"Pharmaceutical Speed ​​Reading Service" FDA approves Alzheimer's disease drug Aduhelm A...

[June 8, 2021/Medical Information List] Shanghai Sunshine Pharmaceutical Purchasing Network released supplementary documents related to national centralized procurement; Dingdang Kuaiyao completed US$220 million financing; the United States approved the first Alzheimer's drug in nearly 20 years; Bluebird is about to Resuming the Zynteglo gene therapy trial.

[June 8, 2021/List of medical information] Daily news about fresh medicines, speed reading and your attention!

Part1 Policy Brief

Part1 policy briefing Part1 policy briefing

Guangxi version of the medical insurance balance retention policy introduced

Guangxi version of the medical insurance balance retention policy introduced

Recently, the Guangxi Autonomous Region Medical Insurance Bureau and the Autonomous Region’s Department of Finance issued the "Implementation Opinions on the Retention of Chinese Medical Insurance Funds for the Centralized Purchase of Drugs by the State and Autonomous Region

Shanghai Sunshine Pharmaceutical Procurement Network releases supplementary documents related to national centralized procurement

Shanghai Sunshine Pharmaceutical Procurement Network releases supplementary documents related to national centralized procurement

On June 7th, Shanghai Sunshine Pharmaceutical Purchasing Network issued the "Supplementary Documents for the National Centralized Procurement of Medicines in Shanghai (GY-YD2021-2)", which dealt with enterprise declaration, drug distribution, quality inspection, tripartite agreement, payment for goods, and use of selected drugs in Shanghai.

Guangzhou accounting investigation found 40 people positive!

Guangzhou accounting investigation found 40 people positive!

On June 8, Guangzhou held a press conference on epidemic prevention and control.

Part2 Observation

Part2 Sankei Observation Part2 Sankei Observation

Liu Guochang, independent director of Boji Pharmaceuticals, resigns after his term of office expires

Liu Guochang, independent director of Boji Pharmaceuticals, resigns after his term of office expires

On June 8, Boji Pharmaceutical issued an announcement stating that it had recently received a resignation report from the company’s independent director, Mr.

Qian Wei appointed as Chief Commercial Officer of Junshi Bio

Qian Wei appointed as Chief Commercial Officer of Junshi Bio

Some media said that they received news about Junshi Biology recently.

Wang Weitao appointed as General Manager of West Pharmaceutical Packaging China

Wang Weitao appointed as General Manager of West Pharmaceutical Packaging China

On the 7th, West Pharmaceutical Packaging announced the appointment of Wang Weitao as its general manager in China

AstraZeneca's organizational structure adjustment

AstraZeneca's organizational structure adjustment

On the 7th, according to relevant media, AstraZeneca China announced the adjustment of its organizational structure, formally merged the existing digestion and respiratory nebulization business, established the digestion and respiratory nebulization business department, and appointed Chen Pengquan as the general manager, under the jurisdiction of marketing, sales, and new Product planning and strategic marketing team

Dingdang Kuaiyao completes US$220 million financing

Dingdang Kuaiyao completes US$220 million financing

On June 8, "Dingdang Kuaiyao" completed a new round of financing, the amount of this round of financing was 220 million US dollars, about 1.

Qi Carbon Technology Completes Over 400 Million RMB in Series B Financing

Qi Carbon Technology Completes Over 400 Million RMB in Series B Financing

On June 8, Qi Carbon Technology officially announced the completion of a series B financing of more than 400 million yuan, which was jointly led by Hillhouse Ventures and CDH VGC.

Jiain Biotech announces the completion of tens of millions of dollars in B++ round of financing

Jiain Biotech announces the completion of tens of millions of dollars in B++ round of financing

Jiain Biotech recently announced the successful completion of tens of millions of US dollars in B++ round of financing.

Olin Biotech officially listed on the Science and Technology Innovation Board

Olin Biotech officially listed on the Science and Technology Innovation Board

This morning, Olin Biologics was officially listed on the Science and Technology Innovation Board of the Shanghai Stock Exchange

Extremely Head of the announced introduction of iTEAR®100 Greater China, Korea and other countries exclusive interests

Extremely Head of the announced introduction of iTEAR®100 Greater China, Korea and other countries exclusive interests

On June 8th, Jimu Biotech and Olympic Ophthalmics jointly announced the signing of an exclusive license agreement.

