Innovent Biologics secures FDA greenlight for first global Phase 3 trial of IBI363 in lung cancer

Innovent Biologics, Inc. (HKEX: 01801) has achieved a major regulatory milestone with the U.S. Food and Drug Administration’s clearance of its investigational new drug application for IBI363, a next-generation bispecific immunotherapy targeting immunotherapy-resistant squamous non-small cell lung cancer. The global Phase 3 trial, codenamed MarsLight-11, will represent the first worldwide pivotal study for the drug and could redefine the treatment paradigm for patients with limited therapeutic options after existing checkpoint inhibitors. The approval marks a significant advance in Innovent’s global innovation strategy and positions the company to compete with entrenched oncology players like Merck & Co. (NYSE: MRK), whose drug Keytruda® remains the current benchmark in immuno-oncology.

Why is FDA clearance of Innovent Biologics’ IBI363 Phase 3 trial considered a breakthrough for squamous non-small cell lung cancer patients?

The FDA’s clearance comes after productive discussions in the company’s End-of-Phase 2 meeting, which confirmed dose selection, study endpoints, and trial design. Innovent Biologics’ IBI363 will be tested against docetaxel in a randomized trial involving roughly 600 patients across the U.S., China, Europe, the UK, Canada, and Japan. The primary endpoint will be overall survival—a gold-standard metric in oncology drug development.

Squamous non-small cell lung cancer remains a difficult-to-treat condition where survival outcomes have stagnated despite the rise of immunotherapy. While agents like pembrolizumab and nivolumab (Opdivo, Bristol Myers Squibb, NYSE: BMY) have transformed outcomes for some patients, a significant cohort experiences resistance, particularly those with PD-L1-low tumors or lacking driver mutations. Historically, the fallback option has been docetaxel, a chemotherapy regimen associated with limited efficacy and considerable toxicity. This clinical vacuum creates an opening for IBI363, which combines PD-1 blockade with a re-engineered IL-2 pathway to enhance T-cell activation in resistant tumor environments.

The FDA has granted IBI363 Fast Track designation, and China’s National Medical Products Administration (NMPA) has similarly awarded Breakthrough Therapy status, underlining the drug’s potential to address an urgent unmet need. Such dual recognition across regulatory regimes is rare and signals strong international momentum behind Innovent’s program.

How does IBI363’s dual mechanism of PD-1 blockade and IL-2 pathway activation differentiate it from existing immunotherapies?

IBI363 is the first clinical-stage PD-1/IL-2α-biased bispecific antibody fusion protein. Its design allows it to both block the PD-1/PD-L1 immune checkpoint and selectively deliver IL-2 stimulation to PD-1-positive T cells. By retaining affinity for IL-2Rα but reducing binding to IL-2Rβ and IL-2Rγ, the drug minimizes systemic toxicity—a common pitfall of traditional IL-2-based therapies—while enhancing tumor-specific immune activation.

This approach positions IBI363 as a potential “best of both worlds” therapy. In early-stage clinical data presented at ASCO 2025, the drug demonstrated responses not only in immunotherapy-resistant lung cancer but also in notoriously cold tumor types such as acral melanoma, mucosal melanoma, and microsatellite stable colorectal cancer. Such breadth of activity suggests a platform potential that could expand well beyond squamous NSCLC into multiple blockbuster-scale markets.

For context, the global PD-1/PD-L1 inhibitor market, led by Merck’s Keytruda, already exceeds $30 billion in annual sales. If IBI363 establishes superiority in resistant patient subgroups, Innovent could carve out a lucrative niche in what is otherwise a highly saturated space.

What historical and sectoral context highlights the significance of Innovent’s global trial strategy?

China-based biopharmaceutical companies have long faced challenges in bringing their home-grown oncology assets to Western markets. Innovent Biologics has already proven adept at overcoming these barriers, having previously partnered with Eli Lilly and Company (NYSE: LLY) for the PD-1 inhibitor sintilimab. However, that asset’s U.S. review ended in a complete response letter in 2022, largely due to FDA concerns about trial generalizability and comparability to global standards.

Learning from that experience, Innovent has now adopted a multi-regional clinical trial model from the outset. The MarsLight-11 program’s global scope reflects a deliberate shift towards true international comparability, a necessity for any company seeking durable competitive positioning in oncology. In doing so, Innovent joins a select group of Chinese biotechs—alongside BeiGene Ltd. (NASDAQ: BGNE) and Zai Lab Ltd. (NASDAQ: ZLAB)—that are now consistently running MRCTs with Western endpoints.

