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【2021224 / 】；Ad5-nCoV； PD-1/TGFβ ……，！
【2021224 / 】，！Part1
Part1Part1PGT
PGT，，，PGT（“”），，，，。（）
Shengnuo Biological Levosimendan injection price drops to 1,625 yuan/bottle
Shengnuo Biological Levosimendan injection price drops to 1,625 yuan/bottleOn February 23, Ningxia Public Resources Trading Service Center issued a notice on adjusting the online price of Levosimendan injection from Chengdu Shengnuo Biopharmaceutical Co.
Central document! The village doctor team shuffled
Central document! The village doctor team shuffledYesterday, the General Office of the Central Committee of the Communist Party of China and the General Office of the State Council issued the "Opinions on Accelerating the Revitalization of Rural Talents.
Part2 Observation
Part2 Sankei Observation Part2 Sankei ObservationEmployees report a large number of frauds by China Life in their real names
Employees report a large number of frauds by China Life in their real namesRecently, a female employee of China Life Heilongjiang reported a large number of frauds by the Nenjiang branch of China Life Insurance Co.
Esheng Biotechnology completes US$130 million in Series B financing
Esheng Biotechnology completes US$130 million in Series B financingEsheng Biotech announced today that it has completed more than 130 million US dollars in Series B financing.
WuXi Austrian Beta completes US$150 million Series B financing
WuXi Austrian Beta completes US$150 million Series B financingArtery Network learned for the first time that WuXi announced today that it has completed a US$150 million Series B financing.
Yiquan Intelligent completes B+ round of 100 million yuan financing
Yiquan Intelligent completes B+ round of 100 million yuan financingRecently, Yizhun Intelligent announced the completion of the B+ round of 100 million yuan financing.
Part3 Medicine News
Part3 Medicine News Part3 Medicine NewsSinopharm China Biotech Wuhan Institute of New Crown Vaccine Releases Interim Analysis Data of Phase III Clinical Trial
Sinopharm China Biotech Wuhan Institute of New Crown Vaccine Releases Interim Analysis Data of Phase III Clinical TrialOn February 24, according to Sinopharm’s China National Biologics CNBG Wuhan Institute of Biological Products, Sinopharm’s China National Biologics Wuhan Institute of Biological Products has launched the "New Coronary Inactivated Vaccine III" in the UAE and other countries on July 16, 2020.
Kangfang Bio/Zhengda Tianqing PD-1 first-line squamous NSCLC phase III clinical trial reached the primary endpoint
Kangfang Bio/Zhengda Tianqing PD-1 first-line squamous NSCLC phase III clinical trial reached the primary endpointOn February 24, Kangfang Biological and Sino Biopharmaceutical jointly announced that their co-developed anti-PD-1 monoclonal antibody Paimrizumab combined with chemotherapy for the first-line treatment of advanced/metastatic squamous non-small cell lung cancer phase III clinical mid-term The analysis has reached the main research endpoint, and plans to communicate with CDE to submit listing applications.
The Phase II study of Zejing Bio-Jacktinib tablets in the treatment of intermediate and high-risk myelofibrosis successfully
The Phase II study of Zejing Bio-Jacktinib tablets in the treatment of intermediate and high-risk myelofibrosis successfullyToday, Zejing Biological released an announcement that its self-developed product Jacketinib Hydrochloride Tablets has achieved successful results in a phase II clinical study for the treatment of intermediate and high-risk myelofibrosis.
Puli Pharmaceutical Terlipressin Injection Obtained CBG Marketing Approval
Puli Pharmaceutical Terlipressin Injection Obtained CBG Marketing ApprovalOn February 23, Privatol Pharmaceuticals announced that Terlipressin Injection was approved by the Dutch Board of Drug Evaluation (CBG).
China Biopharmaceuticals achieves overseas authorization for ROCK2 inhibitor
China Biopharmaceuticals achieves overseas authorization for ROCK2 inhibitorChina Biopharmaceuticals announced on the 24th that its subsidiary Beijing Tide Pharmaceuticals and Graviton of the United States have signed an overseas licensing cooperation agreement to jointly develop and commercialize the group’s self-developed innovative drug TDI01 for the treatment of fibrosis outside of Greater China.
