Recently, Hansoh Pharma's Fosaprepitant Dimeglumine for Injection (trade name: Tanneng) has received the Drug Registration Approval from the National Medical Products Administration, which will be used to prevent acute and delayed nausea and vomiting caused by chemotherapy. As the first and only Fosaprepitant Dimeglumine approved for marketing in China so far, Tanneng is declared as a New Class 3 chemotherapeutic agent, deemed to have passed the consistency evaluation. According to industry insiders,, the approval for marketing of this new drug for stopping vomiting arising from chemotherapy will further enrich and improve the layout of Hansoh's anti-tumor product line.
Chemotherapy is an important method for malignant tumor treatment, and nausea and vomiting are among the most common and subjectively painful adverse reactions in the process of chemotherapy. Chemotherapy-induced nausea and vomiting (CINV) not only affects patients' quality of life and reduces patients' compliance, but also causes water-electrolyte imbalance and nutritional deficiency in severe cases, resulting in suboptimal tumor control.
At present, the main clinical anti-tumor antiemetic drugs in China are those acting on 5 hydroxytryptamine 3 (5HT3) receptors. Although such drugs have good antiemetic effect, they can hardly provide completely effective control due to the different severity of vomiting. Therefore, they need to be used together with other types of drugs, and the emergence of neurokinin-1 (NK-1) drugs remedies the defects of such drugs.
Fosaprepitant Dimeglumine is a NK-1 selective and high-affinity receptor agonist, and an antiemetic drug for highly/moderately emetic chemotherapy (HEC/MEC) unanimously recommended by all domestic and overseas guidelines. It is used to prevent CINV by blocking the brain's nausea and vomiting signaling mechanism and can be combined with 5-HT3 receptor antagonist to improve antiemetic efficacy. As an injection type, this drug can satisfy the needs of patients who are clinically unable to take drugs orally, have difficulty in swallowing or have low digestive functions, so as to benefit a wider population. Clinical studies have shown that, Hansoh pharma‘s Fosaprepitant (Tanneng) is effective in preventing CINV and has a good clinical safety profile. Due to single injection per day, Tanneng is also characterized by accurate dosage, rapid onset of action and ease of use.
On October 9, Fosaprepitant Dimeglumine was officially included in the List of First-Batch Encouraged Generic Drugs. In order to accelerate the implementation of supply guarantee and use of generic drugs, the National Health Commission, together with other authorities, has created this list for the selection and demonstration of drugs that have not yet filed for registration when their domestic patents have expired or are to expire, that are in short supply clinically, or that have been declared by enterprises proactively. Previously, neither original nor generic versions of Fosaprepitant Dimeglumine were available in China. With Tanneng’s approval as the first generic drug, we hope that these clinically urgently needed drugs can be included in the national reimbursement drug list more quickly to help more patients control diseases and enjoy healthy life again.
