I-Mab, a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, announced the signing of a partnership agreement with the Hangzhou Qiantang New Area in China to manufacture its innovative drugs locally and accelerate its transition to commercialization. This strategic partnership will accelerate I-Mab’s commercialization strategy with an execution plan and timeline to commercialize its innovative assets, including felzartamab (TJ202/MOR202), and meet unmet medical needs for patients in China.
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“Today’s announcement demonstrates the Company’s commitment to translating our scientific innovation into clinical and commercial value as soon as possible so that we can provide more high-quality, affordable options for patients through locally-manufactured, innovative drugs,” said Yifei Zhu, Chief Commercial Officer, I-Mab. “This brings us one step closer to our new commercial model that integrates manufacturing, distribution and sales.”
I-Mab Hangzhou has commenced pilot operation in phase I facility, which is equipped with process development and analytical laboratories and in parallel the construction of phase II facility with an 80,000-square-meter manufacturing floor space was completed in December 2021. The GMP operations and quality systems will be fully compliant with standards and requirements of China’s National Medical Product Administration (NMPA), the U.S. Food and Drug Administration (FDA), and the European Medicines Agency (EMA). It also lays the foundation for I-Mab to meet IND (investigational new drug) supply and future commercial demand.
The first planned I-Mab’s innovative assets to be locally manufactured at I-Mab Hangzhou is felzartamab (TJ202/MOR202), a differentiated antibody drug. I-Mab has completed third line Multiple Myeloma (MM) trial of felzartamab successfully, achieving primary and secondary clinical endpoints which validate the product’s differentiated clinical advantages. In addition, patient enrollment for a randomized, open-label, parallel-controlled phase 3 trial for felzartamab, in combination with lenalidomide, for second-line MM treatment was completed in the second half of 2021. I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.
Felzartamab is an investigational human monoclonal antibody derived from MorphoSys’ HuCAL® antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. According to its suggested mode of action, the antibody recruits cells of the body’s immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).