Suzhou, May 28, 2020 - Alphamab Oncology (stock code: 9966 HK) announced today that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. (“Jiangsu Alphamab” or “Alphamab Oncology”), a wholly-owned subsidiary of the Company, has expanded partnership with Sunshine Lake Pharma Co., Ltd. (“Sunshine Lake”) to lead and executed to accelerate the clinical development and commercialization of the combination therapy of PD-L1 / CTLA-4 bispecific antibody (KN046) and Ningetinib Toluenesulfonate (CT053) in China by working together with Sunshine Lake.

The Investigational New Drug (IND) application of the combination therapy of KN046 and CT053 to treat hematological tumors and solid tumors has recently been officially approved by the Center for Drug Evaluation (CDE) in China. Alphamab Oncology and Sunshine Lake have further expanded the scope of existing partnership. According to the agreement, the two parties will initiate the development on liver cancer and lung cancer indications, and will share all the costs of the first stage development.

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, “KN046 is currently the world's first recombinant humanized PD-L1/CTLA-4 bispecific antibody, with the potential to become the backbone of next generation immuno-oncology therapy in the future. Since the preliminary safety and efficacy of KN046 were verified by multiple single drug clinical trials, we believe that it could show better efficacy in combination therapy. Alphamab Oncology is actively cooperating with a few pharmaceutical companies to explore KN046 combination therapy extensively. We are very pleased to expand partnership with Sunshine Lake Pharma Co., Ltd., and hope that the development of multiple indications can help accelerate the launch of KN046 and  provide patients with more effective treatment options. "

Dr. Yingjun Zhang, president of HEC Research Institute, commented : “Ningetinib is a multi-target small molecule kinase inhibitor which can effectively inhibit multiple kinases such as VEGFR2, AXL, MER and c-Met. On the one hand, it can directly and indirectly inhibit the growth of tumor cells by blocking the formation of tumor blood vessels, and also plays an important role in tumor-related immune regulation. It has shown good preliminary efficacy and safety in NSCLC clinical trials. We believe that the combination therapy of CT053 and KN046 can achieve synergy and benefit more patients. "

About KN046

KN046 is the world's first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a proprietary CTLA-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with PD-L1 antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg clearing function. The preclinical and clinical study results of KN046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become the backbone of next generation immuno-oncology therapy in the future.

Previously, KN046's phase I clinical trials in Australia and China have shown a preliminary profile of good safety and promising efficacy, and several phase II clinical trials are ongoing in China for NSCLC, TNBC, ESCC and pancreatic cancer.

About CT053

CT053 (nonproprietary name: Ningetinib Toluenesulfonate) is a multi-target small molecule inhibitor independently developed by HEC Research Institute. The main targets include c-Met, Axl, MER, VEGFR2, etc. With these targets, CT053 can, on the one hand, block MAPK/ERK and PI3K/AKT cancer signaling pathways by inhibiting HGF/c-Met and Gas6/AXL/Mer and directly inhibit tumor growth; on the other hand, block the formation of tumor neovascularization through inhibiting VEGF/VEGFR2 and thus inhibiting the growth of tumor cells indirectly. Ningetinib has shown preliminary better clinical results than some of its competing drugs and is expected to become an important drug for cancer treatment.

About Alphamab Oncology

Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.

Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline consists of eight anti-cancer drug candidates, four of which have advanced into Phase I – III clinical development phases in China, US and Japan.  

The Company also has state-of-the-art manufacturing capability designed and built to meet NMPA and EU/FDA’s cGMP standards.

Alphamab Oncology is committed to further develop its robust pipeline in oncology/immunology to benefit patients around the world.

Visit http://www.alphamabonc.com for more information.

About Sunshine Lake

Sunshine Lake Pharma Co., Ltd. is a limited liability company which is established in China on December 29, 2003. Taking innovation and internationalization as the R&D concept, it is committed to the development of innovative and internationalized medicines and has a rich pipeline of new medicines.

VIsit www.hec.cn for more information.

Alphamab Oncology Forward-Looking Statements

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