Research and Development

Overview

CinnaGen was founded based on research and development of biotechnological products. We produced several molecular biology reagents and diagnostic kits based on our research activities. Our research approaches reached us to realization of biosimilar medicines, first and only in Iran, MENA region and even the world. CinnaGen Research & Development team committee to develop new biosimilar drugs for quality of life and health level improvement of man kinds specially our compatriots. Discovery research is essential to long-term success in our industry, therefor, our ambition is create first Iranian new drug in the world. CinnaGen allocates and invests big part of its annual revenue in R&D (about 20%) to achieve and create new biopharmaceutical drug and be recognized as the biggest research-based biopharmaceutical company around the MENA.

Process Development

Highest quality need to improve and develop process and products criteria. Our mission in development area is improvement of our production process, analytical methods and implementation of new techniques and technologies to achieve better yield and highest quality and efficiency. We work on cloning & cell line development, upstream development, synthesis of critical APIs in field of multiple Sclerosis (MS), Cancer, and infertility and Osteoporosis diseases, downstream development, and formulation development.

Scientific Collaboration

 We believe that faster and better research and development activity realize based on good scientific collaboration with research centers and researchers around the world. Therefor regarding our mission we have constructive scientific partnership and collaboration with Fraunhofer institute (Germany), Boku University (Austria), British Colombia University (Canada), UGA Biopharma (Germany), Medical university of Tehran (Iran), Shahid Beheshti medical University (Iran) and other several research institutes. CinnaGen in line with its social responsibility grant research thesis about biopharmaceutical industry and disease such as MS, Cancer and infertility.

Clinical trials

Clinical trials are scientific study on humans in the medical fields which is based on the specific protocol. According to the WHO definition, a clinical trial is any research study that prospectively assigns human participants to one or more health-related interventions to evaluate the effects on health outcomes. Interventions include but are not restricted to drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, process-of-care changes, preventive care, etc. In these studies, participants are divided into two or more groups (arm), and investigational interventions are received by one of these groups. Then, by comparison of the outcomes, drugs or new therapeutic methods and the advantages and disadvantages of their use will be assessed. After approving of quality and safety of a new medication by preclinical studies, and also achieving approval from authorities, a clinical study is allowed to be performed. A clinical trial should be conducted under supervision of experienced investigators and based on a specific designed plan called protocol.

Investigators should consider the following matters before starting to conduct a clinical trial:

• Evaluation of eligibility criteria
• Determining the sample size in each arm
• The time required to conduct the study
• Investigating limitation and providing a solution to eliminate them
• dose and route of administrative medication.
• The methods of analysis

Clinical trials of novel pharmaceutical molecules which are first introduced to the world include four phases, each phase has specific objectives are as follows:

Phase Ι of clinical trials : This phase of clinical trial is performed on limited number of healthy volunteers or patients (in case of chemotherapy agents and medication with high side effects) for the first time to evaluate the safety and determine the effective dose of the drug in humans

Phase ΙI of clinical trials : This study includes more volunteer or patients (compared to the prior phase) to assess side effects and effectiveness of novel drugs or treatments.

Phase ΙII of clinical trials : This study included more patients (compared to the second phase) and conducted during a longer time to assess side effects and effectiveness of novel drugs or treatments.

Phase ΙV of clinical trials : After approving the phase III study outcomes by corresponding authorities, the medicine is allowed to be launched into the market while surveillance of efficacy and safety of the medicine must be continued in a national and global scales.

regarding Iran food and drug regulatory system, to market biosimilar product (recombinant protein products that are similar to the originator’s in terms of efficacy and safety), performing Phase III clinical trials are absolutely mandatory. This phase of study is in order to ensure the efficacy and safety of a biosimilar are similar to the originator’s. CinnaGen Pharmaceutical Group, a leading group in field of chemical and biological production in Iran, is responsible for conducting several clinical trials in the country to ensure the efficacy and safety of its biosimilar products.