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Tasly Xiaoyao tablets were approved by the Dutch Drug Review Board
Time of Update: 2021-10-23
On September 8, Tasly issued an announcement stating that the company received a notice issued by the Dutch Drug Evaluation Committee regarding the approval of the company’s product Xiaoyao Tablets through drug registration (Traditional UseRegistration), which is used to relieve symptoms such as mental stress and fatigue.
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Okvision's new drug for the treatment of inflammation after cataract surgery was approved for Phase 3 clinical trials
Time of Update: 2021-10-23
Text|Pharmaceutical Mission HillsOn September 14, Ou Kangweishi issued an announcement stating that one of its main drug candidates, OT-502 (Dexycu), has been approved by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration to carry out the treatment of post-cataract inflammation in China.
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Drug Administration of Ningxia Hui Autonomous Region: Cancellation of the drug business licenses for the headquarters of two chain pharmacies
Time of Update: 2021-10-23
Drug Administration Notice, the two chain pharmacy headquarters will sell the certificateDrug Administration Notice, the two chain pharmacy headquarters will sell the certificateOn September 26, the Drug Administration of Ningxia Hui Autonomous Region issued the "Notice on the cancellation of the Pharmaceutical Business License of Guyuan Ruihetang Pharmaceutical Chain Sales Co.
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Beike Biotech and its parent company terminate the associated transaction of cooperation with Sionx's new crown virus vaccine license
Time of Update: 2021-10-23
In June 2021, Beike Biotech and its parent company, Changchun High-tech, intends to obtain the new coronavirus vaccine (PIV-5 vector) and the vaccine (PIV-5 vector) related technologies developed for the new coronavirus mutant strain in the license The exclusive licensing rights in the region and the exclusive production rights in other Asian regions and Oceania regions outside the licensed region have signed the "Licensing Cooperation Agreement .
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Commercialization of Innovative Drugs: A Hundred Flowers Blooming Through Different Paths to the Same Goal
Time of Update: 2021-10-23
On the other hand, from the perspective of channel construction, the way to break the situation is that the commercialization path of innovative drug companies cannot be "closed door"; instead, the "dual channel" of self-built channels and external cooperation should be adopted like the pre-development of products .
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Pyrazinamide tablets, a wholly-owned subsidiary of Baiyunshan, passed the consistency evaluation of generic drugs
Time of Update: 2021-10-23
Mingxing Pharmaceutical submitted a consistency evaluation application to the National Medical Products Administration on December 31, 2019, and was accepted on February 4, 2020 .
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Asia-Pacific Pharmaceuticals Cefmetazole Sodium for Injection Passed the Consistency Evaluation of Generic Drugs
Time of Update: 2021-10-23
It has a good antibacterial effect against Staphylococcus aureus, Escherichia coli, Pneumoniae Bacillus, Proteus mirabilis, and it is resistant to cephalosporins and penicillin-resistant Proteus vulgaris, Morganella morganii, Providence bacteria Genus also has strong antibacterial activity .
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Drug Administration: A batch of medical devices of Ruikang Pharmaceutical Equipment is being recalled
Time of Update: 2021-10-23
Details are as follows:Anhui Ruikang Pharmaceutical Co.
reported that the far-infrared anti-inflammatory analgesic patch with batch number 20200508 failed the random inspection .
Anhui Ruikang Pharmaceutical Co.
voluntarily recalled its batch number 20200508 far-infrared anti-inflammatory analgesic patch .
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Announcement of Phase I study of Hebo Pharma's new-generation anti-CTLA-4 antibody HBM4003
Time of Update: 2021-10-23
On September 13, Harmonicare announced that its self-developed product HBM4003 has achieved positive results in a phase I dose-climbing clinical trial for patients with advanced solid tumors in Australia .
The Phase I study is an open-label, multi-center study conducted in subjects with advanced solid tumors.
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Preventive treatment of migraine!
Time of Update: 2021-10-23
Text|Pharmaceutical Mission HillsOn September 6, Eli Lilly and Company China announced that the preventive treatment of migraine drug Emgality (galcanezumab) has achieved positive main results in a global multi-center phase 3 clinical study.
