Datalai (cetuximab biosimilar) / Sichuan Kelun Pharma - LARVOL DELTA

Commercialization Accelerates: Sales & Market Access Expanding Footprint (PRNewswire) - "Sac- TMT, tagitanlimab and Cetuximab N01 have been successively launched, marking the full-scale initiation of commercialization. The Company expects to launch trastuzumab botidotin in the China market and file one NDA for A400 in the second half of 2025."

China filing • Launch non-US • Colorectal Cancer • HER2 Positive Breast Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

Market access (PRNewswire) - "Preparations for the National Reimburesement Drug List access of marketed products are underway. Currently, sac-TMT, tagitanlimab and Cetuximab N01bhave all passed the preliminary formal examination of National Reimbursement Drug List."

Reimbursement • Colorectal Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

A140 plus mFOLFOX6 compared with cetuximab plus mFOLFOX6 for first-line RAS wild-type metastatic colorectal cancer: A randomized clinical trial. (PubMed, Eur J Cancer) - P3 | "A140 plus mFOLFOX6 is equivalent to cetuximab plus mFOLFOX6 for RASwt mCRC, with no appreciable differences in safety profiles. A140 plus mFOLFOX6 may provide a new treatment option for patients with RASwt mCRC."

Clinical • Journal • Colorectal Cancer • Oncology • Solid Tumor • RAS

A140 plus mFOLFOX6 compared with cetuximab plus mFOLFOX6 for first-line RAS wild-type metastatic colorectal cancer: A randomized clinical trial (Eur J Cancer) - P3 | N=688 | NCT04835142 | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | "Overall, 688 patients were randomized to A140 (n=341) or cetuximab (n=347). As of 22-Mar-2023, the ORR was 71.0% (A140) and 77.5% (cetuximab); the ORR ratio was 0.93 (90% CI, 0.87-0.99). With a median follow-up of 19.6 months, no notable differences in PFS, OS, or duration of response were observed between arms. Safety profiles and immunogenicity were similar between arms and no new safety signals were observed."

P3 data • Colorectal Cancer

A Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of A140 Injection and Cetuximab (Erbitux®) in Healthy Chinese Male Subjects. (PubMed, Adv Ther) - "A140 demonstrated similar PK to cetuximab and comparable safety and immunogenicity in healthy Chinese male subjects."

Journal • P1 data • PK/PD data

VOLUNTARY ANNOUNCEMENT CETUXIMAB N01 INJECTION APPROVED FOR MARKETING BY THE NATIONAL MEDICAL PRODUCTS ADMINISTRATION (HKEXnews) - "The board (the 'Board') of directors ('Directors') of Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...is pleased to announce the Company received marketing authorization in China from the National Medical Products Administration (NMPA) for a recombinant epidermal growth factor receptor (EGFR) human-mouse chimeric monoclonal antibody ('mAb') Cetuximab N01 Injection (formerly A140)...used in combination with FOLFOX or FOLFIRI regimens for first-line treatment of rat sarcoma virus (RAS) wild-type metastatic colorectal cancer (mCRC) with 500 mg/m2 every other week (Q2W), or starting dose of 400 mg/m2 and maintenance dose of 250 mg/m2 weekly (Q1W). The authorization...is based on a randomized, double-blinded, controlled, multicenter phase III clinical study."

China approval • Colorectal Cancer

KL140-Ⅲ-02-CTP: Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC (clinicaltrials.gov) - P3 | N=688 | Completed | Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Apr 2023 ➔ Jan 2024

Trial completion • Trial completion date • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS • NRAS

Sichuan Kelun Pharmaceutical Co., Ltd.’s announcement that the marketing application for its main product A140 injection (cetuximab injection) has been accepted by NMPA [Google translation] (Shanghai Securities News) - "Sichuan Kelun Pharmaceutical Co., Ltd...recently learned that the company's holding subsidiary Sichuan Kelun Botai Biopharmaceutical Co., Ltd. (hereinafter referred to as 'Kelun Botai') developed the marketing application for A140 Injection (Cetuximab Injection, trade name: Datelai) was accepted by the Drug Evaluation Center of the State Drug Administration....This product is used to treat metastatic colorectal cancer with RAS gene wild-type: combined with FOLFOX or FOLFIRI regimen for first-line treatment; combined with irinotecan for patients who have failed irinotecan-containing treatment. This product is used to treat head and neck squamous cell carcinoma: in combination with platinum-based and fluorouracil chemotherapy for the first-line treatment of recurrent and/or metastatic disease; in combination with radiotherapy for the treatment of locally advanced disease."

Non-US regulatory • Colorectal Cancer • Gastrointestinal Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Kelun-Biotech Announces Interim Results for 2023 (Yahoo Finance) - "Today, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd...announced its interim results for the six months ended June 30, 2023....We have completed patient enrolment of A140 (Cetuximab biosimilar) in November 2022 with an anticipated NDA filing with NMPA for RAS wild-type mCRC in the second half of 2023. In July, the company commenced pivotal trial of A400 (RET inhibitor) for advanced RET+ NSCLC, a trial of A400 for advanced RET+ medullary thyroid carcinoma received IND approval from the NMPA."

