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Recently, Benerhera (Shaoxing) Biotechnology Co., Ltd. secured Series A financing, jointly led by Fudan Sci-Tech Innovation and Longpan Investment.This round of funding will be mainly used to advance the Phase I clinical trial of the core pipeline BT-101 and the preclinical research of the cell therapy pipeline., aiming to accelerate the clinical application of its innovative immune tolerance restoration therapy.Benerhera was established in 2021 and is aA biopharmaceutical company dedicated to innovative Treg (Regulatory T cell) immunotherapySmall-molecule drugs and cell-based therapies are being advanced in parallel, focusing on autoimmune and inflammatory diseases. The company's founder and chief scientist, Professor Yan Shi, is a tenured professor at the School of Medicine, Tsinghua University, and a doctoral supervisor. He holds a bachelor's degree from Shanghai Medical University (now Fudan University School of Medicine).Currently, the number of patients with autoimmune diseases is enormous. Taking inflammatory bowel disease (IBD) as an example, there are over 6 million patients globally. Traditional treatments often involve broadly suppressing the immune system using hormones or biologics, which not only present challenges such as a high risk of infection and unstable efficacy but also show that more than 60% of patients do not respond to existing medications.Benerhera, on the other hand, takes a different approach by focusing on rebuilding immune tolerance from the source. It precisely modulates the body's natural "immune regulators," Treg cells, replacing the traditional logic of "complete suppression."Relying on the many years of scientific research accumulation by Professor Shi Yan's team, the company has built two major original technology platforms:One is the oral small molecule-driven proliferation of Tregs in vivo. The core pipeline, BT-101, is an oral small molecule drug that utilizes the principle of "oral tolerance" to initiate antigen-specific immune tolerance locally in the gut, rather than inducing systemic immunosuppression. This drug has successively obtained clinical trial approvals from the U.S. FDA and China's CDE in 2026, and is about to officially enter the first-in-human trial phase, becoming the first drug of its kind globally to receive such approval.The second is the cell therapy platform. For severe diseases such as lupus nephritis and type 1 diabetes, the company has developed the BT-202 (autologous Enforce-T cells) pipeline. This technology uses gene editing to efficiently convert conventional T cells into Treg-like cells with immunosuppressive functions, overcoming the challenges of complex processes and commercialization difficulties associated with traditional Treg cell therapies.Benerhera has systematically laid out small molecule and cell drug pipelines around the novel Mechanism of Action (MoA) of Treg:BT-101: An oral small-molecule GPCRx agonist, with the first targeted indication being Inflammatory Bowel Disease (IBD). This mechanism is highly aligned with the new indication — the oral tolerance mechanism plays a central role in the gut, and BT-101 has almost no systemic exposure, with its effects mainly realized within intestinal immune cells. On January 13, 2026, BT-101 received U.S. FDA IND approval, and on May 13, it obtained IND approval from China's CDE, positioning it to officially enter the first-in-human trial phase as the world’s first drug of its kind to receive such approval. The company simultaneously announced the initiation of a safety evaluation study in healthy volunteers (SAD/MAD design) on the same day.At the same time, the company is also actively promoting another small molecule drug pipeline——BT-201 (Ryr2 Inhibitor), mainly targeting mild to moderate psoriasis and other autoimmune dermatitis (eczema, atopic dermatitis, etc.).BT-202 (Autologous Enforce-T Cells): As a potential next-generation cell therapy product, it aims to overcome the pain points of existing Treg cell therapies by engineering conventional T cells into cells with Treg-like functions. It is under preclinical development for severe autoimmune diseases such as lupus nephritis and type 1 diabetes.Reference: Fudan Sci-Tech Innovation
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