Technical Platform

High-End Generic Drug Platform

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.

Eribulin

The API and key intermediates have successfully registered as DMF in China and the United States, accessible by domestic and overseas partners. ANDA applications of eribulin mesylate injection were submitted both in China and the United States, and are expected to be approved by the end of 2024. We also work with partners to expand the sale of the API and FDF in Europe and other regions.

Iopromide

On August 30, 2022, Lopromide injection, co-developed by Xiling Lab and Beite Pharmaceuticals, received approval from NMPA (National Drug Approval H20223632). This marks the first official approval of this generic drug globally since it was introduced to market in 1985.

Selected Products of Generic Drugs

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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