Solid tumor, including Hepatocellular carcinoma, colorectal cancer

AP505’s is designed for dual targeting of PD-L1, along with angiogenic factors VEGF. This bispecific antibody can thus simultaneously inhibit T cell suppression and tumor angiogenesis and growth, enhancing the immune response and tumor suppression. By targeting both pathways, AP505 aims to provide a more comprehensive treatment approach that improves efficacy and minimizes side effects compared to traditional therapies.

1. Licensing out of AP505/B1962 to Tasly Biopharmaceutical for development, production, and marketing rights in China (Now Tasly Pharmaceutical Group Co., Ltd).
2. Received China NMPA Phase 1 clinical trial approval in August 2022 and successfully recruited the first participant in March 2023
3. Obtained U.S. FDA Phase 1 clinical trial approval in January 2023
4. Received China NMPA Phase 2 clinical trial approval in January 2025
5. In the process of multi-country patent reviews, we have obtained patent approvals in Taiwan, Russia, Australia, and South Korea, and total of 17 countries worldwild.

By binding to PD-L1 on tumor cells, this therapy effectively suppresses angiogenesis within the tumor microenvironment, enhancing anti-tumor activity while requiring a lower therapeutic dose. This mechanism also reduces the bleeding risks commonly observed with traditional anti-angiogenic agents such as Avastin.

In addition, its symmetric antibody structure, comprising only heavy and light chains, provides clear advantages in expression, assembly, and manufacturability. This streamlined design allows the product to be purified using standard downstream processes for conventional monoclonal antibodies, avoiding the complex methods typically needed for asymmetric bispecific formats.

Global HCC and pMMR CRC Market Overview

According to the latest statistics from the World Health Organization (WHO), hepatocellular carcinoma (HCC) remains one of the most significant global cancers. In 2022, there were approximately 870,000 new cases and 780,000 deaths, making HCC one of the top three causes of cancer-related mortality worldwide. In Taiwan, HCC has consistently ranked among the top two cancer-related causes of death, highlighting the urgency of medical needs in the region.

The global HCC treatment market is expanding rapidly. Based on the 2024 report from Grand View Research, the market was valued at US$3.67 billion in 2024 and is projected to reach US$9.81 billion by 2030, representing a strong CAGR of 17.9%.

At the same time, colorectal cancer (CRC) in the pMMR/MSS population represents another major unmet medical need. Approximately 80–85% of CRC patients fall into the pMMR/MSS category and exhibit minimal response to PD-1/PD-L1 monotherapy. As a result, this large patient segment lacks effective immunotherapy options. The global CRC market was estimated at US$15–16 billion in 2022, with pMMR/MSS patients accounting for the vast majority, representing a substantial therapeutic opportunity.

Current therapeutic trends for HCC have shifted toward immunotherapy combined with anti-angiogenic agents. The combination of Tecentriq® (PD-L1 inhibitor) and Avastin® (VEGF inhibitor) has become the NCCN-recommended first-line standard of care.

AP505, a PD-L1 × VEGF bispecific antibody, aligns strongly with this mechanism and is positioned as a next-generation candidate for first-line HCC therapy. In addition, its dual-target mechanism also offers potential clinical benefit for the large pMMR CRC population, enabling AP505 to address two fast-growing global oncology markets with significant unmet needs.