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The development of innovative drugs is an extremely exploratory research process, which usually starts from the unknown and carries out drug screening and discovery based on unmet clinical needs. Different from generic drugs, research on innovative drugs is gradually carried out with different stages. The depth of each stage of research usually corresponds to theRead more

Introduction to IND 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 groupRead more

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.Vastpro president Huang Ping, CEO Zhu Wenfeng, Commercial Director Fang Yuan, Medicilon founder & CEO Chen Chunlin, Chief Scientific Officer Peng Shuangqing, Vice President of Business Development Department Cai Jinna, and SeniorRead more

On February 22, 2021, Nanjing TransThera Biosciences Co., Ltd. (“TransThera”) and the life science company of South Korea’s LG Chem (“LG Chem”) jointly announced the VAP-1 inhibitor TT-01025 (LG0030317) Successfully achieved the first subject administration in the United States. TransThera also announced that the company has completed the submission of an IND clinical trial applicationRead more

In the development of innovative drugs, the progress of the process development of the IND phase of the API often directly affects the subsequent formulation development, preclinical and clinical research, and final commercialization. How to plan and manage the API process development in the IND phase, and how to do the quality control of theRead more

On December 9-10, 2019, the “Fifth Pharmaceutical Frontier Summit Forum” was held concurrently during the “Nanjing International Life and Health Technology Expo”, with the theme of “Leading Life Science and Technology, Empowering the Health Industry”, through academician reports and round tables Dialogues, special exchanges, exhibitions and other ways to gather innovative resources, focus on theRead more

Medicilon CEO Chun-Lin Chen gave a speech during the seminar where he shared his experience on IND filling for both US and China. Professor Shuangqing Peng had a topic on New Drug Safety Evaluation Approach. Dr. Baomin Xin, Medicilon VP of DMPK and BA, shared his experience on big molecule analytical approach and future trend,Read more

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 serviceRead more

Medicilon provide the IND filing for the preclinical services. Medicilon could submit the application for both US FDA and CFDA for your new drug. Medicilon is the first CRO to offer preclinical animal testing service for the global pharmaceutical companies in China. Medicilon is the CRO that fulfill both the Chinese and US GLP standards.Read more