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July 31, 2020 / Medical Information List: Burglinger Ingelheim/Lilly Engele net reached the clinical end point of Phase 3, Shanghai issued the third batch of supplementary documents on volume procurement, Johnson and Johnson Stelara was approved by the FDA for use in children with moderate to severe plaque psoriasis, targeted FcRn eugenics than "first-in-class" therapy was approved in China for the first time... Daily fresh medicine news, quick reading with you to pay attention to! Part 1 Policy Brief July 30, 123 new confirmed local cases nationwide July 30, 0-24 hours, 31 provinces (autonomous regions, municipalities directly under the Central Government) and Xinjiang Production and Construction Corps reported 127 new confirmed cases, including 4 cases imported from abroad (3 cases in Guangdong, 1 case in Tianjin), 123 cases in China (11 cases in Xinjiang, 11 cases in Liaoning);
(National Health Care Commission) National Health Committee issued a clear requirements for the clinical use of anti-tumor drugs recently, the National Health Council issued "on the clinical application of anti-tumor drugs management measures for public consultation announcement", anti-tumor drugs clinical use of clear requirements, in which anti-tumor drugs clinical application of graded management.
according to safety, accessability, economy and other factors, anti-tumor drugs are divided into restricted use and general use level.
(National Health And Health Commission) State Drug Administration: Medical id card landing The State Drug Administration recently held a medical device unique marking system pilot work promotion meeting, on the next step to promote the pilot work to deploy.
it is pointed out that the unique identification of medical devices is the "ID card" of medical devices, is the only, accurate identification of medical devices, throughout the production, circulation, use of medical devices, help medical devices throughout the life cycle management.
(State Drug Administration) Shanghai issued the third batch of supplementary documents with volume procurement according to the Joint Procurement Office issued by the "National Drug Centralized Procurement Document (GY-YD2020-1)", in order to do a good job in the procurement of selected drugs in Shanghai, 30, Shanghai Pharmaceutical Centralized Tender procurement management office on the Shanghai area enterprise declaration, drug distribution, quality testing, three-way agreement, payment, the use of selected drugs and other content issued supplementary documents.
(Sina Pharmaceutical News) Part 2 production after observation of consinoco creation board today opened the purchase of Conschino officially opened in the company board purchase, the issue price of 209.71 yuan per share.
the issue price is the second-highest since the A-share issue, after Stone Technology (271.12 yuan per share), which went public earlier this year.
number of shares issued by the Company shall not exceed 24.8 million, accounting for 10.02% of the company's total share capital after the issuance of A-shares, and the funds raised will be used for the expansion of new vaccine production capacity and the development of new vaccine products.
(Pharmaceutical Mission) Part 3 Drug News Burglinger Ingelheim/Lilly Engele Net Reach Phase 3 Clinical Endpoint BurgerIngerham and Lilly jointly announced that the jointly developed SGLT2 inhibitor Engele Net has reached the main endpoint in Phase 3 clinical trials for adults with heart failure with reduced blood shot scores.
added englie net (10 mg) to standard care compared to placebo, significantly reducing the compound risk of cardiovascular death or hospitalization due to heart failure.
(Drug Mingkangde) Johnson and Johnson Stelara was approved by the FDA for use in children with moderate to severe plaque psoriasis 30, Johnson and Johnson's Xi'an Jansen announced that the U.S. FDA has approved its anti-inflammatory drug Stelara for use in children with moderate to severe plaque psoriasis.
Stelara is a monoclonal antibody that targets leukocytocin 12 (IL-12) and leukocytocin 23 (IL-23) by binding p40 sub-units common to IL-12 and IL-23 to prevent its binding to cell surface receptors, thereby suppressing these two pre-inflammatory cytokines.
(Sina Pharmaceutical News) Mercer East Keytruda treatment of triple negative breast cancer listing application by the FDA priority review Mercer Dong 30 announced that anti-PD-1 monoantigen Keytruda two new supplementary biological products licensing application (sBLA) has been accepted by the FDA.
sBLA is an application to accelerate the approval of Keytruda combined chemotherapy for the treatment of patients with tumor expression PD-L1 with local recurrence that is non-excisible or metastatic tri-negative breast cancer.
Gene Tektronitriq Combination Therapy has been approved to extend the adaptive Roche gene Tektronits today to approve its heavyweight PD-L1 inhibitor Tecentriq, in combination with MEK inhibitors Cotellic and BRAF inhibitor Zelboraf, to treat patients with advanced melanoma who carry the BRAF V600 mutation.
(Drug Mingkangde) Takeda "first-in-class" NAE inhibitors by the FDA breakthrough therapy identified Takeda announced that the U.S. FDA awarded it in the study of the drug pevonedistat breakthrough therapy identified for the treatment of high-risk bone marrow growth abnormal syndrome patients.
Pevonedistat is a "first-in-class" NEDD8 activated enzyme (NAE) inhibitor that promises to be the first innovative drug to treat HR-MDS patients in more than a decade.
Pfizer PDE4 inhibitors approved in China NMPA 30 public announcement, Pfizer's non-steroidal local PDE4 inhibitor Kliboro ointment was approved for the market.
the drug has been included in China's "second batch of clinically urgently needed new drugs abroad", the adaptive disorder is 2 years of age and above mild to severe adistoctive dermatitis.
(Pharmaceutical Mission) targeted FcRn excellent time than "first-in-class" therapy was approved clinically for the first time in China 30 days, CDE day publicity, UZO's class 1 new drug rozanolixizumab injections obtained clinical trials implied permission to develop for the emergence of moderate to severe symptoms and require additional treatment for patients with systemic severe muscle weakness on demand treatment.
this is a "first-in-class" treatment targeted at FcRn and is the first clinical trial to be approved in China.
(CDE)