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[June 9, 2021/Medical Information List] Pfizer's 20-valent pneumococcal conjugate vaccine passed the US FDA approval; Incyte's Jakafi review application was postponed by the FDA for 3 months; 3D electronic abdominal endoscopy was approved for marketing; Blue Sail Medical Deputy President Yang Fan resigns.
[June 9, 2021/Medical Information List] Daily news about fresh medicines and medical news, speed reading and follow you together!
Part1 Policy Brief
Part1 policy briefing Part1 policy briefingThe three departments jointly issued a document to continue to improve the funding standards for residents' medical insurance in 2021
The three departments jointly issued a document to continue to improve the funding standards for residents' medical insurance in 2021On the 8th, the National Medical Insurance Bureau and the Ministry of Finance jointly issued notices on improving the unified basic medical insurance system and critical illness insurance system for urban and rural residents, and earnestly doing a good job in medical security for urban and rural residents
National Health Commission: Establish an expert group to promote the construction of a hierarchical diagnosis and treatment and medical consortium
National Health Commission: Establish an expert group to promote the construction of a hierarchical diagnosis and treatment and medical consortiumOn June 7, the National Health Commission issued a notice on the establishment of an expert group to promote the construction of hierarchical diagnosis and treatment and medical consortia, which will evaluate and supervise the implementation of the national hierarchical diagnosis and treatment and medical consortium construction
The State Food and Drug Administration issued an announcement on the cancellation of a medical device registration certificate
The State Food and Drug Administration issued an announcement on the cancellation of a medical device registration certificateOn June 9, the State Food and Drug Administration issued an announcement that, in accordance with the provisions of the "Medical Device Registration Management Measures," the registration number of Nikon Corporation is now cancelled according to the application of the enterprise: National Machinery Injection 20172226595, product name: Biomicroscope Medical Device registration certificate
The genetic sequencing similarity of all positive cases in Guangzhou exceeds 98%
The genetic sequencing similarity of all positive cases in Guangzhou exceeds 98%On June 9, Li Tiegang, deputy director of the Disease Control and Prevention Department of the Guangzhou Municipal Health Commission, said that at present, the genetic sequencing similarity of all positive cases in Guangzhou has reached more than 98%, that is to say, all positive cases have a chain of transmission
Part2 Observation
Part2 Sankei Observation Part2 Sankei ObservationYang Fan, Vice President of Blue Sail Medical, resigns
Yang Fan, Vice President of Blue Sail Medical, resignsOn June 8, Blue Sail Medical issued an announcement on the Shenzhen Stock Exchange stating that the company's vice president, Mr.
Baiyang Pharmaceutical IPO plans to publicly issue 52.
Baiyang Pharmaceutical IPO plans to publicly issue 52.
Watson Pharmaceuticals: Signed the "Innovative Drug Development Strategic Cooperation Framework Agreement" with Zheyuan Technology and other parties
Watson Pharmaceuticals: Signed the "Innovative Drug Development Strategic Cooperation Framework Agreement" with Zheyuan Technology and other partiesOn June 9, Watson Pharmaceuticals announced that the company, Beijing Zheyuan Technology Co.
Haoyuan Pharmaceutical is listed on the Science and Technology Innovation Board
Haoyuan Pharmaceutical is listed on the Science and Technology Innovation BoardOn June 8, Haoyuan Pharmaceutical was listed on the Science and Technology Innovation Board with the stock code 688131
VVS Medical completed nearly 100 million yuan in A+ round of financing
VVS Medical completed nearly 100 million yuan in A+ round of financingOn June 9, Suzhou VVS Medical Technology Co.
Part3 Medicine News
Part3 Medicine News Part3 Medicine NewsA new generation of ADC in the treatment of HER2-positive breast cancer patients reaches phase 3 clinical endpoint
A new generation of ADC in the treatment of HER2-positive breast cancer patients reaches phase 3 clinical endpointOn June 8, Byondis announced that its new generation of antibody conjugate drug trastuzumab duocarmazine had reached the primary endpoint of progression-free survival in the Phase 3 clinical study TULIP
UK NICE approves Roche Tecentriq as first-line treatment for PD-L1-positive lung cancer
UK NICE approves Roche Tecentriq as first-line treatment for PD-L1-positive lung cancerThe National Institute of Health and Clinical Excellence recently issued guidelines recommending Roche’s anti-PD-L1 therapy Tecentriq as a monotherapy for the first-line treatment of metastatic non-small cell lung cancer
Pfizer pneumococcal 20-valent conjugate vaccine approved by the U.
Pfizer pneumococcal 20-valent conjugate vaccine approved by the U.
Xinrui α-Radiation Cancer Therapy Receives FDA Breakthrough Medical Device Certification
Xinrui α-Radiation Cancer Therapy Receives FDA Breakthrough Medical Device CertificationRecently, Alpha Tau Medical announced that its alpha-radiation cancer therapy Alpha DaRT has received a breakthrough medical device designation granted by the US FDA, which is suitable for the treatment of skin and oral squamous cell carcinomas with no curative standard therapies
Incyte's Jakafi review application was postponed by the FDA for 3 months
Incyte's Jakafi review application was postponed by the FDA for 3 months
Affected by the chain reaction of Pfizer’s Xeljanz negative safety signal, Incyte said on Tuesday that the FDA has also delayed the approval of Jakafi for the treatment of steroid-refractory chronic graft-versus-host disease by 3 months.
