Near-Term Product Portfolio and Commercialization
With the rapid progress of the pipeline, I-Mab’s lead assets, including felzartamab, eftansomatropin alfa, and lemzoparlimab for hematologic malignancies, are expected to achieve BLA submission or even market launch in the next three years between 2023 and 2025 in China. With the potential addition of another pre-BLA product for a hematologic malignancy indication, the Company anticipates its near-term product portfolio to include three products that effectively cover the three major disease entities of hematologic malignancies, i.e. AML, MDS, and NHL, by lemzoparlimab in various combinations with AZA, venetoclax, rituximab, and r/r MM by felzartamab in combination with lenalidomide and other agents. The fourth product, eftansomatropin alfa for PGHD, is also expected for BLA/launch within the period.
I-Mab’s commercialization strategy is to rapidly build up its market position in China as a leader in the therapeutic area of hematologic malignancies with the three key products leveraging various combinations and to become a major player with eftansomatropin alfa in the growth hormone market in China. This is backed by a longer-term portfolio between 2026 and 2028, which focuses primarily on solid tumors. Uliledlimab, efineptakin alfa, enoblituzumab, and lemzoparlimab are among the potential candidate products for solid tumors.
The Company’s near-term product portfolio has significant commercial potential. Firstly, the total annual incidences for three disease entities of major hematologic malignancies, i.e. multiple myeloma, leukemia (AML/MDS), and lymphoma, are estimated to be approximately 173,000 (Globocan, 2020) in China. Secondly, more than 3.4 million children are estimated to suffer from growth hormone deficiency in China. By leveraging the product differentiation, cost advantages by local manufacturing, first-mover advantages (potentially for lemzoparlimab) and commercial synergies, each product in the near-term portfolio has the potential to become a market leader or a major player in its respective therapeutic area.
I-Mab has taken concrete steps to prepare its position for commercialization of the near-term product portfolio. A core commercialization team has formed under the leadership of Mr. Yifei Zhu during the reporting period to cover all key commercialization functions, including market research, market access, medical affairs, pricing, etc. This initial commercialization capability will be expanded accordingly based on the schedule of BLA approvals of the near-term products. Efforts are already underway to work towards the commercialization strategy of “preparing the organization”, “preparing the market” and “preparing the product” for felzartamab. In October 2021, I-Mab entered a strategic partnership with Sinopharm Group Co. Ltd. (“Sinopharm”) as part of its effort to expand commercialization capabilities. I-Mab will authorize more than 300 of Sinopharm’s subsidiaries as distributors across China to support distribution and retail allocation to terminal markets while the Company leads overall commercial activities.
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