Lepu Biopharma (2157.HK) announces 2025 interim results

Focusing on the field of tumor treatment, innovative biopharmaceutical company Lepu Biopharma Co., Ltd. (Lepu Biopharma or the Company, stock code: 2157.HK) announced its interim results for the first half of 2025. During the reporting period, the Company's business showed strong growth momentum, achieving profitability for the first time. Core product sales and international licensing business progressed in tandem, with multiple ADC pipeline products entering key clinical stages and global commercialization efforts accelerating.

Lepu Biopharma is an innovation-driven biopharmaceutical company focusing on oncology therapeutics, in particular, targeted therapy and oncology immunotherapy, with a strong China foundation and global vision. Lepu Biopharma is dedicated to developing innovative ADCs through our comprehensive and advanced ADC technology development platform and we aim to develop optimal and innovative drugs to better serve the unmet medical needs of cancer patients. The Company is committed to continuously developing a market-differentiating pipeline by fully integrating independent innovation capabilities and strategic collaborations. The Company has established and is progressively expanding our internal manufacturing capabilities, driven by the business needs stemming from the upcoming commercialization of our ADC candidates.

Currently, Lepu Biopharma has strategically designed our pipeline with a range of oncology products. For clinical-stage candidates, the Company has one clinical/commercialization-stage drug candidate; nine clinical-stage drug candidates, including one co-developed through a joint venture; and three clinical-stage combination therapies of our candidates. One of our drug candidates has obtained marketing approval with respect to two of its targeted indications, with clinical trials for other indications ongoing. Among the nine clinical-stage drug candidates, seven are targeted therapeutics and two are immunotherapeutics, which are an oncolytic virus drug and T cell agonistic antibody.

As of the end of the reporting period, Lepu Biopharma has achieved significant milestones in the monetisation of our R&D capabilities through commercialization and BD activities: PUYOUHENG (Pucotenlimab Injection) has completed the full commercialization process and is currently under a rapid sales growth, and four other products, CMG901, MRG007 and two pre-clinical TCE assets have also been licensed out through our BD activities. Notably, CMG901’s global rights have been licensed to AstraZeneca, and MRG007’s rights for regions outside Greater China have been licensed to ArriVent. Two pre-clinical TCE assets have entered into a collaboration with Excalipoint.

Revenue scale achieved a 3.5-fold leapfrog growth, with comprehensive improvement in financial indicators

In the first half of 2025, the Company made significant progress in advancing its product pipeline and business operations, recording a total revenue of approximately RMB466 million, which was an increase of 350% of the same period in 2024 at RMB133 million. For licensing activities, the Company has recognized approximately RMB309 million in revenue primarily from the out-licensing of MRG007. The Company recorded a revenue of approximately RMB151 million for the sales of PUYOUHENG (Pucotenlimab Injection), marking a significant increase of 58.8% from the sales recorded in the same period in 2024. In addition, the Group recognized approximately RMB6.3 million in revenue for the provision of CDMO services.

During the reporting period, the Company achieved profitability for the first time, with a profit of approximately RMB 29.3 million, marking a turnaround from a loss in the same period of 2024. Net cash generated from operating activities was approximately RMB 46.7 million, and cash and cash equivalents increased to approximately RMB 473 million, representing a positive net operating cash flow compared to the same period in 2024. Research and development expenses amounted to approximately RMB 202 million, representing a decrease of 6.6% compared to the same period in 2024. While ensuring the advancement of core pipelines, cost control measures have shown tangible results.

The Company actively develops cooperative relationships with various business channel partners. As of June 30, 2025, the Company completed the tendering process on the procurement platform in 28 provinces of the PRC. We have covered approximately 118 cities in the PRC through various sales channels, and we will further expand our sales network.

ADC pipeline enters the critical phase with multiple products, potential for combination therapy highlighted, and fruitful international licensing results

In the first half of 2025, the Company remained focused on the research and development of its drug candidates, while continuously assessing market demand and competitive landscape relating to the range of oncology therapeutics and the broad spectrum of indications covered by its drug candidates, in order to maximize the competitiveness of its products pipeline. In particular, MRG003 for NPC nears approval and other key drug candidates advance to pivotal clinical stage.

MRG003（EGFR-ADC

NPC: MRG003 is under NDA review for the treatment of R/M NPC and has also been granted priority review by the CDE of NMPA. The authority is currently proceeding with the clinical and pharmaceutical evaluation of MRG003. The encouraging data of the pivotal Phase IIb clinical study for the treatment of R/M NPC was read out as “late breaking abstract (LBA)” for oral presentation at the ASCO Congress 2025. The Company is also currently conducting the Phase III clinical trial of combination therapy with MRG003 and pucotenlimab on R/M NPC. The encouraging data in phase II clinical trial of combination therapy on R/M NPC will be presented at the ESMO Congress 2025.

HNSCC: As of June 30, 2025, the Company is conducting a randomized, open-label, multicenter Phase III clinical study on HNSCC. In terms of combination therapy with MRG003 and pucotenlimab, we are currently conducting the Phase II clinical trial on HNSCC, and the encouraging data in phase II clinical trial will be presented at the ESMO Congress 2025. The  European Medicines Agency (EMA) granted Clinical Trial Authorization (CTA) approvals for the Phase II clinical trial targeting LA-SCCHN in June 2025, and the Company will initiate the clinical trial in the second half of 2025.

