About

Strategy: API+FDF.

API：

● Focus on natural-sourced and anti-tumor API sectors, and build an international technical platform covering R&D and manufacturing, patent filing & patent challenges, quality research and regulatory registration.

● Expand the macromolecule pipeline to develop featured product series such as peptides and glycans.

● Tap into the full potential of XDC drugs to build a distinctive product portfolio of toxins and linkers.

● Own a global registration platform and professional team, supported by cGMP-compliant manufacturing quality systems aligned with international standards.

● Provide API CMO/CDMO services, and support clients with triple registration filings in China, the US and Europe as well as worldwide registration work.

FDF：

● License In/Out

● CRO Service:

● Lab-scale process development, pilot-scale process development, and clinical BE study protocol design.

10

Average Annual Experience

20

Successful Projects

100

Registration Countries

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Technical platform

R&D and Production Platform

● IND / NDA (new salts, new crystal form) / ANDA

● Polypeptide / Glycans

● Playload & Linker

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International Quality Research and Registration Platform

● Experienced registration team with more than 10 years experience, and knowledge of registration-related regulations in China, the US Europe and other countries.

● With experience in drug registration in Europe, America, Japan, Eastern Europe, Southeast Asia and other countries, as well as official GMP certifications such as EDQM, FDA, PMDA, NMPA, COFEPRIS, MHRA, etc.

● With experience in more than 100 different countries, we can provide different registration services to meet the different needs of our clients.

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Globle Patent Application and Challenge Platform

● Establish and maintain our own Intellectual Property System Architecture.

● Focusing on the direction of new salts, new crystal forms, new preparation methods, new compounds, etc., to provide customers with services such as new drug development and ANDA P-IV challenges.

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Setting up R&D and production platform for new salt and crystal form, deep cooperation with clients for IND, NDA, ANDA, 505b(2) or P-IV challenge.

About

10

20

100

Product Center

Commercial Drug Subtance

Self-Developed /ADC Products

Linker

CDMO Service

Technical platform

R&D and Production Platform

International Quality Research and Registration Platform

Globle Patent Application and Challenge Platform

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