Meiyouheng (becotatug vedotin) / Lepu Med - LARVOL DELTA

Becotatug vedotin vs. chemotherapy in pre-heavily treated advanced nasopharyngeal carcinoma: A randomized, controlled, multicenter, open-label study. (ASCO 2025) - P2 | " Eligible pts with R/M NPC had failed ≥2 lines of systemic chemotherapy and PD-(L)1 inhibitor, and were randomized to receive MRG003 (2.3 mg/kg, d1, iv, Q3W) or chemotherapy (capecitabine 1000 mg/m2, po, twice daily, d1-14, Q3W; or docetaxel 75 mg/m2, iv, d1, Q3W). As the first ADC clinical study targeting heavily pretreated R/M NPC, becotatug vedotin demonstrated statistically and clinically meaningful benefits while maintaining a manageable safety profile in this population. This study will lead to a paradigm shift in the treatment of R/M NPC. Sponsor: Lepu Biopharma Co., Ltd."

Clinical • Late-breaking abstract • Metastases • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=238 | Active, not recruiting | Sponsor: Shanghai Miracogen Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Feb 2025 ➔ Dec 2026

Enrollment closed • Trial completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Pucotenlimab Combined With Becotatug Vedotin in Advanced Cutaneous Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=38 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Non-melanoma Skin Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Neoadjuvant Becotatug Vedotin Plus Pucotenlimab and Cisplatin for Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

RearTurbo: Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=227 | Not yet recruiting | Sponsor: Kai Hu | N=150 ➔ 227 | Trial completion date: Dec 2031 ➔ Dec 2032

Enrollment change • Trial completion date • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

MRG003 Combined With Immunotherapy in Recurrent/Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: West China Hospital

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Phase II Clinical Trial of Anti-EGFR Antibody-drug Conjugate (ADC) Combined With or Without Immune Checkpoint Inhibitors in the Neoadjuvant Treatment of Resectable Locally Advanced Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=120 | Not yet recruiting | Sponsor: West China Hospital

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

Updated long term efficacy results of phase II study for becotatug vedotin combined with pucotenlimab in recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC) (ESMO 2025) - "It may provide an efficacious treatment option for R/M-NPC pts who had failed anti-PD-(L)1 and platinum-based therapy. The efficacy and safety of MRG003 combined with HX008 in NPC is currently undergoing further investigation in randomized controlled clinical trials."

Clinical • Metastases • P2 data • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • EGFR

Efficacy and Safety of Becotatug Vedotin (EGFR ADC) plus Pucotenlimab and Cisplatin as Neoadjuvant Therapy for LA-HNSCC (ChiCTR) - P=N/A | N=30 | Not yet recruiting | Sponsor: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

New trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • PD-L1

Becotatug Vedotin in Patients with Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck: A Multicenter, Phase IIa Trial. (PubMed, Clin Cancer Res) - P2 | "Becotatug vedotin demonstrated promising antitumor activity with a manageable safety profile in previously heavilytreated R/M SCCHN, particularly the recommended dose of 2.3 mg/kg in patients who had failed platinum-based chemotherapy and PD-1/PD-L1 inhibitors (≤2 prior lines of therapy)."

Journal • P2a data • Constipation • Dermatology • Gastroenterology • Gastrointestinal Disorder • Head and Neck Cancer • Hematological Disorders • Oncology • Pruritus • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Magic-C002: A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=446 | Recruiting | Sponsor: Shanghai Miracogen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

MRG003 Induction and Capecitabine Maintenance With PD-1 in Locally Recurrent NPC (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: Fujian Cancer Hospital

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

RearTurbo: Becotatug Vedotin as Adjuvant Therapy For High-risk Nasopharyngeal Carcinoma (clinicaltrials.gov) - P2 | N=150 | Not yet recruiting | Sponsor: Kai Hu

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

Pembrolizumab + MRGOO3 as Neoadjuvant in NPC (clinicaltrials.gov) - P2 | N=35 | Not yet recruiting | Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

New P2 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

BioDlink...took center stage at Biologics CDMO Europe 2025 to present its critical role in the regulatory approval and manufacturing support of the world's first approved EGFR-targeted antibody-drug conjugate (ADC) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). (PRNewswire) - "Dr. Zhang also introduced BioDlink's cross-regional project execution capabilities, providing case studies on how its integrated one-base, end-to-end CMC (Chemistry, Manufacturing, and Controls) platform facilitated seamless technology transfer, agile regulatory alignment, and accelerated manufacturing timelines....Further reinforcing its industry leadership, BioDlink was named Biologics CDMO of the Year at the Biologics CDMO Excellence Europe 2025 awards, recognized for its overall excellence in biologics across core customer needs, including quality, speed, and cost."

