On January 28, 2022 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported 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 (Press release, I-Mab Biopharma, JAN 28, 2022, View Source [SID1234607474]). 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.
About Felzartamab
Felzartamab (TJ202/MOR202) 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). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific research suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.
HuCAL is a registered trademark of MorphoSys AG.
About Multiple Myeloma in China
Multiple myeloma (MM) is the second most common hematologic malignancy in China, accounting for approximately 1 percent of all cancers and 13 percent of all blood malignancies. Being primarily a disease of the elderly, the incidence of MM in China, which was about 1.6 per 100,000 in 2020, is expected to grow exponentially with the country’s aging population.1 The prognosis of patients with relapsed or refractory MM remains poor, with a huge unmet need for expanding the progression-free survival and overall survival of MM patients.