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[June 4, 2021 / List of medical information] Important notice for licensed pharmacist candidates is here; Huizhi Pharmaceuticals Greater China Chairman Miao Tianxiang retires; BeiGene PD-1 new indications listing application accepted.
[June 4, 2021/Medical Information List] Daily news of fresh medicines and medical news, speed reading and follow you together!
Part1 Policy Brief
Part1 policy briefing Part1 policy briefingEight departments including the National Medical Insurance Bureau issued guidance on the implementation of the state-organized centralized procurement and use of high-value medical consumables
Eight departments including the National Medical Insurance Bureau issued guidance on the implementation of the state-organized centralized procurement and use of high-value medical consumablesEight departments, including the National Medical Insurance Bureau, the National Development and Reform Commission, and the Ministry of Industry and Information Technology, issued guidance on the implementation of centralized procurement and use of high-value medical consumables organized by the state
Office of the State Council: Strengthen the construction of clinical specialties and increase support for Chinese medicine hospitals
Office of the State Council: Strengthen the construction of clinical specialties and increase support for Chinese medicine hospitalsOn June 4, the General Office of the State Council issued its opinions on promoting the high-quality development of public hospitals
Important notice for licensed pharmacist candidates is here
Important notice for licensed pharmacist candidates is hereA few days ago, the official website of the China Personnel Examinations website clarified the relevant requirements for the 2021 vocational qualification examination for licensed pharmacists, involving subject introduction, registration methods, registration conditions, scores and certificate management
Many large hospitals in Guangdong need to close due to epidemic prevention and control
Many large hospitals in Guangdong need to close due to epidemic prevention and controlRecently, many hospitals have issued notices of suspension or adjustment, including Foshan Chancheng People’s Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University, Brain Hospital Affiliated to Guangzhou Medical University, People’s Hospital of Yingde City, Guangdong Province Hospital, the Fourth People’s Hospital of Nanhai District, Foshan City, the Eighth People’s Hospital of Nanhai District, Foshan City, the Seventh People’s Hospital of Nanhai District, Foshan City, Guicheng Hospital, Nanhai District, Foshan City, and the Eighth Hospital Affiliated to Guangzhou Medical University.
Part2 Observation
Part2 Sankei Observation Part2 Sankei ObservationHuizhi Pharmaceutical Greater China Chairman Miao Tianxiang retires
Huizhi Pharmaceutical Greater China Chairman Miao Tianxiang retiresAccording to industry information, Miao Tianxiang, chairman of Huizhi Pharmaceutical Greater China, retired
Chen Jiafu, deputy general manager of Tongrentang, resigns
Chen Jiafu, deputy general manager of Tongrentang, resignsOn the evening of June 3, Tongrentang issued an announcement stating that the board of directors of Beijing Tongrentang Co.
Bayer acquires Noria and PSMA Therapeutics
Bayer acquires Noria and PSMA TherapeuticsBayer announced on June 3, 2021 that it has reached an acquisition agreement between Noria Therapeutics and PSMA Therapeutics
Former Celgene shareholders sued BMS for breach of $6.
Former Celgene shareholders sued BMS for breach of $6.
Eli Lilly sells major products in the field of men's health
Eli Lilly sells major products in the field of men's healthAccording to relevant media reports, not long ago, Eli Lilly issued an internal email notification that the company had signed an agreement with Menarini, an Italian pharmaceutical company, to sell Cialix’s rights in the Chinese mainland market
Mingde Biotech's application for non-public issuance of shares was approved by the China Securities Regulatory Commission
Mingde Biotech's application for non-public issuance of shares was approved by the China Securities Regulatory CommissionOn June 4, Mingde Biotech announced that it had recently received the "Approval for the Approval of the Non-public Issuance of Wuhan Mingde Biotechnology Co.
Beike Biological IPO plans to publicly issue 41,284,070 shares
Beike Biological IPO plans to publicly issue 41,284,070 sharesBeike Biotech issued an announcement that it plans to IPO and list on the Science and Technology Innovation Board.
Simcere Diagnostics completed nearly 600 million yuan in Series B financing
Simcere Diagnostics completed nearly 600 million yuan in Series B financingRecently, Simcere Diagnostics announced the completion of a Series B financing of nearly 600 million yuan
Stablix receives Series A financing
Stablix receives Series A financingToday, Stablix announced that it has received $63 million in Series A financing
Econo received tens of millions of yuan in A3 round of financing
Econo received tens of millions of yuan in A3 round of financingRecently, Jiaxing Econo Biotech announced the completion of tens of millions of yuan in A3 round of financing, led by China Merchants Health, and Haoyue Capital as the exclusive financial advisor
Part3 Medicine News
Part3 Medicine News Part3 Medicine NewsAstraZeneca/Mersk Announces Olapali Phase 3 Clinical Results
AstraZeneca/Mersk Announces Olapali Phase 3 Clinical Results
Today, AstraZeneca and Merck jointly announced that the PARP inhibitor olaparib, jointly developed by the two parties, has obtained positive results in a phase 3 clinical trial for the treatment of high-risk HER2-negative early breast cancer carrying germline BRCA mutations
.
