On March 26, 2024 Alphamab Oncology reported financial results for the full year ended December 31, 2024 and highlighted recent business progress (Press release, Alphamab, MAR 26, 2025, View Source,amounted%20to%20RMB%20159.46%20million. [SID1234654359]).
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Financial Summary
● For the year ended December 31, 2024, we recorded total revenue of RMB 640.08 million, a 192.58% year-on-year increase. Meanwhile, product revenue (attributed to the Company) amounted to RMB 159.46 million.
● For the year ended December 31, 2024, our R&D expenditure amounted to RMB 404.15 million, basically unchanged as compared with prior year.
● For the year ended December 31, 2024, we reached profitability for the first time on an annual basis, recording profit for the year of RMB 166.34 million.
● We have a healthy financial position, with cash reserves of RMB 1,571.47 million as of December 31, 2024.
Business Highlights
With multiple proprietary platforms, the Company has established a globally competitive and differentiated pipeline that includes antibody-drug conjugation (ADC), single domain antibody, and bispecific 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. Multiple assets are in phase III or pivotal clinical trials, and several other bispecific ADC new drug candidates are in preclinical development.
Commercial Product
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.
Events during the Reporting Period
● In January 2024, Envafolimab obtained the market approval by the Pharmaceutical Administration Bureau of the Macau Special Administrative Region of the People’s Republic of China for the treatment of non-metastatic advanced microsatellite instability-high (MSI-H) or non-mismatch-repair deficiency (dMMR) advanced solid tumors.
● In January 2024, Alphamab Oncology and 3D Medicines entered into a license agreement with Glenmark Pharmaceuticals Ltd. (Glenmark) for the subcutaneous injection PD-L1 antibody drug KN035, pursuant to which, Glenmark was granted exclusive licensing interests in clinical development and commercialization of oncology indications of KN035 (the "Field") in India, Asia Pacific (except Singapore, Thailand, Malaysia), the Middle East and Africa, Russia, Commonwealth of Independent States and Latin America (the "Territory"). Glenmark shall bear its own costs and expenses related to the development and commercialization of KN035 in the Field in the Territory. Jiangsu Alphamab retains the exclusive right to produce KN035 for any purpose either inside or outside the Territory.
● In March 2024, Envafolimab was included in the 2024 edition of the "Chinese Expert Consensus on the Use of Immune Checkpoint Inhibitors in Perioperative Treatment of Advanced Gastric Cancer" published by the Gastric Cancer Committee of the Chinese Anti-Cancer Association. Envafolimab has been highly recommended by 16 latest domestic authoritative guidelines and consensus recommendations in 2024.
● In August 2024, Envafolimab was granted breakthrough therapy designation 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.
● In September 2024, the supplementary application for production site, scale and process changes of KN035 successfully passed the GMP compliance inspection, and we received Pharmaceutical GMP Compliance Inspection Certificate in December 2024.
Clinical Product Pipeline
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 BC and GC, including those with prior anti-HER2 treatment. KN026 in combination with chemotherapy for the treatment of patients with HER2-positive GC (including GEJ) who have failed first-line standard treatment was granted breakthrough therapy designation by the Center for Drug Evaluation (CDE) of the National Medical Products Administration of China (NMPA).
Events during the Reporting Period
● The phase III clinical trial of KN026 combined with chemotherapy as second-line and later-line treatment of HER2-positive GC/GEJ is undergoing smoothly.
● The phase III clinical trial of KN026 combined with albumin-bound Docetaxel HB1801 as first-line treatment of HER2-positive recurrent and metastatic BC is undergoing smoothly.
● In October 2024, a phase III clinical trial of KN026 in combination with albumin-bound Docetaxel HB1801 was approved by CDE as neoadjuvant treatment for HER2-positive early or locally advanced BC, and the first patient was successfully dosed in December 2024.
Events after the Reporting Period
● In January 2025, the results of phase II clinical trial 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 trial 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.
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 April 2024, the results of the dose-escalation stage of the phase I clinical trial of JSKN003 conducted in Australia were presented at the 2024 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which demonstrated favorable tolerability and safety profile of JSKN003 in patients with advanced/metastatic solid tumors who received prior multi-line treatment. The occurrence of hematologic toxicity was very low among common treatment-related adverse events (TRAEs) of all grades and no TRAE led to death or treatment discontinuation. The results also demonstrated encouraging preliminary anti-tumor activity.
● In June 2024, data from a phase I clinical trial of JSKN003 conducted in China were presented for the first time at the 2024 Annual Meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper). The results showed that the ORR was 51.1% in all efficacy evaluable patients across HER2 low and HER2 positive populations, of which 28 patients who received prior anti-HER2 the ORR was 57.1%, and 21 patients who received prior anti-HER2 ADC the ORR was 57.1%. The results still showed efficacy signals in patients with previous anti-HER2 ADC treatment.
● In September 2024, clinical data from two studies on JSKN003 for the treatment of PROC and HER2-positive (IHC 3+) advanced solid tumors (excluding BC) were presented at the 2024 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress. The results have demonstrated favorable tolerability and safety profile, with promising efficacy of JSKN003 in heavily pretreated patients with PROC or HER2-positive solid tumors.
