Clinical Development

To bring innovative pharmaceuticals to patients as quickly as possible, Chugai has established a lifecycle management* system for project-level integrated management of research, regulatory affairs, drug safety, manufacturing and other functions, and cooperates with numerous medical institutions and clinical research centers. In this way, we work to implement clinical trials distinguished by exceptional speed, efficiency and scientific rigor.

  • * The various measures taken to maximize the potential value of a drug, including shortening development time, expanding sales, extending the product’s life, and conducting appropriate cost control. Competitiveness can be strengthened further by using earnings from sales of established drugs to strategically reinvest in new drug development, marketing or other areas.

Chugai Pharmaceutical’s own in-house development pipeline has one of the strongest line-ups in Japan. By adding Roche and Genentech products based on license agreements with those companies, Chugai Pharmaceutical has benefited from a development synergy effect*1 and assembled a top-class, innovative domestic development pipeline*2.

  • *1 This refers to the synergistic effect that enables each pharmaceutical company to save large amounts of money and time in the new-drug development process by sharing know-how, R&D results, and data from research in progress.
  • *2 The set of products currently under development at a pharmaceutical company, from the initial development stage of each drug until the start of sales, is called the "development pipeline". The terms "product pipeline" and "new-drug pipeline" are also used.

Evolution of Clinical Development Using Digital Technology

In the early-stage clinical development up to proof of concept (PoC)*1, we are working to develop an intricate understanding of biological responses utilizing innovative technologies such as M&S*2 and human organoid construction*3, from the preclinical stages. These will be combined with the full use of real-world data (RWD) and a wealth of data on diseases and treatments that we have accumulated to improve the predictability of dosage and administration, efficacy, and safety, and to increase the success rates of clinical trials.

In the past, additional indications were developed in stages, but by using M&S and other scientific evidence, we now aim to identify target diseases at an early point and develop indications for multiple diseases simultaneously. Combining this with an understanding and analysis of biological responses, we will focus on the development of digital biomarkers (dBMs) and digital devices while identifying healthcare issues for each disease and linking the results from this work to appropriate diagnosis and treatment. Furthermore, by combining the data obtained in this way with RWD, we will demonstrate the True Endpoints that can help to improve patient QoL at the early stages, thereby maximizing the value delivered to patients.

In late-stage development, we will actively use digital technologies for monitoring and management tasks, and at the same time, we will promote reductions in the size and duration of studies through the use of RWD. In this way, we aim to deliver products to the market faster and reduce the burden on patients.

  • *1 Proof of concept: Confirmation that the therapeutic effect conceived in the research stage is effective in humans
  • *2 Technology that integrates computer-based mathematical simulations with biological sciences. Supports key decision-making during pharmaceutical development.
  • *3 Tissue structures designed to have similarities to organs in the human body

Co-Development and Joint Promotion with Roche

By concluding co-development/joint promotion agreements with Roche, Chugai Pharmaceutical has established a business model that enables it to develop and market its own products overseas as well as in Japan, and enables it to utilise Roche's global network. As a result of coordination of co-development with Roche in Europe and the United States, Chugai Pharmaceutical's development is proceeding more effectively and efficiently. Furthermore, Chugai Pharmaceutical's products can now be sold through Roche's overseas sales network, so the alliance can be expected increase sales.

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