SUZHOU, China, March 26, 2026 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) reported financial results for the full year ended December 31, 2025 and highlighted recent business progress.

Key Highlights

• KN026 (Anbenitamab) achieved robust PFS and OS benefits in second- or third-line HER2-positive GC, with data presented as a LBA oral presentation at the 2025 ESMO Congress. The first NDA was accepted by the NMPA and received priority review status, followed by successful completion of drug registration inspection and GMP compliance inspection, and is on the verge of market launch. Patient enrollment has been completed for two phase III studies in first-line HER2-positive BC and neoadjuvant treatment, while the phase III study in adjuvant treatment for BC has been initiated.

• JSKN003 (Anbenitamab repodatecan), leveraging its "high efficacy, low toxicity" advantages, received two BTDs from the CDE and three international designations from the FDA (BTD, ODD, FTD) in 2025. Promising efficacy and safety data from multiple studies were presented at the ASCO Annual Meeting and ESMO Congress. Four phase III clinical studies are currently ongoing including second-line HER2-positive BC, HER2‑low BC, PROC, and HER2‑positive CRC, with patient enrollment completed for the phase III study in second-line HER2-positive BC.

• JSKN016 has enrolled over 460 patients in total across phase I and II studies, with dose expansion and dose selection completed. After confirming efficacy in later-line lung cancer and breast cancer, first-line combination chemotherapy/immunotherapy have been explored, and a phase III study in TNBC has been initiated. Additionally, high-concentration subcutaneous formulation of JSKN016 has been approved for clinical development in Australia.

• JSKN033 completed POC data accumulation and dose optimization confirmation in second-line CC. The POC cohort in second-line EC is currently enrolling. JSKN033 is also advancing phase II exploration in lung cancer and initiating a phase II clinical study in combination with chemotherapy for first-line CC. Through its ADC/IO combination strategy, JSKN033 continues to strengthen pan-tumor and all comers.

• Leveraging modular and iterative technology platforms, innovative molecules continue to be generated and efficiently advanced into clinical development. JSKN022 has now progressed to the sixth dose‑escalation cohort, showing preliminary efficacy and favorable safety. JSKN027 received approval for phase I clinical study, and the first patient was dosed. JSKN021 presented preclinical data at the AACR Annual Meeting, and its IND application has been accepted by the CDE.

Financial Summary

• For the year ended December 31, 2025, we recorded total revenue of RMB 566.24 million. Meanwhile, product revenue (attributed to the Company) amounted to RMB 130.13 million.
• For the year ended December 31, 2025, our R&D expenditure amounted to RMB 572.16 million, representing a year-on-year increase of 41.57%.
• For the year ended December 31, 2025, we recorded loss for the year of RMB 113.95 million.
• We have a healthy financial position, with cash reserves of RMB 1,350.32 million as of December 31, 2025.

Business Highlights

Product Pipeline

Leveraging its proprietary core technology platforms, including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payload, dual-payload conjugation, and high-concentration subcutaneous formulation, the Company has built a product portfolio with differentiated innovation and global competitiveness, covering cutting-edge fields such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies. Notably, Envafolimab (KN035), the world's first subcutaneous PD-(L)1 inhibitor, has been approved for marketing. The National Medical Products Administration (NMPA) has accepted the new drug application (NDA) for KN026 (Anbenitamab Injection), a HER2 bispecific antibody, for second-line or later HER2-positive gastric cancer (GC). In addition, two bispecific ADC candidates are currently in phase III clinical trials, while several other bispecific ADCs and dual-payload ADCs are advancing rapidly in clinical development.

KN035 (Envafolimab)

KN035, an innovative anti-tumor immunotherapy drug, is the first subcutaneously injectable PD-(L)1 inhibitor worldwide and single-domain antibody in oncology. Envafolimab offers significant advantages in convenience and compliance by avoiding intravenous infusion and can be administered in just 30 seconds, making it particularly suitable for frail, elderly, or IV-intolerant patients. Envafolimab has been granted three Orphan Drug Designations (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of advanced biliary tract cancer, soft tissue sarcoma and gastric cancer and gastroesophageal junction cancer (GC/GEJ); it has been granted Breakthrough Therapy Designation (BTD) by the NMPA for the treatment of unresectable or metastatic solid tumors with high tumor mutation burden (TMB-H).

