Where lies the next BD opportunity amid the fiercely competitive PD‑1/VEGF landscape?
Apr 25,2026
Another Chinese PD-1/VEGF pipeline acquired by an MNC has released clinical data.
At the 2026 American Association for Cancer Research (AACR) Annual Meeting, Merck & Co./Livzon Biologics unveiled the initial clinical results of MK-2010/LM-299, a PD-1/VEGF bispecific antibody. In treatment-naïve patients within the non-small cell lung cancer (NSCLC) expansion cohort, the unconfirmed objective response rate (ORR) reached 55% in the 20 mg/kg Q3W group and 44% in the 30 mg/kg Q3W group.
In 2024, shortly after Akeso Biopharma and its partner Summit Therapeutics announced that ivonescimab (AK112) had outperformed Keytruda in a head-to-head trial, Merck’s stance toward PD-1/VEGF bispecific antibodies underwent a dramatic shift.
That same year, Merck secured global exclusive rights to LM-299 from Livzon Biologics with a **$588 million upfront payment** plus up to $2.7 billion in milestone payments.
The core motivation behind Merck’s high-stakes acquisition of MK-2010 is undoubtedly the looming patent cliff for Keytruda, whose core patents are set to expire in 2028. In 2025, Keytruda recorded annual sales exceeding $31.6 billion, accounting for nearly half of Merck’s total revenue for the period.
Nevertheless, following the acquisition of MK-2010, Merck has disclosed few concrete development plans for the asset. Amid the cutthroat, hyper-competitive PD-1/VEGF landscape, Merck has remained notably low-key.
After over a year of silence, does MK-2010’s newly released clinical performance mark a pleasant surprise—or a sobering disappointment?
01
The MNC Buying Spree
Among second-generation immune-oncology agents, PD-1/VEGF bispecific antibodies represent a flagship track. To trace the origin of this industry boom, Akeso Biopharma stands as an indispensable benchmark.
In 2022, Akeso entered a collaboration with Summit Therapeutics, out-licensing the overseas rights of ivonescimab for a $500 million upfront payment and a total transaction value of up to $5 billion, setting a new record for Chinese innovative drug global out-licensing at the time.
In 2024, ivonescimab gained approval from the National Medical Products Administration (NMPA), becoming the world’s first commercially approved PD-1/VEGF bispecific antibody.
At the World Conference on Lung Cancer (WCLC) held the same year, Akeso presented findings from the HARMONi-2 trial: in first-line treatment for PD-L1-positive NSCLC, single-agent ivonescimab extended median progression-free survival (PFS) from 5.82 months with Keytruda to 11.14 months, reducing the risk of disease progression or death by 49%.
It was the world’s first PD-1/VEGF bispecific antibody to surpass Keytruda in a Phase III head-to-head trial. Since then, market enthusiasm for PD-1/VEGF assets has surged exponentially.
Currently, the vast majority of global PD-1/VEGF bispecific antibody candidates originate from Chinese biotech companies. Notably, nearly all PD-1/VEGF pipelines in the hands of multinational pharmaceutical corporations (MNCs) are sourced from China.
Concurrent with Merck’s partnership with Livzon Biologics, BioNTech completed the full acquisition of Premas Biotech with an $800 million upfront payment plus up to $150 million in milestones, securing full rights to PM8002 (BNT327), a PD-L1/VEGF bispecific antibody.
In 2025, BioNTech further struck a deal with Bristol Myers Squibb (BMS) for the joint development of BNT327, with a total transaction value reaching $11.1 billion.
Pfizer has also joined the fray. In May 2025, the pharmaceutical giant signed an agreement with 3SBio, obtaining exclusive global development, manufacturing and commercialization rights for PF-08634404 (SSGJ-707) outside mainland China, in exchange for a $1.25 billion upfront payment, up to $4.8 billion in milestone payments, and double-digit tiered sales royalties. Pfizer also retained an option to secure commercial rights in mainland China via additional payments.
