Clinical orientation is the expected therapeutic effect of drugs on diseases, and accurate clinical orientation is the key to successful development of new drugs and clinical rational drug use after marketing. The rationality of clinical orientation for traditional Chinese medicine should be evaluated from the aspects of research drugs, targeting diseases, existing therapeutic drugs and review requirements. The methods and basis of clinical orientation include human experience, theory of traditional Chinese medicine, basic researches and clinical trials. By selecting reasonable clinical orientation and taking clinical value as the guidance, the curative effect of traditional Chinese medicine can be truly reflected, and the quality of research and development and success rate of new Chinese medicine will be improved.

The drug R&D of rare diseases in China is still in early stage. Collaborations have become a choice for many companies to enter that field. This article analyzes the collaboration deals involving Chinese companies from year 2011 to April 30th, 2022 on drugs with indication included in the first batch of rare disease list. It is found that as the country has put more emphasis on rare diseases, the number of transactions has increased significantly after the year of 2019. The deal model is mainly licensing deal, and transactions in rare disease indications with a big population is relatively concentrated. A group of biotechnology companies with rare diseases as their strategic focus have emerged. It is suggested to promote the legislation of rare diseases in China and more incentive policies concerning the research and development in rare diseases can be introduced in the future, so as to promote more Chinese companies to join in the research and development of innovative drugs in the rare diseases, and to further accelerate the development of local innovative drugs for rare diseases.

Patents have long been considered as the most important way to protect pharmaceutical innovations, and the drug patent system has exerted a profound impact on the development of the pharmaceutical industry. In the context that domestic effective drug regulations and patent laws and regulations have covered the provisions on drug patent linkage system, this paper, by taking the first case of domestic drug patent linkage litigation as an instance, analyzes the trial effect of the newly launched drug patent linkage system in China, explores its impact on the generic drug industry, and tries to give suggestions to generic drug enterprises on the choice of patent application types and the authenticity of application materials. The research-based pharmaceutical enterprises need to seize the opportunity to safeguard their rights and protect themselves against patent infringement by choosing an appropriate method to resolve patent disputes. Moreover, given the constraints of China's binary separation of procedures of patent infringement and patent invalidation on the early solution of pharmaceutical patent disputes and the problems awaiting to be solved in different types of patent applications, this paper also puts forward related suggestions on patent protection, including the necessity of timely review and analysis of the implementation of the patent linkage system, enhancement of the legal status of administrative adjudication to enable some authorities of administrative confirmation, and the necessity for clearer definition of types of patent applications and further standardization of patent infringement cases under different circumstances.

Elemental impurities in drug products may arise from several sources, and should be controlled within acceptable limits. ICH has published the final version Q3D (R2) Guideline for Element Impurities in 2022, establishing a global harmonized guideline for the control of elemental impurities in new drug products. Based on ICH Q3D (R2), this article summarizes the classification and safety assessment principles of element impurities, proposes the general considerations in the risk assessment and control strategy from the perspective of CMC review, and discusses the key steps and main problems in the evaluation of elemental impurities, providing reference for the establishment of science-based and risk-based control strategy.

Since the first Chimeric Antigen Receptor T Cell (CAR-T) therapeutic drug was approved in 2017, cellular immunotherapy drugs have continued to develop and become a hot spot in the field of biopharmaceuticals. In recent years, with the development of biotechnology, new CAR-T designs have emerged, and their indications have also expanded from hematological tumors to solid tumors, autoimmune diseases, and viral infections. Through optimized design, the activity of novel CAR-T cells has been continuously enhanced, while the toxicity reduced. Meanwhile, in order to further explore the safety and efficacy of CAR-T cells, its non-clinical evaluation models and methods have constantly been improving. In order to provide new ideas and considerations for the safety evaluation of immune cell therapy products, the latest research progress of CAR-T cell therapy and related new non-clinical evaluation methods are reviewed.

A small GTPase encoded by Kirsten rat sarcoma viral proto oncogene (RAS) is a key regulatory protein in multiple cellular signaling pathways. The mutation of glycine to cysteine (G12C) at position 12 often leads to abnormal activation of cellular pathways, which plays an important role in the occurrence and development of tumors. Small molecule covalent inhibitors targeting KRAS^G12C protein can directly inhibit the abnormal activation of cellular pathways caused by KRAS^G12C mutation. In this paper, the structure and function of KRAS protein, as well as the research and development progress, challenges and possible solutions of covalent inhibitors of its G12C mutant are reviewed. The development direction of (K) RAS inhibitors in the future is prospected in order to provide a useful reference for the research and development of such inhibitors.

The scale of pediatric drug use in China exceeds 60 billion, but the quantity of pediatric drugs is limited and the variety is few, making the R&D and drug innovation is particularly necessary. Since children's esophagus is narrow, the respiratory tracts prematurely develop and the medication compliance is low, traditional drug dosage forms such as capsule, tablet, and decoction are easy to cause throat blockage, choking and even suffocation. According to the characteristics of children when taking medicine, the concept of oral gels has been put forward in foreign countries to improve the compliance of pediatric patients to take medicine and reduce the risk of aspiration. Based on the review of related literature in China and abroad, we conclude the common matrix and preparation methods of children's oral gels, summarize the characteristics and quality control methods of the dosage forms. Examples are given to show the general research situation of application both in China and abroad, as well as the situation of registration and listing, in order to promote the development of domestic pediatric oral gels, broaden the space of pediatric drugs' research and development, promote the exploitation of new pediatric drugs to protect children's health.