Chinese CMC: CMAB to make bi-functional antibody for BJ

BJ Bioscience has contracted CMAB Biopharma to provide research, development and manufacturing services for a candidate therapeutic antibody called BJ-005.

Under the deal, CMAB will conduct CMC development and manufacturing to support the planned submission of an IND for the candidate drug in China and the US.

No further details about BJ-005 were provided.

CMAB is based at the Suzhou Industrial Park in China. Image: Wikimedia/CC/Donaldytong

According to BJ Biosciences’ website the drug is a bi-functional antibody intended for the treatment of “cancer.” On the firm’s pipeline page the timing for IND submission is listed as Q4 2020.

BJ Bioscience chair Xiaoyong Jin said, “The primary goal for our cooperation with CMAB is that we may focus more on the innovative R&D fields that we are good at and leave the CMC part to CMAB because it is its expertise.

CEO Haizhou Zhang cited CMAB’s expert workforce, experience developing innovative products and “protection of the intellectual property rights of its customers” as key to winning it the contract.

Manufacturing capacity

CMAB is based at the Suzhou Industrial Park in China. The firm’s facility – which opened in 2018 – has capacity for pilot-scale development projects and commercial production.

The site houses 3,700m² of laboratory space and a 3,000m² GMP manufacturing unit, with reactor capacities ranging from 20 L to 2000 L.

The manufacturing facility was established last year after CMAB secured $34 million in a series B fundraising round.

At the time CMAB said the site would comply with international standards, including “those of the US Food & Drug Administration (21 CFR), European Medicines Agency (Eudralex), WHO, and harmonized PIC/S and ICH standards.”

Late last year CMAB set up an office in Basel, Switzerland.

CDMOs in China

The Chinese contract manufacturing sector is expected to experience growth as a result of the recently introduced Drug Administration Law (DAL).

The law, which was passed by the Chinese National People’s Congress on August 26, introduced a range of measures, including a marketing authorisation holder (MAH) system similar to those in place in the US and EU.

Part of the MAH programme covered the use of CDMOs. Previously, drug approvals were contingent on the developer investing in manufacturing capacity in the county.

However, in 2015 the Government introduced a pilot scheme allowing the approval of products whose manufacture was outsourced.