Jakafi The new target decision date for this indication is September 22
.
(Sina Pharmaceutical News)
first! Rongchang Bio-Injection Vidicuzumab is conditionally approved for marketing
first! Rongchang Bio-Injection Vidicuzumab is conditionally approved for marketing
On June 9th, the State Food and Drug Administration issued an announcement, conditionally approving the listing of vedicitumumab for injection declared by Rongchang Biologics
.
The drug is an innovative antibody conjugate drug independently developed by China, which is suitable for the treatment of locally advanced or metastatic gastric cancer patients with HER2 overexpression who have received at least 2 types of systemic chemotherapy
.
(National Food and Drug Administration)
The State Food and Drug Administration approves the marketing of Donafinil tosylate tablets
The State Food and Drug Administration approves the marketing of Donafinil tosylate tablets
June 9, the State Food and Drug Administration official website announced recently by the State Food and Drug Administration priority review approval procedures Suzhou Ze Jing Biological Pharmaceutical Co.
, Ltd.
declared a Class 1 drug innovation toluene sulfonic acid Dona sorafenib tablets on the market
.
The drug is an innovative drug independently researched and developed by China with independent intellectual property rights.
It is used for patients with unresectable hepatocellular carcinoma who have not received systemic treatment in the past
.
(National Food and Drug Administration)
Another inactivated new crown vaccine in my country is on the market and uses 2 doses throughout the course of vaccination
Another inactivated new crown vaccine in my country is on the market and uses 2 doses throughout the course of vaccination
On June 9th, the first batch of Covifo's new coronavirus inactivated vaccine independently developed by the Institute of Biology of the Medical Academy was put on the market for emergency domestic use
.
The immunization procedure of the new crown inactivated vaccine developed by the Institute of Biology of the Academy of Medical Sciences is the same as that of similar vaccines.
The whole course of inoculation is 2 doses, each dose is 2-4 weeks apart
.
The current vaccination age is 18 years old and above
.
(Sina Pharmaceutical News)
Three-dimensional electronic laparoscopic endoscopy was approved for marketing
Three-dimensional electronic laparoscopic endoscopy was approved for marketing
June 8, the State Food and Drug Administration issued a public notice, after review, approve an application for registration of minimally invasive (Shanghai) Co.
, Ltd.
Medical robot innovative products, "three-dimensional electronic endoscope abdominal cavity," the
.
It is reported that the product provides images through a video monitor for observation, diagnosis, photography or treatment of the thoracic cavity and abdominal cavity
.
(National Food and Drug Administration)
Tetrabenazine tablets are about to be approved for the treatment of Huntington's disease
Tetrabenazine tablets are about to be approved for the treatment of Huntington's disease
Recently, Shandong Bausch & Lomb Freda Pharmaceuticals has entered the administrative stage for the import application of the 5.
1 new drug tetrabenazine tablets.
It is expected that it will be formally approved in the near future, becoming the second domestic approved drug for the treatment of Huntington's disease
.
(CPhl Pharmaceutical Online)
Winbond Health Methylprednisolone Sodium Succinate for Injection passed the consistency evaluation of generic drugs
Winbond Health Methylprednisolone Sodium Succinate for Injection passed the consistency evaluation of generic drugs
On June 9th, Winbond Health announced that Winbond Pharmaceuticals, a wholly-owned subsidiary, has recently received the "Drug Supplementary Application Approval Notice" approved and issued by the State Food and Drug Administration for injection of methylprednisolone sodium succinate.
Pass the consistency evaluation of generic drugs
.
The drug is generally used clinically in the acute and critical phases of critically ill patients, as well as maintenance treatment after first aid
.
(Winbond Health Announcement)
Bayer's innovative cell therapy and gene therapy enter clinical trials
Bayer's innovative cell therapy and gene therapy enter clinical trials
On June 8, Bayer announced that its BlueRock Therapeutics company had successfully transplanted DA01, a dopaminergic neuron therapy produced by pluripotent stem cells, to a Parkinson's disease patient for the first time in a phase 1 clinical trial
.
At the same time, its subsidiary Asklepios Biopharmaceuticals is also advancing gene therapy for the treatment of Parkinson's disease
.
(WuXi AppTec)
Janssen BCMA/CD3 double antibody was approved for clinical use in China
Janssen BCMA/CD3 double antibody was approved for clinical use in China
CDE's official website announced that Johnson & Johnson's new class 1 biological drug teclistamab injection has been approved for clinical use, targeting multiple myeloma
.
It is reported that this is a bispecific antibody that targets the mature antigen of B cells and the CD3 receptor on the surface of T lymphocytes
.
(CDE official website)