About ALPHAMAB-B Company

We are a leading biopharmaceutical company in China with a complete proprietary technology platform for bispecific antibodies, multifunctional protein engineering and ADCs. 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 - A BsAB immune checkpoint inhibitor that simultaneously targets two clinically proven immune checkpoints PD-L1 and CTLA-4 with obvious structural differences, can change the localization of tumor microenvironment and reduce off-target toxicity. KN046 has conducted a number of clinical trials at various stages, including NSCLC in China, the US and Australia. Phase II clinical trial results for first-line triple-negative breast cancer and first-line NSCLC were also published in “NatureCommunications” and “CellReportsMedicine” in February and March 2024, respectively. In September 2024, we completed the final OS analysis of the phase III clinical trial of kn046 for advanced sqnsCLC. After correcting the effects of backline immunotherapy through a reasonable model, kn046 combined with platinum-containing chemotherapy benefited statistically different OS in patients with sqnsCLC compared with placebo combined with platinum-containing chemotherapy. Furthermore, the final analysis of PFS showed significant benefits for KN046 in combination with platinum-containing chemotherapy. kn026 - A new generation of anti-HER2BSAB, can combine two different HER2 epitopes at the same time and has good curative effects. In phase I and phase II clinical trials in China and the US, KN026 showed good initial efficacy and safety in patients with HER2-expressing cancer treated with multiple lines. Currently, KN026 is undergoing several clinical trials in China. A phase III clinical trial of KN026 combined with docetaxel (albumin conjugated type) for first-line treatment of HER2-positive BC and KN026 combined with second-line chemotherapy for HER2-positive GC/GEJ is also being carried out. HER2-positive GC (including GEJ) patients who failed first-line standard treatment (trastuzumab in combination with chemotherapy) with KN026 have been granted breakthrough therapy certification by the CDE of the National Drug Administration. KN035 (Envolimab Injection) (brand name: Enveda) - An innovative anti-tumor immunotherapy drug, jointly developed by us, Siludi Pharmaceuticals and Xiansheng Pharmaceutical. It is the world's first PD-L1 inhibitor that can be injected subcutaneously. It is also the first domestically produced PD-L1 inhibitor. It has the advantages of safety and convenience, high compliance, suitable for patients not suitable for intravenous infusion, and low medical costs. In January 2024, it was registered and listed by the Macau Special Administrative Region Drug Administration for the treatment of adult patients with advanced solid tumors with unresectable or metastatic Msi-H/dMMR. Furthermore, we have entered into a licensing agreement with Siludi Pharmaceuticals and Glenmark, according to which we agree to grant Glenmark an exclusive license and sub-license for KN035 oncology indications to develop and commercialize KN035 in all fields of oncology use (including) in India, the Asia-Pacific region (excluding Singapore, Thailand and Malaysia), the Middle East and Africa, Russia, the CIS countries and Latin America. 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 injectable preparation 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 glycosyl fixed-point coupling. 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. Phase I clinical trials of JSKN003 are currently being conducted in Australia, and phase I/II and phase III clinical trials are being conducted in China. In April 2024, the results of the dose escalation phase of the phase I clinical trial conducted by JSKN003 in Australia were presented at the AACR annual meeting. The study results showed that JSKN003 was well tolerated and safe in patients with advanced/metastatic solid tumors previously treated with multiple lines, showing encouraging initial anti-tumor activity. In June 2024, the phase I clinical results of the phase I/II clinical trial of JSKN003 in China were presented at the ASCO annual meeting, showing that JSKN003 was well tolerated in the dosage range of 2.1 mg/kg to 8.4 mg/kg, and showed encouraging anti-tumor activity in patients who had previously received advanced treatment. The latest research progress in clinical trials of JSKN003 for the treatment of platinum-resistant ovarian cancer and HER2-positive advanced solid tumors (excluding BC) was presented at the European Society of Medical Oncology Congress in September 2024. JSKN033- is the world's first ADC compound preparation 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 carry out clinical studies to treat advanced or metastatic solid tumors with advanced HER2 expression, and the first patient administration was completed in March 2024. JSKN016 - A self-developed bispecific ADC that simultaneously targets HER3 and TROP2 on tumor cells. JSKN016 is designed based on our unique sugar-based fixed-point coupling platform. After JSKN016 binds to TROP2 or HER3 on the surface of tumor cells, it enters the lysosome through target-mediated endocytosis, releasing cytotoxic topoisomerase I inhibitors (TOP1i), which in turn induces tumor cell death. Furthermore, the inhibitor can penetrate the cell membrane into antigen-negative tumor cells and exert a bystander effect. The combined effect of the two can effectively inhibit the growth of tumor cells. In March 2024, the State Drug Administration approved the IND application for JSKN016 for the phase I clinical trial for the treatment of advanced malignant solid tumors, and completed the first patient administration in May 2024.