Chugai R&D Glossary

Antibody Drugs
The human body is protected by a defense system that operates by recognizing proteins of bacteria, viruses, etc., as foreign substances (antigens) and producing antibody proteins that attack the foreign substances (the antigen-antibody reaction). Drugs that utilize this innate response of the human body are antibody drugs.
Best in class
A drug that offers clear advantages over other existing drugs in the same category, such as those with the same molecular target.
Drugs created by applying biotechnology such as genetic recombination and cell fusion. A therapeutic antibody that Chugai discovered, developed and in 2005 began manufacturing Japan’s first is included in biopharmaceuticals. Biopharmaceuticals are usually supplied for injection type.
Breakthrough therapy designation
Breakthrough therapy designation was introduced by FDA Safety and Innovation Act(FDASIA)in July 2012. Its purpose is to expedite the development and review of medicines to treat serious or life-threatening diseases or conditions.
Chugai Pharmabody Research Pte. Ltd.
This company was established in January 2012 as a wholly-owned subsidiary of Chugai Pharmaceutical. It is a laboratory that conducts research focusing on the generation of new antibody drugs by utilizing Chugai’s proprietary innovative antibody engineering technologies.
Clinical Development
A study to assess the safety, efficacy and other characteristics of a drug in human subjects.
Development Pipeline
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.
Development Synergy Effect
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.
DMPK (Drug Metabolism and Pharmacokinetics)
Research the process that a candidate is absorbed, distributed, metabolized and excreted by the body.
First in class
An original drug that is highly novel and useful, and will significantly change the therapeutic system.
Genentech, Inc.
Genentech is a leader in the biotechnology industry, with headquarters in South San Francisco, USA. It was established in 1976 by Robert Swanson and Dr. Herbert Boyer, a pioneer who established the basic techniques of genetic recombination. The company successfully mass-produced human insulin and human growth hormone. It joined the Roche Group in 1990.
GLP (Good Laboratory Practice)
The practice for non-clinical safety assessments of the drug
Information Exchange
Chugai Pharmaceutical and Roche hold regular Joint Research Committee and Joint Development Committee meetings, and regularly exchange information related to R&D in each country and region. This information exchange can be expected to shorten new-drug development periods, enable mutual utilisation of clinical data, etc.
Joint Ventures
In joint ventures, Chugai Pharmaceutical participates in R&D projects by actually investing in partner companies.
Seeds of drug
Line extention
A new indication for a previously approved drug.
Mid-Size Molecule Technology
A technology of significant potential, as they enables approach causative agents of diseases, which is difficult to target with antibodies and small molecules.
Modality refers to the material classification of a drug. (Small molecule, Antibody, Mid-size molecule, etc)
Molecular Entities
This refers to any pure substance composed of two or more elements that is formed by a chemical reaction.
Verify optimal dose of candidate and method of using it.
Phase I Clinical pharmacology (Healthy volunteer/Patient)
Performed on a small number of healthy volunteers (or, for certain therapeutic fields and diseases, on patients) to assess the drug’s safety and the process by which it is absorbed, distributed, metabolized and excreted by the body.
Phase II Exploratory/Confirmatory (Patient)
Performed on a small number of consenting patients to determine the safest and most effective dosage and the dosing regimen.
Phase III Confirmatory (Patient)
Performed on a large number of consenting patients to confirm the efficacy and safety of the new drug in comparison with existing drugs or placebo.
PoC/Early PoC
Proof of concept (PoC) is confirmation that the therapeutic effect conceived in the research stage is effective in humans. Early PoC means that in addition to safety, signs of efficacy or pharmacological effect have been confirmed in a limited number of cases.
Preclinical studies
A study to assess safety, efficacy and other characteristics of a drug using animal subjects.
R&D Portfolio Management
This refers to the study and implementation of the optimal allocation of management resources to R&D projects, for the commercialisation of new drugs. Adjustments to maximise portfolio value and to appropriately balance investments are important. The set of development plans that are actually being realised is called the "development pipeline".
A pharmaceutical company established in 1896 and headquartered in Basel, Switzerland. With business operations in more than 150 countries, the Roche Group contributes to medicine in a wide range of fields through its two business segments: pharmaceuticals and diagnostics. Central to the Roche Group’s strategy is personalized healthcare, the approach of selecting the most appropriate treatment by using biomarkers and diagnostic tests to identify patients most likely to show a significant response to a particular drug.
Roche Group Websites:
Select candidate designed to specifically inhibit the action of a target molecule from several million seeds of drug.
Small Molecules
Drugs created by chemical synthesis technology. Small Molecules are the classic drugs and usually supplies for oral type.
Strategic Alliance with Roche
In October 2002, Chugai merged with Nippon Roche, a wholly owned subsidiary of Roche, and the surviving entity, Chugai Pharmaceutical, became a member of the Roche Group. As a result, Chugai Pharmaceutical gained an infrastructure that allows it to expand its business, both in Japan and overseas.
Target molecule identification
Identify a target molecule that is implicated in a disease process by understanding the real molecular mechanism of the disease.
Unmet medical needs
Medical need that is not adequately met due to a lack of effective treatment.
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