Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

China’s investigator-initiated trial (IIT) system is increasingly being used to generate early human data in cell and gene therapies, and new changes that widen the pathway are expected to drive more multinational companies to conduct IITs in China, panelists said during the Chinabio Partnering Forum in Shanghai April 28-29.

Tumors with strong immunosuppressive microenvironments such as microsatellite-stable colorectal cancer (MSS-CRC) remain unresponsive to immune checkpoint blockade therapy, with <20% of gastrointestinal tumors responding to therapy.

Researchers from Flare Therapeutics Inc. presented the preclinical profile of FX-111, a selective active androgen receptor (ARON) degrader, in models of prostate cancer.

Regulatory uncertainty that dominated the life science sector in 2025 is transitioning into an execution framework for biotechnology companies, provided companies can tailor regulatory strategies early, and across the entire development cycle.

Hypersialylation in tumor cells is a potent mechanism of tumor immune evasion, pushing cancer progression by suppressing both innate and adaptive antitumor immunity. Shanghai Henlius Biotech Inc. has developed an engineered human sialidase enzyme fused to an anti-B7-H3 nanobody, named E-688 or HLX-316, that improves tumor desialylation, durability and efficacy both in vitro and in vivo, while maintaining a safe profile.

Researchers at Epics Therapeutics SA reported preclinical findings on EP-102, a METTL3 inhibitor, in models of pancreatic adenocarcinoma (PDAC).

Ly6E is a cell‑surface protein involved in tumor growth and immune evasion that is overexpressed across multiple solid tumor types, with limited expression in normal tissues. At AACR, researchers from Merck KGaA presented the preclinical characterization of M-7437, an anti-Ly6E ADC with a topoisomerase 1 (TOP1) inhibitor payload.

Shanghai Ailux Biotechnology Co. Ltd. and Ailux Inc. have presented preclinical data regarding the characterization of ALX-006, a 2+2 symmetric IgG1 PD‑1×VEGF bispecific antibody developed and designed for dual PD‑L1 and VEGF blockade as a cancer immunotherapeutic.