About ALPHAMAB-B Company

We are a leading biopharmaceutical company in China with a complete proprietary technology platform for ADC, bispecific antibodies and multi-functional protein engineering. Using our unique drug discovery and development capabilities, we provide world-class innovative therapeutic biologics to patients around the world. 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 ADC, monoclonal antibodies, and bispecific antibody oncology drugs at various stages of development, including one product approved for marketing by the State Drug Administration and various products in phase III or critical clinical trials. KN035 (Envolizumab Injection) (brand name: Envira) - An innovative anti-tumor immunotherapy drug. It is the world's first PD-L1 inhibitor that can be injected subcutaneously, and the first domestically produced PD-L1 inhibitor. It has the advantages of safety, convenience, high compliance, suitable for patients not suitable for intravenous infusion, and low medical costs. We began commercializing the KN035 in November 2021. In 2024, it has been registered and listed by the Macau Drug Administration for the treatment of adult advanced solid tumor patients with unresectable or metastatic MSI-H/dMMR; it has been highly recognized by the consensus of 16 domestic authoritative guidelines; it has obtained CDE breakthrough therapy certification for high tumor mutation burden (TMB-H) unresectable or metastatic solid tumors in patients who have failed previous standard treatments and are unsatisfied with alternative treatment; and we have completed the verification of supplementary applications for site, scale and process changes, and obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices of compliance with the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and we have obtained notices that meet the requirements; and Glenmark entered into a licensing agreement, according to which Siludi Pharmaceuticals and we agreed 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. kn026 - A new generation of anti-HER2BSAB, can combine two different HER2 epitopes at the same time and has good curative effects. Currently, KN026 is undergoing three phase III clinical trials in China, including KN026 combined with docetaxel (albumin binding) for first-line treatment of HER2-positive BC, KN026 combined second-line chemotherapy for HER2-positive GC/GEJ, and KN026 combined with docetaxel (albumin conjugated) BC as a new adjuvant treatment. HER2-positive GC (including GEJ) patients who failed first-line standard treatment (trastuzumab in combination with chemotherapy) with KN026 have been awarded breakthrough therapy by CDE. Registration and communication with the regulatory authorities will be initiated based on the results of the mid-term analysis. 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. Currently, three phase III clinical trials are being conducted in China, including phase III clinical trials of JSKN003 for the treatment of HER2-positive BC, HER2-low BC, and platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. In April 2024, the results of the phase I clinical trial dose escalation phase study conducted by JSKN003 in Australia were presented at the AACR annual meeting. In June 2024, the phase I clinical results of the phase I/II clinical trial conducted by JSKN003 in China were presented at the ASCO annual meeting. In September 2024, the latest research progress in clinical trials of JSKN003 for the treatment of platinum-resistant OC and advanced HER2 positive (IHC3+) solid tumors (excluding BC) was presented at the ESMO conference. Also, in September 2024, we entered into a licensing agreement with Zinmante Biotech to develop, sell, and commercialize JSKN003 in mainland China for the treatment of tumor-related indications. According to the license agreement, the Company is entitled to receive down payments and milestone payments totaling up to RMB 3.08 billion. In addition, the Company also has the right to charge a two-digit percentage of JSKN003's net product sales royalty. Furthermore, JSKN003 has been certified as a breakthrough therapy by CDE to treat platinum-resistant recurrent epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer, and is not limited to HER2 expression levels. 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 (TOPO1i), 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. Phase I clinical trials of JSKN016 for the treatment of advanced malignant solid tumors and clinical trials of JSKN016 in multiple subgroups of monotherapy and combination therapy for lung cancer and breast cancer are ongoing. JSKN033- 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 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. Furthermore, phase I/II clinical trials of JSKN033 for advanced metastatic malignancies are being conducted in China. This study is a pilot project to optimize the review and approval of clinical trials of innovative drugs. In November 2024, the latest research results from the phase I/II clinical trial of JSKN033 for the treatment of advanced or metastatic solid tumors with advanced HER2 expression in Australia were selected as the latest breakthrough summary of the 2024 SITC Annual Meeting, and were first announced in poster form during the annual conference. 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, first-line nsCLC, and phase Ib clinical results for first-line treatment of recurrent and metastatic esophageal squamous cell carcinoma were published in “Nature Communications,” “Cell Reports Medicine,” and “Cancer Immunology, Immunotherapy” in February, March, and August 2024, respectively. The results of the phase II clinical trial of KN046 combined with axitinib for first-line treatment of advanced NSCLC were also presented at the 2024 ESMO Immuno-Oncology Conference. In September 2024, we completed the final OS analysis for the phase III clinical trial of kn046 for advanced Sq NSCLC. The company will decide on the subsequent development plan for KN046 based on the actual situation.