Evogene and Shanghai Lishan Biopharmaceuticals have entered into an exclusive worldwide licensing agreement for BMC128, a microbiome-based therapeutic being developed for renal cell carcinoma and non-small cell lung cancer. The deal covers global clinical development, manufacturing and commercialisation and represents genuine deal-driven news rather than a promotional announcement.

BMC128 was developed by Biomica, a subsidiary of Evogene, and is currently completing a Phase 1 clinical study. Under the agreement, Shanghai Lishan Biopharmaceuticals will take responsibility for advancing the programme into later-stage development, while Biomica is eligible to receive development milestone payments and royalties on future commercial sales.

The asset, designated LS-LBP-002 by Lishan Biopharmaceuticals, is described as a first-in-class live biopharmaceutical consortium made up of four human gut bacterial strains. The therapy is designed to enhance responses to immunotherapy by stimulating anti-tumour immune activity. According to the companies, BMC128 has been evaluated in patients with renal cell carcinoma and non-small cell lung cancer who had previously experienced disease progression.

Early clinical data from the ongoing Phase 1 study indicate an encouraging safety and tolerability profile. The companies also reported early signs of efficacy, including a relatively high proportion of treated patients achieving stable disease despite having progressive disease prior to enrolment. No detailed efficacy data were disclosed.

Shanghai Lishan Biopharmaceuticals plans to initiate a Phase 2 clinical study and pursue regulatory pathways in both China and the USA, with the aim of supporting future commercialisation in major oncology markets. Manufacturing and later-stage clinical execution will be led by the Shanghai-based company, while Biomica will continue to support the programme scientifically.

Weijie Chen, chairman of Shanghai Lishan Biopharmaceuticals, said: “This collaboration ensures that BMC128 continues to advance toward its next clinical milestones. We are impressed by the effects observed with BMC128 in lung and renal cancer patients who had experienced disease progression prior to treatment, and we look forward to advancing the program through further development and ultimately toward commercialization, for the benefit of cancer patients worldwide.”

Evogene, which is a major shareholder in Biomica, said the agreement allows the company to retain long-term upside while transferring the capital-intensive aspects of late-stage development and commercial execution. Ofer Haviv, ceo of Evogene and Biomica, said: “We are pleased to partner with Lishan Biotech as BMC128 enters its next phase of development. Lishan Biotech’s strong development capabilities and commitment to innovative microbiome-based therapeutics position this program for meaningful value creation in difficult-to-treat cancers.”

He added that Evogene expects to benefit from the programme’s future success through its equity stake and the agreed financial terms.

Microbiome-based approaches are an emerging area of oncology research, particularly in combination with immune checkpoint inhibitors, where modulation of gut bacteria has been shown to influence patient response. Several companies are exploring defined bacterial consortia as therapeutic products, although few have progressed beyond early clinical development.

Jing Bao, a board member of Biomica, said the collaboration combines complementary strengths across regions. She said: “We are very pleased to see the execution of this meaningful and impactful collaboration agreement. This partnership brings together China’s clinical development capabilities with Israel’s innovation in microbiome science. We believe the success of this project will benefit patients worldwide and contribute to important breakthroughs in microbiome-based therapeutics.”

The agreement adds to a growing number of cross-border licensing deals between Israeli and Chinese biotech companies, particularly in oncology and immunology, where access to large patient populations and accelerated development timelines are seen as strategic advantages.