Events during the Reporting Period

• In June 2025, data from three phase II studies of Envafolimab (either as monotherapy or combination therapy) were presented as posters at the American Society of Clinical Oncology (ASCO) Annual Meeting, with data from additional eight studies published online.
• In August 2025, a real-world study results of Envafolimab in advanced lung cancer were published in Thoracic Cancer.
• In October 2025, data from six phase II clinical studies of Envafolimab in combination regimens were presented as posters at the 2025 European Society for Medical Oncology (ESMO) Congress, demonstrating robust efficacy across multiple solid tumor types, including biliary tract cancer, cervical cancer (CC), and lung cancer.
• In December 2025, the phase II clinical study results of Envafolimab in combination with chemotherapy as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC) were published in BMC Medicine.
• In December 2025, Envafolimab was granted ODD by the FDA for the treatment of GC/GEJ.

Events after the Reporting Period

• In January 2026, the NDA for Envafolimab in combination with the Gemcitabine and Oxaliplatin (GEMOX) regimen as first-line treatment for unresectable or metastatic biliary tract cancer was accepted by NMPA.

KN026 (Anbenitamab)

KN026 is a HER2 heterodimeric bispecific antibody (BsAb) that can simultaneously bind two non-overlapping epitopes of HER2, leading to HER2 signal blockade. Through antibody-induced receptor clustering, it enhances ADCC and CDC effects while promoting the down-regulation of HER2 receptors on the cell surface. KN026 has been granted ODD by the FDA for the treatment of HER2-positive or low expressing GC; it has been granted BTD by NMPA for the treatment of patients with HER2-positive GC/GEJ who have failed first-line standard treatment.

Events during the Reporting Period

• In January 2025, the results of phase II clinical study of KN026 in combination with docetaxel as first-line treatment for HER2-positive recurrent or metastatic breast cancer (BC) were published in Cancer Communications.
• In March 2025, the results of phase II clinical study of KN026 in combination with KN046 for the treatment of advanced HER2-positive solid tumors (excluding BC) were published in Signal Transduction and Targeted Therapy.
• In April 2025, phase II/III clinical study of KN026 in combination with chemotherapy as second-line or above treatment of HER2-positive GC (including GEJ), completed the first interim analysis and met the pre-specified primary endpoint of progression-free survival (PFS) and overall survival (OS). KN026 is the first HER2 bispecific antibody to demonstrate positive results in the second-line treatment of GC.
• In April 2025, enrollment of all patients was completed in the phase III clinical study of KN026 combined with albumin-bound docetaxel HB1801 as first-line treatment for HER2-positive recurrent or metastatic BC.
• In June 2025, the results of phase II clinical study of KN026 in combination with KN046 for the treatment of HER2-positive BC were published in Clinical Cancer Research.
• In August 2025, enrollment of all patients was completed in the phase III clinical study of KN026 in combination with albumin-bound docetaxel HB1801 as neoadjuvant treatment for early or locally advanced HER2-positive BC.
• In September 2025, the NDA for KN026 in combination with chemotherapy for the treatment of patients with HER2-positive locally advanced, recurrent or metastatic GC/GEJ who have failed at least one prior systemic therapy was accepted by the NMPA and received priority review status.
• In October 2025, the interim analysis results of the phase III clinical study of KN026 were presented as a late-breaking abstract (LBA) oral presentation at the 2025 ESMO Congress. KN026 demonstrated robust PFS and OS benefits in trastuzumab-pretreated patients with second- or third-line HER2-positive GC/GEJ, with the potential to change clinical guidelines for second-line and above GC treatment.
• In November 2025, the phase II clinical study results of KN026 in HER2-positive GC/GEJ were published in Cancer Communications.
• In December 2025, KN026 successfully passed the drug registration inspection (pharmaceutical) and Good Manufacturing Practice (GMP) compliance inspection.
• The phase II clinical study of KN026 in combination with chemotherapy (with or without Enlonstobart) as first-line treatment for HER2-positive locally advanced or metastatic GC/GEJ has been initiated and is progressing smoothly.

