Keymed nets $250M upfront as Gilead acquires Ouro in $2.2B deal, marking China's largest NewCo payout

Ouro Medicines' sole product, CM336/OM336, is an innovative T cell engager (TCE) bispecific antibody independently developed by Keymed Biosciences. Its active component is a BCMA/CD3 humanized bispecific antibody. The clinical indication is for the treatment of autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP), with a potential best-in-class profile.

OM336 is currently under an open Investigational New Drug (IND) application in the United States and is expected to enter registrational studies in 2027.

Pursuant to the merger agreement, as a shareholder of Ouro Medicines, Keymed Biosciences will receive approximately $250 million in upfront payment upon completion of the transaction, along with milestone payments of up to approximately $70 million, resulting in total consideration of approximately $320 million. Concurrently, the tiered sales royalties for CM336/OM336 will be fulfilled by Gilead.

Upon completion of the transaction, Keymed Biosciences will no longer hold equity in Ouro Medicines. However, the exclusive license agreement entered into in November 2024 remains in effect, and Keymed Biosciences retains the exclusive rights to research, develop, manufacture, register, and commercialize CM336/OM336 in the Greater China region (including Mainland China, Hong Kong, Macau, and Taiwan).

Whether viewed as the first NewCo overseas monetization in 2026 or as a multinational corporation's acquisition of a China-developed TCE pipeline, the $1.675 billion upfront payment is particularly compelling. The underlying rationale is that the combination of hard assets (platforms, pipelines) and soft power (overseas teams, global clinical experience, licensing deal resources) collectively establishes a sustainable bargaining position.

In 2024, the NewCo model saw a surge in China, whereby domestic biotech companies typically carved out the ex-Greater China rights to one of their pipelines and licensed them to a newly established overseas entity—namely, a NewCo—in exchange for upfront and milestone payments from licensing deals, as well as an equity stake in the NewCo.

By 2026, the closed capital loop for the NewCo overseas expansion model has materialized, entering a phase of value realization.

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According to Fierce Biotech, Ouro Medicines is named after the serpent that devours its own tail—a symbol of rebirth—with the goal of ending the cycle of immunosuppressive drugs for patients with autoimmune diseases through engineered T cell engagers.

In November 2024, Keymed Biosciences granted Platina Medicines, a wholly-owned subsidiary of Ouro Medicines, exclusive rights to research, develop, manufacture, register, and commercialize CM336 globally (excluding Mainland China, Hong Kong, Macau, and Taiwan), receiving $16 million in upfront and near-term payments, an equity stake in Ouro Medicines, as well as potential additional payments of up to $610 million and tiered royalties.

On January 11, 2025, Ouro Medicines emerged from stealth with a $120 million financing round. Ouro Medicines was incubated by GSK and Monograph Capital. The Series A round was led by TPG, with participation from NEA, Norwest, and other investors including UPMC, Boyu/Zoo Capital, and LongRiver Investments.

Dr. Jaideep Dudani, Ouro's founding Chief Executive Officer and Portfolio Lead at Monograph Capital, believes that T cell engager engineering has now become sufficiently robust to be applied beyond oncology. Ouro is the first and only company in the world to test an immune reset modality in autoimmune cytopenias such as AIHA and ITP.

Dr. Jaideep Dudani previously led portfolio development at Human Immunology Biosciences (Hi-Bio) until its acquisition by Biogen for over $1 billion in 2024. Several Hi-Bio executives have also joined Ouro's 20-person founding team.

Another perspective warrants particular attention: the investors involved in the NewCo will also achieve a rapid exit and value realization through the merger. Less than two years have passed since the initial capital injection.

LongRiver Investments, as a Series A investor in Ouro Medicines, witnessed the project's exit via merger just one year after its investment, achieving a homerun-level return.

Li Jiaan, Partner at LongRiver Investments, shared in an exclusive interview with VCBeat: "We are honored to have participated in this landmark China-for-global transaction and to have witnessed CEO Jaideep Dudani's profound scientific and business insights as well as his exceptional leadership, alongside Keymed Biosciences' strong capabilities in product development. The NewCo model, by integrating Chinese innovation with global capital and clinical development systems, has effectively enhanced the global development efficiency of high-quality assets and broadened the pathways for value realization. The scale of this transaction ranks among the highest in recent NewCo overseas mergers and acquisitions of Chinese healthcare assets, further demonstrating that China's innovation value in healthcare continues to gain global recognition and that the investment value of high-quality assets is increasingly prominent.”

The core asset of this transaction, CM336/OM336, is a BCMA/CD3 bispecific antibody independently developed by Keymed Biosciences. It simultaneously targets and specifically binds to BCMA on the surface of target cells and CD3 receptors on T cells, recruiting immune T cells to the vicinity of target cells, activating T cells, releasing cytokines, and inducing T cell-mediated cytotoxicity (TDCC) to eliminate target cells.

Following the NewCo transaction, Keymed Biosciences initiated a Phase II expansion study of CM336 for the treatment of multiple myeloma, while Ouro focused on testing the reprogrammed OM336 in autoimmune diseases, launching its first Phase I clinical study in 2025.

