Intellective Bio 2023 Annual Summary-Newsroom

First Commercial Project Passed NMPA On-site Inspection: In April 2023, Intellective Bio's first commercial manufacturing project successfully passed the NMPA's drug registration on-site inspection and GMP compliance inspection, with zero major or critical deficiencies.

Completed RMB 300 Million C+ Round Financing: Introduced new investors including CMC Capital, An Cheng Capital, Yunqi Capital, and Xinye Fund.

Annual Contract Value Surpassed RMB 1.05 Billion: Signed contracts totalling RMB 1.05 billion in 2023, with a backlog of RMB 1.94 billion. The total number of Phase III and commercial projects reached 11.

Accelerated Internationalisation: Signed an R&D and manufacturing service agreement with the internationally renowned biopharma company Biocad for an ADC project. Signed multiple R&D and production service agreements with partners in Europe and Southeast Asia. CEO Alex Li was invited to attend the APEC CEO Summit in San Francisco in November 2023.

Annual Revenue Reached RMB 550 Million: Intellective Bio achieved revenue of RMB 550 million in 2023. Executed a total of 138 projects covering various biologics such as antibodies, fusion proteins, vaccines, and ADCs.

Cumulatively Helped Clients Obtain 57 Clinical Trial Approvals: Helped clients secure 25 clinical trial approvals in 2023 and submitted 1 BLA application. Cumulatively assisted clients in obtaining 57 approvals, covering China, the US, New Zealand, Australia, etc.

6000 L Stainless-Steel Production Line Commissioned: The first 6000 L commercial project achieved successful PPQ in a single attempt. Completed 11 consecutive batches of 6000 L GMP production throughout the year with a 100% success rate.

Plant III Commissioned in 18 Months, Total Commissioned Capacity Reached 50,000 Litres: From groundbreaking to first 6000 L harvest, Plant III was completed in 18 months. Obtained the Drug Production Licence and EU QP certification within six months of operation. Passed 58 quality audits from clients, government, and third parties in 2023.

Proprietary Media Successfully Applied: The R&D team's self-developed CHO-K1 chemically defined medium completed PPQ for three batches in a 6000 L bioreactor.

Proprietary Software Developed and Applied: Ten proprietary business systems developed by the R&D team were successfully implemented, covering R&D, testing, and operations.