Olapali reduces the risk of disease recurrence, new tumor or death by 42%
.
(WuXi AppTec)
Merck's blockbuster PD-1 inhibitor Phase 3 results announced
Merck's blockbuster PD-1 inhibitor Phase 3 results announced
On the 4th, Merck announced that its blockbuster PD-1 inhibitor Keytruda, as an adjuvant therapy, has achieved positive results in the phase 3 clinical trial KEYNOTE-564 for the treatment of patients with early renal cell carcinoma
.
At a median follow-up time of 24.
1 months, Keytruda reduced the risk of recurrence or death by 32% in patients with renal cell carcinoma who had undergone total nephrectomy or renal and metastatic lesions compared with placebo
.
(WuXi AppTec)
Novartis radioligand therapy Endocyte Phase 3 clinical trial results are positive
Novartis radioligand therapy Endocyte Phase 3 clinical trial results are positive
Recently, Novartis announced the complete data of the Phase 3 VISION study of 177Lu-PSMA-617, a key drug candidate previously acquired for the treatment of prostate cancer
.
The data results show that, compared with SOC alone treatment, 177Lu-PSMA-617 combined with SOC treatment significantly prolonged overall survival and reduced the risk of death by 38%
.
(Sina Pharmaceutical News)
Hengrui pirotinib maleate tablets combined treatment of breast cancer phase III clinical trial reached the primary endpoint
Hengrui pirotinib maleate tablets combined treatment of breast cancer phase III clinical trial reached the primary endpoint
On June 4th, Hengrui Medicine released the latest clinical trial progress.
Its research and development of pirotinib maleate tablets combined with trastuzumab plus docetaxel for the preoperative treatment of early or locally advanced HER2-positive breast cancer randomized , Double-blind, parallel-controlled, multi-center phase III clinical study, the main research endpoint-total pathological complete remission reached the pre-specified superiority standard
.
The results of the study show that for early or locally advanced HER2-positive breast cancer, neoadjuvant therapy combined with pirotinib on the basis of docetaxel and trastuzumab can significantly increase the tpCR rate of patients
.
(Announcement of Hengrui Medicine)
FDA approves Brexafemme, the first new class of antifungal drug, Hausen owns Chinese rights
FDA approves Brexafemme, the first new class of antifungal drug, Hausen owns Chinese rights
Recently, Synexis, a partner of Hausen Pharmaceuticals, announced that the US Food and Drug Administration has approved a new broad-spectrum antifungal drug Brexafemme, which is an oral drug for the treatment of female patients with vulvovaginal candidiasis
.
It is reported that on February 1 of this year, Hausen Pharmaceuticals and Scinexis signed a strategic cooperation agreement to obtain the exclusive rights and interests of ibrexafungerp in the development and commercialization of ibrexafungerp in Greater China (including Hong Kong, Macau and Taiwan)
.
(Sina Pharmaceutical News)
FDA approves the first auxiliary diagnostic device for autism
FDA approves the first auxiliary diagnostic device for autism
On June 2, Cognoa announced that the U.
S.
FDA has approved the company’s request for the classification of Canvas Dx, a diagnostic aid for autism
.
It is reported that this is the first FDA-approved auxiliary diagnostic device for autism, which aims to diagnose children aged 18 months to 5 years who exhibit underlying symptoms of autism
.
(Medicine Cube)
Puri Pharmaceuticals Pantoprazole Sodium for Injection Receives Health Canada Approval
Puri Pharmaceuticals Pantoprazole Sodium for Injection Receives Health Canada Approval
On June 3, Prism Pharmaceuticals issued an announcement stating that it had recently received a notice of approval of Pantoprazole Sodium for Injection issued by Health Canada
.
Pantoprazole Sodium for Injection is a selective long-acting proton pump inhibitor
.
(Puli Pharmaceutical Announcement)
Roche's oral spinal muscular atrophy drug Evrysdi rejected by NICE
Roche's oral spinal muscular atrophy drug Evrysdi rejected by NICE
On June 3, according to foreign media reports, Roche’s oral spinal muscular atrophy drug Evrysdi was too expensive to be recognized by the UK drug price regulator
.
The British Drug Cost and Efficacy Management Department issued a draft guideline that does not recommend the use of Roche's risdiplam for patients with type 1, 2 and 3 SMA
.
(Sina Pharmaceutical News)
AstraZeneca rosuvastatin approved for new indication in China
AstraZeneca rosuvastatin approved for new indication in China
On June 4th, AstraZeneca China announced that its classic cardiovascular drug could be formally approved in China for new indications: while lipid-lowering treatment, it can delay the progression of atherosclerosis in adult patients
.
