From turning point of profit to platform going overseas, the 2025 report reveals the advanced path of Lepubio Biopharma (02157).

On March 25, Lu Jie Biological (02157) released its 2025 financial report, drawing a clear line for its own development stage. The financial report shows that the company achieved a total income of 935 million yuan in the year, a year-on-year increase of 2.5 times, and historically recorded a net profit of 261 million yuan, fundamentally reversing the loss compared to 2024. More importantly, the end-of-period cash reserves surged to 853 million yuan, and the operating cash flow approached break-even. In the current era of intensified differentiation in the innovative drug industry, this report is more than just "turning losses into profits" in terms of financial data. It signifies that Lu Jie Biological has successfully crossed the "R&D investment period" and entered a new cycle of "commercial realization and self-bloodletting." Its long-standing strategic path of "rapid market launch of small indications, deep cultivation of core pipelines, and global realization of platform value" is now facing a crucial moment of value reassessment. Profit inflection point, establishment of self-bloodletting capability For Lu Jie Biological in 2025, it is a crucial year for the company to transition from the "R&D investment period" to the "realization of self-bloodletting." In terms of revenue, Lu Jie Biological's revenue in 2025 comes mainly from the commercialization of products and BD dual-drive. In terms of products, Lu Jie Biological already has two commercialized products. Among them, the company's first commercialized product, Putu Heng (Putili single-chain injection), achieved revenue of 501 million yuan, a year-on-year increase of 66.8%; the second product, Meiyu (intravenous vedetuximab) was approved for market launch at the end of October 2025, has already generated preliminary revenue, and with the scaling up of Meiyu, the company's revenue is expected to continue to grow rapidly in 2026. In terms of BD, with the global validation of the ADC technology platform value, Lu Jie Biological's CMG901 (AZD0901), MRG007, CTM012, and CTM013 have achieved license out, directly increasing the current period's performance. In terms of profit, a net profit of 200 million yuan was achieved for the first time, marking a fundamental shift in the company's operating logic. On the one hand, benefiting from the revenue breakthrough, on the other hand, from strict "cost reduction and efficiency enhancement" measures. The company has become more focused on pipeline advancement, concentrating resources on core clinical-stage projects such as MRG003, MRG004A, and MRG006A, significantly improving clinical efficiency. The end-of-period cash and cash equivalents exceeded 853 million yuan, more than double the end of 2024. The ample cash reserves are due to the injection of BD down payments and the improvement of operating cash flow. Of particular note is that the company's operating cash flow has narrowed significantly to a net outflow of over 10 million yuan, approaching break-even. This means that without relying on large external financing, the company is on track to achieve internal balance in cash flow through daily operations. This is crucial safety net for a biotech company still in its growth stage. MRG003 (EGFR ADC) from rapid market entry to combination therapy upgrade Apart from the impressive financial data, Lu Jie Biological is also expected to achieve high-speed growth in 2026. The heavyweight product MRG003 this year can contribute a complete commercial cycle year. Regarding commercialization, the commercialization of Putili single-chain antibody has fully validated Lu Jie Biological's sales strategy and business model. Under the existing sales channels of Putili single-chain antibody, MRG003 is expected to rapidly increase market penetration and expand market share. It is worth mentioning that as the world's first ADC targeting EGFR, MRG003 itself is a blockbuster product with full potential in both monotherapy and combination therapy. It is understood that MRG003 is an ADC drug composed of EGFR-targeted single-chain antibodies and potent microtubule inhibition payload MMAE molecules linked through a vc connector. It has an affinity 7 times higher than cetuximab. Indications include nasopharyngeal cancer (NPC) and head and neck squamous cell carcinoma (HNSCC). In recent years, with the advancement of ADC technology, EGFR can serve as a target for delivering toxins, is highly expressed in various tumor types, and has become a hot direction in the development of ADC drugs. In terms of monotherapy, MRG003 was approved