Meiyouheng® (becotatug vedotin for injection) was approved for marketing in China
This announcement is made by Lepu Biotechnology Co., Ltd. (the "Company") in accordance with 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 of the Laws of Hong Kong. The Board of Directors of the Company (the "Board") is pleased to announce that the National Medical Products Administration ("NMPA") has recently approved the marketing application in China for the drug candidate Meiyouheng®; (becotatug vedotin for injection), an innovative epidermal growth factor receptor ("EGFR")-targeting antibody drug conjugate ("ADC") independently developed by us, for the treatment of recurrent or metastatic nasopharyngeal carcinoma ("R/M NPC").
A. Impact on the Company
Meiyouheng® (becotatug vedotin for injection) is the first EGFR-targeting ADC approved for marketing in China, the first of its kind. The approval of Meiyouheng® (becotatug vedotin for injection) is another important milestone for the company. The approval of this drug for the treatment of R/M NPC will improve the treatment effect of patients. The company will also further expand the scope of indications of Meiyouheng® (becotatug vedotin for injection) based on this approval and accelerate the transformation of its potential commercial value.
B. About Meiyouheng®; (becotatug vedotin for injection)
Meiyouheng®; (becotatug vedotin for injection) is an ADC composed of an EGFR-targeting monoclonal antibody coupled with a potent tubulin inhibitory payload, a methyl auristatin E molecule, through a valine-citrulline linker. It specifically binds to EGFR on the surface of tumor cells with high affinity and releases a potent payload after cleavage by endocytosis and lysosomal proteases, thereby leading to tumor cell death. EGFR is highly expressed in various malignant solid tumors such as colorectal cancer, lung cancer, head and neck cancer, and 89% of advanced NPCs express EGFR. Therefore, EGFR is an important target for cancer treatment.
Meiyouheng®; (becotatug vedotin for injection) has shown clinically significant efficacy advantages in patients who have previously failed second-line or above systemic chemotherapy and PD-(L)1 inhibitors, while maintaining a controllable safety profile. The key registration clinical study results of Becotatug vedotin® (becotatug vedotin for injection) for the treatment of R/M NPC were announced in the form of a "Blockbuster Research Abstract (LBA)" at the 2025 American Society of Clinical Oncology Annual Meeting, and an oral report was given at the meeting.
In addition, the combination therapy of Meiyouheng® (becotatug vedotin for injection) and Puyouheng® (pucotenlimab injection) showed significant and durable clinical benefits. In the phase II clinical trial of this combination therapy, patients who failed immunotherapy and platinum-based chemotherapy achieved the highest confirmed objective response rate (cORR) to date (73.3%, 95% CI: 54.1-87.7) and the longest progression-free survival (mPFS) (10.9m, 95% CI: 6.6-15.4), which is expected to provide a more effective treatment option for R/M NPC patients who have failed anti-PD-(L)1 and platinum-based chemotherapy. The above data have been announced at the 2025 European Society of Medical Oncology Annual Meeting.
By order of the board of directors
Lepu Biotechnology Co., Ltd.
Chairman and Executive Director
Dr. Pu Zhongjie
China, Shanghai, October 30, 2025
As at the date of this announcement, the board of directors includes executive directors Dr. Pu Zhongjie (chairman) and Dr. Sui Ziye (general manager); non-executive directors Ms. Pu Jue and Ms. Qin Yiran; and independent non-executive directors Mr. Zhou Demin, Mr. Yang Haifeng and Mr. Hua Fengmao.