On August 29, 2025 Alphamab Oncology (stock code: 9966.HK) reported interim financial results for the six months ended June 30, 2025 and highlighted recent business progress.
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Financial Summary
● For the six months ended June 30, 2025, we recorded total revenue of RMB 319.44 million, an increase of 84.05% compared with the first half of 2024. Meanwhile, product revenue (attributed to the Company) amounted to RMB 67.02 million.
● For the six months ended June 30, 2025, our R&D expenditure amounted to RMB 253.16 million, an increase of 30.14% compared with the first half of 2024.
● For the six months ended June 30, 2025, we recorded a profit for the period of RMB 21.58 million, as compared to a loss of RMB 44.90 million for the first half of 2024, representing a year-on-year turnaround from loss to profit.
● We have a healthy financial position, with cash reserves of RMB 1,644.79 million as of June 30, 2025.
Business Highlights
Product Pipeline
By leveraging its proprietary core technology platforms, the Company has established a product portfolio with differentiated innovation and global competitiveness, covering cutting-edge areas such as antibody-drug conjugates (ADCs), bispecific antibodies, and single-domain antibodies. Envafolimab, the world’s first subcutaneously injectable PD-(L)1 inhibitor, was approved by Chinese authorities in 2021, providing a safer and more convenient tumor immunotherapy for patients. Additionally, the Company has multiple bispecific antibodies and bispecific ADCs in clinical stage, while rapidly advancing the preclinical pipeline prioritizing bispecific ADCs and dual-payload ADCs.
KN035 (Envafolimab)
KN035, an innovative anti-tumor immunotherapy drug, is the first subcutaneously injectable PD-(L)1 inhibitor worldwide, the first immunotherapy drug aimed at cross-tumor indications in China and the first domestically produced PD-L1 drug. KN035 offers advantages in effectiveness, safety, convenience and compliance, particularly suitable for frail, elderly patients and those with adverse reactions to intravenous infusions, while significantly reducing the use of healthcare resources. Envafolimab has been highly recommended by 16 latest domestic authoritative guidelines and consensus recommendations. Envafolimab was granted Breakthrough Therapy Designation (BTD) by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA) for the treatment of patients with unresectable or metastatic solid tumors with high tumor mutation burden (TMB-H) who have failed prior standard treatment and no satisfactory alternative treatment.
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) (Free ASCO Whitepaper) Annual Meeting, with data from additional eight studies published online.
KN026
KN026 is a HER2 heterodimeric bispecific antibody (BsAb) that can simultaneously bind two non-overlapping epitopes of HER2, leading to HER2 signal blockade. KN026 has demonstrated better tumor inhibition in HER2-positive tumor cell lines compared with Trastuzumab and Pertuzumab in combination. Additionally, KN026 has also shown inhibitory effect on tumor cells with Trastuzumab-resistant cell lines. The results of multiple clinical studies in different stages showed that KN026 has significant anti-tumor activities, even in heavily pretreated patients with HER2-positive breast cancer (BC) and gastric cancer (GC), including those with prior anti-HER2 treatment. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC/ gastroesophageal junction cancer (GEJ) who have failed first-line standard treatment was granted BTD by the CDE.
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 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 trial 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 showed a trend toward overall survival (OS) benefit, with both statistical significance and clinical relevance.
● In April 2025, enrollment of all patients was completed in the phase III clinical trial 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.
● The phase III clinical trial of KN026 combined with albumin-bound docetaxel HB1801 as neoadjuvant treatment of HER2-positive early or locally advanced BC is undergoing smoothly.
Events after the Reporting Period
● In July 2025, the Investigational New Drug (IND) application for a phase III clinical trial of KN026 as first-line treatment for HER2-positive GC/GEJ was accepted by the CDE.
● In July 2025, the first interim analysis results from the phase III clinical study of KN026 in combination with chemotherapy as second-line or above treatment of HER2-positive GC/GEJ were accepted by the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress and will be presented during the Congress in October.
Expected Milestones in 2025
● A New Drug Application (NDA) will be submitted in China for KN026 combined with chemotherapy as second-line or above treatment for HER2-positive GC/GEJ.
● Enrollment of all patients will be completed in the phase III clinical trial of KN026 combined with albumin-bound docetaxel HB1801 as neoadjuvant treatment of HER2-positive early or locally advanced BC.
