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The CD39 monoclonal antibody of Kewang Pharma is approved for clinical use in China
Time of Update: 2022-03-09
By blocking the ATPase activity of the CD39 protein, ES002 can inhibit the production of adenosine while maintaining the level of extracellular ATP with pro-inflammatory effects, thereby creating an immune microenvironment conducive to anti-tumor .
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FDA Accepts Samsung Bioepis Humira Biosimilar sBLA Application
Time of Update: 2022-03-09
S. Food and Drug Administration (FDA) has accepted for review a supplemental Biologics License Application (sBLA) for the high-dose 100 mg/mL formulation of Humira biosimilar SB5 (adalimumab-bwwd).
Reference source: FDA Accepts Samsung Bioepis' and Organon's sBLA for their Citrate-Free, High-Concentration HUMIRA® (Adalimumab) Biosimilar Candidate
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Keji Pharmaceutical's product CT041 was awarded "Advanced Therapy for Regenerative Medicine" by the FDA
Time of Update: 2022-03-09
CT041 is a potential first-of-its-kind CAR-T candidate product independently developed by Keji Pharmaceutical, which is mainly used for the treatment of gastric cancer/esophagogastric junction adenocarcinoma and pancreatic cancer .
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Huahai Pharmaceutical's Metoprolol Succinate Sustained-Release Tablets and Silodosin Capsules were approved by the US FDA
Time of Update: 2022-03-09
On January 6, Huahai Pharmaceutical issued an announcement saying that the abbreviated new drug application for metoprolol succinate sustained-release tablets and silodosin capsules submitted by the company to the US FDA has been approved .
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AstraZeneca abandoned the new crown vaccine for beta variants and has entered clinical phase 2/3!
Time of Update: 2022-03-08
CompilationAspirinAstraZeneca's Covid-19 vaccine for the beta variant entered Phase 2/3 of clinical trials last year .
Given the small genetic differences between the beta variant and the original SARS-CoV-2 virus, AstraZeneca responded by tweaking its first-generation Vaxzevria vaccine .
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More than 50 pharmaceutical companies disclosed 2021 performance forecasts, and 7 companies expected to double their net profit
Time of Update: 2022-03-08
Among them, 7 companies are expected to double their net profit, namely Harbin Sanlian, Palin Bio, Northeast Pharmaceutical, Xinhua Medical, Tasly, Haili Bio, and Jiudian Pharmaceutical .
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The latest notice from the National Health Commission affects a large number of pharmaceutical companies
Time of Update: 2022-03-08
Promoting the high-quality development indicators of public hospitals requires controlling the scale of general outpatient clinics in tertiary hospitals, increasing the number of inpatients in the county, and achieving a reasonable level of diagnosis and treatment in primary medical institutions .
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Huadong Medicine and AKSO reached a strategic cooperation to introduce a dual-target fusion protein innovative drug
Time of Update: 2022-03-08
According to the cooperation agreement, Huadong Medicine will be responsible for the clinical development, registration and commercialization of AB002 in the Asia-Pacific region (excluding Japan), and will jointly guide the clinical trial application work with AKSO through the Joint Research Committee .
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In 2022, the prosperity of the pharmaceutical and health industry is expected to continue to rise
Time of Update: 2022-03-08
The data shows that from January to November 2021, the growth rate of operating income and total profit of the medical and health industry has achieved substantial growth, of which the operating income has reached 2,609.
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2022 Guangzhou International Post-press Packaging Equipment Exhibition
Time of Update: 2022-03-08
"2022 Guangzhou International Post-press Processing and Packaging Technology and Equipment Exhibition" will be held in Guangzhou Poly World Trade Exhibition Hall in August 2022 .
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Haichen Pharmaceutical's Tigecycline for Injection passed the consistency evaluation of generic drugs
Time of Update: 2022-03-08
Haichen Pharmaceuticals Tigecycline for Injection (trade name: Zekang) was approved for marketing in May 2013, and passed the consistency evaluation of quality and efficacy in February 2022 .
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Astellas-targeted Claudin18.2 antibody approved for clinical treatment of pancreatic cancer in China
Time of Update: 2022-03-08
On February 10, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of the People's Republic of China announced that the zolbetuximab for injection declared by Astellas has obtained an implied license for a clinical trial in China, and the indication is metastatic pancreas.
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Corning Jereh PD-L1/OX40 double antibody and other clinical approvals
Time of Update: 2022-03-08
On February 9, the official website of the Center for Drug Evaluation (CDE) of the State Food and Drug Administration of the People's Republic of China announced that Corning & Jereh has two Class 1 new drugs that have obtained an implied license for clinical trials .
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Rivus dinitrophenol prodrug HU6 phase II clinical success
Time of Update: 2022-03-08
The best mechanism for designing controllable-release DNP prodrugs is temperature-dependent activation, but because the human body temperature is small, switchable chemical reactions within such a small window do not appear to be reported .
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Jincheng Pharma's wholly-owned subsidiary Adenosylmethionine butanedisulfonate passed CDE approval
Time of Update: 2022-03-08
Adenosylmethionine is a physiologically active molecule that exists in all tissues and body fluids of the human body.
It is mainly suitable for intrahepatic cholestasis during pregnancy; it is suitable for intrahepatic cholestasis before and caused by liver cirrhosis .
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The State Food and Drug Administration held a meeting to release three major signals for the medical device industry
Time of Update: 2022-03-08
Accelerate the review and approval of innovative products, promote the transformation and application of scientific and technological achievements, implement major national strategies, and support the development of industries in key regions .
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2022 Guangzhou Daily Chemical Machinery and Packaging Machinery Exhibition
Time of Update: 2022-03-08
At present, Guangzhou International Daily Chemical Production Machinery and Packaging Machinery Exhibition, with the strong support of many exhibitors and related media, has developed into a domestic packaging machinery and processing enterprise to promote new technologies and equipment, contact advanced technologies at home and abroad, and appreciate the latest development of the industry Trend's go-to show .
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CDE publishes "Technical Guidelines for Clinical Pharmacology Research of Biosimilars"
Time of Update: 2022-03-08
Clinical pharmacology research is an important part of the comparison study of biosimilars, and it is very important to support the similarity evaluation of the efficacy and safety of biosimilars and reference drugs .
Attachment: Technical Guidelines for Clinical Pharmacology Research of Biosimilars.
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Personnel changes!
Time of Update: 2022-03-08
In recent years, under the influence of policies such as the epidemic, the approaching patent cliff of core products, and the procurement of large quantities, multinational pharmaceutical companies have faced relatively great pressure on their performance, structural adjustments, and frequent personnel changes.
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The first domestic PD-1 will "pass the court" FDA!
Time of Update: 2022-03-08
As well as the recent issue of approval by clinical data from a single country or region, E17 also mentioned that rationally designed and implemented MRCT trials according to this guiding principle can accelerate the global marketing process of new drugs and support the marketing requirements of different regions .
