The purpose of this paper is to provide reference for improving the incentive policies of innovative drug research and development in China. Taking Takeda Pharmaceutical Co., Ltd. as an empirical research object, and on the basis of combing Japan's innovative drug R&D incentive policies in terms of R&D support, registration review and approval, intellectual property rights and drug pricing, this paper analyzes how relevant policies encourage enterprises to innovate and develop from the aspects of mechanism and implementation effect. The results show that Takeda Pharmaceutical has achieved innovation transformation under a series of supports of innovative drug research and development incentive policies in Japan. In order to improve the related incentive policy in China, our country should learn from Japan's experience and take incentive measures, such as enhancing the commercial development of scientific research achievements, perfecting the intellectual property financing system, establishing and perfecting the drug data protection system and perfecting the price formation mechanism of innovative drugs.

Traditional clinical trials that are randomized and controlled have exposed some deficiencies in the process of long-term use, prompting a growing number of researchers to look at real-world evidence (RWE). As an important basis of real-world study (RWS), real-world data (RWD) determine whether the RWS is qualified for supervision and review of institutions with reliable RWE. There are some problems about RWD, including unstructured and fragmented data, poor accessibility, lack of standards to standardize data, research design that is not rigorous, failure to control the applicability of RWD, etc. These problems will greatly affect the quality of RWD. Aiming to resolve the above problems, this paper provides six suggestions in order to provide a reference to improve the quality of RWD, including strengthening the management of RWD in medical institutions, improving RWD sharing mechanism, standardizing RWD according to data standards in RWS, collecting RWD according to rigorous research design, defining the responsibilities of personnel related to RWD quality and strictly controlling the applicability of RWD.

Generic drug has made a large contribution to our medical security system; however, the pharmaceutical industry starts late in China and there still exists a wide gap between generic drugs and original drugs. Given this situation, the generic drug consistency evaluation is extremely meaningful to ensure the efficacy and safety of generic drugs, and it is impressive for improving the integral level of pharmaceutical industry. This article discusses the relevant policies of the generic drug consistency evaluation in China, such as ensuring the consistency between generic drugs and original drugs, establishment of the strict review and supervision system, etc. At the same time, this article also outlines the relevant drug policies and their development process in US Food and Drug Administration (FDA) and Japan Pharmaceuticals and Medical Devices Agency (PMDA). We expect that the comparison and analysis would be benefit to the generic drug consistency evaluation in our country.

Glucagon-like peptide-1 (GLP-1), considered as an effective peptide for the treatment of diabetes, can stimulate insulin secretion in response to rising glucose. Moreover, the novel peptide is becoming a new choice to treat type II diabetes. Nevertheless, the half-life of GLP-1 (approximately 1~2 min) is short, limiting its clinical application in diabetes. GLP-1-loaded PLGA microspheres have drawn more attentions in recent years. In this article, we introduces the preparation methods for encapsulation of GLP-1 in preparing PLGA microspheres. In order to solve the shortcomings of large burst release and drug degradation of traditional microspheres, some novel microsphere formulations (double-wall microspheres, self-healing microspheres and other new formulations of microspheres) are summarized. The new formulations effectively enhance protein stability and long-acting efficiency is achieved, providing new strategies for developing protein-loaded microspheres.

Universal CAR-T cell technology belongs to the universal T cell technology based on gene editing in general CAR-T. It knocks out the signal receptor factor of T cell through gene editing, and produces CAR-T cell by using modified T cell from healthy volunteers; therefore it will not cause immune rejection such as graft versus host disease (GvHD) and host versus graft reaction (HvGR) after infusion. In animal experiments and early clinical trials, UCAR-T technology shows significant anti-tumor effect, wide applicability and tremendous application potentials. In terms of industrialization, UCAR-T cell technology is expected to solve the problems of high cost in designing and culturing autologous CAR-T preparations, of long preparation cycle, difficult quality control, insufficient cell quantity and expansion capacity, because of its unique features such as quality controllable, off-the-shelf, and easy for large-scale preparation, etc. This paper introduces the current research progress and existing problems of UCAR-T cells, and conducts a preliminary analysis of the existing problems, providing a reference for the fundamental research and clinical trials of UCAR-T cells.

Poly ADP ribose polymerase (PARP) inhibitors are anti-tumor drugs targeting PARP enzymes. They have been approved by the US Food and Drug Administration (FDA) for the treatment of ovarian cancer, breast cancer, prostate cancer and pancreatic cancer. Additionally, National Medical Products Administration of China has also approved them for ovarian cancer. So far, PARP inhibitors have changed the traditional treatment mode for ovarian cancer. This article conducts literature review for PARP inhibitors in aspects of mechanisms of action, indications, pharmacokinetics, clinical application, and key points for pharmaceutical care, so as to provide reference to clinicians for rational use in clinical and pharmacy service for PARP inhibitors.