SUZHOU, China, Sept. 20, 2019 /PRNewswire/ -- Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops and commercializes high quality medicines for the treatment of oncology, metabolic and other major diseases, announced today that the data for two studies of IBI301, a rituximab biosimilar co-developed with Eli Lilly and Company, was presented at the 22nd Annual Meeting of Chinese Society of Clinical Oncology (CSCO).
The two clinical trials are CTR20160770 and CTR20160493. CTR20160770 is a multicenter, randomized, double-blind, parallel-controlled trial for pharmacokinetics and safety of recombinant chimeric murine/human anti-CD20 monoclonal antibody (IBI301) in comparison with rituximab in patients with CD20-positive B-cell lymphoma. CTR20160493 is a randomized, double-blind, parallel-group, Phase 3 trial for efficacy and safety study of IBI301 plus standard CHOP (I-CHOP) in comparison with rituximab plus CHOP (R-CHOP) in patients with previously untreated Diffuse Large B-cell Lymphoma (DLBCL).
At present, the major indications approved for rituximab in China are follicular non-Hodgkin's lymphoma (NHL) and DLBCL. Branded rituximab has been well recognized for its proven efficacy and safety profile. There are still huge unmet needs in China due to the relatively low affordability. IBI301, the biosimilar product candidate of rituximab, is expected to offer a high-quality and affordable alternative to patients in China. Based on the clinical data of the two clinical studies, the efficacy and safety comparative study in patients with DLBCL and pharmacokinetics (PK) study in patients with CD20-positive B-cell lymphoma have been conducted. Both studies directly compared IBI301 with rituximab and achieved the intended primary endpoint.
In the PK comparison study of IBI301 with rituximab in patients with CD20-positive B-cell lymphoma, a total of 181 patients were enrolled in the IBI301 (n=89) and rituximab (n=92) groups. The geometric mean ratios and 90% CIs of AUC0-inf between IBI301 and rituximab groups are all within the predetermined bioequivalence range (80.00% ~125.00%), which shown bioequivalent of IBI301 with the original drug.
In the Phase 3 comparison study of IBI301 and rituximab in combination with standard chemotherapy (CHOP) for patients with DLBCL, 420 subjects were enrolled with 1:1 randomization. The cutoff date is January 18, 2019. The ORR of IBI301 group and original drug group evaluated by central image was 89.9% and 93.8% respectively, which are well within the threshold qualifying for biosimilarity. This study has reached the primary end point. It confirmed that IBI301 is equivalent to rituximab in clinical efficacy and safety for the initial treatment of DLBCL. Based on the clinical data, the new drug application (NDA) of IBI301 was accepted by the NMPA in June 2019 and has been granted priority review status.
"The two clinical studies with rituximab as the control arm have shown the PK equivalence of IBI301 with rituximab in CD20+B-cell lymphoma patients who achieved CR/CRu after treatment, and the safety and tolerance similarity of both drugs. The launch of IBI301, a high quality rituximab biosimilar co-developed with Eli Lilly and Company, will improve drug accessibility and benefit more patients," said Professor Lugui Qiu from Blood Diseases Hospital, Chinese Academy of Medical Sciences.
"The Phase 3 study comparing IBI301 and rituximab in combination with standard chemotherapy (CHOP) in patients with DLBCL shows a comparable ORR and safety profile with the branded rituximab, which suggests biosimilarity between IBI301 and branded rituximab. We hope that the drug can be launched soon to benefit more lymphoma patients," said Professor Zhu Jun, Beijing Cancer Hospital.
"Innovent is strive to develop and commercialize high quality biopharmaceuticals that are affordable to ordinary people. The clinical results of IBI301 are very exciting, we hope to benefit more patients and their families through our efforts," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent.
IBI301 is a potential biosimilar of rituximab, a recombinant human-mouse chimeric anti-CD20 monoclonal antibody for injection, and is being co-developed by Innovent and Eli Lilly and Company. Rituximab binds to the CD20 antigen on the surface of B lymphocytes and mediates complement-dependent cytotoxicity (CDC) and antibody-dependent cellular cytotoxicity (ADCC). Normal and malignant B cells are targeted for destruction by the antibody, thereby achieving anti-tumor and immunosuppressive therapeutic effects.
Inspired by the spirit of "Start with Integrity, Succeed through Action," Innovent's mission is to develop and commercialize high quality biopharmaceutical products that are affordable to ordinary people. Established in 2011, Innovent is committed to developing, manufacturing and commercializing high quality innovative medicines for the treatment of oncology, autoimmunity and other major diseases. On October 31, 2018, Innovent was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code: 01801.HK.
Since it was founded, Innovent has developed a fully-integrated platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), clinical development and commercialization capabilities. Leveraging the platform, the company has built a robust pipeline of 21 innovative assets in the fields of oncology, metabolic diseases and other major therapeutic areas. Sixteen have entered into clinical development, four have entered Phase 3 clinical trials, three monoclonal antibodies have their New Drug Application (NDA) under review and three of them have been granted with priority review status, and one, Tyvyt® (sintilimab injection), is now approved for relapsed or refractory classical Hodgkin's lymphoma (r/r cHL).
Innovent has built an international team of advanced talents in high-end biological drug development and commercialization, including many overseas experts. The company has also entered into strategic collaborations with Eli Lilly and Company, Adimab, Incyte, Hanmi and other international pharmaceutical companies. Innovent strives to work with all relevant parties to help advance China's biopharmaceutical industry, improve drug availability to ordinary people and enhance the quality of the patients' lives. For more information, please visit： www.innoventbio.com.
About Eli Lilly and Company
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
About Innovent Biologics' strategic collaboration with Eli Lilly and Company
Eli Lilly and Company (Lilly) and Innovent Biologics (Innovent) in March 2015 announced one of the largest biotech drug development collaborations in China to date between a multi-national and domestic company. Under the terms of the agreement, Lilly and Innovent will collaborate on the development and potential commercialization of at least three cancer treatments over the next decade. In October 2015, they announced an expansion of their drug development collaboration. The Innovent and Lilly partnership is one of the most comprehensive strategic collaborations between a Chinese company and a multinational partner in terms of the scope and breadth ranging from discovery to commercialization and involving up to six therapeutic antibodies for cancers. In August 2019, Lilly and Innovent announced a new licensing agreement, expanding the collaborative drug development to diabetes and associated metabolic diseases.
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