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Changchun Hi-tech and its subsidiary company receive 840 million yuan exclusive authorization from Sion Biotech's new crown vaccine

Changchun Hi-tech and its subsidiary company receive 840 million yuan exclusive authorization from Sion Biotech's new crown vaccine

On June 7, Changchun High-tech announced that the company and its subsidiary Beike Biosciences intends to sign the exclusive license rights in the license area for the acquisition of new coronavirus vaccines and vaccine-related technologies developed against new coronavirus mutants.

Part3 Medicine News

Part3 Medicine News Part3 Medicine News

Sansheng Guojian: Recombinant anti-VEGF humanized monoclonal antibody pmCNV project completed Phase II clinical trial and the first subject was enrolled

Sansheng Guojian: Recombinant anti-VEGF humanized monoclonal antibody pmCNV project completed Phase II clinical trial and the first subject was enrolled

On June 8, Sansheng Guojian announced that the company’s self-developed recombinant anti-VEGF humanized monoclonal antibody is currently undergoing “an evaluation of 601A in patients with visual impairment caused by choroidal neovascularization secondary to pathological myopia A multi-center, randomized, double-blind, positive-drug-controlled phase II clinical trial on the safety and efficacy of "

Positive early clinical results of "ready-to-use" NK cell therapy

Positive early clinical results of "ready-to-use" NK cell therapy

Recently, Fate Therapeutics announced at the annual meeting of the American Society of Clinical Oncology in 2021 that it has announced its active phase 1 clinical trial data for the natural killer cell therapy FT516, combined with rituximab, to treat patients with relapsed/refractory B-cell lymphoma

Novartis announces overall survival data for MET inhibitors

Novartis announces overall survival data for MET inhibitors

Recently, at the American Society of Clinical Oncology in 2021, Novartis announced the latest phase 2 clinical trial data of the oral highly selective small molecule MET inhibitor Tabrecta in the treatment of adult patients with metastatic non-small cell lung cancer
.
These patients carry genetic mutations that cause the skipping of exon 14 of the MET gene
.
The results of the test showed that the median overall survival of the newly treated patients and the treated patients were 20.
8 months and 13.
6 months, respectively
.
In addition, the total remission rates of newly-treated patients and treated patients were 67.
9% and 40.
6%, respectively
.
(WuXi AppTec)

The United States approves the first Alzheimer's disease drug in the past 20 years at an annual cost of 56,000 US dollars

The United States approves the first Alzheimer's disease drug in the past 20 years at an annual cost of 56,000 US dollars

On June 7, local time, the US Food and Drug Administration issued a statement on its official website stating that the Aduhelm developed by the pharmaceutical company Bojian was approved to treat patients with Alzheimer’s disease.
This is the first time it has been approved for use in Alzheimer’s disease since 2003.
New treatments for disease
.
According to reports, the company and its Japanese partner Eisai Co.
, Ltd.
stated in an announcement that the annual treatment cost of Adunazumab is $56,000
.
(Sina Pharmaceutical News)

GlaxoSmithKline's PD-1 inhibitor Jemperli is approved by the UK

GlaxoSmithKline's PD-1 inhibitor Jemperli is approved by the UK

Recently, GlaxoSmithKline’s PD-1 inhibitor Jemperli received conditional approval from the Drugs and Health Products Administration of the United Kingdom for the treatment of relapsed or advanced endometrial cancer
.
It is reported that Jemperli is a PD-1 blocking antibody
.
(Sina Pharmaceutical News)

Hengrui's new indication for carrelizumab for injection will be approved soon

Hengrui's new indication for carrelizumab for injection will be approved soon

On June 7, the official website of the State Food and Drug Administration showed that Hengrui's application for the new indication of carrelizumab for injection has been "under approval" and it is expected to be approved by the NMPA in the near future
.
The indications to be approved this time are: combined cisplatin and gemcitabine for the first-line treatment of patients with locally recurring or metastatic nasopharyngeal carcinoma
.
(CDE official website)

New indications for AstraZeneca olaparib tablets are about to be approved

New indications for AstraZeneca olaparib tablets are about to be approved

On June 7, the official website of the State Food and Drug Administration showed that the new indications for AstraZeneca Olapali tablets were already in the "under review" stage and will be approved by the NMPA in the near future
.
This upcoming indication may be monotherapy for adult patients with metastatic castration-resistant prostate cancer who carry BRCA1/2 mutations (germline and/or somatic cell lines) and have progressed after previous treatment with new hormone drugs.

