Nanjing, China, and Newark, U.S.A, July 3, 2025——Biosion, a global, clinical-stage biotechnology company, announced that its partner, AnkeBio has received official Clinical Trial Approval from China's National Medical Products Administration (NMPA) for their jointed developed Class 1 innovative drug, AK2024 (also known as BSI-128) Injection. This approval, marked by the issuance of the "Notice of Drug Clinical Trial Approval," authorizes the initiation of clinical trials in China targeting HER2-positive advanced solid tumors. Notably, this is the first time worldwide that this novel HER2 antibody from by Biosion’s discovery platform has been approved to enter clinical research, representing a significant milestone in the collaboration between Biosion and AnkeBio in advancing HER2-targeted therapies.
About BSI-128
BSI-128 (Her2 5G9) is a novel monoclonal antibody that targets a unique epitope on the HER2 receptor, distinguishing it from existing therapies like trastuzumab and pertuzumab. Its key feature is the strong synergy it exhibits when combined with trastuzumab, resulting in significantly enhanced antitumor effects. BSI-128 also promotes HER2 receptor internalization and degradation at rates much higher than current antibodies, which may help overcome resistance to existing treatments. Additionally, BSI-128 maintains robust antibody-dependent cellular cytotoxicity (ADCC), supporting its therapeutic potential. Overall, BSI-128 offers a promising new approach for more effective treatment of HER2-positive cancers. For more information about BSI-128 (Her2 5G9), please visit: https://pubmed.ncbi.nlm.nih.gov/32950002/
In July 2022, Biosion licensed the product development and commercialization rights of BSI-128 in mainland China to Anko Biopharma, while Biosion retained the product development and commercialization rights outside Greater China.
About AnkeBio
AnkeBio, officially known as Anhui Anke Bioengineering (Group) Co., Ltd., is an A-share listed company based in Hefei, China. As a national-level modern high-tech enterprise, its primary business spans several fields, including biological products, traditional Chinese medicine, and chemically synthesized drugs. AnkeBio holds a leading position in the field of gene engineering drugs. Its core products include Recombinant Human Growth Hormone (trade name: Ansomone) and Recombinant Human Interferon α2b, which have a broad impact on various therapeutic areas such as growth disorders and oncology. AnkeBio is committed to independent innovation, operating several national-level R&D platforms, and continuously investing in cutting-edge technologies like gene editing and cellular immunotherapy. For more information, please visit www.ankebio.com.
About Biosion
Biosion is a global clinical-stage biotechnology company focused on developing innovative antibody-based therapies to improve outcomes for patients with immune and oncologic diseases. Leveraging its proprietary technologies including the H³ antibody discovery platform, SynTracer® HT endocytosis platform, and Flexibody® bispecific platform, Biosion creates highly differentiated medicines to address significant unmet medical needs worldwide. With its “discover-development-partnership” model, the company has forged 10 global collaborations, advancing 8 clinical-stage assets, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Biosion operates across the US, China, and Australia. For more information, please visit www.biosion.com.
BIOSION ALL RIGHTS RESERVED.
Nanjing, China, and Newark, U.S.A, July 3, 2025——Biosion, a global, clinical-stage biotechnology company, announced that its partner, AnkeBio has received official Clinical Trial Approval from China's National Medical Products Administration (NMPA) for their jointed developed Class 1 innovative drug, AK2024 (also known as BSI-128) Injection. This approval, marked by the issuance of the "Notice of Drug Clinical Trial Approval," authorizes the initiation of clinical trials in China targeting HER2-positive advanced solid tumors. Notably, this is the first time worldwide that this novel HER2 antibody from by Biosion’s discovery platform has been approved to enter clinical research, representing a significant milestone in the collaboration between Biosion and AnkeBio in advancing HER2-targeted therapies.
About BSI-128
BSI-128 (Her2 5G9) is a novel monoclonal antibody that targets a unique epitope on the HER2 receptor, distinguishing it from existing therapies like trastuzumab and pertuzumab. Its key feature is the strong synergy it exhibits when combined with trastuzumab, resulting in significantly enhanced antitumor effects. BSI-128 also promotes HER2 receptor internalization and degradation at rates much higher than current antibodies, which may help overcome resistance to existing treatments. Additionally, BSI-128 maintains robust antibody-dependent cellular cytotoxicity (ADCC), supporting its therapeutic potential. Overall, BSI-128 offers a promising new approach for more effective treatment of HER2-positive cancers. For more information about BSI-128 (Her2 5G9), please visit: https://pubmed.ncbi.nlm.nih.gov/32950002/
In July 2022, Biosion licensed the product development and commercialization rights of BSI-128 in mainland China to Anko Biopharma, while Biosion retained the product development and commercialization rights outside Greater China.
About AnkeBio
AnkeBio, officially known as Anhui Anke Bioengineering (Group) Co., Ltd., is an A-share listed company based in Hefei, China. As a national-level modern high-tech enterprise, its primary business spans several fields, including biological products, traditional Chinese medicine, and chemically synthesized drugs. AnkeBio holds a leading position in the field of gene engineering drugs. Its core products include Recombinant Human Growth Hormone (trade name: Ansomone) and Recombinant Human Interferon α2b, which have a broad impact on various therapeutic areas such as growth disorders and oncology. AnkeBio is committed to independent innovation, operating several national-level R&D platforms, and continuously investing in cutting-edge technologies like gene editing and cellular immunotherapy. For more information, please visit www.ankebio.com.
About Biosion
Biosion is a global clinical-stage biotechnology company focused on developing innovative antibody-based therapies to improve outcomes for patients with immune and oncologic diseases. Leveraging its proprietary technologies including the H³ antibody discovery platform, SynTracer® HT endocytosis platform, and Flexibody® bispecific platform, Biosion creates highly differentiated medicines to address significant unmet medical needs worldwide. With its “discover-development-partnership” model, the company has forged 10 global collaborations, advancing 8 clinical-stage assets, including monoclonal antibodies, bispecific antibodies, and antibody-drug conjugates. Biosion operates across the US, China, and Australia. For more information, please visit www.biosion.com.
BIOSION ALL RIGHTS RESERVED.