Enlituo (cetuximab biosimilar) / Mabpharm Limited, Sorrento, Simcere - LARVOL DELTA

THE INCLUSION OF THREE INNOVATIVE DRUGS, COSELA, ENLITUO AND SANBEXIN, IN THE NEW NATIONAL REIMBURSEMENT DRUG LIST [Google translation] (HKEXnews) - "The board (the 'Board') of directors (the 'Directors') of the Company is pleased to announce that, on November 28, 2024, the National Healthcare Security Administration and the Ministry of Human Resources and Social Security published the 'Drugs Catalogue for the National Basic Medical Insurance, Work-related Injury Insurance and Maternity Insurance (2024)'...pursuant to which...innovative drugs of the Group, including COSELA (Trilaciclib Hydrochloride for Injection), ENLITUO (Cetuximab Beta Injection)...were successfully included in the New NRDL."

Reimbursement • Oncology • Solid Tumor

CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=520 | Completed | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | Active, not recruiting ➔ Completed

Metastases • Trial completion • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Oncology • Solid Tumor • BRAF • RAS

Simcere Zaiming Announce Approval of Cetuximab Beta in China by the NMPA (PRNewswire) - P3 | N=520 | NCT03206151 | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | "On June 25, 2024, Simcere Zaiming...announced that Enlituo...has recently received approval from the China National Medical Administration (NMPA) for marketing. Enlituo is indicated for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC)...Enlituo received approval based on robust evidence from a phase 2/3 study and a phase 3 confirmatory clinical trial...Clinical data revealed that combining cetuximab beta with FOLFIRI significantly extended progression-free survival (PFS) compared to FOLFIRI alone (13.133 months vs. 9.567 months, P = 0.004). Additionally, the combination increased the objective response rate (ORR) (69.1% vs. 42.3%, P < 0.001) and overall survival (OS) (2.322 years vs. 1.900 years, P = 0.024)."

China approval • P3 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=520 | Active, not recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | Trial completion date: Jun 2023 ➔ Jun 2024

Metastases • Trial completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • RAS

Highly drug/target-tolerant neutralizing antibody (NAb) assay development through target-based drug depletion and drug-based NAb extraction for an anti-EGFR therapeutic monoclonal antibody. (PubMed, J Pharm Biomed Anal) - "One of the requirements for the clinical research of a Erbitux biobetter candidate (CMAB009) is to develop a neutralizing antibody (NAb) assay, and sufficient drug and target tolerance for the assay is necessary...Following troubleshooting and optimization, the NAb assay was validated for clinical sample analysis with the sensitivity of 92 ng/mL, drug tolerance of 70 μg/mL and target tolerance of 798 ng/mL. The innovative drug depletion and NAb extraction achieved though the combination of drug and target beads would enable the development of reliable NAb assays for many other therapeutics that overcome drug and its target interference for more precise and sensitive NAb assessment."

Journal

Mab Pharmaceutical-B (02181) Subsidiary entered into a CMAB009 commercial interest cooperation agreement in Mainland China with Jiangsu Xiansheng Zaiming [Google translation] (Stockstar) - "Zhitong Finance APP News, Mab Pharmaceutical-B (02181) announced that on August 18, 2023, Taizhou Mabtech Pharmaceutical Co., Ltd., an indirect wholly-owned subsidiary of the company, and Simcere Pharmaceutical (02096) wholly-owned Subsidiary Jiangsu Xiansheng Zaiming Pharmaceutical Co., Ltd. entered into a commercial rights cooperation agreement, pursuant to which, Taizhou Pharmaceuticals granted Jiangsu Xiansheng Zaiming the exclusive commercial rights of CMAB009 in mainland China (including but not limited to the sale of CMAB009 in the cooperation area management, marketing promotion, formulation and adjustment of related strategies and the right to obtain related benefits, etc.). Taizhou Pharmaceutical will continue to own all the rights and interests of CMAB009 in the cooperation area, except for the above-mentioned commercial interests."

Licensing / partnership • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=520 | Active, not recruiting | Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd | Trial completion date: Jun 2022 ➔ Jun 2023

Trial completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • RAS

CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer (clinicaltrials.gov) - P3; N=520; Active, not recruiting; Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer (clinicaltrials.gov) - P3; N=512; Recruiting; Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd; Trial completion date: Dec 2021 ➔ Jun 2022; Trial primary completion date: Oct 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

CMAB009 Combined With FOLFIRI First-line Treatment in Patients With RAS/BRAF Wild-type, Metastatic Colorectal Cancer (clinicaltrials.gov) - P3; N=512; Recruiting; Sponsor: Taizhou Mabtech Pharmaceutical Co.,Ltd; Trial completion date: Apr 2021 ➔ Dec 2021; Trial primary completion date: Jul 2020 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF

Sorrento announces positive data from phase 3 studies of biosimilar antibodies, STI-001 and STI-002 (Sorrento Therapeutics Press Release) - P3, N=501 & 330; "Sorrento Therapeutics...announced today that its partner, MabTech Ltd. has successfully completed Phase 3 clinical trials in China for STI-001...and STI-002...STI-001 was well tolerated. Adverse events (AEs), especially Grade 3 and 4 AEs were found to be significantly fewer than those previously reported using Erbitux...STI-002 demonstrated an improvement in RA patients' pain symptoms, functions, quality of life and inflammation markers while also inhibiting bone and joint injuries...'MabTech is applying for marketing approval of STI-001 and STI-002 in China, Sorrento Biologics...is expediting our efforts for the development and commercialization of these products...including the North America, Europe and Japan...'"

Anticipated BLA • Anticipated EU regulatory • Anticipated Japanese regulatory • Anticipated non-US regulatory • P3 data • Biosimilar