JSKN003
JSKN003 is a bispecific ADC developed based on KN026 using the proprietary glycan-specific conjugation platform. JSKN003 can bind HER2 on the surface of tumor cells and release topoisomerase I inhibitors (TOPIi) through cellular endocytosis, thereby exerting anti-tumor effects. Compared with its ADC counterparts, JSKN003 demonstrated better serum stability and stronger bystander effect, which effectively expands the therapeutic window. Results of multiple clinical studies at various stages of JSKN003 in China and Australia have demonstrated favorable safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with advanced solid tumors, especially in patients with platinum-resistant ovarian cancer (PROC), HER2-expressing BC, or high HER2-expressing solid tumors.
Events during the Reporting Period
● In February 2025, JSKN003 received approval from the CDE to initiate a phase III clinical trial 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 successfully dosed in the same month. The trial is now undergoing smoothly.
● In February 2025, the first patient was successfully dosed in a phase III clinical trial to compare the efficacy of JSKN003 versus investigator-selected chemotherapy for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. The trial is now undergoing smoothly.
● In March 2025, JSKN003 was granted BTD by the CDE for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, 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 (Free ASCO Whitepaper) Annual Meeting.
● In June 2025, results of a preclinical study of JSKN003 were published in RSC Chemical Biology.
● The phase III clinical trial of JSKN003 for the treatment of unresectable locally advanced or metastatic HER2-low expressing BC is undergoing smoothly.
● The phase II clinical trial 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 currently being conducted.
● Multiple exploratory phase II clinical studies of JSKN003 are currently being conducted.
Events after the Reporting Period
● In July 2025, JSKN003 has been granted Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration (FDA) for the treatment of GC/GEJ.
● In July 2025, JSKN003 has received approval from the FDA to initiate a phase II clinical study in the U.S. for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels.
● In July 2025, two latest research results of JSKN003 for the treatment of primary platinum-refractory ovarian cancer (OC) and HER2-positive metastatic colorectal cancer (mCRC), along with the study design of the phase III study of JSKN003 versus physician’s choice of chemotherapy in PROC, were accepted by the 2025 ESMO (Free ESMO Whitepaper) Congress and will be presented during the Congress in October.
Expected Milestones in 2025
● Enrollment of all patients will be completed in the phase III clinical trial of JSKN003 versus trastuzumab emtansine (T-DM1) as second-line or above treatment for HER2-positive advanced BC.
● File an application with the CDE for one pivotal clinical study of JSKN003.
● File an application with the CDE for BTD for one indication of JSKN003.
JSKN016
JSKN016 is a bispecific ADC simultaneously targeting HER3 (Human epidermal growth factor receptor 3) and TROP2 (Trophoblast cell surface antigen 2), which is developed with proprietary single-domain antibody platform and glycan-specific conjugation platform. TROP2 and HER3 are overexpressed in multiple solid tumors. JSKN016 exerts tumor cell-killing activity through dual binding to both antigens, killing tumor cell through endocytosis and bystander effects, demonstrating superior efficacy compared to monospecific TROP2 or HER3 ADCs. Furthermore, JSKN016 shows enhanced ability to overcome drug resistance caused by tumor heterogeneity.
Events during the Reporting Period
● Enrollment has been completed in the cohort expansion clinical study of JSKN016 monotherapy in HER2-negative BC.
● In March 2025, IND application for a phase II clinical trial of JSKN016 in combination with chemotherapy/IO as first-line and later-line treatment of HER2-negative BC was approved by the CDE. Dose optimization of JSKN016 in combination with chemotherapy as later-line treatment of HER2-negative BC is currently ongoing.
● The phase II clinical study of JSKN016 monotherapy in multiple cohorts of non-small cell lung cancer (NSCLC) to evaluate efficacy, safety, and dose optimization is currently being conducted. Enrollment has been completed for both the cohorts of second-line and third-line treatment for EGFR-mutant patients.
● In March 2025, IND application for a phase II clinical trial of JSKN016 in combination with chemotherapy/IO/tyrosine kinase inhibitors (TKI) as first-line and later-line treatment of NSCLC was approved by the CDE. Dose confirmation has been completed for multiple cohorts until now.
● Phase I clinical trial of JSKN016 for the treatment of advanced malignant solid tumors in China is currently undergoing smoothly.
