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Haihe Pharmaceutical's Paclitaxel Oral Solution (RMX3001) China Marketing Authorization Application Officially Accepted
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On September 13, 2022, Shanghai Haihe Pharmaceutical Research and Development Co., Ltd. and South Korea's Daehwa Pharmaceutical Co., Ltd. jointly announced that the paclitaxel oral solution jointly developed by the two parties has been officially accepted by the Center for Drug Evaluation of the State Drug Administration. The Chinese marketing application for this indication is mainly based on a randomized, open-label, parallel-controlled, non-inferiority design, multi-center Phase III clinical trial based on RMX3001/DHP107C2301, which aims to compare paclitaxel oral solution and paclitaxel injection in the second-line treatment of patients with advanced gastric cancer efficacy and safety. Professor Li Jin from Shanghai Oriental Hospital and Professor Qin Shukui from Nanjing Jinling Hospital jointly served as the principal investigators of the study. They said: "Paclitaxel oral solution adopts the patented self-emulsifying drug delivery technology, which has precise curative effect and avoids the common injection solvent Cremophor EL. some toxic and side effects, and easy to use.
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Hengrui Medicine: The first KRAS G12D inhibitor in China has been approved for clinical use!
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On August 2, 2022, Hengrui Medicine issued an announcement that the company received the approval and issuance of the "Drug Clinical Trial Approval Notice" by the State Food and Drug Administration for HRS-4642 injection. HRS-4642 targets the KRAS G12D mutation and inhibits tumor cell proliferation. At present, no similar drugs have entered the clinic at home and abroad, and there is no relevant sales data. Therefore, Hengrui Medicine HRS-4642 is the first KRAS G12D inhibitor approved for clinical use in China. According to the statistics of Yaorong Cloud database, Hengrui Medicine HRS-4642 injection was undertaken by the Drug Application Center on May 20 this year, and it took 67 days to get the clinical approval.
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Novel Bisamide Insecticide Cyclopramide
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Cyproteramide is a bisamide insecticide developed by Japan Ishihara Sangyo Co., Ltd. It has the structure of o-formamidobenzamide. It was listed in 2017 and has been registered and listed in the United States, Canada, Australia, Brazil and other countries. As a new type of bisamide insecticide, cyproteramide has a wide insecticidal spectrum, low dosage and long lasting effect. It is effective against both order pests and their resistant pests. At the same time, cyproteramide has less impact on mammals, beneficial arthropods, and the environment. With the ban and restriction of neonicotinoid insecticides in some countries and regions, cyproteramide can be used as a substitute for neonicotinoid insecticides in some markets, and it can also be regarded as an important part of chlorantraniliprole. Replenish. The mechanism of action of cyproteramide is different from other bisamide insecticides, and the market potential in the field of resistant pest control is huge in the future. At present, cyproteramide has been registered and listed in many countries and regions around the world, and the compound patent will expire in 2025.
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BMS Novel Oral TYK2 Inhibitor deucravicitinib
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Bristol-Myers Squibb (BMS) recently announced positive results from the Phase 2 PAISLEY study (NCT03252587) of the novel oral TYK2 inhibitor deucravicitinib in moderate-to-severe systemic lupus erythematosus (SLE) at the European Union of Rheumatology Association (EULAR) 2022 Congress. result. The data showed that the study met its primary endpoint of SRI-4 (SLE Responder Index 4) response at week 32 of treatment. SRI-4 is a composite endpoint used in SLE clinical trials to assess disease activity.
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CPhI & P-MEC China 2022 Postponement Notice
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Sponsored by Informa Markets, China Chamber of Commerce for Import and Export of Medicines and Health Products, and co-organized by Shanghai Bohua International Exhibition Co., Ltd. The 21st world pharmaceutical raw materials China Exhibition and the 16th world pharmaceutical machinery, packaging equipment and materials China exhibition, originally scheduled to be held in Shanghai New International Expo Center from June 21 to 23, 2022, will be postponed, and the specific time will be notified.
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The first batch of Pfizer's new crown special drug PAXLOVID in China began to be used for treatment
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On March 23, the National Health and Medical Commission issued the "Notice on Adjusting Indications of Anti-New Coronavirus Drug PF-07321332/Ritonavir Tablets (Paxlovid), etc." Ordinary type and adults with high risk factors for progression to severe disease", delete "Adolescents aged 12-17 years weighing more than 40 kg". PAXLOVID is a combination drug developed by Pfizer. Nematevir is a protease inhibitor that blocks the protease activity necessary for coronavirus replication. Ritonavir, on the other hand, is used to slow down the metabolism or breakdown of nematevir, allowing it to remain active in the body for longer at higher concentrations, which together affect the reproduction of the virus. According to Pfizer's previously published clinical trial data, compared with the placebo group, patients treated with PAXLOVID within 3 days and 5 days after symptom onset had an 89% and 88% reduction in hospitalization or mortality, respectively, and viral load The amount has been reduced by a factor of 10. In the overall 28-day study population, no deaths were reported in patients receiving the drug, compared with 10 (1.6%) deaths in patients receiving placebo.
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