Kailitai: The Egyptian registration certificate for kyphoplasty system was approved
Kailitai: The Egyptian registration certificate for kyphoplasty system was approvedOn February 24, Kailitai announced that the company has recently obtained the approval of the Egyptian competent authority to approve the registration of the Kyphosplasty System.
FDA approves Hengrui Medicine's PARP inhibitor international multi-center phase 3 clinical trial
FDA approves Hengrui Medicine's PARP inhibitor international multi-center phase 3 clinical trialRecently, Hengrui Medicine announced that its PARP inhibitor fluzoparib capsules have been approved by the US FDA to conduct an international multi-center phase 3 clinical trial to evaluate fluzoparib capsules combined with abiraterone acetate tablets and prednisone tablets.
FDA suspends clinical study of bluebird bio-sickle cell disease gene therapy
FDA suspends clinical study of bluebird bio-sickle cell disease gene therapyOn February 23, Bluebird Bio announced that the US FDA has put on hold its LentiGlobin gene therapy clinical trial program for the treatment of sickle cell disease.
Pamu Medical's original PADN catheter was qualified as a breakthrough medical device by the FDA
Pamu Medical's original PADN catheter was qualified as a breakthrough medical device by the FDARecently, the multi-polar synchronous pulmonary artery radiofrequency ablation catheter independently developed by Pamuir Medical for the treatment of pulmonary hypertension has obtained the US FDA's breakthrough medical device qualification.
Pfizer's encephalitis vaccine receives FDA priority review qualification
Pfizer's encephalitis vaccine receives FDA priority review qualificationPfizer announced today that the U.
Kangfang Bio-PD-1/CTLA-4 dual anti-cervical cancer was approved by the U.
S.
FDA as an orphan drug
S.
FDA as an orphan drug
On the 23rd, Kangfang Bio-Bio announced that its PD-1/CTLA-4 bispecific antibody Cadonilimab has obtained orphan drug designation granted by the FDA for the treatment of cervical cancer (except for the very early stage IA1).
(Biological Exploration)
Pfizer's "Vupanorsen Injection" was first approved for clinical use in China
Pfizer's "Vupanorsen Injection" was first approved for clinical use in China
On February 23, the CDE official website showed that Pfizer's "Vupanorsen injection" was approved for clinical use in China for the first time.
The drug is an antisense nucleotide therapy lipid-lowering drug.
In 2019, Pfizer obtained the exclusive global license rights of the drug from Akcea and Ionis with a down payment of up to US$1.
55 billion + milestone payment.
(Insight database)
Junshi PD-1/TGFβ double antibody clinical application accepted
Junshi PD-1/TGFβ double antibody clinical application accepted
According to the official website of CDE today, the clinical application of Junshi Bio-JS201 injection has been accepted.
JS201 is a PD-1/TGFβ bispecific antibody.
At present, no other company in China has developed PD-1/TGFβ bi-antibody.
According to the information officially disclosed by Junshi, the PD-1 antibody of JS201 is partly based on teriprizumab.
Preclinical studies have shown that simultaneous inhibition of PD-1 and TGFβ pathways can enhance T cell activation compared with monotherapy, which has a better curative effect.
And the security is controllable.
(Insight database)
Zhejiang Medicine: Obtained the ARX788 clinical trial approval notice
Zhejiang Medicine: Obtained the ARX788 clinical trial approval notice
On February 24, Zhejiang Pharmaceutical announced that its subsidiary, Zhejiang Xinma Biopharmaceutical, received the "Notice of Approval of Drug Clinical Trials" for the recombinant humanized anti-HER2 monoclonal antibody-AS269 conjugate (ARX788) for injection approved and issued by NMPA , Agreed to launch Phase II/III clinical trials for the treatment of gastric cancer and gastroesophageal junction adenocarcinoma.
The drug is used to treat HER2-positive advanced breast cancer and gastric cancer, etc.
It is an innovative biotechnology drug.
(Zhejiang Pharmaceutical Bulletin)
CanSino Ad5-nCoV listing application accepted
CanSino Ad5-nCoV listing application accepted
CanSino Bio announced today on the Hong Kong Stock Exchange that the conditional listing application of the recombinant new coronavirus vaccine (type 5 adenovirus vector) has been accepted by the NMPA.