Dr. Jaideep Dudani of Ouro mentioned in an interview, "The expectation is that as the indication shifts from multiple myeloma to autoimmunity, the safety requirements become more stringent because, in practice, the drug is killing fewer autoimmune cells than myeloma cells." Keymed provided the Ouro team with access to the Phase I/II clinical data of CM336 in multiple myeloma. When compared cross-trial with the approved multiple myeloma therapy Tecvayli, the incidence of severe cytokine release syndrome was lower.

For Keymed Biosciences, the NewCo overseas expansion represented a strategic bifurcation of CM336 across two major indication areas. On one hand, domestic research and development targeted multiple myeloma, a major hematologic malignancy indication. On the other hand, through the NewCo's overseas clinical development, Keymed explored high-profile autoimmune areas such as autoimmune hemolytic anemia (AIHA), demonstrating the versatility of TCE bispecific antibodies across different immune scenarios, while retaining the rights in Greater China. This approach is expected to accelerate future approval and launch of related indications in China by leveraging global clinical data.

In clinical studies for multiple myeloma, a rapid reduction of B cells and plasma cells in patients' peripheral blood confirmed that CM336 could serve as a potential new treatment option for autoimmune diseases by eliminating plasma cells that secrete pathogenic antibodies.

Data presented in a poster at the 66th American Society of Hematology (ASH) Annual Meeting in December 2024 showed that with a median follow-up of 12.1 months in the dose-escalation phase, 52% (12/23) of subjects achieved stringent complete response (sCR) or complete response (CR). With a median follow-up of 3.1 months, the overall response rate (ORR) for the 3/20/80 mg and 3/20/80/160 mg dose groups (including dose-escalation and expansion phases) was 67% (16/24) and 76% (19/25), respectively. Among 19 subjects evaluable for minimal residual disease (MRD), the MRD-negative rate was 95% (18/19), with a median time to MRD negativity of 2.1 months. Safety and tolerability were favorable. The dose was successfully escalated to 160 mg, and the maximum tolerated dose has not yet been reached.

For autoimmune indications, CM336/OM336 has received Fast Track Designation (FTD) and Orphan Drug Designation (ODD) from the U.S. FDA for the treatment of autoimmune hemolytic anemia (AIHA) and primary immune thrombocytopenia (ITP), and is expected to enter registrational studies in 2027. Results from a study on its use in autoimmune hemolytic anemia were published in The New England Journal of Medicine, one of the world's top-tier medical journals.

Autoimmune hemolytic anemia (AIHA) has a high incidence rate (1.8–3.0 per 100,000 person-years), high prevalence rate (17 per 100,000), and a high proportion of refractory/relapsed patients. Approximately 50% of patients experience multiple rounds of relapse and are unable to discontinue drug dependence after treatment with first-line glucocorticoids, second-line CD20 monoclonal antibodies, and various conventional immunosuppressants. The disease impacts patients' quality of life, with patients often experiencing thrombosis, severe infections, osteonecrosis of the femoral head, and other complications, with a disability and mortality risk of 10%–30%. There is an urgent clinical need for innovative therapeutic breakthroughs.

Results published in The New England Journal of Medicine showed that two patients experienced significant improvement in hemolysis following CM336 treatment. The first patient achieved partial response on Day 13 and normal hemoglobin levels on Day 17. The second patient achieved partial response on Day 19 and complete response on Day 21, without receiving other concomitant medications during the treatment period. Hemolytic markers (reticulocyte percentage, lactate dehydrogenase, indirect bilirubin) decreased significantly in both patients and remained sustained through six months of follow-up, with patients remaining in treatment-free remission. The only adverse reactions observed were Grade 1 skin induration and hypogammaglobulinemia. No other severe adverse events, cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or infections were reported. Overall safety was favorable.

Notably, this study demonstrated, for the first time, the successful use of a BCMA x CD3 bispecific antibody in a patient with AIHA who had relapsed following CD19 CAR-T therapy, showing rapid control and sustained efficacy in relapsed/refractory AIHA patients who had received multiple prior lines of therapy.

Beyond autoimmune cytopenias, Ouro Medicines is also conducting an open-label, multinational basket study (NCT07229144) in adult participants with active, autoantibody-positive, relapsed/refractory Sjögren's syndrome or idiopathic inflammatory myopathies (including dermatomyositis, polymyositis, immune-mediated necrotizing myopathy, and antisynthetase syndrome).

Gilead stated that T cell engagers represent an important patient treatment modality alongside Gilead's portfolio of CAR-T assets.

"This acquisition underscores our commitment to advancing transformative therapies for people living with serious autoimmune diseases," said Dietmar Berger, MD, PhD, Chief Medical Officer of Gilead. "BCMA is a validated target with emerging data demonstrating potentially transformative outcomes in autoimmune diseases. BCMA-targeted T cell engagers represent a differentiated approach with the potential to induce durable disease control. This novel framework complements our expanding inflammation pipeline and reflects our strategy to invest in innovative science that may redefine standards of care."

BCMA-targeted T cell engagers are being investigated as a precision approach for severe inflammatory and autoimmune diseases by eliminating pathogenic B cells and plasma cells. Clinical data suggests that by redirecting a patient's own T cells toward BCMA-expressing plasma cells, these agents may reduce inflammation, improve organ-level disease, and, in some cases, enable an immune reset marked by durable, drug-free remission without ongoing immunosuppression.

Gilead is currently in advanced discussions with its long-standing partner and equity portfolio company Galapagos regarding a potential research and development collaboration on the acquired Ouro Medicines assets. The contemplated terms are as follows: