Medicilon´s IND Application Platform

Medicilon’s IND application service platform has an in-depth understanding of the regulatory and policy environment of China and the United States and its technical requirements for chemical drugs. It can provide domestic customers with CFDA IND declaration and USFDA IND/ANDA declaration services; it can provide foreign customers with CFDA IND /ANDA declaration service.

The service targets of Medicilon’s IND application platform include not only clients who do a complete set of preclinical research on Medicilon, but also pharmaceutical industry counterparts who require separate registration and declaration. The details are as follows:

Medicilon IND Application Service:

◇ Preparation and submission of CFDA IND documents for domestic customers;

◇ Submission of USFDA IND/ANDA documents as an agent for domestic customers;

◇ Submission of CFDA IND/ANDA documents as an agent for foreign clients;

◇ Provide project management services (limited to clients who provide preclinical research services by Medicilon);

◇ Review, sort out and technical evaluation of the IND/ANDA application documents provided by the customer; and then complete the compilation, review, editing and finalization.

Before submitting the application materials, Medicilon’s registration department will organize an internal technical communication meeting to analyze the application items in detail; after the application materials are submitted, there will be a senior application leader who will continue to communicate with the regulatory agency and follow up the application progress in real time until the application is submitted. Done successfully. In addition, according to the analysis of domestic drug declaration data in recent years, the country’s policy of encouraging innovation has clearly appeared in drug declaration, so it is foreseeable that innovative drugs have a good development momentum in China.

Projects independently declared by Medicilon to complete the entire set of preclinical studies:

◇ 3 IND packages are accepted by US FDA;

◇ 3 IND packages are accepted by TGA;

◇ 15 IND packages have been approved by CFDA;

◇ 10 IND packages have been submitted to CFDA

The complete set of pre-clinical research and declared public projects independently completed by Medicilon:

◇ FZ016, Class 1 chemical drug, plans to apply for CFDA and USFDA IND, has obtained CFDA clinical approval in August 2016, and will apply for USFDA soon

◇ X842, a chemical drug category 1, plans to apply for CFDA, EMEA and USFDA IND. It has submitted EMEA CTA in November 2016 and CFDA IND in January 2017. It will apply for USFDA soon.

Note: The complete set of pre-clinical research includes: API production process and quality research, preparation process and quality research, efficacy, pharmacokinetics and safety evaluation

In order to avoid registration risks, Medicilon’s application service platform can customize practical registration strategies for customers, ensure timely and accurate submission of application materials, and track the review progress in time to help customers quickly complete the registration review process.

Advantages of Medicilon IND application service:

◇ Have a professional IND, ANDA research team, which can provide one-stop research, full project management and reporting services;

◇ Possess a wealth of CFDA, USFDA review expert resources, and can provide targeted technology, regulations, and reporting strategy suggestions.

The management team of Medicilon IND service platform is composed of senior experts led by vice presidents of various departments. It wholeheartedly provides one-stop services for pharmaceutical research, non-clinical research and clinical application for Chinese and American customers.

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