Halpryza (rituximab biosimilar) / Innovent Biologics, Eli Lilly - LARVOL DELTA

Innovent Announces Inclusion in the China National Reimbursement Drug List (NRDL) of TYVYT in Two New Indications, Olverembatinib for the First Listing, BYVASDA, HALPRYZA and SULINNO in Multiple New Indications (PRNewswire) - "Innovent Biologics...announced that, five products (including new indications) of the company have been included in the updated National Reimbursement Drug List (2022 Version) ('NRDL')....The updated NRDL will officially take effect on March 1st, 2023....HALPRYZA® (rituximab injection): HALPRYZA® is newly included in the NRDL for the maintenance therapy for previously untreated follicular lymphoma and the treatment of chronic lymphocytic leukemia. HALPRYZA® has been approved in China for the treatment of non-Hodgkin's lymphoma and chronic lymphocytic leukemia, all of which are included in the NRDL."

Reimbursement • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Ascentage Pharma and Innovent Biologics Reach Multifaceted Strategic Agreement Totaling US$245 Million Including Commercialization of Olverembatinib (HQP1351) in China, Joint Clinical Development of Lisaftoclax (APG-2575) and Equity Investment (PRNewswire) - "According to the agreement, Innovent and Ascentage Pharma will be jointly responsible for the subsequent R&D of HQP1351 in China. Upon being granted a New Drug Application (NDA) approval, the two companies will jointly commercialize HQP1351 in China and equally split the profit generated by the joint commercialization...The two companies agree to jointly explore the development of APG-2575 with the anti-CD20 monoclonal antibody HALPRYZA® (rituximab biosimilar injection) and the anti-CD47 monoclonal antibody letaplimab (IBI188) in certain indications."

Clinical • Commercial • Licensing / partnership • Oncology

Efficacy and Safety of the Biosimilar 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): A Randomized, Double-Blind, Parallel-Group, Phase 3 Trial. (PubMed, Adv Ther) - P3 | "IBI301 had a non-inferiority efficacy and a comparable safety compared with rituximab. IBI301 plus CHOP could be suggested as a candidate treatment regimen for untreated patients with CD20 DLBCL."

Clinical • Journal • P3 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

"#InnoventBiologics and #EliLilly Jointly Announce the #NMPA Granted Marketing Approval for #HALPRYZA (#RituximabInjection) in China $LLY https://t.co/cAGRsHWlZE" (@1stOncology)

Innovent and Lilly Jointly Announce the NMPA Granted Marketing Approval for HALPRYZA (Rituximab Injection) in China (PRNewswire) - “Innovent Biologics, Inc…and Eli Lilly and Company…jointly announce that HALPRYZA® (rituximab injection), a recombinant human/murine chimeric monoclonal antibody drug co-developed by Innovent and Lilly, has been officially approved by the National Medical Products Administration (NMPA) of China for patients with diffuse large b cell lymphoma (DLBCL), follicular lymphoma (FL), and chronic lymphocytic leukemia (CLL) in China.”

Non-US regulatory • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

[VIRTUAL] Biosimilar in China- Will Indication-Based Approach Help Improve Patient Access? (ISPOR-EU 2020) - P3 | "Domestic biotechnology company Innovent in collaboration with Eli Lilly followed shortly with an application for IBI301 in CD20-Positive Lymphoma which was accepted for review in June 2019. However, with an active trial in iBCL, HLX01 may be seeking to demonstrate clinical benefit in targeted patient subgroups that are more difficult-to-treat in the on-label indications as compared to rituximab. This would potentially improve physician perceptions of biosimilars and their willingness to prescribe and use in clinical practice."

Clinical • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immunology • Indolent Lymphoma • Inflammatory Arthritis • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rheumatoid Arthritis • Rheumatology • CD20

A Study to Assess the Pharmacokinetics and Safety of Recombinant Human Murine Chimeric Anti CD20 Monoclonal Antibody Injection (IBI301) Compared to Rituximab Injection in CD20 Positive B Cell Lymphoma Patients (clinicaltrials.gov) - P1; N=181; Completed; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Recruiting ➔ Completed; Trial completion date: Apr 2018 ➔ Oct 2019

Trial completion • Trial completion date • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

A Study Comparing the Efficacy and Safety Between I-CHOP and R-CHOP in Untreated CD20-Positive Diffuse Large B-cell Lymphoma Patients (clinicaltrials.gov) - P3; N=420; Completed; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; Recruiting ➔ Completed; Trial completion date: Dec 2018 ➔ Dec 2019; Trial primary completion date: Dec 2018 ➔ Sep 2019

Clinical • Combination therapy • Trial completion • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

Pharmacokinetics and safety of IBI301 versus rituximab in patients with CD20 B-cell lymphoma: a multicenter, randomized, double-blind, parallel-controlled study. (PubMed, Sci Rep) - "IBI301 was PK bioequivalent to rituximab in patients with CD20 B-cell lymphoma. The PD, safety, and immunogenicity profiles of IBI301 were similar to those of rituximab."

Clinical • Journal • PK/PD data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19 • CD20

Innovent announces financial results for full year ended December 31, 2019 and corporate progress (PRNewswire) - “IBI-301 (rituximab biosimilar): Receive the NDA approval by late 2020 or early 2021; IBI-310, an anti-CTLA-4 monoclonal antibody: Enroll the first patient in a Phase 3 study in melanoma and a pivotal Phase 2 study dMRD or MSI-H locally-advanced or metastatic colorectal cancer in China in the first half of 2020, in each case combined with Tyvyt; IBI-188, a potentially best-in-class anti-CD47 monoclonal antibody: Expected to initiate a global pivotal registration study with first patient enrolled in the second half of 2020 in both US and China.”

Enrollment status • NDA • New trial

Innovent provides update on two studies of IBI301 (rituximab biosimilar) in the treatment of CD20-positive lymphoma at Annual Meeting of CSCO (PRNewswire) - "Innovent Biologics...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."

P3 data • PK/PD data

"#NMPA Accepts New Drug Application for #IBI301, a Biosimilar Product Candidate of #Rituximab (#MabThera/#Rituxan) https://t.co/0oXIqlwr9n" (@1stOncology)

NDA

NMPA accepts New Drug Application for IBI301, a biosimilar product candidate of rituximab (MabThera/Rituxan) (PRNewswire) - "Innovent Biologics...and Eli Lilly and Company...jointly announced...that the National Medical Products Administration (NMPA) has accepted its new drug application (NDA) for IBI301, a co-developed biosimilar product candidate of rituximab (MabThera/Rituxan)....IBI301 is a recombinant human-mouse chimeric anti-cell surface protein (anti-CD20) monoclonal antibody for injection co-developed by Lilly and Innovent for the treatment of non-Hodgkin's lymphoma (NHL) and other diseases."

Non-US regulatory

Two clinical studies with IBI301, a biosimilar candidate to rituximab, met primary endpoints (PRNewswire) - P1, N=140; NCT02945215; P3, N=400; NCT02867566; Sponsor: Innovent Biologics (Suzhou) Co. Ltd.; "Innovent Biologics, Inc. (Innovent) (HKEX: 01801) and Eli Lilly and Company ("Lilly") jointly announced today that IBI301...has met pre-defined primary endpoints in two randomized clinical trials comparing IBI301 to rituximab, namely: a phase III clinical trial (CIBI301A301) in patients with diffuse large B-cell lymphoma (DLBCL) and a pharmacokinetic (PK) study (CIBI301A201) in patients with CD20-positive B-cell lymphoma. The details of these studies will be disclosed in future publications in scientific journals and conferences."

P1 data • P3 data