About ALPHAMAB-B Company

We are a leading biopharmaceutical company in China with a fully integrated proprietary biologics platform in bispecific and protein engineering. Our mission is to provide world-class innovative therapeutic biologics to patients around the world by applying our unique drug discovery and development capabilities. We believe this capability can be proven through our strong R&D track record and supported by our proprietary technology, platform, and expertise. Product pipeline Our highly differentiated internal pipeline consists of tumor monoclonal antibodies, bispecific antibodies, and ADCs at various stages of development, including one approved for marketing by the State Drug Administration and three products in the advanced clinical stages. kn046 is a BsAB immune checkpoint inhibitor that simultaneously targets two clinically proven immune checkpoints PD-L1 and CTLA-4, and is a potentially groundbreaking next-generation tumor immunization major drug. KN046 has conducted about 20 clinical trials covering more than 10 types of tumors (including NSCLC, TNBC, ESCC, HCC, PDAC and thymic cancer) at various stages in China, the United States and Australia. The results of these clinical trials have initially shown that KN046 has good safety and significant curative effects. We are also conducting key clinical trials to treat NSCLC and PDAC. We continue to seek cooperative opportunities to conduct clinical trials of drug candidates with KN046's joint business partners to achieve better efficacy. The results of the phase I clinical trial of KN046 were published online in the “Journal for Immunotherapy of Cancer” in June 2023. KN046 is well tolerated and has shown good anti-tumor efficacy in treating advanced solid tumors (especially patients with nasopharyngeal cancer). Meanwhile, KN046 showed good efficacy and good safety in single-arm phase II clinical trials for the treatment of advanced NSCLC. The results were published in the European Journal of Cancer in July 2023. The results of four recent studies of KN046 were presented at the ESMO conference in October 2023, including first-line treatment of advanced NSCLC with axitinib, NSCLC that failed to be treated with immune checkpoint inhibitors, NSCLC that failed treatment with EGFR-TKI (s), and second-line thymic cancer. Regarding the phase III clinical trial of KN046 combined with albumin paclitaxel/gemcitabine for locally advanced unresectable or metastatic PDAC, and the phase III clinical trial of kN046 combined with platinum-containing chemotherapy for advanced unresectable or metastatic sQ NSCLC, the Independent Data Monitoring Committee recommended continuing the study and further collecting follow-up OS follow-up data until the final OS analysis. KN026 - A new generation of anti-HER2 BsAb, can simultaneously combine two different clinically proven HER2 epitopes to produce potentially superior efficacy. Currently, KN026 is undergoing several clinical trials in China. We are also conducting phase III clinical trials of KN026 combined with docetaxel (albumin conjugated type) for first-line treatment of HER2-positive BC and KN026 combined second-line chemotherapy for HER2-positive GC/GEJ. In phase I and phase II clinical trials in China and the US, KN026 has shown good initial efficacy and safety in severely treated HER2-expressing cancer patients. In May 2023, IND for KN026 combined with docetaxel (albumin binding type) as a first-line treatment for HER2-positive recurrent and metastatic BC was approved by the National Drug Administration, and the first patient administration was successfully completed in July 2023. We achieved good efficacy and safety in the phase II clinical trial of KN026 combined with KN046 to treat locally advanced unresectable or metastatic HER2-positive solid tumors (excluding BC or GC/GEJ). The results were presented at the 2023 ASCO Annual Meeting in June 2023. The results of two recent studies on KN026 combined with docetaxel for first-line and new adjuvant treatments for HER2-positive BC were presented at the 2023 ESMO conference, and follow-up data for KN026 plus docetaxel as first-line treatment for HER2-positive BC was also presented at the 2023 SABCS conference in December 2023. In November 2023, HER2-positive GC (including GEJ) patients who failed first-line standard treatment (trastuzumab combined with chemotherapy) with KN026 were granted breakthrough therapy certification by the CDE of the National Drug Administration. KN035 (Envolizumab Injection) - An innovative anti-tumor immunotherapy drug, jointly developed by us, Siludi Pharmaceuticals and Xiansheng Pharmaceutical. It is the world's first subcutaneously injectable PD-L1 inhibitor, the only immunotherapeutic drug for cross-tumor indications in China, and the first domestically produced PD-L1 drug. It has the advantages of safety, convenience, high compliance, suitable for patients unsuitable for intravenous infusion, and low medical costs. Key tests for undifferentiated pleomorphic sarcoma/myxofibrosarcoma are being conducted overseas. In August 2023, the IND for the phase III clinical trial of KN035 for the new adjuvant/adjuvant treatment of NSCLC was approved by the National Drug Administration. In October 2023, the FDA approved IND for a phase III clinical trial of KN035 combined with lenvatinib versus carboplatin-paclitaxel chemotherapy for first-line treatment of patients with advanced or recurrent mismatch repair (pMMR) endometrial cancer. In November 2023, kn035 combined with lenvatinib for treatment of advanced non-MSI-H/ non-dmMR endometrial cancer that has failed or is intolerable to at least first-line platinum-containing chemotherapy was awarded a breakthrough therapy by the CDE of the State Drug Administration. KN019-an immunosuppressant fusion protein based on CTLA-4 has potential wide application in immune disorders caused by autoimmune diseases and tumor treatment. Its subcutaneous formulation was approved by IND by the State Drug Administration in November 2023 for clinical development. JSKN003 - A HER2 bi-epitopic ADC that links a topoisomerase I inhibitor to the N glycosylation site of the antibody KN026 (recombinant humanized anti-HER2 bispecific antibody) through glycosylated fixed-point coupling technology. Click reaction conjugates have better serum stability than maleimide-Michael reaction conjugates. Dual epitope HER2 targeting makes JSKN003 have stronger endocytosis induction and bystander killing effects, making it have strong anti-tumor activity in HER2-expressing tumors. The phase I/II clinical trial of JSKN003 in China completed its first patient administration in March 2023, and we are also actively promoting its key clinical trials in China. In the phase I clinical trial conducted in Australia, clinical trial data for the dose escalation phase was presented at the 2024 AACR Annual Meeting in April 2024, showing good tolerability, safety, and initial anti-tumor efficacy. KN052- is an innovative PD-L1/OX40 bispecific antibody independently developed by the Group using a bispecific antibody platform. It can combine PD-L1 and OX40 at the same time, effectively reverse tumor-induced immunosuppression by blocking PD-L1/PD-1 pathways, and promote immune response by stimulating OX40. On the one hand, KN052 blocks immune escape from tumor cells, and on the other hand, it can promote the proliferation of activated T cells and reduce Treg-mediated immunosuppression. Through a collaborative mechanism, KN052 is expected to exert strong anti-tumor effects. In February 2023, the company collaborated strategically with Siwei (Shanghai) Biotechnology Co., Ltd. (“Si Microbiology Technology”) for the combination therapy of kn052 and the personalized mRNA tumor vaccine SWP1001 in several types of solid tumors. In March 2023, KN052's preclinical findings were selected for Late-Breaking Research and presented in poster form at the 2023 AACR Annual Meeting in April 2023. JSKN003- is the world's first ADC compound formulation for subcutaneous injections independently developed by the Group. It consists of JSKN003 and KN035. It has been approved by the Bellberry Clinical Research Ethics Committee in Australia to conduct clinical research on advanced HER2 expression or metastatic solid tumors, and the first patient administration was completed on March 26, 2024.