Junshi PD-1 combined with chemotherapy for first-line esophageal squamous cell carcinoma reached the primary endpoint; unable to repay the debts due. A bank filed for bankruptcy to reorganize Kangmei in the court; Fu Jen under revision 2020 Annual performance: The annual loss may be nearly 1.3 billion; Roche trastuzumab subcutaneous injection is declared for listing... Daily fresh medicine news, speed reading and you will pay attention to it together!
Part 1 Policy Brief
Significant price cuts for high-value consumables involving Abbott, MicroPort, Poco, etc.
On the 22nd, the Heilongjiang Public Resources Trading Network released the "Announcement on Adjusting the Price Information of High-Value Medical Consumables." This price information adjustment includes 1,008 products, involving products from well-known domestic and foreign machinery companies such as Abbott, Poco, Weigao, MicroPort, and Lepu. Among them, a drug-eluting coronary stent system from Abbott decreased by 76.87%; a coronary rapamycin targeted eluting stent system from Minimally Invasive Medical decreased by 72.97%; a platinum-chromium alloy degradable coating from Poco Everolimus eluting coronary stent system decreased by 63.16%. (Heilongjiang Public Resources Trading Network)
Part 2 Observation of Sankei
Unable to pay off due debts, a bank filed a bankruptcy reorganization with Kangmei to the court
On the 22nd, Kangmei Pharmaceutical issued an announcement stating that the company received the (2021) Yue 52 Poshen No. 1 "Notice" served by the Intermediate People’s Court of Jieyang City, Guangdong Province, and Guangdong Jiedong Rural Commercial Bank Co., Ltd. could not pay off the compensation by Kangmei. When the debts are due, they file for bankruptcy reorganization to the court. (a)
Fu Jen revises 2020 performance: the full year may lose nearly 1.3 billion
On the 22nd, *ST Furen revised its 2020 annual results. The net profit attributable to shareholders of listed companies for the whole year is expected to lose about 1.292 billion yuan. Previously, the company predicted that the net profit attributable to shareholders of the listed company would lose 780 million yuan to 960 million yuan in 2020. (a)
A fire broke out in the workshop of the cubic pharmaceutical factory
At 10 a.m. on the 21st, a fire broke out in the storage warehouse of the listed company Lifang Pharmaceutical located in the factory area of Hefei High-tech Zone. The fire has now been contained. It is understood that the fire broke out at about 10 am, when the incident occurred, smoke was billowing, and the fire started in the workshop in the factory. According to the news, the burning materials at the scene were cartons, aluminum foil, pvc, and raw materials. So far, dozens of fire trucks have rushed to the scene to put out the fire. There are no casualties. The fire has been brought under control. (China Net)
Part 3 Drug News
Junshi PD-1 combined with chemotherapy for first-line esophageal squamous cell carcinoma phase III clinical reach the primary endpoint
On the 22nd, Junshi Biopharmaceuticals announced that the phase III clinical study of teriprizumab combined with paclitaxel/cisplatin in the first-line treatment of advanced or metastatic esophageal squamous cell carcinoma reached the main research endpoint and plans to communicate and submit a marketing application soon. (Insight database)
FDA accelerates approval of GlaxoSmithKline PD-1 antibody to treat patients with specific endometrial cancer
The US FDA announced that it has accelerated the approval of the anti-PD-1 antibody Jemperli (dostarlimab) developed by GlaxoSmithKline (GSK) to treat patients with relapsed or advanced endometrial cancer. These patients progressed after receiving platinum-containing chemotherapy and carried abnormal characteristics of DNA repair called mismatch repair defects (dMMR). (WuXi AppTec)
Roche trastuzumab subcutaneous injection application for listing
According to the official website of CDE, the listing application for trastuzumab subcutaneous injection submitted by Roche was officially accepted by NMPA. Trastuzumab subcutaneous injection is a compound preparation composed of Roche anti-Her2 monoclonal antibody trastuzumab and the recombinant human hyaluronidase PH20 (rHuPH20, an endoglycosidase) developed by Halozyme based on the Enhanze technology platform. Use by subcutaneous injection. (Medical Rubik's Cube)
The listing application for MSI-H of Fuhong Henlius Slulimumab was accepted
Helius announced that its recombinant anti-PD-1 humanized monoclonal antibody belimumab (HLX10) has been formally accepted by the State Food and Drug Administration and announced that it will be included in the priority review for approval. Patients with unresectable or metastatic highly unstable microsatellite solid tumors who have failed standard treatment. (a)
Hua Medicine's new diabetes drug listing application was accepted by the State Drug Administration
Hua Medicine announced that the new drug listing application submitted by the company's first innovative drug for diabetes, dorzagliatin, has been officially accepted by the NMPA. Dozaglietin has become the first glucokinase activator diabetes treatment drug in the world to submit a new drug marketing application, and it is expected to be the first to be marketed in China. (Immediately smell the medicine)
Hausen's first copy of Varenicline tartrate tablets will soon be approved for adult smoking cessation
On the 22nd, the listing application for the new four-category generic drug "Varenicline Tartrate Tablets" of Hausen Pharmaceuticals entered the approval status and is expected to be approved soon, becoming the first domestic imitation of this product. (WuXi AppTec)
Review of Ceftazidime for Injection in Guangdong Jincheng Jinsu Pharmaceutical
NMPA official website shows that Guangdong Jincheng Jinsu Pharmaceutical's ceftazidime for injection passed the consistency evaluation. Ceftazidime for injection is the fifth batch of varieties to be collected. According to data from Minai.com, terminal ceftazidime sales in China's public medical institutions exceeded 6 billion yuan in 2019. (NMPA)
1.2 billion antihypertensive drugs Shanghai Pharmaceuticals first reviewed
Shanghai Pharmaceuticals announced that the wholly-owned subsidiary Shanghai Xinyi Tianping's Nifedipine Sustained-Release Tablets (II) passed the consistency evaluation and was the first in China. According to data from Meinenet, in 2019, the total sales of Nifedipine Sustained-Release Tablets (II) in Chinese public medical institutions and Chinese urban physical pharmacies exceeded 1.2 billion yuan. (Minenet)
Teyi Pharmaceutical Amoxicillin Capsules Passed the Consistency Evaluation
On the 22nd, Teyi Pharmaceuticals issued an announcement stating that its wholly-owned subsidiary Haili Pharmaceuticals had recently obtained the "Amoxicillin Capsules" "Drug Supplementary Application Approval Notice" approved and issued by the State Food and Drug Administration. After review, the drug passed Consistency evaluation of the quality and efficacy of generic drugs. The amoxicillin capsules that Haili Pharmaceutical passed the one-time evaluation this time have two specifications, 0.25g, and 0.5g respectively. (Sina Pharmaceutical News)
Innovative therapy reverses the symptoms of Alzheimer's disease in animals and stimulates the ability of cells to "clean up garbage"
On the 22nd, researchers at the Albert Einstein College of Medicine in New York, USA, announced the design of an experimental drug designed to stimulate a special cell "junk cleaning" mechanism, which can reverse the main cause of Alzheimer’s disease in animals models. symptom. The research was published online today in the journal Cell. (Sina Pharmaceutical News)
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