Akeso Announces Clinical Trial Collaboration with Chipscreen Biosciences to Evaluate Cadonilimab in Combination with Chiauranib for Extensive-Stage Small-Cell Lung Cancer

HONG KONG,March 2,2022 /PRNewswire/-- Akeso,Inc. (9926.HK) ("Akeso"),a biopharmaceutical company dedicated to the research,development,manufacturing and commercialization of innovative antibody drugs that are affordable to patients worldwide todayannounced that it has entered into a collaboration agreement with Shenzhen Chipscreen Biosciences,Ltd. (SHA Code 688321) to conduct a Phase Ib/II clinical study of combination therapy of Cadonilimab (PD-1/CTLA-4 bispecific antibody,AK104) and Chiauranib (a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor) in patients with ES-SCLC which progressed on combination therapy of platinum-based chemotherapy and PD-(L)1 inhibitor as first-line treatment.

The drug development strategy of Akeso is to use its bispecific antibody as backbone of next generation immunotherapy to combo with innovative drugs or drug candidates from leading partners in respective fields. Akeso believes such a strategy will differentiate its therapy from peers,and further enhance the value of products,which will benefit the company and its partners. This collaboration provides a solid proof for Akeso's commitment to promote combination therapy strategy. Combining the superior advantage of Cadonilimab as a dual immuno-checkpoint inhibitor and Chiauranib as an active multi-target inhibitor that simultaneously inhibits the angiogenesis-related kinases,Akeso is confident this combination therapy will bring exciting new therapeutic solution for the patients suffering from cancers including lung cancer.

About Cadonilimab (PD-1/CTLA-4 bispecific antibody,AK104)

Cadonilimab (AK104) is a novel first-in-class PD-1/CTLA-4 bi-specific immuno-oncology backbone drug independently developed by the Company,and its major indications include lung cancer,liver cancer,stomach cancer,cervical cancer,renal cancer,esophageal squamous cell cancer,nasopharyngeal carcinoma and other malignant tumors. The periodic research data show that,as compared with the combination therapy of PD-1 and CTLA-4,Cadonilimab has much lower toxicity and demonstrates promising safety profile and efficacy. Based on the positive effects of Cadonilimab obtained in the clinical trial of recurrent/metastatic cervical cancer,CDE accepted the new drug application of Cadonilimab for the treatment of recurrent/metastatic cervical cancer in September 2021 and granted priority review designation. Cadonilimab is therefore expected to be the world's first-in-class PD-1 based bi-specific antibody approved for market launch. In addition,a global phase III clinical trial of Cadonilimab plus platinum-based chemotherapy combined with/without bevacizumab in the first-line treatment of persistent,recurrent or metastatic cervical cancer was initiated in May 2021.

About Chiauranib

Chiauranib,a highly selective Aurora B/VEGFR/PDGFR /c-Kit/CSF1R inhibitor,was developed by Chipscreen Biosciences specifically to address drug resistance.Chiauranib exerts a comprehensive anti-tumor effect by a triple-pathway mechanism that simultaneously inhibits tumor angiogenesis,prevents tumor cell mitosis,and modulates the tumor microenvironment. With a favorable safety profile,Chiauranib has outperformed drugs with a similar mechanism in its pharmacodynamic activity in animal studies.

About Akeso

Akeso is a biopharmaceutical company dedicated to the research,manufacturing and commercialization of innovative antibody drugs that are affordable to patients worldwide. Since the Company's establishment,the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system,encompassing fully integrated drug discovery and development functions,including target validation,antibody drug discovery and development,CMC production process development,and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors,autoimmune diseases,inflammation and metabolism diseases,13 of which have entered clinical stage,including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). The Company's vision is to become a global leading biopharmaceutical company through research and development of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.

About Shenzhen Chipscreen Biosciences,Ltd.

Founded in March 2001 by a group of senior scientists returned from the United States,Chipscreen Biosciences focuses on developing innovative drugs with new mechanisms of action (MOA) for the treatment of human diseases in five major therapeutic areas,including cancer,metabolic diseases,autoimmune disorders,central nervous system disorders and antivirals,so as to provide patients with affordable,efficacious drugs to meet their clinical needs. Chipscreen Biosciences was the first biotech firm approved for listing on the Shanghai Stock Exchange Science and Technology Innovation Board Market (Stock code: 688321.SH).

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