This landmark deal not only set a new record for the highest upfront payment in Chinese innovative drug out-licensing, but also established a new high for single-drug transaction value. The deal propelled Pfizer into the crowded PD-1/VEGF bispecific arena and heralded a broader recovery across the biotech secondary market.
In January 2026, AbbVie in-licensed RC148, a PD-1/VEGF bispecific antibody from Rochem Therapeutics, with a $650 million upfront payment and a total deal value of up to $5.6 billion, gaining exclusive development, production and commercialization rights outside Greater China.
Fang Jianmin, CEO of Rochem Therapeutics, stated that RC148 is a globally competitive PD-1/VEGF bispecific candidate within the company’s pipeline. As a core modality for next-generation tumor immunotherapy, PD-1/VEGF bispecifics are poised to become backbone therapies for oncology treatment.
At the 2025 ESMO-IO Congress, Rochem released Phase I/II clinical data via poster presentation, evaluating single-agent and combination regimens of RC148 in first- and second-line treatment for NSCLC, demonstrating robust preliminary efficacy.
To date, there are more than 40 global PD-(L)1/VEGF bispecific programs, over 20 of which are developed domestically in China. Bloomberg analysis indicates that as of October 2025, approximately 104 clinical trials for PD-(L)1/VEGF bispecific antibodies are ongoing or planned, enrolling an estimated 27,000+ cancer patients worldwide.
02
The Homogenization Dilemma
Such dense pipeline expansion inevitably intensifies homogenized competition.
According to a research report by Soochow Securities, multiple PD-(L)1/VEGF(R) bispecific antibodies adopt a symmetric 2+2 molecular structure. For instance, candidates from Akeso, Livzon Biologics and Premas share similar design frameworks, utilizing a bevacizumab backbone targeting VEGF-A, with PD-(L)1-targeted scFv or VHH fragments fused to the C-terminus of heavy chains.
By contrast, 3SBio’s SSGJ-707 features a differentiated design. Though also built on a bevacizumab IgG scaffold, its C-terminal Fv fragment binds to VEGF while the Fab region targets PD-1. Constructed with a native IgG4 format, it exhibits no ADCC or CDC activity. Most other peers adopt LALA-mutated IgG1 backbones to attenuate ADCC/CDC effects and minimize off-target immune damage to normal tissues.
From ivonescimab, which is advancing toward FDA approval, to MK-2010 newly presented at AACR, and multiple domestically developed bispecifics in-licensed by Pfizer, BioNTech and other industry giants, the PD-1/VEGF track has become severely overcrowded. A review of publicly disclosed ORR data reveals largely comparable efficacy profiles across these candidates.
In the Phase I/II trial of MK-2010 for treatment-naïve PD-L1-positive NSCLC patients, the unconfirmed ORR stood at 55%. Nevertheless, this result was derived from an extremely small sample of only 11 patients. Merck offered cautious commentary, describing the data merely as “early signs of promising antitumor activity”.
As the world’s only approved asset in this class, ivonescimab reported a first-line ORR of approximately 50% in the Phase III HARMONi-2 study. Pfizer/3SBio’s PF-08634404 achieved ORRs of 62% and 55% at the 10 mg and 20 mg dose levels, respectively. BNT327, co-developed by BioNTech and BMS, demonstrated a 47% ORR in a small-scale trial for non-squamous NSCLC.
Beyond these MNC-backed PD-1/VEGF candidates, multiple Chinese biotech programs have delivered even higher response rates when combined with chemotherapy.
HB0025, developed by Hua Medicine’s subsidiary Huaotai Biotech, achieved an ORR of 83.3% in first-line combination chemotherapy for squamous NSCLC and 56.4% for non-squamous NSCLC. IMM2510 from ImmuneOnco recorded an 80% ORR in squamous NSCLC, 46% in non-squamous subtypes, and an overall ORR of 62% across evaluable patients when paired with chemotherapy.
It is critical to note that these impressive response rates are largely observed in combination regimens and based on limited sample sizes.
For example, as of July 1, 2025, only 33 patients received the 10 mg/kg dose of IMM2510. The median follow-up duration for HB0025 was merely 4.47 months, with mature PFS data yet to be reported.