● In September 2024, the Company entered a licensing agreement with JMT-Bio Technology Co., Ltd. (JMT-Bio), a wholly-owned subsidiary of CSPC Pharmaceutical Group Co., Ltd. (CSPC) (stock code: 1093.HK), pursuant to which, JMT-Bio was granted the exclusive license and sublicense rights to develop, sell, offer for sale and commercialize JSKN003, for the treatment of tumor-related indications (the "Field") in mainland China (excluding Hong Kong, Macau or Taiwan) (the "Territory") and become the sole marketing authorization holder for JSKN003 for the Field in the Territory. Alphamab retains the sole right to supply JSKN003. According to the licensing agreement, Alphamab is entitled to receive upfront payment and milestone payments of up to RMB3.08 billion in total, and a double-digit percentage of royalties on net product sales of JSKN003.
● In December 2024, JSKN003 received approval from CDE to initiate 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, and the first patient was successfully dosed in February 2025.
● The phase III clinical trial of JSKN003 for the treatment of unresectable locally advanced or metastatic HER2-low expressing BC is undergoing smoothly.
● Multiple exploratory phase II clinical studies of JSKN003 are currently being conducted.
Events after the Reporting Period
● In February 2025, JSKN003 received approval from CDE to initiate a phase III clinical trial to compare the efficacy and safety of JSKN003 versus trastuzumab emtansine (T-DM1) for the treatment of HER2-positive advanced BC, and the first patient was successfully dosed in the same month.
● In March 2025, JSKN003 was granted breakthrough therapy designation by CDE. The designation is for the treatment of platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, not restricted to HER2 expression levels.
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, coupled with 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
● In March 2024, JSKN016 received approval from CDE to initiate a phase I clinical trial for the treatment of advanced malignant solid tumors and the first patient was successfully dosed in May 2024. JSKN016 has demonstrated preliminary antitumor activity and a favorable safety profile across multiple solid tumor types, supporting its advancement to the next phase of clinical study.
Events after the Reporting Period
● The phase II clinical trial of JSKN016 monotherapy in multiple subgroups of lung cancer to evaluate efficacy, safety, and dose optimization is currently being conducted.
● The cohort expansion phase clinical trial of JSKN016 monotherapy for the treatment of non-HER2-positive BC is currently being conducted.
● In March 2025, IND application for JSKN016 combined with chemotherapy/immunotherapy /tyrosine kinase inhibitors (TKI) as first-line and later-line treatment of multiple subgroups of non-small cell lung cancer (NSCLC) was approved by CDE.
● In March 2025, IND application for JSKN016 combined with chemotherapy/immunotherapy as first-line and later-line treatment of multiple subgroups of non-HER2-positive BC was approved by CDE.
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 March 2024, the first patient has been successfully dosed in Australia in the phase I/II clinical study of JSKN033 for the treatment of HER2-expressing advanced or metastatic solid tumors. The dose escalation phase has been completed until now.
● In November 2024, the research updates of the first-in-human phase I/II clinical trial of JSKN033 for the treatment of HER2-expressing advanced or metastatic solid tumors, have been presented for the first time as a poster in the Late-Breaking Abstract session at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper). JSKN033 presented a favorable safety profile and encouraging anti-cancer activity in heavily treated patients.
● In December 2024, JSKN033 received approval from CDE to initiate a phase I/II clinical trial in Chinese patients with advanced metastatic malignant tumors and the first patient was successfully dosed in January 2025. This study has previously been included in the "Pilot Program for Optimizing the Review and Approval of Clinical Trials for Innovative Drugs".
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 at different stages covering different types of tumors including non-small cell lung cancer (NSCLC) have been conducted in China, the United States and Australia.
Events during the Reporting Period
● In February 2024, the results of the phase II clinical trial of KN046 in combination with nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer were published in Nature Communications.
● In March 2024, the results of the phase II clinical trial of KN046 in combination with chemotherapy as first-line treatment for metastatic NSCLC were published in Cell Reports Medicine.
● In August 2024, the results of phase Ib clinical trial of KN046 in combination with chemotherapy and palliative radiotherapy as first-line treatment for advanced esophageal squamous cell carcinoma were published in Cancer Immunology, Immunotherapy.
● In September 2024, we completed OS final analysis for a phase III clinical trial of KN046 for the treatment of advanced squamous NSCLC (sq NSCLC).
● In December 2024, the results of the phase II clinical trial of KN046 in combination with Axitinib as first-line treatment for advanced NSCLC were presented at the European Society for Medical Oncology Immuno-Oncology (ESMO IO) Congress 2024.
Events after the Reporting Period
● In February 2025, the results of phase II clinical trial 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 June 2024, Jiangsu Alphamab entered into a research and collaboration agreement with ArriVent BioPharma, Inc. to use Jiangsu Alphamab’s proprietary linker-payload (Alphatecan) and glycan-specific conjugation platforms to discover and develop novel bispecific ADCs.
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). The production lines are equipped with world-class equipment capable of meeting the large-scale manufacturing needs for a variety of biologics, including ADCs, both in the clinical and commercial stages. In 2024, the Company further expanded its production capacity by constructing the new suite dedicated to ADC drugs, which will be put into operation soon.
Other Highlights
● In November 2024, the Company was granted "2024 Top 100 Chinese Pharmaceutical Innovative Enterprises"and"2024 China Pharmaceutical Innovative Enterprise Bispecific Antibody Track Top5"by Healthcare Executive, a specialized magazine focusing on the pharmaceutical industry.
● In November 2024, the Company was granted "2024 Top 100 Brand Influence of Chinese Pharmaceutical Enterprise" by the China Health Culture Association, the China Hospital Association, and the National Health Commission of the People’s Republic of China Health TV Channel (CHTV) at the 2024 Healthy China Communication Conference.
For more information, please refer to the Company’s Annual Results Announcement for the Year Ended December 31, 2024 published on the Hong Kong Stock Exchange and the Company’s official website.