Events after the Reporting Period

• In January 2026, the phase III clinical study results of KN026 in patients with HER2-positive GC/GEJ were published in Annals of Oncology, a top-tier oncology journal.
• In March 2026, the first patient was dosed in the phase III clinical study of KN026 in combination with albumin-bound docetaxel HB1801 and chemotherapy as adjuvant treatment for HER2-positive BC.

Expected Milestones in 2026 (from Q2 2026)

• KN026 for second-line and above HER2‑positive GC/GEJ will receive marketing approval in China.
• Phase III data release and NDA submission for KN026 in neoadjuvant HER2‑positive BC will be completed.
• Phase III data release and NDA submission for KN026 in first‑line HER2‑positive BC will be completed.

JSKN003 (Anbenitamab repodatecan)

JSKN003 is developed by site-specific conjugation to the Fc glycans of KN026, resulting in a homogeneous and stable ADC with a drug-to-antibody ratio (DAR) of 4. JSKN003 binds to two HER2 epitopes on tumor cells and release topoisomerase I inhibitors upon internalization, exerting anti-tumor effects. Compared to most of ADCs, JSKN003 demonstrates better serum stability, reduced hematological toxicity, and stronger tumor inhibition and bystander effect, resulting in significantly wider therapeutic window. JSKN003 has been granted Fast Track Designation (FTD) (All comer) and BTD (HER2 expression) for platinum-resistant epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer (PROC) and who have received prior treatment with bevacizumab; It has also been granted two BTDs by the NMPA for PROC and HER2-positive advanced colorectal cancer (CRC) that has failed prior oxaliplatin, fluorouracil, and irinotecan therapy. In addition, JSKN003 has been granted ODD by the FDA for GC/GEJ.

Events during the Reporting Period

• In February 2025, JSKN003 received approval from the CDE to initiate a phase III clinical study to compare the efficacy and safety of JSKN003 versus trastuzumab emtansine (T-DM1) as second-line or above treatment for HER2-positive advanced BC, and the first patient was dosed in the same month.
• In February 2025, the first patient was successfully dosed in a phase III clinical study to compare the efficacy of JSKN003 versus investigator-selected chemotherapy for the treatment of PROC. The trial is now undergoing smoothly.
• In March 2025, JSKN003 was granted BTD by the CDE for the treatment of PROC, not restricted to HER2 expression levels.
• In June 2025, results of three pooled analysis from the phase I study in Australia and the phase I/II study in China evaluating the efficacy and safety of JSKN003 in non-primary platinum-refractory PROC, heavily pretreated HER2-positive BC and advanced HER2-overexpressing (IHC 3+) gastrointestinal tumors were presented at the 2025 ASCO Annual Meeting. 
• In June 2025, results of a preclinical study of JSKN003 were published in RSC Chemical Biology.
• In July 2025, JSKN003 was granted ODD by the FDA for the treatment of GC/GEJ.
• In July 2025, JSKN003 received FDA IND approval to initiate a phase II clinical study in the United States for the treatment of PROC, regardless of HER2 expression level.
• In September 2025, enrollment of all patients was completed in the phase III clinical study of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced BC.
• In October 2025, JSKN003 was granted BTD by the CDE for the treatment of HER2-positive advanced CRC that has failed prior treatment with oxaliplatin, fluorouracil, and irinotecan.
• In October 2025, results from two clinical studies of JSKN003 (in primary platinum-refractory ovarian cancer and HER2-positive metastatic CRC) and the design of a phase III study of JSKN003 versus investigator's choice of chemotherapy for PROC were presented at the 2025 ESMO Congress. The favorable efficacy and safety data demonstrated JSKN003's differentiated advantages of "high efficacy, low toxicity" and its broad-spectrum potential across tumor types and HER2 expression levels, highlighting its promising clinical prospects.
• In October 2025, JSKN003 was approved by the CDE to initiate a phase III clinical study to evaluate the efficacy and safety of JSKN003 versus investigator's choice of regimen (regorafenib/fruquintinib/trifluridine tipiracil) in HER2-positive advanced CRC patients who have failed prior oxaliplatin, fluorouracil, and irinotecan therapy. The first patient was dosed in February 2026.
• In October 2025, JSKN003 was granted FTD by the FDA for the treatment of PROC, regardless of HER2 expression level.
• In December 2025, JSKN003 was granted BTD by the FDA for the treatment of advanced or metastatic HER2-expressing PROC in patients previously treated with bevacizumab.
• The phase III clinical study of JSKN003 for the treatment of unresectable locally advanced or metastatic HER2-low expressing BC is undergoing smoothly.
• The phase II clinical study of JSKN003 in combination with KN026, immunotherapy (IO), or chemotherapy as first-line and perioperative treatment for HER2-positive GC/GEJ has been initiated and is undergoing smoothly.

