12 pharmaceutical companies entered the blacklist
It involves failure to fulfill relevant obligations, breach of financial systems, etc
Recently, through the inquiry of the national enterprise credit system, a total of 12 pharmaceutical companies in 2021 were included in the list of serious violations of the law and untrustworthiness (blacklist) for reasons such as not fulfilling relevant obligations for 3 years and violating the financial system.
Figure 1. List of 12 Pharmaceutical Companies seriously violating the law and untrustworthiness (blacklist) (data source: National Enterprise Credit Information Publicity System, tabulation: Biological Exploration Editing Team)
The revocation of the qualification of 46 pharmaceutical companies to hang on the network involves 113 drug product regulations
On January 24, the Shanxi Provincial Centralized Bidding and Procurement Network for Pharmaceutical Equipment issued the Notice on Announcing the Revocation of Platform-Linked Procurement Qualifications by Some Enterprises (Jin Yao Zhao [2022] No. 9). According to the notice, according to the application of enterprises, according to the relevant provisions of the Shanxi Provincial Medical Security Bureau, the Shanxi Provincial Health Commission, and the Shanxi Provincial Drug Administration on Further Improving the Interprovincial Dynamic Linkage Work on the Procurement of Drugs and Medical Consumables (Jin Medical Insurance Fa [2020] No. 18), 46 pharmaceutical manufacturers such as Ruiyang Pharmaceutical Co., Ltd. and 113 drug product regulations applied for the cancellation of the platform hanging network procurement qualifications, and the above-mentioned enterprise products did not accept the product to hang the network again within two years after the revocation of the network. It is hereby made public.
Hanhui Pharmaceutical HS301 tablets, a wholly-owned subsidiary of Haizheng Pharmaceutical, were approved for clinical trial
On January 25, Haizheng Pharmaceutical issued an announcement that its wholly-owned subsidiary, Hanhui Pharmaceutical, received the "Drug Clinical Trial Approval Notice" of HS301 tablets (40 mg, 80 mg) approved and issued by the State Food and Drug Administration.
HS301 tablets are second-generation oral NTRK/ROS1 small molecule kinase inhibitors, a pan-cancer treatment drug capable of overcoming multiple mutations and resistance, suitable for the treatment of solid tumors containing NTRK1/2/3 and ROS1 fusion positive.
Tasly B1344 injection is licensed for clinical trials by the US FDA
On January 25, Tasly announced that tasly, its holding subsidiary, Tasly Biotech, received a letter from the FDA approving the use of B1344 injection for clinical trials in non-alcoholic steatohepatitis (NASH) (IND number: 152391).
B1344 Injection is an innovative biological drug developed by Tasly Bio Research for the treatment of NASH. B1344 is a polyethylene glycolated recombinant human fibroblast growth factor 21 mutant that activates downstream signaling molecular pathways by binding to the co-receptor β-klotho protein to the fibroblast growth factor receptor (FGFR) and participating in the pathophysiology of multiple glycolipid metabolism diseases.
The results of preclinical animal efficacy experiments showed that B1344 could significantly reduce the degree of liver steatosis, balloon degeneration and hepatic lobular inflammation in model animals, improve the activity integral score and fibrosis of non-alcoholic fatty liver disease, and reduce serum alanine aminotransferase and asparta aminotransferase levels, suggesting that B1344 has similar clinical benefit potential in PATIENTS WITH NASH.
Source: Figureworm Creative
Tonghua Dongbao engliflozin API filing was accepted by the State Food and Drug Administration
On January 25, Tonghua Dongbao issued an announcement that it had recently received a notice of acceptance of empagliflozin APIs issued by the State Food and Drug Administration.
Empagliflozin is a highly selective SGLT2 inhibitor with a unique insulin-independent hypoglycemic mechanism that reduces the renal glucose threshold by reducing the kidneys' glucose reabsorption and promoting the direct excretion of glucose from the urine. It is mainly used to improve blood glucose control in patients with type 2 diabetes.
Empagliflozin tablets original research products were approved to enter the domestic market in September 2017, since 2020, domestic generic drugs have been approved and evaluated, there are currently 1 domestic import, 5 domestic listings, empagliflozin tablets in 2021 was included in the fourth batch of national centralized procurement directory.
Merck P2X3 receptor antagonist Lyfnua, which significantly reduces cough frequency, is approved in Japan
Recently, Merck's new cough drug Lyfnua (gefapixant, MK-7264) 45 mg tablets was approved in Japan: it is an oral, selective P2X3 receptor antagonist for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.
RCC refers to coughs that persist despite appropriate treatment of the underlying disease, and UCC refers to coughs whose underlying cause cannot be determined despite a thorough evaluation. In terms of medication, Lyfnua 45 mg tablets are taken 2 times a day.
It is worth mentioning that Lyfnua is the world's first approved selective P2X3 receptor antagonist and the first drug to specifically treat RCC and UCC. Lyfnua inhibits extracellular ATP signaling through P2X3 receptors present on the airway vagus nerve C fibers and reduces sensory nerve activation and coughing.
Source: Bio Exploration
Original title: 12 pharmaceutical companies entered the blacklist, and 46 pharmaceutical companies' products were revoked from hanging on the net, involving 113 drug product regulations!
All text/video works that do not indicate "Source: Health Community" are reproduced from other media/self-media for the purpose of conveying more information and do not mean that the health community endorses its views or is responsible for its authenticity. The health community strives for the completeness and accuracy of the content, but cannot guarantee the timeliness, completeness and accuracy of the published content and the cited materials, so it is only for reference and is not recommended for readers to make decisions.