This strategic pivot also reflects broader macro trends. As patent cliffs loom for blockbuster immunotherapies in the late 2020s, global oncology players are accelerating licensing, co-development, and M&A activity to replenish pipelines. Analysts already speculate that assets like IBI363 could become acquisition targets if late-stage data validate their differentiated mechanisms.

What has been the investor sentiment around Innovent Biologics following this regulatory milestone?

Shares of Innovent Biologics (HKEX: 01801) have shown positive momentum in the days leading up to and following the FDA IND clearance. Institutional sentiment has tilted cautiously bullish, with foreign institutional investors (FIIs) increasing their net inflows into the stock in August. Domestic institutional investors (DIIs) have maintained neutral positions, awaiting clarity on trial initiation timelines and early enrollment data. Technical indicators suggest the stock is consolidating above its 50-day moving average, with buy-side analysts flagging potential upside if enrollment proceeds smoothly.

Market watchers interpret the IND approval as a credibility boost for Innovent’s globalization strategy. After the FDA’s rejection of sintilimab in 2022, some investors had questioned whether the company could navigate U.S. regulatory standards. The clearance of IBI363 now appears to answer that skepticism, fueling renewed confidence in Innovent’s ability to deliver globally relevant oncology assets.

That said, buy-side commentary remains cautious, citing risks related to trial competition. Merck’s Keytruda continues to expand label indications aggressively, and Bristol Myers Squibb is also pursuing combination regimens in resistant NSCLC. Analysts have characterized Innovent as a potential challenger brand rather than a category leader, but note that its dual-activation approach is genuinely differentiated. For now, consensus leans towards a “Buy” rating with the caveat that pivotal readouts, expected by 2027, will determine whether IBI363 achieves breakout status or remains a niche play.

How does IBI363 fit within Innovent Biologics’ broader pipeline and global growth ambitions?

Beyond IBI363, Innovent is advancing a pipeline spanning multiple next-generation modalities. This includes bispecific antibody drug conjugates, dual-payload ADCs, and expanded immuno-oncology assets targeting both solid tumors and hematological malignancies. The company has explicitly tied this diversified R&D model to its globalization strategy, signaling an ambition to transform from a domestic Chinese player into a premier multinational biopharmaceutical entity.

Company executives emphasize that IBI363 is not just a scientific milestone but also a commercial and reputational one. Its success could open doors to new licensing agreements and partnerships with U.S. and European drugmakers, particularly those seeking to hedge against patent expirations in immuno-oncology. The global Phase 3 trial is therefore as much about patient benefit as it is about Innovent’s brand positioning on the world stage.

Analysts expect that if IBI363 achieves clinical success, Innovent may seek secondary listings on Western exchanges such as NASDAQ to increase liquidity and broaden investor access. Such a move would mirror BeiGene’s dual-listing strategy, which significantly increased its valuation and visibility among institutional investors.

What does this development mean for the global oncology landscape over the next five years?

The initiation of a global Phase 3 trial for IBI363 marks a broader inflection point in oncology drug development. It underscores the growing role of Chinese innovation in shaping the competitive dynamics of immunotherapy. While Western firms continue to dominate revenue share, the pipeline quality emerging from companies like Innovent is increasingly difficult to ignore.

If IBI363 succeeds in demonstrating superiority to docetaxel in resistant squamous NSCLC, it could become the first bispecific immunotherapy to achieve global approval in this indication. More importantly, it would validate dual-immune activation as a therapeutic paradigm, potentially opening the floodgates for follow-on molecules in the same mechanistic class.

For patients, the implications are profound. Immunotherapy resistance has been one of the most frustrating bottlenecks in oncology. A therapy that can unlock responses in resistant tumors would represent not just an incremental advance but a genuine shift in the treatment landscape. For investors, meanwhile, the drug represents both opportunity and risk—a chance to bet on a differentiated mechanism in a crowded space, but one still subject to the high attrition rates of late-stage oncology development.

Innovent Biologics’ journey with IBI363 exemplifies both the challenges and opportunities facing global biotech today. The FDA IND approval signals not only regulatory progress but also a strategic victory for Innovent’s international ambitions. Whether the company can translate this milestone into a transformative therapy and durable commercial success will depend on trial execution, competitive positioning, and investor confidence. For now, both patients and markets are watching closely as the MarsLight-11 study prepares to enroll its first cohort.