Expected Milestones in 2026 (from Q2 2026)

• Data readout and pre-BLA submission will be completed for the phase III clinical study of JSKN003 as second-line or above treatment for HER2-positive BC.
• Patient enrollment will be completed for phase III clinical study of JSKN003 in PROC.
• Patient enrollment will be completed for phase III clinical study of JSKN003 as later-line treatment for HER2‑low BC.

JSKN016

JSKN016 is a TROP2/HER3 targeting bispecific ADC developed using the proprietary single-domain antibody and bispecific antibody platforms. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a DAR of 4. JSKN016 binds to TROP2 and/or HER3 on tumor cells and release topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects.

Events during the Reporting Period

• The phase I and II clinical studies of JSKN016 have enrolled over 460 patients cumulatively, with dose expansion and dose selection completed.
• Patient enrollment was completed in cohort expansion for JSKN016 monotherapy as later-line treatment for HR‑positive BC.
• The phase II clinical study of JSKN016 in combination with capecitabine for the treatment of patients with HR‑positive BC, who have been pretreated with CDK4/6 but not received prior chemotherapy is undergoing smoothly.
• In December 2025, the phase II clinical study of JSKN016 in combination with oral SERD for the treatment of CDK4/6‑pretreated HR‑positive, HER2‑negative BC was approved by the CDE, and the first patient was dosed in February 2026.
• The phase II clinical study of JSKN016 monotherapy in later‑line treatment of driver gene‑positive (EGFR mutation/rare mutation) non‑small cell lung cancer (NSCLC) has completed efficacy confirmation.
• The phase II clinical study of JSKN016 in combination with furmonertinib as first‑line and second‑line treatment for EGFR‑mutant NSCLC is progressing smoothly.
• The phase II clinical study of JSKN016 in combination with ivonescimab and carboplatin as first‑line treatment for driver gene‑negative NSCLC is progressing smoothly.

Events after the Reporting Period

• In March 2026, the first patient was dosed in the phase III clinical study of JSKN016 versus investigator's choice of regimen for the treatment of unresectable locally advanced, recurrent or metastatic triple-negative breast cancer (TNBC) in patients who have failed at least two prior lines of systemic therapy.
• In March 2026, the phase I clinical study of the high-concentration subcutaneous formulation of JSKN016 for the treatment of advanced solid tumors was approved by the Bellberry Human Research Ethics Committee in Australia.

Expected Milestones in 2026 (from Q2 2026)

• Pre‑IND communication for the combination study of JSKN016 in CDK4/6‑pretreated HR‑positive BC will be completed in the United States.
• The phase I clinical study of the subcutaneous formulation of JSKN016 in Australia will complete the first patient dosing.
• Results of JSKN016 monotherapy in TNBC and HR‑positive BC will be presented.
• Results of JSKN016 monotherapy and combination therapy in NSCLC will be presented.
• Phase III clinical study of JSKN016 in combination therapy as first‑line treatment for NSCLC will be initiated.

JSKN033

JSKN033 is an independently developed high-concentration subcutaneous formulation, combining the ADC (JSKN003) with PD-L1(Envafolimab). JSKN033 combines the benefits of immunotherapy and ADCs while enhancing safety and convenience through subcutaneous administration.

