Meiyouheng (becotatug vedotin) / Lepu Med - LARVOL DELTA

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

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

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

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

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

MRG003 CLINICAL TRIAL RESULTS SELECTED AS LBA FOR ORAL PRESENTATION AT 2025 ASCO ANNUAL MEETING (HKEXnews) - "The board of directors of the Company is pleased to announce that, the results of the pivotal Phase IIb study for the treatment of recurrent or metastatic nasopharyngeal cancer ('R/M NPC') for our drug candidate MRG003, an innovative antibody drug conjugate ('ADC') drug candidate independently developed by us targeting epidermal growth factor receptor ('EGFR'), was selected as 'late breaking abstract (LBA)' for oral presentation at the 2025 American Society of Clinical Oncology (the 'ASCO') Annual Meeting."

Late-breaking abstract • P2b data • Nasopharyngeal Carcinoma

UPDATE ON NEW DRUG APPLICATION OF MRG003 (HKEXnews) - "As disclosed in the Announcement, we have received the Acceptance Notice...issued by China National Medical Products Administration ('NMPA') in relation to the acceptance of the NDA of MRG003 in September 2024, and has been granted priority review by the Centre for Drug Evaluation ('CDE') of the NMPA (the 'Priority Review'). The authority is currently proceeding with the clinical and pharmaceutical evaluation of MRG003 in an orderly manner. Based on the latest communication between the Company and the authority, in order to submit relevant supplementary information, the Company has voluntarily withdrawn the previous NDA of MRG003, and has already supplemented relevant application materials and prepared the eCTD documents. The Company will resubmit an NDA for MRG003 on March 4, 2025 and will use its best endeavors to work with the authority in its subsequent review procedures to obtain the NDA approval."

China filing • Priority review • Nasopharyngeal Carcinoma

Preliminary results of phase II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC) (ESMO Asia 2024) - P1/2 | "It may provide an efficacious salvage treatment option for R/M-NPC pts who had failed anti-PD-(L)1 and platinum-based therapy. Further follow-up is ongoing."

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

Lepu Biotech (02157.HK)’s new drug marketing application for drug candidate MRG003 was accepted by the Food and Drug Administration [Google translation] (Yahoo Finance) - "Lepu Biotech...announced that it has received an 'Acceptance Notice' from the State Food and Drug Administration, and the new drug marketing application for its candidate drug MRG003 has been accepted. MRG003 has also been included in priority review by the NMPA Center for Drug Evaluation (CDE)....The new drug marketing application for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC) has been accepted. After the State Food and Drug Administration accepts the drug registration application for MRG003, MRG003 still needs to go through technical review, clinical trial on-site inspection, production on-site inspection and other procedures. It can only be marketed after obtaining NDA approval. The company will make every effort to promote the commercialization of MRG003 in the future."

China filing • Priority review • Nasopharyngeal Carcinoma

Lepu Biotech’s ADC pipeline has made significant progress [Google translation] (iis.aastocks.com) - "...MRG003 has completed patient enrollment in the NPC phase IIb registration clinical study and is expected to apply for an NDA in China in the second half of the year.....The company is currently conducting Phase II trials and has observed good data, which is planned to be presented at the 2024 ESMO Asia Annual Meeting."

China filing • P2 data • Nasopharyngeal Carcinoma • Solid Tumor

Lepu Bio-B(02157): MRG003 successfully obtained FDA approval as a breakthrough therapy for the treatment of R/M NPC (Zhitong Finance) - "According to the Zhitong Finance APP, Lepu Bio-B (02157) announced that the company's drug candidate MRG003 (an epidermal growth factor receptor (EGFR) targeted antibody drug conjugate (ADC) candidate and the company's core product) has recently been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the treatment of recurrent or metastatic nasopharyngeal carcinoma (R/M NPC). Previously, MRG003 has been granted BTD by the Center for Drug Evaluation (CDE) of the State Drug Administration of the People's Republic of China, Orphan Drug Designation (ODD) by the FDA, and Fast Track Designation (FTD) by the FDA for the treatment of R/M NPC. The company has also completed the enrollment of patients in the Phase IIb registration clinical study of MRG003 for nasopharyngeal carcinoma (NPC), and the company expects to submit a new drug application in China soon."

Breakthrough therapy • Enrollment closed • Fast track • Orphan drug • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor

A Phase II Study of MRG003 Injection Combined With Pucotenlimab Injection ± Cisplatin Injection in the Neoadjuvant Treatment Locally Advanced EGFR-positive Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Lei Liu

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

A Phase II Study of Anti-EGFR Antibody-drug Conjugate (ADC) Combine With CDK4/6 Inhibitors Posterior Line in the Treatment of Recurrent/Metastatic CDKN2A Gene Variant Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - P2 | N=30 | Not yet recruiting | Sponsor: Lei Liu

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

Preliminary results of phase I/II study to evaluate safety and efficacy of combination pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in patients with EGFR positive solid tumors. (ASCO 2024) - P1/2 | "The Phase I/II study pts treated with HX008 in combination with MRG003 demonstrated good tolerability and encouraging antitumor activity in NPC and SCCHN, especially in PD-1 treatment failed NPC pts. The Phase II study is currently ongoing. Research Sponsor: Shanghai Miracogen Inc."

Clinical • P1/2 data • Anemia • Dermatology • Head and Neck Cancer • Hematological Disorders • Nasopharyngeal Carcinoma • Oncology • Pruritus • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • EGFR

A systematic review of antibody-drug conjugates and bispecific antibodies in head and neck squamous cell carcinoma and nasopharyngeal carcinoma: Charting the course of future therapies. (PubMed, Cancer Treat Rev) - "ADC and BsAb antibodies show promise in R/M HNSCC and NPC. Results are premature by small sample sizes and lack of control arm. ADC mainly caused myelosuppression and a pneumonitis case, and BsAb IRR. Further research is warranted in this setting."

Journal • Review • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Pneumonia • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Lepu Biopharma Co, Ltd. Announces Results of Three Clinical Trials Presented at 2024 Asco Meeting Announces Presentation of Three Clinical Trial Results at 2024 Asco Annual Meeting [Google translation] (Zonebourse) - P1/2 | N=18 | NCT05688605 | Sponsor: Shanghai Miracogen Inc. | "Preliminary results of the phase I/II study to evaluate the safety and efficacy of the combination of Pucotenlimab with epidermal growth factor receptor-ADC (EGFR-ADC) MRG003 in EGFR patients -positive patients with solid tumors....As of the January 30, 2024 cutoff, 33 patients (9 patients with NPC, 1 with SCCHN and 3 other solid tumors in phase I, 14 patients with NPC and 6 with SCCHN in phase II) were enrolled in this study, with a median age of 52 years, and 25 patients were male. Of the 27 evaluable patients, 17 patients achieved a PR and 7 patients achieved an SD, so the ORR and DCR were 63.0% (95% CI: 42.4, 80.6) and 88.9, respectively. % (95% CI: 70.8, 97.7)."

P1/2 data • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • EGFR