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January 5, 2021 / Medical Information At a Glance: 17 new confirmed cases of neo-crown pneumonia were added on January 4, 14 of which were in Hebei; Broshu single anti-listing application in China entered "in the approval"; 11433 drugs or was removed from the network ... Daily fresh medicine news, speed reading society and you pay attention to! Part 1 Policy Brief January 4 17 new confirmed cases of neo-crown pneumonia, 14 cases in Hebei January 4 0-24 hours, 31 provinces (autonomous regions, municipalities directly under the Central Government) and Xinjiang Production and Construction Corps reported 33 new confirmed cases, including 16 cases imported from abroad (6 cases in Shanghai, 4 cases in Guangdong, 1 case in Tianjin, 1 case in Liaoning, 1 case in Jiangsu, 1 case in Fujian, 1 case in Henan, 1 case in Sichuan), 17 cases in China (14 cases in Hebei, 2 cases in Liaoning, 1 case in Beijing);
(official website of the National Health Council) the 38th batch of chemical generic drug ginseng preparation catalog published on the 5th, CDE released the "Chemical generic drug gradore preparation catalog (38th batch)", in which hydrochloric acid dopamine glucose injection, Malay acid ergoxine / microcosm injection, hydrochloric acid fentanyl release capsules, hydrochloric acid cephalosporine tablets four varieties have not been considered.
The CDE Organization selected the 38th batch of ginseng preparations in the Bulletin on the Release of procedures for the Selection and Determination of Chemical Imitation Drug Ginseng Preparations (No. 25 of 2019), issued on March 28, 2019.
(CDE) 11433 drugs or was removed from the network 4 days, Liaoning Province medical institutions drug and consumables collection leadership group office issued "on the proposed cancellation of no procurement records of drugs online procurement notice."
notice said that in order to further do a good job in the centralized procurement of drugs to ensure the effective clinical demand for drugs, it is proposed to February 15, 2019 zero hours - February 14, 2020 at 24:00, Liaoning Province drug centralized procurement platform procurement record of "0" 11433 drugs to cancel the network procurement.
The drugs to be removed from the network are chlorovine flat tablets, azithromycin particles, greta pyridoxine tablets and other commonly used Western medicine;
(Liaoning Medical Institutions Drug and Supplies Collection Leading Group Office) Part 2 after observation of 87 million U.S. dollars! Idea Di Pharmaceuticals was authorized by the next generation of dual-specific antibodies in Greater China 5, Widi Pharmaceuticals announced a cooperation agreement with South Korean biotechnology company Y-Biologics, will obtain the latter a dual-specific antibody YBL-013 in Greater China exclusive development, production and commercial rights, and will jointly develop the product worldwide.
(Drug Mingkangde) Part 3 drug information Sanxiang Biological research and development within 1 hour of the rapid identification of the new crown variant virus nucleic acid detection reagent Sanxiang Bio announced the development of a rapid new coronary mutant virus identification test kit, can be used to identify B.1.1.7 new crown virus strain.
the reagent can be used to identify and distinguish between new mutant strains B.1.1.7 and non-mutant strains within 1 hour.
sanxiang biological has been listed in the new coronary nucleic acid testing kit has been covered by B.1.1.7 mutation strain detection.
(Kotsun Board Daily) Gene Tektronox anti-TIGIT antibody Tiragolumab was recognized by the FDA breakthrough therapy 5, Roche Group member Genente announced that its target combination with TIGIT new cancer immunotherapy tiragolumab obtained the FDA breakthrough therapy identified as intended to be used in combination with Atili pearl monoantigenic treatment tumor PD-L1 high expression and no EGFR or ALK genome tumor metastasis non-small cell lung cancer patients.
(Immediate Drug News) Aesen Pharmaceutical APG-2575 was approved by the U.S. FDA Orphan Drug for the treatment of AML5, Aachen Pharmaceuticals announced that the U.S. FDA has awarded it the original innovative drug Bcl-2 inhibitor APG-2575 Orphan Drug Qualification for the treatment of acute myeloid leukemia.
this is the fourth FDA-granted orphan drug qualification for APG-2575, following Fahrenheit globulinemia, chronic lymphocytic leukemia, and multiple myeloma adaptation.
, as of now, assassin Pharmaceuticals has obtained 9 FDA orphan drug certifications in the study of new drugs.
(AGENCY) Innovative Antibody Association Drug was approved by the FDA Fast Track For Treatment of HER2-positive breast cancer Ambrx announced that the FDA granted ARC788 Fast Track eligibility.
ARX788 will be used as a single drug for patients with advanced or metastasis HER2-positive breast cancer who have received one or more anti-HER2 treatments.
