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Notice on the public solicitation of opinions on two standards including "Principles for Printing of Drug Traceability Codes (Draft for Solicitation of Comments)"
Time of Update: 2021-11-14
Please fill in the standard feedback form for soliciting opinions (see Annex 3), and feedback to the Information Center of the State Food and Drug Administration in the form of e-mail before July 20, 2021 .
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CDE publicly solicits ICH E14, Q&A and Q3C (R8) guidelines for implementation suggestions
Time of Update: 2021-11-14
On November 2, the CDE official website issued an announcement stating that in order to do a good job in the implementation of the ICH guidelines, the center drafted the ICH "E14 and Questions and Answers: Non-antiarrhythmic drugs cause QT/QTc interval prolongation and potential arrhythmic effects.
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WOO SWEE LIAN, Chairman of Wise Medicine, resigns and by-elections Fan Shixin as non-independent director
Time of Update: 2021-11-14
On November 2, Ruizhi Medicine issued an announcement stating that the company’s board of directors had recently received a written resignation report from the company’s chairman, Mr.
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Announcement of the State Drug Administration on 18 batches of drugs that do not meet the requirements (No. 59 of 2021)
Time of Update: 2021-11-14
After inspection by Hubei Provincial Institute of Drug Supervision and Inspection, a batch of Atractylodes japonicus (fried atractylodes with bran) produced by Anhui Wukeng Chinese Medicine Decoction Pieces Co.
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A number of blockbuster new drugs have been approved for clinical use, and the R&D capabilities of local pharmaceutical companies have greatly improved
Time of Update: 2021-11-14
As of October 29, 2021, data from the Center for Drug Evaluation (CDE) of the China National Medical Products Administration show that a total of 5670 clinical trial applications have passed "implicit permission .
According to data, in 2020, the Center for Drug Evaluation has approved 1,435 IND (New Drug Clinical Trial) applications, an increase of 54.
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The first domestic product! Connoa's MASP-2 monoclonal antibody was approved for clinical use
Time of Update: 2021-11-14
CM338 is the first domestic innovative monoclonal antibody drug targeting MASP-2 and the second clinically approved MASP-2 inhibitor in the world .
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AstraZeneca sells two COPD drugs for $270 million
Time of Update: 2021-11-14
Eklira is a long-acting muscarinic antagonist (LAMA), which was approved for marketing in the European Union and the United States in 2012 .
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FDA approves multiple investigational new drug applications
Time of Update: 2021-11-14
” Theseus intends to initiate a phase I/II dose escalation and expansion clinical trial, which will include For patients with advanced GIST who have previously received treatment, the study is expected to start at the end of the fourth quarter of 2021 or the first quarter of 2022 .
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The competitive landscape of the innovative drug industry is facing reconstruction, and FIC drugs are more favored by capital
Time of Update: 2021-11-14
Also in September, Yinming Bio, which is committed to the research and development of first-in-class drugs with global competitiveness, announced the completion of nearly US$50 million in A+ round of financing .
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21 batches of medicines in Yunnan Province were found to be unqualified, and Chinese herbal medicines accounted for the majority
Time of Update: 2021-11-14
Subsequently, in May of the same year, the State Food and Drug Administration held a video and telephone conference, requesting drug regulatory authorities at all levels to implement territorial regulatory responsibilities in accordance with the "four strictest" requirements, carefully inspect the production and operation units of traditional Chinese medicine decoction pieces and preparations, and resolutely investigate and punish violations of the law.
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To accelerate innovation and upgrading, pharmaceutical companies are constantly introducing new drugs
Time of Update: 2021-11-14
In this context, the industry believes that in the future, more and more pharmaceutical companies will frequently introduce new drugs, enrich their product pipelines through the license in (authorized introduction) model, and enhance their innovation capabilities.
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Announcement of the State Drug Administration on 16 batches of drugs that do not meet the requirements (No. 36 of 2021)
Time of Update: 2021-11-14
After inspection by 8 drug inspection institutions including Anhui Food and Drug Inspection and Research Institute, 16 batches of drugs including compound clotrimazole cream produced by 14 companies including Hebei Jiuzheng Pharmaceutical Co.
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Yantai: This is how the blueprint of the biomedical industry will be described!
Time of Update: 2021-11-14
In accordance with the layout principle of “coordinated linkage, intensive clustering, and characteristic development”, Yantai City will build a “1+3+X” biomedical industry spatial layout, namely, to create a life science innovation leading core area in the east, a high-end medical equipment cluster development area in the west, and a central area.
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10 pharmaceutical companies are favored by capital, accelerating the development of innovative drugs
Time of Update: 2021-11-14
On November 1st, Anjisheng Bio, which focuses on the research and development of innovative drugs for bone, joint and muscle diseases, announced the completion of the B round of US$70 million in financing .
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Announcement of the State Drug Administration on Protected Varieties of Traditional Chinese Medicines (Extended Protection Period No. 7) (No. 73 of 2021)
Time of Update: 2021-11-14
According to Article 16 of the Regulations on the Protection of Traditional Chinese Medicines and related regulations, after review by the members organized by the National Traditional Chinese Medici
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Digital technology + pharmaceutical equipment, or open up a broader market space
Time of Update: 2021-11-14
The industry pointed out that digital technology + pharmaceutical equipment will help companies open up a broader market space .
As more and more pharmaceutical machinery companies gradually transform and upgrade from traditional single equipment suppliers to system integrators and solution providers, they will bring more benefits to customers and create greater value .
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The 31-year-old pharmaceutical company changes ownership!
Time of Update: 2021-11-14
On November 2, Asia-Pacific Pharmaceuticals issued the "Announcement on the Progress of the Judicial Auction of Some Shares of the Controlling Shareholders and Those Acting in Concert".
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Traditional Chinese medicine is ushering in a broad space for development, and the status of decocting machine is becoming more and more prominent
Time of Update: 2021-11-14
Therefore, in terms of automation and information technology improvement of the decocting machine, the industry still needs to make continuous efforts to better contribute to the sustainable development of traditional Chinese medicine .
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Industry: In the fourth quarter, the performance of the pharmaceutical high-prosperity sector is expected to grow rapidly
Time of Update: 2021-11-14
Looking forward to the fourth quarter, the industry believes that the performance of the pharmaceutical high-prosperity sector is expected to grow rapidly, including CXO, medical devices, vaccines, medical services and APIs .
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Chinese pharmaceutical companies continue to make efforts in the field of anti-epileptic drugs
Time of Update: 2021-11-14
As recently, CSPC's anti-epileptic drug Enrivi (lacosamide tablets) was launched nationwide .
. In addition, in June, the State Food and Drug Administration issued a new drug approval document, and Renfu Pharmaceutical's carbamazepine tablets had been evaluated for consistency .