In addition, cross-trial comparisons are constrained by divergent enrollment criteria, sample sizes and follow-up timelines. Such indirect comparisons serve only as reference and cannot directly differentiate clinical performance.
Most importantly, nearly all compelling early data remain confined to Phase I/II studies. Pivotal Phase III registration trials remain the ultimate litmus test. Ivonescimab is widely recognized as the gold standard precisely because it has successfully completed rigorous Phase III validation.
For MK-2010, PF-08634404 and other early-stage candidates, the true competitive battle has only just begun.
03
Who Will Be Next?
Despite the large-scale MNC consolidation of Chinese PD-1/VEGF assets, high-quality pipeline candidates still remain available for collaboration and licensing.
JS207 from Junshi Biosciences is one notable example. During ESMO Asia 2025, Junshi released initial clinical data for JS207, reporting ORRs of 56.3% and 60.0% at 10 mg/kg and 15 mg/kg dose levels in PD-L1-positive (TPS≥1%) NSCLC patients.
At AACR 2026, the company further unveiled preliminary Phase II results of JS207 in combination with JS007, an anti-CTLA-4 antibody, for first-line advanced hepatocellular carcinoma (HCC). Among 22 efficacy-evaluable patients, the combination regimen delivered an ORR of 45.5% and a disease control rate (DCR) of 86.4%.
In November 2025, Sinocelltech initiated a Phase III trial for SCTB14, comparing its efficacy versus Keytruda as first-line therapy for locally advanced or metastatic driver-gene-negative NSCLC with PD-L1 TPS ≥10%. This randomized, double-blind, multicenter trial plans to enroll 246 patients in China, with BICR-assessed PFS per RECIST v1.1 as the primary endpoint and overall survival (OS) as a key secondary endpoint.
IMM2510 from ImmuneOnco represents another potential licensing target. Earlier this year, the company terminated its collaboration with Axion Bio, a subsidiary of Instil Bio, and reclaimed global rights to the program, confirming ongoing efforts to secure new partnership opportunities.
Meanwhile, MNC-owned PD-1/VEGF pipelines are advancing at full speed.
In late January 2026, BMS launched two new Phase III trials for BNT327. In November 2025, Pfizer unveiled seven upcoming clinical studies for PF-08634404, predominantly focused on lung and colorectal cancers. The company is also exploring combination strategies pairing this bispecific with its in-house vedotin-based ADC for NSCLC, with plans to expand indications to liver, bladder and renal cell carcinomas.
In sharp contrast, Merck’s investment and promotion of MK-2010 appear relatively limited.
Per Fierce Biotech, a Merck spokesperson stated: “While it is too early to disclose detailed clinical development plans, we will leverage insights from our robust oncology portfolio to define the optimal use of MK-2010 as monotherapy and in combination regimens to maximize patient benefit.”
Merck’s strategic prioritization is understandable. Compared with PD-1/VEGF assets, the company has clearly allocated far more resources to another key in-licensed candidate from China.
In May 2022, Kelun-Biotech partnered with Merck, granting exclusive global development, manufacturing and commercialization rights for SKB264, a TROP2 ADC, outside Greater China, in a deal valued at nearly $1.4 billion.
To date, Merck has initiated 16 global Phase III clinical programs for sacituzumab kelunate across lung, breast, gastric and gynecological oncology, reflecting its high strategic priority for the asset.
From its emergence to rapid market expansion, the PD-1/VEGF bispecific track has been deeply intertwined with Chinese pharmaceutical innovation. This booming therapeutic modality is a true Chinese-origin breakthrough, representing a domestically driven first-in-class innovation.
Within the broader second-generation IO landscape, similar China-led innovation stories are unfolding across multiple novel targets. While early clinical data requires further validation and industry homogenization will eventually be streamlined, one trend is undeniable: Chinese innovative drug developers have evolved from passive suppliers in the global pharmaceutical supply chain to core contributors and even potential rule-setters for next-generation tumor immunotherapy.
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