for market launch on October 30, 2025, to treat relapsed/metastatic nasopharyngeal cancer (NPC) adult patients who have received at least second-line systemic chemotherapy and PD-1/PD-L1 inhibitor therapy. This product is the world's first approved EGFR ADC and the first domestically targeted EGFR ADC drug. Prior to this, MRG003 had been granted breakthrough therapy designation (BTD) by the CDE and FDA, as well as orphan drug designation (ODD) and fast track qualification (FTD) for the treatment of NPC. At the 2025 ASCO Conference, significant data from a key Phase IIb clinical study for the treatment of R/M NPC was presented as a "landmark research abstract" (LBA). The number of NPC patients in China accounts for about half of the global total, with approximately 60,000 new cases annually. While comprehensive treatment primarily involving chemoradiotherapy is effective, 20%-30% of patients still experience recurrence or metastasis. There is a lack of options for secondary-line treatment, leading to a poor prognosis. Currently, the standard treatment for relapsed/metastatic NPC is a combination of GP chemotherapy and PD-1 inhibitors. However, once resistance develops, the efficacy of secondary-line conventional chemotherapy is limited (ORR often less than 20%, mPFS about 2-4 months), leaving a significant unmet need. MRG003 monotherapy has shown excellent survival benefits in the secondary-line treatment of NPC. At the 2025 ASCO Conference, Lu Jie Biological presented the latest data from Phase IIb registration studies of MRG003 for the treatment of third-line and above NPC. The data showed that in patients with a median of three previous lines of treatment and nearly half with baseline liver metastases, MRG003 increased ORR to 30.2%, nearly three times that of the chemotherapy group (11.5%), doubling the median PFS benefit (5.82 months vs 2.83 months), and reducing the risk of disease progression or death by 37%. The median OS was extended by 5 months (17.08 months vs 11.99 months), with an HR of 0.73, indicating a clear benefit trend. In terms of safety, the rate of Grade 3 or above treatment-related adverse events for MRG003 (45.3%) was lower than the chemotherapy group, with the main adverse reactions being anemia and leukopenia. As the first ADC clinical study targeting heavily treated relapsed/metastatic NPC, MRG003 demonstrated statistically and clinically significant benefits in this population while maintaining controllable safety. In terms of combination therapy, MRG003 in combination with Putili single-chain antibody achieved an ORR of 73.3% in R/M-NPC patients who failed prior immunotherapy and platinum-based therapy, with a disease control rate (DCR) of 93.3% and a median PFS of 10.9 months, with a 12-month OS rate of 92.8%. The MRG003 treatment for third-line and beyond resistant NPC to PD-1 and platinum-based chemotherapy was selected as an LBA study, with a median overall survival of 17.08 months, significantly prolonging the survival compared to chemotherapy. More importantly, the ORR of MRG003 in combination with PD-1 in first-line treatment was as high as 67%. The synergistic effect of "ADC+IO" is pushing MRG003 from a tertiary treatment option to a broader primary-line and even perioperative market, targeting annual sales peaks in diseases such as nasopharyngeal cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer. From the development process of MRG003, it is clear that Lu Jie Biological's approach to drug development involves achieving rapid market access through tertiary treatment and small indications, obtaining a first-mover advantage, and then exploring combination or first-line treatments to further unleash the potential of the pipeline. Pipeline depth and clinical breakthroughs, ADC leader's strategy of "small indication breakthrough + combination therapy upgrade" pays off In the field of ADCs, Lu Jie Biological has formed a gradient pattern of "market launch, clinical batch, reserve batch" in its pipeline. In addition to MRG003, the company also has 6 ADC drugs, including MRG004A (TF ADC), MRG002 (Her2 ADC), and co-developed CMG901 (CLDN18.2 ADC), which have entered key registration clinical stages, with early-stage projects such as MRG001 (CD20 ADC), MRG006A (GPC3 ADC), and MRG007 (CDH17 ADC). In other areas, Lu Jie Biological has introduced one oncolytic virus and one TCE drug entering the clinical stage. Overall, the company's pipeline gradient is well-implemented, and in the next 3-5 years, it is expected to enter a harvest period with new drugs being successively approved and launched. 