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
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.
C&C Research Laboratories
This company was established in January 1992 as a joint venture between Chugai Pharmaceutical (capital ratio:
50%) and Choongwae Pharma Corp. (South Korea) (capital ratio: 50%). Its new-drug laboratory in Hwaseong
(Gyeonggi Province, South Korea) conducts research commissioned by its two parent companies and also exploratory
research based on its own ideas.
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.
A study to assess the safety, efficacy and other characteristics of a drug in human subjects.
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
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 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
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.
In joint ventures, Chugai Pharmaceutical participates in R&D projects by actually investing in partner
Seeds of drug
Middle molecules are a technology of significant potential, as they enables approach causative agents of
diseases, which is difficult to target with antibodies and small molecules.
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.
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
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.