Expected Milestones in 2025
● Initiate patient enrollment in the clinical trial of JSKN016 in combination with IO and chemotherapy as first-line treatment for wild-type NSCLC.
● File an application with the CDE for one to two pivotal clinical studies of JSKN016.
● File an application with the CDE for BTD for one to two indications of JSKN016.
● Release HER2-negative BC related clinical data.
JSKN033
JSKN033 is a proprietary high-concentration co-formulation consisting of ADC and immune checkpoint inhibitor, independently developed by the Company, which can be administered subcutaneously. JSKN033 is the world’s first subcutaneous injectable ADC for clinical trials. By combining immunotherapy (KN035) and ADC (JSKN003), JSKN033 is anticipated to significantly enhance efficacy while leading to improved safety and convenience.
Events during the Reporting Period
● In January 2025, the first patient was successfully dosed in the phase I/II clinical trial of JSKN033 in China for the treatment of advanced metastatic malignant tumors, with dose escalation already completed and cohort expansion currently ongoing. This study has previously been included in the "Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs".
● The phase II clinical study of JSKN033 in HER2-mutated or HER2-expressing NSCLC has been initiated.
● The dose escalation phase has been completed in the phase I/II clinical study in Australia of JSKN033 for the treatment of HER2-expressing advanced or metastatic solid tumors.
Expected Milestones in 2025
● File an application with the CDE for a phase II clinical study of JSKN033 in combination with chemotherapy.
JSKN022
JSKN022 is a first-in-class ADC targeting both PD-L1 and integrin αvβ6. Based on independently developed Envafolimab, Alphamab integrates immuno-oncology (IO) mechanisms with ADC approaches. This novel drug molecule utilizes glycan-specific conjugation technology to enhance both stability and homogeneity. The topoisomerase I inhibitor T01 is site-specifically conjugated to antibodies via a cleavable linker, enhancing therapeutic efficacy. JSKN022 is expected to provide a novel therapeutic option for cancers that are refractory or resistant to PD-1/PD-L1 inhibitors.
Events during the Reporting Period
● In April 2025, preclinical data on JSKN022 were presented at the 2025 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Preclinical data demonstrated that JSKN022 exhibited potent antitumor activity in both in vitro and in vivo models against tumor cells expressing integrin αvβ6 and/or PD-L1.
Events after the Reporting Period
● In August 2025, IND application for the phase I clinical study of JSKN022 in patients with advanced malignant solid tumors who have failed standard therapies has been officially accepted by the CDE.
Expected Milestones in 2025
● The first patient will be dosed in the Chinese phase I clinical study of JSKN022 in patients with advanced malignant solid tumors who have failed standard therapies.
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.
Early-stage R&D
Leveraging proprietary platform technologies including glycan-specific conjugation, linker-payload, dual-payload conjugation, and bispecific antibodies, the Company has developed globally competitive new drugs such as ADCs and bispecific antibodies. The bispecific ADCs (BADC) and dual-drug conjugates (BADDC) developed by the Company, not only improve tumor targeting but also address heterogeneity and resistance issues, offering new strategies for cancer treatment. Currently multiple innovative bispecific ADC new drug candidates are in preclinical development and will be advanced into clinical trials sequentially.
● In April 2025, preclinical data on JSKN021, a bispecific EGFR/HER3 dual-payload ADC, were presented at the 2025 AACR (Free AACR Whitepaper) Annual Meeting. Preclinical studies showed that JSKN021 exhibits excellent stability. Its dual-payload design effectively addresses tumor heterogeneity, demonstrating significantly superior tumor inhibition compared to single-payload ADCs.
Expected Milestones in 2025
● JSKN027: File an IND application with the CDE.
● JSKN021: File an application for a phase I clinical study in Australia.
Manufacturing Facilities
The Company’s manufacturing facility was constructed in compliance with Good Manufacturing Practice (GMP) standards of the National Medical Products Administration of China (NMPA), the U.S. Food and Drug Administration (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 Company further expanded its production capacity by constructing the new suite dedicated to ADC drugs in 2024, which has now already commenced operations.
For more information, please refer to the Company’s Interim Results Announcement for the Six Months Ended June 30, 2025 published on the Hong Kong Stock Exchange and the Company’s official website.