This announcement is made by Lepu Biopharma Co., Ltd. (the “Company”) pursuant to Rule 13.09 of the Rules Governing the Listing of Securities on The Stock Exchange of Hong Kong Limited (the “Listing Rules”) and the Inside Information Provisions (as defined in the Listing Rules) under Part XIVA of the Securities and Futures Ordinance (Chapter 571, Laws of Hong Kong).

The board of directors of the Company (the “Board”) is pleased to announce that, the National Medical Products Administration (the “NMPA”) has recently granted marketing approval in China for our drug candidate MEIYOUHENG (Becotatug Vedotin Injection), an innovative antibody drug conjugate (“ADC”) independently developed by us targeting epidermal growth factor receptor (“EGFR”) for the treatment of recurrent or metastatic nasopharyngeal cancer (“R/M NPC”).

A. IMPACT ON THE COMPANY

MEIYOUHENG (Becotatug Vedotin Injection) is the first EGFR-targeted ADC approved for marketing in China, demonstrating its first-in-class potential. The approval of MEIYOUHENG (Becotatug Vedotin Injection) for R/M NPC, which is expected to improve treatment outcomes for patients, represents another important milestone for the Company. Building on this achievement, the Company will further expand additional indications for MEIYOUHENG (Becotatug Vedotin Injection) to accelerate the realization of its potential commercial value.

B. ABOUT MEIYOUHENG (BECOTATUG VEDOTIN INJECTION)

MEIYOUHENG (Becotatug Vedotin Injection) is an ADC comprised of an EGFR-targeted monoclonal antibody conjugated with the potent microtubulin inhibiting payload monomethyl auristatin E via a valine-citrulline linker. It binds specifically with high affinity to EGFR on the surface of tumor cells, releases the potent payload upon internalization and lysosomal protease cleavage of the linker and results in tumor cell death. EGFR is highly expressed in colorectal cancer, lung cancer, head and neck cancer and other malignant solid tumors, and is expressed in 89% advanced NPC. Therefore, EGFR is an important target for cancer treatment.

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. The results of the pivotal clinical trial study for the treatment of R/M NPC for MEIYOUHENG (Becotatug Vedotin Injection) were presented as “late breaking abstract (LBA)” for oral presentation at the 2025 American Society of Clinical Oncology Annual Meeting.

Furthermore, the combination therapy of MEIYOUHENG (Becotatug Vedotin Injection) with PUYOUHENG (Pucotenlimab Injection) demonstrated the significant and sustained clinical benefits, with the highest cORR (73.3%, 95% CI: 54.1-87.7) and longest mPFS (10.9m, 95% CI: 6.6-15.4) as reported so far in the patients after failed IO and platinum-based therapy, as observed in the Phase II clinical trial of the combination therapy. It may provide an efficacious treatment option for R/M NPC patients who had failed anti-PD-(L)1 and platinum-based therapy. The results were presented at the European Society for Medical Oncology Congress 2025.

By order of the Board

Lepu Biopharma Co., Ltd.

Dr. Pu Zhongjie

Chairman of the Board and Executive Director

Shanghai, the PRC, October 30, 2025

As at the date of this announcement, the Board comprises Dr. Pu Zhongjie (chairman) and Dr. Sui Ziye (chief executive officer) as executive Directors; Ms. Pu Jue and Ms. Qin Yiran as non-executive Directors; and Mr. Zhou Demin, Mr. Yang Haifeng and Mr. Fengmao Hua as independent non-executive Directors.