Chime Biologics has unveiled plans to scale up its manufacturing operations in China and expand into the Asia-Pacific markets.

The contract development and manufacturing organisation (CDMO) plans to increase its current drug substance capacity from 28,000L to around 100,000L, which will enable Chime to commercially manufacture 15 to 20 commercial products, as per Dr Jimmy Wei, president at Chime Biologics.

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Chime is headquartered in Wuhan, but Wei emphasises the company is a “100% foreign-owned company in China”, with all of its shareholders or investors residing in either the US, Europe, or Hong Kong. Due to this, the company is unlikely to be targeted by the BIOSECURE Act.

Chinese CDMOs have faced significant challenges since the introduction of the US BIOSECURE Act in January. The Act prohibits the purchase of equipment or contracting services from Chinese companies such as WuXi AppTec and WuXi Biologics. This has led to many pharmaceutical companies seeking CDMO partners with no ties to China.

Wei noted that “[Chime] is a pure CDMO, and does not touch the human side. For example, we don’t do any clinical trials, we don’t generate any genetic-related information. So, we are only there dealing with the drug substance and drug product. So, in that aspect, we’re quite different from some of our other larger competitors that offer a much broader service”.

Chime also plans to expand into the Asia-Pacific market, with Wei saying the company is building a team in Japan to target that area. He adds that Chime is also interested in emerging markets such as the Middle East, South America, and Africa, and plans to enter the biosimilar business, especially in the Asian-Pacific markets.

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Chime has also announced plans to expand beyond “traditional CDMO services” to include early-phase R&D such as the “early discovery stage service” and analytical testing. The company plans to become a “full-service global CDMO to cover almost all the major aspects of drug discovery, development and manufacturing”, with Wei adding “[Chime’s] goal is to become a global top ten CDMO and certainly top three in China”. 

Chime also plans to establish a European subsidiary in Switzerland, to expand its European business. The company also plans to expand its offerings from “traditional antibody protein manufacturing” to include antibody-drug conjugate (ADC) services.

ADCs have been an area of interest in recent months, with multiple companies investing in the space. In January, Roche signed a global partnership and licence deal with Medilink Therapeutics for its YL211 ADC against solid tumours. The deal is expected to be worth over $1bn in potential milestone payments.

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