Enrollment closed • Non-US regulatory • Trial status • Colorectal Cancer • Endocrine Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thyroid Gland Carcinoma • Thyroid Gland Medullary Carcinoma

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer (clinicaltrials.gov) - P2/3; N=613; Recruiting; Sponsor: National Cancer Institute (NCI); Active, not recruiting ➔ Recruiting

Clinical • Enrollment open • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • EGFR • PCR

Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2; N=124; Recruiting; Sponsor: Academic and Community Cancer Research United; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS

Comparison of A140 and Erbitux Combined With mfolfox6 to Evaluate Efficacy and Safety of First-line Treatment for Ras Wild-type mCRC (clinicaltrials.gov) - P3; N=686; Recruiting; Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

New P3 trial • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS • NRAS

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma (clinicaltrials.gov) - P2; N=70; Recruiting; Sponsor: Jonsson Comprehensive Cancer Center; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Head and Neck Cancer • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • KRAS

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer (clinicaltrials.gov) - P2/3; N=675; Active, not recruiting; Sponsor: Radiation Therapy Oncology Group; Trial completion date: May 2025 ➔ Jan 2032; Trial primary completion date: May 2020 ➔ Jan 2027

Clinical • Trial completion date • Trial primary completion date • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • EGFR • PCR

Radiation Therapy and Cisplatin With or Without Cetuximab in Treating Patients With HPV Positive, KRAS-Variant Stage III-IV Oropharyngeal Squamous Cell Carcinoma (clinicaltrials.gov) - P2; N=70; Not yet recruiting; Sponsor: Jonsson Comprehensive Cancer Center

Clinical • New P2 trial • Oncology • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • KRAS

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer (clinicaltrials.gov) - P2/3; N=675; Recruiting; Sponsor: Radiation Therapy Oncology Group

Clinical • New P2/3 trial • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • EGFR • PCR

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-Risk Head and Neck Cancer (clinicaltrials.gov) - P2/3; N=675; Active, not recruiting; Sponsor: Radiation Therapy Oncology Group; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Head and Neck Cancer • Hypopharyngeal Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD4 • EGFR • PCR

Utomilumab, Cetuximab, and Irinotecan Hydrochloride in Treating Patients With Metastatic Colorectal Cancer (clinicaltrials.gov) - P1; N=42; Active, not recruiting; Sponsor: M.D. Anderson Cancer Center; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MSI

LY3214996 and Cetuximab Alone or in Combination With Abemaciclib for the Treatment of Unresectable or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1b/2; N=46; Recruiting; Sponsor: M.D. Anderson Cancer Center; Not yet recruiting ➔ Recruiting; Trial primary completion date: Dec 2020 ➔ Dec 2021

Clinical • Combination therapy • Enrollment open • Trial primary completion date • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • KRAS • MAP2K1

Testing Docetaxel-Cetuximab or the Addition of an Immunotherapy Drug, Atezolizumab, to the Usual Chemotherapy and Radiation Therapy in High-risk Head and Neck Cancer (clinicaltrials.gov) - P2/3; N=613; Suspended; Sponsor: National Cancer Institute (NCI)

Clinical • New P2/3 trial • Head and Neck Cancer • Oncology • Oral Cancer • Oropharyngeal Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR • PCR

Lenalidomide and Cetuximab in Treating Patients With Advanced Colorectal Cancer or Head and Neck Cancer (clinicaltrials.gov) - P1; N=24; Completed; Sponsor: National Cancer Institute (NCI); Active, not recruiting ➔ Completed

Clinical • Trial completion • EGFR • KRAS

Irinotecan and Cetuximab With or Without Bevacizumab in Treating Patients With RAS Wild-Type Locally Advanced or Metastatic Colorectal Cancer That Cannot Be Removed by Surgery (clinicaltrials.gov) - P2; N=36; Completed; Sponsor: Academic and Community Cancer Research United; Active, not recruiting ➔ Completed

Clinical • Trial completion • EGFR

Encorafenib, Cetuximab, and Nivolumab in Treating Patients With Microsatellite Stable, BRAFV600E Mutated Unresectable or Metastatic Colorectal Cancer (clinicaltrials.gov) - P1/2; N=38; Recruiting; Sponsor: M.D. Anderson Cancer Center

Clinical • New P1/2 trial

Epidermal Growth Factor Receptor (EGFR) Antagonist Chimeric Anti-EGFR Monoclonal Antibody Trial (clinicaltrials.gov) - P3; N=570; Recruiting; Sponsor: Sichuan Kelun Pharmaceutical Research Institute Co., Ltd.

Clinical • New P3 trial

Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer (clinicaltrials.gov) - P2; N=124; Not yet recruiting; Sponsor: Academic and Community Cancer Research United; Initiation date: Nov 2019 ➔ Feb 2020

Clinical • Trial initiation date • BRAF • KRAS