The protective effects of the vaccine against severe illnesses were as follows: 90.
07% after 28 days of single-dose vaccination; 95.
47% after 14 days of single-dose vaccination.
(Cansino Biological Announcement)
Deqi Pharmaceutical's Selinexor New Drug Listing Application Receives Priority Review by NMPA
Deqi Pharmaceutical's Selinexor New Drug Listing Application Receives Priority Review by NMPA
On February 24, Deqi Pharmaceuticals announced that NMPA has granted the world's first selective nuclear export inhibitor ATG-010 (selinexor, XPOVIO®) the priority review qualification for new drug listing applications for the treatment of refractory and relapsed multiple myeloma patient.
(Medicine Cube)
Haisco's Palonosetron Injection Passed the Consistency Evaluation
Haisco's Palonosetron Injection Passed the Consistency Evaluation
On February 23, the official website of the State Food and Drug Administration showed that Liaoning Haisco Palonosetron Hydrochloride Injection passed the consistency evaluation and became the first company to pass the evaluation.
Palonosetron is the first-line drug in the triple combination drug for the prevention of CINV (nausea and vomiting caused by chemotherapy) in the clinical guidelines.
It is also the first-line medication to prevent postoperative nausea and vomiting.
(Medicine Cube)
Yuandong Bio-Caffeine Citrate Injection Passes the Consistency Evaluation of Injection Quality and Efficacy
Yuandong Bio-Caffeine Citrate Injection Passes the Consistency Evaluation of Injection Quality and Efficacy
Today, Yuandong Biologics issued an announcement stating that it had recently received the "Drug Supplementary Application Approval Notice" for its chemical drug "Caffeine Citrate Injection" approved and issued by the NMPA, which is used for the treatment of premature newborns.
Sexual apnea.
(Yuandong Biological Announcement)
Haisco: Palonosetron Hydrochloride Injection Passed the Consistency Evaluation of Generic Drugs
Haisco: Palonosetron Hydrochloride Injection Passed the Consistency Evaluation of Generic Drugs
On February 24, Haisco announced that the company recently received the "Drug Supplement Application Approval Notice" issued by NMPA, and Palonosetron Hydrochloride Injection passed the consistency evaluation of generic drugs.
Palonosetron hydrochloride injection is better than traditional 5-HT3 receptor antagonists for acute CINV (chemotherapy-related nausea and vomiting) and delayed CINV, especially for delayed CINV.
(Hisco Announcement)
Shijiazhuang's four-drug dexmedetomidine hydrochloride and sodium chloride injection has been accepted as imitation 3 categories
Shijiazhuang's four-drug dexmedetomidine hydrochloride and sodium chloride injection has been accepted as imitation 3 categories
On February 24, the official website of CDE showed that Shijiazhuang Four Drugs Dexmedetomidine Hydrochloride and Sodium Chloride Injection was accepted as imitation 3 types.
Data show that dexmedetomidine hydrochloride is a relatively selective α2-adrenergic receptor agonist, which is suitable for tracheal intubation and sedation during mechanical ventilation in surgical patients undergoing general anesthesia, and is used during intensive care treatment.
Tube and sedation of patients using a ventilator.
(Minenet)
Ouyi Pharmaceutical's listing application for lenalidomide capsules has been accepted
Ouyi Pharmaceutical's listing application for lenalidomide capsules has been accepted
Recently, the official website of CDE showed that CSPC Ouyi Pharmaceutical's lenalidomide capsules were accepted for the application of imitation 4 types of lenalidomide capsules.
Data show that lenalidomide is a synthetic glutamate derivative, which has the effect of inhibiting angiogenesis and immune regulation.
(Minenet)
The first UK real-world study shows the protective efficacy of the new crown vaccine
The first UK real-world study shows the protective efficacy of the new crown vaccine
A few days ago, the Department of Public Health of the United Kingdom announced that the real-world data it analyzed showed that the new crown vaccine BNT162b2 jointly developed by Pfizer and BioNTech can reduce the risk of new crown virus infection by 70% after one vaccination, and after the second dose of vaccine, the risk of infection Reduce by 85%.
(WuXi AppTec)
