12 drug companies on the blacklist, 46 drug companies products were withdrawn from the network qualification

12 pharmaceutical companies into the blacklist

Involved in the failure to fulfill the relevant obligations, violation of the financial system, etc.

Recently, through the national enterprise credit system query, a total of 12 pharmaceutical companies have been included in the serious violation of law and credit (blacklist) list in 2021 for failure to fulfill relevant obligations for 3 years, violation of financial system, etc.

46 pharmaceutical companies' products were withdrawn from the network involving 113 drug specifications

On January 24, the centralized competitive bidding procurement network of Shanxi Province issued a notice on the revocation of the qualification of some enterprises to be listed on the procurement platform (Jin Pharmaceutical Recruitment [2022] No. 9). Notice shows that, according to enterprise applications, according to the Shanxi Provincial Medical Security Bureau, Shanxi Provincial Health and Health Commission, Shanxi Province Drug Administration "on further improving the inter-provincial dynamic linkage of drugs and medical supplies procurement notice" (Jin Medical Security Fa [2020] No. 18) related provisions, Ruiyang Pharmaceutical Co., Ltd. and other 46 drug manufacturers 113 drug specifications, apply for withdrawal of the platform Ltd. and other 46 pharmaceutical manufacturers have applied for withdrawal of the platform procurement qualification, and the products of the above enterprises will not be accepted again within two years after the withdrawal of the network, which is hereby announced.

Hazen Pharma's wholly-owned subsidiary Hanhui Pharmaceuticals HS301 tablets were approved for clinical use

On January 25, Hazen Pharma announced that its wholly-owned subsidiary, Hanhui Pharmaceuticals, received the Notice of Approval of Drug Clinical Trial for HS301 Tablets (40 mg and 80 mg) approved by the State Drug Administration.

HS301 Tablets is a second generation oral NTRK/ROS1 small molecule kinase inhibitor, a pan-cancer therapeutic drug, capable of overcoming multiple mutations and drug resistance, and is suitable for the treatment of solid tumors containing NTRK1/2/3 and ROS1 fusion positive.

Tianshili B1344 Injection Receives U.S. FDA Clinical Trial Approval

On January 25, Tianshi-Li announced that its holding subsidiary, Tianshi-Li Bio, received a letter from the FDA (IND No. 152391) regarding consent to conduct clinical trials for B1344 injection for non-alcoholic steatohepatitis (NASH).

B1344 injection is an innovative biologic drug developed by Tensili Bio for the treatment of NASH. B1344 is a polyethylene glycolized recombinant human fibroblast growth factor 21 mutant that activates downstream signaling molecular pathways through binding to the co-receptor β-klotho protein and fibroblast growth factor receptor (FGFR), and is involved in the pathophysiology of several glucolipid metabolic diseases .

Results from preclinical animal pharmacodynamic experiments showed that B1344 significantly reduced hepatic steatosis, ballooning degeneration and the degree of inflammation in liver lobules in model animals, improved the non-alcoholic fatty liver disease activity score score and fibrosis, and reduced serum ghrelin and ghrelin levels, suggesting that B1344 has similar potential for clinical benefit in NASH patients.

Tonghua Dongbao's ENGL API filing was accepted by the State Drug Administration

On January 25, Tonghua Dongbao announced that it had recently received a notification of acceptance of the filing of engramlizine API from the State Drug Administration.

Englestrin is a highly selective SGLT2 inhibitor with a unique insulin-independent glucose-lowering mechanism, i.e. by reducing glucose reabsorption in the kidney, lowering the renal glucose threshold and promoting the direct excretion of glucose from the urine. It is mainly used to improve glycemic control in patients with type 2 diabetes.

The original product of Engeletin Tablets was approved to enter the domestic market in September 2017, and domestic generics have been approved and evaluated since 2020, with one domestic import and five domestic listings, and Engeletin Tablets was included in the fourth batch of the national centralized quantity procurement catalog in 2021.

Lyfnua, a Merck Sharp & Dohme P2X3 receptor antagonist, was approved in Japan

Recently, Lyfnua (gefapixant, MK-7264), a new Merck Sharp & Dohme cough medicine, was approved in Japan as a 45 mg tablet: an oral, selective P2X3 receptor antagonist for the treatment of refractory chronic cough (RCC) or unexplained chronic cough (UCC) in adults.

RCC is defined as a cough that persists despite appropriate treatment of the underlying disease, and UCC is defined as a cough for which the underlying cause cannot be determined despite a thorough evaluation. For dosing, Lyfnua 45 mg tablets are taken twice daily.

Notably, Lyfnua is the world's first approved selective P2X3 receptor antagonist and the first drug specifically for the treatment of RCC and UCC. Lyfnua inhibits extracellular ATP signaling through P2X3 receptors present on airway vagal C-fibers and reduces sensory nerve activation and cough.