1) CMG901 (AZD0901): Introduced by AstraZeneca with an expected BLA by the end of the year If the first two ADCs are biologics assets with the same target points and rapid R&D progress, CMG901 (AZD0901) recognized by international giants is equally noteworthy. CMG901 (AZD0901) is an ADC drug targeting CLDN18.2 developed jointly by Lu Jie Biological and Conoia. Its unique design, with a DAR value of 4, and the antibody CM311 used for CLDN18.2 (especially on low-expressing tumor cells) has a significantly higher affinity than the already marketed monoclonal antibody Zolbetuximab, showing potential advantages. In 2023, the global pharmaceutical giant AstraZeneca acquired exclusive global rights to CMG901 (AZD0901) for a total potential value of 630 million U.S. dollars, with milestone payments of up to 1.125 billion U.S. dollars. The giant's favor is authoritative recognition of the potential and molecular quality of CMG901 (AZD0901). Currently, AstraZeneca is pushing forward global clinical development of CMG901 (AZD0901), conducting multiple studies for indications such as advanced gastric/gastroesophageal junction adenocarcinoma, pancreatic cancer, and cholangiocarcinoma. The most anticipated study is the global Phase III registration clinical trial for the use of CMG901 (AZD0901) at least second-line treatment of CLDN18.2 positive gastric/gastroesophageal junction adenocarcinoma. The trial has completed enrollment of all patients in 2025, with top-line data expected to be announced in the first half of 2026, and is expected to submit a new drug application before the end of the year. AstraZeneca has initiated their phase III clinical trial (CLARITY-Gastric02) using CLDN18.2 positivity, HER2 negativity advanced gastric cancer for first-line treatment, with the first dosing completed triggering a $45 million milestone payment, and the global development process accelerating. 2) MRG004A (TF ADC) Phase III clinical trial initiated, breakthrough therapeutic variety MRG004A is an innovative ADC drug targeting tissue factor TF through Glyco Connect site-specific conjugation and Hydra Space polar spacer technology linking TF-targeting monoclonal antibodies with the potent microtubule inhibitor MMAE, making it the first domestically entering TF ADC clinical drug, with manageable safety and significant antitumor activity, especially in patients with relapsed or metastatic pancreatic cancer. Pancreatic cancer, as a highly aggressive malignancy, mainly originates from pancreatic ductal epithelial cells, clinically characterized by subtle early symptoms, rapid disease progression, and poor prognosis, with a less than 10% 5-year survival rate. Epidemiological data shows that about 70%-80% of patients are diagnosed with locally advanced or distant metastatic disease, with 533,000 new cases globally in 2024, including 125,000 in China. The current first-line treatment options primarily involve various chemotherapy regimens such as FOLFIRINOX. However, these regimens have significant side effects and limited survival for patients. In terms of second-line treatment, there is no standard therapy, with new drug development focusing on RAS small molecule inhibitors and antibody-drug conjugates (ADCs). It is worth noting that the KRAS gene is considered a key driving gene in pancreatic cancer, with over 90% of cases having KRAS gene mutations, with the KRAS G12D mutation being the most common site, with an expression rate of about 40% in pancreatic cancer. MRG004A has shown good efficacy in advanced pancreatic cancer: In the latest data from a Phase I/II trial for MRG004A in relapsed pancreatic cancer presented at ESMO 2025, efficacy-wise, at a dose of 2mpk Q3W, the ORR and DCR of 2L patients (n=10) were 40% and 80%, with mPFS = 5.8 months, mOS = 13.2 months; 27 3L patients had an ORR and DCR of 18.5% and 70.4%, with mPFS = 2.7 months, mOS = 5.8 months. On the safety side, the common TRAE was conjunctivitis, with a proportion of TRAE 3 grade in evaluable patients being 38.5%. Currently, globally, only Genmab/Seagen's Tivdak, a TF ADC, has been approved, with full FDA approval for use in relapsed cervical cancer in 2024. Among the rapidly advancing drugs is Sanofi's XNW28012, which is in a Phase III trial for relapsed pancreatic cancer. From a competitive perspective, Lu Jie Biological's MRG004A product holds a relatively strong position in the market competition. If it can make a breakthrough in the underserved area of pancreatic cancer, MRG004A's clinical and commercial value will be reassessed. 