the State Construction and Drug Administration issued an announcement on the revision of the drug inserts for tramadol suppositories and compound preparations, and it was effective for tramadol suppositories (tramadol hydrochloride suppositories) and compound preparations (acetaminophen, tramadol tablets, acetaminophen).
2 provinces issued quality announcements for 73 batches of unqualified drugs
2 provinces issued quality announcements for 73 batches of unqualified drugsRecently, Jiangsu and Fujian Food and Drug Administration issued quality announcements.
Part2 Observation
Part2 Sankei Observation Part2 Sankei ObservationKweichow Moutai 1.
Kweichow Moutai 1.
Xinhua Pharmaceutical: intends to cooperate with Common Pharmaceutical to build anecort acetate and other projects
Xinhua Pharmaceutical: intends to cooperate with Common Pharmaceutical to build anecort acetate and other projectsOn April 13, Xinhua Pharmaceutical announced that the company signed an investor agreement with Common Pharmaceutical on April 13, and plans to jointly fund the establishment of Shandong Tongxin Pharmaceutical Co.
Shan Hu Health receives tens of millions of Pre-A rounds of financing from Sequoia China
Shan Hu Health receives tens of millions of Pre-A rounds of financing from Sequoia ChinaArtery Network learned for the first time that Shan Hu Health completed a Pre-A round of financing of tens of millions of yuan, which was invested by Sequoia Capital China Fund.
Part3 Medicine News
Part3 Medicine News Part3 Medicine NewsYiling Pharmaceutical's Aniprofen Injection Formally Started Phase III Clinical Trial
Yiling Pharmaceutical's Aniprofen Injection Formally Started Phase III Clinical TrialOn April 13, Yiling Pharmaceutical issued an announcement that the company's Phase III clinical trial plan for the company's 1.
Cansino: 13-valent pneumococcal polysaccharide conjugate vaccine enters phase III clinical trial
Cansino: 13-valent pneumococcal polysaccharide conjugate vaccine enters phase III clinical trialOn April 13, Cansino announced that the 13-valent pneumococcal polysaccharide conjugate vaccine developed by the company has completed preparations for phase III clinical trials and officially entered phase III clinical trials.
Regeneron Neutralizing Antibody Therapy Reached Phase 3 Clinical Endpoint
Regeneron Neutralizing Antibody Therapy Reached Phase 3 Clinical EndpointToday, Regeneron announced that its new crown neutralizing antibody combination therapy REGEN-COV has reached the main clinical endpoint in a phase 3 clinical trial for the prevention of new crown infection.
The first domestic mRNA new crown vaccine is close to phase III clinical trials
The first domestic mRNA new crown vaccine is close to phase III clinical trialsRecently, Suzhou Aibo Biology revealed that the new coronavirus mRNA vaccine jointly developed by Abbi Biology, the Academy of Military Medical Research of the Academy of Military Sciences and Yunnan Watson Biology has entered the end of phase II clinical trials, and everything is progressing smoothly.
Sage and Bojian SAGE-324 Phase II tremor test reached the primary endpoint
Sage and Bojian SAGE-324 Phase II tremor test reached the primary endpointA few days ago, Sage Pharmaceuticals and Biogen announced that the Phase 2 KINETIC trial evaluating SAGE-324 in patients with essential tremor has reached the primary endpoint.
The latest clinical results of Tengshengbo medicine/VBI joint development of immunotherapy are announced
The latest clinical results of Tengshengbo medicine/VBI joint development of immunotherapy are announcedToday, VBI Vaccines announced that the innovative immunotherapy VBI-2601 jointly developed by the company and Tengshengbo Pharmaceutical has achieved positive results in phase 1b/2a clinical trials.
Idiopathic narcolepsy drug Xywav oral solution receives priority review by the U.
Idiopathic narcolepsy drug Xywav oral solution receives priority review by the U.
Kelun Pharmaceutical's Propofol Fumarate Tenofovir Tablets Obtained Drug Registration Certificate
Kelun Pharmaceutical's Propofol Fumarate Tenofovir Tablets Obtained Drug Registration CertificateOn April 13, Kelun Pharmaceuticals issued an announcement stating that the company had recently obtained the "Drug Registration Certificate" for the chemical drug "Propofol Fumarate Tenofovir Tablets" approved and issued by the National Medical Products Administration.
Junshi PD-1 urothelial cancer indication is officially approved
Junshi PD-1 urothelial cancer indication is officially approved
On April 12, Junshi Bio announced that the third indication of "Treplimumab" was officially approved by the NMPA for the treatment of locally advanced or metastatic urothelial cancer that has previously been treated.
Prior to this, in the agreement reached between Junshi and AstraZeneca, AstraZeneca obtained the right to promote teriplizumab in non-core markets in mainland China and the exclusive right to promote urothelial cancer indications nationwide.
(Insight database)
Fuhong Henlius Obtained New Indication for Adalimumab
Fuhong Henlius Obtained New Indication for Adalimumab
On April 12, Henlius Group announced that it had received the NMPA's approval for the issuance of a supplementary application for new indications of Handayuan®.
This is the fourth indication that Handayuan® has been approved.
At present, Handayuan® has been approved for uveitis indications in addition to the three indications approved for rheumatoid arthritis, ankylosing spondylitis and psoriasis in China.
(Insight database)
Topiramate tablets of Huahai Pharmaceutical will be approved soon
Topiramate tablets of Huahai Pharmaceutical will be approved soon
Recently, Huahai Pharmaceutical’s application for the imitation of topiramate tablets in category 4 has entered the status of "approval".
If successfully approved, it will become the first imitation in China.
Topiramate tablets are a new broad-spectrum anti-epileptic drug for patients who are newly diagnosed with epilepsy.
Epilepsy patients who have been treated with monotherapy or who have been combined with drugs and are now switched to monotherapy can also be used for the additional treatment of partial epileptic seizures in adults and children aged 2-16 years.
(Minenet)
Amgen's bispecific antibody AMG 570 received clinical approval in China
Amgen's bispecific antibody AMG 570 received clinical approval in China
According to the latest announcement from the Drug Evaluation Center of the National Medical Products Administration of China, Amgen's Class 1 new drug, AMG 570, has obtained an implied license for a clinical trial and plans to develop a treatment for systemic lupus erythematosus.
Public information shows that AMG 570 is a bispecific antibody targeting BAFF and ICOSL and is currently in phase 2 clinical research worldwide.
(Medicine Guanlan)
AstraZeneca's diabetes drug Farxiga fails in COVID-19 study
AstraZeneca's diabetes drug Farxiga fails in COVID-19 study
On April 12, AstraZeneca announced that its diabetes drug Farxiga failed to reach the end point in a phase three study.
This study is a study of potential treatments for hospitalized COVID-19 patients who are at serious risk of complications.
(Sina Pharmaceutical News)
