Samsung Bioepis, a South Korean leader in biopharmaceuticals, has struck a deal with private equity firm C-Bridge Capital to develop and commercialize next-generation biosimilars in China. This strategic licensing agreement will see C-Bridge set up a new biopharma venture, AffaMed Therapeutics, to collaborate with Samsung Bioepis on key areas including clinical development, regulatory registration, and commercialization within the Chinese market.

This agreement covers several important biosimilar candidates developed by Samsung Bioepis, including SB11 (which references LUCENTIS for age-related macular degeneration), SB12 (a biosimilar to SOLIRIS, used for rare blood disorders), and SB3, a candidate referencing HERCEPTIN for breast cancer treatment. C-Bridge’s new company, AffaMed Therapeutics, will leverage its expertise in navigating China’s regulatory environment, helping expand access to these high-quality biosimilars for Chinese patients.

In terms of financials, Samsung Bioepis will receive an upfront payment followed by royalties on future sales, although the specific financial details have not been disclosed.

Strategic partnership to expand global reach

Christopher Hansung Ko, President and CEO of Samsung Bioepis, expressed confidence in the partnership, highlighting that C-Bridge’s proven track record in building successful biopharmaceutical ventures, such as AffaMed Therapeutics, makes it an ideal partner. Ko emphasized that the goal is to widen access to life-saving medicines, improving healthcare for patients across China.

Samsung Bioepis has already established a strong presence in Europe with four approved biosimilars, including BENEPALI (etanercept), FLIXABI (infliximab), IMRALDI (adalimumab), and ONTRUZANT (trastuzumab). In the United States, Samsung Bioepis has seen success with RENFLEXIS (infliximab-abda) and ONTRUZANT (trastuzumab-dttb). The company is currently awaiting FDA approval for SB5, its adalimumab biosimilar.

China remains a key growth market

Earlier in 2024, Samsung Bioepis also entered into a licensing agreement with Chinese biotech company 3SBio to further its biosimilar ambitions in China. This move strengthens Samsung Bioepis’ growing presence in the Chinese market, with the added benefit of C-Bridge’s local expertise, which could provide an edge in the highly competitive biosimilars landscape in China.

  AffaMed Therapeutics, biosimilars, C-Bridge Capital, China, FDA, Herceptin, lucentis, ONTRUZANT, RENFLEXIS, Samsung Bioepis, SB11, SB12, SB3, SOLIRIS