.
(CDE official website)

New indications for BeiGene Zebutinib Capsules are about to be approved

New indications for BeiGene Zebutinib Capsules are about to be approved

On June 7, the official website of the State Food and Drug Administration showed that the new adaptation of BeiGene Zebutinib Capsules was in the "under review" stage and will be approved by the NMPA in the near future
.
For the treatment of adult patients with Waldenstrom's macroglobulinemia, this will be the third indication for the product to be approved
.
(CDE official website)

Hutchison Whampoa Sofantinib's new indication will be approved soon

Hutchison Whampoa Sofantinib's new indication will be approved soon

On June 7th, Hutchison Whampoa Sofantinib's new indication for the market entered the approval stage and is expected to be approved in the near future
.
According to Hutchison Whampoa’s announcement, the indication is advanced pancreatic neuroendocrine tumor
.
(Sina Pharmaceutical News)

Rongchang Bio-Injection Vedicutumab will be approved soon

Rongchang Bio-Injection Vedicutumab will be approved soon

On June 7th, according to public information, Rongchang Bio's independent research and development of the ADC new drug for injection vedicitumumab listing application entered the approval stage, and will be approved in the near future
.
This will be the first domestically produced ADC
.
(Sina Pharmaceutical News)

BeiGene Baizean's new indications for listing application are accepted in China

BeiGene Baizean's new indications for listing application are accepted in China

BeiGene announced today that the NMPA Drug Evaluation Center has accepted its anti-PD-1 antibody drug Bezan for the treatment of previously treated, locally advanced unresectable or metastatic highly microsatellite unstable or mismatch repair defective entities Application for new indications for tumor patients
.
(PR Newswire)

Kanghong Pharmaceutical's Aripiprazole Oral Solution Approved New Indication for Adolescent Schizophrenia

Kanghong Pharmaceutical's Aripiprazole Oral Solution Approved New Indication for Adolescent Schizophrenia

On June 8th, Kanghong Pharmaceutical issued an announcement stating that the company received the "Drug Supplementary Application Approval Notice" from the State Food and Drug Administration regarding its aripiprazole oral solution, and was approved to "agree to extend the indication population to 13-17 years old.
" adolescent patients with schizophrenia, agreed to add 3ml sampler "on the basis of the original cup
.
(Announcement from Kanghong Pharmaceutical)

Huadong Medicine Metformin and Enpagliflozin Tablets (I) obtained the drug registration certificate

Huadong Medicine Metformin and Enpagliflozin Tablets (I) obtained the drug registration certificate

On the 8th, Huadong Pharmaceutical announced that its wholly-owned subsidiary, Sino-US Huadong, received the approval of the State Food and Drug Administration to issue the "Drug Registration Certificate" concerning metformin and enpagliflozin tablets (I)
.
It is understood that metformin is a biguanide oral hypoglycemic drug
.
(Huadong Medicine Announcement)

Fuwo Pharmaceutical's fourth-generation EGFR small molecule targeted drug was approved for clinical use in China

Fuwo Pharmaceutical's fourth-generation EGFR small molecule targeted drug was approved for clinical use in China

According to the latest announcement from the Drug Evaluation Center of the National Food and Drug Administration of China, the fourth-generation EGFR small molecule targeted drug FWD1509 independently developed by Fuwo Pharmaceutical has been approved for clinical use in China, and its indication is advanced non-small cell lung cancer
.
(CDE official website)

Sihuan Medicine Degu Aspart Double Insulin Injection was approved for clinical use

Sihuan Medicine Degu Aspart Double Insulin Injection was approved for clinical use

On June 7, the official website of CDE showed that the diabetes drug Degu aspartic insulin injection developed by a subsidiary of Sihuan Pharmaceutical was approved for clinical use, making it the first biosimilar drug approved for clinical use in China
.
(CDE official website)

Bluebird is about to resume Zynteglo gene therapy trials

Bluebird is about to resume Zynteglo gene therapy trials

On Monday, Bluebird said that the FDA has cancelled the clinical shelving of two phase 3 studies of its gene therapy Zynteglo in transfusion-dependent β-thalassemia
.
And recently stated that it will resume Zynteglo clinical trials
.
(Sina Pharmaceutical News)