Events during the Reporting Period

• The phase I and II clinical studies of JSKN033 have enrolled approximately 130 patients cumulatively.
• In December 2025, the phase II clinical study application for JSKN033 in combination with platinum‑based chemotherapy (with or without bevacizumab) as first‑line treatment for advanced CC was accepted by the CDE, and was officially approved in March 2026.
• Patient enrollment was completed in two dose cohorts of JSKN033 monotherapy as second‑line or above treatment for CC, with POC data accumulation and dose optimization confirmed.
• Enrollment is ongoing for the POC cohort of JSKN033 monotherapy as second‑line or above treatment for endometrial cancer (EC).
• The phase II clinical study of JSKN033 in HER2‑mutant or HER2‑expressing NSCLC is progressing smoothly.

Expected Milestones in 2026 (from Q2 2026)

• The phase II clinical study of JSKN033 in combination regimens as first‑line treatment for CC will be initiated.
• Registrational clinical study of JSKN033 as later‑line treatment for CC (all‑comer) will be initiated.

JSKN022

JSKN022 is a bispecific single-domain antibody targeting both PD-L1 and integrin αvβ6, developed through antibody-directed evolution. It is conjugated via site-specific glycosylation to generate a homogeneous and stable ADC with a DAR of 4. Upon binding to PD-L1 and/or integrin αvβ6 on the surface of tumor cells, JSKN022 can release topoisomerase I inhibitors through cellular endocytosis, exerting anti-tumor effects. Additionally, JSKN022 blocks the binding of PD-L1 and PD-1, thereby activating antitumor immune responses. Simultaneously, by blocking integrin αvβ6, it inhibits the production of TGFB 1/3 and modulates the tumor immune microenvironment.

Events during the Reporting Period

• In April 2025, preclinical data of JSKN022 were presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. Preclinical data demonstrate that JSKN022 exhibits potent antitumor activity in both in vitro and in vivo models against tumor cells expressing integrin αvβ6 and/or PD-L1.
• In October 2025, JSKN022 was approved by the CDE to initiate a phase I clinical study for the treatment of advanced malignant solid tumors, and the first patient was dosed in the same month. The study has now progressed to the sixth dose‑escalation cohort, with preliminary efficacy and favorable safety observed.

Expected Milestones in 2026 (from Q2 2026)

• Dose escalation and dose expansion for JSKN022 will be completed.

JSKN027

JSKN027 is a first-in-class bispecific ADC designed to co-engage PD-L1 and VEGFR2. By leveraging glycan-specific conjugation technology, it precisely links its cleavable linker and topoisomerase I inhibitor payload to the antibody's Fc region - maintaining a strong safety profile while unlocking potent anti-tumor activity. JSKN027's efficacy stems from a unique three-fold synergistic mechanism. Beyond the standard ADC effects of targeted cell killing and bystander activity, it also inhibits tumor angiogenesis by blocking VEGF/VEGFR2 signaling and reverses immune suppression by disrupting the PD-1/PD-L1 checkpoint. This integrated attack enhances overall anti-tumor power and is anticipated to help overcome therapeutic resistance.

Events after the Reporting Period

• In March 2026, JSKN027 was approved by the CDE to initiate a phase I clinical study for the treatment of advanced malignant solid tumors, and the first patient was dosed in the same month.

Expected Milestones in 2026 (from Q2 2026)

• Dose escalation and dose expansion for JSKN027 will be completed.

JSKN021

JSKN021 is a first-in-class dual payload ADC consisting of an EGFR/HER3 bispecific antibody conjugated with novel topoisomerase I inhibitor (T01) and Monomethyl auristatin E (MMAE). Engineered with finely tuned binding avidity in both arms to address tumor heterogeneity while minimizing on-target, off-tumor toxicity, JSKN021 was designed for enhanced stability and improved homogeneity. It combines T01 (DAR 4) and MMAE (DAR 2) payloads to overcome non-response and resistance observed with single-payload treatment strategies.

