With the deep understanding of chemistry and engineering problems, our CMC team is excelled at the development of safe, scalable, robust and cost-effective chemical processes for complex molecules, addressing the great demand from pharmaceutical and the related chemical industries. Through the years, our team is pioneered in the development of two types of generic drugs, both are highly demanded in Chinese market and overseas.
1) Iodine-based and gadolinium-based contrast agents;
2) Natural product based anti-tumor drugs such as Eribulin, Lurbinectedin, Trabectedin, DXD and their analogs that can also be utilized as payloads for ADC.
Types | Product | API & Formulation | Development Status | Note |
---|---|---|---|---|
Contrast Agents | Iopromide | DMF/ANDA | Approved in China | Licensed out |
lodixanol | DMF/ANDA | Approved in China | Licensed out | |
loversol | DMF/ANDA | Submission for approval in China | Licensed out | |
XL-804 | DMF/ANDA | Submission for approval in China | Licensed out | |
XL-571 | DMF/ANDA | Process Development | Co-Development | |
XL-389 | DMF/ANDA | DMF Filed in China | MAH | |
Anti-tumor Drugs | Eribulin | DMF/ANDA | Submission for approval in China and US | MAH |
Lurbinectedin | DMF | API available by April 2024 | MAH | |
Trabectedin | DMF | API available by June 2024 | MAH |
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