(Immediately smell the medicine)
BeiGene's PD-1 New Indication Listing Application Accepted
BeiGene's PD-1 New Indication Listing Application Accepted
On June 4, the official website of CDE showed that BeiGene's PD-1 tislelizumab submitted a listing application for a new indication and was accepted
.
According to the previous disclosure of Baiji's financial report, it is speculated that the indication for the listing application may be MSI-H/dMMR solid tumor
.
(CDE official website)
Simcere Pharmaceutical's "Idoxaban Toluenesulfonate Tablets" Declared for Listing
Simcere Pharmaceutical's "Idoxaban Toluenesulfonate Tablets" Declared for Listing
On June 2, Hainan Simcere Pharmaceutical's application for the listing of 4 types of generic drug idoxaban tosylate tablets was accepted for the treatment of stroke in patients with atrial fibrillation and the prevention of systemic embolism.
It was the first domestic product of this variety
.
(Insight database)
China Resources Shuanghe Parecoxib Sodium for Injection Obtained Drug Registration Certificate
China Resources Shuanghe Parecoxib Sodium for Injection Obtained Drug Registration Certificate
On the 4th, China Resources Double-Crane announced that it had received the "Drug Registration Certificate" for Parecoxib Sodium for Injection issued by the State Food and Drug Administration
.
This medicine is used for short-term treatment of pain after surgery
.
(Announcement from China Resources Double Crane)
Kanghong Pharmaceutical's Conbercept ophthalmic injection was approved for clinical use
Kanghong Pharmaceutical's Conbercept ophthalmic injection was approved for clinical use
On the 4th, Kanghong Pharmaceutical issued an announcement stating that its wholly-owned subsidiary had recently received the "Drug Clinical Trial Approval Notice" for Conbercept ophthalmic injection issued by the State Food and Drug Administration, and agreed to carry out clinical trials
.
It is reported that the product can bind to VEGF in blood vessels and tissues and block the signal transmission that promotes the sprouting and growth of new blood vessels mediated by VEGF
.
(Announcement from Kanghong Pharmaceutical)
China Resources Double Crane: the first domestic irbesartan dispersible tablet to pass the consistency evaluation
China Resources Double Crane: the first domestic irbesartan dispersible tablet to pass the consistency evaluation
On June 4, China Resources Double Crane announced that the first domestic dispersible tablet of Irbesartan passed the consistency evaluation
.
The drug is mainly used for the treatment of essential hypertension and type 2 diabetic nephropathy combined with hypertension
.
(Announcement from China Resources Double Crane)
Baiyunshan Medicine Cefixime Capsules Passed the Consistency Evaluation
Baiyunshan Medicine Cefixime Capsules Passed the Consistency Evaluation
On June 4, Baiyunshan Pharmaceutical announced that its branch company received the "Drug Supplementary Application Approval Notice" issued by the State Food and Drug Administration.
Cefixime capsules have passed the quality and efficacy consistency evaluation of generic drugs
.
Cefixime is a third-generation cephalosporin antibiotic.
This product is suitable for Streptococcus (except Enterococcus) that are sensitive to cefixime, pneumococcus, Neisseria gonorrhoeae, Branhamella catarrhalis, Escherichia coli, Cree.
The following bacterial infectious diseases caused by primordial bacteria, serratia, proteus and influenzae
.
(Announcement of Baiyun Mountain)
Junshi Biology JS007 injection was approved for clinical use
Junshi Biology JS007 injection was approved for clinical use
On the 4th, Junshi Biological issued an announcement stating that it had received the "Notice of Drug Clinical Trial Approval" approved and issued by the State Food and Drug Administration, and the clinical trial application for JS007 injection was approved
.
JS007 is a recombinant humanized anti-CTLA-4 monoclonal antibody injection independently developed by the company, which is mainly used for the treatment of advanced malignant tumors
.
(Junshi biological announcement)
Academician Chen Wei: Nebulized and inhaled new crown vaccine is applying for emergency use
Academician Chen Wei: Nebulized and inhaled new crown vaccine is applying for emergency use
On June 3, Chen Wei, an academician of the Chinese Academy of Engineering, said at a forum that the vaccine can be injected subcutaneously or inhaled through nasal spray.
The dose required for the latter is 1/5 of the former and can form mucosal immunity
.
"The nasal spray/inhalation new crown vaccine is applying for emergency use
.
" (Sina Pharmaceutical News)
Vietnam approves emergency use of Sinopharm's new crown pneumonia vaccine
Vietnam approves emergency use of Sinopharm's new crown pneumonia vaccine
On June 4, according to the Ministry of Health of Vietnam, the Ministry of Health of Vietnam approved the emergency use of Sinopharm's new crown pneumonia vaccine in Vietnam to meet the urgent needs of Vietnam's current new crown pneumonia epidemic prevention and control
.
(Associated Finance Press)