According to the pharmaceutical and biotech industry on the 13th, Samsung Biologics was confirmed to have signed a conditional commercial production contract for zumilokibart early this year with Apogee, which AbbVie is in the process of acquiring. Under the deal, Samsung Biologics will handle commercial active pharmaceutical ingredient production if zumilokibart receives regulatory approval. Samsung Biologics also secured a termination fee worth several million dollars, including contractual obligation costs, should distribution become impossible due to issues on the developer's side.
The contract expands the CDO deal Samsung Biologics signed with Apogee in February last year. At that time, Samsung Biologics agreed to handle clinical batch production, process characterization, and validation of the novel drug candidate. Zumilokibart is an autoimmune disease treatment indicated for conditions such as atopic dermatitis, and is being developed with the goal of entering phase 3 clinical trials within the year and commercialization in 2029. It is regarded as the core asset that led AbbVie to acquire Apogee for about $10.9 billion, having shown potential as a next-generation standard-of-care therapy in phase 2 trials. AbbVie is the company that developed "Humira," an autoimmune disease treatment that was the world's top-selling drug by revenue until Keytruda broke the record.
Samsung Biologics also joined Eli Lilly's phase 2 clinical trials in China last month for the autoimmune disease treatment "LY4005130." A candidate for treating conditions such as vitiligo and alopecia areata, the industry believes Samsung Biologics likely took on clinical batch production and other tasks. Since CDO firms that collaborate from the clinical stage often go on to handle commercial production after approval, this is expected to lead to a CMO contract as well.
Samsung Biologics has also conducted CDO work for autoimmune disease candidates in the past. With HanAll Biopharma's "batoclimab," the two companies collaborated on cell line development, production process development, and clinical sample production from 2021. Immunovant, a subsidiary of U.S.-based Roivant, later licensed the substance and signed a CMO contract, but commercial production effectively fell through after batoclimab failed its phase 3 trial in April this year. In contrast, the two recent candidates are being developed directly by big pharma firms such as AbbVie and Lilly, so their prospects for eventual commercialization are seen as high.
Unlike CMO, in which drugs are produced based on a completed manufacturing process handed over, CDO is a business that builds the manufacturing foundation for candidate substances. Because it involves participation from the early stages of drug development, it allows the accumulation of data on the characteristics and manufacturing of candidate substances, serving as a foundation for strengthening the competitiveness of the contract development and manufacturing organization (CDMO) business. An industry official said, "Since CDO often leads to CMO several years later, it has the effect of pre-securing production volume," adding, "Competitor Lonza generates about 30% of its total revenue from CDO, and China's WuXi Biologics generates about 40%, showing how much they are focusing on it."
Meanwhile, Samsung Biologics started with CMO in 2011 and entered the CDO business in 2018. As of early this year, it had signed a cumulative 164 CDO contracts, 49 of which received Investigational New Drug (IND) approval. Unlike the early stages of the business, which centered on domestic biotech firms, 70-80% of clients are now known to be global. Lee Sang-myung, executive vice president in charge of CDO development at Samsung Biologics, stressed at the JP Morgan Healthcare Conference early this year, "By combining Samsung Biologics' technology, know-how, and infrastructure with our clients' ideas, we will establish ourselves as a one-stop partner spanning the entire novel drug development cycle."