(Drug Mingkangde) Prevention of Type 1 Diabetes Innovative CD3 Antibodies qualified for FDA Priority Review Development Bio announced that the company has submitted to the FDA its CD3 monoclonal antibody teplizumab Biological Products Licensing Application (BLA) for delaying or preventing clinical type 1 diabetes (T1D) in high-risk individuals.
FDA has granted priority review of the application and is expected to respond by July 21 this year.
, teplizumab is expected to be the first approved treatment to change the progression of type 1 diabetes, according to a press release.
(Mamine) glutamine inhibitor RCC blocked U.S. biotech company Calithera announced its main product, glutamine enzyme inhibitor telaglenastat (CB-839) in a phase II clinical trial called Cantata missed the end of the trial.
the trial, which recruited 444 second-line RCC patients, compared the effects of telaglenastat and placebo on PFS in Cabometyx of Exelixis, resulting in no difference between the two groups.
(U.S. and Chinese medicine source) Deqi Pharmaceuticals submitted to NMPA ATG-010 Global Phase 3 clinical trial application Deqi Pharmaceuticals announced today that it has submitted ATG-010 (selinexor) clinical trial application (IND) for the treatment of endometrial cancer to the National Drug Administration.
The trial is a global multi-center, randomized, double-blind Phase 3 clinical trial (SIENDO) designed to evaluate and compare the efficacy and safety of ATG-010 and placebo as maintenance therapy in patients with advanced or relapsed endometrial cancer after combined chemotherapy.
is being conducted at more than 80 research centres in North America, Europe and Asia.
(American News Agency) clinically in urgent need of new drugs from abroad! Broshu single anti-listing application in China into the "approval" of China's State Drug Administration drug registration progress query results of the latest public announcement, Concorde Fermentation Kirin (China) Pharmaceuticals in China submitted a rare disease new drug Brosumab three listing application status has been updated to: in the approval.
means the new drug is a step closer to approval in China.
(Drug Mingkangde) Qilu anti-tumor drug first imitation injection first review ... On the 5th, NMPA's official website announced the latest drug approval information, Qilu Pharmaceuticals took three products in one go: qufluoruricoside tablets domestic first imitation, hydrochloric acid Fashudir injection first evaluation, hydrochloric acid Prakso tablets domestic third.
meters intranet data show that the current Qilu's Enqutaibin capsule class 3 imitation listing application has also entered the "in the approval" state, is expected to usher in good news in the near future.
(National Drug Administration) 400 million tinib varieties of stone drugs were approved and over-evaluated Zhengda Tianqing has accounted for 70% of the market 5, NMPA official website announced the latest batch of drug approval information, stone pharmaceutical group Ohi Pharmaceuticals 4 imitation of the market application was approved and treated as a review.
Dasatini tablets for the national health insurance catalog class B varieties, Zhengda Tianqing Pharmaceutical Group in 2013 won the first imitation of the domestic, this stone drug was approved successfully won the first domestic evaluation.
(National Drug Administration) 2 billion injections of the first review! On the 5th, NMPA's official website published the latest drug approval information, Chengdu Ptot Pharmaceuticals injection cephalosporine sodium 4 specifications all passed the consistent evaluation.
to date, there have been 8 cephalosporine injection products that have been evaluated/evaluated.
(National Drug Administration) Xinhua Pharmaceuticals: cephalosporine tablets first through generic drug consistency evaluation Xinhua Pharmaceuticals issued a notice, received the Approval of the State Drug Administration issued cephalosporine tablets (0.125g and 0.25g) "Drug Supplemental Application Approval Notice", the above two specifications are the first in the country through generic drug quality and efficacy evaluation.
cephalosporine is suitable for acute tonsillitis, pharyngitis, otitis media pneumonia and other respiratory infections caused by sensitive bacteria.
(Xinhua Pharmaceutical Announcement) Green leaf pharmaceutical monthly long-acting micro-ball preparation LY03009 in Australia to start Phase I clinical 4, Greenlee Pharmaceutical Group announced that its independent research and development of micro-ball injection LY03009 has started phase I clinical trials in Australia.
LY03009 is given once a month to treat Parkinson's disease and moderate to severe leg syndrome.
(American News Agency) Enhua Pharmaceuticals disposable use of anaesthetic nasal mask to obtain a medical device registration certificate Enhua Pharmaceuticals issued a notice that the company recently obtained the Jiangsu Provincial Drug Administration issued a one-time use of anesthesia nasal mask "people's Republic of China medical device registration certificate."
(Enhua Pharmaceuticals Announcement)