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 antibody-conjugated drugs at different stages of development, including one product approved for marketing by the State Drug Administration, three in the late clinical stage, and two in phase I clinical trials. 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 blockbuster. 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 initially showed that KN046 has good safety and significant curative effects. Among them, the preliminary results of the phase II clinical trial in China showed that KN046 (as monotherapy and combination chemotherapy) has good curative effects in treating NSCLC, PDAC, HCC, and TNBC. We have published preliminary good safety and efficacy data for KN046 in patients who failed previous immunological checkpoint inhibitors. We have begun critical clinical trials for 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 phase I clinical trial results of KN046 were published on the “Journal for Immuno Therapy of Cancer” (Journal for Immuno Therapy of Cancer) online website 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 (European Journal of Cancer) in July 2023. KN026 - A new generation of anti-HER2 BsAb, can simultaneously combine two different clinically proven HER2 epitopes to produce potentially superior efficacy. Two phase I clinical trials for HER2-positive or HER2-expressing solid tumors in China and the US, respectively, have been completed. Currently, KN026 is undergoing several phase II clinical trials in China. We are also conducting 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, and exploratory trials of KN026 combined with KN046. In phase I and phase II clinical trials of KN026 in China and the US, KN026 has shown good initial efficacy signals and good safety in patients with HER2-expressing cancer who had previously been severely treated. 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 have obtained good efficacy and safety from the phase II clinical trial of KN026 combined with KN046 for 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. KN035 (Envolizumab Injection) - An innovative anti-tumor immunotherapy drug, jointly developed by us, Siludi (Beijing) Pharmaceutical Technology Co., Ltd. (“Siludi Pharmaceuticals”) and Xiansheng Pharmaceutical Group Co., Ltd. (stock code: 2096). It is the world's first subcutaneously injectable PD-L1 inhibitor. It is also the only immunotherapeutic drug for cross-tumor indications in China, and the first domestically produced PD-L1 drug. It has advantages in terms of safety, convenience, compliance, suitable for patients unsuitable for intravenous infusion, and low medical costs. KN035 (envolizumab injection) is currently undergoing phase III clinical trials for biliary tract cancer in China. Key trials for undifferentiated pleomorphic sarcoma/myxofibrosarcoma are being conducted in the US and UK. In August 2023, IND was approved by the National Drug Administration for the phase III clinical trial of KN035 (envolizumab injection) for a new adjuvant/adjuvant treatment for NSCLC. KN019-an immunosuppressant fusion protein based on CTLA-4 has potential wide application in immune disorders caused by autoimmune diseases and tumor treatment. JSKN003 - A HER2 bi-epitopic antibody conjugation drug that links a topoisomerase I inhibitor to the N glycosylation site of the antibody KN026 (recombinant humanized anti-HER2 bispecific antibody) through glucose-based 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, and the toxicity of the payload drug is low. In March 2023, jSKN003 completed its first phase IA/iB clinical trial administration in China, and was further approved by the ethics committee of its team leader unit to adjust to phase I/II clinical trial in May 2023. KN052- is an innovative PD-L1/OX40 bispecific antibody independently developed by the Group using its 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 activate cytotoxic T lymphocyte T cells and reduce immune suppression mediated by regulatory T cells. Through a collaborative mechanism, KN052 is expected to exert strong anti-tumor effects. In February 2023, the company entered into a strategic cooperation with Siwei (Shanghai) Biotechnology Co., Ltd. (“Si Microbiology Technology”) to target 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 as Late-Breaking Research and presented as a poster at the 2023 AACR Annual Meeting in April 2023.