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[May 27, 2021/Medical Information List] The State Food and Drug Administration issued an announcement on protected varieties of traditional Chinese medicines; Yahong Medical Science and Technology Innovation Board IPO was accepted; Sinopharm officially announced the Phase 3 clinical data of two new crown inactivated vaccines.
[May 27, 2021/List of medical information] Daily news about fresh medicines and medical news, speed reading and follow you together!
Part1 Policy Brief
Part1 policy briefing Part1 policy briefingThe State Food and Drug Administration issued an announcement on protected varieties of traditional Chinese medicines
The State Food and Drug Administration issued an announcement on protected varieties of traditional Chinese medicinesOn May 26, the State Food and Drug Administration issued an announcement on protected varieties of traditional Chinese medicines.
China Food and Drug Administration issued a voluntary recall notice for medical devices involving implantable cardiac pacemakers
China Food and Drug Administration issued a voluntary recall notice for medical devices involving implantable cardiac pacemakersOn May 26, the State Food and Drug Administration issued a recall information announcement.
Shanghai Municipality Issues Notice on Centralized Procurement of Coronary Balloon Medical Consumables
Shanghai Municipality Issues Notice on Centralized Procurement of Coronary Balloon Medical ConsumablesOn May 26, Shanghai Sunshine Pharmaceutical Purchasing Network issued a notice on the implementation of Shanghai’s centralized procurement of coronary balloon medical consumables.
Part2 Observation
Part2 Sankei Observation Part2 Sankei ObservationAstraZeneca China reached a cooperation with Boan Biotechnology on bevacizumab injection
AstraZeneca China reached a cooperation with Boan Biotechnology on bevacizumab injectionOn May 26, AstraZeneca China announced that it has obtained the approval of Boyounuo (bevacizumab injection), an anti-tumor biological drug from Boan Bio, a subsidiary of Luye Pharmaceutical Group, in 21 provinces, cities, and autonomous regions in mainland China.
Yahong Pharmaceutical Science and Technology Innovation Board IPO is accepted, plans to raise 2.
Yahong Pharmaceutical Science and Technology Innovation Board IPO is accepted, plans to raise 2.
Xiruan Technology completes A+ round of financing
Xiruan Technology completes A+ round of financingRecently, Xiruan Technology announced that it has completed a 100 million yuan A+ round of financing.
Part3 Medicine News
Part3 Medicine News Part3 Medicine NewsSinopharm officially announced phase 3 clinical data of two new crown inactivated vaccines
Sinopharm officially announced phase 3 clinical data of two new crown inactivated vaccinesOn May 26, the international medical journal "Journal of the American Medical Association" published the interim analysis results of the Phase 3 clinical trial of the COVID-19 inactivated virus vaccine published by Sinopharm Sino Biotech.
Phase 3 clinical results of innovative peptide-conjugated drugs for the treatment of multiple myeloma are positive
Phase 3 clinical results of innovative peptide-conjugated drugs for the treatment of multiple myeloma are positiveOn May 25, Oncopeptides AB announced that its peptide-conjugated drug Pepaxto has obtained positive results in a phase 3 clinical trial for the treatment of relapsed/refractory multiple myeloma.
Successful Chinese Phase III Bridging Trial of New Antibiotics
Successful Chinese Phase III Bridging Trial of New AntibioticsOn May 25th, Lunsheng Pharmaceutical and Nabriva announced that the Phase III bridging trial of lefamulin for the treatment of adult community-acquired bacterial pneumonia in China has achieved positive results.
Innovative topical therapy for neurofibromatosis type 1 has positive phase 2 clinical results
Innovative topical therapy for neurofibromatosis type 1 has positive phase 2 clinical resultsOn May 26, NFlection Therapeutics announced that its topical NFX-179 gel has achieved positive results in a phase 2a clinical trial for the treatment of neurofibromatosis type 1.
Legendary Bio's BCMA CAR-T listing application received FDA priority review
Legendary Bio's BCMA CAR-T listing application received FDA priority reviewOn May 27, GenScript issued an announcement that its non-wholly-owned subsidiary Legendary Bio-Targeting BCMA's CAR-T therapy Cidacchi Oronza's biologics license application has been granted priority review by the FDA for the treatment of relapse and / Or patients with refractory multiple myeloma.
Innovative treatment for uterine fibroids received FDA approval today
Innovative treatment for uterine fibroids received FDA approval todayToday, Myovant Sciences and Pfizer announced that the US FDA has approved the listing of Myfembree.
GlaxoSmithKline/Vir neutralizing antibody sotrovimab was granted emergency use authorization by the U.
GlaxoSmithKline/Vir neutralizing antibody sotrovimab was granted emergency use authorization by the U.
Bayer's "unrestricted cancer type" therapy market application plans to be included in priority review
Bayer's "unrestricted cancer type" therapy market application plans to be included in priority review
On May 26, the CDE official website revealed that Bayer's application for the launch of larotrectinib capsules and oral liquids was planned to be included in the priority review and started to be publicized.
This therapy is used to treat adult and child patients with solid tumors carrying neurotrophic tyrosine receptor kinase fusion genes.
(Medical Rubik's Cube Info)
Yingli Pharmaceutical's PI3Kδ inhibitor listing application plans to be included in priority review
Yingli Pharmaceutical's PI3Kδ inhibitor listing application plans to be included in priority review
On May 27, the Drug Evaluation Center of the State Food and Drug Administration announced that Yingli Pharmaceutical's new drug listing application for the new generation of PI3Kδ inhibitor Linpris tablets has been included in the proposed priority review list.
The drug is suitable for the treatment of patients with relapsed or refractory follicular lymphoma who have previously received second-line or above systemic treatment.
(CDE official website)
Biopharmaceuticals Ivabradine Hydrochloride Tablets Approved for Marketing
Biopharmaceuticals Ivabradine Hydrochloride Tablets Approved for Marketing
On May 25, CDE data showed that the ivabradine hydrochloride tablets declared by Beijing Baiao Pharmaceutical Co.
, Ltd.
under the new 4 types of regulations have been approved for marketing and deemed to have been reviewed.
It is understood that the drug is mainly used to treat heart failure.
(Cyber Blue)
Qilu imatinib mesylate tablets will be approved soon
Qilu imatinib mesylate tablets will be approved soon
Recently, Qilu Pharmaceutical has entered the administrative examination and approval stage with imatinib mesylate tablets for imitation of category 4 applications.
It is understood that imatinib mesylate is a Bcr-Abl tyrosine kinase inhibitor developed by Novartis.
(Minenet)
Decitabine for injection passed the consistency evaluation of generic drugs
Decitabine for injection passed the consistency evaluation of generic drugs
On May 27, Osaikang issued an announcement stating that its subsidiary had recently received the "Approval Notice for Supplementary Drug Application" for decitabine for injection approved and issued by the State Food and Drug Administration, and approved the drug to pass the generic drug quality and efficacy consistency evaluation .
It is understood that the drug is mainly used to treat myelodysplastic syndrome.
(Osaikang announcement)
Jinfang Pharmaceutical KRAS G12C Inhibitor Application for Clinical Application
Jinfang Pharmaceutical KRAS G12C Inhibitor Application for Clinical Application
On May 26, according to the official website of CDE Jinfang Pharmaceutical, the clinical trial application of GFH925, a new class 1 drug, was accepted.
It is reported that the target of GFH925 is KRAS G12C, which is intended to be developed for the treatment of solid tumors such as NSCLC.
(CPhl Pharmaceutical Online)