Events during the Reporting Period

• In April 2025, preclinical data of JSKN021 were presented at the 2025 AACR Annual Meeting. The data demonstrated that JSKN021 inhibited the growth of cancer cells with either HER3 or EGFR or both expressions. Furthermore, JSKN021 showed stronger tumor inhibition efficacy than mono payload ADCs in multiple CDX models.

Events after the Reporting Period

• In March 2026, the IND application for JSKN021 for the treatment of advanced malignant solid tumors was accepted by the CDE.

Expected Milestones in 2026 (from Q2 2026)

• Dose escalation for JSKN021 will be completed.

KN046

KN046, a bispecific antibody (BsAb) immune checkpoint inhibitor, composed of a fusion of CTLA-4 and PD-L1 single domain antibody, engineered to target the tumor microenvironment with high PD-L1 expression. Multiple clinical trials of KN046 have been conducted in China, the United States and Australia.

Events during the Reporting Period

• In February 2025, the results of phase II clinical study of KN046 in combination with lenvatinib for the treatment of advanced unresectable or metastatic hepatocellular carcinoma were published in Nature Communications.

Manufacturing Facilities

The Company's manufacturing facility was constructed in compliance with GMP standards of the NMPA, the FDA, and the European Medicines Agency (EMA), with current capacity meeting the large-scale manufacturing needs for a variety of biologic both in the clinical and commercial stages. The new suite dedicated to ADC drugs has been already commenced operations, further strengthening the industrialization foundation of the ADC platform. In 2025, the Company successfully passed the GMP compliance inspection conducted by the Medicines Control Authority of Zimbabwe (MCAZ). In early 2026, it successively passed the cGMP inspection by the Saudi Food and Drug Authority (SFDA) and the GMP inspection by the Australian Therapeutic Goods Administration (TGA). The quality system continues to receive recognition from internationally authoritative regulatory agencies.

Other Highlights

• In September 2025, at the 2025 China Healthcare Decision-makers Conference (2025 CHDC) and the China Innovative Drug Decade Achievement Tour organized by Pharmcube, the Company was listed on the "China Innovative Drug Decade Glory" honor roll and awarded the "Industry-leading Biotech Company".
• In November 2025, the Company was granted with "2025 Top 100 Chinese Pharmaceutical Innovative Enterprises" for the seventh time at the 17th China Healthcare Summit of Entrepreneurs, Scientists, and Investors (2025 CHSESI).
• In December 2025, the Company was granted the "Annual Innovation Award" at the Annual Excellence Company Selection organized by Gelonghui.

For more information, please refer to the Company's Annual Results Announcement for the Year Ended December 31, 2025 published on the Hong Kong Stock Exchange and the Company's official website.

About Alphamab Oncology

Alphamab Oncology (Stock Code: 9966.HK) is an innovative biopharmaceutical company focused on oncology. Leveraging proprietary platforms-including single-domain antibodies, bispecific antibodies, glycan-specific conjugation, linker-payloads, dual-payload ADCs, and high-concentration subcutaneous formulations, the Company has built a differentiated and globally competitive pipeline, covering cutting-edge candidates in ADCs, bispecific antibodies, and single-domain antibodies.

One product has received market approval: Envafolimab (KN035, brand name: 恩维达^®), the world's first subcutaneously injected PD-(L)1 inhibitor, offering greater convenience and accessibility in cancer treatment. The NMPA has accepted the new drug application for KN026 (Anbenitamab Injection), a HER2 bispecific antibody, for second-line or later HER2-positive gastric cancer. Five bispecific ADC candidates have entered clinical stages, and next-generation ADC pipelines—such as dual-payload ADCs—are advancing rapidly. The Company has established strategic partnerships with organizations including CSPC, ArriVent, and Glenmark, covering both product development and technology platforms.

Our overarching mission is to make cancer manageable and curable by addressing unmet clinical needs in oncology. Alphamab Oncology is continuously dedicated to the development of effective, safe, and globally competitive anti-tumor drugs, enabling patients to achieve long-term, high-quality survival and delivering China-innovated cancer therapies to benefit patients worldwide.

Source: Alphamab Oncology Related Stocks: HongKong:9966