MRG004A (TF-ADC): The Company has completed the Phase I clinical study on solid tumors in China and the encouraging Phase Ib expansion data on PC will be presented at the ESMO Congress 2025. Protocol communication with CDE for the pivotal clinical trial of MRG004A has been completed, and we have entered the Phase III clinical trial stage in August 2025. In addition, MRG004A was granted BTD by the CDE in August 2025, which offers a brand-new treatment option to patients with pancreatic cancer.

MRG006A (GPC3-ADC): MRG006A is a GPC3-targeted ADC with FIC potential globally. We received IND clearance from the FDA in January 2025. We are currently advancing Phase I clinical trial in China. In pre-clinical studies, MRG006A resulted in a robust and dose-dependent tumor growth inhibition on multiple CDX models and HCC PDX models. In the meantime, MRG006A also demonstrated good tolerability in the exploratory toxicology study.

MRG007 (CDH17-ADC): We received the IND approval from the NMPA in June 2025 and are currently conducting a Phase Ia clinical trial for the treatment of unresectable locally advanced or metastatic solid tumors. MRG007 has shown robust antitumor activity in preclinical models of GI cancers and a favorable therapeutic index based on IND enabling studies. The pre-clinical data of MRG007 was presented at the AACR Annual Meeting in April 2025. In January 2025, the Company entered into an exclusive licensing agreement with ArriVent, pursuant to which the Company has granted ArriVent exclusive rights to develop, manufacture and commercialize MRG007 outside of Greater China. Under the terms of the agreement, the Company is eligible to receive up to US$1.2 billion in total in upfront payment and development, regulatory and sales milestones, together with tiered royalties on net sales. As of June 30, 2025, the upfront payment has been received.

CG0070 (Oncolytic virus): CG0070 was granted BTD by the CDE in January 2025. CG0070 is currently in a MRCT Phase III clinical study conducted by the Company’s U.S. partner, CG Oncology. The latest encouraging data observed has been orally presented in the 120th American Urological Association Annual Meeting in April 2025. The Company has completed the Phase I clinical trial in China and are currently engaged in protocol communication with the CDE regarding the domestic bridging pivotal linical trial.

Combination therapy layout: As of June 30, 2025, the Company has completed the Phase II trial of combination therapy with MRG002 and pucotenlimab in the treatment of HER2-expressing solid tumors, which has moved to first-line treatment, and protocol communication for phase III clinical trial has been completed. The Company has observed encouraging data on UC. In terms of combination therapy with MRG003 and pucotenlimab, the Company is currently conducting the Phase II clinical trial on HNSCC, which has moved to first-line treatment, and the encouraging data in phase II clinical trial will be presented at the ESMO Congress 2025. The European Medicines Agency (EMA) granted Clinical Trial Authorization (CTA) approvals for the Phase II clinical trial targeting LA-SCCHN in June 2025, and we will initiate the clinical trial in the second half of 2025, which has been moved up to first-line treatment for advanced disease.

Preclinical: Laying the groundwork for innovative platforms and innovative targets

The Company continuously strives to build up and develop novel technology platforms as innovative engines for the Company. The Company has developed multiple innovative linker-payload platforms for ADC drug candidates, including the Hi-TOPi ADC platform and other early-stage platforms. During the reporting period, our innovative ADC platforms have achieved significant progress. Based on these innovation platforms, the Company has generated two ADC candidates, which are MRG006A with global first-in-class potential and MRG007 with global best-in-class potential, all of which have shown encouraging pre-clinical data and received IND approvals in China. Pre-clinical data of MRG007 was presented at the AACR Annual Meeting in April 2025.

On August 1, 2025, the Company entered into a licensing transaction for the license-out and/or transfer of certain intellectual property rights relating to two preclinical assets developed by the Company’s proprietary T cell engager-TOPAbody platform with Excalipoint through entering into the Intellectual Property Assignment and License Agreement.

The Company shall receive (i) an upfront payment in cash of US$10 million in aggregate, development and commercial milestone payments in cash of up to US$847.5 million in aggregate and sales royalties, holding a 10% interest, marking international recognition of the platform's value.

Future Outlook: Accelerating the Commercialization of Core Products and Advancing Global Strategic Development

In respect of drug R&D, the Company will further focus on advancing strategic research and development priorities in next generation ADC drugs and IO bi/tri specific antibodies, while accelerating the commercialization of late-stage products. For our registrational stage product MRG003, the relevant authority is currently proceeding with the clinical and pharmaceutical evaluation in an orderly manner. The Company will concentrate our resources and endeavour to expedite the approval process. Meanwhile, our other key drug candidates are entering pivotal clinical stages. Protocol communication for the pivotal clinical trial of MRG004A has been completed, and we have entered the Phase III clinical trial stage in August 2025. In addition, we are currently conducting protocol communication with the CDE regarding the domestic pivotal clinical trial of CG0070. The Company will also explore further potential clinical value of our other innovative drug candidates, such as MRG006A and MRG007. Concurrently, the potential efficacy of combination therapies within our pipeline is being continuously explored, with greater clinical benefits striving to be delivered to a broader patient population.

In terms of domestic commercialization, the Company will take further actions to enhance the market accessibility of PUYOUHENG (Pucotenlimab Injection), accelerating market penetration at all levels to further increase market share and enhance the Company's brand image and market recognition. At the same time, the Company will commence the preparation process for the commercial launch of MRG003 and continue to expand our marketing and commercialization teams.

On the international front, the Company will ramp up our efforts to expand into the global market. We will expand our international network and explore new business development cooperation opportunities. The Company will remain committed to seeking more strategic partners worldwide to develop our ADC products and other innovative candidates through partnerships, licensing agreements, or joint ventures.