Takeda’s Application for Marketing Authorization of the New Version of myPKFiT® in China is Officially Accepted by NMPA with the Help of CCRC

On October 7, 2023, the change of application for myPKFiT® (a pharmacokinetic-dosing software for Recombinant Human Coagulation Factor Ⅷ for Injection) submitted by Takeda, a leading biopharmaceutical company, was officially accepted by the National Medical Product Administration (NMPA), for which CCRC provided guidance throughout the entire product registration process. This new version includes an optimized app for healthcare professionals and an additional mobile app for patients.

The myPKFiT® of Takeda is currently the only NMPA-approved personalized pharmacokinetic dosing software for prophylactic coagulation factor FVIII. It is intended to be used in combination with Recombinant Human Coagulation Factor Ⅷ for Injection of Takeda (firstly approved for marketing in China in 2013) to predict pharmacokinetics based on the values of the PK parameters in the patients, so as to estimate the PK curves and calculate the doses of coagulation factor VIII. Patients can maintain a sufficient FⅧ level to prevent bleeding through the optimization of the doses and dosing intervals. At the same time, based on the different characteristics and needs of each patient, the dose of coagulation factor FVIII needed in hemophilia patients can be calculated individually, which continuously improves the quality of life of the patients by effectively avoiding insufficient or excessive treatment.

The new version in this submission contains an app for healthcare professionals and a mobile app for patients, and the changes are as follows:

Compared with the original version (version 2.0.11, an approved application for healthcare professionals), the new version is updated with an added app for the patients.

The new mobile app for patients, available on phones with Android or iOS operating systems, allows patients to see their blood coagulation factor FVIII levels in real time, to help them make appropriate decisions under the guidance of healthcare professionals. The mobile app can help the patients to maintain and adhere to the dosing regimen, enabling physicians to track and retrieve records of all bleeding and infusions of recombinant human coagulation factor VIII of the patients. The mobile app can also replace the original paper log with bleeding and infusion information, allowing patients to know in real time when transfusions are given and when FVIII estimates are low.

The new version of myPKFiT® has been approved for marketing in the United States, Canada, Europe, Australia, and Japan, etc. The application for marketing authorization in China has been officially accepted, so that the new version is expected to benefit Chinese hemophilia A patients in the near future. The new mobile app for patients is also Takeda’s first digital therapy product to be used for individual patients, which is a landmark of Takeda’s digital innovation. Besides, the new mobile app for patients provides a more diversified treatment solution for hemophilia A patients, further consolidating Takeda’s leading position in the field.