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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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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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Yahong Pharmaceutical was selected as one of the top 30 innovative small molecule drug companies in China
Time of Update: 2021-10-23
Adhering to the corporate mission of "improving human health and making life more dignified", Yahong is determined to become a leading international pharmaceutical company integrating R&D, production and commercialization in the field of focused treatment, providing the best integration of diagnosis and treatment for patients in China and around the world Solutions .
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Anke Biological Holding Subsidiary ZG033 Injection Drug Registration Application Accepted
Time of Update: 2021-10-23
At present, monoclonal antibodies and double antibodies targeting 4-1BB have shown their anti-tumor efficacy in preclinical or clinical trials.
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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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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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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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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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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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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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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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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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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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Hengrui JAK1 inhibitor phase II clinical trial for alopecia areata reached the primary endpoint
Time of Update: 2021-10-23
Article source: Medical Rubik's Cube InfoAuthor: SunshineOn August 24, Hengrui announced that the Phase II clinical study RSJ10521 (CRYSTAL2) of the SHR0302 tablet for the treatment of alopecia areata developed by its subsidiary Ruishi Biotechnology has reached the primary study endpoint .
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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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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.
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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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Murderous!
Time of Update: 2021-10-23
After the companies are shortlisted, according to the proposed selection rules, the price reductions of all A competition units of the 17 product groups are ranked from high to low, and the top 70% of the companies (rounded to the nearest integer, the same below) are directly eligible for the proposed selection.
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The follow-up to the national adoption of the abandonment standard: the replacement company has been determined!
Time of Update: 2021-10-23
The announcement showed that because North China Pharmaceutical failed to supply drugs in accordance with the agreed procurement volume, the joint procurement member units collectively After deliberation, it was decided to include it on the "list of violations" and cancel the company's qualification to participate in the centralized drug procurement activities organized by the state from August 11, 2021 to May 10, 2022 .
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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) .
