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Medicilon was awarded the Top Ten Drug Innovation Service Organizations of the Year in the 2021 Drug Innovation Award

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On April 20th, the "2021 Drug Innovation Award", sponsored by Securities Times, was officially released after rounds of the company's self-recommendation, recommendation, online voting and expert selection.
Shanghai Medicilon Inc. (Medicilon) was listed on the "Top Ten Drug Innovation Service Organizations of the Year".

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The "2021 Drug Innovation Award" aims to promote the development of the innovative drug industry through the selection of outstanding drug innovation individuals, projects and enterprises in China. The event attracted the participation of nearly 100 pharmaceutical and innovative drug R&D companies and drew extensive attention from industry experts and academia.
Innovation is the development strategy that Medicilon has always adhered to.  In the process of development, Medicilon has always strengthened R&D innovation with a global perspective such as vigorously developing drug R&D technologies with independent IP rights, forward-looking layout of a diversified and high-tech innovative R&D service platform, facilitating the cross-integration of new drug R&D, big data and AI, and hire and train the high-end innovative talent teams.  Medicilon continues to focus the importance on multi-dimensional innovation and enhances its core competitiveness for sustainable high-quality development.
Innovation drives the continuous upgrading and expansion of services, and also drives the continuous development and growth of Medicilon.  Medicilon has carried out diversified collaboration with 1,460 pharmaceutical companies, research institutions and scientific researchers around the world, providing one-stop R&D services from lead compound screening and optimization to new drug clinical approval application.  Medicilon has successfully assisted the registration of 221 IND R&D projects, and actively boost the speed and efficiency, and lower the cost of new drug R&D.
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Vastpro and Medicilon signed a strategic cooperation agreement for pre-clinical IND application services

On July 15, 2021, Vastpro and Medicilon signed a strategic cooperation agreement  in the Medicilon Chuansha Park  to reach a long-term strategic cooperation relationship.

At the signing ceremony, Dr. Chunlin Chen, Founder & CEO of Medicilon, first extended a warm welcome to the visit of  Vastpro and his entourage, and expressed his enthusiasm and confidence in the upcoming strategic cooperation between the two parties.


Talking about IND application

IND, Investigational New Drug, generally refers to a new drug that has not been approved for marketing and is undergoing clinical trials at various stages. In actual applications, IND or CTA (clinical trial application) has become synonymous with pre-marketing human clinical trials.

The IND application may be one or a sequential group of studies, with the purpose of obtaining evidence of product safety and effectiveness. Generally speaking, INDs can be divided into commercial INDs and non-commercial INDs.


Pharmaceutical Research of Innovative Drug IND Application

In 2013, the FDA again issued a guideline “Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND”.

The guideline is designed to help clinical applicants determine whether relevant studies must be Research, such as 21 CFR 312; and specified when an IND application is required and under what circumstances an IND application is not required, and a certain scope of application has been determined.


The United States Exempts the IND's BA/BE Safety Report Requirements

Not all BA/BEs meet the requirements of IND exemption (that is, there is no need to submit an IND application and perform clinical trials in accordance with IND requirements). For example, BA/BE involving cytotoxic drugs does not meet the requirements of IND exemption.

The guidelines followed by the US IND and BA/BE safety reports are 21 CFR 312.32, 312.64(b) and 320.31(d)(3). The requirements and time limits of the two security reports are not consistent. The former focuses on reports of suspicious and unexpected serious adverse events (SUSAR), while the latter focuses on reports of serious adverse events (SAE).

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