SHANGHAI and GAITHERSBURG, Md., Jan. 28, 2022 /PRNewswire/ — I-Mab (the “Firm”) (Nasdaq: IMAB), a clinical-stage biopharmaceutical firm dedicated to the invention, improvement, and commercialization of novel biologics, introduced the signing of a partnership settlement with the Hangzhou Qiantang New Space in China to fabricate its modern medication domestically and speed up its transition to commercialization. This strategic partnership will speed up I-Mab’s commercialization technique with an execution plan and timeline to commercialize its modern belongings, together with felzartamab (TJ202/MOR202), and meet unmet medical wants for sufferers in China.
“As we speak’s announcement demonstrates the Firm’s dedication to translating our scientific innovation into medical and business worth as quickly as potential in order that we will present extra high-quality, reasonably priced choices for sufferers via locally-manufactured, modern medication,” stated Yifei Zhu, Chief Business Officer, I-Mab. “This brings us one step nearer to our new business mannequin that integrates manufacturing, distribution and gross sales.”
I-Mab Hangzhou has commenced pilot operation in section I facility, which is provided with course of improvement and analytical laboratories and in parallel the development of section II facility with an 80,000-square-meter manufacturing ground area was accomplished in December 2021. The GMP operations and high quality methods shall be absolutely compliant with requirements and necessities of China’s Nationwide Medical Product Administration (NMPA), the U.S. Meals and Drug Administration (FDA), and the European Medicines Company (EMA). It additionally lays the muse for I-Mab to fulfill IND (investigational new drug) provide and future business demand.
The primary deliberate I-Mab’s modern belongings to be domestically manufactured at I-Mab Hangzhou is felzartamab (TJ202/MOR202), a differentiated antibody drug. I-Mab has accomplished third line A number of Myeloma (MM) trial of felzartamab efficiently, attaining major and secondary medical endpoints which validate the product’s differentiated medical benefits. As well as, affected person enrollment for a randomized, open-label, parallel-controlled section 3 trial for felzartamab, together with lenalidomide, for second-line MM remedy was accomplished within the second half of 2021. I-Mab owns the unique rights for improvement and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.
Felzartamab (TJ202/MOR202) is an investigational human monoclonal antibody derived from MorphoSys’ HuCAL® antibody expertise. The antibody is directed towards CD38 on the floor of a number of myeloma cells, which has been characterised as one of the vital strongly and uniformly expressed antigens on the floor of malignant plasma cells. Based on its advised mode of motion, the antibody recruits cells of the physique’s immune system to kill the tumor via antibody-dependent mobile cytotoxicity (ADCC) and antibody-dependent mobile phagocytosis (ADCP). The antibody doesn’t contain complement dependent cytotoxicity, or CDC, an extra immune mechanism concerned in tumor cell killing. Scientific analysis means that an anti-CD38 antibody might have therapeutic potential additionally in different cancers in addition to autoimmune illnesses. Primarily based on a licensing settlement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the unique rights for improvement and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.
HuCAL® is a registered trademark of MorphoSys AG.
About A number of Myeloma in China
A number of myeloma (MM) is the second most typical hematologic malignancy in China, accounting for roughly 1 p.c of all cancers and 13 p.c of all blood malignancies. Being primarily a illness of the aged, the incidence of MM in China, which was about 1.6 per 100,000 in 2020, is anticipated to develop exponentially with the nation’s growing old inhabitants.1 The prognosis of sufferers with relapsed or refractory MM stays poor, with an enormous unmet want for increasing the progression-free survival and general survival of MM sufferers.
I-Mab (Nasdaq: IMAB) is an innovation-driven international biopharma firm centered on the invention, improvement and commercialization of novel and extremely differentiated biologics for immuno-oncology and autoimmune illnesses. The Firm’s mission is to convey transformational medicines to sufferers world wide via innovation. I-Mab’s globally aggressive pipeline of greater than 20 medical and preclinical-stage drug candidates is pushed by its inner discovery and international partnerships for in-licensing, primarily based on the Firm’s Quick-to-Proof-of-Idea and Quick-to-Market improvement methods. The Firm is progressing from a clinical-stage biotech firm into a totally built-in international biopharmaceutical firm with cutting-edge R&D capabilities, a world-class GMP manufacturing facility, and business functionality. I-Mab has established its international footprint in Shanghai (headquarters), Beijing, Hangzhou, Guangzhou, Lishui and Hong Kong in China, and Maryland and San Diego in the US. For extra data, please go to https://ir.i-mabbiopharma.com and comply with I-Mab on LinkedIn, Twitter , and WeChat.
I-Mab Ahead-Trying Statements
This press launch comprises forward-looking statements throughout the which means of the Non-public Securities Litigation Reform Act of 1995 and different federal securities legal guidelines, together with statements relating to knowledge from the felzartamab medical research, the potential implications of medical knowledge for sufferers, and I-Mab’s development of, and anticipated medical improvement, regulatory milestones, and commercialization of felzartamab. Precise outcomes might differ materially from these indicated within the forward-looking statements because of varied essential elements, together with however not restricted to I-Mab’s potential to show the security and efficacy of its drug candidates; the medical outcomes for its drug candidates, which can not assist additional improvement or NDA/BLA approval; the content material and timing of selections made by the related regulatory authorities relating to regulatory approval of I-Mab’s drug candidates; I-Mab’s potential to realize business success for its drug candidates, if accepted; I-Mab’s potential to acquire and keep safety of mental property for its expertise and medicines; I-Mab’s reliance on third events to conduct drug improvement, manufacturing and different providers; I-Mab’s restricted working historical past and I-Mab’s potential to acquire extra funding for operations and to finish the event and commercialization of its drug candidates; and the affect of the COVID-19 pandemic on the Firm’s medical improvement, business and different operations, in addition to these dangers extra absolutely mentioned within the “Threat Elements” part in I-Mab’s most up-to-date annual report on Kind 20-F, in addition to discussions of potential dangers, uncertainties, and different essential elements in I-Mab’s subsequent filings with the US Securities and Alternate Fee. All forward-looking statements are primarily based on data at present accessible to I-Mab, and I-Mab undertakes no obligation to publicly replace or revise any forward-looking statements, whether or not because of new data, future occasions or in any other case, besides as could also be required by regulation.
For extra data, please contact:
John Lengthy, Chief Monetary Officer
E-mail: [email protected]
Workplace line: +86 21 6057 8000
Gigi Feng, Chief Communications Officer
E-mail: [email protected]
Workplace line: +86 21 6057 5709
The Piacente Group, Inc.
E-mail: [email protected]
Workplace line: + 86 21 6039 8363
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