The pharmaceutical industry continues to see the formation of strategic collaborations and executive licensing agreements, including Manifold Bio’s collaboration with Roche, 4DMT’s exclusive licensing agreement with Otsuka Pharmaceuticals, and Kaigene’s exclusive licensing agreement with Celltrion.

Manifold Bio

Manifold Bio announced a strategic research collaboration and license agreement with Roche, aiming to apply Manifold's tissue-targeting shuttle portfolio and mDesign AI-driven in vivo discovery engine to generate multiple next-generation blood-brain barrier (BBB) shuttles for the treatment of neurological and neurodegenerative diseases.

Per the terms of the agreement, Manifold is expected to lead research and discovery activities, directly identifying and developing BBB shuttles that are designed to select Roche therapeutic payloads, followed by Roche leading preclinical, clinical, and commercialization efforts.¹

Manifold is set to receive an upfront fee of $55 million along with eligibility to receive significant research, discovery, and preclinical milestones, clinical and sales milestones, and tiered royalties. valued upwards of $2 billion.¹ The company will also retain its right to co-fund development of one program in exchange for enhanced royalties, as well as the right to apply its BBB shuttles to therapeutic payloads outside of Roche’s licensed targets.

“Manifold is delighted to have the opportunity to collaborate with Roche’s team of talented research and translational neuroscientists,” said Steven Holtzman, executive chair of Manifold Bio. “This alliance provides Manifold with a foundational partnership that contains key structural elements that will enable the Company to grow as an independent biopharmaceutical company, thereby enabling us to create significant value for patients, caregivers, employees, and shareholders.”

4DMT’s

4D Molecular Therapeutics revealed its strategic partnership with Otsuka Pharmaceutical focused on developing and commercializing 4D-150, a potential backbone therapy designed to provide multi-year (and potentially lifelong) sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection. The collaboration will focus on 4D-150 being developed as a treatment for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME) in the greater Asia-Pacific region including Japan.²

Under the terms of the agreement, Otsuka is granted exclusive rights to develop and commercialize 4D-150 for retinal vascular diseases, including wet AMD and DME, in Japan, China, Australia, and other Asia-Pacific markets.² Otsuka is also expected to lead all regulatory and commercialization activities in its licensed territories, with 4DMT continuing to lead all Phase III clinical activities globally, including within the Asia-Pacific region. 4DMT will receive a $85 million upfront payment, with expected cost sharing of at least $50 million over the next three years for global development activities.² Additionally, 4DMT is granted eligibility for upwards of $336 million in potential regulatory and commercial milestone payments, along with tiered double-digit royalties dependent on net sales in Otsuka’s territories.²

“We are thrilled to announce this strategic partnership with Otsuka, a leading global pharmaceutical company with a strong presence in the APAC region, reflecting our shared long-term commitment to improving outcomes for patients with retinal vascular diseases,” said David Kirn, M.D., co-founder and chief executive officer of 4DMT. “This partnership is a key pillar of our global strategy, with 4DMT continuing to lead Phase 3 clinical trial and manufacturing activities globally, in addition to pre-commercial and commercial activities outside the APAC region.”

Kaigene

Kaigene announced that it has entered into an exclusive global licensing agreement with Celltrion for Kaigene's nonclinical-stage antibody therapeutic assets, KG006 and KG002.³ The partnership aims to advance KG006, a next-generation FcRn inhibitor with an antibody structure, offering extended durability and best-in-class potential compared with existing therapies, and KG002, a first-in-class, dual-acting antibody selectively degrading disease-specific autoantibodies while simultaneously suppressing disease-specific B cells in certain autoimmune disorders.³

Per the terms of the agreement, Kaigene is set to receive upwards of $8 million as an upfront payment and up to $736 million in total milestone payments, including $11 million in near-term milestones through the initiation of Phase I clinical trials.³ Kaigene is also granted eligibility to receive tiered royalties on net sales if the product from the collaboration is commercialized. Additionally, Celltrion is expected to obtain the exclusive rights to develop and commercialize KG006 worldwide, with exceptions for Greater China and Japan, and worldwide rights for KG002.³

Sources

1. Manifold Bio Announces Strategic Collaboration with Roche to Develop Multiple Next-Generation Brain Shuttles for Neurological Diseases Manifold Bio November 3, 2025 https://www.businesswire.com/news/home/20251101912697/en/Manifold-Bio-Announces-Strategic-Collaboration-with-Roche-to-Develop-Multiple-Next-Generation-Brain-Shuttles-for-Neurological-Diseases
2. 4DMT Announces Exclusive License Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of 4D-150 in Asia-Pacific 4D Molecular Therapeutics October 30, 2025 https://www.globenewswire.com/news-release/2025/10/31/3178071/0/en/4DMT-Announces-Exclusive-License-Agreement-with-Otsuka-Pharmaceutical-Co-Ltd-for-Development-and-Commercialization-of-4D-150-in-Asia-Pacific.html
3. Kaigene Enters into Exclusive Licensing Agreement with Celltrion for Novel Antibody Therapeutics in Autoimmune Diseases Kaigene November 3, 2025 https://www.prnewswire.com/news-releases/kaigene-enters-into-exclusive-licensing-agreement-with-celltrion-for-novel-antibody-therapeutics-in-autoimmune-diseases-302602595.html