3) MRG006A - the world's first Phase II clinical GPC3 ADC In addition to MRG004A, another core asset owned by Lu Jie Biological, MRG006A, has potential for innovative drug value. MRG006A, developed based on the Hi-TOPi platform, is a novel topoisomerase I inhibitor GPC-3 ADC, and is the world's first ADC to enter clinical trials targeting the same marker. MRG006A completed the FPI of its domestic Phase II trial in October 2025, is the first GPC3 ADC drug to enter Phase II trials globally, and has received FDA fast track and orphan drug qualification. In addition to monotherapy, an IND application for MRG006A in combination with immune checkpoint inhibitors and targeted therapies for the first-line late-stage liver cancer patients has been approved by the NMPA is set to enter clinical trials. Normal liver tissues, including those with developmental abnormalities or cirrhotic liver cells, or other primary malignant tumors' liver metastases, are GPC3-negative. However, GPC3 is highly expressed in about 80% of hepatocellular carcinoma (HCC) cases and is correlated with tumor growth, invasion, and poor prognosis, making it an ideal tumor-specific target. According to a report from People's Daily, Lu Jie Biological observed tumor reduction in 14 enrolled patients at the Hepatobiliary Surgery Department of the Chinese Academy of Medical Sciences Cancer Hospital through treatment with MRG006A, showing treatment effects exceeding existing treatment options. The dose escalation study in the Phase I trial yielded results that exceeded expectations. The liver cancer market is vast, with no standard treatments for secondary-line liver cancer. In 2022, there were 870,000 new cases of liver cancer globally, with nearly 370,000 new cases in China, with 80% being hepatocellular carcinoma (HCC). After first-line treatment failure, there are significant limitations in secondary-line treatment. Currently, new drugs mainly focus on CAR-T therapy, with increasing numbers of antibodies and ADCs. 4) MRG007 (CDH17 ADC) global collaboration progress, advancing smoothly in the clinical stage MRG007 is the best evidence of Lu Jie Biological's platform value. CDH17 shows high-specificity expression in various gastrointestinal malignancies (such as colorectal cancer, gastric cancer, pancreatic cancer), and limited expression in normal tissues, making it an ideal tumor-specific target. In early 2025, Lu Jie Biological licensed this early-stage asset to the US Biotech ArriVent, receiving a 47 million U.S. dollar upfront payment and over 1.2 billion U.S. dollar milestone payment. Clinical pre-study data presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting show that MRG007 and its antibody component exhibit strong binding activity to CDH17 on the surfaces of various gastrointestinal cancer cells and can be rapidly internalized. Currently, the clinical development of MRG007 has achieved double start-up and progressing in both China and the US. IND approval was granted in China in June 2025, with the first Chinese patient enrolled in July, and IND approval in the US obtained in November. The first US patient is expected to be enrolled in March 2026. Both statistically and clinically, this not only represents a simple licensing but also demonstrates Lu Jie Biological's ability to incubate early-stage assets. The shift in the BD paradigm from "product outflow" to "platform outflow" in 2025 2025 is a big year for Chinese innovative drugs to go overseas. According to statistics from the China National Medical Products Administration and the PharmaCube database, the total amount of BD transactions in the Chinese innovative drug sector reached 135.655 billion U.S. dollars in 2025, setting a historical record and showing unprecedented enthusiasm from global capital towards Chinese innovation in medicines. As a leader in the ADC field, in 2025, Lu Jie Biological completed two markedly different but equally exciting major licensing transactions, not only reaping hefty capital returns but also fulfilling a strategic evolution from "product outflow" to "platform outflow" in the global market. Earlier in the year, its preclinical asset MRG007 (ADC targeting CDH17) was licensed to ArriVent BioPharma for a total potential value of as high as 1.2 billion U.S. dollars, gaining heavyweight international backing even before entering the clinical stage, which is a top-notch endorsement of its target foresight and R&D capabilities. The other deal in mid-year is even more paradigmally innovative, as the company licensed its two early-stage TCE assets based on its proprietary TOPAbody platform to Excalipoint in a NewCo model involving a "cash upfront + equity ownership + milestone revenue" structure, marking not just the monetization of individual assets but also signifying that its underlying technical platforms have gained independent international valuations and commercialization paths. By licensing early-stage assets (such as