Commercial • Nasopharyngeal Carcinoma

On November 20, 2025, BioDlink…together with Lepu Biopharma…announced the successful market launch of MEIYOUHENG (Becotatug Vedotin injection) , the world's first EGFR-targeting antibody-drug conjugate (ADC) (PRNewswire) - "The first ADC fully manufactured by a CDMO to reach the market in China, underscoring a new level of maturity for the region's biopharmaceutical ecosystem."

Launch non-US • Nasopharyngeal Carcinoma

MRG003 and Pucotenlimab to Treat Locally Advanced or Metastatic ATC/PDTC (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Fudan University

New P2 trial • Oncology • Solid Tumor • Thyroid Gland Carcinoma • BRAF

Preliminary results of phase II study to evaluate safety and efficacy of becotatug vedotin in combination with pucotenlimab as first-line treatment for recurrent or metastatic squamous cell carcinoma of the head and neck (R/M-SCCHN) (ESMO 2025) - P1/2 | "There is further improved ORR trend as observed at higher dose cohort with 2.3mg/kg. Further follow-up is ongoing to determine the optimal dose of becotatug vedotin."

Clinical • Combination therapy • Metastases • P2 data • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

MARKETING APPROVAL OBTAINED IN CHINA FOR MEIYOUHENG (BECOTATUG VEDOTIN INJECTION) (HKEXnews) - "MEIYOUHENG (Becotatug Vedotin Injection) demonstrated clinically meaningful efficacy benefits while maintaining a manageable safety profile in patients who failed ≥2 lines of systemic chemotherapy and PD-(L)1 inhibitor therapy."

China approval • Nasopharyngeal Carcinoma

IDEAL: Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck (clinicaltrials.gov) - P2 | N=106 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete et Cou | Initiation date: Jun 2025 ➔ Oct 2025

Trial initiation date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

MH-Penile-001: MRG003 Plus HX008 as First-Line Treatment for EGFR-Positive Locally Advanced or Metastatic Penile Squamous Cell Carcinoma (clinicaltrials.gov) - P1 | N=10 | Not yet recruiting | Sponsor: Jiyan Liu

New P1 trial • Genito-urinary Cancer • Oncology • Penile Cancer • Solid Tumor • Squamous Cell Carcinoma

A Study to Evaluate the Efficacy and Safety of MRG003 in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of Head and Neck (clinicaltrials.gov) - P2 | N=116 | Recruiting | Sponsor: Shanghai Miracogen Inc. | Trial completion date: Sep 2023 ➔ Dec 2026 | Trial primary completion date: Jan 2023 ➔ Jun 2026

Trial completion date • Trial primary completion date • Head and Neck Cancer • Oncology • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

CS5007: A novel EGFR and HER3 dual-targeted antibody-drug conjugate (ADC) with potent antitumor activity in preclinical studies (AACR 2025) - "For instance, MRG003, an EGFR-targeted ADC, has shown encouraging clinical outcomes in NPC and HNSCC...Daiichi's HER3-ADC, U3-1402, has shown promising clinical results in advanced EGFR-mutant NSCLC, confirming HER3 as a valid therapeutic target for ADC. Additionally, BL-B01D1, an EGFR/HER3 bispecific ADC, has shown encouraging phase 1 data in advanced cancers... CS5007 is a promising dual-targeted ADC that demonstrates potent antitumor efficacy with a favorable safety and PK profile. These preclinical findings support its further IND-enabling studies and clinical investigations for the treatment of various advanced solid tumors."

Preclinical • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ERBB3

Magic-C002: A Study of MRG003 in Combination With Pucotenlimab Versus Chemotherapy in the Treatment of Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=446 | Not yet recruiting | Sponsor: Shanghai Miracogen Inc.

New P3 trial • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

IDEAL: Clinical Trial Comparing Induction Treatment With EGFR-ADC MRG003 Alone or in Combination With the Anti PD1 Pucotenlimab, Followed by Radiochemotherapy in Locally Advanced Squamous Cell Cancers of the Head and Neck (clinicaltrials.gov) - P2 | N=106 | Not yet recruiting | Sponsor: Groupe Oncologie Radiotherapie Tete et Cou

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