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Hengrui Medicine's opium poppy lipiodol injection obtained drug registration certificate
Time of Update: 2021-10-23
According to the "Pharmaceutical Administration Law of the People's Republic of China" and related regulations, after review, the poppy lipiodol injection meets the relevant requirements for drug registration, and the additional indications are approved.
The new indication is "for hysterosalpingography", and drugs are issued Registration certificate .
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175 million yuan Xinlitai introduced GLP-1/GCGR dual target agonist to join the new track of hypoglycemic
Time of Update: 2021-10-23
(3) If the product is sold in mainland China, if the annual net sales of the product reaches the agreed amount for the first time, the company will pay the sales milestone .
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51 more medicines entered the province and most of the purchases were injections
Time of Update: 2021-10-23
According to the notice, the clinical and pharmacy experts selected and determined 51 centralized purchases of drugs as follows :The Anhui Provincial Medical Insurance Bureau requires medical institutions to fill in the pre-purchasing volume of related drugs for a year based on the actual purchases of the previous year according to the variety, dosage form, specifications, and manufacturers.
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Genting Xinyao Announces SPR206 Clinical Trial Application Approved by the National Medical Products Administration
Time of Update: 2021-10-23
HK), a biopharmaceutical company focusing on the development and commercialization of innovative drugs, is committed to satisfying the needs of Greater China and Asia The medical needs of other markets that have not yet been met, today announced the approval of SPR206 (also known as EVER206) by the Drug Evaluation Center of the China National Medical Products Administration for a Class 1 New Drug Clinical Trial Application (IND) .
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Different players in the tens of billions market enter two domestic pharmaceutical companies to enter Phase 3 clinical trials
Time of Update: 2021-10-23
A few days ago, the US FDA has expanded the emergency use authorization (EUA) of the new crown neutralizing antibody cocktail double antibody therapy (estivirimab and banivirimab) to include post-expo
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Preparation Overview The current status of product development of microsphere injections
Time of Update: 2021-10-23
Microspheres are solid tiny spheres formed by drugs in a dissolved state or dispersed in a matrix of polymer materials such as gelatin, high molecular weight polypeptides, and proteins, and then processed and solidified.
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Discussion on the application of off label operation in Chinese medical practice and the progress of regulations
Time of Update: 2021-10-23
1- Drug Administration Law provides for instructions1- Drug Administration Law provides for instructionsArticle 72 of the "Drug Administration Law" (revised in 2019) states that medical institutions should adhere to the principles of safe, effective, economical and reasonable medication, follow the guidelines for clinical application of drugs, clinical diagnosis and treatment guidelines, and drug inserts and other rational use of drugs, and treat physicians Review the suitability of prescriptions and medication orders .
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Buchang Pharmaceutical Rivaroxaban Tablets Obtained Drug Registration Certificate
Time of Update: 2021-10-23
According to the announcement, Rivaroxaban tablets are suitable for: 1.
Treat adult deep vein thrombosis (DVT) and pulmonary embolism (PE) ; Used to reduce the risk of DVT and/or PE recurrence in patients whose risk of DVT and/or PE recurrence persists after completing at least 6 months of initial treatment .
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Roche voluntarily withdraws accelerated approval of Tecentriq+ chemotherapy regimen from the U.S.
Time of Update: 2021-10-23
Roche recently announced that the company has decided to voluntarily withdraw an accelerated approval from the United States: anti-PD-L1 therapy Tecentriq (generic name: atezolizumab, atezolizumab) combined with chemotherapy (Abraxane, albumin) Conjugated paclitaxel [nab-paclitaxel]) is used to treat adult patients with FDA-approved detection methods that confirm that tumors express PD-L1, unresectable, locally advanced or metastatic triple-negative breast cancer (mTNBC) .
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Beihai Biotechnology's third-generation taxane derivative new drug was approved for clinical use
Time of Update: 2021-10-23
Public information shows that BH002 belongs to the third-generation taxane derivative, and this time it has been approved for clinical development for the treatment of metastatic castration-resistant prostate cancer .
Retrieved Sep 22, 2021, from https:// The BH002 project of Beihai Biotechnology obtained the new drug clinical trial approval.